Commentary

During the last 25 years, green tea, which is derived from Camellia sinensis (an evergreen member of the Theaceae family), has gained considerable attention because of its purported antioxidant and anticarcinogenic properties. Believed to have been used by human beings for 4,000 years,¹ green tea is now one of the most heavily researched of the antioxidants, with numerous studies of its cutaneous effects appearing in the literature.² Laden with plant polyphenols, orally administered or topically applied green tea has been shown to display significant antioxidant, chemopreventive, immunomodulatory, and anti-inflammatory activity, affecting the biochemical pathways important in cell proliferation.^3-6 For this reason, and due to its global popularity as a beverage, green tea polyphenols are among the most frequently studied herbal agents used in medicine.

Polyphenols, many of which are potent antioxidants, are a large diverse family of thousands of chemical compounds present in plants. The four major polyphenolic catechins present in green tea include: ECG [(-)EpiCatechin-3-O-Gallate], GCG [(-)GalloCatechin-3-O-Gallate], EGC [(-)EpiGalloCatechin], and EGCG [(-)EpiGalloCatechin-3-O-Gallate], the most abundant and biologically active green tea constituent. In fact, EGCG is the component associated with the greatest anticarcinogenic and chemopreventive properties.⁶

A wide-ranging evidence-based review of the use of botanicals in dermatology, published in 2010, showed that the oral administration, in particular, as well as topical application of antioxidant plant extracts of green tea, among other botanicals, can protect skin against the harmful effects of UV exposure, including erythema, premature aging, and cancer.⁷

Green tea is thought to be challenging to formulate because of the inherent hydrophilicity of EGCG, which limits penetration into human skin.^8,9 Nevertheless, green tea is thought to have great potential in traditional sunscreens to enhance photoprotection.^10,11 The photoprotective activity of orally administered or topically applied green tea has been supported in various studies.^12-15

The remainder of this column will focus on recent studies of topically applied green tea polyphenols in human beings as well as clinical uses of this agent.

Topical uses

Topical green tea appears to reduce skin inflammation and neutralize free radicals, which explains its popularity as an additive in rosacea and antiaging skin care products. The antiaging effects of green tea are difficult to measure because it functions as an antioxidant that prevents aging and does not have the capacity to increase collagen synthesis or ameliorate already existing wrinkles. However, there is relatively good evidence, in comparison to other antioxidants, suggesting that topically applied green tea can help protect skin from UV radiation.¹⁶

Investigators performed a thorough literature search of all in vitro, in vivo, and controlled clinical trials involving green tea formulations and their dermatologic applications, which was published in 2012. They evaluated 20 studies, with evidence suggesting that orally administered green tea displays a broad range of healthy activity, and supportive data for the use of topically applied green tea extract for treatment of various cutaneous conditions, including acne, rosacea, atopic dermatitis, androgenetic alopecia, hirsutism, candidiasis, keloids, leishmaniasis, and genital warts.¹⁷

Also, a green tea topical formulation, green tea sinecatechin Polyphenon E (Veregen) ointment, has recently been shown to exert antioxidant, antiviral, and antitumor activity, and has demonstrated efficacy in treating Condylomata acuminata (external anogenital warts).¹⁸ In addition, topically applying green tea catechins in the morning in combination with traditional sunscreens is believed to have the potential to protect the skin from UV-induced damage. Topical green tea may improve rosacea, prevent retinoid dermatitis, and play a role in managing pigmentation disorders. Few of the many over-the-counter products that contain green tea catechins have been tested in controlled clinical trials and the concentration of polyphenols in these products is too low to demonstrate efficacy. It is necessary to know the amount of green tea catechins in a formulation to judge its efficacy.

Acne

In 2009, in a 6-week study investigating the efficacy of 2% green tea lotion for the treatment of mild-to-moderate acne vulgaris in 20 patients, researchers reported statistically significant reductions in mean total lesion count and mean severity index (devised by the authors to correlate with total lesion count in increasing intensity, scaled from 1 to 3). They concluded that 2% green tea lotion is both an effective and cost effective approach for treating mild-to-moderate acne lesions.¹⁹

A 2012 study revealed that ethanol extracts of several herbs, including green tea, exhibited the potential for inhibiting acne when incorporated into a topical moisturizer, specifically acting against acne-causing bacteria without provoking irritation.²⁰ Earlier that year, other investigators conducted in vitro and in vivo experiments to evaluate the effects against acne of polyphenon-60, which contains various green tea catechins (now referred to as sinecatechins in the United States.).²¹ In this clinical study, patients exhibited improvement in acne symptoms, including a reduction in the number of pustules and comedones.²²

A study published in 2013, a single-blind, placebo-controlled, split-face comparative study in 22 individuals over 60 days, evaluated the efficacy of green tea, as well as green tea plus lotus, compared with placebo for controlling casual sebum secretions in healthy adults. Compared with placebo, consistent and statistically significant decreases in sebum secretions were observed in both treatment groups. The combination of green tea and lotus extracts also achieved statistically sounder results than green tea alone. The investigators concluded that a synergistic interaction between green tea and lotus extract constituents appears to hold promise for the treatment of skin conditions in which elevated sebum levels are involved.²³

Anogenital warts

In 2006, the Food and Drug Administration approved for the first time a botanical drug formulation for the topical treatment of genital and perianal warts: sinecatechins, derived from green tea catechins and other C. sinensis constituents in a topical 15% ointment (Veregen).^{21, 24-28}

Two years later, Tatti et al. conducted a randomized, double-blind, vehicle-controlled trial to evaluate the efficacy of topical sinecatechins in 502 male and female patients (aged 18 years and older) for the treatment of anogenital warts. For 16 weeks or until complete clearance, subjects applied sinecatechins ointment 15% or 10% or vehicle (placebo) three times daily. Complete clearance was achieved in 57.2% of patients treated with 15% ointment, 56.3% using 10% ointment, and 33.7% who used only the vehicle. Respective recurrence rates, after 12 weeks, were 6.5%, 8.3%, and 8.8%. The investigators concluded that topical sinecatechins in 15% and 10% concentrations represent effective and well-tolerated options for anogenital wart treatment.²⁹

Similarly favorable results regarding polyphenon E 15% were reported in reference to three placebo-controlled clinical studies in 1,400 patients with genital warts from Europe, North and South America, and South Africa,^30,31 and by Tatti et al. again in 2010 after randomized, double-blind, vehicle-controlled safety and efficacy trials in nearly 1,000 patients treated with polyphenon E 15% and 10% formulations.²¹

Two years later, investigators evaluated sinecatechins (Polyphenon E) 10% ointment in two double-blind, multinational studies in adults with external genital and perianal warts. Polyphenon E 10% was found to be significantly more effective than vehicle in completely or partially clearing all warts.³²

Earlier that year, a review of the use of sinecatechins ointment for the treatment of external anogenital warts noted that while clearance rates are similar among sinecatechins and other indicated topical medications such as imiquimod and podophyllotoxin, recurrence rates are lower for patients treated with sinecatechins. The authors concluded that the use of sinecatechins for condylomata acuminata was safe and effective and its various molecular activities suggest broader applications to other viral and tumor lesions.³³

In 2015, Gupta and Daigle reported that sinecatechins 10% ointment for the treatment of external genital warts was found in phase III trials to display greater efficacy and lower rates of recurrence in comparison to patient-applied treatments now available.²⁸ Later that year, in a systematic PubMed and Embase review of clinical trials involving the use of polyphenol-based therapies, Tuong et al. identified cogent evidence suggesting the effectiveness of green tea polyphenols for the treatment of anogenital warts.³⁴

Antiaging activity

Green tea has been shown to work in combination with red light to exert a rejuvenating effect on the skin, as Sommer and Zhu reported in 2009 that green tea filled cotton pads applied once daily for 20 minutes prior to treatment with light-emitting diodes (central wavelength 670 nm, dermal dose 4 J/cm²) reduced wrinkles in 1 month comparably to 10 months of light treatment alone.³⁵

In 2013, Hong et al. studied the antiwrinkle effects of topically applied green tea extract with high antioxidant activity after tannase treatment. Study participants were randomly divided to receive either green tea extract or tannase-converted green tea extract on their crow’s feet for an 8-week period. The investigators found that tannase treatment elevated the antioxidant activity of green tea and imparted antiwrinkle effects.³⁶

At around the same time, Gianeti conducted clinical studies in 24 volunteers to assess the effects of a cosmetic formulation containing 6% C. sinensis glycolic leaf extracts. Skin moisture was enhanced after 30 days of topical application as was the viscoelastic-to-elastic ratio compared with vehicle and control (a forearm area left untreated). Skin roughness was significantly diminished after 30 days. The investigators concluded that the topical cosmetic formulation with green tea yielded salient moisturizing and cutaneous microrelief benefits.³⁷

Also in 2013, oral intake of green tea catechins in 16 healthy human subjects (with 14 completing the study) appeared to result in the integration of catechin metabolites into human skin linked to the negation of UV-induced 12-hydroxyeicosatetraenoic acid (12-HETE). The investigators speculated that this incorporation of catechins may render protection against sunburn inflammation and even cumulative UV-induced harm.³⁸

After earlier showing the efficacy of green tea and lotus extracts in skin disorders involving excess sebum in a single-blinded, placebo-controlled, split-face comparative study,²³ Mahmood and Akhtar conducted a 60-day placebo-controlled comparative split-face study in 33 healthy Asian men to evaluate the efficacy of two cosmetic formulations (green tea and lotus extract) for facial wrinkles. All of the formulations yielded improvements in skin roughness, scaliness, smoothness, and wrinkling, with the greatest reduction in wrinkling conferred by the combination formulation. The investigators concluded that the synergistic activity of green tea and lotus extracts exerted significant improvement along several skin parameters, suggesting the potential for these ingredients in antiaging products.³⁸

In 2014, the synergistic effects of green tea and ginkgo biloba were explored in preclinical and clinical studies. In the clinical study, 48 participants applied the formulations on forearm skin and were evaluated before and after 3 hours and following 15- and 30-day use periods. Results showed a moisturizing effect and enhancement in skin microrelief, as well as improvements in skin elasticity and barrier function.³

Conclusion

Green tea remains one of the most researched antioxidants as benefits from its use continue to emerge. Indeed, green tea polyphenols are in use for a growing number of indications, especially acne and anogenital warts, and there is reason for optimism that topically applied green tea will gain momentum as an increasingly selected therapeutic option. More clinical studies are necessary to further establish the potential role of green tea for a wider range of cutaneous indications. Green tea holds particular promise in relation to photoprotection against UV-induced skin cancer and skin aging.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin typing systems and related products

References:

1. Cancer Lett. 1997 Mar 19;114(1-2):315-7.

2. J Am Acad Dermatol. 2005 Jun;52(6):1049-59.

3. Arch Dermatol. 2000 Aug;136(8):989-94.

4. Photochem Photobiol. 1995 Nov;62(5):855-61.

5. Oxid Med Cell Longev. 2012:2012:560682.

6. J Dtsch Dermatol Ges. 2015 Aug;13(8):768-75.

7. Am J Clin Dermatol. 2010;11(4):247-67.

8. Dermatol Ther. 2007 Sep-Oct;20(5):322-9.

9. J Clin Aesthet Dermatol. 2010 Feb;3(2):22-41.

10. Photodermatol Photoimmunol Photomed. 2007 Feb;23(1):48-56.

11. Skin Res Technol. 2009 Aug;15(3):338-45.

12. Exp Dermatol. 2009 Jan;18(1):69-77.

13. Exp Dermatol. 2009 Jun;18(6):522-6.

14. Arch Biochem Biophys. 2011 Apr 15;508(2):152-8.

15. Cancer Prev Res (Phila). 2010 Feb;3(2):179-89.

16. Complement Ther Clin Pract. 2014 Feb;20(1):11-5.

17. Skinmed. 2012 Nov-Dec;10(6):352-5.

18. J Eur Acad Dermatol Venereol. 2011 Mar;25(3):345-53.

19. J Drugs Dermatol. 2009 Apr;8(4):358-64.

20. Pak J Pharm Sci. 2012 Oct;25(4):867-70.

21. Br J Dermatol. 2010 Jan;162(1):176-84.

22. Arch Dermatol Res. 2012 Oct;304(8):655-63.

23. Hippokratia. 2013 Jan;17(1):64-7.

24. Food Chem Toxicol. 2008 Aug;46(8):2606-10.

25. Nat Biotechnol. 2008 Oct;26(10):1077-83.

26. Skin Therapy Lett. 2012 Apr;17(4):5-7.

27. J Clin Aesthet Dermatol. 2012 Jan;5(1):19-26.

28. Skin Therapy Lett. 2015 Jan-Feb;20(1):6-8.

29. Obstet Gynecol. 2008 Jun;111(6):1371-9.

30. Hautarzt. 2008 Jan;59(1):31-5.

31. J Eur Acad Dermatol Venereol. 2007 Nov;21(10):1404-12.

32. Am J Clin Dermatol. 2012 Aug 1:13(4):275-81.

33. Expert Opin Biol Ther. 2012 Jun;12(6):783-93.

34. J Dermatolog Treat. 2015;26(4):381-8.

35. Photomed Laser Surg. 2009 Dec;27(6):969-71.

36. J Cosmet Dermatol. 2013 Jun;12(2):137-43.

37. Dermatol Ther. 2013 May-Jun;26(3):267-71.

38. Rejuvenation Res. 2013 Apr;16(2):91-7.

39. J Drugs Dermatol. 2014 Sep;13(9):1092-7.

During the last 25 years, green tea, which is derived from Camellia sinensis (an evergreen member of the Theaceae family), has gained considerable attention because of its purported antioxidant and anticarcinogenic properties. Believed to have been used by human beings for 4,000 years,¹ green tea is now one of the most heavily researched of the antioxidants, with numerous studies of its cutaneous effects appearing in the literature.² Laden with plant polyphenols, orally administered or topically applied green tea has been shown to display significant antioxidant, chemopreventive, immunomodulatory, and anti-inflammatory activity, affecting the biochemical pathways important in cell proliferation.^3-6 For this reason, and due to its global popularity as a beverage, green tea polyphenols are among the most frequently studied herbal agents used in medicine.

Polyphenols, many of which are potent antioxidants, are a large diverse family of thousands of chemical compounds present in plants. The four major polyphenolic catechins present in green tea include: ECG [(-)EpiCatechin-3-O-Gallate], GCG [(-)GalloCatechin-3-O-Gallate], EGC [(-)EpiGalloCatechin], and EGCG [(-)EpiGalloCatechin-3-O-Gallate], the most abundant and biologically active green tea constituent. In fact, EGCG is the component associated with the greatest anticarcinogenic and chemopreventive properties.⁶

A wide-ranging evidence-based review of the use of botanicals in dermatology, published in 2010, showed that the oral administration, in particular, as well as topical application of antioxidant plant extracts of green tea, among other botanicals, can protect skin against the harmful effects of UV exposure, including erythema, premature aging, and cancer.⁷

Green tea is thought to be challenging to formulate because of the inherent hydrophilicity of EGCG, which limits penetration into human skin.^8,9 Nevertheless, green tea is thought to have great potential in traditional sunscreens to enhance photoprotection.^10,11 The photoprotective activity of orally administered or topically applied green tea has been supported in various studies.^12-15

The remainder of this column will focus on recent studies of topically applied green tea polyphenols in human beings as well as clinical uses of this agent.

Topical uses

Topical green tea appears to reduce skin inflammation and neutralize free radicals, which explains its popularity as an additive in rosacea and antiaging skin care products. The antiaging effects of green tea are difficult to measure because it functions as an antioxidant that prevents aging and does not have the capacity to increase collagen synthesis or ameliorate already existing wrinkles. However, there is relatively good evidence, in comparison to other antioxidants, suggesting that topically applied green tea can help protect skin from UV radiation.¹⁶

Investigators performed a thorough literature search of all in vitro, in vivo, and controlled clinical trials involving green tea formulations and their dermatologic applications, which was published in 2012. They evaluated 20 studies, with evidence suggesting that orally administered green tea displays a broad range of healthy activity, and supportive data for the use of topically applied green tea extract for treatment of various cutaneous conditions, including acne, rosacea, atopic dermatitis, androgenetic alopecia, hirsutism, candidiasis, keloids, leishmaniasis, and genital warts.¹⁷

Also, a green tea topical formulation, green tea sinecatechin Polyphenon E (Veregen) ointment, has recently been shown to exert antioxidant, antiviral, and antitumor activity, and has demonstrated efficacy in treating Condylomata acuminata (external anogenital warts).¹⁸ In addition, topically applying green tea catechins in the morning in combination with traditional sunscreens is believed to have the potential to protect the skin from UV-induced damage. Topical green tea may improve rosacea, prevent retinoid dermatitis, and play a role in managing pigmentation disorders. Few of the many over-the-counter products that contain green tea catechins have been tested in controlled clinical trials and the concentration of polyphenols in these products is too low to demonstrate efficacy. It is necessary to know the amount of green tea catechins in a formulation to judge its efficacy.

Acne

In 2009, in a 6-week study investigating the efficacy of 2% green tea lotion for the treatment of mild-to-moderate acne vulgaris in 20 patients, researchers reported statistically significant reductions in mean total lesion count and mean severity index (devised by the authors to correlate with total lesion count in increasing intensity, scaled from 1 to 3). They concluded that 2% green tea lotion is both an effective and cost effective approach for treating mild-to-moderate acne lesions.¹⁹

A 2012 study revealed that ethanol extracts of several herbs, including green tea, exhibited the potential for inhibiting acne when incorporated into a topical moisturizer, specifically acting against acne-causing bacteria without provoking irritation.²⁰ Earlier that year, other investigators conducted in vitro and in vivo experiments to evaluate the effects against acne of polyphenon-60, which contains various green tea catechins (now referred to as sinecatechins in the United States.).²¹ In this clinical study, patients exhibited improvement in acne symptoms, including a reduction in the number of pustules and comedones.²²

A study published in 2013, a single-blind, placebo-controlled, split-face comparative study in 22 individuals over 60 days, evaluated the efficacy of green tea, as well as green tea plus lotus, compared with placebo for controlling casual sebum secretions in healthy adults. Compared with placebo, consistent and statistically significant decreases in sebum secretions were observed in both treatment groups. The combination of green tea and lotus extracts also achieved statistically sounder results than green tea alone. The investigators concluded that a synergistic interaction between green tea and lotus extract constituents appears to hold promise for the treatment of skin conditions in which elevated sebum levels are involved.²³

Anogenital warts

In 2006, the Food and Drug Administration approved for the first time a botanical drug formulation for the topical treatment of genital and perianal warts: sinecatechins, derived from green tea catechins and other C. sinensis constituents in a topical 15% ointment (Veregen).^{21, 24-28}

Two years later, Tatti et al. conducted a randomized, double-blind, vehicle-controlled trial to evaluate the efficacy of topical sinecatechins in 502 male and female patients (aged 18 years and older) for the treatment of anogenital warts. For 16 weeks or until complete clearance, subjects applied sinecatechins ointment 15% or 10% or vehicle (placebo) three times daily. Complete clearance was achieved in 57.2% of patients treated with 15% ointment, 56.3% using 10% ointment, and 33.7% who used only the vehicle. Respective recurrence rates, after 12 weeks, were 6.5%, 8.3%, and 8.8%. The investigators concluded that topical sinecatechins in 15% and 10% concentrations represent effective and well-tolerated options for anogenital wart treatment.²⁹

Similarly favorable results regarding polyphenon E 15% were reported in reference to three placebo-controlled clinical studies in 1,400 patients with genital warts from Europe, North and South America, and South Africa,^30,31 and by Tatti et al. again in 2010 after randomized, double-blind, vehicle-controlled safety and efficacy trials in nearly 1,000 patients treated with polyphenon E 15% and 10% formulations.²¹

Two years later, investigators evaluated sinecatechins (Polyphenon E) 10% ointment in two double-blind, multinational studies in adults with external genital and perianal warts. Polyphenon E 10% was found to be significantly more effective than vehicle in completely or partially clearing all warts.³²

Earlier that year, a review of the use of sinecatechins ointment for the treatment of external anogenital warts noted that while clearance rates are similar among sinecatechins and other indicated topical medications such as imiquimod and podophyllotoxin, recurrence rates are lower for patients treated with sinecatechins. The authors concluded that the use of sinecatechins for condylomata acuminata was safe and effective and its various molecular activities suggest broader applications to other viral and tumor lesions.³³

In 2015, Gupta and Daigle reported that sinecatechins 10% ointment for the treatment of external genital warts was found in phase III trials to display greater efficacy and lower rates of recurrence in comparison to patient-applied treatments now available.²⁸ Later that year, in a systematic PubMed and Embase review of clinical trials involving the use of polyphenol-based therapies, Tuong et al. identified cogent evidence suggesting the effectiveness of green tea polyphenols for the treatment of anogenital warts.³⁴

Antiaging activity

Green tea has been shown to work in combination with red light to exert a rejuvenating effect on the skin, as Sommer and Zhu reported in 2009 that green tea filled cotton pads applied once daily for 20 minutes prior to treatment with light-emitting diodes (central wavelength 670 nm, dermal dose 4 J/cm²) reduced wrinkles in 1 month comparably to 10 months of light treatment alone.³⁵

In 2013, Hong et al. studied the antiwrinkle effects of topically applied green tea extract with high antioxidant activity after tannase treatment. Study participants were randomly divided to receive either green tea extract or tannase-converted green tea extract on their crow’s feet for an 8-week period. The investigators found that tannase treatment elevated the antioxidant activity of green tea and imparted antiwrinkle effects.³⁶

At around the same time, Gianeti conducted clinical studies in 24 volunteers to assess the effects of a cosmetic formulation containing 6% C. sinensis glycolic leaf extracts. Skin moisture was enhanced after 30 days of topical application as was the viscoelastic-to-elastic ratio compared with vehicle and control (a forearm area left untreated). Skin roughness was significantly diminished after 30 days. The investigators concluded that the topical cosmetic formulation with green tea yielded salient moisturizing and cutaneous microrelief benefits.³⁷

Also in 2013, oral intake of green tea catechins in 16 healthy human subjects (with 14 completing the study) appeared to result in the integration of catechin metabolites into human skin linked to the negation of UV-induced 12-hydroxyeicosatetraenoic acid (12-HETE). The investigators speculated that this incorporation of catechins may render protection against sunburn inflammation and even cumulative UV-induced harm.³⁸

After earlier showing the efficacy of green tea and lotus extracts in skin disorders involving excess sebum in a single-blinded, placebo-controlled, split-face comparative study,²³ Mahmood and Akhtar conducted a 60-day placebo-controlled comparative split-face study in 33 healthy Asian men to evaluate the efficacy of two cosmetic formulations (green tea and lotus extract) for facial wrinkles. All of the formulations yielded improvements in skin roughness, scaliness, smoothness, and wrinkling, with the greatest reduction in wrinkling conferred by the combination formulation. The investigators concluded that the synergistic activity of green tea and lotus extracts exerted significant improvement along several skin parameters, suggesting the potential for these ingredients in antiaging products.³⁸

In 2014, the synergistic effects of green tea and ginkgo biloba were explored in preclinical and clinical studies. In the clinical study, 48 participants applied the formulations on forearm skin and were evaluated before and after 3 hours and following 15- and 30-day use periods. Results showed a moisturizing effect and enhancement in skin microrelief, as well as improvements in skin elasticity and barrier function.³

Conclusion

Green tea remains one of the most researched antioxidants as benefits from its use continue to emerge. Indeed, green tea polyphenols are in use for a growing number of indications, especially acne and anogenital warts, and there is reason for optimism that topically applied green tea will gain momentum as an increasingly selected therapeutic option. More clinical studies are necessary to further establish the potential role of green tea for a wider range of cutaneous indications. Green tea holds particular promise in relation to photoprotection against UV-induced skin cancer and skin aging.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin typing systems and related products

References:

1. Cancer Lett. 1997 Mar 19;114(1-2):315-7.

2. J Am Acad Dermatol. 2005 Jun;52(6):1049-59.

3. Arch Dermatol. 2000 Aug;136(8):989-94.

4. Photochem Photobiol. 1995 Nov;62(5):855-61.

5. Oxid Med Cell Longev. 2012:2012:560682.

6. J Dtsch Dermatol Ges. 2015 Aug;13(8):768-75.

7. Am J Clin Dermatol. 2010;11(4):247-67.

8. Dermatol Ther. 2007 Sep-Oct;20(5):322-9.

9. J Clin Aesthet Dermatol. 2010 Feb;3(2):22-41.

10. Photodermatol Photoimmunol Photomed. 2007 Feb;23(1):48-56.

11. Skin Res Technol. 2009 Aug;15(3):338-45.

12. Exp Dermatol. 2009 Jan;18(1):69-77.

13. Exp Dermatol. 2009 Jun;18(6):522-6.

14. Arch Biochem Biophys. 2011 Apr 15;508(2):152-8.

15. Cancer Prev Res (Phila). 2010 Feb;3(2):179-89.

16. Complement Ther Clin Pract. 2014 Feb;20(1):11-5.

17. Skinmed. 2012 Nov-Dec;10(6):352-5.

18. J Eur Acad Dermatol Venereol. 2011 Mar;25(3):345-53.

19. J Drugs Dermatol. 2009 Apr;8(4):358-64.

20. Pak J Pharm Sci. 2012 Oct;25(4):867-70.

21. Br J Dermatol. 2010 Jan;162(1):176-84.

22. Arch Dermatol Res. 2012 Oct;304(8):655-63.

23. Hippokratia. 2013 Jan;17(1):64-7.

24. Food Chem Toxicol. 2008 Aug;46(8):2606-10.

25. Nat Biotechnol. 2008 Oct;26(10):1077-83.

26. Skin Therapy Lett. 2012 Apr;17(4):5-7.

27. J Clin Aesthet Dermatol. 2012 Jan;5(1):19-26.

28. Skin Therapy Lett. 2015 Jan-Feb;20(1):6-8.

29. Obstet Gynecol. 2008 Jun;111(6):1371-9.

30. Hautarzt. 2008 Jan;59(1):31-5.

31. J Eur Acad Dermatol Venereol. 2007 Nov;21(10):1404-12.

32. Am J Clin Dermatol. 2012 Aug 1:13(4):275-81.

33. Expert Opin Biol Ther. 2012 Jun;12(6):783-93.

34. J Dermatolog Treat. 2015;26(4):381-8.

35. Photomed Laser Surg. 2009 Dec;27(6):969-71.

36. J Cosmet Dermatol. 2013 Jun;12(2):137-43.

37. Dermatol Ther. 2013 May-Jun;26(3):267-71.

38. Rejuvenation Res. 2013 Apr;16(2):91-7.

39. J Drugs Dermatol. 2014 Sep;13(9):1092-7.

During the last 25 years, green tea, which is derived from Camellia sinensis (an evergreen member of the Theaceae family), has gained considerable attention because of its purported antioxidant and anticarcinogenic properties. Believed to have been used by human beings for 4,000 years,¹ green tea is now one of the most heavily researched of the antioxidants, with numerous studies of its cutaneous effects appearing in the literature.² Laden with plant polyphenols, orally administered or topically applied green tea has been shown to display significant antioxidant, chemopreventive, immunomodulatory, and anti-inflammatory activity, affecting the biochemical pathways important in cell proliferation.^3-6 For this reason, and due to its global popularity as a beverage, green tea polyphenols are among the most frequently studied herbal agents used in medicine.

Polyphenols, many of which are potent antioxidants, are a large diverse family of thousands of chemical compounds present in plants. The four major polyphenolic catechins present in green tea include: ECG [(-)EpiCatechin-3-O-Gallate], GCG [(-)GalloCatechin-3-O-Gallate], EGC [(-)EpiGalloCatechin], and EGCG [(-)EpiGalloCatechin-3-O-Gallate], the most abundant and biologically active green tea constituent. In fact, EGCG is the component associated with the greatest anticarcinogenic and chemopreventive properties.⁶

A wide-ranging evidence-based review of the use of botanicals in dermatology, published in 2010, showed that the oral administration, in particular, as well as topical application of antioxidant plant extracts of green tea, among other botanicals, can protect skin against the harmful effects of UV exposure, including erythema, premature aging, and cancer.⁷

Green tea is thought to be challenging to formulate because of the inherent hydrophilicity of EGCG, which limits penetration into human skin.^8,9 Nevertheless, green tea is thought to have great potential in traditional sunscreens to enhance photoprotection.^10,11 The photoprotective activity of orally administered or topically applied green tea has been supported in various studies.^12-15

The remainder of this column will focus on recent studies of topically applied green tea polyphenols in human beings as well as clinical uses of this agent.

Topical uses

Topical green tea appears to reduce skin inflammation and neutralize free radicals, which explains its popularity as an additive in rosacea and antiaging skin care products. The antiaging effects of green tea are difficult to measure because it functions as an antioxidant that prevents aging and does not have the capacity to increase collagen synthesis or ameliorate already existing wrinkles. However, there is relatively good evidence, in comparison to other antioxidants, suggesting that topically applied green tea can help protect skin from UV radiation.¹⁶

Investigators performed a thorough literature search of all in vitro, in vivo, and controlled clinical trials involving green tea formulations and their dermatologic applications, which was published in 2012. They evaluated 20 studies, with evidence suggesting that orally administered green tea displays a broad range of healthy activity, and supportive data for the use of topically applied green tea extract for treatment of various cutaneous conditions, including acne, rosacea, atopic dermatitis, androgenetic alopecia, hirsutism, candidiasis, keloids, leishmaniasis, and genital warts.¹⁷

Also, a green tea topical formulation, green tea sinecatechin Polyphenon E (Veregen) ointment, has recently been shown to exert antioxidant, antiviral, and antitumor activity, and has demonstrated efficacy in treating Condylomata acuminata (external anogenital warts).¹⁸ In addition, topically applying green tea catechins in the morning in combination with traditional sunscreens is believed to have the potential to protect the skin from UV-induced damage. Topical green tea may improve rosacea, prevent retinoid dermatitis, and play a role in managing pigmentation disorders. Few of the many over-the-counter products that contain green tea catechins have been tested in controlled clinical trials and the concentration of polyphenols in these products is too low to demonstrate efficacy. It is necessary to know the amount of green tea catechins in a formulation to judge its efficacy.

Acne

In 2009, in a 6-week study investigating the efficacy of 2% green tea lotion for the treatment of mild-to-moderate acne vulgaris in 20 patients, researchers reported statistically significant reductions in mean total lesion count and mean severity index (devised by the authors to correlate with total lesion count in increasing intensity, scaled from 1 to 3). They concluded that 2% green tea lotion is both an effective and cost effective approach for treating mild-to-moderate acne lesions.¹⁹

A 2012 study revealed that ethanol extracts of several herbs, including green tea, exhibited the potential for inhibiting acne when incorporated into a topical moisturizer, specifically acting against acne-causing bacteria without provoking irritation.²⁰ Earlier that year, other investigators conducted in vitro and in vivo experiments to evaluate the effects against acne of polyphenon-60, which contains various green tea catechins (now referred to as sinecatechins in the United States.).²¹ In this clinical study, patients exhibited improvement in acne symptoms, including a reduction in the number of pustules and comedones.²²

A study published in 2013, a single-blind, placebo-controlled, split-face comparative study in 22 individuals over 60 days, evaluated the efficacy of green tea, as well as green tea plus lotus, compared with placebo for controlling casual sebum secretions in healthy adults. Compared with placebo, consistent and statistically significant decreases in sebum secretions were observed in both treatment groups. The combination of green tea and lotus extracts also achieved statistically sounder results than green tea alone. The investigators concluded that a synergistic interaction between green tea and lotus extract constituents appears to hold promise for the treatment of skin conditions in which elevated sebum levels are involved.²³

Anogenital warts

In 2006, the Food and Drug Administration approved for the first time a botanical drug formulation for the topical treatment of genital and perianal warts: sinecatechins, derived from green tea catechins and other C. sinensis constituents in a topical 15% ointment (Veregen).^{21, 24-28}

Two years later, Tatti et al. conducted a randomized, double-blind, vehicle-controlled trial to evaluate the efficacy of topical sinecatechins in 502 male and female patients (aged 18 years and older) for the treatment of anogenital warts. For 16 weeks or until complete clearance, subjects applied sinecatechins ointment 15% or 10% or vehicle (placebo) three times daily. Complete clearance was achieved in 57.2% of patients treated with 15% ointment, 56.3% using 10% ointment, and 33.7% who used only the vehicle. Respective recurrence rates, after 12 weeks, were 6.5%, 8.3%, and 8.8%. The investigators concluded that topical sinecatechins in 15% and 10% concentrations represent effective and well-tolerated options for anogenital wart treatment.²⁹

Similarly favorable results regarding polyphenon E 15% were reported in reference to three placebo-controlled clinical studies in 1,400 patients with genital warts from Europe, North and South America, and South Africa,^30,31 and by Tatti et al. again in 2010 after randomized, double-blind, vehicle-controlled safety and efficacy trials in nearly 1,000 patients treated with polyphenon E 15% and 10% formulations.²¹

Two years later, investigators evaluated sinecatechins (Polyphenon E) 10% ointment in two double-blind, multinational studies in adults with external genital and perianal warts. Polyphenon E 10% was found to be significantly more effective than vehicle in completely or partially clearing all warts.³²

Earlier that year, a review of the use of sinecatechins ointment for the treatment of external anogenital warts noted that while clearance rates are similar among sinecatechins and other indicated topical medications such as imiquimod and podophyllotoxin, recurrence rates are lower for patients treated with sinecatechins. The authors concluded that the use of sinecatechins for condylomata acuminata was safe and effective and its various molecular activities suggest broader applications to other viral and tumor lesions.³³

In 2015, Gupta and Daigle reported that sinecatechins 10% ointment for the treatment of external genital warts was found in phase III trials to display greater efficacy and lower rates of recurrence in comparison to patient-applied treatments now available.²⁸ Later that year, in a systematic PubMed and Embase review of clinical trials involving the use of polyphenol-based therapies, Tuong et al. identified cogent evidence suggesting the effectiveness of green tea polyphenols for the treatment of anogenital warts.³⁴

Antiaging activity

Green tea has been shown to work in combination with red light to exert a rejuvenating effect on the skin, as Sommer and Zhu reported in 2009 that green tea filled cotton pads applied once daily for 20 minutes prior to treatment with light-emitting diodes (central wavelength 670 nm, dermal dose 4 J/cm²) reduced wrinkles in 1 month comparably to 10 months of light treatment alone.³⁵

In 2013, Hong et al. studied the antiwrinkle effects of topically applied green tea extract with high antioxidant activity after tannase treatment. Study participants were randomly divided to receive either green tea extract or tannase-converted green tea extract on their crow’s feet for an 8-week period. The investigators found that tannase treatment elevated the antioxidant activity of green tea and imparted antiwrinkle effects.³⁶

At around the same time, Gianeti conducted clinical studies in 24 volunteers to assess the effects of a cosmetic formulation containing 6% C. sinensis glycolic leaf extracts. Skin moisture was enhanced after 30 days of topical application as was the viscoelastic-to-elastic ratio compared with vehicle and control (a forearm area left untreated). Skin roughness was significantly diminished after 30 days. The investigators concluded that the topical cosmetic formulation with green tea yielded salient moisturizing and cutaneous microrelief benefits.³⁷

Also in 2013, oral intake of green tea catechins in 16 healthy human subjects (with 14 completing the study) appeared to result in the integration of catechin metabolites into human skin linked to the negation of UV-induced 12-hydroxyeicosatetraenoic acid (12-HETE). The investigators speculated that this incorporation of catechins may render protection against sunburn inflammation and even cumulative UV-induced harm.³⁸

After earlier showing the efficacy of green tea and lotus extracts in skin disorders involving excess sebum in a single-blinded, placebo-controlled, split-face comparative study,²³ Mahmood and Akhtar conducted a 60-day placebo-controlled comparative split-face study in 33 healthy Asian men to evaluate the efficacy of two cosmetic formulations (green tea and lotus extract) for facial wrinkles. All of the formulations yielded improvements in skin roughness, scaliness, smoothness, and wrinkling, with the greatest reduction in wrinkling conferred by the combination formulation. The investigators concluded that the synergistic activity of green tea and lotus extracts exerted significant improvement along several skin parameters, suggesting the potential for these ingredients in antiaging products.³⁸

In 2014, the synergistic effects of green tea and ginkgo biloba were explored in preclinical and clinical studies. In the clinical study, 48 participants applied the formulations on forearm skin and were evaluated before and after 3 hours and following 15- and 30-day use periods. Results showed a moisturizing effect and enhancement in skin microrelief, as well as improvements in skin elasticity and barrier function.³

Conclusion

Green tea remains one of the most researched antioxidants as benefits from its use continue to emerge. Indeed, green tea polyphenols are in use for a growing number of indications, especially acne and anogenital warts, and there is reason for optimism that topically applied green tea will gain momentum as an increasingly selected therapeutic option. More clinical studies are necessary to further establish the potential role of green tea for a wider range of cutaneous indications. Green tea holds particular promise in relation to photoprotection against UV-induced skin cancer and skin aging.

Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin typing systems and related products

References:

1. Cancer Lett. 1997 Mar 19;114(1-2):315-7.

2. J Am Acad Dermatol. 2005 Jun;52(6):1049-59.

3. Arch Dermatol. 2000 Aug;136(8):989-94.

4. Photochem Photobiol. 1995 Nov;62(5):855-61.

5. Oxid Med Cell Longev. 2012:2012:560682.

6. J Dtsch Dermatol Ges. 2015 Aug;13(8):768-75.

7. Am J Clin Dermatol. 2010;11(4):247-67.

8. Dermatol Ther. 2007 Sep-Oct;20(5):322-9.

9. J Clin Aesthet Dermatol. 2010 Feb;3(2):22-41.

10. Photodermatol Photoimmunol Photomed. 2007 Feb;23(1):48-56.

11. Skin Res Technol. 2009 Aug;15(3):338-45.

12. Exp Dermatol. 2009 Jan;18(1):69-77.

13. Exp Dermatol. 2009 Jun;18(6):522-6.

14. Arch Biochem Biophys. 2011 Apr 15;508(2):152-8.

15. Cancer Prev Res (Phila). 2010 Feb;3(2):179-89.

16. Complement Ther Clin Pract. 2014 Feb;20(1):11-5.

17. Skinmed. 2012 Nov-Dec;10(6):352-5.

18. J Eur Acad Dermatol Venereol. 2011 Mar;25(3):345-53.

19. J Drugs Dermatol. 2009 Apr;8(4):358-64.

20. Pak J Pharm Sci. 2012 Oct;25(4):867-70.

21. Br J Dermatol. 2010 Jan;162(1):176-84.

22. Arch Dermatol Res. 2012 Oct;304(8):655-63.

23. Hippokratia. 2013 Jan;17(1):64-7.

24. Food Chem Toxicol. 2008 Aug;46(8):2606-10.

25. Nat Biotechnol. 2008 Oct;26(10):1077-83.

26. Skin Therapy Lett. 2012 Apr;17(4):5-7.

27. J Clin Aesthet Dermatol. 2012 Jan;5(1):19-26.

28. Skin Therapy Lett. 2015 Jan-Feb;20(1):6-8.

29. Obstet Gynecol. 2008 Jun;111(6):1371-9.

30. Hautarzt. 2008 Jan;59(1):31-5.

31. J Eur Acad Dermatol Venereol. 2007 Nov;21(10):1404-12.

32. Am J Clin Dermatol. 2012 Aug 1:13(4):275-81.

33. Expert Opin Biol Ther. 2012 Jun;12(6):783-93.

34. J Dermatolog Treat. 2015;26(4):381-8.

35. Photomed Laser Surg. 2009 Dec;27(6):969-71.

36. J Cosmet Dermatol. 2013 Jun;12(2):137-43.

37. Dermatol Ther. 2013 May-Jun;26(3):267-71.

38. Rejuvenation Res. 2013 Apr;16(2):91-7.

39. J Drugs Dermatol. 2014 Sep;13(9):1092-7.

I have learned a few things in my almost half-century of hurtling through space with all of you on this fragile blue-green rock. My most recent enlightenment is that the universe has a way of flipping our certitude on its head. Mental acrobatics requires flexibility, requiring us to bend so we don’t break.

On July 1, Minnesota began allowing clinicians to certify patients for “intractable pain” as a qualifying condition for the Minnesota Medical Cannabis Program. Recall that medical marijuana is a Schedule I drug, and we cannot prescribe it. These programs are set up in such a way that the only role a clinician plays is to certify patients with qualifying conditions. This allows a patient to pay a registration fee and visit a cannabis patient center, where a pharmacist will recommend cannabis dose and type.

Months before this, I was waxing professorial about our lack of certainty about dosing and efficacy of medical marijuana. Then I met a 30-year-old with chronic back pain.

She had been evaluated by every subspecialist. This patient was taking and failing supertherapeutic doses of NSAIDs, acetaminophen, and gabapentin. No more surgical options existed. She had been removed from opioid contracts for aberrant behavior. She had had a hysterectomy for severe bleeding. She was in pain and asking for help.

She relates to you that street marijuana has helped with the pain, but she is worried about being arrested and losing her job. Do we put her on another opioid contract? Do we throw up our hands in defeat, apologize, and show her the door?

Serendipitously, I ran across a study evaluating the relationship between cannabis use over a 20-year period and health conditions. The study by Madeline Meier, Ph.D., and her colleagues evaluated 1,037 New Zealanders followed into their late 30s. Laboratory measures were available, and tobacco use was determined (JAMA Psychiatry. 2016 Jul 1;73[7]:731-40).

Cannabis was associated with poorer periodontal health, but with no other health conditions in early midlife. In contrast, tobacco use was associated with significant adverse health consequences in multiple domains.

This study looked at smoked cannabis. In contrast, the cannabis that my patient would take is an oil, negating any potential respiratory health issues from by-products of burning. Furthermore, products with higher concentrations of or consisting exclusively of cannabidiol can be selected. Cannabidiol is proposed to possess health benefits and is not psychoactive.

As the opioid crisis rages, solutions are not readily presenting themselves. Will we be on the wrong side of medical history by providing patients with chronic pain access to medical marijuana? Perhaps we can avoid, at least for a short time, the all-too inevitable outcome of chronic pain patients in their 30s: ever-increasing opioid doses with the same amount of pain, frequent emergency department visits, a fractured patient-physician relationship, and drug overdose.

For our patients’ sake, I hope we can bend before we break.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

I have learned a few things in my almost half-century of hurtling through space with all of you on this fragile blue-green rock. My most recent enlightenment is that the universe has a way of flipping our certitude on its head. Mental acrobatics requires flexibility, requiring us to bend so we don’t break.

On July 1, Minnesota began allowing clinicians to certify patients for “intractable pain” as a qualifying condition for the Minnesota Medical Cannabis Program. Recall that medical marijuana is a Schedule I drug, and we cannot prescribe it. These programs are set up in such a way that the only role a clinician plays is to certify patients with qualifying conditions. This allows a patient to pay a registration fee and visit a cannabis patient center, where a pharmacist will recommend cannabis dose and type.

Months before this, I was waxing professorial about our lack of certainty about dosing and efficacy of medical marijuana. Then I met a 30-year-old with chronic back pain.

She had been evaluated by every subspecialist. This patient was taking and failing supertherapeutic doses of NSAIDs, acetaminophen, and gabapentin. No more surgical options existed. She had been removed from opioid contracts for aberrant behavior. She had had a hysterectomy for severe bleeding. She was in pain and asking for help.

She relates to you that street marijuana has helped with the pain, but she is worried about being arrested and losing her job. Do we put her on another opioid contract? Do we throw up our hands in defeat, apologize, and show her the door?

Serendipitously, I ran across a study evaluating the relationship between cannabis use over a 20-year period and health conditions. The study by Madeline Meier, Ph.D., and her colleagues evaluated 1,037 New Zealanders followed into their late 30s. Laboratory measures were available, and tobacco use was determined (JAMA Psychiatry. 2016 Jul 1;73[7]:731-40).

Cannabis was associated with poorer periodontal health, but with no other health conditions in early midlife. In contrast, tobacco use was associated with significant adverse health consequences in multiple domains.

This study looked at smoked cannabis. In contrast, the cannabis that my patient would take is an oil, negating any potential respiratory health issues from by-products of burning. Furthermore, products with higher concentrations of or consisting exclusively of cannabidiol can be selected. Cannabidiol is proposed to possess health benefits and is not psychoactive.

As the opioid crisis rages, solutions are not readily presenting themselves. Will we be on the wrong side of medical history by providing patients with chronic pain access to medical marijuana? Perhaps we can avoid, at least for a short time, the all-too inevitable outcome of chronic pain patients in their 30s: ever-increasing opioid doses with the same amount of pain, frequent emergency department visits, a fractured patient-physician relationship, and drug overdose.

For our patients’ sake, I hope we can bend before we break.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

I have learned a few things in my almost half-century of hurtling through space with all of you on this fragile blue-green rock. My most recent enlightenment is that the universe has a way of flipping our certitude on its head. Mental acrobatics requires flexibility, requiring us to bend so we don’t break.

On July 1, Minnesota began allowing clinicians to certify patients for “intractable pain” as a qualifying condition for the Minnesota Medical Cannabis Program. Recall that medical marijuana is a Schedule I drug, and we cannot prescribe it. These programs are set up in such a way that the only role a clinician plays is to certify patients with qualifying conditions. This allows a patient to pay a registration fee and visit a cannabis patient center, where a pharmacist will recommend cannabis dose and type.

Months before this, I was waxing professorial about our lack of certainty about dosing and efficacy of medical marijuana. Then I met a 30-year-old with chronic back pain.

She had been evaluated by every subspecialist. This patient was taking and failing supertherapeutic doses of NSAIDs, acetaminophen, and gabapentin. No more surgical options existed. She had been removed from opioid contracts for aberrant behavior. She had had a hysterectomy for severe bleeding. She was in pain and asking for help.

She relates to you that street marijuana has helped with the pain, but she is worried about being arrested and losing her job. Do we put her on another opioid contract? Do we throw up our hands in defeat, apologize, and show her the door?

Serendipitously, I ran across a study evaluating the relationship between cannabis use over a 20-year period and health conditions. The study by Madeline Meier, Ph.D., and her colleagues evaluated 1,037 New Zealanders followed into their late 30s. Laboratory measures were available, and tobacco use was determined (JAMA Psychiatry. 2016 Jul 1;73[7]:731-40).

Cannabis was associated with poorer periodontal health, but with no other health conditions in early midlife. In contrast, tobacco use was associated with significant adverse health consequences in multiple domains.

This study looked at smoked cannabis. In contrast, the cannabis that my patient would take is an oil, negating any potential respiratory health issues from by-products of burning. Furthermore, products with higher concentrations of or consisting exclusively of cannabidiol can be selected. Cannabidiol is proposed to possess health benefits and is not psychoactive.

As the opioid crisis rages, solutions are not readily presenting themselves. Will we be on the wrong side of medical history by providing patients with chronic pain access to medical marijuana? Perhaps we can avoid, at least for a short time, the all-too inevitable outcome of chronic pain patients in their 30s: ever-increasing opioid doses with the same amount of pain, frequent emergency department visits, a fractured patient-physician relationship, and drug overdose.

For our patients’ sake, I hope we can bend before we break.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

A 47-year-old woman with a history of right-sided breast cancer – status after lumpectomy, lymph node dissection, and radiation – comes in to clinic for evaluation. She asks the MA to take precautions on blood pressure measurement.

What precautions should be done?

A. Check BP in left arm only.

B. Do not inflate cuff greater than 180 mm in the right arm.

C. It’s okay to check BP in either arm.

About 10 years ago, a person asked me after a medical myth lecture I had given if I had any information on whether avoiding blood pressure readings in the ipsilateral arm in breast cancer patients was a myth. We both agreed that it sounded like a myth, and I promised to research it.

I found no studies at that time that refuted the advice that breast cancer patients were given to avoid blood pressure measurement, blood draws, and injections in the ipsilateral arm. I found no evidence at that time supporting this practice, just very authoritative statements in medical and nursing journals. Currently, the American Cancer society website recommends against blood pressure checks and blood draws from the ipsilateral arm in breast cancer patients.¹

Are there more data now to weigh in on whether this is a myth or not?

The rationale behind this longstanding advice is that women who have had breast surgery, lymph node dissections, or radiation were at higher risk for lymphedema in the ipsilateral arm.

The advice to avoid blood draws and injections was to decrease the risk of infection and subsequent cellulitis that could lead to longstanding lymphedema. The avoidance of blood pressure measurements was, I suppose, to decrease venous pressure that could stimulate edema.

Sarah A. McLaughlin, MD, and her colleagues reported on the precautionary behaviors that patients with breast cancer observed in an attempt to avoid lymphedema.² They looked at two groups: women who had undergone axillary lymph node biopsy and those who had undergone sentinel node biopsy.

More than 90% of the women who had undergone axillary node dissection avoided blood draws, intravenous lines, and blood pressure measurements on the involved side – with more than 70% in the sentinel node biopsy group avoiding blood pressure measurements on the involved side, and almost 90% avoiding intravenous lines.

In the Physical Activity and Lymphedema trial, Shayna L. Showalter, MD, and her colleagues looked at a number of potential risk factors for arm swelling in patients with a history of breast cancer.³ There was no increased risk of arm swelling in patients who had blood draws or blood pressure checks in the ipsilateral arm. There also was no association with burns, bug bites, hangnails, or cuts in the ipsilateral arm – all risks that would suggest an increased risk of infection in the arm.

Chantal Ferguson and her colleagues reported on a 10-year prospective study looking at lymphedema and risk factors for lymphedema in breast cancer patients.⁴ Bilateral arm volume measurements were made preoperatively and postoperatively, and at each visit, patients reported on whether they had blood pressure measurements, injections, or blood draws in the ipsilateral arm.

In more than 3,000 measurements, there was no evidence of volume change associated with blood pressure measurements, blood draws, or injections. Risk factors that did increase arm volume were body mass index greater than 25 kg/m², axillary lymph node dissection, cellulitis, and regional lymph node irradiation.

There just isn’t evidence that these classic behaviors to protect the ipsilateral arm are warranted. Hopefully, patients will have less worry and less stress if they do not have to be so vigilant trying to “protect” their arm.

References

1. American Cancer Society: “Lymphedema: What Every Woman With Breast Cancer Should Know.” Accessed online at www.cancer.org.

2. J Am Coll Surg. 2013 Mar;216(3):380-9.

3. Ann Surg Oncol. 2013 Mar;20(3):842-9.

4. J Clin Oncol. 2016 Mar 1;34(7):691-8.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 47-year-old woman with a history of right-sided breast cancer – status after lumpectomy, lymph node dissection, and radiation – comes in to clinic for evaluation. She asks the MA to take precautions on blood pressure measurement.

What precautions should be done?

A. Check BP in left arm only.

B. Do not inflate cuff greater than 180 mm in the right arm.

C. It’s okay to check BP in either arm.

About 10 years ago, a person asked me after a medical myth lecture I had given if I had any information on whether avoiding blood pressure readings in the ipsilateral arm in breast cancer patients was a myth. We both agreed that it sounded like a myth, and I promised to research it.

I found no studies at that time that refuted the advice that breast cancer patients were given to avoid blood pressure measurement, blood draws, and injections in the ipsilateral arm. I found no evidence at that time supporting this practice, just very authoritative statements in medical and nursing journals. Currently, the American Cancer society website recommends against blood pressure checks and blood draws from the ipsilateral arm in breast cancer patients.¹

Are there more data now to weigh in on whether this is a myth or not?

The rationale behind this longstanding advice is that women who have had breast surgery, lymph node dissections, or radiation were at higher risk for lymphedema in the ipsilateral arm.

The advice to avoid blood draws and injections was to decrease the risk of infection and subsequent cellulitis that could lead to longstanding lymphedema. The avoidance of blood pressure measurements was, I suppose, to decrease venous pressure that could stimulate edema.

Sarah A. McLaughlin, MD, and her colleagues reported on the precautionary behaviors that patients with breast cancer observed in an attempt to avoid lymphedema.² They looked at two groups: women who had undergone axillary lymph node biopsy and those who had undergone sentinel node biopsy.

More than 90% of the women who had undergone axillary node dissection avoided blood draws, intravenous lines, and blood pressure measurements on the involved side – with more than 70% in the sentinel node biopsy group avoiding blood pressure measurements on the involved side, and almost 90% avoiding intravenous lines.

In the Physical Activity and Lymphedema trial, Shayna L. Showalter, MD, and her colleagues looked at a number of potential risk factors for arm swelling in patients with a history of breast cancer.³ There was no increased risk of arm swelling in patients who had blood draws or blood pressure checks in the ipsilateral arm. There also was no association with burns, bug bites, hangnails, or cuts in the ipsilateral arm – all risks that would suggest an increased risk of infection in the arm.

Chantal Ferguson and her colleagues reported on a 10-year prospective study looking at lymphedema and risk factors for lymphedema in breast cancer patients.⁴ Bilateral arm volume measurements were made preoperatively and postoperatively, and at each visit, patients reported on whether they had blood pressure measurements, injections, or blood draws in the ipsilateral arm.

In more than 3,000 measurements, there was no evidence of volume change associated with blood pressure measurements, blood draws, or injections. Risk factors that did increase arm volume were body mass index greater than 25 kg/m², axillary lymph node dissection, cellulitis, and regional lymph node irradiation.

There just isn’t evidence that these classic behaviors to protect the ipsilateral arm are warranted. Hopefully, patients will have less worry and less stress if they do not have to be so vigilant trying to “protect” their arm.

References

1. American Cancer Society: “Lymphedema: What Every Woman With Breast Cancer Should Know.” Accessed online at www.cancer.org.

2. J Am Coll Surg. 2013 Mar;216(3):380-9.

3. Ann Surg Oncol. 2013 Mar;20(3):842-9.

4. J Clin Oncol. 2016 Mar 1;34(7):691-8.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 47-year-old woman with a history of right-sided breast cancer – status after lumpectomy, lymph node dissection, and radiation – comes in to clinic for evaluation. She asks the MA to take precautions on blood pressure measurement.

What precautions should be done?

A. Check BP in left arm only.

B. Do not inflate cuff greater than 180 mm in the right arm.

C. It’s okay to check BP in either arm.

About 10 years ago, a person asked me after a medical myth lecture I had given if I had any information on whether avoiding blood pressure readings in the ipsilateral arm in breast cancer patients was a myth. We both agreed that it sounded like a myth, and I promised to research it.

I found no studies at that time that refuted the advice that breast cancer patients were given to avoid blood pressure measurement, blood draws, and injections in the ipsilateral arm. I found no evidence at that time supporting this practice, just very authoritative statements in medical and nursing journals. Currently, the American Cancer society website recommends against blood pressure checks and blood draws from the ipsilateral arm in breast cancer patients.¹

Are there more data now to weigh in on whether this is a myth or not?

The rationale behind this longstanding advice is that women who have had breast surgery, lymph node dissections, or radiation were at higher risk for lymphedema in the ipsilateral arm.

The advice to avoid blood draws and injections was to decrease the risk of infection and subsequent cellulitis that could lead to longstanding lymphedema. The avoidance of blood pressure measurements was, I suppose, to decrease venous pressure that could stimulate edema.

Sarah A. McLaughlin, MD, and her colleagues reported on the precautionary behaviors that patients with breast cancer observed in an attempt to avoid lymphedema.² They looked at two groups: women who had undergone axillary lymph node biopsy and those who had undergone sentinel node biopsy.

More than 90% of the women who had undergone axillary node dissection avoided blood draws, intravenous lines, and blood pressure measurements on the involved side – with more than 70% in the sentinel node biopsy group avoiding blood pressure measurements on the involved side, and almost 90% avoiding intravenous lines.

In the Physical Activity and Lymphedema trial, Shayna L. Showalter, MD, and her colleagues looked at a number of potential risk factors for arm swelling in patients with a history of breast cancer.³ There was no increased risk of arm swelling in patients who had blood draws or blood pressure checks in the ipsilateral arm. There also was no association with burns, bug bites, hangnails, or cuts in the ipsilateral arm – all risks that would suggest an increased risk of infection in the arm.

Chantal Ferguson and her colleagues reported on a 10-year prospective study looking at lymphedema and risk factors for lymphedema in breast cancer patients.⁴ Bilateral arm volume measurements were made preoperatively and postoperatively, and at each visit, patients reported on whether they had blood pressure measurements, injections, or blood draws in the ipsilateral arm.

In more than 3,000 measurements, there was no evidence of volume change associated with blood pressure measurements, blood draws, or injections. Risk factors that did increase arm volume were body mass index greater than 25 kg/m², axillary lymph node dissection, cellulitis, and regional lymph node irradiation.

There just isn’t evidence that these classic behaviors to protect the ipsilateral arm are warranted. Hopefully, patients will have less worry and less stress if they do not have to be so vigilant trying to “protect” their arm.

References

1. American Cancer Society: “Lymphedema: What Every Woman With Breast Cancer Should Know.” Accessed online at www.cancer.org.

2. J Am Coll Surg. 2013 Mar;216(3):380-9.

3. Ann Surg Oncol. 2013 Mar;20(3):842-9.

4. J Clin Oncol. 2016 Mar 1;34(7):691-8.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

You start your day refreshed, enthusiastic, and ready to take on every challenge that comes your way.

You print your list of patients for the day – not too bad, a mere 15; quite doable for a seasoned hospitalist. You scan your list: a hypertensive crisis – piece of cake; 3 patients with acute systolic heart failure – just follow the guidelines; 2 with a COPD exacerbation – no worries. You know how to treat these conditions, almost with your eyes closed. But, of course, all conditions do not have such straightforward treatments.

The next patient on your list is a 35-year-old on a methadone maintenance program admitted with an accidental heroin overdose. So sad. Then there is a 59-year-old with chronic back pain and known drug-seeking behavior, well known to you and your entire team. So frustrating. Next, you read about a healthy 24-year-old mother of two who slipped on a baby bottle and tumbled down two flights of stairs, breaking both femurs, a clavicle, and nine ribs.

As you mull over your approach to the first two, you cannot help but be concerned about the likelihood that this young mother will require strong narcotics to manage her pain for a considerable time, long after discharge. She has a legitimate reason to receive opioid analgesics, but how can you minimize her chances of becoming another statistic?

In 2012, an estimated 2.1 million Americans suffered from substance use disorders due to prescription opioid pain relievers while close to 467,000 were addicted to heroin.

To complicate matters, many who were legitimately prescribed painkillers go on to abuse heroin when they can no longer get prescription opiates from their health care providers. Naturally, we want to take away our patients’ pain, but in 2016 we must be keenly aware that every time we prescribe opiates for our patients there is a risk, whether great or small, that individual may some day suffer from a substance abuse disorder.

Evidence shows that the way the human brain deals with opiates, and subsequent opiate dependence, necessitates that we rethink how we view addiction. Addicts simply cannot be stereotyped as derelicts, always looking for their next high. They have a real disease.

According to the American Society of Addiction Medicine, addiction is a primary, chronic, and relapsing disease of the brain. When one thinks of addiction as a true disease, and not simply as a weakness of pleasure seekers with morals we deem beneath our own, it paints the addict in a completely different light.

We would never order a procedure or prescribe a medication that had more than a negligible risk of causing diabetes or hypertension. Remember, “First, do no harm?” Perhaps we should approach opiate prescribing by considering not only the immediate benefit our patients will receive, and thus how quickly they can be discharged, but the potential long term pain they may experience in the future should they become addicted.

The heroin epidemic has hit America with a vengeance. It is an equal opportunity destroyer with an unprecedented predilection to decimate lives in all communities – affluent, impoverished, and everyplace in between. It has no regard for race or ethnicity and knows no boundaries whatsoever.

No doubt, some of our most challenging patients are the ones who are least sick, medically speaking, but suffer from addictions that are beyond our expertise. They often require us to reach down much deeper than a textbook to find more understanding, more insight, more wisdom, and a huge helping of compassion, even in the midst of own frustration.

Sure, we want to relieve pain and suffering. There are few things as rewarding as doing so. Yet, because we have not understood the long-term consequences of writing an opioid prescription, health care professionals have played a tremendous role in the epidemic of addiction that is decimating lives. In the past, we simply didn’t know, but now we do and this knowledge empowers us to take the lead in turning around this monstrous epidemic.

I believe 3 simple steps can help us all become more responsible opiate prescribers and thus begin the long process of conquering the beast of addiction.

1. Think before you order. Is it possible that pain can be controlled with a non-narcotic medication, such as tramadol or NSAIDs?

2. Hone your prescribing skills by taking CMEs or simply reading reputable journal articles and other noteworthy resources.

3. Do not hesitate to consult your pain management service. Doing so does not denote weakness; it signifies wisdom and humility when you put your patient’s best interest above your pride. It’s honorable to “know what you don’t know” and seek help when needed.

Finally, I would like to dedicate this article to Mark, my 25-year-old, athletic father-to-be who accidentally overdosed on heroin long before his baby was born. May your child grow up in an America that rids itself of this drug nightmare long before he is old enough to know what drug addiction means. Rest in peace, Mark.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

You start your day refreshed, enthusiastic, and ready to take on every challenge that comes your way.

You print your list of patients for the day – not too bad, a mere 15; quite doable for a seasoned hospitalist. You scan your list: a hypertensive crisis – piece of cake; 3 patients with acute systolic heart failure – just follow the guidelines; 2 with a COPD exacerbation – no worries. You know how to treat these conditions, almost with your eyes closed. But, of course, all conditions do not have such straightforward treatments.

The next patient on your list is a 35-year-old on a methadone maintenance program admitted with an accidental heroin overdose. So sad. Then there is a 59-year-old with chronic back pain and known drug-seeking behavior, well known to you and your entire team. So frustrating. Next, you read about a healthy 24-year-old mother of two who slipped on a baby bottle and tumbled down two flights of stairs, breaking both femurs, a clavicle, and nine ribs.

As you mull over your approach to the first two, you cannot help but be concerned about the likelihood that this young mother will require strong narcotics to manage her pain for a considerable time, long after discharge. She has a legitimate reason to receive opioid analgesics, but how can you minimize her chances of becoming another statistic?

In 2012, an estimated 2.1 million Americans suffered from substance use disorders due to prescription opioid pain relievers while close to 467,000 were addicted to heroin.

To complicate matters, many who were legitimately prescribed painkillers go on to abuse heroin when they can no longer get prescription opiates from their health care providers. Naturally, we want to take away our patients’ pain, but in 2016 we must be keenly aware that every time we prescribe opiates for our patients there is a risk, whether great or small, that individual may some day suffer from a substance abuse disorder.

Evidence shows that the way the human brain deals with opiates, and subsequent opiate dependence, necessitates that we rethink how we view addiction. Addicts simply cannot be stereotyped as derelicts, always looking for their next high. They have a real disease.

According to the American Society of Addiction Medicine, addiction is a primary, chronic, and relapsing disease of the brain. When one thinks of addiction as a true disease, and not simply as a weakness of pleasure seekers with morals we deem beneath our own, it paints the addict in a completely different light.

We would never order a procedure or prescribe a medication that had more than a negligible risk of causing diabetes or hypertension. Remember, “First, do no harm?” Perhaps we should approach opiate prescribing by considering not only the immediate benefit our patients will receive, and thus how quickly they can be discharged, but the potential long term pain they may experience in the future should they become addicted.

The heroin epidemic has hit America with a vengeance. It is an equal opportunity destroyer with an unprecedented predilection to decimate lives in all communities – affluent, impoverished, and everyplace in between. It has no regard for race or ethnicity and knows no boundaries whatsoever.

No doubt, some of our most challenging patients are the ones who are least sick, medically speaking, but suffer from addictions that are beyond our expertise. They often require us to reach down much deeper than a textbook to find more understanding, more insight, more wisdom, and a huge helping of compassion, even in the midst of own frustration.

Sure, we want to relieve pain and suffering. There are few things as rewarding as doing so. Yet, because we have not understood the long-term consequences of writing an opioid prescription, health care professionals have played a tremendous role in the epidemic of addiction that is decimating lives. In the past, we simply didn’t know, but now we do and this knowledge empowers us to take the lead in turning around this monstrous epidemic.

I believe 3 simple steps can help us all become more responsible opiate prescribers and thus begin the long process of conquering the beast of addiction.

1. Think before you order. Is it possible that pain can be controlled with a non-narcotic medication, such as tramadol or NSAIDs?

2. Hone your prescribing skills by taking CMEs or simply reading reputable journal articles and other noteworthy resources.

3. Do not hesitate to consult your pain management service. Doing so does not denote weakness; it signifies wisdom and humility when you put your patient’s best interest above your pride. It’s honorable to “know what you don’t know” and seek help when needed.

Finally, I would like to dedicate this article to Mark, my 25-year-old, athletic father-to-be who accidentally overdosed on heroin long before his baby was born. May your child grow up in an America that rids itself of this drug nightmare long before he is old enough to know what drug addiction means. Rest in peace, Mark.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

You start your day refreshed, enthusiastic, and ready to take on every challenge that comes your way.

You print your list of patients for the day – not too bad, a mere 15; quite doable for a seasoned hospitalist. You scan your list: a hypertensive crisis – piece of cake; 3 patients with acute systolic heart failure – just follow the guidelines; 2 with a COPD exacerbation – no worries. You know how to treat these conditions, almost with your eyes closed. But, of course, all conditions do not have such straightforward treatments.

The next patient on your list is a 35-year-old on a methadone maintenance program admitted with an accidental heroin overdose. So sad. Then there is a 59-year-old with chronic back pain and known drug-seeking behavior, well known to you and your entire team. So frustrating. Next, you read about a healthy 24-year-old mother of two who slipped on a baby bottle and tumbled down two flights of stairs, breaking both femurs, a clavicle, and nine ribs.

As you mull over your approach to the first two, you cannot help but be concerned about the likelihood that this young mother will require strong narcotics to manage her pain for a considerable time, long after discharge. She has a legitimate reason to receive opioid analgesics, but how can you minimize her chances of becoming another statistic?

In 2012, an estimated 2.1 million Americans suffered from substance use disorders due to prescription opioid pain relievers while close to 467,000 were addicted to heroin.

To complicate matters, many who were legitimately prescribed painkillers go on to abuse heroin when they can no longer get prescription opiates from their health care providers. Naturally, we want to take away our patients’ pain, but in 2016 we must be keenly aware that every time we prescribe opiates for our patients there is a risk, whether great or small, that individual may some day suffer from a substance abuse disorder.

Evidence shows that the way the human brain deals with opiates, and subsequent opiate dependence, necessitates that we rethink how we view addiction. Addicts simply cannot be stereotyped as derelicts, always looking for their next high. They have a real disease.

According to the American Society of Addiction Medicine, addiction is a primary, chronic, and relapsing disease of the brain. When one thinks of addiction as a true disease, and not simply as a weakness of pleasure seekers with morals we deem beneath our own, it paints the addict in a completely different light.

We would never order a procedure or prescribe a medication that had more than a negligible risk of causing diabetes or hypertension. Remember, “First, do no harm?” Perhaps we should approach opiate prescribing by considering not only the immediate benefit our patients will receive, and thus how quickly they can be discharged, but the potential long term pain they may experience in the future should they become addicted.

The heroin epidemic has hit America with a vengeance. It is an equal opportunity destroyer with an unprecedented predilection to decimate lives in all communities – affluent, impoverished, and everyplace in between. It has no regard for race or ethnicity and knows no boundaries whatsoever.

No doubt, some of our most challenging patients are the ones who are least sick, medically speaking, but suffer from addictions that are beyond our expertise. They often require us to reach down much deeper than a textbook to find more understanding, more insight, more wisdom, and a huge helping of compassion, even in the midst of own frustration.

Sure, we want to relieve pain and suffering. There are few things as rewarding as doing so. Yet, because we have not understood the long-term consequences of writing an opioid prescription, health care professionals have played a tremendous role in the epidemic of addiction that is decimating lives. In the past, we simply didn’t know, but now we do and this knowledge empowers us to take the lead in turning around this monstrous epidemic.

I believe 3 simple steps can help us all become more responsible opiate prescribers and thus begin the long process of conquering the beast of addiction.

1. Think before you order. Is it possible that pain can be controlled with a non-narcotic medication, such as tramadol or NSAIDs?

2. Hone your prescribing skills by taking CMEs or simply reading reputable journal articles and other noteworthy resources.

3. Do not hesitate to consult your pain management service. Doing so does not denote weakness; it signifies wisdom and humility when you put your patient’s best interest above your pride. It’s honorable to “know what you don’t know” and seek help when needed.

Finally, I would like to dedicate this article to Mark, my 25-year-old, athletic father-to-be who accidentally overdosed on heroin long before his baby was born. May your child grow up in an America that rids itself of this drug nightmare long before he is old enough to know what drug addiction means. Rest in peace, Mark.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

You start your day refreshed, enthusiastic, and ready to take on every challenge that comes your way.

You print your list of patients for the day – not too bad, a mere 15; quite doable for a seasoned hospitalist. You scan your list: a hypertensive crisis – piece of cake; 3 patients with acute systolic heart failure – just follow the guidelines; 2 with a COPD exacerbation – no worries. You know how to treat these conditions, almost with your eyes closed. But, of course, all conditions do not have such straightforward treatments.

The next patient on your list is a 35-year-old on a methadone maintenance program admitted with an accidental heroin overdose. So sad. Then there is a 59-year-old with chronic back pain and known drug-seeking behavior, well known to you and your entire team. So frustrating. Next, you read about a healthy 24-year-old mother of two who slipped on a baby bottle and tumbled down two flights of stairs, breaking both femurs, a clavicle, and nine ribs.

As you mull over your approach to the first two, you cannot help but be concerned about the likelihood that this young mother will require strong narcotics to manage her pain for a considerable time, long after discharge. She has a legitimate reason to receive opioid analgesics, but how can you minimize her chances of becoming another statistic?

In 2012, an estimated 2.1 million Americans suffered from substance use disorders due to prescription opioid pain relievers while close to 467,000 were addicted to heroin.

To complicate matters, many who were legitimately prescribed painkillers go on to abuse heroin when they can no longer get prescription opiates from their health care providers. Naturally, we want to take away our patients’ pain, but in 2016 we must be keenly aware that every time we prescribe opiates for our patients there is a risk, whether great or small, that individual may some day suffer from a substance abuse disorder.

Evidence shows that the way the human brain deals with opiates, and subsequent opiate dependence, necessitates that we rethink how we view addiction. Addicts simply cannot be stereotyped as derelicts, always looking for their next high. They have a real disease.

According to the American Society of Addiction Medicine, addiction is a primary, chronic, and relapsing disease of the brain. When one thinks of addiction as a true disease, and not simply as a weakness of pleasure seekers with morals we deem beneath our own, it paints the addict in a completely different light.

We would never order a procedure or prescribe a medication that had more than a negligible risk of causing diabetes or hypertension. Remember, “First, do no harm?” Perhaps we should approach opiate prescribing by considering not only the immediate benefit our patients will receive, and thus how quickly they can be discharged, but the potential long term pain they may experience in the future should they become addicted.

The heroin epidemic has hit America with a vengeance. It is an equal opportunity destroyer with an unprecedented predilection to decimate lives in all communities – affluent, impoverished, and everyplace in between. It has no regard for race or ethnicity and knows no boundaries whatsoever.

No doubt, some of our most challenging patients are the ones who are least sick, medically speaking, but suffer from addictions that are beyond our expertise. They often require us to reach down much deeper than a textbook to find more understanding, more insight, more wisdom, and a huge helping of compassion, even in the midst of own frustration.

Sure, we want to relieve pain and suffering. There are few things as rewarding as doing so. Yet, because we have not understood the long-term consequences of writing an opioid prescription, health care professionals have played a tremendous role in the epidemic of addiction that is decimating lives. In the past, we simply didn’t know, but now we do and this knowledge empowers us to take the lead in turning around this monstrous epidemic.

I believe 3 simple steps can help us all become more responsible opiate prescribers and thus begin the long process of conquering the beast of addiction.

1. Think before you order. Is it possible that pain can be controlled with a non-narcotic medication, such as tramadol or NSAIDs?

2. Hone your prescribing skills by taking CMEs or simply reading reputable journal articles and other noteworthy resources.

3. Do not hesitate to consult your pain management service. Doing so does not denote weakness; it signifies wisdom and humility when you put your patient’s best interest above your pride. It’s honorable to “know what you don’t know” and seek help when needed.

Finally, I would like to dedicate this article to Mark, my 25-year-old, athletic father-to-be who accidentally overdosed on heroin long before his baby was born. May your child grow up in an America that rids itself of this drug nightmare long before he is old enough to know what drug addiction means. Rest in peace, Mark.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

You start your day refreshed, enthusiastic, and ready to take on every challenge that comes your way.

You print your list of patients for the day – not too bad, a mere 15; quite doable for a seasoned hospitalist. You scan your list: a hypertensive crisis – piece of cake; 3 patients with acute systolic heart failure – just follow the guidelines; 2 with a COPD exacerbation – no worries. You know how to treat these conditions, almost with your eyes closed. But, of course, all conditions do not have such straightforward treatments.

The next patient on your list is a 35-year-old on a methadone maintenance program admitted with an accidental heroin overdose. So sad. Then there is a 59-year-old with chronic back pain and known drug-seeking behavior, well known to you and your entire team. So frustrating. Next, you read about a healthy 24-year-old mother of two who slipped on a baby bottle and tumbled down two flights of stairs, breaking both femurs, a clavicle, and nine ribs.

As you mull over your approach to the first two, you cannot help but be concerned about the likelihood that this young mother will require strong narcotics to manage her pain for a considerable time, long after discharge. She has a legitimate reason to receive opioid analgesics, but how can you minimize her chances of becoming another statistic?

In 2012, an estimated 2.1 million Americans suffered from substance use disorders due to prescription opioid pain relievers while close to 467,000 were addicted to heroin.

To complicate matters, many who were legitimately prescribed painkillers go on to abuse heroin when they can no longer get prescription opiates from their health care providers. Naturally, we want to take away our patients’ pain, but in 2016 we must be keenly aware that every time we prescribe opiates for our patients there is a risk, whether great or small, that individual may some day suffer from a substance abuse disorder.

Evidence shows that the way the human brain deals with opiates, and subsequent opiate dependence, necessitates that we rethink how we view addiction. Addicts simply cannot be stereotyped as derelicts, always looking for their next high. They have a real disease.

According to the American Society of Addiction Medicine, addiction is a primary, chronic, and relapsing disease of the brain. When one thinks of addiction as a true disease, and not simply as a weakness of pleasure seekers with morals we deem beneath our own, it paints the addict in a completely different light.

We would never order a procedure or prescribe a medication that had more than a negligible risk of causing diabetes or hypertension. Remember, “First, do no harm?” Perhaps we should approach opiate prescribing by considering not only the immediate benefit our patients will receive, and thus how quickly they can be discharged, but the potential long term pain they may experience in the future should they become addicted.

The heroin epidemic has hit America with a vengeance. It is an equal opportunity destroyer with an unprecedented predilection to decimate lives in all communities – affluent, impoverished, and everyplace in between. It has no regard for race or ethnicity and knows no boundaries whatsoever.

No doubt, some of our most challenging patients are the ones who are least sick, medically speaking, but suffer from addictions that are beyond our expertise. They often require us to reach down much deeper than a textbook to find more understanding, more insight, more wisdom, and a huge helping of compassion, even in the midst of own frustration.

Sure, we want to relieve pain and suffering. There are few things as rewarding as doing so. Yet, because we have not understood the long-term consequences of writing an opioid prescription, health care professionals have played a tremendous role in the epidemic of addiction that is decimating lives. In the past, we simply didn’t know, but now we do and this knowledge empowers us to take the lead in turning around this monstrous epidemic.

I believe 3 simple steps can help us all become more responsible opiate prescribers and thus begin the long process of conquering the beast of addiction.

1. Think before you order. Is it possible that pain can be controlled with a non-narcotic medication, such as tramadol or NSAIDs?

2. Hone your prescribing skills by taking CMEs or simply reading reputable journal articles and other noteworthy resources.

3. Do not hesitate to consult your pain management service. Doing so does not denote weakness; it signifies wisdom and humility when you put your patient’s best interest above your pride. It’s honorable to “know what you don’t know” and seek help when needed.

Finally, I would like to dedicate this article to Mark, my 25-year-old, athletic father-to-be who accidentally overdosed on heroin long before his baby was born. May your child grow up in an America that rids itself of this drug nightmare long before he is old enough to know what drug addiction means. Rest in peace, Mark.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

You start your day refreshed, enthusiastic, and ready to take on every challenge that comes your way.

You print your list of patients for the day – not too bad, a mere 15; quite doable for a seasoned hospitalist. You scan your list: a hypertensive crisis – piece of cake; 3 patients with acute systolic heart failure – just follow the guidelines; 2 with a COPD exacerbation – no worries. You know how to treat these conditions, almost with your eyes closed. But, of course, all conditions do not have such straightforward treatments.

The next patient on your list is a 35-year-old on a methadone maintenance program admitted with an accidental heroin overdose. So sad. Then there is a 59-year-old with chronic back pain and known drug-seeking behavior, well known to you and your entire team. So frustrating. Next, you read about a healthy 24-year-old mother of two who slipped on a baby bottle and tumbled down two flights of stairs, breaking both femurs, a clavicle, and nine ribs.

As you mull over your approach to the first two, you cannot help but be concerned about the likelihood that this young mother will require strong narcotics to manage her pain for a considerable time, long after discharge. She has a legitimate reason to receive opioid analgesics, but how can you minimize her chances of becoming another statistic?

In 2012, an estimated 2.1 million Americans suffered from substance use disorders due to prescription opioid pain relievers while close to 467,000 were addicted to heroin.

To complicate matters, many who were legitimately prescribed painkillers go on to abuse heroin when they can no longer get prescription opiates from their health care providers. Naturally, we want to take away our patients’ pain, but in 2016 we must be keenly aware that every time we prescribe opiates for our patients there is a risk, whether great or small, that individual may some day suffer from a substance abuse disorder.

Evidence shows that the way the human brain deals with opiates, and subsequent opiate dependence, necessitates that we rethink how we view addiction. Addicts simply cannot be stereotyped as derelicts, always looking for their next high. They have a real disease.

According to the American Society of Addiction Medicine, addiction is a primary, chronic, and relapsing disease of the brain. When one thinks of addiction as a true disease, and not simply as a weakness of pleasure seekers with morals we deem beneath our own, it paints the addict in a completely different light.

We would never order a procedure or prescribe a medication that had more than a negligible risk of causing diabetes or hypertension. Remember, “First, do no harm?” Perhaps we should approach opiate prescribing by considering not only the immediate benefit our patients will receive, and thus how quickly they can be discharged, but the potential long term pain they may experience in the future should they become addicted.

The heroin epidemic has hit America with a vengeance. It is an equal opportunity destroyer with an unprecedented predilection to decimate lives in all communities – affluent, impoverished, and everyplace in between. It has no regard for race or ethnicity and knows no boundaries whatsoever.

No doubt, some of our most challenging patients are the ones who are least sick, medically speaking, but suffer from addictions that are beyond our expertise. They often require us to reach down much deeper than a textbook to find more understanding, more insight, more wisdom, and a huge helping of compassion, even in the midst of own frustration.

Sure, we want to relieve pain and suffering. There are few things as rewarding as doing so. Yet, because we have not understood the long-term consequences of writing an opioid prescription, health care professionals have played a tremendous role in the epidemic of addiction that is decimating lives. In the past, we simply didn’t know, but now we do and this knowledge empowers us to take the lead in turning around this monstrous epidemic.

I believe 3 simple steps can help us all become more responsible opiate prescribers and thus begin the long process of conquering the beast of addiction.

1. Think before you order. Is it possible that pain can be controlled with a non-narcotic medication, such as tramadol or NSAIDs?

2. Hone your prescribing skills by taking CMEs or simply reading reputable journal articles and other noteworthy resources.

3. Do not hesitate to consult your pain management service. Doing so does not denote weakness; it signifies wisdom and humility when you put your patient’s best interest above your pride. It’s honorable to “know what you don’t know” and seek help when needed.

Finally, I would like to dedicate this article to Mark, my 25-year-old, athletic father-to-be who accidentally overdosed on heroin long before his baby was born. May your child grow up in an America that rids itself of this drug nightmare long before he is old enough to know what drug addiction means. Rest in peace, Mark.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

When a Food and Drug Administration advisory committee met on June 28 to consider a new indication for the type 2 diabetes drug empagliflozin – reduction of cardiovascular mortality in patients with type 2 diabetes with existing cardiovascular disease or at high risk for cardiovascular disease – an inevitable question was, How will this matter to empagliflozin?

Empagliflozin (Jardiance) received FDA approval in 2014 for treating patients with type 2 diabetes. In 2015, an unexpected result from the EMPA-REG OUTCOME trial showed that treatment of such high-risk diabetes patients with empagliflozin led to a dramatic and still unexplained 38% relative risk reduction in cardiovascular disease (CVD) death, compared with placebo (a 2.2% absolute risk reduction) during a median 2.6 years of treatment and 3.1 years of total follow-up. This surprising result from a trial designed to test empagliflozin’s CVD safety but not its preventive efficacy first went public in a report at the European Association for the Study of Diabetes annual meeting in Stockholm in September 2015 and in a simultaneously published article (N Engl J Med. 2015;373:2117-28).

So the drug is already on the U.S. market, and its remarkable effect on CVD mortality in a selected population is already on record. Will translating this into a FDA-approved indication mean anything more?

The short answer is it probably will, especially for persuading health insurance payers to cover the substantial cost for prescribing empagliflozin. The other end an added FDA indication achieves is objective confirmation that the CVD mortality benefit seen in the EMPA-REG OUTCOME trial was real and could be anticipated in routine practice.

Some clinicians have already concluded this was a believable result, and that it gives empagliflozin an edge above other oral hypoglycemic drugs for patients who match the study’s enrollment criteria.

“Based on available evidence, the sodium-glucose cotransporter-2 inhibitors [the class that includes empagliflozin] are the preferred therapy for patients with type 2 diabetes and CVD or at high risk for CVD in patients treated with metformin or where metformin is not tolerated. It also should be given preference in patients with or at risk for heart failure,” Gregg C. Fonarow, MD, professor and associate chief of cardiology at the University of California, Los Angeles, said in an interview.

“I am using [empagliflozin] in addition to metformin and aggressive lifestyle changes in patients with established CVD and uncontrolled type 2 diabetes,” said another cardiologist, Alison L. Bailey, MD.

But Dr. Bailey also highlighted her concern about the extra cost to patients for empagliflozin, especially if their insurer wouldn’t pay for it.

“Metformin should be the first step based on it’s documented efficacy and cost. I would then add empagliflozin to most of my patients who can get the drug without financial burden,” she told me in an interview.

If an insurer balks at paying for empagliflozin, or if the patient has little or no drug insurance, the financial burden could be substantial. The cost of a month on empagliflozin at the dosage used in the EMPA-REG OUTCOME study is about $415 from one web-based drug supplier, compared with a monthly price of about $6 for a typical monthly regimen of generic metformin. Over the course of a year, that’s about $5,000, compared with $72.

Empagliflozin is “an expensive drug with limited experience,” commented Prakash Deedwania, MD, a cardiologist at the University of California, San Francisco, in Fresno. Metformin, the current linchpin oral agent for treating most patients with type 2 diabetes, has the advantages of low cost and a large, worldwide track record of efficacy and safety, he added.

An FDA indication for reducing cardiovascular disease mortality in selected patients with type 2 diabetes would set empagliflozin apart as the only oral hypoglycemic drug recognized to have this activity and might help grease the wheels for reimbursement.

“Patients can only get the medications their insurance covers. I have a feeling that this indication might help drive coverage,” commented Abraham Thomas, MD, an endocrinologist at New York University, when explaining his vote in favor of the new indication as a member of the FDA advisory committee.

Mitchel L. Zoler/Frontline Medical News

The other consequence from a positive FDA decision would be a strong statement of confidence that the EMPA-REG OUTCOME result is real. Clearly not everyone on the advisory panel was convinced. The panel’s vote split 12 in favor of the FDA granting the indication and 11 votes against, and many panelists said they found it very hard to balance the powerful result on the one hand against the inexplicable mechanism of the effect and the fact that the mortality benefit came from left field, without prespecification in the study’s design. Now it’s on the FDA’s shoulders to make a decision after parsing the vote, the panelists’ comments, the data, and concerns.

“An FDA-approved indication for reduction in cardiovascular death would be influential with physicians and patients,” predicted Dr. Fonarow.

A FDA imprimatur on the cardiovascular mortality benefit would help buttress belief in the EMPA-REG OUTCOME result and might help drive better reimbursement coverage. A thumbs down will likely dampen enthusiasm in and practicality of the treatment until additional, corroborative data appear.

[email protected]

On Twitter @mitchelzoler

When a Food and Drug Administration advisory committee met on June 28 to consider a new indication for the type 2 diabetes drug empagliflozin – reduction of cardiovascular mortality in patients with type 2 diabetes with existing cardiovascular disease or at high risk for cardiovascular disease – an inevitable question was, How will this matter to empagliflozin?

Empagliflozin (Jardiance) received FDA approval in 2014 for treating patients with type 2 diabetes. In 2015, an unexpected result from the EMPA-REG OUTCOME trial showed that treatment of such high-risk diabetes patients with empagliflozin led to a dramatic and still unexplained 38% relative risk reduction in cardiovascular disease (CVD) death, compared with placebo (a 2.2% absolute risk reduction) during a median 2.6 years of treatment and 3.1 years of total follow-up. This surprising result from a trial designed to test empagliflozin’s CVD safety but not its preventive efficacy first went public in a report at the European Association for the Study of Diabetes annual meeting in Stockholm in September 2015 and in a simultaneously published article (N Engl J Med. 2015;373:2117-28).

So the drug is already on the U.S. market, and its remarkable effect on CVD mortality in a selected population is already on record. Will translating this into a FDA-approved indication mean anything more?

The short answer is it probably will, especially for persuading health insurance payers to cover the substantial cost for prescribing empagliflozin. The other end an added FDA indication achieves is objective confirmation that the CVD mortality benefit seen in the EMPA-REG OUTCOME trial was real and could be anticipated in routine practice.

Some clinicians have already concluded this was a believable result, and that it gives empagliflozin an edge above other oral hypoglycemic drugs for patients who match the study’s enrollment criteria.

“Based on available evidence, the sodium-glucose cotransporter-2 inhibitors [the class that includes empagliflozin] are the preferred therapy for patients with type 2 diabetes and CVD or at high risk for CVD in patients treated with metformin or where metformin is not tolerated. It also should be given preference in patients with or at risk for heart failure,” Gregg C. Fonarow, MD, professor and associate chief of cardiology at the University of California, Los Angeles, said in an interview.

“I am using [empagliflozin] in addition to metformin and aggressive lifestyle changes in patients with established CVD and uncontrolled type 2 diabetes,” said another cardiologist, Alison L. Bailey, MD.

But Dr. Bailey also highlighted her concern about the extra cost to patients for empagliflozin, especially if their insurer wouldn’t pay for it.

“Metformin should be the first step based on it’s documented efficacy and cost. I would then add empagliflozin to most of my patients who can get the drug without financial burden,” she told me in an interview.

If an insurer balks at paying for empagliflozin, or if the patient has little or no drug insurance, the financial burden could be substantial. The cost of a month on empagliflozin at the dosage used in the EMPA-REG OUTCOME study is about $415 from one web-based drug supplier, compared with a monthly price of about $6 for a typical monthly regimen of generic metformin. Over the course of a year, that’s about $5,000, compared with $72.

Empagliflozin is “an expensive drug with limited experience,” commented Prakash Deedwania, MD, a cardiologist at the University of California, San Francisco, in Fresno. Metformin, the current linchpin oral agent for treating most patients with type 2 diabetes, has the advantages of low cost and a large, worldwide track record of efficacy and safety, he added.

An FDA indication for reducing cardiovascular disease mortality in selected patients with type 2 diabetes would set empagliflozin apart as the only oral hypoglycemic drug recognized to have this activity and might help grease the wheels for reimbursement.

“Patients can only get the medications their insurance covers. I have a feeling that this indication might help drive coverage,” commented Abraham Thomas, MD, an endocrinologist at New York University, when explaining his vote in favor of the new indication as a member of the FDA advisory committee.

Mitchel L. Zoler/Frontline Medical News

The other consequence from a positive FDA decision would be a strong statement of confidence that the EMPA-REG OUTCOME result is real. Clearly not everyone on the advisory panel was convinced. The panel’s vote split 12 in favor of the FDA granting the indication and 11 votes against, and many panelists said they found it very hard to balance the powerful result on the one hand against the inexplicable mechanism of the effect and the fact that the mortality benefit came from left field, without prespecification in the study’s design. Now it’s on the FDA’s shoulders to make a decision after parsing the vote, the panelists’ comments, the data, and concerns.

“An FDA-approved indication for reduction in cardiovascular death would be influential with physicians and patients,” predicted Dr. Fonarow.

A FDA imprimatur on the cardiovascular mortality benefit would help buttress belief in the EMPA-REG OUTCOME result and might help drive better reimbursement coverage. A thumbs down will likely dampen enthusiasm in and practicality of the treatment until additional, corroborative data appear.

[email protected]

On Twitter @mitchelzoler

When a Food and Drug Administration advisory committee met on June 28 to consider a new indication for the type 2 diabetes drug empagliflozin – reduction of cardiovascular mortality in patients with type 2 diabetes with existing cardiovascular disease or at high risk for cardiovascular disease – an inevitable question was, How will this matter to empagliflozin?

Empagliflozin (Jardiance) received FDA approval in 2014 for treating patients with type 2 diabetes. In 2015, an unexpected result from the EMPA-REG OUTCOME trial showed that treatment of such high-risk diabetes patients with empagliflozin led to a dramatic and still unexplained 38% relative risk reduction in cardiovascular disease (CVD) death, compared with placebo (a 2.2% absolute risk reduction) during a median 2.6 years of treatment and 3.1 years of total follow-up. This surprising result from a trial designed to test empagliflozin’s CVD safety but not its preventive efficacy first went public in a report at the European Association for the Study of Diabetes annual meeting in Stockholm in September 2015 and in a simultaneously published article (N Engl J Med. 2015;373:2117-28).

So the drug is already on the U.S. market, and its remarkable effect on CVD mortality in a selected population is already on record. Will translating this into a FDA-approved indication mean anything more?

The short answer is it probably will, especially for persuading health insurance payers to cover the substantial cost for prescribing empagliflozin. The other end an added FDA indication achieves is objective confirmation that the CVD mortality benefit seen in the EMPA-REG OUTCOME trial was real and could be anticipated in routine practice.

Some clinicians have already concluded this was a believable result, and that it gives empagliflozin an edge above other oral hypoglycemic drugs for patients who match the study’s enrollment criteria.

“Based on available evidence, the sodium-glucose cotransporter-2 inhibitors [the class that includes empagliflozin] are the preferred therapy for patients with type 2 diabetes and CVD or at high risk for CVD in patients treated with metformin or where metformin is not tolerated. It also should be given preference in patients with or at risk for heart failure,” Gregg C. Fonarow, MD, professor and associate chief of cardiology at the University of California, Los Angeles, said in an interview.

“I am using [empagliflozin] in addition to metformin and aggressive lifestyle changes in patients with established CVD and uncontrolled type 2 diabetes,” said another cardiologist, Alison L. Bailey, MD.

But Dr. Bailey also highlighted her concern about the extra cost to patients for empagliflozin, especially if their insurer wouldn’t pay for it.

“Metformin should be the first step based on it’s documented efficacy and cost. I would then add empagliflozin to most of my patients who can get the drug without financial burden,” she told me in an interview.

If an insurer balks at paying for empagliflozin, or if the patient has little or no drug insurance, the financial burden could be substantial. The cost of a month on empagliflozin at the dosage used in the EMPA-REG OUTCOME study is about $415 from one web-based drug supplier, compared with a monthly price of about $6 for a typical monthly regimen of generic metformin. Over the course of a year, that’s about $5,000, compared with $72.

Empagliflozin is “an expensive drug with limited experience,” commented Prakash Deedwania, MD, a cardiologist at the University of California, San Francisco, in Fresno. Metformin, the current linchpin oral agent for treating most patients with type 2 diabetes, has the advantages of low cost and a large, worldwide track record of efficacy and safety, he added.

An FDA indication for reducing cardiovascular disease mortality in selected patients with type 2 diabetes would set empagliflozin apart as the only oral hypoglycemic drug recognized to have this activity and might help grease the wheels for reimbursement.

“Patients can only get the medications their insurance covers. I have a feeling that this indication might help drive coverage,” commented Abraham Thomas, MD, an endocrinologist at New York University, when explaining his vote in favor of the new indication as a member of the FDA advisory committee.

Mitchel L. Zoler/Frontline Medical News

The other consequence from a positive FDA decision would be a strong statement of confidence that the EMPA-REG OUTCOME result is real. Clearly not everyone on the advisory panel was convinced. The panel’s vote split 12 in favor of the FDA granting the indication and 11 votes against, and many panelists said they found it very hard to balance the powerful result on the one hand against the inexplicable mechanism of the effect and the fact that the mortality benefit came from left field, without prespecification in the study’s design. Now it’s on the FDA’s shoulders to make a decision after parsing the vote, the panelists’ comments, the data, and concerns.

“An FDA-approved indication for reduction in cardiovascular death would be influential with physicians and patients,” predicted Dr. Fonarow.

A FDA imprimatur on the cardiovascular mortality benefit would help buttress belief in the EMPA-REG OUTCOME result and might help drive better reimbursement coverage. A thumbs down will likely dampen enthusiasm in and practicality of the treatment until additional, corroborative data appear.

[email protected]

On Twitter @mitchelzoler

Question: A patient was admitted with heart failure, developed deep vein thrombosis, and was started on warfarin and Lovenox as “bridge” therapy. On day 4, the patient achieved anticoagulation with a prothrombin time of 29.8 and international normalized ratio (INR) of 2.86, but continued to receive both warfarin and Lovenox for a total of 13 days. Both medications were dispensed and administered for 2 days when the PT was greater than 50; the supratherapeutic coagulation profile result was overlooked. Medications held on day 14 (PT, 68; INR, 8.35). The patient developed a right subdural hematoma and was transferred to a tertiary care facility for neurosurgery consult.

Given these facts, which of the following statements is best?

A. The hospital is under a legal obligation to disclose the error.

B. The doctor should be sympathetic and apologize for the injury, but not admit fault.

C. All jurisdictions have so-called “apology statutes,” which encourage error disclosure in return for immunity.

D. This is a case of medication, not medical, error.

E. Silence is golden.

Answer: B. A recent publication concluded, “If medical error were a disease, it would rank as the third leading cause of death in the United States.”¹ This is the latest follow through on the original landmark report from the Institute of Medicine in 2000, which drew the public’s attention to the fact that medical errors were responsible for between 44,000 and 98,000 annual fatalities in the United States.

A medical error denotes a preventable adverse event, which in turn can be described as an injury caused by medical mismanagement rather than the underlying condition of the patient. It is more formally defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.”² The term is not synonymous with medical negligence, which is a legal term of art encompassing four separate elements: duty, breach, causation, and damages.

The most common type of medical error is a medication error, which is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health professional, patient, or consumer.

Medication errors account for 6.3%-30% of all malpractice claims, and a 1999 Texas case is an example.³ A 43-year-old Hispanic man with chest pain was prescribed the anti-angina drug Isordil (isosorbide dinitrate) by his cardiologist, to be taken four times a day in doses of 20 mg. The pharmacist misread the order as Plendil (felodipine), a calcium channel blocker for treatment of hypertension. This exceeded the drug’s top dose, and the patient suffered a heart attack and died several days later.

The cardiologist’s illegible prescription was the sole reason for the error, and his overall quality of care was not at issue. The jury returned a verdict for the plaintiff, awarding $450,000 to his estate: $225,000 from the cardiologist, and $225,000 from the pharmacist.

Many, but not all, jurisdictions now require some form of reporting of medical errors occurring in a hospital setting. States such as California and Florida mandate disclosure to patients. Pennsylvania actually requires hospitals to issue a written disclosure within 7 days of a serious event.

Most states have enacted “apology statutes” to encourage open discussions with patients and their families about adverse results. The apologies may cover expressions of regret, sympathy, and compassion, and they are barred from being presented to the jury should a trial ensue. However, an acknowledgment of fault remains admissible into evidence.

Typical is California’s Evidence Code 1160(a), which provides that only “the portions of statements or benevolent gestures expressing sympathy” are inadmissible against a treating physician. On the other hand, some states have chosen to exclude all disclosures, including admissions of fault. An example is Colorado’s Apology Statute (Colo. Rev. Stat. Ann. 13-25-135), which provides that “any and all statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence ... shall be inadmissible as evidence of an admission of liability or as evidence of an admission against interest.”

Ohio is one of only a few states whose apology statutes fail to clearly distinguish between the admissibility of a physician’s statement of sympathy and one acknowledging fault. R.C. 2317.43, enacted by the Ohio General Assembly in 2004, renders inadmissible “statements, affirmations, gestures, or conduct expressing apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.”

In Davis v. Wooster Orthopaedics & Sports Medicine,⁴ the plaintiff alleged that Dr. Michael Knapic, an orthopedic surgeon, negligently performed a lumbar microdiscectomy, severing the patient’s common iliac artery. The surgeon allegedly then said to the patient’s husband, “It’s my fault. I take full responsibility.”

In a wrongful-death action, the plaintiff argued that the statute did not prohibit the use of statements of fault, responsibility, or liability as compared to statements of sympathy or condolence.

Ohio’s Ninth Appellate District concluded that the intent behind the apology statute was to protect pure expressions of sympathy but not admissions of fault. The court held that Dr. Knapic’s statements constituted an admission of liability that could be admitted into evidence. The jury awarded damages of $3 million.

More recently, the Ohio Supreme Court ruled that Dr. Randall Smith’s alleged confession regarding accidentally sectioning his patient’s common bile duct was properly excluded from evidence, even though the incident took place before the Ohio law went into effect.⁵

The patient had to be readmitted within 3 weeks for obstructive jaundice. After the doctor informed her that she would have to undergo additional surgery, she became very emotional. He reportedly took her hand, saying, “I take full responsibility for this.”

The Ohio Supreme Court ruled, “The trial court had determined that Dr. Smith was faced with a distressed patient who was upset and made a statement that was designed to comfort his patient. This is precisely the type of evidence that R.C. 2317.43 was designed to exclude as evidence of liability in a medical-malpractice case.”

Do disclosures and apologies work?

Both claim frequency and severity have diminished following the adoption of a humanistic risk management policy at the Lexington Veterans Affairs Medical Center since 1987.⁶ The protocol includes early injury review, steadfast maintenance of the relationship between the hospital and the patient, proactive disclosure to patients who have been injured because of accidents or medical negligence, and fair compensation for injuries.

Other institutions such as the University of Michigan have adopted “disclosure and offer” in place of “denial and defend” policies, but these have yet to achieve widespread use.

Many health care providers continue to heed the traditional legal advice to say and admit nothing, believing that it is unsettled whether an apology will influence any decision to sue the doctor. They argue that the odds of a lawsuit are low to begin with.

In the oft-cited Harvard study, there was only one malpractice claim for every 7.6 adverse events caused by negligence among the 3.7% of hospitalized patients who suffered significant iatrogenic injuries, typically from errors or negligence.⁷

Notwithstanding the controversy, the AMA has properly taken the moral high ground: It asserts that error disclosure is the right thing to do.

References

1. BMJ. 2016 May 3;353:i2139.

2. Institute of Medicine: To Err is Human: Building a Safer Health System. National Academy Press, Washington, 2000.

3. Estate of Velasquez v. Albertsons, Inc. et al., Civ. No. A-103-042 (Ector Cnty, TX 1999).

4. Davis v. Wooster Orthopaedics & Sports Medicine, Inc., 193 Ohio App.3d 581 (2011).

5. Estate of Johnson v. Randall Smith, Inc., 131 Ohio St.3d 1543 (2013).

6. N Engl J Med. 2010 Apr 15;362(15):1353-6.

7. N Engl J Med. 1991 Jul 25;325(4):245-51.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at [email protected].

Question: A patient was admitted with heart failure, developed deep vein thrombosis, and was started on warfarin and Lovenox as “bridge” therapy. On day 4, the patient achieved anticoagulation with a prothrombin time of 29.8 and international normalized ratio (INR) of 2.86, but continued to receive both warfarin and Lovenox for a total of 13 days. Both medications were dispensed and administered for 2 days when the PT was greater than 50; the supratherapeutic coagulation profile result was overlooked. Medications held on day 14 (PT, 68; INR, 8.35). The patient developed a right subdural hematoma and was transferred to a tertiary care facility for neurosurgery consult.

Given these facts, which of the following statements is best?

A. The hospital is under a legal obligation to disclose the error.

B. The doctor should be sympathetic and apologize for the injury, but not admit fault.

C. All jurisdictions have so-called “apology statutes,” which encourage error disclosure in return for immunity.

D. This is a case of medication, not medical, error.

E. Silence is golden.

Answer: B. A recent publication concluded, “If medical error were a disease, it would rank as the third leading cause of death in the United States.”¹ This is the latest follow through on the original landmark report from the Institute of Medicine in 2000, which drew the public’s attention to the fact that medical errors were responsible for between 44,000 and 98,000 annual fatalities in the United States.

A medical error denotes a preventable adverse event, which in turn can be described as an injury caused by medical mismanagement rather than the underlying condition of the patient. It is more formally defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.”² The term is not synonymous with medical negligence, which is a legal term of art encompassing four separate elements: duty, breach, causation, and damages.

The most common type of medical error is a medication error, which is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health professional, patient, or consumer.

Medication errors account for 6.3%-30% of all malpractice claims, and a 1999 Texas case is an example.³ A 43-year-old Hispanic man with chest pain was prescribed the anti-angina drug Isordil (isosorbide dinitrate) by his cardiologist, to be taken four times a day in doses of 20 mg. The pharmacist misread the order as Plendil (felodipine), a calcium channel blocker for treatment of hypertension. This exceeded the drug’s top dose, and the patient suffered a heart attack and died several days later.

The cardiologist’s illegible prescription was the sole reason for the error, and his overall quality of care was not at issue. The jury returned a verdict for the plaintiff, awarding $450,000 to his estate: $225,000 from the cardiologist, and $225,000 from the pharmacist.

Many, but not all, jurisdictions now require some form of reporting of medical errors occurring in a hospital setting. States such as California and Florida mandate disclosure to patients. Pennsylvania actually requires hospitals to issue a written disclosure within 7 days of a serious event.

Most states have enacted “apology statutes” to encourage open discussions with patients and their families about adverse results. The apologies may cover expressions of regret, sympathy, and compassion, and they are barred from being presented to the jury should a trial ensue. However, an acknowledgment of fault remains admissible into evidence.

Typical is California’s Evidence Code 1160(a), which provides that only “the portions of statements or benevolent gestures expressing sympathy” are inadmissible against a treating physician. On the other hand, some states have chosen to exclude all disclosures, including admissions of fault. An example is Colorado’s Apology Statute (Colo. Rev. Stat. Ann. 13-25-135), which provides that “any and all statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence ... shall be inadmissible as evidence of an admission of liability or as evidence of an admission against interest.”

Ohio is one of only a few states whose apology statutes fail to clearly distinguish between the admissibility of a physician’s statement of sympathy and one acknowledging fault. R.C. 2317.43, enacted by the Ohio General Assembly in 2004, renders inadmissible “statements, affirmations, gestures, or conduct expressing apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.”

In Davis v. Wooster Orthopaedics & Sports Medicine,⁴ the plaintiff alleged that Dr. Michael Knapic, an orthopedic surgeon, negligently performed a lumbar microdiscectomy, severing the patient’s common iliac artery. The surgeon allegedly then said to the patient’s husband, “It’s my fault. I take full responsibility.”

In a wrongful-death action, the plaintiff argued that the statute did not prohibit the use of statements of fault, responsibility, or liability as compared to statements of sympathy or condolence.

Ohio’s Ninth Appellate District concluded that the intent behind the apology statute was to protect pure expressions of sympathy but not admissions of fault. The court held that Dr. Knapic’s statements constituted an admission of liability that could be admitted into evidence. The jury awarded damages of $3 million.

More recently, the Ohio Supreme Court ruled that Dr. Randall Smith’s alleged confession regarding accidentally sectioning his patient’s common bile duct was properly excluded from evidence, even though the incident took place before the Ohio law went into effect.⁵

The patient had to be readmitted within 3 weeks for obstructive jaundice. After the doctor informed her that she would have to undergo additional surgery, she became very emotional. He reportedly took her hand, saying, “I take full responsibility for this.”

The Ohio Supreme Court ruled, “The trial court had determined that Dr. Smith was faced with a distressed patient who was upset and made a statement that was designed to comfort his patient. This is precisely the type of evidence that R.C. 2317.43 was designed to exclude as evidence of liability in a medical-malpractice case.”

Do disclosures and apologies work?

Both claim frequency and severity have diminished following the adoption of a humanistic risk management policy at the Lexington Veterans Affairs Medical Center since 1987.⁶ The protocol includes early injury review, steadfast maintenance of the relationship between the hospital and the patient, proactive disclosure to patients who have been injured because of accidents or medical negligence, and fair compensation for injuries.

Other institutions such as the University of Michigan have adopted “disclosure and offer” in place of “denial and defend” policies, but these have yet to achieve widespread use.

Many health care providers continue to heed the traditional legal advice to say and admit nothing, believing that it is unsettled whether an apology will influence any decision to sue the doctor. They argue that the odds of a lawsuit are low to begin with.

In the oft-cited Harvard study, there was only one malpractice claim for every 7.6 adverse events caused by negligence among the 3.7% of hospitalized patients who suffered significant iatrogenic injuries, typically from errors or negligence.⁷

Notwithstanding the controversy, the AMA has properly taken the moral high ground: It asserts that error disclosure is the right thing to do.

References

1. BMJ. 2016 May 3;353:i2139.

2. Institute of Medicine: To Err is Human: Building a Safer Health System. National Academy Press, Washington, 2000.

3. Estate of Velasquez v. Albertsons, Inc. et al., Civ. No. A-103-042 (Ector Cnty, TX 1999).

4. Davis v. Wooster Orthopaedics & Sports Medicine, Inc., 193 Ohio App.3d 581 (2011).

5. Estate of Johnson v. Randall Smith, Inc., 131 Ohio St.3d 1543 (2013).

6. N Engl J Med. 2010 Apr 15;362(15):1353-6.

7. N Engl J Med. 1991 Jul 25;325(4):245-51.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at [email protected].

Question: A patient was admitted with heart failure, developed deep vein thrombosis, and was started on warfarin and Lovenox as “bridge” therapy. On day 4, the patient achieved anticoagulation with a prothrombin time of 29.8 and international normalized ratio (INR) of 2.86, but continued to receive both warfarin and Lovenox for a total of 13 days. Both medications were dispensed and administered for 2 days when the PT was greater than 50; the supratherapeutic coagulation profile result was overlooked. Medications held on day 14 (PT, 68; INR, 8.35). The patient developed a right subdural hematoma and was transferred to a tertiary care facility for neurosurgery consult.

Given these facts, which of the following statements is best?

A. The hospital is under a legal obligation to disclose the error.

B. The doctor should be sympathetic and apologize for the injury, but not admit fault.

C. All jurisdictions have so-called “apology statutes,” which encourage error disclosure in return for immunity.

D. This is a case of medication, not medical, error.

E. Silence is golden.

Answer: B. A recent publication concluded, “If medical error were a disease, it would rank as the third leading cause of death in the United States.”¹ This is the latest follow through on the original landmark report from the Institute of Medicine in 2000, which drew the public’s attention to the fact that medical errors were responsible for between 44,000 and 98,000 annual fatalities in the United States.

A medical error denotes a preventable adverse event, which in turn can be described as an injury caused by medical mismanagement rather than the underlying condition of the patient. It is more formally defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.”² The term is not synonymous with medical negligence, which is a legal term of art encompassing four separate elements: duty, breach, causation, and damages.

The most common type of medical error is a medication error, which is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health professional, patient, or consumer.

Medication errors account for 6.3%-30% of all malpractice claims, and a 1999 Texas case is an example.³ A 43-year-old Hispanic man with chest pain was prescribed the anti-angina drug Isordil (isosorbide dinitrate) by his cardiologist, to be taken four times a day in doses of 20 mg. The pharmacist misread the order as Plendil (felodipine), a calcium channel blocker for treatment of hypertension. This exceeded the drug’s top dose, and the patient suffered a heart attack and died several days later.

The cardiologist’s illegible prescription was the sole reason for the error, and his overall quality of care was not at issue. The jury returned a verdict for the plaintiff, awarding $450,000 to his estate: $225,000 from the cardiologist, and $225,000 from the pharmacist.

Many, but not all, jurisdictions now require some form of reporting of medical errors occurring in a hospital setting. States such as California and Florida mandate disclosure to patients. Pennsylvania actually requires hospitals to issue a written disclosure within 7 days of a serious event.

Most states have enacted “apology statutes” to encourage open discussions with patients and their families about adverse results. The apologies may cover expressions of regret, sympathy, and compassion, and they are barred from being presented to the jury should a trial ensue. However, an acknowledgment of fault remains admissible into evidence.

Typical is California’s Evidence Code 1160(a), which provides that only “the portions of statements or benevolent gestures expressing sympathy” are inadmissible against a treating physician. On the other hand, some states have chosen to exclude all disclosures, including admissions of fault. An example is Colorado’s Apology Statute (Colo. Rev. Stat. Ann. 13-25-135), which provides that “any and all statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence ... shall be inadmissible as evidence of an admission of liability or as evidence of an admission against interest.”

Ohio is one of only a few states whose apology statutes fail to clearly distinguish between the admissibility of a physician’s statement of sympathy and one acknowledging fault. R.C. 2317.43, enacted by the Ohio General Assembly in 2004, renders inadmissible “statements, affirmations, gestures, or conduct expressing apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.”

In Davis v. Wooster Orthopaedics & Sports Medicine,⁴ the plaintiff alleged that Dr. Michael Knapic, an orthopedic surgeon, negligently performed a lumbar microdiscectomy, severing the patient’s common iliac artery. The surgeon allegedly then said to the patient’s husband, “It’s my fault. I take full responsibility.”

In a wrongful-death action, the plaintiff argued that the statute did not prohibit the use of statements of fault, responsibility, or liability as compared to statements of sympathy or condolence.

Ohio’s Ninth Appellate District concluded that the intent behind the apology statute was to protect pure expressions of sympathy but not admissions of fault. The court held that Dr. Knapic’s statements constituted an admission of liability that could be admitted into evidence. The jury awarded damages of $3 million.

More recently, the Ohio Supreme Court ruled that Dr. Randall Smith’s alleged confession regarding accidentally sectioning his patient’s common bile duct was properly excluded from evidence, even though the incident took place before the Ohio law went into effect.⁵

The patient had to be readmitted within 3 weeks for obstructive jaundice. After the doctor informed her that she would have to undergo additional surgery, she became very emotional. He reportedly took her hand, saying, “I take full responsibility for this.”

The Ohio Supreme Court ruled, “The trial court had determined that Dr. Smith was faced with a distressed patient who was upset and made a statement that was designed to comfort his patient. This is precisely the type of evidence that R.C. 2317.43 was designed to exclude as evidence of liability in a medical-malpractice case.”

Do disclosures and apologies work?

Both claim frequency and severity have diminished following the adoption of a humanistic risk management policy at the Lexington Veterans Affairs Medical Center since 1987.⁶ The protocol includes early injury review, steadfast maintenance of the relationship between the hospital and the patient, proactive disclosure to patients who have been injured because of accidents or medical negligence, and fair compensation for injuries.

Other institutions such as the University of Michigan have adopted “disclosure and offer” in place of “denial and defend” policies, but these have yet to achieve widespread use.

Many health care providers continue to heed the traditional legal advice to say and admit nothing, believing that it is unsettled whether an apology will influence any decision to sue the doctor. They argue that the odds of a lawsuit are low to begin with.

In the oft-cited Harvard study, there was only one malpractice claim for every 7.6 adverse events caused by negligence among the 3.7% of hospitalized patients who suffered significant iatrogenic injuries, typically from errors or negligence.⁷

Notwithstanding the controversy, the AMA has properly taken the moral high ground: It asserts that error disclosure is the right thing to do.

References

1. BMJ. 2016 May 3;353:i2139.

2. Institute of Medicine: To Err is Human: Building a Safer Health System. National Academy Press, Washington, 2000.

3. Estate of Velasquez v. Albertsons, Inc. et al., Civ. No. A-103-042 (Ector Cnty, TX 1999).

4. Davis v. Wooster Orthopaedics & Sports Medicine, Inc., 193 Ohio App.3d 581 (2011).

5. Estate of Johnson v. Randall Smith, Inc., 131 Ohio St.3d 1543 (2013).

6. N Engl J Med. 2010 Apr 15;362(15):1353-6.

7. N Engl J Med. 1991 Jul 25;325(4):245-51.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at [email protected].

WASHINGTON – What has the increased access to contraception over the last 50 years meant for American women?

We asked Ob.Gyn. News editorial advisory board member Dr. Eve Espey, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, along with three experts in family planning, to explore how expanded contraception options have affected public health, what barriers still remain, and what new products are in the pipeline.

Perhaps the biggest impact for women has been the ability to participate in the workforce, and that includes women entering medical school.

“Over the last 50 years, we’ve seen a big increase in the number of women who are professionals, who are physicians,” Dr. Espey said during the roundtable. “And during that same period of time, we’ve seen the growth of more focus on family planning.”

“I think that really would not be possible without the ability to control our fertility,” said Dr. Sarah W. Prager, associate professor of obstetrics and gynecology and director of the Ryan Family Planning Program at the University of Washington, Seattle.

And the widespread availability of contraception has translated into a decrease in maternal mortality as a result of fewer unintended pregnancies. “The implications for public health – for women and children in this country – is huge,” Dr. Prager said.

LARCs

One of the big shifts in contraceptive trends has been the slow but increasing uptake of long-acting reversible contraceptives (LARCs), such as IUDs and implants. After a drop-off in the 1970s following safety problems with the Dalkon Shield, there has been a resurgence in interest.

In the last decade, the rate of LARC use has grown from about 2% to 10%, corresponding to a slight drop in rates of unintended pregnancy, said Dr. Nikki B. Zite, professor and residency program director in the department of obstetrics and gynecology at the University of Tennessee, Knoxville.

The Contraceptive CHOICE Project, which enrolled more than 9,000 women who were provided with the no-cost reversible contraceptive method of their choice, found that about three-quarters of the women chose an IUD or an implant, which was associated with significant reductions in unintended and teen pregnancies.

“What we saw was that when we removed barriers to contraception in general, that uptake of IUDs and implants really went up,” said Dr. Tessa Madden, director of the division of family planning and associate professor in the department of obstetrics and gynecology at Washington University, St. Louis.

There is no “best” contraceptive method, Dr. Madden said. “Contraception really needs to be tailored to the individual woman [ensuring] that her values and preferences about contraception are taken into consideration during counseling, to help her choose the method that’s going to be the best fit for her.”

Resources

There are resources available to aid in tailoring contraception methods to the needs of patients.

U.S. Medical Eligibility Criteria for Contraceptive Use, guidance that is available through the Centers for Disease Control and Prevention, allows physicians to tailor the method to a patient’s comorbid medical conditions, Dr. Zite said. Physicians can search by contraceptive method or patient characteristic to determine the risk for a given patient, rated on a scale of 1-4 (where 1 or 2 means generally safe, 3 means that the risks may outweigh the benefits, and 4 means that the risks clearly outweigh the benefits).

“It’s a really easy starting-off point to use with patients and physicians when trying to decide what contraceptive method is safe for their patient,” Dr. Zite said.

Common medical comorbidities, including obesity, diabetes, thyroid disease, and hypertension, are all addressed in the medical eligibility criteria.

Another resource is the U.S. Selected Practice Recommendations for Contraceptive Use, which can help in deciding when it is appropriate to start a contraceptive method, what exams and tests are needed before initiation, what follow-up is needed, and how to handle problems such as missed pills or potential side effects.

Barriers

Over the years, many of the barriers to contraceptive access have been reduced. Some forms of emergency contraception are now available over the counter to women of all ages; more states are considering laws allowing women to access up to a year’s supply of hormonal contraceptives at one time; and a few states have passed laws allowing pharmacists to prescribe hormonal birth control directly. In addition, the Affordable Care Act’s mandate for insurers to cover approved methods of contraception without cost sharing has eliminated some cost barriers.

But other systems barriers still remain, such as making women return for multiple visits for the insertion of an IUD or implant, or limiting LARC use only to women who have already had a child. “There’s not a reason to avoid use of IUDs in women that have not had babies but there are still providers out there who will not insert an IUD, so we need to still do a better job to increase access even more,” Dr. Zite said.

Future trends

What new contraceptive options are in the pipeline? Dr. Prager predicted more development in the area of longer-acting injectables and implants, potentially even biodegradable implants. Also likely is the development of nonsurgical sterilization methods for women that eliminate some of the risk and cost barriers. And male contraceptive methods are in the works, both hormonal and nonhormonal, Dr. Prager said.

There’s an increasing interested in nonhormonal longer-acting methods, beyond just the copper IUD, Dr. Madden said, and there are new products on the horizon in that area. Researchers are exploring new methods to protect against HIV and other sexually transmitted infections, while offering contraception, Dr. Zite said.

Dr. Espey reported having no relevant financial disclosures. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Zite is an unpaid trainer for Nexplanon and serves on an international IUD advisory board for Bayer. Dr. Madden serves on a scientific advisory board for Bayer and on a data safety monitoring board for phase IV safety studies of Bayer contraceptive products.

Throughout 2016, Ob.Gyn. News is celebrating its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of infertility treatment, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

[email protected]

On Twitter @maryellenny

WASHINGTON – What has the increased access to contraception over the last 50 years meant for American women?

We asked Ob.Gyn. News editorial advisory board member Dr. Eve Espey, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, along with three experts in family planning, to explore how expanded contraception options have affected public health, what barriers still remain, and what new products are in the pipeline.

Perhaps the biggest impact for women has been the ability to participate in the workforce, and that includes women entering medical school.

“Over the last 50 years, we’ve seen a big increase in the number of women who are professionals, who are physicians,” Dr. Espey said during the roundtable. “And during that same period of time, we’ve seen the growth of more focus on family planning.”

“I think that really would not be possible without the ability to control our fertility,” said Dr. Sarah W. Prager, associate professor of obstetrics and gynecology and director of the Ryan Family Planning Program at the University of Washington, Seattle.

And the widespread availability of contraception has translated into a decrease in maternal mortality as a result of fewer unintended pregnancies. “The implications for public health – for women and children in this country – is huge,” Dr. Prager said.

LARCs

One of the big shifts in contraceptive trends has been the slow but increasing uptake of long-acting reversible contraceptives (LARCs), such as IUDs and implants. After a drop-off in the 1970s following safety problems with the Dalkon Shield, there has been a resurgence in interest.

In the last decade, the rate of LARC use has grown from about 2% to 10%, corresponding to a slight drop in rates of unintended pregnancy, said Dr. Nikki B. Zite, professor and residency program director in the department of obstetrics and gynecology at the University of Tennessee, Knoxville.

The Contraceptive CHOICE Project, which enrolled more than 9,000 women who were provided with the no-cost reversible contraceptive method of their choice, found that about three-quarters of the women chose an IUD or an implant, which was associated with significant reductions in unintended and teen pregnancies.

“What we saw was that when we removed barriers to contraception in general, that uptake of IUDs and implants really went up,” said Dr. Tessa Madden, director of the division of family planning and associate professor in the department of obstetrics and gynecology at Washington University, St. Louis.

There is no “best” contraceptive method, Dr. Madden said. “Contraception really needs to be tailored to the individual woman [ensuring] that her values and preferences about contraception are taken into consideration during counseling, to help her choose the method that’s going to be the best fit for her.”

Resources

There are resources available to aid in tailoring contraception methods to the needs of patients.

U.S. Medical Eligibility Criteria for Contraceptive Use, guidance that is available through the Centers for Disease Control and Prevention, allows physicians to tailor the method to a patient’s comorbid medical conditions, Dr. Zite said. Physicians can search by contraceptive method or patient characteristic to determine the risk for a given patient, rated on a scale of 1-4 (where 1 or 2 means generally safe, 3 means that the risks may outweigh the benefits, and 4 means that the risks clearly outweigh the benefits).

“It’s a really easy starting-off point to use with patients and physicians when trying to decide what contraceptive method is safe for their patient,” Dr. Zite said.

Common medical comorbidities, including obesity, diabetes, thyroid disease, and hypertension, are all addressed in the medical eligibility criteria.

Another resource is the U.S. Selected Practice Recommendations for Contraceptive Use, which can help in deciding when it is appropriate to start a contraceptive method, what exams and tests are needed before initiation, what follow-up is needed, and how to handle problems such as missed pills or potential side effects.

Barriers

Over the years, many of the barriers to contraceptive access have been reduced. Some forms of emergency contraception are now available over the counter to women of all ages; more states are considering laws allowing women to access up to a year’s supply of hormonal contraceptives at one time; and a few states have passed laws allowing pharmacists to prescribe hormonal birth control directly. In addition, the Affordable Care Act’s mandate for insurers to cover approved methods of contraception without cost sharing has eliminated some cost barriers.

But other systems barriers still remain, such as making women return for multiple visits for the insertion of an IUD or implant, or limiting LARC use only to women who have already had a child. “There’s not a reason to avoid use of IUDs in women that have not had babies but there are still providers out there who will not insert an IUD, so we need to still do a better job to increase access even more,” Dr. Zite said.

Future trends

What new contraceptive options are in the pipeline? Dr. Prager predicted more development in the area of longer-acting injectables and implants, potentially even biodegradable implants. Also likely is the development of nonsurgical sterilization methods for women that eliminate some of the risk and cost barriers. And male contraceptive methods are in the works, both hormonal and nonhormonal, Dr. Prager said.

There’s an increasing interested in nonhormonal longer-acting methods, beyond just the copper IUD, Dr. Madden said, and there are new products on the horizon in that area. Researchers are exploring new methods to protect against HIV and other sexually transmitted infections, while offering contraception, Dr. Zite said.

Dr. Espey reported having no relevant financial disclosures. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Zite is an unpaid trainer for Nexplanon and serves on an international IUD advisory board for Bayer. Dr. Madden serves on a scientific advisory board for Bayer and on a data safety monitoring board for phase IV safety studies of Bayer contraceptive products.

Throughout 2016, Ob.Gyn. News is celebrating its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of infertility treatment, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

[email protected]

On Twitter @maryellenny

WASHINGTON – What has the increased access to contraception over the last 50 years meant for American women?

We asked Ob.Gyn. News editorial advisory board member Dr. Eve Espey, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, along with three experts in family planning, to explore how expanded contraception options have affected public health, what barriers still remain, and what new products are in the pipeline.

Perhaps the biggest impact for women has been the ability to participate in the workforce, and that includes women entering medical school.

“Over the last 50 years, we’ve seen a big increase in the number of women who are professionals, who are physicians,” Dr. Espey said during the roundtable. “And during that same period of time, we’ve seen the growth of more focus on family planning.”

“I think that really would not be possible without the ability to control our fertility,” said Dr. Sarah W. Prager, associate professor of obstetrics and gynecology and director of the Ryan Family Planning Program at the University of Washington, Seattle.

And the widespread availability of contraception has translated into a decrease in maternal mortality as a result of fewer unintended pregnancies. “The implications for public health – for women and children in this country – is huge,” Dr. Prager said.

LARCs

One of the big shifts in contraceptive trends has been the slow but increasing uptake of long-acting reversible contraceptives (LARCs), such as IUDs and implants. After a drop-off in the 1970s following safety problems with the Dalkon Shield, there has been a resurgence in interest.

In the last decade, the rate of LARC use has grown from about 2% to 10%, corresponding to a slight drop in rates of unintended pregnancy, said Dr. Nikki B. Zite, professor and residency program director in the department of obstetrics and gynecology at the University of Tennessee, Knoxville.

The Contraceptive CHOICE Project, which enrolled more than 9,000 women who were provided with the no-cost reversible contraceptive method of their choice, found that about three-quarters of the women chose an IUD or an implant, which was associated with significant reductions in unintended and teen pregnancies.

“What we saw was that when we removed barriers to contraception in general, that uptake of IUDs and implants really went up,” said Dr. Tessa Madden, director of the division of family planning and associate professor in the department of obstetrics and gynecology at Washington University, St. Louis.

There is no “best” contraceptive method, Dr. Madden said. “Contraception really needs to be tailored to the individual woman [ensuring] that her values and preferences about contraception are taken into consideration during counseling, to help her choose the method that’s going to be the best fit for her.”

Resources

There are resources available to aid in tailoring contraception methods to the needs of patients.

U.S. Medical Eligibility Criteria for Contraceptive Use, guidance that is available through the Centers for Disease Control and Prevention, allows physicians to tailor the method to a patient’s comorbid medical conditions, Dr. Zite said. Physicians can search by contraceptive method or patient characteristic to determine the risk for a given patient, rated on a scale of 1-4 (where 1 or 2 means generally safe, 3 means that the risks may outweigh the benefits, and 4 means that the risks clearly outweigh the benefits).

“It’s a really easy starting-off point to use with patients and physicians when trying to decide what contraceptive method is safe for their patient,” Dr. Zite said.

Common medical comorbidities, including obesity, diabetes, thyroid disease, and hypertension, are all addressed in the medical eligibility criteria.

Another resource is the U.S. Selected Practice Recommendations for Contraceptive Use, which can help in deciding when it is appropriate to start a contraceptive method, what exams and tests are needed before initiation, what follow-up is needed, and how to handle problems such as missed pills or potential side effects.

Barriers

Over the years, many of the barriers to contraceptive access have been reduced. Some forms of emergency contraception are now available over the counter to women of all ages; more states are considering laws allowing women to access up to a year’s supply of hormonal contraceptives at one time; and a few states have passed laws allowing pharmacists to prescribe hormonal birth control directly. In addition, the Affordable Care Act’s mandate for insurers to cover approved methods of contraception without cost sharing has eliminated some cost barriers.

But other systems barriers still remain, such as making women return for multiple visits for the insertion of an IUD or implant, or limiting LARC use only to women who have already had a child. “There’s not a reason to avoid use of IUDs in women that have not had babies but there are still providers out there who will not insert an IUD, so we need to still do a better job to increase access even more,” Dr. Zite said.

Future trends

What new contraceptive options are in the pipeline? Dr. Prager predicted more development in the area of longer-acting injectables and implants, potentially even biodegradable implants. Also likely is the development of nonsurgical sterilization methods for women that eliminate some of the risk and cost barriers. And male contraceptive methods are in the works, both hormonal and nonhormonal, Dr. Prager said.

There’s an increasing interested in nonhormonal longer-acting methods, beyond just the copper IUD, Dr. Madden said, and there are new products on the horizon in that area. Researchers are exploring new methods to protect against HIV and other sexually transmitted infections, while offering contraception, Dr. Zite said.

Dr. Espey reported having no relevant financial disclosures. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Zite is an unpaid trainer for Nexplanon and serves on an international IUD advisory board for Bayer. Dr. Madden serves on a scientific advisory board for Bayer and on a data safety monitoring board for phase IV safety studies of Bayer contraceptive products.

Throughout 2016, Ob.Gyn. News is celebrating its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of infertility treatment, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

[email protected]

On Twitter @maryellenny

In The Case Report Issue, we feature four separate case reports presenting different conditions, much like patients may present in succession to a busy ED. Though considered of lesser importance than other types of peer-reviewed literature in this era of evidence-based medicine, case reports nevertheless fulfill an important role in clinical practice, medical education, and even medical research by identifying and tracking an important cause of a developing disease--especially one with a toxicologic or infectious etiology. In some instances, case reports also identify effective or ineffective treatments (though the latter is more rarely reported) and adverse effects of approved treatments, especially those of a newly introduced “Phase IV” medication.

Often, the ED is the initial setting for many reportable occurrences, and in recent years, patients first presenting to EDs have alerted the entire medical community to serious emerging illnesses such as Legionnaires’ disease, HIV and AIDS, anthrax, and Ebola. Most recently, firsthand reports by a pair of mother/daughter physicians in Brazil linked an alarming appearance of several new cases of microcephaly to a rash that followed a mosquito bite during pregnancy, and ultimately to identification of the mosquito-borne Zika virus.

Similarly, toxicologists at urban poison centers have been able to rapidly link cases of new and puzzling adverse effects and deaths reported by area emergency physicians to a dangerous new street drug or combination of drugs in that area, such as synthetic cannabinoid agonists, or heroin mixed with scopolamine, and then immediately alert other physicians and the public to these dangers.

As recently described by Florek and Dellavalle in Journal of Medical Case Reports (http://bit.ly/28PLi7w), case reports make meaningful contributions to the knowledge and education of medical students, residents, fellows, and (we would add) attendings. Written with the goal of sharing information for medical or scientific purposes, they often serve as a young physician’s first experience with medical writing and provide a solid foundation for manuscript preparation and publication.

Finally, a good ED case report that includes accurate descriptions of all relevant features along with any unique departures from classical presentations, followed by an up-to-date review of current treatments, presents most of us with a vivid means of identifying and remembering the salient features of a clinical problem or disease.

In The Case Report Issue, we feature four separate case reports presenting different conditions, much like patients may present in succession to a busy ED. Though considered of lesser importance than other types of peer-reviewed literature in this era of evidence-based medicine, case reports nevertheless fulfill an important role in clinical practice, medical education, and even medical research by identifying and tracking an important cause of a developing disease--especially one with a toxicologic or infectious etiology. In some instances, case reports also identify effective or ineffective treatments (though the latter is more rarely reported) and adverse effects of approved treatments, especially those of a newly introduced “Phase IV” medication.

Often, the ED is the initial setting for many reportable occurrences, and in recent years, patients first presenting to EDs have alerted the entire medical community to serious emerging illnesses such as Legionnaires’ disease, HIV and AIDS, anthrax, and Ebola. Most recently, firsthand reports by a pair of mother/daughter physicians in Brazil linked an alarming appearance of several new cases of microcephaly to a rash that followed a mosquito bite during pregnancy, and ultimately to identification of the mosquito-borne Zika virus.

Similarly, toxicologists at urban poison centers have been able to rapidly link cases of new and puzzling adverse effects and deaths reported by area emergency physicians to a dangerous new street drug or combination of drugs in that area, such as synthetic cannabinoid agonists, or heroin mixed with scopolamine, and then immediately alert other physicians and the public to these dangers.

As recently described by Florek and Dellavalle in Journal of Medical Case Reports (http://bit.ly/28PLi7w), case reports make meaningful contributions to the knowledge and education of medical students, residents, fellows, and (we would add) attendings. Written with the goal of sharing information for medical or scientific purposes, they often serve as a young physician’s first experience with medical writing and provide a solid foundation for manuscript preparation and publication.

Finally, a good ED case report that includes accurate descriptions of all relevant features along with any unique departures from classical presentations, followed by an up-to-date review of current treatments, presents most of us with a vivid means of identifying and remembering the salient features of a clinical problem or disease.

In The Case Report Issue, we feature four separate case reports presenting different conditions, much like patients may present in succession to a busy ED. Though considered of lesser importance than other types of peer-reviewed literature in this era of evidence-based medicine, case reports nevertheless fulfill an important role in clinical practice, medical education, and even medical research by identifying and tracking an important cause of a developing disease--especially one with a toxicologic or infectious etiology. In some instances, case reports also identify effective or ineffective treatments (though the latter is more rarely reported) and adverse effects of approved treatments, especially those of a newly introduced “Phase IV” medication.

Often, the ED is the initial setting for many reportable occurrences, and in recent years, patients first presenting to EDs have alerted the entire medical community to serious emerging illnesses such as Legionnaires’ disease, HIV and AIDS, anthrax, and Ebola. Most recently, firsthand reports by a pair of mother/daughter physicians in Brazil linked an alarming appearance of several new cases of microcephaly to a rash that followed a mosquito bite during pregnancy, and ultimately to identification of the mosquito-borne Zika virus.

Similarly, toxicologists at urban poison centers have been able to rapidly link cases of new and puzzling adverse effects and deaths reported by area emergency physicians to a dangerous new street drug or combination of drugs in that area, such as synthetic cannabinoid agonists, or heroin mixed with scopolamine, and then immediately alert other physicians and the public to these dangers.

As recently described by Florek and Dellavalle in Journal of Medical Case Reports (http://bit.ly/28PLi7w), case reports make meaningful contributions to the knowledge and education of medical students, residents, fellows, and (we would add) attendings. Written with the goal of sharing information for medical or scientific purposes, they often serve as a young physician’s first experience with medical writing and provide a solid foundation for manuscript preparation and publication.

Finally, a good ED case report that includes accurate descriptions of all relevant features along with any unique departures from classical presentations, followed by an up-to-date review of current treatments, presents most of us with a vivid means of identifying and remembering the salient features of a clinical problem or disease.

The 2015 American Heart Association CPR/ACLS update categorizes amiodarone and lidocaine as IIb drugs that “may be considered” for ventricular fibrillation or pulseless ventricular tachycardia unresponsive to CPR, defibrillation, or vasopressors. Out-of-hospital use of these drugs has previously been shown to increase survival rate to hospital admission, but not necessarily to hospital discharge.

The effects of amiodarone and lidocaine on the rate of survival to hospital discharge are addressed in a recent randomized, double-blind, out-of-hospital trial comparing amiodarone, lidocaine, and placebo in the treatment of shock-refractory ventricular fibrillation or pulseless ventricular tachycardia (N Engl J Med. 2016;374[18]:1711-1722). This study was conducted by the Resuscitation Outcomes Consortium (ROC) in 3,026 patients at 10 US and Canadian sites. The ROC authors concluded that “overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo.” But the article raises concerns about its methodology, appropriateness of its primary and secondary outcomes to out-of-hospital (or prehospital) care, and the manner in which its findings were reported.

Because of the condition (unconscious) and circumstances (out of hospital) of the patients at the time medication or placebo must be administered, this NIH-supported trial was conducted under exception from informed consent in emergency research, with FDA and Health Canada oversight, and with approval by trial-site Institutional Review Boards. Notwithstanding the list of regulatory bodies that approved the exception, is the trial appropriate for drugs previously demonstrated to be efficacious in improving survival rates to hospital admission—long considered the goal of prehospital care—when subsequent care from admission to hospital discharge is not standardized or controlled across multiple sites in two countries?

Another concern is the way the results were reported. Will the authors’ conclusion that overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival  suggest to hurried readers that there is no benefit to any patient to hospital discharge from either antiarrhythmic agent? In the results section, the authors report “active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest.” Also noted in the accompanying editorial entitled “Out-of-Hospital Cardiac Arrest—Are Drugs Ever the Answer?” (N Engl J Med. 2016;374[18]:1781-1782), both drugs were associated with nonsignificant increases in survival rate, fewer subsequent shocks, and less administration of rhythm-control medications or need for CPR during hospitalization, compared with patients’ courses after placebo. 

The ROC trial is not the first or only out-of-hospital trial to use survival to hospital discharge as its primary outcome measure. A 1990-1991 study using death or discharge home to determine survival from out-of-hospital cardiac arrests in New York City found that of the 2,329 patients who met entry criteria for that study, overall survival was only 1.4%—which the authors attributed partly to lengthy elapsed time intervals at every step in the chain of survival, lack of adequate bystander CPR, and possibly sociodemographic features common to victims of cardiac arrest in large cities (JAMA. 1994;271[9]:678-683). The poor results  led to increases in first responders and AED availability but not the abandonment of properly performed CPR and ACLS. In the ROC trial, length of time from cardiac arrest to administration of medications clearly was shown to be a significant outcome determinant and was emphasized in the accompanying editorial. Here too shouldn’t we concentrate on optimizing the setting and timing of CPR and ACLS measures?  

The 2015 American Heart Association CPR/ACLS update categorizes amiodarone and lidocaine as IIb drugs that “may be considered” for ventricular fibrillation or pulseless ventricular tachycardia unresponsive to CPR, defibrillation, or vasopressors. Out-of-hospital use of these drugs has previously been shown to increase survival rate to hospital admission, but not necessarily to hospital discharge.

The effects of amiodarone and lidocaine on the rate of survival to hospital discharge are addressed in a recent randomized, double-blind, out-of-hospital trial comparing amiodarone, lidocaine, and placebo in the treatment of shock-refractory ventricular fibrillation or pulseless ventricular tachycardia (N Engl J Med. 2016;374[18]:1711-1722). This study was conducted by the Resuscitation Outcomes Consortium (ROC) in 3,026 patients at 10 US and Canadian sites. The ROC authors concluded that “overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo.” But the article raises concerns about its methodology, appropriateness of its primary and secondary outcomes to out-of-hospital (or prehospital) care, and the manner in which its findings were reported.

Because of the condition (unconscious) and circumstances (out of hospital) of the patients at the time medication or placebo must be administered, this NIH-supported trial was conducted under exception from informed consent in emergency research, with FDA and Health Canada oversight, and with approval by trial-site Institutional Review Boards. Notwithstanding the list of regulatory bodies that approved the exception, is the trial appropriate for drugs previously demonstrated to be efficacious in improving survival rates to hospital admission—long considered the goal of prehospital care—when subsequent care from admission to hospital discharge is not standardized or controlled across multiple sites in two countries?

Another concern is the way the results were reported. Will the authors’ conclusion that overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival  suggest to hurried readers that there is no benefit to any patient to hospital discharge from either antiarrhythmic agent? In the results section, the authors report “active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest.” Also noted in the accompanying editorial entitled “Out-of-Hospital Cardiac Arrest—Are Drugs Ever the Answer?” (N Engl J Med. 2016;374[18]:1781-1782), both drugs were associated with nonsignificant increases in survival rate, fewer subsequent shocks, and less administration of rhythm-control medications or need for CPR during hospitalization, compared with patients’ courses after placebo. 

The ROC trial is not the first or only out-of-hospital trial to use survival to hospital discharge as its primary outcome measure. A 1990-1991 study using death or discharge home to determine survival from out-of-hospital cardiac arrests in New York City found that of the 2,329 patients who met entry criteria for that study, overall survival was only 1.4%—which the authors attributed partly to lengthy elapsed time intervals at every step in the chain of survival, lack of adequate bystander CPR, and possibly sociodemographic features common to victims of cardiac arrest in large cities (JAMA. 1994;271[9]:678-683). The poor results  led to increases in first responders and AED availability but not the abandonment of properly performed CPR and ACLS. In the ROC trial, length of time from cardiac arrest to administration of medications clearly was shown to be a significant outcome determinant and was emphasized in the accompanying editorial. Here too shouldn’t we concentrate on optimizing the setting and timing of CPR and ACLS measures?  

The 2015 American Heart Association CPR/ACLS update categorizes amiodarone and lidocaine as IIb drugs that “may be considered” for ventricular fibrillation or pulseless ventricular tachycardia unresponsive to CPR, defibrillation, or vasopressors. Out-of-hospital use of these drugs has previously been shown to increase survival rate to hospital admission, but not necessarily to hospital discharge.

The effects of amiodarone and lidocaine on the rate of survival to hospital discharge are addressed in a recent randomized, double-blind, out-of-hospital trial comparing amiodarone, lidocaine, and placebo in the treatment of shock-refractory ventricular fibrillation or pulseless ventricular tachycardia (N Engl J Med. 2016;374[18]:1711-1722). This study was conducted by the Resuscitation Outcomes Consortium (ROC) in 3,026 patients at 10 US and Canadian sites. The ROC authors concluded that “overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo.” But the article raises concerns about its methodology, appropriateness of its primary and secondary outcomes to out-of-hospital (or prehospital) care, and the manner in which its findings were reported.

Because of the condition (unconscious) and circumstances (out of hospital) of the patients at the time medication or placebo must be administered, this NIH-supported trial was conducted under exception from informed consent in emergency research, with FDA and Health Canada oversight, and with approval by trial-site Institutional Review Boards. Notwithstanding the list of regulatory bodies that approved the exception, is the trial appropriate for drugs previously demonstrated to be efficacious in improving survival rates to hospital admission—long considered the goal of prehospital care—when subsequent care from admission to hospital discharge is not standardized or controlled across multiple sites in two countries?

Another concern is the way the results were reported. Will the authors’ conclusion that overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival  suggest to hurried readers that there is no benefit to any patient to hospital discharge from either antiarrhythmic agent? In the results section, the authors report “active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest.” Also noted in the accompanying editorial entitled “Out-of-Hospital Cardiac Arrest—Are Drugs Ever the Answer?” (N Engl J Med. 2016;374[18]:1781-1782), both drugs were associated with nonsignificant increases in survival rate, fewer subsequent shocks, and less administration of rhythm-control medications or need for CPR during hospitalization, compared with patients’ courses after placebo. 

The ROC trial is not the first or only out-of-hospital trial to use survival to hospital discharge as its primary outcome measure. A 1990-1991 study using death or discharge home to determine survival from out-of-hospital cardiac arrests in New York City found that of the 2,329 patients who met entry criteria for that study, overall survival was only 1.4%—which the authors attributed partly to lengthy elapsed time intervals at every step in the chain of survival, lack of adequate bystander CPR, and possibly sociodemographic features common to victims of cardiac arrest in large cities (JAMA. 1994;271[9]:678-683). The poor results  led to increases in first responders and AED availability but not the abandonment of properly performed CPR and ACLS. In the ROC trial, length of time from cardiac arrest to administration of medications clearly was shown to be a significant outcome determinant and was emphasized in the accompanying editorial. Here too shouldn’t we concentrate on optimizing the setting and timing of CPR and ACLS measures?