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Does routine amniotomy have a role in normal labor?
It may, depending on the stage of labor and whether the woman has given birth previously. Routine amniotomy doesn’t significantly reduce the duration of first-stage labor in either primiparous or multiparous women (strength of recommendation [SOR]: A, systematic review of several randomized, controlled trials [RCTs]); it slightly shortens second-stage labor in primiparous women only (SOR: A, systematic review of several RCTs). A trend toward increased rates of cesarean section has been noted in low-risk women who undergo routine amniotomy (SOR: A, systematic review of several RCTs). The procedure doesn’t appear to affect neonatal outcomes (SOR: B, uncommon endpoint in several large RCTs).
Discuss amniotomy with first-time moms
Jon O. Neher, MD
Valley Medical Center, Renton, Wash
There does not appear to be a compelling reason to perform amniotomy routinely in laboring patients. While not particularly harmful (the trend toward increased surgical delivery was not statistically significant), amniotomy is not particularly helpful either. It has no obvious benefit in multiparous patients. In primips, it shortens the entire process of labor by just a few minutes. Some family physicians may want to explore the option with their primips. Otherwise, just forget it.
Evidence summary
More than 4 million babies are delivered each year in the United States, and amniotomy is one of the most common obstetric procedures. It’s typically employed to accelerate labor and was originally thought to decrease cesarean section rates. However, the extent to which amniotomy alone shortens labor varies widely from study to study, and no clear consensus exists concerning the potential harms or unintended effects of this practice.1-7
A 2007 Cochrane review of 14 trials (4893 women) investigated the risks and benefits of routine amniotomy vs intention to leave membranes intact. All trials included only very-low-risk women in spontaneous labor at term with a singleton fetus in vertex presentation.8 Because of the strict inclusion criteria, up to 80% of women giving birth in participating centers were excluded. Plus, many of the women in control groups underwent amniotomy at some stage of labor, because most trials allowed clinicians to perform amniotomy if clinically indicated.1-7
Little effect on first-stage labor
Five of the trials (1127 women) reported length of first-stage labor. No statistically significant difference was found between amniotomy and control groups (weighted mean difference [WMD]=–20.43 minutes; 95% confidence interval [CI], –95.93 to 55.06). Furthermore, subgroup analysis found no statistically significant reduction in length of first-stage labor for nulliparous (WMD=–57.93 min; 95% CI, –152.66 to 36.80) or multiparous women (WMD= 23.10 min; 95% CI, –50.89 to 97.09).
Seven trials (1237 women) in the Cochrane review reported length of second-stage labor. No statistically significant difference was noted between amniotomy and control groups (WMD=–2.38 minutes; 95% CI, –5.27 to 0.50). However, subgroup analysis of primiparous women showed a statistically significant reduction in length of second-stage labor in the amniotomy group (WMD=–6.59 minutes; 95% CI, –12.34 to –0.84).8
More cesareans
Nine trials (4370 women) included in the Cochrane review reported cesarean section rates. Women in the amniotomy group had an increased risk of cesarean delivery compared with the control group, but the difference did not reach statistical significance (relative risk=1.26; 95% CI, 0.98-1.62).8 Because cesarean section was surprisingly rare in this low-risk patient population compared with the national average, the studies were not powered to show statistical significance in this secondary outcome.
What about neonatal outcomes?
No significant differences between the amniotomy and intact groups were noted in less uniformly reported maternal outcomes, including need for oxytocin to augment labor, rate of infection, serious morbidity, or death.8 Likewise, differences in neonatal outcomes—such as sepsis, respiratory failure, admission to the special care unit, and death—weren’t statistically significant. Notably, however, these secondary outcomes occurred too rarely to measure the effect precisely.
Because of the relatively small sample sizes and rarity of complications, the studies have limited ability to address the effect of routine amniotomy on maternal and neonatal morbidity in the general population. Larger studies, with a wider variety of patients, would improve clarity.
Recommendations
The American College of Obstetricians and Gynecologists (ACOG) hasn’t issued a statement on the use of routine amniotomy in normal labor. With regard to labor dystocia, ACOG states that “amniotomy may enhance progress in the active phase and negate the need for oxytocin augmentation, but it may increase the risk of chorioamnionitis.”9
And the ACOG bulletin on induction of labor reports that “the potential risks associated with amniotomy include prolapse of the umbilical cord, chorioamnionitis, significant umbilical cord compression, and rupture of vasa previa.”10
1. UK Amniotomy Group. A multicentre randomized trial of amniotomy in spontaneous first labour at term. Br J Obstet Gynaecol. 1994;101:307-309.
2. Fraser WD, Marcoux S, Moutquin JM, et al. effect of early amniotomy on the risk of dystocia in nulliparous women. N Engl J Med. 1993;328:1145-1149.
3. Johnson N, Lilford R, Guthrie K, et al. Randomised trial comparing a policy of early with selective amniotomy in uncomplicated labour at term. Br J Obstet Gynaecol. 1997;104:340-346.
4. Garite TJ, Porto M, Carlson NJ, et al. The influence of elective amniotomy on fetal heart rate patterns and the course of labor in term patients: a randomized study. Br J Obstet Gynaecol. 1993;168:1827-1832.
5. Barrett J, Savage J, Phillips K, et al. Randomized trial of amniotomy in labour versus the intention to leave membranes intact until the second stage. Br J Obstet Gynaecol. 1992;99:5-9.
6. Fraser WD, Sauve R, Parboosingh IJ, et al. A randomized, controlled trial of early amniotomy. Br J Obstet Gynaecol. 1991;98:84-91.
7. Ajadi MA, Kuti O, Orji EO, et al. The effect of amniotomy on the outcome of spontaneous labour in uncomplicated pregnancy. J Obstet Gynaecol. 2006;26:631-634.
8. Smyth RMD, Alldred SK, Markham C. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2007;(4):CD006167.
9. American College of Obstetricians and Gynecologists Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin. Dystocia and augmentation of labor. Obstet Gynecol. 2003;102:1445-1454.
10. American College of Obstetricians and Gynecologists Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin. Induction of labor. Obstet Gynecol. 1999;94:1-10.
It may, depending on the stage of labor and whether the woman has given birth previously. Routine amniotomy doesn’t significantly reduce the duration of first-stage labor in either primiparous or multiparous women (strength of recommendation [SOR]: A, systematic review of several randomized, controlled trials [RCTs]); it slightly shortens second-stage labor in primiparous women only (SOR: A, systematic review of several RCTs). A trend toward increased rates of cesarean section has been noted in low-risk women who undergo routine amniotomy (SOR: A, systematic review of several RCTs). The procedure doesn’t appear to affect neonatal outcomes (SOR: B, uncommon endpoint in several large RCTs).
Discuss amniotomy with first-time moms
Jon O. Neher, MD
Valley Medical Center, Renton, Wash
There does not appear to be a compelling reason to perform amniotomy routinely in laboring patients. While not particularly harmful (the trend toward increased surgical delivery was not statistically significant), amniotomy is not particularly helpful either. It has no obvious benefit in multiparous patients. In primips, it shortens the entire process of labor by just a few minutes. Some family physicians may want to explore the option with their primips. Otherwise, just forget it.
Evidence summary
More than 4 million babies are delivered each year in the United States, and amniotomy is one of the most common obstetric procedures. It’s typically employed to accelerate labor and was originally thought to decrease cesarean section rates. However, the extent to which amniotomy alone shortens labor varies widely from study to study, and no clear consensus exists concerning the potential harms or unintended effects of this practice.1-7
A 2007 Cochrane review of 14 trials (4893 women) investigated the risks and benefits of routine amniotomy vs intention to leave membranes intact. All trials included only very-low-risk women in spontaneous labor at term with a singleton fetus in vertex presentation.8 Because of the strict inclusion criteria, up to 80% of women giving birth in participating centers were excluded. Plus, many of the women in control groups underwent amniotomy at some stage of labor, because most trials allowed clinicians to perform amniotomy if clinically indicated.1-7
Little effect on first-stage labor
Five of the trials (1127 women) reported length of first-stage labor. No statistically significant difference was found between amniotomy and control groups (weighted mean difference [WMD]=–20.43 minutes; 95% confidence interval [CI], –95.93 to 55.06). Furthermore, subgroup analysis found no statistically significant reduction in length of first-stage labor for nulliparous (WMD=–57.93 min; 95% CI, –152.66 to 36.80) or multiparous women (WMD= 23.10 min; 95% CI, –50.89 to 97.09).
Seven trials (1237 women) in the Cochrane review reported length of second-stage labor. No statistically significant difference was noted between amniotomy and control groups (WMD=–2.38 minutes; 95% CI, –5.27 to 0.50). However, subgroup analysis of primiparous women showed a statistically significant reduction in length of second-stage labor in the amniotomy group (WMD=–6.59 minutes; 95% CI, –12.34 to –0.84).8
More cesareans
Nine trials (4370 women) included in the Cochrane review reported cesarean section rates. Women in the amniotomy group had an increased risk of cesarean delivery compared with the control group, but the difference did not reach statistical significance (relative risk=1.26; 95% CI, 0.98-1.62).8 Because cesarean section was surprisingly rare in this low-risk patient population compared with the national average, the studies were not powered to show statistical significance in this secondary outcome.
What about neonatal outcomes?
No significant differences between the amniotomy and intact groups were noted in less uniformly reported maternal outcomes, including need for oxytocin to augment labor, rate of infection, serious morbidity, or death.8 Likewise, differences in neonatal outcomes—such as sepsis, respiratory failure, admission to the special care unit, and death—weren’t statistically significant. Notably, however, these secondary outcomes occurred too rarely to measure the effect precisely.
Because of the relatively small sample sizes and rarity of complications, the studies have limited ability to address the effect of routine amniotomy on maternal and neonatal morbidity in the general population. Larger studies, with a wider variety of patients, would improve clarity.
Recommendations
The American College of Obstetricians and Gynecologists (ACOG) hasn’t issued a statement on the use of routine amniotomy in normal labor. With regard to labor dystocia, ACOG states that “amniotomy may enhance progress in the active phase and negate the need for oxytocin augmentation, but it may increase the risk of chorioamnionitis.”9
And the ACOG bulletin on induction of labor reports that “the potential risks associated with amniotomy include prolapse of the umbilical cord, chorioamnionitis, significant umbilical cord compression, and rupture of vasa previa.”10
It may, depending on the stage of labor and whether the woman has given birth previously. Routine amniotomy doesn’t significantly reduce the duration of first-stage labor in either primiparous or multiparous women (strength of recommendation [SOR]: A, systematic review of several randomized, controlled trials [RCTs]); it slightly shortens second-stage labor in primiparous women only (SOR: A, systematic review of several RCTs). A trend toward increased rates of cesarean section has been noted in low-risk women who undergo routine amniotomy (SOR: A, systematic review of several RCTs). The procedure doesn’t appear to affect neonatal outcomes (SOR: B, uncommon endpoint in several large RCTs).
Discuss amniotomy with first-time moms
Jon O. Neher, MD
Valley Medical Center, Renton, Wash
There does not appear to be a compelling reason to perform amniotomy routinely in laboring patients. While not particularly harmful (the trend toward increased surgical delivery was not statistically significant), amniotomy is not particularly helpful either. It has no obvious benefit in multiparous patients. In primips, it shortens the entire process of labor by just a few minutes. Some family physicians may want to explore the option with their primips. Otherwise, just forget it.
Evidence summary
More than 4 million babies are delivered each year in the United States, and amniotomy is one of the most common obstetric procedures. It’s typically employed to accelerate labor and was originally thought to decrease cesarean section rates. However, the extent to which amniotomy alone shortens labor varies widely from study to study, and no clear consensus exists concerning the potential harms or unintended effects of this practice.1-7
A 2007 Cochrane review of 14 trials (4893 women) investigated the risks and benefits of routine amniotomy vs intention to leave membranes intact. All trials included only very-low-risk women in spontaneous labor at term with a singleton fetus in vertex presentation.8 Because of the strict inclusion criteria, up to 80% of women giving birth in participating centers were excluded. Plus, many of the women in control groups underwent amniotomy at some stage of labor, because most trials allowed clinicians to perform amniotomy if clinically indicated.1-7
Little effect on first-stage labor
Five of the trials (1127 women) reported length of first-stage labor. No statistically significant difference was found between amniotomy and control groups (weighted mean difference [WMD]=–20.43 minutes; 95% confidence interval [CI], –95.93 to 55.06). Furthermore, subgroup analysis found no statistically significant reduction in length of first-stage labor for nulliparous (WMD=–57.93 min; 95% CI, –152.66 to 36.80) or multiparous women (WMD= 23.10 min; 95% CI, –50.89 to 97.09).
Seven trials (1237 women) in the Cochrane review reported length of second-stage labor. No statistically significant difference was noted between amniotomy and control groups (WMD=–2.38 minutes; 95% CI, –5.27 to 0.50). However, subgroup analysis of primiparous women showed a statistically significant reduction in length of second-stage labor in the amniotomy group (WMD=–6.59 minutes; 95% CI, –12.34 to –0.84).8
More cesareans
Nine trials (4370 women) included in the Cochrane review reported cesarean section rates. Women in the amniotomy group had an increased risk of cesarean delivery compared with the control group, but the difference did not reach statistical significance (relative risk=1.26; 95% CI, 0.98-1.62).8 Because cesarean section was surprisingly rare in this low-risk patient population compared with the national average, the studies were not powered to show statistical significance in this secondary outcome.
What about neonatal outcomes?
No significant differences between the amniotomy and intact groups were noted in less uniformly reported maternal outcomes, including need for oxytocin to augment labor, rate of infection, serious morbidity, or death.8 Likewise, differences in neonatal outcomes—such as sepsis, respiratory failure, admission to the special care unit, and death—weren’t statistically significant. Notably, however, these secondary outcomes occurred too rarely to measure the effect precisely.
Because of the relatively small sample sizes and rarity of complications, the studies have limited ability to address the effect of routine amniotomy on maternal and neonatal morbidity in the general population. Larger studies, with a wider variety of patients, would improve clarity.
Recommendations
The American College of Obstetricians and Gynecologists (ACOG) hasn’t issued a statement on the use of routine amniotomy in normal labor. With regard to labor dystocia, ACOG states that “amniotomy may enhance progress in the active phase and negate the need for oxytocin augmentation, but it may increase the risk of chorioamnionitis.”9
And the ACOG bulletin on induction of labor reports that “the potential risks associated with amniotomy include prolapse of the umbilical cord, chorioamnionitis, significant umbilical cord compression, and rupture of vasa previa.”10
1. UK Amniotomy Group. A multicentre randomized trial of amniotomy in spontaneous first labour at term. Br J Obstet Gynaecol. 1994;101:307-309.
2. Fraser WD, Marcoux S, Moutquin JM, et al. effect of early amniotomy on the risk of dystocia in nulliparous women. N Engl J Med. 1993;328:1145-1149.
3. Johnson N, Lilford R, Guthrie K, et al. Randomised trial comparing a policy of early with selective amniotomy in uncomplicated labour at term. Br J Obstet Gynaecol. 1997;104:340-346.
4. Garite TJ, Porto M, Carlson NJ, et al. The influence of elective amniotomy on fetal heart rate patterns and the course of labor in term patients: a randomized study. Br J Obstet Gynaecol. 1993;168:1827-1832.
5. Barrett J, Savage J, Phillips K, et al. Randomized trial of amniotomy in labour versus the intention to leave membranes intact until the second stage. Br J Obstet Gynaecol. 1992;99:5-9.
6. Fraser WD, Sauve R, Parboosingh IJ, et al. A randomized, controlled trial of early amniotomy. Br J Obstet Gynaecol. 1991;98:84-91.
7. Ajadi MA, Kuti O, Orji EO, et al. The effect of amniotomy on the outcome of spontaneous labour in uncomplicated pregnancy. J Obstet Gynaecol. 2006;26:631-634.
8. Smyth RMD, Alldred SK, Markham C. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2007;(4):CD006167.
9. American College of Obstetricians and Gynecologists Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin. Dystocia and augmentation of labor. Obstet Gynecol. 2003;102:1445-1454.
10. American College of Obstetricians and Gynecologists Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin. Induction of labor. Obstet Gynecol. 1999;94:1-10.
1. UK Amniotomy Group. A multicentre randomized trial of amniotomy in spontaneous first labour at term. Br J Obstet Gynaecol. 1994;101:307-309.
2. Fraser WD, Marcoux S, Moutquin JM, et al. effect of early amniotomy on the risk of dystocia in nulliparous women. N Engl J Med. 1993;328:1145-1149.
3. Johnson N, Lilford R, Guthrie K, et al. Randomised trial comparing a policy of early with selective amniotomy in uncomplicated labour at term. Br J Obstet Gynaecol. 1997;104:340-346.
4. Garite TJ, Porto M, Carlson NJ, et al. The influence of elective amniotomy on fetal heart rate patterns and the course of labor in term patients: a randomized study. Br J Obstet Gynaecol. 1993;168:1827-1832.
5. Barrett J, Savage J, Phillips K, et al. Randomized trial of amniotomy in labour versus the intention to leave membranes intact until the second stage. Br J Obstet Gynaecol. 1992;99:5-9.
6. Fraser WD, Sauve R, Parboosingh IJ, et al. A randomized, controlled trial of early amniotomy. Br J Obstet Gynaecol. 1991;98:84-91.
7. Ajadi MA, Kuti O, Orji EO, et al. The effect of amniotomy on the outcome of spontaneous labour in uncomplicated pregnancy. J Obstet Gynaecol. 2006;26:631-634.
8. Smyth RMD, Alldred SK, Markham C. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2007;(4):CD006167.
9. American College of Obstetricians and Gynecologists Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin. Dystocia and augmentation of labor. Obstet Gynecol. 2003;102:1445-1454.
10. American College of Obstetricians and Gynecologists Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin. Induction of labor. Obstet Gynecol. 1999;94:1-10.
Evidence-based answers from the Family Physicians Inquiries Network
What lifestyle changes should we recommend for the patient with newly diagnosed hypertension?
Hypertensive patients should reduce sodium intake (strength of recommendation [SOR]: A). The Dietary Approaches to Stop Hypertension diet (DASH diet)—with salt restriction and increased fruit, vegetable, calcium, and potassium intake—reduces blood pressure and should be recommended (SOR: A).
Aerobic exercise is effective in the general, as well as elderly, populations for reducing blood pressure (SOR: A). Patients should be encouraged to reduce alcohol consumption (SOR: A). Evidence that weight loss is significantly associated with blood pressure reduction is inconclusive (SOR: C). Smoking cessation should be encouraged for all hypertensive patients for prevention of cardiovascular disease (SOR: A).
When advising patients to make lifestyle changes, be participatory, personalized, practical, and persistent
Linda N. Meurer, MD, MPH
Medical College of Wisconsin
Lifestyle modifications can prevent and lessen hypertension, but persuading patients to make lasting changes in their long-held eating and activity patterns is challenging. When advising patients to make meaningful lifestyle changes, remember these 4 “Ps”: Participatory, Personalized, Practical, and Persistent. First, engage patients in a conversation about their lifestyle habits and partner with them to develop specific, personalized strategies to make improvements. For example, target significant sources of sodium in the specific foods they eat and find practical opportunities for physical activity in the context of their own schedule and circumstances.
Most importantly, persist in your advice by revisiting lifestyle recommendations and the patients’ progress at each visit, and modify as needed. Often, once medications are prescribed, patients disregard the lifestyle changes, and may need repeated encouragement to adopt regular, healthful habits.
Evidence summary
Healthy lifestyles are an important part of both prevention and management of hypertension. These changes include maintenance of normal body weight, regular aerobic exercise, dietary salt reduction, alcohol consumption reduction, and consumption of diets rich in potassium, fruits, and vegetables. These recommendations have been reviewed in recent meta-analyses (TABLE).
Lifestyle changes that have not shown any significant effect on blood pressure or that are still under review include dietary omega-3 fatty acid supplementation and antioxidant supplementation.10
TABLE
Summary of recommendations
| INTERVENTION | OUTCOME | STUDY DETAILS | SOR |
|---|---|---|---|
| Reduction of dietary sodium intake | Lowers SBP by 4.97 mm Hg (95% CI,–5.76 to –4.18) | 2004 Cochrane review1,2 (17 trials; 734 participants) | A |
| DASH diet | Lowers SBP by 4.3 mm Hg (P<.001) | Multicenter randomized control trial (810 adults)2,3 | A |
| Regular aerobic exercise | Lowers SBP by 4.0 mm Hg (95% CI,–5.32 to –2.75) | Meta-analysis of 54 RCTs (2419 participants)4,5 | A |
| Reduced alcohol consumption | Lowers SBP by 3.31mm Hg (95% CI,–4.10 to –2.52 | Meta-analysis of 15 RCTs (2234 participants)6 | A |
| Smoking cessation | 36% relative risk reduction in mortality (RR=0.64; 95% CI,0.58 to 0.71) | 2004 Cochrane review (20 prospective cohort studies)7 | A |
| Weight loss | 3%–9% body weight loss may be associated with decrease in blood pressure by 3 mm Hg; not statistically significant (95% CI,–6.8 to 0.7). | 2000 Cochrane review of 18 trials (though 1997; 361 participants in the primary 6 studies)8,9 | C |
| SOR, strength of recommendation; SBP, systolic blood pressure; CI, confidence interval; RR, relative risk; RCT, randomized controlled trial. | |||
Recommendations from others
The National High Blood Pressure Education Program recommends the following for primary prevention of hypertension:11
- Maintain normal body weight for adults
- Reduce dietary sodium intake to no more than 100 mmol/d
- Engage in regular aerobic physical activity
- Limit alcohol consumption to 30 mL ethanol per day for men, and 15 mL ethanol per day for women or lighter persons
- Maintain adequate intake of dietary potassium (>90 mmol/d)
- Consume a diet rich in fruits, vegetables, and low-fat dairy, with reduced content of saturated and total fat.
The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure agrees with the recommendations in the TABLE.12
1. He FJ, MacGregor GA. Effect of longer-term modest salt reduction on blood pressure. Cochrane Database Syst Rev 2004;(3):CD004937.-
2. Bray GA, Vollmer WM, Sacks FM, Obarzanek E, Svetkey LP, Appel LJ. DASH Collaborative Research Group. A further subgroup analysis of the effects of the DASH diet and three dietary sodium levels on blood pressure: results of the DASH-Sodium Trial. Am J Cardiol 2004;94:222-227.
3. Appel LJ, Champagne CM, Harsha DW, et al. Writing Group of the PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. JAMA 2003;289:2083-2093.
4. Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med 2002;136:493-503.
5. Kelley GA, Sharpe Kelley K. Aerobic exercise and resting blood pressure in older adults: a meta-analytic review of randomized controlled trials. J Gerontol A Biol Sci Med Sci 2001;56:M298-303.
6. Xin X, He J, Frontini MG, Ogden LG, Motsamai OI, Whelton PK. Effects of alcohol reduction on blood pressure: a meta-analysis of randomized controlled trials. Hypertension 2001;38:1112-1117.
7. Critchley J, Capewell S. Smoking cessation for the secondary prevention of coronary heart disease. Cochrane Database Syst Rev 2004;(1):CD003041.-
8. Mulrow CD, Chiquette E, Angel L, et al. Dieting to reduce body weight for controlling hypertension in adults. Cochrane Database Syst Rev 2000;(2):CD000484.-
9. He J, Whelton PK, Appel LJ, Charleston J, Klag MJ. Long-term effects of weight loss and dietary sodium reduction on incidence of hypertension. Hypertension 2000;35:544-549.
10. Hooper L, Thompson RL, Harrison RA, et al. Omega 3 fatty acids for prevention and treatment of cardiovascular disease. Cochrane Database Syst Rev 2004;(4):CD003177.-
11. Whelton PK, He J, Appel LJ, et al. National High Blood Pressure Education Program Coordinating Committee. Primary prevention of hypertension: clinical and public health advisory from The National High Blood Pressure Education Program. JAMA 2002;288:1882-1888.
12. Chobanian AV, Bakris GL, Black HR, et al. National Heart, Lung and Blood Institute; National High Blood Pressure Education Program Coordinating Committee Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003;42:1206-1252.
Hypertensive patients should reduce sodium intake (strength of recommendation [SOR]: A). The Dietary Approaches to Stop Hypertension diet (DASH diet)—with salt restriction and increased fruit, vegetable, calcium, and potassium intake—reduces blood pressure and should be recommended (SOR: A).
Aerobic exercise is effective in the general, as well as elderly, populations for reducing blood pressure (SOR: A). Patients should be encouraged to reduce alcohol consumption (SOR: A). Evidence that weight loss is significantly associated with blood pressure reduction is inconclusive (SOR: C). Smoking cessation should be encouraged for all hypertensive patients for prevention of cardiovascular disease (SOR: A).
When advising patients to make lifestyle changes, be participatory, personalized, practical, and persistent
Linda N. Meurer, MD, MPH
Medical College of Wisconsin
Lifestyle modifications can prevent and lessen hypertension, but persuading patients to make lasting changes in their long-held eating and activity patterns is challenging. When advising patients to make meaningful lifestyle changes, remember these 4 “Ps”: Participatory, Personalized, Practical, and Persistent. First, engage patients in a conversation about their lifestyle habits and partner with them to develop specific, personalized strategies to make improvements. For example, target significant sources of sodium in the specific foods they eat and find practical opportunities for physical activity in the context of their own schedule and circumstances.
Most importantly, persist in your advice by revisiting lifestyle recommendations and the patients’ progress at each visit, and modify as needed. Often, once medications are prescribed, patients disregard the lifestyle changes, and may need repeated encouragement to adopt regular, healthful habits.
Evidence summary
Healthy lifestyles are an important part of both prevention and management of hypertension. These changes include maintenance of normal body weight, regular aerobic exercise, dietary salt reduction, alcohol consumption reduction, and consumption of diets rich in potassium, fruits, and vegetables. These recommendations have been reviewed in recent meta-analyses (TABLE).
Lifestyle changes that have not shown any significant effect on blood pressure or that are still under review include dietary omega-3 fatty acid supplementation and antioxidant supplementation.10
TABLE
Summary of recommendations
| INTERVENTION | OUTCOME | STUDY DETAILS | SOR |
|---|---|---|---|
| Reduction of dietary sodium intake | Lowers SBP by 4.97 mm Hg (95% CI,–5.76 to –4.18) | 2004 Cochrane review1,2 (17 trials; 734 participants) | A |
| DASH diet | Lowers SBP by 4.3 mm Hg (P<.001) | Multicenter randomized control trial (810 adults)2,3 | A |
| Regular aerobic exercise | Lowers SBP by 4.0 mm Hg (95% CI,–5.32 to –2.75) | Meta-analysis of 54 RCTs (2419 participants)4,5 | A |
| Reduced alcohol consumption | Lowers SBP by 3.31mm Hg (95% CI,–4.10 to –2.52 | Meta-analysis of 15 RCTs (2234 participants)6 | A |
| Smoking cessation | 36% relative risk reduction in mortality (RR=0.64; 95% CI,0.58 to 0.71) | 2004 Cochrane review (20 prospective cohort studies)7 | A |
| Weight loss | 3%–9% body weight loss may be associated with decrease in blood pressure by 3 mm Hg; not statistically significant (95% CI,–6.8 to 0.7). | 2000 Cochrane review of 18 trials (though 1997; 361 participants in the primary 6 studies)8,9 | C |
| SOR, strength of recommendation; SBP, systolic blood pressure; CI, confidence interval; RR, relative risk; RCT, randomized controlled trial. | |||
Recommendations from others
The National High Blood Pressure Education Program recommends the following for primary prevention of hypertension:11
- Maintain normal body weight for adults
- Reduce dietary sodium intake to no more than 100 mmol/d
- Engage in regular aerobic physical activity
- Limit alcohol consumption to 30 mL ethanol per day for men, and 15 mL ethanol per day for women or lighter persons
- Maintain adequate intake of dietary potassium (>90 mmol/d)
- Consume a diet rich in fruits, vegetables, and low-fat dairy, with reduced content of saturated and total fat.
The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure agrees with the recommendations in the TABLE.12
Hypertensive patients should reduce sodium intake (strength of recommendation [SOR]: A). The Dietary Approaches to Stop Hypertension diet (DASH diet)—with salt restriction and increased fruit, vegetable, calcium, and potassium intake—reduces blood pressure and should be recommended (SOR: A).
Aerobic exercise is effective in the general, as well as elderly, populations for reducing blood pressure (SOR: A). Patients should be encouraged to reduce alcohol consumption (SOR: A). Evidence that weight loss is significantly associated with blood pressure reduction is inconclusive (SOR: C). Smoking cessation should be encouraged for all hypertensive patients for prevention of cardiovascular disease (SOR: A).
When advising patients to make lifestyle changes, be participatory, personalized, practical, and persistent
Linda N. Meurer, MD, MPH
Medical College of Wisconsin
Lifestyle modifications can prevent and lessen hypertension, but persuading patients to make lasting changes in their long-held eating and activity patterns is challenging. When advising patients to make meaningful lifestyle changes, remember these 4 “Ps”: Participatory, Personalized, Practical, and Persistent. First, engage patients in a conversation about their lifestyle habits and partner with them to develop specific, personalized strategies to make improvements. For example, target significant sources of sodium in the specific foods they eat and find practical opportunities for physical activity in the context of their own schedule and circumstances.
Most importantly, persist in your advice by revisiting lifestyle recommendations and the patients’ progress at each visit, and modify as needed. Often, once medications are prescribed, patients disregard the lifestyle changes, and may need repeated encouragement to adopt regular, healthful habits.
Evidence summary
Healthy lifestyles are an important part of both prevention and management of hypertension. These changes include maintenance of normal body weight, regular aerobic exercise, dietary salt reduction, alcohol consumption reduction, and consumption of diets rich in potassium, fruits, and vegetables. These recommendations have been reviewed in recent meta-analyses (TABLE).
Lifestyle changes that have not shown any significant effect on blood pressure or that are still under review include dietary omega-3 fatty acid supplementation and antioxidant supplementation.10
TABLE
Summary of recommendations
| INTERVENTION | OUTCOME | STUDY DETAILS | SOR |
|---|---|---|---|
| Reduction of dietary sodium intake | Lowers SBP by 4.97 mm Hg (95% CI,–5.76 to –4.18) | 2004 Cochrane review1,2 (17 trials; 734 participants) | A |
| DASH diet | Lowers SBP by 4.3 mm Hg (P<.001) | Multicenter randomized control trial (810 adults)2,3 | A |
| Regular aerobic exercise | Lowers SBP by 4.0 mm Hg (95% CI,–5.32 to –2.75) | Meta-analysis of 54 RCTs (2419 participants)4,5 | A |
| Reduced alcohol consumption | Lowers SBP by 3.31mm Hg (95% CI,–4.10 to –2.52 | Meta-analysis of 15 RCTs (2234 participants)6 | A |
| Smoking cessation | 36% relative risk reduction in mortality (RR=0.64; 95% CI,0.58 to 0.71) | 2004 Cochrane review (20 prospective cohort studies)7 | A |
| Weight loss | 3%–9% body weight loss may be associated with decrease in blood pressure by 3 mm Hg; not statistically significant (95% CI,–6.8 to 0.7). | 2000 Cochrane review of 18 trials (though 1997; 361 participants in the primary 6 studies)8,9 | C |
| SOR, strength of recommendation; SBP, systolic blood pressure; CI, confidence interval; RR, relative risk; RCT, randomized controlled trial. | |||
Recommendations from others
The National High Blood Pressure Education Program recommends the following for primary prevention of hypertension:11
- Maintain normal body weight for adults
- Reduce dietary sodium intake to no more than 100 mmol/d
- Engage in regular aerobic physical activity
- Limit alcohol consumption to 30 mL ethanol per day for men, and 15 mL ethanol per day for women or lighter persons
- Maintain adequate intake of dietary potassium (>90 mmol/d)
- Consume a diet rich in fruits, vegetables, and low-fat dairy, with reduced content of saturated and total fat.
The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure agrees with the recommendations in the TABLE.12
1. He FJ, MacGregor GA. Effect of longer-term modest salt reduction on blood pressure. Cochrane Database Syst Rev 2004;(3):CD004937.-
2. Bray GA, Vollmer WM, Sacks FM, Obarzanek E, Svetkey LP, Appel LJ. DASH Collaborative Research Group. A further subgroup analysis of the effects of the DASH diet and three dietary sodium levels on blood pressure: results of the DASH-Sodium Trial. Am J Cardiol 2004;94:222-227.
3. Appel LJ, Champagne CM, Harsha DW, et al. Writing Group of the PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. JAMA 2003;289:2083-2093.
4. Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med 2002;136:493-503.
5. Kelley GA, Sharpe Kelley K. Aerobic exercise and resting blood pressure in older adults: a meta-analytic review of randomized controlled trials. J Gerontol A Biol Sci Med Sci 2001;56:M298-303.
6. Xin X, He J, Frontini MG, Ogden LG, Motsamai OI, Whelton PK. Effects of alcohol reduction on blood pressure: a meta-analysis of randomized controlled trials. Hypertension 2001;38:1112-1117.
7. Critchley J, Capewell S. Smoking cessation for the secondary prevention of coronary heart disease. Cochrane Database Syst Rev 2004;(1):CD003041.-
8. Mulrow CD, Chiquette E, Angel L, et al. Dieting to reduce body weight for controlling hypertension in adults. Cochrane Database Syst Rev 2000;(2):CD000484.-
9. He J, Whelton PK, Appel LJ, Charleston J, Klag MJ. Long-term effects of weight loss and dietary sodium reduction on incidence of hypertension. Hypertension 2000;35:544-549.
10. Hooper L, Thompson RL, Harrison RA, et al. Omega 3 fatty acids for prevention and treatment of cardiovascular disease. Cochrane Database Syst Rev 2004;(4):CD003177.-
11. Whelton PK, He J, Appel LJ, et al. National High Blood Pressure Education Program Coordinating Committee. Primary prevention of hypertension: clinical and public health advisory from The National High Blood Pressure Education Program. JAMA 2002;288:1882-1888.
12. Chobanian AV, Bakris GL, Black HR, et al. National Heart, Lung and Blood Institute; National High Blood Pressure Education Program Coordinating Committee Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003;42:1206-1252.
1. He FJ, MacGregor GA. Effect of longer-term modest salt reduction on blood pressure. Cochrane Database Syst Rev 2004;(3):CD004937.-
2. Bray GA, Vollmer WM, Sacks FM, Obarzanek E, Svetkey LP, Appel LJ. DASH Collaborative Research Group. A further subgroup analysis of the effects of the DASH diet and three dietary sodium levels on blood pressure: results of the DASH-Sodium Trial. Am J Cardiol 2004;94:222-227.
3. Appel LJ, Champagne CM, Harsha DW, et al. Writing Group of the PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. JAMA 2003;289:2083-2093.
4. Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med 2002;136:493-503.
5. Kelley GA, Sharpe Kelley K. Aerobic exercise and resting blood pressure in older adults: a meta-analytic review of randomized controlled trials. J Gerontol A Biol Sci Med Sci 2001;56:M298-303.
6. Xin X, He J, Frontini MG, Ogden LG, Motsamai OI, Whelton PK. Effects of alcohol reduction on blood pressure: a meta-analysis of randomized controlled trials. Hypertension 2001;38:1112-1117.
7. Critchley J, Capewell S. Smoking cessation for the secondary prevention of coronary heart disease. Cochrane Database Syst Rev 2004;(1):CD003041.-
8. Mulrow CD, Chiquette E, Angel L, et al. Dieting to reduce body weight for controlling hypertension in adults. Cochrane Database Syst Rev 2000;(2):CD000484.-
9. He J, Whelton PK, Appel LJ, Charleston J, Klag MJ. Long-term effects of weight loss and dietary sodium reduction on incidence of hypertension. Hypertension 2000;35:544-549.
10. Hooper L, Thompson RL, Harrison RA, et al. Omega 3 fatty acids for prevention and treatment of cardiovascular disease. Cochrane Database Syst Rev 2004;(4):CD003177.-
11. Whelton PK, He J, Appel LJ, et al. National High Blood Pressure Education Program Coordinating Committee. Primary prevention of hypertension: clinical and public health advisory from The National High Blood Pressure Education Program. JAMA 2002;288:1882-1888.
12. Chobanian AV, Bakris GL, Black HR, et al. National Heart, Lung and Blood Institute; National High Blood Pressure Education Program Coordinating Committee Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003;42:1206-1252.
Evidence-based answers from the Family Physicians Inquiries Network
What are the relative risks and benefits of progestin-only contraceptives?
Little evidence describes the risks and benefits of progestin-only contraceptives therapy options.
Risks
No good-quality evidence exists to determine the risk of cancer associated with progestin-only contraceptives. Data are insufficient to discern their effect on milk quality and quantity during lactation, though no effect on infant growth or weight was identified (strength of recommendation [SOR]:A, based on systematic Cochrane review).1
No increase in blood pressure occurred with oral progestin-only contraceptives or depot medroxyprogesterone acetate (DMPA) (SOR: B, cohort studies).2 A decrease in bone mineral density was associated with current use of DMPA in studies lasting 2 years or less, yet the cessation of use may attenuate the effect (SOR: B, mostly case-control).3 Oral and injectable progestin-only contraceptives demonstrated no significant increase in venous thromboembolism, stroke, acute myocardial infarction, or combined cardiovascular disease endpoint (SOR: B, case-control study).4 Termination rates for nonmenstrual effects with progesterone implants were less than 3% (SOR: B, cohort studies).5
Benefits
Progestin-only contraceptives are an effective form of birth control. For the treatment of premenstrual syndrome or dysfunctional uterine bleeding, inadequate evidence exists to support using progestin-only options (SOR: A, RCTs).6,7
Patient-centered, not evidence-based, reasons contribute to shifts in contraception patterns
Paul Crawford, MD
Headquarters AAC Family Medicine Residency, Eglin Air Force Base, Eglin, Fla
Nonlactating women in my practice are choosing progestin-only contraceptives less often than previously, when DMPA was my second-most-common contraceptive prescription. Patient-centered, not evidence-based, reasons contribute to this shift in prescribing patterns.
Many women who chose injectable progestin-only contraceptives because of difficulty remembering to take oral contraceptives have changed to patch-delivered or intravaginal estrogen-progestins due to concern over potential weight gain and increased bone loss with progestin-only contraceptives. Intrauterine devices have experienced a surge in popularity with the addition of slow-release progesterone, and condoms remain popular because they reduce disease transmission. When women receive evidence-based risk/benefit contraceptive counseling, they then have the knowledge to choose the contraceptive that best fits their lifestyle.
Evidence summary
The risks and benefits associated with progestin-only contraceptives are not completely studied for all routes of administration. There is insufficient evidence regarding their risks to point to a definitive harm with their administration (TABLE).
The risk of pregnancy with progestinonly contraceptives ranges from 0.0% to 13.2% based on the method that is selected.8 Evidence is lacking to support use of progestin-only contraceptives for premenstrual syndrome or dysfunctional uterine bleeding.6,7
TABLE
Risks and benefits of progestin-only contraceptives
| RISK | TYPE | EVIDENCE |
| VTE, stroke, acute MI, or combined CVD endpoint4 | Oral injectable | No significant association with increased incidence of VTE, stroke, acute MI, or the combined CVD endpoint |
| Increased blood pressure2 | Oral DMPA | No significant association with increased blood pressure for up to 2–3 years of use |
Nonmenstrual adverse events5
| Progesterone implants |
|
| Effect on lactation1 | All progestin-only contraceptives* |
|
| Decreased BMD3 | DMPA |
|
| Pregnancy8 | Oral, DMPA, progesterone implants | Based on perfect use and typical use evaluations:
|
| BENEFIT | TYPE | EVIDENCE |
| Treatment of PMS6 | Suppositories, pessaries, oral | No evidence of improvement in PMS symptoms |
| Dysfunctional uterine bleeding with anovulation7 | Oral | No evidence to support the use of progesterones or progestogens in dysfunctional uterine bleeding |
| *Only trials with oral dosages met criteria. | ||
| DMPA, depot medroxyprogesterone acetate; VTE, venous thromboembolism; MI, myocardial infarction; CVD, cardiovascular disease; PMS, premenstrual syndrome | ||
Recommendations from others
The World Health Organization (WHO) highlights the need to avoid progestin-only contraceptives for women younger than 18 or older than 45 years, secondary to concerns of decreased bone mass. Immediately postpartum, women may initiate progestinonly contraceptives if they are not breast-feeding; if breastfeeding, women should wait until at least 6 months postpartum.
Hypertensive women should avoid progestin-only contraceptives; women at risk for hypertension—particularly DMPA users—are encouraged to measure blood pressure before and after use. The WHO document points out the increased possibility for abnormal uterine bleeding with progestin-only contraceptives use.9
American College of Physician’s PIER: Physicians’ Information and Education Resource describes using progestin-only contraceptives in hypercoagulable states and severe hyperlipidemia and avoiding use in osteoporosis, osteopenia, and chronic glucocorticoid use due to a decrease in bone mineral density.10
The American College of Obstetricians and Gynecologists (ACOG) specifically endorses the preferential use of progestin-only contraceptives by lactating women and women at an increased risk of venous thromboembolism based on good evidence. For women with systemic lupus erythematosus, ACOG recommends use of progestin-only contraceptives over combined oral contraceptive, based on fair evidence. By consensus, ACOG recognizes benefits of DMPA for women with sickle-cell disease and women with coronary artery disease, congestive heart failure, or cerebrovascular disease. In general, ACOG recommends progestin-only contraceptives over combined oral contraceptives for patients with the following conditions: migraine headaches, cigarette smoker of age greater than 35, history of venous thromboembolism, coronary artery disease, congestive heart failure, cerebrovascular disease, postpartum <2 weeks, hypertension with vascular disease or age greater than 35, diabetes with vascular disease or age greater than 35, systemic lupus erythematosus with vascular disease, nephritis, or antiphospholipid antibodies, or hypertriglyceridemia.11
1. Truitt ST, Fraser AB, Grimes DA, Gallo MF, Schulz KF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation. Cochrane Database Syst Rev 2003;(2):CD003988.-
2. Hussain SF. Progestogen only pills and high blood pressure: is there an association? A literature review. Contraception 2004;69:89-97.
3. Banks E, Berrington A, Casabonne D. Overview of the relationship between use of progestogen-only contraceptives and bone mineral density. BJOG 2001;108:1214-1221.
4. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Cardiovascular disease and use of oral and injectable progestogen-only contraceptives and combined injectable contraceptives. Contraception 1998;57:315-324.
5. Brache V, Faundes A, Alvarez F, Cochon L. Nonmenstrual adverse events during use of implantable contraceptives for women: data from clinical trials. Contraception 2002;65:63-74.
6. Wyatt K, Dimmock P, Jones P, Obhrai M, O’Brien S. Efficacy of progesterone and progestogens in management of premenstrual syndrome: systematic review. BMJ 2001;323:776-780.
7. Hickey M, Higham J, Fraser IS. Progestogens versus oestrogens and progestogens for irregular uterine bleeding associated with anovulation. Cochrane Database Syst Rev 2000;(2):CD001895.-
8. Trussell J. Contraceptive efficacy. In: Hatcher RA et al, eds. Contraceptive Technology. 18th rev ed. New York, NY: Ardent Media; 2004;773-845.
9. World Health Organization. Improving Access to Quality Care in Family Planning: Medical Eligibility Criteria for Contraceptive Use. 3rd ed. Geneva: World Health Organization; 2004.
10. American College of Physicians. Contraception recommendations for selected conditions or medications. PIER: Physicians’ Information and Education Resource [online]. Philadelphia: American College of Physicians, 2005. Available at: online.statref.com. Accessed on August 12, 2005.
11. ACOG Practice Bulletin. The use of hormonal contraception in women with coexisting medical conditions. Int J Gynaecol Obstet 2001;75:93-106.
Little evidence describes the risks and benefits of progestin-only contraceptives therapy options.
Risks
No good-quality evidence exists to determine the risk of cancer associated with progestin-only contraceptives. Data are insufficient to discern their effect on milk quality and quantity during lactation, though no effect on infant growth or weight was identified (strength of recommendation [SOR]:A, based on systematic Cochrane review).1
No increase in blood pressure occurred with oral progestin-only contraceptives or depot medroxyprogesterone acetate (DMPA) (SOR: B, cohort studies).2 A decrease in bone mineral density was associated with current use of DMPA in studies lasting 2 years or less, yet the cessation of use may attenuate the effect (SOR: B, mostly case-control).3 Oral and injectable progestin-only contraceptives demonstrated no significant increase in venous thromboembolism, stroke, acute myocardial infarction, or combined cardiovascular disease endpoint (SOR: B, case-control study).4 Termination rates for nonmenstrual effects with progesterone implants were less than 3% (SOR: B, cohort studies).5
Benefits
Progestin-only contraceptives are an effective form of birth control. For the treatment of premenstrual syndrome or dysfunctional uterine bleeding, inadequate evidence exists to support using progestin-only options (SOR: A, RCTs).6,7
Patient-centered, not evidence-based, reasons contribute to shifts in contraception patterns
Paul Crawford, MD
Headquarters AAC Family Medicine Residency, Eglin Air Force Base, Eglin, Fla
Nonlactating women in my practice are choosing progestin-only contraceptives less often than previously, when DMPA was my second-most-common contraceptive prescription. Patient-centered, not evidence-based, reasons contribute to this shift in prescribing patterns.
Many women who chose injectable progestin-only contraceptives because of difficulty remembering to take oral contraceptives have changed to patch-delivered or intravaginal estrogen-progestins due to concern over potential weight gain and increased bone loss with progestin-only contraceptives. Intrauterine devices have experienced a surge in popularity with the addition of slow-release progesterone, and condoms remain popular because they reduce disease transmission. When women receive evidence-based risk/benefit contraceptive counseling, they then have the knowledge to choose the contraceptive that best fits their lifestyle.
Evidence summary
The risks and benefits associated with progestin-only contraceptives are not completely studied for all routes of administration. There is insufficient evidence regarding their risks to point to a definitive harm with their administration (TABLE).
The risk of pregnancy with progestinonly contraceptives ranges from 0.0% to 13.2% based on the method that is selected.8 Evidence is lacking to support use of progestin-only contraceptives for premenstrual syndrome or dysfunctional uterine bleeding.6,7
TABLE
Risks and benefits of progestin-only contraceptives
| RISK | TYPE | EVIDENCE |
| VTE, stroke, acute MI, or combined CVD endpoint4 | Oral injectable | No significant association with increased incidence of VTE, stroke, acute MI, or the combined CVD endpoint |
| Increased blood pressure2 | Oral DMPA | No significant association with increased blood pressure for up to 2–3 years of use |
Nonmenstrual adverse events5
| Progesterone implants |
|
| Effect on lactation1 | All progestin-only contraceptives* |
|
| Decreased BMD3 | DMPA |
|
| Pregnancy8 | Oral, DMPA, progesterone implants | Based on perfect use and typical use evaluations:
|
| BENEFIT | TYPE | EVIDENCE |
| Treatment of PMS6 | Suppositories, pessaries, oral | No evidence of improvement in PMS symptoms |
| Dysfunctional uterine bleeding with anovulation7 | Oral | No evidence to support the use of progesterones or progestogens in dysfunctional uterine bleeding |
| *Only trials with oral dosages met criteria. | ||
| DMPA, depot medroxyprogesterone acetate; VTE, venous thromboembolism; MI, myocardial infarction; CVD, cardiovascular disease; PMS, premenstrual syndrome | ||
Recommendations from others
The World Health Organization (WHO) highlights the need to avoid progestin-only contraceptives for women younger than 18 or older than 45 years, secondary to concerns of decreased bone mass. Immediately postpartum, women may initiate progestinonly contraceptives if they are not breast-feeding; if breastfeeding, women should wait until at least 6 months postpartum.
Hypertensive women should avoid progestin-only contraceptives; women at risk for hypertension—particularly DMPA users—are encouraged to measure blood pressure before and after use. The WHO document points out the increased possibility for abnormal uterine bleeding with progestin-only contraceptives use.9
American College of Physician’s PIER: Physicians’ Information and Education Resource describes using progestin-only contraceptives in hypercoagulable states and severe hyperlipidemia and avoiding use in osteoporosis, osteopenia, and chronic glucocorticoid use due to a decrease in bone mineral density.10
The American College of Obstetricians and Gynecologists (ACOG) specifically endorses the preferential use of progestin-only contraceptives by lactating women and women at an increased risk of venous thromboembolism based on good evidence. For women with systemic lupus erythematosus, ACOG recommends use of progestin-only contraceptives over combined oral contraceptive, based on fair evidence. By consensus, ACOG recognizes benefits of DMPA for women with sickle-cell disease and women with coronary artery disease, congestive heart failure, or cerebrovascular disease. In general, ACOG recommends progestin-only contraceptives over combined oral contraceptives for patients with the following conditions: migraine headaches, cigarette smoker of age greater than 35, history of venous thromboembolism, coronary artery disease, congestive heart failure, cerebrovascular disease, postpartum <2 weeks, hypertension with vascular disease or age greater than 35, diabetes with vascular disease or age greater than 35, systemic lupus erythematosus with vascular disease, nephritis, or antiphospholipid antibodies, or hypertriglyceridemia.11
Little evidence describes the risks and benefits of progestin-only contraceptives therapy options.
Risks
No good-quality evidence exists to determine the risk of cancer associated with progestin-only contraceptives. Data are insufficient to discern their effect on milk quality and quantity during lactation, though no effect on infant growth or weight was identified (strength of recommendation [SOR]:A, based on systematic Cochrane review).1
No increase in blood pressure occurred with oral progestin-only contraceptives or depot medroxyprogesterone acetate (DMPA) (SOR: B, cohort studies).2 A decrease in bone mineral density was associated with current use of DMPA in studies lasting 2 years or less, yet the cessation of use may attenuate the effect (SOR: B, mostly case-control).3 Oral and injectable progestin-only contraceptives demonstrated no significant increase in venous thromboembolism, stroke, acute myocardial infarction, or combined cardiovascular disease endpoint (SOR: B, case-control study).4 Termination rates for nonmenstrual effects with progesterone implants were less than 3% (SOR: B, cohort studies).5
Benefits
Progestin-only contraceptives are an effective form of birth control. For the treatment of premenstrual syndrome or dysfunctional uterine bleeding, inadequate evidence exists to support using progestin-only options (SOR: A, RCTs).6,7
Patient-centered, not evidence-based, reasons contribute to shifts in contraception patterns
Paul Crawford, MD
Headquarters AAC Family Medicine Residency, Eglin Air Force Base, Eglin, Fla
Nonlactating women in my practice are choosing progestin-only contraceptives less often than previously, when DMPA was my second-most-common contraceptive prescription. Patient-centered, not evidence-based, reasons contribute to this shift in prescribing patterns.
Many women who chose injectable progestin-only contraceptives because of difficulty remembering to take oral contraceptives have changed to patch-delivered or intravaginal estrogen-progestins due to concern over potential weight gain and increased bone loss with progestin-only contraceptives. Intrauterine devices have experienced a surge in popularity with the addition of slow-release progesterone, and condoms remain popular because they reduce disease transmission. When women receive evidence-based risk/benefit contraceptive counseling, they then have the knowledge to choose the contraceptive that best fits their lifestyle.
Evidence summary
The risks and benefits associated with progestin-only contraceptives are not completely studied for all routes of administration. There is insufficient evidence regarding their risks to point to a definitive harm with their administration (TABLE).
The risk of pregnancy with progestinonly contraceptives ranges from 0.0% to 13.2% based on the method that is selected.8 Evidence is lacking to support use of progestin-only contraceptives for premenstrual syndrome or dysfunctional uterine bleeding.6,7
TABLE
Risks and benefits of progestin-only contraceptives
| RISK | TYPE | EVIDENCE |
| VTE, stroke, acute MI, or combined CVD endpoint4 | Oral injectable | No significant association with increased incidence of VTE, stroke, acute MI, or the combined CVD endpoint |
| Increased blood pressure2 | Oral DMPA | No significant association with increased blood pressure for up to 2–3 years of use |
Nonmenstrual adverse events5
| Progesterone implants |
|
| Effect on lactation1 | All progestin-only contraceptives* |
|
| Decreased BMD3 | DMPA |
|
| Pregnancy8 | Oral, DMPA, progesterone implants | Based on perfect use and typical use evaluations:
|
| BENEFIT | TYPE | EVIDENCE |
| Treatment of PMS6 | Suppositories, pessaries, oral | No evidence of improvement in PMS symptoms |
| Dysfunctional uterine bleeding with anovulation7 | Oral | No evidence to support the use of progesterones or progestogens in dysfunctional uterine bleeding |
| *Only trials with oral dosages met criteria. | ||
| DMPA, depot medroxyprogesterone acetate; VTE, venous thromboembolism; MI, myocardial infarction; CVD, cardiovascular disease; PMS, premenstrual syndrome | ||
Recommendations from others
The World Health Organization (WHO) highlights the need to avoid progestin-only contraceptives for women younger than 18 or older than 45 years, secondary to concerns of decreased bone mass. Immediately postpartum, women may initiate progestinonly contraceptives if they are not breast-feeding; if breastfeeding, women should wait until at least 6 months postpartum.
Hypertensive women should avoid progestin-only contraceptives; women at risk for hypertension—particularly DMPA users—are encouraged to measure blood pressure before and after use. The WHO document points out the increased possibility for abnormal uterine bleeding with progestin-only contraceptives use.9
American College of Physician’s PIER: Physicians’ Information and Education Resource describes using progestin-only contraceptives in hypercoagulable states and severe hyperlipidemia and avoiding use in osteoporosis, osteopenia, and chronic glucocorticoid use due to a decrease in bone mineral density.10
The American College of Obstetricians and Gynecologists (ACOG) specifically endorses the preferential use of progestin-only contraceptives by lactating women and women at an increased risk of venous thromboembolism based on good evidence. For women with systemic lupus erythematosus, ACOG recommends use of progestin-only contraceptives over combined oral contraceptive, based on fair evidence. By consensus, ACOG recognizes benefits of DMPA for women with sickle-cell disease and women with coronary artery disease, congestive heart failure, or cerebrovascular disease. In general, ACOG recommends progestin-only contraceptives over combined oral contraceptives for patients with the following conditions: migraine headaches, cigarette smoker of age greater than 35, history of venous thromboembolism, coronary artery disease, congestive heart failure, cerebrovascular disease, postpartum <2 weeks, hypertension with vascular disease or age greater than 35, diabetes with vascular disease or age greater than 35, systemic lupus erythematosus with vascular disease, nephritis, or antiphospholipid antibodies, or hypertriglyceridemia.11
1. Truitt ST, Fraser AB, Grimes DA, Gallo MF, Schulz KF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation. Cochrane Database Syst Rev 2003;(2):CD003988.-
2. Hussain SF. Progestogen only pills and high blood pressure: is there an association? A literature review. Contraception 2004;69:89-97.
3. Banks E, Berrington A, Casabonne D. Overview of the relationship between use of progestogen-only contraceptives and bone mineral density. BJOG 2001;108:1214-1221.
4. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Cardiovascular disease and use of oral and injectable progestogen-only contraceptives and combined injectable contraceptives. Contraception 1998;57:315-324.
5. Brache V, Faundes A, Alvarez F, Cochon L. Nonmenstrual adverse events during use of implantable contraceptives for women: data from clinical trials. Contraception 2002;65:63-74.
6. Wyatt K, Dimmock P, Jones P, Obhrai M, O’Brien S. Efficacy of progesterone and progestogens in management of premenstrual syndrome: systematic review. BMJ 2001;323:776-780.
7. Hickey M, Higham J, Fraser IS. Progestogens versus oestrogens and progestogens for irregular uterine bleeding associated with anovulation. Cochrane Database Syst Rev 2000;(2):CD001895.-
8. Trussell J. Contraceptive efficacy. In: Hatcher RA et al, eds. Contraceptive Technology. 18th rev ed. New York, NY: Ardent Media; 2004;773-845.
9. World Health Organization. Improving Access to Quality Care in Family Planning: Medical Eligibility Criteria for Contraceptive Use. 3rd ed. Geneva: World Health Organization; 2004.
10. American College of Physicians. Contraception recommendations for selected conditions or medications. PIER: Physicians’ Information and Education Resource [online]. Philadelphia: American College of Physicians, 2005. Available at: online.statref.com. Accessed on August 12, 2005.
11. ACOG Practice Bulletin. The use of hormonal contraception in women with coexisting medical conditions. Int J Gynaecol Obstet 2001;75:93-106.
1. Truitt ST, Fraser AB, Grimes DA, Gallo MF, Schulz KF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation. Cochrane Database Syst Rev 2003;(2):CD003988.-
2. Hussain SF. Progestogen only pills and high blood pressure: is there an association? A literature review. Contraception 2004;69:89-97.
3. Banks E, Berrington A, Casabonne D. Overview of the relationship between use of progestogen-only contraceptives and bone mineral density. BJOG 2001;108:1214-1221.
4. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Cardiovascular disease and use of oral and injectable progestogen-only contraceptives and combined injectable contraceptives. Contraception 1998;57:315-324.
5. Brache V, Faundes A, Alvarez F, Cochon L. Nonmenstrual adverse events during use of implantable contraceptives for women: data from clinical trials. Contraception 2002;65:63-74.
6. Wyatt K, Dimmock P, Jones P, Obhrai M, O’Brien S. Efficacy of progesterone and progestogens in management of premenstrual syndrome: systematic review. BMJ 2001;323:776-780.
7. Hickey M, Higham J, Fraser IS. Progestogens versus oestrogens and progestogens for irregular uterine bleeding associated with anovulation. Cochrane Database Syst Rev 2000;(2):CD001895.-
8. Trussell J. Contraceptive efficacy. In: Hatcher RA et al, eds. Contraceptive Technology. 18th rev ed. New York, NY: Ardent Media; 2004;773-845.
9. World Health Organization. Improving Access to Quality Care in Family Planning: Medical Eligibility Criteria for Contraceptive Use. 3rd ed. Geneva: World Health Organization; 2004.
10. American College of Physicians. Contraception recommendations for selected conditions or medications. PIER: Physicians’ Information and Education Resource [online]. Philadelphia: American College of Physicians, 2005. Available at: online.statref.com. Accessed on August 12, 2005.
11. ACOG Practice Bulletin. The use of hormonal contraception in women with coexisting medical conditions. Int J Gynaecol Obstet 2001;75:93-106.
Evidence-based answers from the Family Physicians Inquiries Network