Gynecology

VANCOUVER – A retrospective analysis of women who became pregnant after undergoing laparoscopic radiofrequency ablation (Lap-RFA) of symptomatic myomas found no evidence that the procedure negatively impacted pregnancy or birth outcomes, according to Jay Berman, MD.

The procedure is a minimally invasive alternative to myomectomy, hysterectomy, and other surgical techniques, with minimal scarring and quick recovery. But the pivotal trials excluded women who were planning to become pregnant, and the Food and Drug Administration recommends against its use in women planning a future pregnancy because of the lack of safety and efficacy data in that population.

The procedure, which gained FDA approval in 2016, combines laparoscopic ultrasound with targeted radiofrequency to heat fibroids, which then shrink over the next few months. “There have been a lot of questions from infertility specialists regarding whether Lap-RFA can be applied to their patients because there’s very little scarring and a quick return to work. It’s really a very nice outpatient procedure for dealing with fibroids,” Dr. Berman said in an interview.

There is natural concern, however, because clinicians are uncomfortable exposing women to a pregnancy risk. “I think there’s concern from many gynecologists and reproductive endocrinologists on the pregnancy outcomes following fibroid therapy, whatever that happens to be – traditional open laparoscopic myomectomy, robotic myomectomy, all of those kinds of therapies. We were interested in looking at pregnancy outcomes following [RFA for fibroids] and whether or not C-sections would need to be recommended, similar to what you see following myomectomy, where if you enter the cavity or go through more than half of the myometrium, you recommend a C-section for that patient in subsequent pregnancies,” said Dr. Berman, who is a professor of obstetrics and gynecology at Wayne State University, Detroit.

Early case studies, mostly done in Mexico and Guatemala, found the uteri of women to be normal following Lap-RFA, he said.

The results of this study are encouraging, but are far from the final word, as the data are retrospective and small. Acessa, which provided statistical analysis for the current work, is planning a prospective study. “I don’t think there’s enough to say that the labeling should be changed, but we’re moving in that direction. There needs to be a lot more information,” Dr. Berman said at the meeting sponsored by AAGL.

The study combined data from two randomized, controlled trials in the United States and Germany; six cohort studies in the United States, Germany, and Latin America; and commercial procedures performed in the United States. The researchers relied on standardized case reports that focused primarily on maternal and infant safety, and the mode of delivery. They collected data from 38 women (mean age, 36 years) who had fibroids types 1-6 that were of a maximum 0.2-13 cm in diameter. In 19 cases, it was 5.5 cm or smaller. The number of fibroids treated ranged from 1 to 31; 19 women had one or two fibroids treated.

There were a total of 43 pregnancies, 32 of which resulted in full-term live births (74%) and there was 1 preterm birth (2.3%). All infants were healthy, and there 19 vaginal births and 13 C-sections. The reasons for the C-sections were previous C-sections or obstetric indications, such as unusual bleeding, nonprogression of labor, or abnormal fetal heartbeat. There were eight spontaneous abortions (19%) and one therapeutic abortion (2.3%), and one pregnancy was ongoing (2.3%).

Dr. Berman has been a consultant for Acessa Health, Bayer, Boston Scientific, Medtronic, and Abbvie. He has been on the speakers bureau for Acessa, Merck, Boston Scientific, Medtronic, Abbvie, and Lupin. He has performed contracted research for Acessa, Bayer, Allergan, and Obseva.

VANCOUVER – A retrospective analysis of women who became pregnant after undergoing laparoscopic radiofrequency ablation (Lap-RFA) of symptomatic myomas found no evidence that the procedure negatively impacted pregnancy or birth outcomes, according to Jay Berman, MD.

The procedure is a minimally invasive alternative to myomectomy, hysterectomy, and other surgical techniques, with minimal scarring and quick recovery. But the pivotal trials excluded women who were planning to become pregnant, and the Food and Drug Administration recommends against its use in women planning a future pregnancy because of the lack of safety and efficacy data in that population.

The procedure, which gained FDA approval in 2016, combines laparoscopic ultrasound with targeted radiofrequency to heat fibroids, which then shrink over the next few months. “There have been a lot of questions from infertility specialists regarding whether Lap-RFA can be applied to their patients because there’s very little scarring and a quick return to work. It’s really a very nice outpatient procedure for dealing with fibroids,” Dr. Berman said in an interview.

There is natural concern, however, because clinicians are uncomfortable exposing women to a pregnancy risk. “I think there’s concern from many gynecologists and reproductive endocrinologists on the pregnancy outcomes following fibroid therapy, whatever that happens to be – traditional open laparoscopic myomectomy, robotic myomectomy, all of those kinds of therapies. We were interested in looking at pregnancy outcomes following [RFA for fibroids] and whether or not C-sections would need to be recommended, similar to what you see following myomectomy, where if you enter the cavity or go through more than half of the myometrium, you recommend a C-section for that patient in subsequent pregnancies,” said Dr. Berman, who is a professor of obstetrics and gynecology at Wayne State University, Detroit.

Early case studies, mostly done in Mexico and Guatemala, found the uteri of women to be normal following Lap-RFA, he said.

The results of this study are encouraging, but are far from the final word, as the data are retrospective and small. Acessa, which provided statistical analysis for the current work, is planning a prospective study. “I don’t think there’s enough to say that the labeling should be changed, but we’re moving in that direction. There needs to be a lot more information,” Dr. Berman said at the meeting sponsored by AAGL.

The study combined data from two randomized, controlled trials in the United States and Germany; six cohort studies in the United States, Germany, and Latin America; and commercial procedures performed in the United States. The researchers relied on standardized case reports that focused primarily on maternal and infant safety, and the mode of delivery. They collected data from 38 women (mean age, 36 years) who had fibroids types 1-6 that were of a maximum 0.2-13 cm in diameter. In 19 cases, it was 5.5 cm or smaller. The number of fibroids treated ranged from 1 to 31; 19 women had one or two fibroids treated.

There were a total of 43 pregnancies, 32 of which resulted in full-term live births (74%) and there was 1 preterm birth (2.3%). All infants were healthy, and there 19 vaginal births and 13 C-sections. The reasons for the C-sections were previous C-sections or obstetric indications, such as unusual bleeding, nonprogression of labor, or abnormal fetal heartbeat. There were eight spontaneous abortions (19%) and one therapeutic abortion (2.3%), and one pregnancy was ongoing (2.3%).

Dr. Berman has been a consultant for Acessa Health, Bayer, Boston Scientific, Medtronic, and Abbvie. He has been on the speakers bureau for Acessa, Merck, Boston Scientific, Medtronic, Abbvie, and Lupin. He has performed contracted research for Acessa, Bayer, Allergan, and Obseva.

VANCOUVER – A retrospective analysis of women who became pregnant after undergoing laparoscopic radiofrequency ablation (Lap-RFA) of symptomatic myomas found no evidence that the procedure negatively impacted pregnancy or birth outcomes, according to Jay Berman, MD.

The procedure is a minimally invasive alternative to myomectomy, hysterectomy, and other surgical techniques, with minimal scarring and quick recovery. But the pivotal trials excluded women who were planning to become pregnant, and the Food and Drug Administration recommends against its use in women planning a future pregnancy because of the lack of safety and efficacy data in that population.

The procedure, which gained FDA approval in 2016, combines laparoscopic ultrasound with targeted radiofrequency to heat fibroids, which then shrink over the next few months. “There have been a lot of questions from infertility specialists regarding whether Lap-RFA can be applied to their patients because there’s very little scarring and a quick return to work. It’s really a very nice outpatient procedure for dealing with fibroids,” Dr. Berman said in an interview.

There is natural concern, however, because clinicians are uncomfortable exposing women to a pregnancy risk. “I think there’s concern from many gynecologists and reproductive endocrinologists on the pregnancy outcomes following fibroid therapy, whatever that happens to be – traditional open laparoscopic myomectomy, robotic myomectomy, all of those kinds of therapies. We were interested in looking at pregnancy outcomes following [RFA for fibroids] and whether or not C-sections would need to be recommended, similar to what you see following myomectomy, where if you enter the cavity or go through more than half of the myometrium, you recommend a C-section for that patient in subsequent pregnancies,” said Dr. Berman, who is a professor of obstetrics and gynecology at Wayne State University, Detroit.

Early case studies, mostly done in Mexico and Guatemala, found the uteri of women to be normal following Lap-RFA, he said.

The results of this study are encouraging, but are far from the final word, as the data are retrospective and small. Acessa, which provided statistical analysis for the current work, is planning a prospective study. “I don’t think there’s enough to say that the labeling should be changed, but we’re moving in that direction. There needs to be a lot more information,” Dr. Berman said at the meeting sponsored by AAGL.

The study combined data from two randomized, controlled trials in the United States and Germany; six cohort studies in the United States, Germany, and Latin America; and commercial procedures performed in the United States. The researchers relied on standardized case reports that focused primarily on maternal and infant safety, and the mode of delivery. They collected data from 38 women (mean age, 36 years) who had fibroids types 1-6 that were of a maximum 0.2-13 cm in diameter. In 19 cases, it was 5.5 cm or smaller. The number of fibroids treated ranged from 1 to 31; 19 women had one or two fibroids treated.

There were a total of 43 pregnancies, 32 of which resulted in full-term live births (74%) and there was 1 preterm birth (2.3%). All infants were healthy, and there 19 vaginal births and 13 C-sections. The reasons for the C-sections were previous C-sections or obstetric indications, such as unusual bleeding, nonprogression of labor, or abnormal fetal heartbeat. There were eight spontaneous abortions (19%) and one therapeutic abortion (2.3%), and one pregnancy was ongoing (2.3%).

Dr. Berman has been a consultant for Acessa Health, Bayer, Boston Scientific, Medtronic, and Abbvie. He has been on the speakers bureau for Acessa, Merck, Boston Scientific, Medtronic, Abbvie, and Lupin. He has performed contracted research for Acessa, Bayer, Allergan, and Obseva.

PHILADELPHIA – Elagolix has emerged as an effective second-tier treatment option for patients with dysmenorrhea attributed to endometriosis, Charles E. Miller, MD, said at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

Although clinicians need prior authorization and evidence of treatment failure before prescribing Elagolix, the drug is a viable option as a second-tier treatment for patients with endometriosis-associated dysmenorrhea, said Dr. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill. “We have a drug that is very effective, that has a very low adverse event profile, and is tolerated by the vast majority of our patients.”

First-line options

NSAIDs are first-line treatment for endometriosis-related dysmenorrhea, with acetaminophen used in cases where NSAIDs are contraindicated or cause side effects such as gastrointestinal issues. Hormonal contraceptives also can be used as first-line treatment, divided into estrogen/progestin and progestin-only options that can be combined. Evidence from the literature has shown oral pills decrease pain, compared with placebo, but the decrease is not dose dependent, said Dr. Miller.

“We also know that if you use it continuously or prolonged, we find that there is going to be greater success with dysmenorrhea, and that ultimately you would use a higher-dose pill because of the greater risk of breakthrough when using a lesser dose in a continuous fashion,” he said. “Obviously if you’re not having menses, you’re not going to have dysmenorrhea.”

Other estrogen/progestin hormonal contraception such as the vaginal ring or transdermal patch also have been shown to decrease dysmenorrhea from endometriosis, with one study showing a reduction from 17% to 6% in moderate to severe dysmenorrhea in patients using the vaginal ring, compared with patients receiving oral contraceptives. In a separate randomized, controlled trial, “dysmenorrhea was more common in patch users, so it doesn’t appear that the patch is quite as effective in terms of reducing dysmenorrhea,” said Dr. Miller (JAMA. 2001 May 9. doi: 10.1001/jama.285.18.2347).

Compared with combination hormone therapy, there has been less research conducted on progestin-only hormone contraceptives on reducing dysmenorrhea from endometriosis. For example, there is little evidence for depot medroxyprogesterone acetate in reducing dysmenorrhea, but rather with it causing amenorrhea; one study showed a 50% amenorrhea rate at 1 year. “The disadvantage, however, in our infertile population is ultimately getting the menses back,” said Dr. Miller.

IUDs using levonorgestrel appear comparable with gonadotropin-releasing hormone (GnRH) agonists in reducing endometriosis-related pain; in one study, most women treated with either of these had visual analogue scores of less than 3 at 6 months of treatment. Between 68% and 75% of women with dysmenorrhea who receive an implantable contraceptive device with etonogestrel report decreased pain, and one meta-analysis reported 75% of women had “complete resolution of dysmenorrhea.” Concerning progestin-only pills, they can be used for endometriosis-related dysmenorrhea, but they are “problematic in that there’s a lot of breakthrough bleeding, and often times that is associated with pain,” said Dr. Miller.

Second-tier options

Injectable GnRH agonists are effective options as second-tier treatments for endometriosis-related dysmenorrhea, but patients are at risk of developing postmenopausal symptoms such as hot flashes, insomnia, spotting, and decreased libido. “One advantage to that is, over the years and particularly something that I’ve done with my endometriosis-related dysmenorrhea, is to utilize add-back with these patients,” said Dr. Miller, who noted that patients on 2.5 mg of norethindrone acetate and 0.5 mg of ethinyl estradiol“do very well” with that combination of add-back therapy.

Elagolix is the most recent second-tier treatment option for these patients, and was studied in the Elaris EM-I and Elaris EM-II trials in a once-daily dose of 150 mg and a twice-daily dose of 200 mg. In Elaris EM-1, 76% of patients in the 200-mg elagolix group had a clinical response, compared with 46% in the 150-mg group and 20% in the placebo group (N Engl J Med. 2017 Jul 6. doi: 10.1056/NEJMoa1700089). However, patients should not be on elagolix at 200 mg for more than 6 months, while patients receiving elagolix at 150 mg can stay on the treatment for up to 2 years.

Patients taking elagolix also showed postmenopausal symptoms, with 24% in the 150-mg group and 46% in the 200-mg group experiencing hot flashes, compared with 9% of patients in the placebo group. While 6% of patients in the 150-mg group and 10% in the 200-mg group discontinued because of adverse events, 1% and 3% of patients in the 150-mg and 200-mg group discontinued because of hot flashes or night sweats, respectively. “Symptoms are well tolerated, far different than in comparison with leuprolide acetate and GnRH agonists,” said Dr. Miller.

There also is a benefit to how patients recover from bone mineral density (BMD) changes after remaining on elagolix, Dr. Miller noted. In patients who received elagolix for 12 months at doses of 150 mg and 200 mg, there was an increase in lumbar spine BMD recovered 6 months after discontinuation, with patients in the 150-mg group experiencing a recovery close to baseline BMD levels. Among patients who discontinued treatment, there also was a quick resumption in menses for both groups: 87% of patients in the 150 mg group and 88% of patients in the 200-mg group who discontinued treatment after 6 months had resumed menses by 2 months after discontinuation, while 95% of patients in the 150-mg and 91% in the 200-mg group who discontinued after 12 months resumed menses by 2 months after discontinuation.

Dr. Miller reported relationships with AbbVie, Allergan, Blue Seas Med Spa, Espiner Medical, Gynesonics, Halt Medical, Hologic, Karl Storz, Medtronic, and Richard Wolf in the form of consultancies, grants, speakers’ bureau appointments, stock options, royalties, and ownership interests.

PHILADELPHIA – Elagolix has emerged as an effective second-tier treatment option for patients with dysmenorrhea attributed to endometriosis, Charles E. Miller, MD, said at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

Although clinicians need prior authorization and evidence of treatment failure before prescribing Elagolix, the drug is a viable option as a second-tier treatment for patients with endometriosis-associated dysmenorrhea, said Dr. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill. “We have a drug that is very effective, that has a very low adverse event profile, and is tolerated by the vast majority of our patients.”

First-line options

NSAIDs are first-line treatment for endometriosis-related dysmenorrhea, with acetaminophen used in cases where NSAIDs are contraindicated or cause side effects such as gastrointestinal issues. Hormonal contraceptives also can be used as first-line treatment, divided into estrogen/progestin and progestin-only options that can be combined. Evidence from the literature has shown oral pills decrease pain, compared with placebo, but the decrease is not dose dependent, said Dr. Miller.

“We also know that if you use it continuously or prolonged, we find that there is going to be greater success with dysmenorrhea, and that ultimately you would use a higher-dose pill because of the greater risk of breakthrough when using a lesser dose in a continuous fashion,” he said. “Obviously if you’re not having menses, you’re not going to have dysmenorrhea.”

Other estrogen/progestin hormonal contraception such as the vaginal ring or transdermal patch also have been shown to decrease dysmenorrhea from endometriosis, with one study showing a reduction from 17% to 6% in moderate to severe dysmenorrhea in patients using the vaginal ring, compared with patients receiving oral contraceptives. In a separate randomized, controlled trial, “dysmenorrhea was more common in patch users, so it doesn’t appear that the patch is quite as effective in terms of reducing dysmenorrhea,” said Dr. Miller (JAMA. 2001 May 9. doi: 10.1001/jama.285.18.2347).

Compared with combination hormone therapy, there has been less research conducted on progestin-only hormone contraceptives on reducing dysmenorrhea from endometriosis. For example, there is little evidence for depot medroxyprogesterone acetate in reducing dysmenorrhea, but rather with it causing amenorrhea; one study showed a 50% amenorrhea rate at 1 year. “The disadvantage, however, in our infertile population is ultimately getting the menses back,” said Dr. Miller.

IUDs using levonorgestrel appear comparable with gonadotropin-releasing hormone (GnRH) agonists in reducing endometriosis-related pain; in one study, most women treated with either of these had visual analogue scores of less than 3 at 6 months of treatment. Between 68% and 75% of women with dysmenorrhea who receive an implantable contraceptive device with etonogestrel report decreased pain, and one meta-analysis reported 75% of women had “complete resolution of dysmenorrhea.” Concerning progestin-only pills, they can be used for endometriosis-related dysmenorrhea, but they are “problematic in that there’s a lot of breakthrough bleeding, and often times that is associated with pain,” said Dr. Miller.

Second-tier options

Injectable GnRH agonists are effective options as second-tier treatments for endometriosis-related dysmenorrhea, but patients are at risk of developing postmenopausal symptoms such as hot flashes, insomnia, spotting, and decreased libido. “One advantage to that is, over the years and particularly something that I’ve done with my endometriosis-related dysmenorrhea, is to utilize add-back with these patients,” said Dr. Miller, who noted that patients on 2.5 mg of norethindrone acetate and 0.5 mg of ethinyl estradiol“do very well” with that combination of add-back therapy.

Elagolix is the most recent second-tier treatment option for these patients, and was studied in the Elaris EM-I and Elaris EM-II trials in a once-daily dose of 150 mg and a twice-daily dose of 200 mg. In Elaris EM-1, 76% of patients in the 200-mg elagolix group had a clinical response, compared with 46% in the 150-mg group and 20% in the placebo group (N Engl J Med. 2017 Jul 6. doi: 10.1056/NEJMoa1700089). However, patients should not be on elagolix at 200 mg for more than 6 months, while patients receiving elagolix at 150 mg can stay on the treatment for up to 2 years.

Patients taking elagolix also showed postmenopausal symptoms, with 24% in the 150-mg group and 46% in the 200-mg group experiencing hot flashes, compared with 9% of patients in the placebo group. While 6% of patients in the 150-mg group and 10% in the 200-mg group discontinued because of adverse events, 1% and 3% of patients in the 150-mg and 200-mg group discontinued because of hot flashes or night sweats, respectively. “Symptoms are well tolerated, far different than in comparison with leuprolide acetate and GnRH agonists,” said Dr. Miller.

There also is a benefit to how patients recover from bone mineral density (BMD) changes after remaining on elagolix, Dr. Miller noted. In patients who received elagolix for 12 months at doses of 150 mg and 200 mg, there was an increase in lumbar spine BMD recovered 6 months after discontinuation, with patients in the 150-mg group experiencing a recovery close to baseline BMD levels. Among patients who discontinued treatment, there also was a quick resumption in menses for both groups: 87% of patients in the 150 mg group and 88% of patients in the 200-mg group who discontinued treatment after 6 months had resumed menses by 2 months after discontinuation, while 95% of patients in the 150-mg and 91% in the 200-mg group who discontinued after 12 months resumed menses by 2 months after discontinuation.

Dr. Miller reported relationships with AbbVie, Allergan, Blue Seas Med Spa, Espiner Medical, Gynesonics, Halt Medical, Hologic, Karl Storz, Medtronic, and Richard Wolf in the form of consultancies, grants, speakers’ bureau appointments, stock options, royalties, and ownership interests.

PHILADELPHIA – Elagolix has emerged as an effective second-tier treatment option for patients with dysmenorrhea attributed to endometriosis, Charles E. Miller, MD, said at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

Although clinicians need prior authorization and evidence of treatment failure before prescribing Elagolix, the drug is a viable option as a second-tier treatment for patients with endometriosis-associated dysmenorrhea, said Dr. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill. “We have a drug that is very effective, that has a very low adverse event profile, and is tolerated by the vast majority of our patients.”

First-line options

NSAIDs are first-line treatment for endometriosis-related dysmenorrhea, with acetaminophen used in cases where NSAIDs are contraindicated or cause side effects such as gastrointestinal issues. Hormonal contraceptives also can be used as first-line treatment, divided into estrogen/progestin and progestin-only options that can be combined. Evidence from the literature has shown oral pills decrease pain, compared with placebo, but the decrease is not dose dependent, said Dr. Miller.

“We also know that if you use it continuously or prolonged, we find that there is going to be greater success with dysmenorrhea, and that ultimately you would use a higher-dose pill because of the greater risk of breakthrough when using a lesser dose in a continuous fashion,” he said. “Obviously if you’re not having menses, you’re not going to have dysmenorrhea.”

Other estrogen/progestin hormonal contraception such as the vaginal ring or transdermal patch also have been shown to decrease dysmenorrhea from endometriosis, with one study showing a reduction from 17% to 6% in moderate to severe dysmenorrhea in patients using the vaginal ring, compared with patients receiving oral contraceptives. In a separate randomized, controlled trial, “dysmenorrhea was more common in patch users, so it doesn’t appear that the patch is quite as effective in terms of reducing dysmenorrhea,” said Dr. Miller (JAMA. 2001 May 9. doi: 10.1001/jama.285.18.2347).

Compared with combination hormone therapy, there has been less research conducted on progestin-only hormone contraceptives on reducing dysmenorrhea from endometriosis. For example, there is little evidence for depot medroxyprogesterone acetate in reducing dysmenorrhea, but rather with it causing amenorrhea; one study showed a 50% amenorrhea rate at 1 year. “The disadvantage, however, in our infertile population is ultimately getting the menses back,” said Dr. Miller.

IUDs using levonorgestrel appear comparable with gonadotropin-releasing hormone (GnRH) agonists in reducing endometriosis-related pain; in one study, most women treated with either of these had visual analogue scores of less than 3 at 6 months of treatment. Between 68% and 75% of women with dysmenorrhea who receive an implantable contraceptive device with etonogestrel report decreased pain, and one meta-analysis reported 75% of women had “complete resolution of dysmenorrhea.” Concerning progestin-only pills, they can be used for endometriosis-related dysmenorrhea, but they are “problematic in that there’s a lot of breakthrough bleeding, and often times that is associated with pain,” said Dr. Miller.

Second-tier options

Injectable GnRH agonists are effective options as second-tier treatments for endometriosis-related dysmenorrhea, but patients are at risk of developing postmenopausal symptoms such as hot flashes, insomnia, spotting, and decreased libido. “One advantage to that is, over the years and particularly something that I’ve done with my endometriosis-related dysmenorrhea, is to utilize add-back with these patients,” said Dr. Miller, who noted that patients on 2.5 mg of norethindrone acetate and 0.5 mg of ethinyl estradiol“do very well” with that combination of add-back therapy.

Elagolix is the most recent second-tier treatment option for these patients, and was studied in the Elaris EM-I and Elaris EM-II trials in a once-daily dose of 150 mg and a twice-daily dose of 200 mg. In Elaris EM-1, 76% of patients in the 200-mg elagolix group had a clinical response, compared with 46% in the 150-mg group and 20% in the placebo group (N Engl J Med. 2017 Jul 6. doi: 10.1056/NEJMoa1700089). However, patients should not be on elagolix at 200 mg for more than 6 months, while patients receiving elagolix at 150 mg can stay on the treatment for up to 2 years.

Patients taking elagolix also showed postmenopausal symptoms, with 24% in the 150-mg group and 46% in the 200-mg group experiencing hot flashes, compared with 9% of patients in the placebo group. While 6% of patients in the 150-mg group and 10% in the 200-mg group discontinued because of adverse events, 1% and 3% of patients in the 150-mg and 200-mg group discontinued because of hot flashes or night sweats, respectively. “Symptoms are well tolerated, far different than in comparison with leuprolide acetate and GnRH agonists,” said Dr. Miller.

There also is a benefit to how patients recover from bone mineral density (BMD) changes after remaining on elagolix, Dr. Miller noted. In patients who received elagolix for 12 months at doses of 150 mg and 200 mg, there was an increase in lumbar spine BMD recovered 6 months after discontinuation, with patients in the 150-mg group experiencing a recovery close to baseline BMD levels. Among patients who discontinued treatment, there also was a quick resumption in menses for both groups: 87% of patients in the 150 mg group and 88% of patients in the 200-mg group who discontinued treatment after 6 months had resumed menses by 2 months after discontinuation, while 95% of patients in the 150-mg and 91% in the 200-mg group who discontinued after 12 months resumed menses by 2 months after discontinuation.

Dr. Miller reported relationships with AbbVie, Allergan, Blue Seas Med Spa, Espiner Medical, Gynesonics, Halt Medical, Hologic, Karl Storz, Medtronic, and Richard Wolf in the form of consultancies, grants, speakers’ bureau appointments, stock options, royalties, and ownership interests.

VANCOUVER, B.C. – Marijuana and cannabidiol (CBD) use is quite common among patients with pelvic pain resulting from endometriosis, with over a third reporting either current or past use, according to a new survey.

VladK213/Getty Images

The finding comes as more and more companies are marketing CBD-containing products to women, with unsubstantiated claims about efficacy, according to Anna Reinert, MD, who presented the research at a meeting sponsored by AAGL.

Women self-reported that marijuana use was moderately effective, while the median value for CBD corresponded to “slightly effective.”

To investigate use patterns, Dr. Reinert and colleagues created a questionnaire with 55-75 questions, which followed a branching logic tree. Topics included pain history, demographics, and experience with marijuana and CBD for the purpose of controlling pelvic pain. The survey was sent to two populations: an endometriosis association mailing list, and patients at a chronic pain center in Phoenix.

About 24,500 surveys were sent out; 366 were received and analyzed. The response rate was much different between the two populations, at 1% in the endometriosis association and 16% of the clinic population. Dr. Reinert attributed the low response rate in the association sample to the continuing stigma surrounding marijuana use, citing much higher response rates to other surveys sent out by the association around the same time.

Overall, 63% of respondents said they had never used marijuana; 37% reported past or present use; 65% said they had never used CBD; and 35% reported past or present use. About 45% of marijuana users reported that its use was very effective, and 25% said it was moderately effective. About 22% of CBD users said it was very effective, and about 33% said it was moderately effective. The median values lay in the moderately effective range for marijuana, and in the slightly effective range for CBD.

The findings suggest a need for more research into the potential benefit and limitations of cannabis for pelvic pain from endometriosis, said Dr. Reinert, an obstetrician/gynecologist the University of Southern California, Los Angeles.

Until this study, evidence of efficacy of marijuana for this indication has been sparse. A report from the National Academy of Sciences showed that there is evidence that cannabis and cannabinoids have a therapeutic effect on chronic pain in adults (National Academies Press (US) 2017 Jan 12), but the report made no mention of gynecological applications. Despite this lack of evidence, surveys have shown that women of reproductive age use marijuana, and an analysis by the Ameritox Laboratory in a pain management population found that 13% of women and 19% of men tested positive for marijuana in their urine.

Still, “there is not research looking at marijuana for women with chronic health pain,” Dr. Reinert said at the meeting.

But that doesn’t stop companies from developing CBD vaginal suppositories and marketing them for menstrual pelvic discomfort, pain during sex, and other issues. Lay press articles often boost these claims, although some skeptical takes address the lack of evidence. Still, “there’s a lot on the more positive side,” she said.

That leads to a lot of interest among patients in using marijuana or CBD for symptom relief, which is part of the reason that Dr. Reinert’s team decided to examine its use and perceived efficacy. Another reason is that there is some biological basis to believe that cannabis could be helpful. There is some evidence that women with endometriosis have changes in their endocannabinoid system (Cannabis Cannabinoid Res. 2017;2:72-80), and there are clinical trials examining the impact of non-CBD, non-tetrahydrocannabinol (THC) endocannabinoid ligands.

Dr. Reinert has no financial disclosures.

VANCOUVER, B.C. – Marijuana and cannabidiol (CBD) use is quite common among patients with pelvic pain resulting from endometriosis, with over a third reporting either current or past use, according to a new survey.

VladK213/Getty Images

The finding comes as more and more companies are marketing CBD-containing products to women, with unsubstantiated claims about efficacy, according to Anna Reinert, MD, who presented the research at a meeting sponsored by AAGL.

Women self-reported that marijuana use was moderately effective, while the median value for CBD corresponded to “slightly effective.”

To investigate use patterns, Dr. Reinert and colleagues created a questionnaire with 55-75 questions, which followed a branching logic tree. Topics included pain history, demographics, and experience with marijuana and CBD for the purpose of controlling pelvic pain. The survey was sent to two populations: an endometriosis association mailing list, and patients at a chronic pain center in Phoenix.

About 24,500 surveys were sent out; 366 were received and analyzed. The response rate was much different between the two populations, at 1% in the endometriosis association and 16% of the clinic population. Dr. Reinert attributed the low response rate in the association sample to the continuing stigma surrounding marijuana use, citing much higher response rates to other surveys sent out by the association around the same time.

Overall, 63% of respondents said they had never used marijuana; 37% reported past or present use; 65% said they had never used CBD; and 35% reported past or present use. About 45% of marijuana users reported that its use was very effective, and 25% said it was moderately effective. About 22% of CBD users said it was very effective, and about 33% said it was moderately effective. The median values lay in the moderately effective range for marijuana, and in the slightly effective range for CBD.

The findings suggest a need for more research into the potential benefit and limitations of cannabis for pelvic pain from endometriosis, said Dr. Reinert, an obstetrician/gynecologist the University of Southern California, Los Angeles.

Until this study, evidence of efficacy of marijuana for this indication has been sparse. A report from the National Academy of Sciences showed that there is evidence that cannabis and cannabinoids have a therapeutic effect on chronic pain in adults (National Academies Press (US) 2017 Jan 12), but the report made no mention of gynecological applications. Despite this lack of evidence, surveys have shown that women of reproductive age use marijuana, and an analysis by the Ameritox Laboratory in a pain management population found that 13% of women and 19% of men tested positive for marijuana in their urine.

Still, “there is not research looking at marijuana for women with chronic health pain,” Dr. Reinert said at the meeting.

But that doesn’t stop companies from developing CBD vaginal suppositories and marketing them for menstrual pelvic discomfort, pain during sex, and other issues. Lay press articles often boost these claims, although some skeptical takes address the lack of evidence. Still, “there’s a lot on the more positive side,” she said.

That leads to a lot of interest among patients in using marijuana or CBD for symptom relief, which is part of the reason that Dr. Reinert’s team decided to examine its use and perceived efficacy. Another reason is that there is some biological basis to believe that cannabis could be helpful. There is some evidence that women with endometriosis have changes in their endocannabinoid system (Cannabis Cannabinoid Res. 2017;2:72-80), and there are clinical trials examining the impact of non-CBD, non-tetrahydrocannabinol (THC) endocannabinoid ligands.

Dr. Reinert has no financial disclosures.

VANCOUVER, B.C. – Marijuana and cannabidiol (CBD) use is quite common among patients with pelvic pain resulting from endometriosis, with over a third reporting either current or past use, according to a new survey.

VladK213/Getty Images

The finding comes as more and more companies are marketing CBD-containing products to women, with unsubstantiated claims about efficacy, according to Anna Reinert, MD, who presented the research at a meeting sponsored by AAGL.

Women self-reported that marijuana use was moderately effective, while the median value for CBD corresponded to “slightly effective.”

To investigate use patterns, Dr. Reinert and colleagues created a questionnaire with 55-75 questions, which followed a branching logic tree. Topics included pain history, demographics, and experience with marijuana and CBD for the purpose of controlling pelvic pain. The survey was sent to two populations: an endometriosis association mailing list, and patients at a chronic pain center in Phoenix.

About 24,500 surveys were sent out; 366 were received and analyzed. The response rate was much different between the two populations, at 1% in the endometriosis association and 16% of the clinic population. Dr. Reinert attributed the low response rate in the association sample to the continuing stigma surrounding marijuana use, citing much higher response rates to other surveys sent out by the association around the same time.

Overall, 63% of respondents said they had never used marijuana; 37% reported past or present use; 65% said they had never used CBD; and 35% reported past or present use. About 45% of marijuana users reported that its use was very effective, and 25% said it was moderately effective. About 22% of CBD users said it was very effective, and about 33% said it was moderately effective. The median values lay in the moderately effective range for marijuana, and in the slightly effective range for CBD.

The findings suggest a need for more research into the potential benefit and limitations of cannabis for pelvic pain from endometriosis, said Dr. Reinert, an obstetrician/gynecologist the University of Southern California, Los Angeles.

Until this study, evidence of efficacy of marijuana for this indication has been sparse. A report from the National Academy of Sciences showed that there is evidence that cannabis and cannabinoids have a therapeutic effect on chronic pain in adults (National Academies Press (US) 2017 Jan 12), but the report made no mention of gynecological applications. Despite this lack of evidence, surveys have shown that women of reproductive age use marijuana, and an analysis by the Ameritox Laboratory in a pain management population found that 13% of women and 19% of men tested positive for marijuana in their urine.

Still, “there is not research looking at marijuana for women with chronic health pain,” Dr. Reinert said at the meeting.

But that doesn’t stop companies from developing CBD vaginal suppositories and marketing them for menstrual pelvic discomfort, pain during sex, and other issues. Lay press articles often boost these claims, although some skeptical takes address the lack of evidence. Still, “there’s a lot on the more positive side,” she said.

That leads to a lot of interest among patients in using marijuana or CBD for symptom relief, which is part of the reason that Dr. Reinert’s team decided to examine its use and perceived efficacy. Another reason is that there is some biological basis to believe that cannabis could be helpful. There is some evidence that women with endometriosis have changes in their endocannabinoid system (Cannabis Cannabinoid Res. 2017;2:72-80), and there are clinical trials examining the impact of non-CBD, non-tetrahydrocannabinol (THC) endocannabinoid ligands.

Dr. Reinert has no financial disclosures.

VANCOUVER – Presurgical ultrasound does a good job predicting advanced versus early American Society of Reproductive Medicine endometriosis stage, and that can help ensure that a patient gets to the right surgeon.

Researchers retrospectively collected data from ultrasounds, using it to create an ASRM stage, and compared the results with the stage seen at surgery. “We’re very good at telling people what they should expect at surgery,” said Mathew Leonardi, MD, who is a gynecologist at the University of Sydney’s Nepean Hospital.

The researchers conducted the study because of perceived mistrust among surgeons when it comes to presurgical imaging. “There is still a lot of cynicism and a lot of hesitancy to adopt this,” Dr. Leonardi said at the meeting sponsored by AAGL. He was unapologetic about the activist nature of the research. “We thought, what better way [to convince surgeons] than to produce an ultrasound-based ASRM scoring system to then match to the surgical findings, because if we can predict the ASRM score preoperatively, there may be more buy-in by the surgeons for the value of imaging.”

He noted that surgeons differ in their training, so getting the patient to the right surgeon is critical. “If you go to a gynecologist who is not minimally invasive trained, you may [end up with] an abandoned surgery, or an incomplete surgical excision leading to residual disease. So being able to predict the severity of the disease preoperatively, you can allow the patient to get to the right surgeon with the right team members.”

The analysis included 204 procedures performed between January 2016 and April 2018. Participants underwent deep endometriosis transvaginal ultrasound at one of two tertiary referral service centers, and laparoscopy by surgeons in the Sydney metropolitan area. Each case was received as a ASRM score of 0-4 at both ultrasound and surgery, and scores of 0-2 and 3-4 were grouped together for analysis.

“We grouped patients that have ASRM 3-4 into one group and those who have less than that [into another group], because clinically that seems to be where the most practical divide is,” said Dr. Leonardi.

It was difficult to differentiate individual ASRM stages from one another using ultrasound, but the technique performed much better in the combined analysis. In assigning a patient to the ASRM stage 0-2 endometriosis group, it had 94.9% sensitivity and 93.8% specificity, and for assigning to ASRM stage 3-4, it had values of 93.8% and 94.9%, respectively.

The success is encouraging, but there is more work to be done. “We are going to have to differentiate those with early-stage endometriosis or stage 1-2, and those that are negative. We are working on being able to identify superficial endometriosis noninvasively, but for now, as a triaging tool ultrasound can get the patient to the right surgeon,” Dr. Leonardi said.

Dr. Leonardi reported no relevant financial disclosures

VANCOUVER – Presurgical ultrasound does a good job predicting advanced versus early American Society of Reproductive Medicine endometriosis stage, and that can help ensure that a patient gets to the right surgeon.

Researchers retrospectively collected data from ultrasounds, using it to create an ASRM stage, and compared the results with the stage seen at surgery. “We’re very good at telling people what they should expect at surgery,” said Mathew Leonardi, MD, who is a gynecologist at the University of Sydney’s Nepean Hospital.

The researchers conducted the study because of perceived mistrust among surgeons when it comes to presurgical imaging. “There is still a lot of cynicism and a lot of hesitancy to adopt this,” Dr. Leonardi said at the meeting sponsored by AAGL. He was unapologetic about the activist nature of the research. “We thought, what better way [to convince surgeons] than to produce an ultrasound-based ASRM scoring system to then match to the surgical findings, because if we can predict the ASRM score preoperatively, there may be more buy-in by the surgeons for the value of imaging.”

He noted that surgeons differ in their training, so getting the patient to the right surgeon is critical. “If you go to a gynecologist who is not minimally invasive trained, you may [end up with] an abandoned surgery, or an incomplete surgical excision leading to residual disease. So being able to predict the severity of the disease preoperatively, you can allow the patient to get to the right surgeon with the right team members.”

The analysis included 204 procedures performed between January 2016 and April 2018. Participants underwent deep endometriosis transvaginal ultrasound at one of two tertiary referral service centers, and laparoscopy by surgeons in the Sydney metropolitan area. Each case was received as a ASRM score of 0-4 at both ultrasound and surgery, and scores of 0-2 and 3-4 were grouped together for analysis.

“We grouped patients that have ASRM 3-4 into one group and those who have less than that [into another group], because clinically that seems to be where the most practical divide is,” said Dr. Leonardi.

It was difficult to differentiate individual ASRM stages from one another using ultrasound, but the technique performed much better in the combined analysis. In assigning a patient to the ASRM stage 0-2 endometriosis group, it had 94.9% sensitivity and 93.8% specificity, and for assigning to ASRM stage 3-4, it had values of 93.8% and 94.9%, respectively.

The success is encouraging, but there is more work to be done. “We are going to have to differentiate those with early-stage endometriosis or stage 1-2, and those that are negative. We are working on being able to identify superficial endometriosis noninvasively, but for now, as a triaging tool ultrasound can get the patient to the right surgeon,” Dr. Leonardi said.

Dr. Leonardi reported no relevant financial disclosures

VANCOUVER – Presurgical ultrasound does a good job predicting advanced versus early American Society of Reproductive Medicine endometriosis stage, and that can help ensure that a patient gets to the right surgeon.

Researchers retrospectively collected data from ultrasounds, using it to create an ASRM stage, and compared the results with the stage seen at surgery. “We’re very good at telling people what they should expect at surgery,” said Mathew Leonardi, MD, who is a gynecologist at the University of Sydney’s Nepean Hospital.

The researchers conducted the study because of perceived mistrust among surgeons when it comes to presurgical imaging. “There is still a lot of cynicism and a lot of hesitancy to adopt this,” Dr. Leonardi said at the meeting sponsored by AAGL. He was unapologetic about the activist nature of the research. “We thought, what better way [to convince surgeons] than to produce an ultrasound-based ASRM scoring system to then match to the surgical findings, because if we can predict the ASRM score preoperatively, there may be more buy-in by the surgeons for the value of imaging.”

He noted that surgeons differ in their training, so getting the patient to the right surgeon is critical. “If you go to a gynecologist who is not minimally invasive trained, you may [end up with] an abandoned surgery, or an incomplete surgical excision leading to residual disease. So being able to predict the severity of the disease preoperatively, you can allow the patient to get to the right surgeon with the right team members.”

The analysis included 204 procedures performed between January 2016 and April 2018. Participants underwent deep endometriosis transvaginal ultrasound at one of two tertiary referral service centers, and laparoscopy by surgeons in the Sydney metropolitan area. Each case was received as a ASRM score of 0-4 at both ultrasound and surgery, and scores of 0-2 and 3-4 were grouped together for analysis.

“We grouped patients that have ASRM 3-4 into one group and those who have less than that [into another group], because clinically that seems to be where the most practical divide is,” said Dr. Leonardi.

It was difficult to differentiate individual ASRM stages from one another using ultrasound, but the technique performed much better in the combined analysis. In assigning a patient to the ASRM stage 0-2 endometriosis group, it had 94.9% sensitivity and 93.8% specificity, and for assigning to ASRM stage 3-4, it had values of 93.8% and 94.9%, respectively.

The success is encouraging, but there is more work to be done. “We are going to have to differentiate those with early-stage endometriosis or stage 1-2, and those that are negative. We are working on being able to identify superficial endometriosis noninvasively, but for now, as a triaging tool ultrasound can get the patient to the right surgeon,” Dr. Leonardi said.

Dr. Leonardi reported no relevant financial disclosures

VANCOUVER – In patients undergoing hysterectomy, preoperative depression is associated with an increased risk of first-time persistent opioid use after surgery.

Liderina/Thinkstock

Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.

Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.

“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.

That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.

“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.

The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).

There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.

Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.

Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.

The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”

Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.

VANCOUVER – In patients undergoing hysterectomy, preoperative depression is associated with an increased risk of first-time persistent opioid use after surgery.

Liderina/Thinkstock

Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.

Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.

“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.

That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.

“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.

The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).

There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.

Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.

Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.

The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”

Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.

VANCOUVER – In patients undergoing hysterectomy, preoperative depression is associated with an increased risk of first-time persistent opioid use after surgery.

Liderina/Thinkstock

Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.

Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.

“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.

That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.

“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.

The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).

There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.

Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.

Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.

The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”

Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

[email protected]

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

[email protected]

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

[email protected]

VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.

Ingram Publishing/Thinkstock

In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.

The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.

The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.

Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).

At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).

The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.

The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”

The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).

The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.

The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.

Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*

* This article was updated 11/27/2019.

VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.

Ingram Publishing/Thinkstock

In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.

The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.

The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.

Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).

At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).

The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.

The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”

The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).

The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.

The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.

Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*

* This article was updated 11/27/2019.

VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.

Ingram Publishing/Thinkstock

In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.

The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.

The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.

Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).

At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).

The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.

The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”

The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).

The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.

The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.

Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*

* This article was updated 11/27/2019.

PHILADELPHIA – Women who underwent either hysterectomy or myomectomy had similar short-term outcomes between 6 weeks and 12 weeks after surgery despite different baseline characteristics, according to recent results from the COMPARE-UF study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

“Both hysterectomy and myomectomy can substantially improve women’s quality of life scores and substantially reduce symptom severity,” reported Wanda K. Nicholson, MD, MPH, lead investigator for COMPARE-UF and professor of general obstetrics and gynecology at the University of North Carolina at Chapel Hill.

Researchers included 1,295 women in the COMPARE-UF study who were at least 30 years old, not attempting pregnancy, and undergoing hysterectomy or myomectomy for treatment of fibroids. Overall, 727 patients underwent hysterectomy, and 568 patients underwent myomectomy.

The researchers measured QoL and symptom severity using the Uterine Fibroid Scale-QoL, the EQ-5D, and Visual Analog Scale (VAS). The UFS-QoL contained subscales for concern, activities, energy and mood, control, self-consciousness, and sexual function, while the EQ-5D had subscales for mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

After surgery, UFS-QoL overall scores were similar in both hysterectomy and myomectomy groups between 6 weeks and 12 weeks (77 vs. 76), but there was less postsurgery symptom severity in the hysterectomy group over the same time period (16 vs. 20; P less than .05). However, both groups had a significant improvement in overall UFS-QoL post surgery (hysterectomy, 31; myomectomy, 30) and in UFS-QoL symptom severity (hysterectomy, 41; myomectomy, 37), Dr. Nicholson noted. EQ-5D VAS scores also were similar in both hysterectomy and myomectomy groups after treatment (82 vs. 79), and showed a 10.9 score improvement in hysterectomy patients and an 8.6 score improvement in myomectomy patients.

“This is really important, because it shows that, regardless of which procedure that you’ve chosen, at least at short-term follow up, it appears that you will have improvement in quality of life,” she said.

When researchers analyzed the UFS-QoL subscale scores, they found patients who underwent abdominal myomectomy scored better than abdominal hysterectomy on the activities subscale (79 vs. 72; P equals .01) and energy/mood subscale (82 vs. 75; P equals .03). In examining minimally invasive procedures, Dr. Nicholson and colleagues found higher improvements in health-related QoL scores among patients undergoing minimally invasive hysterectomy (45-80 vs. 45 vs. 75), and these patients also had lower symptom severity, compared with patients who underwent myomectomy (59-13 vs. 58-21).

“At least at the short-term follow-up, we think that some of that difference that we see in minimally invasive procedures vs. nonminimally invasive may be in part due to women’s perceptions or what their expectations are having minimally invasive surgery, and how they might feel in the short-term follow-up period,” said Dr. Nicholson.

These similar short-term outcomes occurred even though there were significant differences in baseline patient characteristics for the hysterectomy and myomectomy groups, with women undergoing hysterectomy being significantly younger (40 years) than patients undergoing hysterectomy (45 years). Differences also were significant between hysterectomy and myomectomy groups in the percentage of patients who were white (50% vs. 41%; P less than .01), African-American (38% vs. 41%; P less than .01) or other races (12% vs. 18%; P less than .01). There also were significant differences in baseline body mass index between hysterectomy (31 kg/m²) and myomectomy (29 kg/m²) groups.

Patients in both groups further differed in presurgery quality-of-life (QoL) scores.

Women in the hysterectomy group had lower presurgery overall QoL (44 vs. 50), greater symptom severity (60 vs. 52), and lower VAS (69 vs. 73) scores, compared with the myomectomy group (P less than .05). This difference continued in the UFS-QoL subscale scores, where women in the hysterectomy group had significantly lower scores in the concern (38 vs. 45), activities (46 vs. 52), energy/mood (45 vs. 51), control (48 vs. 52), self-consciousness (41 vs. 50), and sexual function (45 vs. 50) subscales, compared with women in the myomectomy group (P less than .05). The researchers used propensity scoring to adjust for baseline characteristics, and inverse propensity weighting to adjust for potential confounding in the multivariate analysis.

COMPARE-UF is funded by the Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI), and the National Institutes of Health. Dr. Nicholson reported no relevant conflicts of interest.

SOURCE: Nicholson WK et al. ASRM 2019, Abstract SYT07.

PHILADELPHIA – Women who underwent either hysterectomy or myomectomy had similar short-term outcomes between 6 weeks and 12 weeks after surgery despite different baseline characteristics, according to recent results from the COMPARE-UF study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

“Both hysterectomy and myomectomy can substantially improve women’s quality of life scores and substantially reduce symptom severity,” reported Wanda K. Nicholson, MD, MPH, lead investigator for COMPARE-UF and professor of general obstetrics and gynecology at the University of North Carolina at Chapel Hill.

Researchers included 1,295 women in the COMPARE-UF study who were at least 30 years old, not attempting pregnancy, and undergoing hysterectomy or myomectomy for treatment of fibroids. Overall, 727 patients underwent hysterectomy, and 568 patients underwent myomectomy.

The researchers measured QoL and symptom severity using the Uterine Fibroid Scale-QoL, the EQ-5D, and Visual Analog Scale (VAS). The UFS-QoL contained subscales for concern, activities, energy and mood, control, self-consciousness, and sexual function, while the EQ-5D had subscales for mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

After surgery, UFS-QoL overall scores were similar in both hysterectomy and myomectomy groups between 6 weeks and 12 weeks (77 vs. 76), but there was less postsurgery symptom severity in the hysterectomy group over the same time period (16 vs. 20; P less than .05). However, both groups had a significant improvement in overall UFS-QoL post surgery (hysterectomy, 31; myomectomy, 30) and in UFS-QoL symptom severity (hysterectomy, 41; myomectomy, 37), Dr. Nicholson noted. EQ-5D VAS scores also were similar in both hysterectomy and myomectomy groups after treatment (82 vs. 79), and showed a 10.9 score improvement in hysterectomy patients and an 8.6 score improvement in myomectomy patients.

“This is really important, because it shows that, regardless of which procedure that you’ve chosen, at least at short-term follow up, it appears that you will have improvement in quality of life,” she said.

When researchers analyzed the UFS-QoL subscale scores, they found patients who underwent abdominal myomectomy scored better than abdominal hysterectomy on the activities subscale (79 vs. 72; P equals .01) and energy/mood subscale (82 vs. 75; P equals .03). In examining minimally invasive procedures, Dr. Nicholson and colleagues found higher improvements in health-related QoL scores among patients undergoing minimally invasive hysterectomy (45-80 vs. 45 vs. 75), and these patients also had lower symptom severity, compared with patients who underwent myomectomy (59-13 vs. 58-21).

“At least at the short-term follow-up, we think that some of that difference that we see in minimally invasive procedures vs. nonminimally invasive may be in part due to women’s perceptions or what their expectations are having minimally invasive surgery, and how they might feel in the short-term follow-up period,” said Dr. Nicholson.

These similar short-term outcomes occurred even though there were significant differences in baseline patient characteristics for the hysterectomy and myomectomy groups, with women undergoing hysterectomy being significantly younger (40 years) than patients undergoing hysterectomy (45 years). Differences also were significant between hysterectomy and myomectomy groups in the percentage of patients who were white (50% vs. 41%; P less than .01), African-American (38% vs. 41%; P less than .01) or other races (12% vs. 18%; P less than .01). There also were significant differences in baseline body mass index between hysterectomy (31 kg/m²) and myomectomy (29 kg/m²) groups.

Patients in both groups further differed in presurgery quality-of-life (QoL) scores.

Women in the hysterectomy group had lower presurgery overall QoL (44 vs. 50), greater symptom severity (60 vs. 52), and lower VAS (69 vs. 73) scores, compared with the myomectomy group (P less than .05). This difference continued in the UFS-QoL subscale scores, where women in the hysterectomy group had significantly lower scores in the concern (38 vs. 45), activities (46 vs. 52), energy/mood (45 vs. 51), control (48 vs. 52), self-consciousness (41 vs. 50), and sexual function (45 vs. 50) subscales, compared with women in the myomectomy group (P less than .05). The researchers used propensity scoring to adjust for baseline characteristics, and inverse propensity weighting to adjust for potential confounding in the multivariate analysis.

COMPARE-UF is funded by the Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI), and the National Institutes of Health. Dr. Nicholson reported no relevant conflicts of interest.

SOURCE: Nicholson WK et al. ASRM 2019, Abstract SYT07.

PHILADELPHIA – Women who underwent either hysterectomy or myomectomy had similar short-term outcomes between 6 weeks and 12 weeks after surgery despite different baseline characteristics, according to recent results from the COMPARE-UF study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

“Both hysterectomy and myomectomy can substantially improve women’s quality of life scores and substantially reduce symptom severity,” reported Wanda K. Nicholson, MD, MPH, lead investigator for COMPARE-UF and professor of general obstetrics and gynecology at the University of North Carolina at Chapel Hill.

Researchers included 1,295 women in the COMPARE-UF study who were at least 30 years old, not attempting pregnancy, and undergoing hysterectomy or myomectomy for treatment of fibroids. Overall, 727 patients underwent hysterectomy, and 568 patients underwent myomectomy.

The researchers measured QoL and symptom severity using the Uterine Fibroid Scale-QoL, the EQ-5D, and Visual Analog Scale (VAS). The UFS-QoL contained subscales for concern, activities, energy and mood, control, self-consciousness, and sexual function, while the EQ-5D had subscales for mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

After surgery, UFS-QoL overall scores were similar in both hysterectomy and myomectomy groups between 6 weeks and 12 weeks (77 vs. 76), but there was less postsurgery symptom severity in the hysterectomy group over the same time period (16 vs. 20; P less than .05). However, both groups had a significant improvement in overall UFS-QoL post surgery (hysterectomy, 31; myomectomy, 30) and in UFS-QoL symptom severity (hysterectomy, 41; myomectomy, 37), Dr. Nicholson noted. EQ-5D VAS scores also were similar in both hysterectomy and myomectomy groups after treatment (82 vs. 79), and showed a 10.9 score improvement in hysterectomy patients and an 8.6 score improvement in myomectomy patients.

“This is really important, because it shows that, regardless of which procedure that you’ve chosen, at least at short-term follow up, it appears that you will have improvement in quality of life,” she said.

When researchers analyzed the UFS-QoL subscale scores, they found patients who underwent abdominal myomectomy scored better than abdominal hysterectomy on the activities subscale (79 vs. 72; P equals .01) and energy/mood subscale (82 vs. 75; P equals .03). In examining minimally invasive procedures, Dr. Nicholson and colleagues found higher improvements in health-related QoL scores among patients undergoing minimally invasive hysterectomy (45-80 vs. 45 vs. 75), and these patients also had lower symptom severity, compared with patients who underwent myomectomy (59-13 vs. 58-21).

“At least at the short-term follow-up, we think that some of that difference that we see in minimally invasive procedures vs. nonminimally invasive may be in part due to women’s perceptions or what their expectations are having minimally invasive surgery, and how they might feel in the short-term follow-up period,” said Dr. Nicholson.

These similar short-term outcomes occurred even though there were significant differences in baseline patient characteristics for the hysterectomy and myomectomy groups, with women undergoing hysterectomy being significantly younger (40 years) than patients undergoing hysterectomy (45 years). Differences also were significant between hysterectomy and myomectomy groups in the percentage of patients who were white (50% vs. 41%; P less than .01), African-American (38% vs. 41%; P less than .01) or other races (12% vs. 18%; P less than .01). There also were significant differences in baseline body mass index between hysterectomy (31 kg/m²) and myomectomy (29 kg/m²) groups.

Patients in both groups further differed in presurgery quality-of-life (QoL) scores.

Women in the hysterectomy group had lower presurgery overall QoL (44 vs. 50), greater symptom severity (60 vs. 52), and lower VAS (69 vs. 73) scores, compared with the myomectomy group (P less than .05). This difference continued in the UFS-QoL subscale scores, where women in the hysterectomy group had significantly lower scores in the concern (38 vs. 45), activities (46 vs. 52), energy/mood (45 vs. 51), control (48 vs. 52), self-consciousness (41 vs. 50), and sexual function (45 vs. 50) subscales, compared with women in the myomectomy group (P less than .05). The researchers used propensity scoring to adjust for baseline characteristics, and inverse propensity weighting to adjust for potential confounding in the multivariate analysis.

COMPARE-UF is funded by the Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI), and the National Institutes of Health. Dr. Nicholson reported no relevant conflicts of interest.

SOURCE: Nicholson WK et al. ASRM 2019, Abstract SYT07.

Requests for crowd diagnosis of sexually transmitted diseases were frequent on a social media website, new research found.

The social media website Reddit, which currently has 330 million monthly active users, is home to more than 230 health-related subreddits, including r/STD, a forum that allows users to publicly share “stories, concerns, and questions” about “anything and everything STD related,” Alicia L. Nobles, PhD, of the department of medicine at the University of California, San Diego, and associates wrote in a research letter published in JAMA.

Dr. Noble and associates conducted an analysis of all posts published to r/STD from the subreddit’s inception during November 2010–February 2019, a total of 16,979 posts. Three coauthors independently coded each post, recording whether or not a post requested a crowd diagnosis, and if so, whether that request was made to obtain a second opinion after a visit to a health care professional.

About 58% of posts requested a crowd diagnosis, 31% of which included an image of the physical signs. One-fifth of the requests for a crowd diagnosis were seeking a second opinion after a previous diagnosis by a health care professional. Nearly 90% of all crowd-diagnosis requests received at least one reply (mean responses, 1.7), with a median response time of 3.04 hours. About 80% of requests were answered in less than 1 day.

While crowd diagnoses do seem to be popular and have the benefits of anonymity, rapid response, and multiple opinions, the accuracy of crowd diagnoses is unknown given the limited information responders operate with and the potential lack of responder medical training, the study authors noted. Misdiagnosis could allow further disease transmission, and third parties viewing posts could incorrectly self-diagnose their own condition.

“Health care professionals could partner with social media outlets to promote the potential benefits of crowd diagnosis while suppressing potential harms, for example by having trained professionals respond to posts to better diagnose and make referrals to health care centers,” Dr. Nobles and associates concluded.

One coauthor reported receiving personal fees from Bloomberg and Good Analytics, and another reported receiving grants from the National Institutes of Health; no other disclosures were reported.

[email protected]

SOURCE: Nobles AL et al. JAMA. 2019 Nov 5;322(17):1712-3.

Requests for crowd diagnosis of sexually transmitted diseases were frequent on a social media website, new research found.

The social media website Reddit, which currently has 330 million monthly active users, is home to more than 230 health-related subreddits, including r/STD, a forum that allows users to publicly share “stories, concerns, and questions” about “anything and everything STD related,” Alicia L. Nobles, PhD, of the department of medicine at the University of California, San Diego, and associates wrote in a research letter published in JAMA.

Dr. Noble and associates conducted an analysis of all posts published to r/STD from the subreddit’s inception during November 2010–February 2019, a total of 16,979 posts. Three coauthors independently coded each post, recording whether or not a post requested a crowd diagnosis, and if so, whether that request was made to obtain a second opinion after a visit to a health care professional.

About 58% of posts requested a crowd diagnosis, 31% of which included an image of the physical signs. One-fifth of the requests for a crowd diagnosis were seeking a second opinion after a previous diagnosis by a health care professional. Nearly 90% of all crowd-diagnosis requests received at least one reply (mean responses, 1.7), with a median response time of 3.04 hours. About 80% of requests were answered in less than 1 day.

While crowd diagnoses do seem to be popular and have the benefits of anonymity, rapid response, and multiple opinions, the accuracy of crowd diagnoses is unknown given the limited information responders operate with and the potential lack of responder medical training, the study authors noted. Misdiagnosis could allow further disease transmission, and third parties viewing posts could incorrectly self-diagnose their own condition.

“Health care professionals could partner with social media outlets to promote the potential benefits of crowd diagnosis while suppressing potential harms, for example by having trained professionals respond to posts to better diagnose and make referrals to health care centers,” Dr. Nobles and associates concluded.

One coauthor reported receiving personal fees from Bloomberg and Good Analytics, and another reported receiving grants from the National Institutes of Health; no other disclosures were reported.

[email protected]

SOURCE: Nobles AL et al. JAMA. 2019 Nov 5;322(17):1712-3.

Requests for crowd diagnosis of sexually transmitted diseases were frequent on a social media website, new research found.

The social media website Reddit, which currently has 330 million monthly active users, is home to more than 230 health-related subreddits, including r/STD, a forum that allows users to publicly share “stories, concerns, and questions” about “anything and everything STD related,” Alicia L. Nobles, PhD, of the department of medicine at the University of California, San Diego, and associates wrote in a research letter published in JAMA.

Dr. Noble and associates conducted an analysis of all posts published to r/STD from the subreddit’s inception during November 2010–February 2019, a total of 16,979 posts. Three coauthors independently coded each post, recording whether or not a post requested a crowd diagnosis, and if so, whether that request was made to obtain a second opinion after a visit to a health care professional.

About 58% of posts requested a crowd diagnosis, 31% of which included an image of the physical signs. One-fifth of the requests for a crowd diagnosis were seeking a second opinion after a previous diagnosis by a health care professional. Nearly 90% of all crowd-diagnosis requests received at least one reply (mean responses, 1.7), with a median response time of 3.04 hours. About 80% of requests were answered in less than 1 day.

While crowd diagnoses do seem to be popular and have the benefits of anonymity, rapid response, and multiple opinions, the accuracy of crowd diagnoses is unknown given the limited information responders operate with and the potential lack of responder medical training, the study authors noted. Misdiagnosis could allow further disease transmission, and third parties viewing posts could incorrectly self-diagnose their own condition.

“Health care professionals could partner with social media outlets to promote the potential benefits of crowd diagnosis while suppressing potential harms, for example by having trained professionals respond to posts to better diagnose and make referrals to health care centers,” Dr. Nobles and associates concluded.

One coauthor reported receiving personal fees from Bloomberg and Good Analytics, and another reported receiving grants from the National Institutes of Health; no other disclosures were reported.

[email protected]

SOURCE: Nobles AL et al. JAMA. 2019 Nov 5;322(17):1712-3.