A health-related quality-of-life instrument for symptomatic patients with endometriosis: a validation study. Quantification of endometriosis-associated pain and quality of life during the stimulatory phase of gonadotropin-releasing hormone agonist therapy: a double-blind, randomized, placebo-controlled trial. Postoperative medical treatment of chronic pelvic pain related to severe endometriosis: levonorgestrel-releasing intrauterine system versus gonadotropin-releasing hormone analogue. Continuous versus cyclic use of oral contraceptives after surgery for symptomatic endometriosis: a prospective cohort study. Implanon versus medroxyprogesterone acetate: effects on pain scores in patients with symptomatic endometriosis--a pilot study. Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain. Endometriosis fertility index: the new, validated endometriosis staging system. Randomized clinical trial of two laparoscopic treatments of endometriomas: cystectomy versus drainage and coagulation. Anti-TNF-α treatment for deep endometriosis-associated pain: a randomized placebo-controlled trial Effectiveness of complementary pain treatment for women with deep endometriosis through Transcutaneous Electrical Nerve Stimulation (TENS): randomized controlled trial. Efficacy of medroxyprogesterone treatment in infertile women with endometriosis: a prospective, randomized, placebo-controlled study. Low-dose oral contraceptive pill for dysmenorrhea associated with endometriosis: a placebo-controlled, double-blind, randomized trial. A gonadotrophin‐releasing hormone agonist compared with expectant management after conservative surgery for symptomatic endometriosis Long-term use of dienogest for the treatment of endometriosis. A randomized trial of excision versus ablation for mild endometriosis. Hormonal suppression treatment or dietary therapy versus placebo in the control of painful symptoms after conservative surgery for endometriosis stage III-IV. A randomized comparative trial. Elagolix, an Oral GnRH Antagonist for Endometriosis-Associated Pain: A Randomized Controlled Study
OBJECTIVE This study was design ed to evaluate the reliability , validity , and responsiveness of a newly developed , health-related quality -of-life measure . STUDY DESIGN A total of 137 women ( 122 from a Phase III clinical trial and 15 from a private practice setting ) with endometriosis completed the question naire several times . RESULTS Reproducibility and internal-consistency reliability were acceptable with intraclass correlation coefficients ranging from 0.94 to 1.00 and Cronbach 's alpha coefficients ranging from 0.84 to 0.97 . Construct validity was demonstrated on the basis of correlations between items and scales . Health-related quality of life varied in a consistent manner according to clinician-rated measures of pelvic pain and dysmenorrhea and patient-reported levels of endometriosis pain , but no relationship emerged according to the revised American Fertility Society classification . In general , the question naire was moderately to highly responsive to change . CONCLUSION This is the first comprehensive health-related quality -of-life question naire available for use with endometriosis patients that has demonstrated reliability , validity , and responsiveness OBJECTIVE The purpose of this study was a quantification of changes in endometriosis-associated  pain and quality of life during the stimulatory phase of gonadotropin-releasing hormone agonist therapy . STUDY DESIGN One hundred twenty women with significant endometriosis-associated pain participated in a 1-month double-blind , r and omized , placebo-controlled trial . Pain was measured at baseline and at 2 and 4 weeks with  visual analog scales  and the Endometriosis Symptom Severity score . Quality of life was measured with the SF-36 instrument . Group means and SEMs were calculated . Paired t tests were used after determination of data normality . RESULTS Compared with placebo-treated control subjects women treated with gonadotropin-releasing hormone agonist had a statistically ( P < . 0001 ) and clinical ly significant temporary increase in pain and a concomitant decrease in quality of life . CONCLUSION The stimulatory phase of gonadotropin-releasing hormone agonist therapy is associated with an increase in endometriosis-associated pain and a decrease in quality of life OBJECTIVE To compare efficacy of the levonorgestrel-releasing intrauterine system ( LNG-IUS ; Mirena ) with depot GnRH analogue ( GnRH-a ; gosareline acetate ; Zoladex ) on endometriosis-related chronic pelvic pain ( CPP ) in patients with severe endometriosis during 12 months . DESIGN Prospect i ve , r and omized , controlled study . SETTING The reproductive endocrinology unit of a tertiary , research and education hospital . PATIENT(S ) Forty women with severe endometriosis ( revised The American Fertility Society [ AFS ] classification > 40 ) and endometriosis-related CPP and control groups were enrolled in the study . INTERVENTION(S ) The patients were treated with either LNG-IUS ( n = 20 ) or GnRH-a ( n = 20 ) . The GnRH-a dose was repeated every 4 weeks for 24 weeks . MAIN OUTCOME MEASURE(S ) Scores of CPP were evaluated using a visual analogue scale ( VAS ) and total endometriosis severity profile ( TESP ) . RESULT ( S ) The TESP score decreased in the LNG-IUS group at first , third , and sixth month follow-up visits , whereas at the 12th month follow-up visit , the TESP scores were increased to values similar to pretreatment values . Although the VAS score had no significant alteration during the follow-up period in the LNG-IUS group , the GnRH-a group showed a significant decrease in the VAS score and TESP score at the end of 1 year . The LNG-IUS treatment showed a lower patient satisfaction . CONCLUSION ( S ) Both treatment modalities showed comparable effectiveness in the treatment of CPP-related endometriosis OBJECTIVE To evaluate the efficacy of continuous oral contraceptive ( OC ) use versus the usual cyclic fashion in the recurrence of endometriosis-related symptoms after surgery . DESIGN Prospect i ve cohort trial involving patients in two tertiary care units . SETTING Academic institution in collaboration with a private hospital . PATIENT(S ) 356 patients underwent surgical treatment by laparoscopy for symptomatic endometriosis . INTERVENTION(S ) After surgical treatment for endometriosis , patients offered 6-month course of cyclic OC ( including a 7-day pill-free period ) or continuous OC . MAIN OUTCOME MEASURE(S ) Recurrence rate of endometriosis-related symptoms and endometriomas after fertility-sparing surgery . RESULT ( S ) Out of 356 patients , 167 were placed on the usual cyclic OC course  and 85 on  continuous OC for a minimum of 6 months . The continuous OC group experienced a statistically significant reduction in recurrence rates for endometrioma , dysmenorrhea , and non-menstrual pelvic pain as compared with the cyclic OC group . There was no reduction in the recurrence of dyspareunia between the two groups . CONCLUSION ( S ) After surgical treatment of endometriosis , the use of both cyclic and continuous OC improves pain symptoms when compared with preoperative scores . Continuous OC appears to be associated with a reduced recurrence rate for dysmenorrhea , non-menstrual pelvic pain , and endometrioma but not for dyspareunia as compared with cyclic OC BACKGROUND Implanon has been reported to be effective in the treatment of dysmenorrhea . We compared the therapeutic efficacies of depot medroxyprogesterone acetate ( DMPA ) and Implanon with regard to pain relief in women with endometriosis . STUDY DESIGN In a clinical research center at a university hospital , 41 patients with dysmenorrhea , nonmenstrual pelvic pain and dyspareunia associated with histologically proven endometriosis were included in an open , prospect i ve , r and omized , controlled clinical trial . Twenty-one women were assigned by computer-generated r and omization to receive  Implanon , and 20 women to receive DMPA . As main outcome measures of this pilot study , we evaluated pain improvement quantified according to visual analog scale score , side effects , vaginal bleeding patterns , withdrawal rate and overall degree of satisfaction . RESULTS During a follow-up period of 1 year , we ascertained a clear improvement in pain intensity for both treatment options . After 6 months , the average decrease in pain was 68 % in the Implanon group and 53 % in the DMPA group . The side-effects profile and the overall degree of satisfaction after study termination were comparable for both treatment options . CONCLUSION Concerning pain relief , the therapeutic efficacy of the contraceptive implant Implanon is not inferior to that of DMPA in symptomatic endometriosis BACKGROUND A clinical study compared efficacy and safety of depot medroxyprogesterone acetate ( DMPA ) with leuprolide for  endometriosis-associated pain .  METHODS This multicentre , 18 month , evaluator-blinded , comparator-controlled trial r and omized 300 women with laparoscopically diagnosed endometriosis to 6 month treatment with subcutaneous injection of  104 mg/0.65 ml DMPA ( DMPA-SC 104 ) every 3 months or leuprolide ( 3.75 mg monthly or 11.25 mg every 3 months ) , with 12 months post-treatment follow-up . Endpoints included patient response to treatment in five signs/symptoms ( dysmenorrhoea , dyspareunia , pelvic pain , pelvic tenderness , in duration ) and changes in bone mineral density ( BMD ) and productivity at 6 and 18 months . RESULTS DMPA-SC 104 and leuprolide produced equivalent ( P < 0.02 ) reductions in at least four pain categories and significant ( P < 0.001 ) improvements in composite score at months 6 and 18 . At month 6 , reductions in total hip and lumbar spine BMD were significantly less ( P < 0.001 ) with DMPA-SC 104 versus leuprolide .  BMD returned to pre-treatment levels 12 months post-treatment in the DMPA-SC 104 but not the leuprolide group . Total productivity also significantly ( P < or = 0.05 ) improved in both groups at 6 and 18 months . CONCLUSIONS DMPA-SC 104 reduces endometriosis-associated pain as effectively as leuprolide and improves productivity with significantly less BMD decline OBJECTIVE To develop a clinical tool that predicts pregnancy rates ( PRs ) in patients with surgically documented endometriosis who attempt non-IVF conception . DESIGN Prospect i ve data collection on 579 patients and comprehensive statistical analysis to derive a new staging system -- the endometriosis fertility index (EFI)--from data rather than a priori assumptions , followed by testing the EFI prospect ively on 222 additional patients for correlation of predicted and actual outcomes . SETTING Private reproductive endocrinology practice . PATIENT(S ) A total of 801 consecutively diagnosed and treated infertile patients with endometriosis . INTERVENTION(S ) Surgical diagnosis and treatment followed by non-IVF fertility management . MAIN OUTCOME MEASURE(S ) The EFI and life table PRs . RESULT ( S ) A statistically significant variable used to create the EFI was the least function score ( i.e. , the sum of those scores determined intraoperatively after surgical intervention that describe the function of the tube , fimbria , and ovary on both sides ) . Sensitivity analysis showed that the EFI varies little , even with variation in the assignment of functional scores , and predicted PRs . CONCLUSION ( S ) The EFI is a simple , robust , and vali date d clinical tool that predicts PRs after endometriosis surgical staging . Its use provides reassurance to those patients with good prognoses and avoids wasted time and treatment for those with poor prognoses OBJECTIVE To assess the efficacy of two laparoscopic methods for the management of endometriomas with regard to pain relief , pregnancy rate , and disease recurrence . DESIGN Prospect i ve , r and omized clinical trial . SETTING Tertiary care hospital . PATIENT(S ) Sixty-four patients with advanced stages of endometriosis . INTERVENTION(S ) Patients were r and omly allocated at the time of laparoscopy to undergo either cystectomy of the endometrioma ( group 1 ) or drainage of the endometrioma and bipolar coagulation of the inner lining ( group 2 ) . MAIN OUTCOME MEASURE(S ) Pain relief and pregnancy rate . RESULT ( S ) Thirty-two patients were enrolled in each group . The 24-month cumulative recurrence rates of dysmenorrhea , deep dyspareunia , and nonmenstrual pelvic pain were lower in group 1 than in group 2 ( dysmenorrhea : 15.8 % versus 52.9 % ; deep dyspareunia : 20 % versus 75 % ; nonmenstrual pelvic pain : 10 % versus 52.9 % ) . The median interval between the operation and the recurrence of moderate to severe pelvic pain was longer in group 1 than in group 2 ( 19 months [ range , 13.5 - 24 months ] versus 9.5 months [ range , 3 - 20 months ] ) . The 24-month cumulative pregnancy rate was higher in group 1 than in group 2 ( 66.7 % versus 23.5 % ) . CONCLUSION ( S ) For the treatment of ovarian endometriomas , a better outcome with a similar rate of complications is achieved with laparoscopic cystectomy than with drainage and coagulation BACKGROUND Endometriosis is associated with an inflammatory response . Hence infliximab , an anti-TNF-α monoclonal antibody , might relieve pain . METHODS A r and omized placebo-controlled trial was design ed with 21 women with severe pain and a rectovaginal nodule of at least 1 cm . After 1 month of observation , three infusions of infliximab ( 5 mg/kg ) or placebo were given . Surgery was performed 3 months later and follow-up continued for 6 months . The primary end-point was pain ( dysmenorrhea , deep dyspareunia and non-menstrual pain ) rated at each visit by the clinician and on a daily basis by the patient who in addition scored pain by visual analog pain scale and analgesia intake . Secondary end-points included the volume of the endometriotic nodule , pelvic tenderness and the visual appearance of endometriotic lesions at laparoscopy . RESULTS Pain severity decreased during the treatment by 30 % in both the placebo ( P < 0.001 ) and infliximab groups ( P < 0.001 ) . However , no effect of infliximab was observed for any of the outcome measures . After surgery , pain scores decreased in both groups to less than 20 % of the initial value . CONCLUSIONS Infliximab appears not to affect pain associated with deep endometriosis . Treatment is associated with an important placebo effect . After surgery , pain decreases to less than 20 % . Trials registration number Clinical Trials.gov : NCT00604864 OBJECTIVE Evaluate TENS effectiveness as a complementary treatment of chronic pelvic pain and deep dyspareunia  in women with deep endometriosis . STUDY DESIGN This r and omized controlled trial was performed in a tertiary health care center , including twenty-two women with deep endometriosis undergoing hormone therapy with persistent pelvic pain and /or deep dyspareunia . This study was registered in the Brazilian Record of Clinical Trials ( ReBEC ) , under n RBR-3rndh6 . TENS application for 8 weeks followed a r and omized allocation into two groups : Group 1 - acupuncture-like TENS ( Frequency : 8Hz , pulse duration : 250μs ) - VIF ( n=11 ) and Group 2 - self-applied TENS ( Frequency : 85Hz , pulse duration : 75μs ) ( n=11 ) . The intensity applied was " strong , but comfortable " . We evaluated patients before and after treatment by the use of the Visual Analogue Scale , Deep Dyspareunia Scale and Endometriosis Quality of Life Question naire . We used the Wilcoxon and Mann-Whitney tests to compare before and after treatment conditions . RESULTS Despite the use of hormone therapy for 1.65±2.08 years , the 22 women with deep endometriosis  sustained pelvic pain complaints ( VAS=5.95±2.13 and 2.45±2.42 , p<.001 ) and /or deep dyspareunia ( DDS=2.29±0.46 and 1.20±1.01 , p=.001 ) . We observed significant improvement for chronic pelvic pain , deep dyspareunia and quality of life by the use of TENS . Both application types of TENS were effective for improving the evaluated types of pain . CONCLUSIONS Both re sources ( acupuncture-like TENS and self-applied TENS ) demonstrated effectiveness as a complementary treatment of pelvic pain and deep dyspareunia , improving quality of life in women with deep endometriosis regardless of the device used for treatment OBJECTIVE To determine the efficacy of medroxyprogesterone acetate ( MPA ) , 50 mg/d for 3 months , in treating endometriosis , with a follow-up of 6 months . DESIGN Prospect i ve , r and omized , double-blind , placebo-controlled trial . SETTING Academic infertility unit in a teaching hospital . PATIENT(S ) One hundred infertile women found to have endometriosis at laparoscopy , with 50 recruited to each treatment arm . INTERVENTION(S ) Laparoscopy within 3 months of finishing therapy . MAIN OUTCOME MEASURE(S ) Initial and second-look laparoscopy for revised American Fertility Society stages and scores , pregnancies achieved , effects on well-being via symptomatic improvement , and side effects . RESULT ( S ) Whether initially high or low , both MPA and placebo therapy achieved similar statistically significant reductions in stages and scores at second-look laparoscopy .  MPA was rated more effective in improving overall well-being . Side effects were minimal in both groups ( 10 % MPA ; 2 % placebo ) . Six pregnancies occurred without other endometriosis therapy being instituted in the placebo group ( 3 during therapy ) , and one with MPA ( 0 during therapy ) . CONCLUSION ( S ) Both MPA and placebo appear equally and significantly effective in treating endometriosis over a 3-month period , as judged by comparative laparoscopy . Therefore , not only must the use of MPA at 50 mg/d over 3 months be question ed , but the performance of placebo also suggests the need to review whether therapy should be instituted at all as well as the present concept that endometriosis is frequently a spontaneously progressive phenomenon OBJECTIVE To evaluate the efficacy of a low-dose oral contraceptive pill ( OCP ) for patients with dysmenorrhea associated with endometriosis . DESIGN A double-blind , r and omized , placebo-controlled trial . SETTING S Clinical trial sites in Japan . PATIENT(S ) One hundred patients with dysmenorrhea associated with endometriosis . Most enrolled patients had radiologic evidence of endometriosis rather than surgical diagnosis . INTERVENTION(S ) Patients were r and omly assigned to receive either monophasic OCP ( ethinylestradiol plus norethisterone ) or placebo . Participants used their usual pain medications as needed during the trial . MAIN OUTCOME MEASURE(S ) After four cyclic treatments , we used a zero- to three-point verbal rating scale and a visual analogue scale to measure the severity of disability because of dysmenorrhea in daily life , and the patients ' use of analgesics . RESULT ( S ) Total dysmenorrhea scores assessed by the verbal rating scale were significantly decreased at the end of treatment in both groups . From the first cycle through the end of treatment , dysmenorrhea in the OCP group was significantly milder than in the placebo group . Nonmenstrual pelvic pain was present at baseline in 24.5 % ( 12 of 49 ) of the OCP group and 34.0 % ( 16 of 47 ) of the placebo group . The volume of endometrioma ( larger than 3 cm in diameter ) was significantly decreased in the OCP group , but not in the placebo group . No serious adverse events related to using OCPs occurred . CONCLUSION ( S ) The present study clearly demonstrated for the first time that OCPs could be used to effectively and safely treat pain associated with endometriosis Objective To ascertain whether the frequency of pelvic pain recurrence is reduced and time to symptoms recurrence is prolonged in women with symptomatic endometriosis undergoing conservative surgery and post‐operative hormonal therapy  compared with women treated with  surgery  only . Pregnancy rates and time to conception in women wanting children were also evaluated AIM To investigate the safety and efficacy of 52 weeks of dienogest treatment in patients with endometriosis . METHODS One hundred and thirty-five patients with endometriosis received 2 mg of dienogest orally each day for 52 weeks . Adverse drug reactions and bone density were evaluated . Global improvement was assessed based on the changes in severity categories of five subjective symptoms during non-menstruation ( lower abdominal pain , lumbago , dyschezia , dyspareunia , and pain on vaginal examination ) and two objective findings ( in duration involving the pouch of Douglas and limited uterine mobility ) . RESULTS The most common adverse drug reactions included metrorrhagia ( 71.9 % ) , headaches ( 18.5 % ) , and constipation ( 10.4 % ) . No clinical ly significant changes were noted in the incidence or severity of reactions associated with the course of the treatment period ( 52 weeks ) . Changes from the baseline bone mineral density of the lumbar spine measured by dual-energy X-ray absorptiometry were -1.6 + /- 2.4 % and -1.7 + /- 2.2 % ( mean + /- st and ard deviation ) at 24 and 52 weeks , respectively , which were statistically significant decreases ; however , there was no cumulative decrease . The proportions of patients assessed as marked or moderate improvement in terms of global improvement were 72.5 % ( 95/131 cases ) at 24 weeks and 90.6 % ( 106/117 cases ) at 52 weeks . CONCLUSION The long-term effect of dienogest on bone mineral density was slight , whereas the efficacy increased cumulatively OBJECTIVE To compare excisional and ablative treatment modalities for mild ( revised American Fertility score 1 - 2 ) endometriosis in the management of  chronic pelvic pain .  DESIGN A r and omized study of excision or ablation for mild endometriosis , participants and investigators alike blinded to the treatment modality at the follow-up visit . SETTING District general hospital with a specialist pelvic pain clinic in the United Kingdom . PATIENT(S ) Women presenting with chronic pelvic pain . INTERVENTION(S ) Participants were asked to complete a question naire detailing symptoms related to chronic pelvic pain and rating their pain on a ranked ordinal scale . Areas of pelvic tenderness were identified and similarly ranked . At laparoscopy they were r and omly assigned to excision or ablation of any endometriotic lesions , and the question naire was repeated at 6 months . MAIN OUTCOME MEASURE(S ) Changes in pain score on a ranked ordinal scale after surgical treatment for mild endometriosis . RESULT ( S ) Both treatment modalities produced good symptomatic relief and reduction of pelvic tenderness ( 67 % ) . There was no difference in morbidity ; one woman in each group became pregnant during the study period . Only two participants reported no relief or a worsening of symptoms or signs . CONCLUSION ( S ) This small study showed good symptom relief at 6 months from pelvic pain for the majority of participants irrespective of the treatment modality , but two participants did not improve or got worse . A high pain score before treatment was a predictor of appreciable improvement . Further work is needed to identify women in whom surgical intervention is likely to produce a good response OBJECTIVE To evaluate the effectiveness for the outcomes of endometriosis-related pain and quality of life of conservative surgery plus placebo compared with conservative surgery plus hormonal suppression treatment or dietary therapy . DESIGN R and omized comparative trial . SETTING University hospital . PATIENT(S ) Two hundred twenty-two consecutive women who underwent conservative pelvic surgery for symptomatic endometriosis stage III-IV ( r-AFS ) . INTERVENTION(S ) Six months of placebo ( n = 110 ) versus GnRH-a ( tryptorelin or leuprorelin , 3.75 mg every 28 days ) ( n = 39 ) or continuous estroprogestin ( ethynilestradiol , 0.03 mg plus gestoden , 0.75 mg ) ( n = 38 ) versus dietary therapy ( vitamins , minerals salts , lactic ferments , fish oil ) ( n = 35 ) . MAIN OUTCOME MEASURE(S ) Painful symptoms ( visual analogue scale score ) and quality -of-life endometriosis-related symptoms ( SF-36 score ) at 12 months ' follow-up . RESULT ( S ) Patients treated with postoperative hormonal suppression therapy showed less visual analogue scale scores for dysmenorrhoea than patients of the other groups . Hormonal suppression therapy and dietary supplementation were equally effective in reducing nonmenstrual pelvic pain . Surgery plus placebo showed significative decrease in dyspareunia scores . Postoperative medical and dietary therapy allowed a better quality of life than placebo . CONCLUSION ( S ) Postoperative hormonal suppression treatment or dietary therapy are more effective than surgery plus placebo to obtain relief of pain associated with endometriosis stage III-IV and improvement of quality of life Objective The aim of this study was to estimate the efficacy of elagolix , an oral gonadotropin-releasing hormone ( GnRH ) antagonist , for the treatment of endometriosis-associated pelvic pain . Methods This was a phase II , r and omized , placebo-controlled parallel group study conducted at 37 US centers , consisting of an 8-week double-blind period followed by a 16-week open-label period . Patients were 137 women aged 18 to 49 , with laparoscopically confirmed endometriosis and moderate to severe nonmenstrual pelvic pain and dysmenorrhea , who were administered elagolix 150 mg daily or placebo . The primary outcomes of the study were the daily assessment of dysmenorrhea , nonmenstrual pelvic pain and dyspareunia using a modified Biberoglu-Behrman scale . Results During the double-blind period , there were significantly greater mean reductions from baseline to week 8 in dysmenorrhea ( -1.13 ± 0.11 vs. −0.37 ± 0.11 , p<0.0001 ) , nonmenstrual pelvic pain ( -0.47 ± 0.07 vs. −0.19 ± 0.07 , p = 0.0066 ) , and dyspareunia scores ( -0.61 ± 0.10 vs. −0.23 ± 0.10 , p = 0.0070 ) in the elagolix group compared with placebo . Continued improvements were observed during the open-label treatment regardless of initial treatment allocation . Elagolix treatment was also associated with significant improvements in quality -of-life measures during the double-blind and open-label periods . The most common adverse events occurring with elagolix were nausea , headache and hot flush , each in 9.9 % of patients . Conclusion Elagolix effectively reduced endometriosis-associated pelvic pain over a 24-week period and was well-tolerated
( S ) Few studies of medical therapies for endometriosis report outcomes that are relevant to patients , and many women gain only limited or intermittent benefit from treatment
OBJECTIVE To assess patient response rates to medical therapies used to treat endometriosis-associated pain .