An evidence-based medicine approach to the treatment of endometriosis-associated chronic pelvic pain: Placebo-controlled studies

Objective. Use an evidence-based medicine (EBM) approach to evaluate the ev idence regarding efficacy of treatment of endometriosis-associated chronic pelvic pain (CPP) in placebo-controlled randomized clinical trials (RCT) Design. Review of six randomized, controlled trials (Canadian Task Force cl assification 1). Setting. University of Rochester School of Medicine and Dentistry. Patients. Three hundred eighty-one women with endometriosis enrolled in pla cebo-controlled randomized clinical trials. Intervention. A MEDLINE search of published medical articles from January 1 976, to january 1998. Measurements and Main Results. Six placebo-controlled randomized clinical t rials were found that addressed the treatment of pelvic pain associated wit h endometriosis and met validity criteria; one was a study of surgical trea tment, two of medical therapies, and three of combined surgical and medical treatments. They clearly show that laparoscopic surgery and medical treatm ent with medroxyprogesterone acetate, danazol, or nafarelin are more effect ive than placebo. Evidence for efficacy of leuprolide acetate is weaker. At 6 months, absolute decreases in pain scores are quite similar with surgica l or medical treatment. Medical therapy after surgical treatment significan tly reduced pain, but six months after it was stopped there was no differen ce between women treated and not treated postoperatively. Conclusions. Although either surgical or medical treatment of endometriosis in women with CPP is clearly indicated, pain relief of 6 or more months' d uration can be expected in only 40 to 70% of women with endometriosis-assoc iated CPP.