An evidence-based medicine approach to the treatment of endometriosis-associated chronic pelvic pain: placebo-controlled studies Howard F M

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1 An evidence-based medicine approach to the treatment of endometriosis-associated chronic pelvic pain: placebo-controlled studies Howard F M Authors' objectives To assess the efficacy of treatment of endometriosis-associated chronic pelvic pain. Searching MEDLINE was searched from 1976 to 1998 for articles published in the English language, using a combination of the following MeSH and textwords: 'endometriosis', 'pelvic pain', 'treatment'. Additional studies were located by examining the references from the identified studies, and by contacting the authors of selected studies. Study selection Study designs of evaluations included in the review Placebo-controlled randomised clinical trials (RCTs) were eligible if they scored at least four points on the validity criteria. Specific interventions included in the review The inclusion criteria were not defined in terms of the interventions. The actual interventions were surgical treatment, medical therapy, and combinations of surgical and medical treatments. The study of surgical treatment compared operative laparoscopy with expectant management after diagnostic laparoscopy. Operative laparoscopy consisted of either the laser ablation of endometriosis, lysis of any adhesions, or bilateral uterosacral nerve transection. Studies of medical therapy consisted of: leuprolide acetate given every 4 weeks (for a total of six 3.75 mg injections), compared with placebo; and 6 months' treatment with either medroxyprogesterone acetate (100 mg/day), danazol (600 mg/day) or placebo. Somme of the women had electrocoagulation of endometriosis at the time of their diagnostic laparoscopies. The combinations of surgical and medical treatment included: surgical debulking at laparotomy followed by 6 months' treatment with danazol (600 mg/day), medroxyprogesterone acetate (100 mg/day) or placebo; surgical debulking at laparotomy followed by 3 months' treatment with nafarelin (400 microg/day) or placebo nasal spray; and reductive laparoscopic surgery by laser or electrosurgery, followed by 180 days' treatment with nafarelin (200 microg, twice daily) or placebo nasal spray (twice daily). Participants included in the review Women with endometriosis-associated chronic pelvic pain were eligible for inclusion. The participants had been diagnosed with stage I to stage IV endometriosis Outcomes assessed in the review The inclusion criteria were not defined in terms of the outcomes. The studies assessed pain scores, measured via the following: visual analogue scores (scores from 0 to 10); pain ratings, categorised as none, mild, moderate or severe, or scored from 1 to 3; and pelvic pain as one component of a multifactorial score, which included functional impairment, dysmenorrhoea, dyspareunia, and physical examination findings. Page: 1 / 5

2 How were decisions on the relevance of primary studies made? The author does not state how the papers were selected for the review, or how many of the reviewers performed the selection. Assessment of study quality Validity was assessed and scored using the criteria suggested by the Evidence-Based Medicine Working Group (see Other Publications of Related Interest no.1). The criteria were: whether the assignment of patients was randomised; whether the follow-up was complete; whether an intention to treat analysis was performed; whether the patients, health workers and study personnel were blinded to the treatment; whether the groups were comparable at baseline; and whether the groups, other than the treatment under study, were treated equally. One point was awarded for each criterion that was clearly satisfied; zero points were given if it was uncertain whether the criterion was satisfied, or if satisfaction was inadequate. The maximum possible score was six points. The author does not state how the papers were assessed for validity, or how many of the reviewers performed the validity assessment. Data extraction The author does not state how the data were extracted for the review, or how many of the reviewers performed the data extraction. Details of the individual studies were described in the text of the review. Whenever possible, only pelvic pain scores were used in the analysis and all values were converted to a scale of 0 to 10. The confidence intervals (CIs) were not presented in the primary studies, and so were estimated using formulae for differences in proportions and continuous variables (see Other Publications of Related Interest no.2). The results from the individual studies were reported as: the absolute and relative control effects; the absolute and relative experimental effects; and the absolute and relative attributable experimental effects. Methods of synthesis How were the studies combined? Studies were combined in a narrative review under the headings of: Are the results valid? What are the results and are they important? Will the results help me in caring for my patients?. Where possible, the number-needed-to-treat and/or the number-needed- to-harm were calculated. How were differences between studies investigated? Where the follow-up was considered incomplete, the results from the individual studies were reanalysed using the worstcase scenario. Page: 2 / 5

3 Results of the review Six RCTs (381 women) were included. Significant placebo effects were seen in all studies at 3 months. Surgical treatment (1 RCT). The trial compared surgical laparoscopic treatment with expectant treatment (74 women entered; results from 63 analysed; stage IV endometriosis excluded). At 3 months, there was no significant difference between the treatment groups; the relative attributable experimental effect was 14%. At 6 months, significantly less pain was reported by the surgically-treated women than the control; the relative control effect was -2.0% and the relative experimental effect was 45%; the relative attributable experimental effect was 47%. Repeat laparoscopy for continued pain was less common in those treated surgically (16%) than in those with expectant treatment (52%). Where the follow-up was judged incomplete, reanalysis using the worst-case scenario significantly changed the results. Medical treatment (2 RCTs). Leuprolide versus placebo for 3 months (1 RCT; 48 women entered): there was no significant difference between the treatment groups at 3 months. The follow-up was judged incomplete (70% of the placebo group were 'lost' after 3 months). Blinding was broken at 3 months and women with significant pain were switched to leucoprolide. The analysis was not conducted on an intention to treat basis. Medroxyprogesterone versus danazol versus placebo for 6 months (1 RCT; 59 women with stage I or II endometriosis; 14 women also received electrocoagulation of endometriosis implants). At 12 months, women who received medroxyprogesterone or danazol had significantly less pain than those receiving placebo. The relative attributable experimental effect was 50% (95% CI: 30, 71) for medroxyprogesterone and 74% (95% CI: 54, 95) for danazol. There was no significant difference between medroxyprogesterone and danazol. The analysis was not conducted on an intention to treat basis. Combination of surgery and medical treatment (3 RCTs, all women had surgical debulking). Medroxyprogesterone versus danazol versus placebo for 6 months (60 women with stage I to IV endometriosis; 51 women completed 12 months' follow-up). At 6 months, pain was reduced on average by 54 and 32% in the medroxyprogesterone and danazol groups, respectively, compared with placebo. At 12 months, the pain levels had returned to baseline in the control group (who had undergone surgical debulking at baseline). Nafarelin versus placebo nasal spray (2 RCTs; 184 women). One RCT was of treatment with nafarelin versus placebo nasal spray for 3 months (75 women with stage III or IV endometriosis; 61 women completed 12 months' follow-up;). At 12 months, there was no significant difference in pain between the intervention groups. The other RCT was of treatment with nafarelin versus placebo nasal spray for 180 days (109 women with stage I to IV endometriosis; results from 93 reported). Only 50% of the patients had significant pelvic pain, and a combined dysmenorrhoea-dyspareunia-pelvic pain score was presented. At 6 months, nafarelin was associated with significantly less pain than placebo. However, at 12 months, 6 months after stopping nafarelin, there was no statistically-significant difference in the pain scores between the treatment groups; the absolute attributable experimental effect was 0.4 (95% CI: -0.4, 1.2). The follow-up was judged incomplete and reanalysis using the worst-case scenario significantly changed the results. The analysis was not conducted on an intention to treat basis. Side-effects. The following side-effects were observed in patients receiving medical treatment with medroxyprogesterone or danazol: acne, in 1 of 4.5 and 1 of 2.4 women, respectively; oedema, in 1 of 1.8 women, in both groups; Page: 3 / 5

4 muscle cramps, in 1 of 9.1 and 1 of 3.8 women, respectively; abnormal bleeding, in 1 of 2 and 1 of 1.8 women, respectively. The side-effects of medical treatment with leuprolide included hot flushes, headaches, and 'total adverse effects'. The side-effects were similar in the combined treatment and medical treatment only groups. Surgical treatment alone: either the data were not reported or the sample sizes were too small to calculate the number-needed-to-harm. Medical treatment: the number-needed-to-harm ranged from 2 to 5. The quality scores of the included studies ranged from 4 to 6. Problems with the studies included: unsatisfactory description of the method of randomisation (2 RCTs); incomplete follow-up (3 RCTs); analysis not conducted on an intention to treat basis (3 RCTs); and a lack of CIs around the outcome of interest. All studies were considered to have similar groups at baseline, equal ancillary treatment, and adequate blinding. Authors' conclusions Although either the surgical or medical treatment of endometriosis in women with chronic pelvic pain is clearly indicated, pain relief of at least 6 months can only be expected in 40 to 70% of women with endometriosis-associated chronic pelvic pain. CRD commentary The aims were stated, and the inclusion criteria were defined in terms of the study design and participants. The inclusion criteria were not defined in terms of the interventions or outcomes. The literature search was restricted to articles published in the English language, as identified by one database (MEDLINE). Thus, other relevant studies may have been omitted. No details were given of the methods used to select the studies. The included studies were restricted to placebo-controlled randomised trials scoring at least four on defined validity criteria; other aspects of validity were commented upon in the text. Some relevant information on the included studies was presented in the text, but the methods used to extract the data were not described. A narrative review was appropriate given the heterogeneity among studies. In addition, results from individual studies were reanalysed using a worst-case scenario when the follow-up was judged incomplete. However, the study results were not considered in relation to study validity, but were considered in separate sections of the text of the review; this made it more difficult to assess the quality of the evidence on which conclusions about specific treatment options were based. The author's conclusions should be interpreted with caution given the methodological concerns, small sample sizes, and the general lack of replicated studies. There appears to be discrepancies between the reference numbers in the main text and those reported in the tables. Implications of the review for practice and research Practice: The author states that treatment with conservative laser laparoscopic surgery, and with medroxyprogesterone, danazol, leuprolide or nafarelin, are effective. However, there is no clear advantage of either medical or surgical treatment. Research: The author states that further placebo-controlled trials are probably not ethical. Studies of other medical treatments should probably be performed using 6 months' medroxyprogesterone (100 mg/day) or danazol (600 mg/day) as the control, whilst evaluations of surgical trials should use laser laparoscopy with uterine nerve ablation as the control group. Bibliographic details Howard F M. An evidence-based medicine approach to the treatment of endometriosis-associated chronic pelvic pain: placebo-controlled studies. Journal of the American Association of Gynecologic Laparoscopists 2000; 7(4): Page: 4 / 5

5 Powered by TCPDF ( PubMedID Other publications of related interest 1. Oxman AD, Sackett DL, Guyatt GH. Users' guide to the medical literature. I. How to get started. Evidence-Based Medicine Working Group. JAMA 1993;270: Sackett DL, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine: how to practice and teach it. London: Churchill Livingstone; Indexing Status Subject indexing assigned by NLM MeSH Chronic Disease; Endometriosis /complications /therapy; Evidence-Based Medicine /methods; Female; Humans; Pelvic Pain /etiology /therapy; Prognosis; Randomized Controlled Trials as Topic; Sensitivity and Specificity; Treatment Outcome; Uterine Diseases /complications /therapy AccessionNumber Date bibliographic record published 31/07/2002 Date abstract record published 31/07/2002 Record Status This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. Page: 5 / 5

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