Hornstein 1997.
Methods | No. of centres: 13
Location: 13 clinics (North America) Recruitment period: not stated |
|
Participants | Inclusion criteria: age 18‐47, normal menstrual cycles of 24‐36 days, clinical pelvic pain, dysmenorrhoea, dyspareunia Exclusion criteria: received medical therapy for endometriosis within 3 months, abnormal bone density, significant medical illness, laboratory abnormalities, pregnancy and lactation No. randomised: 109 No. analysed: 93 7 in nafarelin group and 8 in placebo group withdrew after 90 days of therapy 1 in placebo group excluded because missed 5 days of medication | |
Interventions | Post‐surgery medical therapy 1. Nafarelin nasal 400 uG daily x 6/12 (n = 49) 2. Placebo (n = 44) | |
Outcomes | Pain Physician scores for tenderness and induration on physical examination at end of treatment and 6/12 after treatment | |
Notes | Power calculation: NS Funding: Syntex laboratory, California | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "multicenter, prospective, randomized, double‐blind study" method of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | not mentioned |
Blinding (performance bias and detection bias) All outcomes | Low risk | "double blind" but authors acknowledge difficulty of maintaining blinding with this treatment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 7 and 8 patients were excluded from analyses of treatment and placebo groups because they withdrew before completing 90 days of therapy. Remaining 93 patients included in analysis even though 39 and 43 patients from treatment and placebo groups terminated the study early |
Selective reporting (reporting bias) | Low risk | primary outcome was time to requiring alternative treatment; pain & recurrence also reported |
Other bias | Low risk | groups appear comparable at baseline |