Skip to main content
. 2004 Jul 19;2004(3):CD003678. doi: 10.1002/14651858.CD003678.pub2

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