Fraser 1991.
Study characteristics | ||
Methods | Trial design: "Double‐blind, double‐dummy, randomised, parallel study" | |
Participants | Participants: 49 women with endometriosis stage 1‐3 were randomised and 45 were analysed. Mean age: not stated Inclusion criteria:
Exclusion criteria:
Setting: Australia/New Zealand Timing: not stated |
|
Interventions | Nafarelin 200 mcg twice a day (400 μg/d) IN + placebo PO for 6 months (n = 33)
versus
Danazol 200 mg three times a day (600 mg/d) PO + placebo IN for 6 months (n = 16) Subdivisions were made: Stage 1‐2: Subgroup A (27 patients; 2 dropouts) who received intranasal nafarelin acetate 200 pg twice daily, or Subgroup B (13 patients; no dropouts) who received oral danazol 200 mg 3 times daily. Stage 3: Subgroup A (6 patients; 1 dropout) who received intranasal nafarelin acetate 200 pg twice daily for 6 months followed by conservative laparotomy, or Subgroup B (3 patients; no dropouts) who received oral danazol 200 mg three times daily followed by conservative laparotomy. |
|
Outcomes | ‐ Dyspareunia, pelvic pain, pelvic tenderness, induration ‐ Change in rAFS score ‐ Adverse effects | |
Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: Syntex Pharmaceuticals International supplied nafarelin acetate, and a grant to cover the expenses of the trial. Note previous version: Authors contacted with regards to allocation concealment. Author replied that the data were difficult to find but would try. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computer generated list of random numbers" |
Allocation concealment (selection bias) | Unclear risk | No details of method used to conceal allocation were provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo pill + placebo nasal spray so patient and investigators were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo pill + placebo nasal spray so assessors were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3/33 participants "dropped out" of intranasal nafarelin group; no "drop outs" from danazol group (0/16) |
Selective reporting (reporting bias) | Low risk | The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified. |
Other bias | Low risk | No other risk of bias detected |