Kennedy 1990.
Study characteristics | ||
Methods | Trial design: Randomised controlled trial | |
Participants | Participants: 82 women were randomised and analysed. Mean age: Nafarelin group was 31.5 ± 5.20 years (range = 21 to 41 years), danazol group 30.2 ± 4.89 years (range = 21 to 42 years). Inclusion criteria:
Exclusion criteria: not stated Setting: United Kingdom Timing: not stated |
|
Interventions | Nafarelin 200 μg twice daily IN with placebo tablets (n = 55) versus Danazol 200 mg three times daily orally with placebo nasal spray (n = 27) |
|
Outcomes |
|
|
Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: Supported by Syntex (U.K.) Ltd., Maidenhead, United Kingdom Author could not be contacted due to lack of information. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly allocated, stratification on a 2:1 ratio, according to disease severity. No further details of method used to generate the randomisation sequence were provided. |
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‐controlled study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo‐controlled study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Eight patients did not complete treatment and their scores were omitted; their stages at first laparoscopy were I = 2, II = 4, III = 1, and IV = 1. Four patients withdrew from the nafarelin group because of depression, muscle aches, mastalgia and bloating (1); giddiness, nausea, and vague paraesthesia on the right side of the face and left hand (1); travel abroad (1); and a maculopapular rash (1). Two patients withdrew from the danazol group because of a viral illness (1) and a maculopapular rash (1). One patient from each group was withdrawn from the study because of poor compliance. |
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 |