Mäkäräinen 1996.
Study characteristics | ||
Methods | Trial design: Randomised, double blind, placebo‐controlled trial | |
Participants | Participants: 38 women were randomised; 29 women were analysed after second‐look laparoscopy. Mean age: 30.6 years (range 22 to 38 years) Inclusion criteria:
Exclusion criteria: not stated Setting: Finland Timing: not stated |
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Interventions | Once‐a‐month SC injections of goserelin acetate 3.6 mg (Zoladex depot; Zeneca Pharmaceutics, Cheshire, United Kingdom) randomly combined with either Medroxyprogesterone acetate 100 mg daily (n = 19) versus Placebo, one tablet daily (n = 19) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: Zeneca Pharma, Helsinki, Finland, for supplying the active drugs and placebo Author could not be contacted due to lack of information. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly assigned". 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 | Double‐blind, placebo‐controlled study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind, placebo‐controlled study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Four patients interrupted the treatment because of side effects (three in the medroxyprogesterone acetate group and one in the placebo group). Increasing pelvic symptoms in one patient receiving medroxyprogesterone acetate required laparoscopy already 4 months after the end of treatment. Four women (two in the medroxyprogesterone acetate group and two in the placebo group) became pregnant within 6 months after the treatment. Thus, 29 women (13/19 in the medroxyprogesterone acetate and 16/19 in the placebo group) were included in the second‐look laparoscopy, which was performed 6 months after the end of medical treatment. |
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 |