Bergqvist 1997.
Study characteristics | ||
Methods | Trial design: "Double‐blind randomised study" | |
Participants | Participants: 49 eligible women; 49 were randomised and 47 were analysed Mean age: mean age not stated, median age 30 years (range 21‐46years) Inclusion criteria:
Exclusion criteria: not stated Setting: Europe Timing: not stated |
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Interventions | Nafarelin 200 mcg daily IN + placebo PO for 6 months (n = 12) versus Nafarelin 400 mcg daily IN + placebo PO for 6 months (n = 12) versus Nafarelin 200 mcg daily IN + norethisterone 1.2 mg daily PO for 6 months (n = 25) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated Note previous version: Need raw data for symptom scores. Authors contacted regarding methods and data. No response to date |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomisation was carried out on a block basis". 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‐blinded, placebo‐controlled study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blinded, placebo‐controlled study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two participants (2/25) from the nafareline + norethisterone group withdrew from the trial due to mood swings (1 participant) and pregnancy (1 participant). |
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 |