Bergqvist 1998.
Study characteristics | ||
Methods | Trial design: "Prospective, randomised, placebo‐controlled, double‐blind, parallel study" | |
Participants | Participants: 49 women eligible; 49 were randomised and 46 were analysed Age: mean of 31 years (19‐44years) Stage: most mild‐to‐moderate (IV n = 1) Inclusion criteria:
Exclusion criteria:
Setting: Sweden Timing: Not stated |
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Interventions | Triptorelin 3.75 mg IM depot every 4 weeks for 24 weeks (n = 24) versus Placebo IM every 4 weeks for 24 weeks (n = 25) | |
Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated Note previous version: Needs raw score for pain. Authors contacted and awaiting response |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details were provided of method used to generate the randomisation sequence. |
Allocation concealment (selection bias) | Unclear risk | No details were provided of method used to conceal treatment group allocation. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and researchers were blinded through the use of identical kits for injections. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants and researchers were blinded through the use of identical kits for injections. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Three participants withdrew from the study. Two from the placebo group (1 prior to the first injection due to pregnancy, and one after 4 months due to lack of effect), and one from the triptorelin group due to hypoestrogenic side effects and depression. |
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 |