Howell 1995.
Study characteristics | ||
Methods | Trial design: Randomised controlled trial | |
Participants | Participants: 50 women were randomised; 48 completed 24 weeks of treatment and underwent second laparoxcopic assessment. Mean age: Group 1: 29 ± 6 years, group 2: 30 ± 5 years Inclusion criteria:
Exclusion criteria:
Setting: United Kingdom Timing: not stated |
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Interventions | Group 1: 3.6 mg SC depot injection of goserelin every 4 weeks versus Group 2: 3.6 mg SC injection every four weeks and transdermal oestrogen 25 ug daily and 5 mg medroxyprogesterone acetate daily for 20 weeks commencing with the second goserelin depot |
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Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: Study sponsored by Zeneca Pharmaceuticals Note previous version: 20 participants did not complete all the bone mineral density assessments ‐ 2 did not complete treatment and the other 18 did not complete follow‐up. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Were randomised". 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 | Unclear risk | Open‐label trial. No further details provided of blinding of participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided of blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | High risk | 20/48 participants did not complete all the bone mineral density assessments. 2/48 did not complete treatment and the other 18/48 did not complete follow‐up. |
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 |