Buslau 1996.
| Study characteristics | ||
| Methods | Design: randomised, double‐blind, placebo‐controlled, parallel Duration: 12 weeks Interval of assessment: daily by participant |
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| Participants | Number randomised: 50 (25 each in the active and placebo groups) Sex (M/F): 18/32 total (8/17 in the active group and 10/15 in the placebo group) Age of participants: not mentioned Unit of allocation: whole person Country and setting: Germany, not noted Inclusion criteria of the study
Exclusion criteria of the study
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| Interventions |
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| Outcomes |
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| Notes | Concomitant treatment: not permitted Compliance to treatment: not undertaken Previous treatment: unsure |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | The trial did not specify the method of sequence generation |
| Allocation concealment (selection bias) | High risk | The trial did not specify the method of allocation concealment |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 7/25 participants in the active group withdrew, and 11/25 in the placebo group withdrew. The trial undertook ITT analysis, but dropouts were not balanced between the groups |
| Selective reporting (reporting bias) | Low risk | The trial reported all prespecified outcomes |
| Other bias | Unclear risk | No detail of funding or support was listed |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | This was adequate for participants, but it was unclear if they blinded the clinician outcome assessor |