Gokhale 1996.
Methods | RCT | |
Participants | Included: 556 girls aged 12 to 21 years, with moderate to very severe spasmodic dysmenorrhoea Location: India |
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Interventions | Group 1: thiamine hydrochloride (vitamin B1) 100 mg orally daily for 90 days Group 2: placebo |
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Outcomes |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "using random tables...a randomised, double‐blind, placebo‐controlled study was carried out on 556 girls aged 12‐21 yr". |
Allocation concealment (selection bias) | Unclear risk | "a randomised, double‐blind, placebo‐controlled study was carried out on 556 girls aged 12‐21 yr". |
Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: participants and observers were blinded, and the placebo was identical. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: final outcomes were unobtainable for 24 girls, and the dropout rate was 4.3% (24/556). |
Selective reporting (reporting bias) | Unclear risk | Comment: there were no comparative data on adverse events. |
Other bias | Low risk | Comment: we did not identify any other potential sources of bias. |