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. 2016 Mar 22;2016(3):CD002124. doi: 10.1002/14651858.CD002124.pub2

Gokhale 1996.

Methods RCT
Participants Included: 556 girls aged 12 to 21 years, with moderate to very severe spasmodic dysmenorrhoea
Location: India
Interventions Group 1: thiamine hydrochloride (vitamin B1) 100 mg orally daily for 90 days
Group 2: placebo
Outcomes
  • Cured: complete disappearance of pain;

  • pain relief;

  • side effects.

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.