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. 2017 Mar 28;2017(3):CD011648. doi: 10.1002/14651858.CD011648.pub2

Manzillo 1993b.

Methods Randomised clinical trial.
Participants Country: Italy.
Number randomised: 6.
Post‐randomisation dropouts: not stated.
Revised sample size: 6.
Mean age: not stated.
Females: not stated.
Symptomatic participants: not stated.
AMA positive: not stated.
Responders: not stated.
Mean follow‐up period (for all groups): all participants followed up for 2 months.
Inclusion criteria
  • Symptom status: not stated.

  • AMA status: not stated.

  • Response status: not stated.

Interventions Participants were randomly assigned to 2 groups.
Group 1: SAMe (n = 3).
Further details: SAMe: 1600 mg/day orally for 8 weeks.
Group 2: placebo (n = 3).
Outcomes None of the outcomes of interest reported.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: information not available.
Allocation concealment (selection bias) Unclear risk Comment: information not available.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: although placebo was used, there was no mention of blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: although placebo was used, there was no mention of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: information not available.
Selective reporting (reporting bias) High risk Comment: neither mortality nor adverse events reported.
For‐profit bias Unclear risk Comment: information not available.
Other bias Low risk Comment: no other bias.