Table 2.

Adverse effects.

Number evaluableaAdverse eventAttritionNumber of patientsComment
Infection (grade 1)Not related1Upper respiratory tract; resolved
Pancreatitis (grade 2)Not related1Began 7 days after stopping agent; not resolved at the 1-month post Follow-up
Increased transaminases: AST (grade 2), ALT (grade 3)Probably1Observed at month three on agent, resolve at 1-month post follow-up
Diarrhea (grade 1)Not related1Two separate events, each lasting 1 day; participant had abdominal discomfort for 3 years prior to study entry and at baseline
Nausea (grade 1)Possible1Occurred the day berberine was started; never occurred again
Placebo4No adverse events reported
  • aNumber evaluable after 3 months. Two participants on berberine withdrew from study at 1 and 2.5 months, did not report any adverse events, and are not included in this analysis.