Adverse reaction incidence (unstandardised)

Method

Proportion of participants for whom investigators recorded at least one adverse reaction attributed to the study product, tallied by each trial's own ascertainment with no severity classification system applied.

The method is part of the endpoint identity. Studies measuring the same quantity by a different method are held as separate endpoints.

Notes

Any adverse event incidence shares the denominator but not the numerator: that node counts events regardless of attributed causality, this one counts only those an investigator judged related, and the causality judgement is unblinded and unstandardised. The second near-miss is CTCAE-graded adverse event counts (PMID 32840126). Both are proportions of participants, but a graded tally separates severities — a grade-1 nausea and a grade-3 hepatitis are distinguishable there and are indistinguishable here — so the rates are not comparable in either direction and this node's value cannot be split by severity after the fact. Serious adverse event incidence and withdrawal due to adverse events are nested subsets.

Findings

2 findings from 2 compounds, strongest first.

• berberine — no detected effect on

  BLikelyGrade B, Likely. Human evidence, limited replication or design limits.FindingNull result

  “Nonetheless, the impact of BBR on reducing adverse reactions was not statistically significant (RR = 0.75, 95% CI [0.42, 1.33], P > 0.05).”

  Study

  meta-analysis

  Population

  patients with ulcerative colitis; berberine plus 5-aminosalicylic acid versus 5-aminosalicylic acid

  Efficacy and safety of berberine plus 5-ASA for ulcerative colitis: A systematic review and meta-analysis.2024PMID:39241013

• caffeine — decreases

  BLikelyGrade B, Likely. Human evidence, limited replication or design limits.Finding

  “The analysis found that compared with aminophylline, infants in the caffeine group had a lower chance of developing total adverse effects (OR 0.41, 95%CI: 0.17–0.97, P = 0.042).”

  Study

  meta-analysis

  Population

  Preterm infants (<37 weeks gestation) with apnea of prematurity; caffeine citrate against an ACTIVE COMPARATOR (aminophylline), not placebo; safety outcome pooled from 4 of the 10 included studies.

  Effect 0.41 odds ratio, 95% CI 0.17 to 0.97

  Comparative efficacy and safety of caffeine citrate and aminophylline in treating apnea of prematurity: A systematic review and meta-analysis.2022PMID:36121807