Table 5: Subgroup analyses for harms
Outcome, subgroupEffectStatistical heterogeneity (within-group), Test for between-group differences, No. of participantsNo. of studiesGRADE quality of evidence*
Risk ratio (95% CI)Absolute risk increase, %No. needed to harm (95% CI)p valueI2 value, %p valueI2 value, %
Any adverse events
BehaviouralNot estimable†NANA4823Moderate
Pharmacological + behavioural1.03(0.99 to 1.08)NA5331Low
Serious adverse events
Behavioural0.51(0.09 to 2.73)NA0.37(0)3221Moderate
Pharmacological + behavioural1.25(0.46 to 3.35)0.5605732Low
Gastrointestinal events
Pharmacological + behavioural3.77(2.56 to 5.55)36.73(2 to 5)NANA5331Moderate
Study withdrawal due to adverse events
Pharmacological + behavioural2.49(0.79 to 7.87)0.450NA5732Low

Note: Note: GRADE =Grading of Recommendations Assessment, Development and Evaluation, NA = not applicable.
* Rating reflects confidence in the estimate of effect assessed through 5 domains of the evidence (risk of bias, indirectness, imprecision, inconsistency and reporting bias) as follows: moderate = downgraded for risk of bias; low = downgraded for risk of bias and imprecision.
†No events reported in both groups in all studies.