| Outcome, subgroup | Effect | Statistical heterogeneity (within-group), | Test for between-group differences, | No. of participants | No. of studies | GRADE quality of evidence* | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Risk ratio (95% CI) | Absolute risk increase, % | No. needed to harm (95% CI) | p value | I2 value, % | p value | I2 value, % | ||||||
| Any adverse events | ||||||||||||
| Behavioural | Not estimable† | — | — | NA | NA | 482 | 3 | Moderate | ||||
| Pharmacological + behavioural | 1.03 | (0.99 to 1.08) | — | — | NA | 533 | 1 | Low | ||||
| Serious adverse events | ||||||||||||
| Behavioural | 0.51 | (0.09 to 2.73) | — | — | NA | 0.37 | (0) | 322 | 1 | Moderate | ||
| Pharmacological + behavioural | 1.25 | (0.46 to 3.35) | — | — | 0.56 | 0 | 573 | 2 | Low | |||
| Gastrointestinal events | ||||||||||||
| Pharmacological + behavioural | 3.77 | (2.56 to 5.55) | 36.7 | 3 | (2 to 5) | NA | NA | 533 | 1 | Moderate | ||
| Study withdrawal due to adverse events | ||||||||||||
| Pharmacological + behavioural | 2.49 | (0.79 to 7.87) | — | — | 0.45 | 0 | NA | 573 | 2 | Low | ||
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.