| Outcome; intervention focus | Effect | Statistical heterogeneity (within group) p value (I2 value, %) | Test for between group differences p value (I2 value, %) | No. of participants | No. of studies | Quality of evidence rating | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RR (95% CI) | Absolute risk increase, % | No. needed to harm (95% CI) | ||||||||||||||
| Any adverse events | ||||||||||||||||
| Overall | 1.16 | (1.09–1.23) | 9.31 | 11 | (7–19) | < 0.00001 | (73) | NA | 5 512 | 17 | Moderate | |||||
| Behavioural | 0.19 | (0.03–1.16) | — | — | 0.41 | (0) | 0.05 (74) | 561 | 3 | Low | ||||||
| Pharmacological + behavioural | 1.16 | (1.09–1.23) | 10.36 | 10 | (7–17) | < 0.00001 | (75) | 4 951 | 15 | Moderate | ||||||
| Serious adverse events | ||||||||||||||||
| Overall | 1.07 | (0.96–1.20) | — | — | 0.74 | (0) | NA | 10 811 | 14 | Low | ||||||
| Behavioural | 0.995 | (0.80–1.24) | — | — | 0.68 | (0) | 0.44 (0) | 2 174 | 3 | Low | ||||||
| Pharmacological + behavioural | 1.10 | (0.97–1.25) | — | — | 0.62 | (0) | 8 637 | 12 | Low | |||||||
| Gastrointestinal events | ||||||||||||||||
| Pharmacological + behavioural | 1.58 | (1.47–1.70) | 18.72 | 5 | (4–7) | < 0.00001 | (71) | NA | 12 954 | 23 | Low | |||||
| Study withdrawal because of adverse events | ||||||||||||||||
| Overall | 1.69 | (1.43–2.00) | 3.05 | 33 | (23–53) | 0.65 | (0) | NA | 12 987 | 26 | Moderate | |||||
| Behavioural | 3.40 | (0.16–70.16) | — | — | NA | 0.65 (0) | 302 | 1 | Low | |||||||
| Pharmacological + behavioural | 1.68 | (1.42–2.00) | 3.09 | 32 | (22–47) | 0.25 | (15) | 12 685 | 25 | Moderate | ||||||
Note: CI = confidence interval, NA = not applicable, RR = risk ratio.