Table 5: Subgroup analyses for harms.
| 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.