Table 3.
Primary and secondary outcomes and adverse events by intention to treat analysis in all patients*. Figures are numbers (percentages) unless stated otherwise
| Outcome | Control (n=129) | Intervention (n=136) | RR/mean difference† (95% CI, P value) |
|---|---|---|---|
| Primary outcome | |||
| Treatment success | |||
| Overall | 100 (78) | 103 (76) | 0.98 (0.86 to 1.11, 0.7) |
| Before conflict | 82 (85) | 86 (84) | 1.0 (0.88 to 1.12, 1.0) |
| After conflict | 18 (56) | 17 (50) | 0.89 (0.56 to 1.40, 0.6) |
| Secondary outcomes | |||
| Mean % (SD) compliance: | |||
| Intensive | 91.4 (13.3) | 86.7 (18.6) | −4.7 (−0.8 to −8.6, 0.02) |
| Continuation | 98.3 (6.7) | 98.2 (6.7) | 0 (−1.7 to 1.7, 1.0) |
| Mean % (SD) weight gain: | |||
| 8 weeks | 3.5 (6.3) | 5.2 (6.2) | 1.7 (0.1 to 3.2, 0.04) |
| 32 weeks | 7.5 (7.6) | 10.1 (9.6) | 2.6 (0.1 to 5.1, 0.04) |
| Cough clearance: | |||
| 4 weeks | 54 (42) | 52 (43) | 1.02 (0.76 to 1.36, 0.9) |
| 8 weeks | 60 (61) | 57 (58) | 0.94 (0.75 to 1.18, 0.6) |
| 32 weeks | 76 (80) | 80 (84) | 1.05 (0.92 to 1.20, 0.4) |
| Adverse events: | |||
| Itch | 12 (9) | 28 (21) | 2.27 (1.20 to 4.26, 0.008) |
*Data missing for success (4 control and 1 intervention); compliance (1 control in intensive phase, 13 control and 14 intervention in continuation phase); weight (11 control and 16 intervention at 8 weeks, 42 control and 40 intervention at 32 weeks); cough (3 control and 14 intervention at 4 weeks, 35 control and 38 intervention at 8 weeks, 38 control and 42 intervention at 32 weeks).
†Relative risk for comparisons of categorical variables or mean difference for comparisons of means of continuous variables.