Table 1.
Trials | Studies with π = 0% (head-to-head trials) (n = 169, 100%)a | Studies with π between 20% and 50% (placebo-controlled trials)(n = 252, 100%)a | P-value |
---|---|---|---|
Median year of study completion [range] | 1999 | 1999.5 | 0.71 |
[1980, 2015] | [1978, 2014] | ||
Use of rescue medication | 66 (39.1%) | 76 (30.2%) | 0.06 |
Use of placebo run-in phase | 71 (42.0%) | 148 (58.7%) | 0.001 |
No. of arms | |||
2 | 158 (93.5%) | 55 (21.8%) | <0.001 |
3 | 9 (5.3%) | 142 (56.3%) | |
>3 | 2 (1.2%) | 55 (21.8%) | |
Risk of bias | |||
Generation of random sequence | 0.41 | ||
Low risk of bias | 30 (17.8%) | 53 (21.0%) | |
Unclear risk of bias | 139 (82.2%) | 199 (79.0%) | |
Concealment of allocation | 0.18 | ||
Low risk of bias | 19 (11.2%) | 40 (15.9%) | |
Unclear risk of bias | 150 (88.8%) | 212 (84.1%) | |
Blinding of assessors | 0.04 | ||
Stated but not tested | 34 (20.1%) | 32 (12.7%) | |
Unclear risk of bias | 135 (79.9%) | 220 (87.3%) | |
Response rates available | 154 (91.1%) | 232 (92.1%) | 0.73 |
Unpublished report available and presents adequate response data | 50 (29.6%) | 121 (48.0%) | <0.001 |
Response rate presented in published report | 128 (83.1%) | 163 (70.3%) | 0.005 |
Published and unpublished reports on response are in agreement | 139 (90.3%) | 197 (84.9%) | 0.126 |
All-cause dropout reported | 153 (90.5%) | 225 (89.3%) | 0.68 |
Response and all-cause dropout reported | 141 (83.4%) | 213 (84.5%) | 0.76 |
Dropout for adverse events reported | 134 (79.3%) | 220 (87.3%) | 0.03 |
Funding | <0.001 | ||
High risk of sponsorship bias (Industry funding or unclear) | 159 (94.0%) | 205 (81.3%) | |
Low risk of sponsorship bias (not-for profit funding or no funding) | 10 (6.0%) | 47 (18.7%) |
π: probability of receiving placebo.
Percentages are calculated out of the total number of trials reporting on response (154 and 232, respectively).