Characteristic | Pharmacological, n = 66 | Nonpharmacological, n = 117 | Both, n = 13 | All Trials, n = 196 |
---|---|---|---|---|
Randomization | ||||
Generation of allocation sequence | p = 0.104 | |||
Adequate | 26 (39) | 51 (44) | 8 (62) | 85 (43) |
Inadequate | 1 (2) | 12 (10) | 0 (0) | 13 (7) |
Not reported | 39 (59) | 54 (46) | 5 (39) | 98 (49) |
Allocation concealment | p = 0.403 | |||
Adequate | 29 (44) | 40 (34) | 7 (54) | 76 (39) |
Inadequate | 1 (2) | 5 (4) | 0 (0) | 6 (3) |
Not reported | 36 (55) | 72 (62) | 6 (46) | 114 (58) |
Intervention reproducible | p = 0.430 | |||
Adequate | 64 (97) | 114 (97) | 12 (93) | 190 (97) |
Inadequate | 1 (2) | 2 (2) | 0 (0) | 3 (2) |
Not reported | 1 (2) | 1 (1) | 1 (8) | 3 (2) |
Influence of care provider skill | p = 0.850 | |||
Yes | 1 (2) | 1 (1) | 0 (0) | 2 (1) |
No | 65 (99) | 116 (99) | 13 (100) | 194 (99) |
CONSORT diagram reported | p = 0.19 | |||
Adequate | 9 (14) | 7 (7) | 4 (30) | 20 (10) |
Not reported | 57 (86) | 110 (93) | 9 (69) | 176 (90) |
Control intervention | p < 0.001 | |||
Placebo | 31 (47) | 0 (0) | 5 (39) | 36 (18) |
No placebo | 35 (53) | 107 (100) | 8 (61) | 150 (82) |
Influence of care provider skill | p = 0.850 | |||
Yes | 1 (2) | 1 (1) | 0 | 2 (1) |
No | 65 (99) | 116 (99) | 13 (100) | 194 (99) |
Potential similar placebo effect | p < 0.001 | |||
Adequate | 57 (86) | 55 (47) | 13 (100) | 125 (64) |
Inadequate | 2 (3) | 10 (9) | 0 (0) | 12 (6) |
Not reported* | 7 (11) | 52 (45) | 0 (0) | 59 (30) |
Blinding | ||||
Patients | p < 0.001 | |||
Adequate | 40 (61) | 14 (12) | 6 (46) | 60 (31) |
Inadequate | 1 (2) | 7 (4) | 2 (15) | 10 (5) |
Not reported* | 25 (38) | 98 (84) | 5 (39) | 128 (65) |
Care providers | p < 0.001 | |||
Adequate | 28 (42) | 2 (2) | 3 (23) | 33 (17) |
Inadequate | 13 (20) | 89 (76) | 4 (31) | 106 (54) |
Not reported | 25 (38) | 26 (22) | 6 (46) | 57 (29) |
Outcome assessors | p = 0.001 | |||
Adequate | 42 (64) | 39 (33) | 8 (62) | 89 (45) |
Inadequate | 1 (2) | 12 (10) | 0 (0) | 13 (7) |
Not reported | 23 (35) | 66 (57) | 5 (39) | 94 (48) |
Statistical analysis | p < 0.001 | |||
Described as ITT or modified ITT | 15 (23) | 4 (3) | 1 (8) | 20 (10) |
Not described as ITT or modified ITT | 51 (77) | 113 (97) | 12 (92) | 176 (90) |
Sample size justification/power reported | p = 0.001 | |||
Adequate | 30 (46) | 31 (27) | 9 (69) | 70 (36) |
Not reported | 36 (55) | 86 (74) | 4 (31) | 126 (64) |
Were adverse events reported | p = 0.116 | |||
Adequate | 46 (70) | 58 (50) | 7 (54) | 111 (57) |
Inadequate | 20 (30) | 1 (1) | 0 (0) | 21 (11) |
Not reported | 0 (0) | 58 (50) | 6 (46) | 64 (33) |
Lost to followup < 20 | p = 0.524 | |||
Adequate | 35 (53) | 56 (48) | 8 (62) | 99 (51) |
Inadequate | 8 (12) | 10 (9) | 2 (15) | 20 (10) |
Not reported | 23 (35) | 51 (44) | 3 (23) | 77 (39) |
↵* Combination of not reported and not applicable. CONSORT: Consolidated Standards of Reporting Trials10; ITT: intention to treat. Percentages in parentheses are rounded; total may not sum to 100%.