Table 2.
Trial design of TCM interventional studies.
| Parameter | Number/total number (%) | |||
|---|---|---|---|---|
| All Trials (N = 1270) | Oct 2000–Sep 2005 (N = 95) | Oct 2005–Sep 2010 (N = 396) | Oct 2010–Sep 2015 (N = 779) | |
| Type of intervention, N | ||||
| Drug | 439/1270 (34.6) | 20/95 (21.1) | 122/396 (30.8) | 297/779 (38.1) |
| Procedure/Device | 657/1270 (51.7) | 58/95 (61.1) | 223/396 (56.3) | 376/779 (48.3) |
| Behavioral | 145/1270 (11.4) | 15/95 (15.8) | 43/396 (10.9) | 87/779 (11.2) |
| Other intervention | 29/1270 (2.3) | 2/95 (2.1) | 8/396 (2.0) | 19/779 (2.4) |
| Enrollment, N | ||||
| Median (interquartile range) | 90.0 (45.0–200.0) | 90.0 (45.0–140.0) | 80.0 (40.0–166.0) | 96.0 (50.0–216.0) |
| 1–100 | 708/1270 (55.7) | 47/95 (49.5) | 239/396 (60.4) | 422/779 (54.2) |
| 101–500 | 445/1270 (35.0) | 24/95 (25.3) | 129/396 (32.6) | 292/779 (37.5) |
| 501–1000 | 59/1270 (4.6) | 4/95 (4.2) | 14/396 (3.5) | 41/779 (5.3) |
| >1000 | 31/1270 (2.4) | 0 | 10/396 (2.5) | 21/779 (2.7) |
| Missing | 27/1270 (2.1) | 20/95 (21.1) | 4/396 (1.0) | 3/779 (0.4) |
| Allocation, N | ||||
| Randomized | 1099/1270 (86.5) | 80/95 (84.2) | 344/396 (86.9) | 675/779 (86.6) |
| Nonrandomized | 69/1270 (5.4) | 6/95 (6.3) | 25/396 (6.3) | 38/779 (4.9) |
| Missing | 102/1270 (8.0) | 9/95 (9.5) | 27/396 (6.8) | 66/779 (8.5) |
| Masking/blinding | ||||
| Open | 206/1270 (16.2) | 17/95 (17.9) | 72/396 (18.2) | 117/779 (15.0) |
| Single-blind | 20/1270 (1.6) | 1/95 (1.1) | 6/396 (1.5) | 13/779 (1.7) |
| Double-blind | 1044/1270 (82.2) | 77/95 (81.1) | 318/396 (80.3) | 649/779 (83.3) |
| Number of arms, N | ||||
| 1 | 132/1270 (10.4) | 2/95 (2.1) | 52/396 (13.1) | 78/779 (10.0) |
| 2 | 719/1270 (56.6) | 10/95 (10.5) | 207/396 (52.3) | 502/779 (64.4) |
| 3 | 226/1270 (17.8) | 7/95 (7.4) | 73/396 (18.4) | 146/779 (18.7) |
| 4 | 58/1270 (4.6) | 2/95 (2.1) | 13/396 (3.3) | 43/779 (5.5) |
| ≥5 | 15/1270 (1.2) | 0 | 8/396 (2.0) | 7/779 (0.9) |
| Missing | 120/1270 (9.4) | 74/95 (77.9) | 43/396 (10.9) | 3/779 (0.4) |
| Comparator, N | ||||
| Experimental | 1116/1270 (87.9) | 20/95 (21.1) | 332/396 (83.8) | 778/779 (99.9) |
| Active comparator | 627/1270 (49.4) | 11/95 (11.6) | 189/396 (47.7) | 427/779 (54.8) |
| Placebo comparator | 319/1270 (25.1) | 10/95 (10.5) | 109/396 (27.5) | 200/779 (25.7) |
| Sham comparator | 198/1270 (15.6) | 7/95 (7.4) | 65/396 (16.4) | 126/779 (16.2) |
| No intervention | 197/1270 (15.5) | 2/95 (2.1) | 52/396 (13.1) | 143/779 (18.4) |
| Other | 71/1270 (5.6) | 1/95 (1.1) | 20/396 (5.1) | 50/779 (6.4) |
| Missing | 140/1270 (11.0) | 75/95 (78.9) | 64/396 (16.2) | 1/779 (0.1) |