Review Article
The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov
Table 2
Trial design of TCM interventional studies.
| | Parameter | Number/total number (%) | | All Trials | Oct 2000–Sep 2005 | Oct 2005–Sep 2010 | Oct 2010–Sep 2015 |
| | 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) |
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