|
| Item | No. | Subitem | Number (%) |
|
| The introduction of background which lead to the complex interventions | 1 | Introduction of target disease | 214 (60.5%) |
| Limitations of using single interventions | 145 (41.0%) |
| Not mentioned | 93 (26.3%) |
|
| The type of objectives | 2 | Main purpose of observing clinical efficacy | 324 (91.5%) |
| Demonstrate results of former research(es) | 30 (8.5%) |
|
| Rationale for the selection of the intervention’s components | 3 | Depend on systematic review results of clinical trials | 1 (0.3%) |
| Based on former clinical trials | 99 (28.0%) |
| The results of animal studies | 112 (31.6%) |
| Experts consensus | 5 (1.4%) |
| Personal clinical experiences | 29 (8.2%) |
| Not mentioned | 108 (30.5%) |
|
| Description the theoretical basis of complex interventions’ program | 4 | Depend on systematic review results of clinical trials | 0 (0.0%) |
| Based on former clinical trials | 25 (7.1%) |
| The results of animal studies | 0 (0.0%) |
| Experts consensus | 1 (0.3%) |
| Personal clinical experiences | 11 (3.1%) |
| Not mentioned | 317 (89.5%) |
|
| Pilot study | 5 | Is there pilot study or not? | 0 (0.0%) |
|
| Sample size | 6 | <50 | 32 (9.0%) |
| 50–99 | 193 (54.5%) |
| 100–299 | 118 (33.3%) |
| ≥300 | 11 (3.1%) |
|
| The type of design | 7 | Randomized controlled trials | 312 (88.1%) |
| (i) Randomization | 225 (63.6%) |
| (ii) Quasi-randomization | 49 (13.8%) |
| (iii) Randomized, no method stated | 38 (10.7%) |
| Cohort study | 8 (2.3%) |
| Crossover design | 1 (0.3%) |
| Case-control study | 1 (0.3%) |
| Non-randomized concurrent controlled trials | 32 (9.0%) |
|
| The categories of combinations between intervention’s components | 8 | Chinese medicine alone | 113 (31.9%) |
| (i) Chinese medicines with different formulations | 22 (6.2%) |
| (ii) Chinese medicines + non-drug | 67 (18.9%) |
| (iii) Difference kinds of non-drug TCM | 24 (6.8%) |
| Western medicine alone | 0 (0.0%) |
| Chinese plus western medicine | 241 (68.1%) |
| (i) Chinese medicines + western medicines/basic treatments | 207 (58.5%) |
| (ii) Western medicines + non-drug | 20 (5.6%) |
| (iii) Chinese medicines + western medicines + non-drug | 14 (4.0%) |
|
| Control interventions | 9 | A single component as effective control | 156 (44.1%) |
| Several components combined as a effective control | 185 (52.3%) |
| Placebo control | 12 (3.4%) |
| Blank control | 1 (0.3%) |
|
| Indicators for evaluating the outcomes | 10 | One indicator | 116 (32.8%) |
| Multiple indicators for comprehensive evaluation | 238 (67.2%) |
|
| Elaborating interactions between different components | 11 | Interactions lead to better efficacy | 118 (33.3%) |
| (i) Some similar components combined for enhancing the overall efficacy | 60 (16.9%) |
| (ii) Components complemented each other to enhance the efficacy | 27 (7.6%) |
| (iii) Improved by reducing side effects | 31 (8.8%) |
| Interactions lead to worse efficacy | 0 (0.0%) |
| (i) Efficacy reduced without side effect | 0 (0.0%) |
| (ii) Some side effects generated | 0 (0.0%) |
| Not mentioned | 236 (66.7%) |
|
| The advantages of using complex interventions’ program | 12 | More effective | 297 (83.9%) |
| Shorten the treatment time | 24 (7.6%) |
| Fewer side effects (security) | 96 (27.1%) |
| Easier to implement | 19 (5.4%) |
| Less cost of treatment | 18 (5.1%) |
| Not mentioned | 36 (10.2%) |
|
