|
| Paper section and topic | Item | Description | Number (%) |
|
| Title and abstract | 1 | Is there abstract or not? | 269 (76.0%) |
| Introduction | | | |
| Background | 2 | A brief statement of reasons for trials and medicines | 261 (73.7%) |
| Objectives | 3 | Specific objectives or hypotheses | 237 (66.9%) |
| Methods | | | |
| Participants | 4 | Diagnostic criteria of Western medicine | 299 (84.5%) |
| Using the diagnostic criteria and Syndromes of TCM | 151 (42.7%) |
| Inclusion criteria | 268 (75.7%) |
| Exclusion criteria | 254 (71.8%) |
| The settings and location where the data collected | 301 (85.0%) |
| Interventions | 5 | Details on interventions of each group (such as dosage, metropolis, concocting method, and batch number) | 161 (45.5%) |
| Strategy of quality control | 5 (1.4%) |
| Outcomes | 6 | Clearly defined outcome measures and when applicable | 256 (72.3%) |
| Using the syndrome indicators to evaluate the outcome | 88 (24.9%) |
| Sample size | 7 | How sample size was determined | 4 (1.1%) |
| Randomization | | | |
| (i) Sequence generation | 8 | Method used to generate the random allocation sequence | 260 (73.4%) |
| (ii) Allocation concealment | 9 | Method used to implement the random allocation sequence | 29 (8.2%) |
| (iii) Implementation | 10 | Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups? | 12 (3.4%) |
| (iv) Blinding | 11 | Single blinding | 8 (2.3%) |
| Double blinding | 13 (3.7%) |
| Not mentioned | 333 (94.1%) |
| Statistical methods | 12 | Description of statistical methods | 347 (98.0%) |
| Results | | | |
| Participant flow | 13 | Flow of participants’ changes in each stage | 90 (25.4%) |
| A diagram of flow | 0 (0.0%) |
| Compliance | 15 (4.2%) |
| Recruitment | 14 | The method for collection | 6 (1.7%) |
| Follow-up record | 103 (29.1%) |
| Baseline data | 15 | Baseline demographic and clinical characteristics of each group | 68 (19.2%) |
| Numbers analyzed | 16 | Whether the analysis was by ‘‘intention-to-treat’’ | 7 (2.0%) |
| Outcomes and estimation | 17 | Positive results | 352 (99.4%) |
| Negative results | 0 (0.0%) |
| Equivalent results | 2 (0.6%) |
| The precise of data | 323 (91.2%) |
| Give the confidence interval and value of “” | 40 (11.3%) |
| Ancillary analyses | 18 | Results of any other analyses performed, including Subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory | 5 (1.4%) |
| Harms | 19 | All important harms or unintended effects in each group | 198 (55.9%) |
| Discussion | | | |
| Interpretation | 20 | Interpretation of the results | 353 (99.7%) |
| Explaining the significance in statistics and treatment | 255 (72.0%) |
| Explain the results with theories of TCM | 218 (61.6%) |
| Potential bias | 28 (7.9%) |
| Generalizability | 21 | Generalizability (external validity) of the results | 86 (24.3%) |
| Overall evidence | 22 | Description of the interest conflict between researchers and participants | 0 (0.0%) |
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