Table 1 Checklist of items for reporting trials of Chinese herbal medicine formulas
Section/topic | Item number | Standard CONSORT checklist item | Extension for CHM formulas | Reported on page number |
|---|---|---|---|---|
Title, abstract, and keywords | 1a | Identification as a randomized trial in the title | Statement of whether the trial targets a TCM pattern, a Western medicine-defined disease, or a Western medicine-defined disease with a specific TCM pattern, if applicable | 1–4;19–49;52 |
1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance, see CONSORT for abstracts [26, 27]) | Illustration of the name and form of the formula used, and the TCM pattern applied, if applicable | 39–45;86–94 | |
1c | Determination of appropriate keywords, including “Chinese herbal medicine formula” and “randomized controlled trial” | 52 | ||
Introduction | ||||
Background and objectives | 2a | Scientific background and explanation of rationale | Statement with biomedical science approaches and/or TCM approaches | 55–95 |
2b | Specific objectives or hypotheses | Statement of whether the formula targets a Western medicine–defined disease, a TCM Pattern, or a Western medicine-defined disease with a specific TCM Pattern | 96–99;106–111 | |
Methods | ||||
Trial design | 3a | Description of trial design (such as parallel, factorial), including allocation ratio | 156–161 | |
3b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | Not applicable | ||
Participants | 4a | Eligibility criteria for participants | Statement of whether participants with a specific TCM Pattern were recruited, in terms of (1) diagnostic criteria and (2) inclusion and exclusion criteria. All criteria used should be universally recognized, or reference given to where detailed explanation can be found. | 113–122; 137–144 |
4b | Settings and locations where the data were collected | 124–128 | ||
Interventions | 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | Description(s) for different types of formulas should include the following: 5a. For fixed CHM formulas 1. Name, source, and dosage form (e.g., decoctions, granules, powders) 2. Name, source, processing method, and dosage of each medical substance. Names of substances should be presented in at least 2 languages: Chinese (Pinyin), Latin, or English. Names of the parts of the substances used should be specified. 3. Authentication method of each ingredient and how, when, where, and by whom it was conducted; statement of whether any voucher specimen was retained, and if so, where they were kept and whether they are accessible 4. Principles, rationale, and interpretation of forming the formula 5. Reference(s) as to the efficacy of the formula, if any 6. Pharmacologic study results of the formula, if any 7. Production method of the formula, if any 8. Quality control of each ingredient and of the product of the formula, if any. This would include any quantitative and/or qualitative testing method(s); when, where, how, and by whom these tests were conducted; whether the original data and samples were kept, and, if so, whether they are accessible. 9. Safety assessment of the formula, including tests for heavy metals and toxic elements, pesticide residues, microbial limit, and acute/chronic toxicity, if any. If yes, it should be stated when, where, how, and by whom these tests were conducted; if the original data and samples were kept; and, if so, whether they are accessible. 10. Dosage of the formula, and how the dosage was determined 11. Administration route (e.g., oral, external) 5b. For individualized CHM formulas 1. See recommendations 5a 1–11 2. Additional information: how, when, and by whom the formula was modified 5c. For patent proprietary CHM formulas 156–163 1. Reference to publicly available materials, such as pharmacopeia, for the details about the composition, dosage, efficacy, safety, and quality control of the formula 2. Illustration of the details of the formula, namely (1) the proprietary product name (i.e., brand name), (2) name of manufacturer, (3) lot number, (4) production date and expiry date, (5) name and percentage of added materials, and (6) whether any additional quality control measures were conducted 3. Statement of whether the patent proprietary formula used in the trial is for a condition that is identical to the publicly available reference 5d. Control groups 156–161 Placebo control 1. Name and amount of each ingredient 2. Description of the similarity of placebo with the intervention (e.g., color, smell, taste, appearance, packaging) 3. Quality control and safety assessment, if any 4. Administration route, regimen, and dosage 5. Production information: where, when, how, and by whom the placebo was produced Active control 1. If a CHM formula was used, see recommendations 5a–5c 2. If a chemical drug was used, see item 5 of the CONSORT Statement (24) | 86–92; 162–176; 201–202 Since GSATP is a national class III new drug approved according to the new drug registration standard, its specific content is confidential, so it cannot be published. The drug instructions can be queried at the address provided in the article. The rest are not applicable. |
Outcomes | 6a | Completely defined, prespecified primary and secondary outcome measures, including how and when they were assessed | Illustration of outcome measures with Pattern in detail | 187–194 |
6b | Any changes to trial outcomes after the trial commenced, with reasons | Not applicable | ||
Sample size | 7a | How sample size was determined | 196–202 | |
7b | When applicable, explanation of any interim analyses and stopping guidelines | 179–188 | ||
Randomization | ||||
Sequence | 8a | Method used to generate the random allocation sequence | 220 | |
8b | Type of randomization; details of any restriction (such as blocking and block size) | 220–224 | ||
Allocation concealment mechanism | 9 | Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | 225–232 | |
Implementation | 10 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 222; 226–232 | |
Blinding | 11a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | 230–233 | |
11b | If relevant, a description of the similarity of interventions | 164–165 | ||
Statistical methods | 12a | Statistical methods used to compare groups for primary and secondary outcomes | 205–212 | |
12b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | Not applicable | ||
Results | ||||
Participant flow (a diagram is strongly recommended) | 13a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome | This is only a research protocol, and the subjects have not been recruited, so this item is not applicable. | |
13b | For each group, losses and exclusions after randomization, together with reasons | This is only a research protocol, and the subjects have not been recruited, so this item is not applicable. | ||
Recruitment | 14a | Dates defining the periods of recruitment and follow-up | 135–136; 185–187 | |
14b | Why the trial ended or was stopped | 167–169; 186–188 | ||
Baseline data | 15 | A table showing baseline demographic and clinical characteristics for each group | This is only a research protocol, and the subjects have not been recruited, so this item is not applicable. | |
Numbers analyzed | 16 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | This is only a research protocol, and the subjects have not been recruited, so this item is not applicable. | |
Outcomes and estimation | 17a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | This is only a research protocol, and the subjects have not been recruited, so this item is not applicable. | |
17b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | Not applicable. | ||
Ancillary analyses | 18 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory | Not applicable. | |
Harms | 19 | All important harms or unintended effects in each group (for specific guidance, see CONSORT for harms [28]) | (There is no extension for this item) | Not applicable. |
Discussion | ||||
Limitations | 20 | Trial limitations; addressing sources of potential bias; imprecision; and, if relevant, multiplicity of analyses | 271–274 | |
Generalizability | 21 | Generalizability (external validity, applicability) of the trial findings | Discussion of how the formula works on different TCM Patterns or diseases | Not Applicable. |
Interpretation | 22 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | Interpretation with TCM theory | Not applicable. |
Other information | ||||
Registration | 23 | Registration number and name of trial registry | 50 | |
Protocol | 24 | Where the full trial protocol can be accessed, if available | Not applicable. | |
Funding | 25 | Sources of funding and other support (such as supply of drugs), role of funders | 292–294 | |