Table 2. Reporting quality evaluation by STRICTA checklist.
| Section/Topic | No. | Item | Assessment (Ref.) |
|||
|---|---|---|---|---|---|---|
| Geng 2017 (28) |
Zhao 2017 (29) |
Shi 2017 (30) |
Li 2018 (31) |
|||
| Title and abstract | ||||||
| 1a | Identification as a randomized trial in the title | N | N | N | N | |
| 1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) | Y | Y | Y | Y | |
| Introduction | ||||||
| Background and objectives | 2a | Scientific background and explanation of rationale | Y | Y | Y | Y |
| 2b | Specific objectives or hypotheses | Y | Y | Y | Y | |
| Methods | ||||||
| Trial design | 3a | Description of trial design (such as parallel, factorial) including allocation ratio | N | Y | Y | N |
| 3b | Important changes in methods after trial commencement (such as eligibility criteria), with reasons | N | N | N | N | |
| Participants | 4a | Eligibility criteria for participants | Y | Y | Y | Y |
| 4b | Settings and locations where the data were collected | Y | Y | Y | Y | |
| Acupuncture rationale | 5a | Style of acupuncture (e.g. Traditional Chinese Medicine, Japanese, Korean, Western medical, Five Element, ear acupuncture, etc.) | Y | Y | Y | Y |
| 5b | Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate | P | Y | P | P | |
| 5c | Extent to which treatment was varied | Y | Y | Y | Y | |
| Details of needling | 6a | Number of needle insertions per subject per session (mean and range where relevant) | P | P | P | P |
| 6b | Names (or location if no standard name) of points used (uni/bilateral) | Y | Y | Y | Y | |
| 6c | Depth of insertion, based on a specified unit of measurement, or on a particular tissue level | P | P | P | P | |
| 6d | Response sought (e.g. de qi or muscle twitch response) | Y | Y | Y | Y | |
| 6e | Needle stimulation (e.g. manual, electrical) | Y | Y | Y | Y | |
| 6f | Needle retention time | Y | Y | Y | Y | |
| 6g | Needle type (diameter, length, and manufacturer or material) | Y | Y | Y | Y | |
| Treatment regimen | 7a | Number of treatment sessions | Y | Y | Y | Y |
| 7b | Frequency and duration of treatment sessions | Y | Y | Y | Y | |
| Other components of treatment | 8a | Details of other interventions administered to the acupuncture group (e.g. moxibustion, cupping, herbs, exercises, lifestyle advice) | Y | Y | Y | Y |
| 8b | Setting and context of treatment, including instructions to practitioners, and information and explanations to patients | N | N | N | N | |
| Practitioner background | 9 | Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience) | N | N | N | N |
| Control or comparator | 10a | Rationale for the control or comparator in the context of the research question, with sources that justify this choice | P | P | P | P |
| 10b | Precise description of the control or comparator. If sham acupuncture or any other type of acupuncture-like control is used, provide details as for items 5 to 8 above | P | P | P | P | |
| Outcomes | 11a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | P | P | P | P |
| 11b | Any changes to trial outcomes after the trial commenced, with reasons | N | Y | Y | N | |
| Sample size | 12a | How sample size was determined | N | N | N | N |
| 12b | When applicable, explanation of any interim analyses and stopping guidelines | N | N | N | N | |
| Randomization | ||||||
| Sequence generation | 13a | Method used to generate the random allocation sequence | N | Y | N | N |
| 13b | Type of randomization; details of any restriction (such as blocking and block size) | N | P | P | N | |
| Allocation concealment mechanism | 14 | 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 | N | Y | N | N |
| Implementation | 15 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | N | N | N | N |
| Blinding | 16a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | N | N | N | N |
| 16b | If relevant, description of the similarity of interventions | N | Y | Y | N | |
| Statistical methods | 17a | Statistical methods used to compare groups for primary and secondary outcomes | Y | Y | Y | Y |
| 17b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | N | N | N | N | |
| Results | ||||||
| Participant flow (a diagram is strongly recommended) | 18a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome | N | P | P | N |
| 18b | For each group, losses and exclusions after randomization, together with reasons | Y | Y | Y | Y | |
| Recruitment | 19a | Dates defining the periods of recruitment and follow-up | N | Y | Y | Y |
| 19b | Why the trial ended or was stopped | N | N | N | N | |
| Baseline data | 20 | A table showing baseline demographic and clinical characteristics for each group | N | Y | Y | N |
| Numbers analyzed | 21 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | Y | Y | Y | Y |
| Outcomes and estimation | 22a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | Y | Y | Y | Y |
| 22b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | N | N | N | N | |
| Ancillary analyses | 23 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | N | N | N | N |
| Harms | 24 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | N | P | P | N |
| Discussion | ||||||
| Limitations | 25 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | N | P | P | N |
| Generalizability | 26 | Generalizability (external validity, applicability) of the trial findings | Y | Y | Y | Y |
| Interpretation | 27 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | P | P | P | P |
| Other information | ||||||
| Registration | 28 | Registration number and name of trial registry | N | N | N | N |
| Protocol | 29 | Where the full trial protocol can be accessed, if available | N | N | N | N |
| Funding | 30 | Sources of funding and other support (such as supply of drugs), role of funders | Y | Y | Y | N |
| RATING OVERALL CONFIDENCE IN THE RESULITS OF THE TRIALS | VL | L | L | VL | ||
N: no reporting; P: partly reporting; Y: fully reporting. Evaluation criteria depended on the percentage of fully reporting items: ≤ 30%: Very Low quality (VL); 30-50%: Low quality (L); 50-70%: Medium quality (M); > 70%: High quality (H).