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| Item number | Paper section | Question |
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| 1 | Abstract | Is there an explicit statement that patients were randomly assigned to interventions? |
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| 2 | Introduction/Background | (a) Is scientific background provided and (b) is the rationale explained? |
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| 3 | Methods | (a) Are the eligibility criteria (inclusion and exclusion criteria) stated and (b) are the setting(s) and location(s) where the data was collected described? |
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| 4 | Methods | (a) Is the style of acupuncture stated? (b) Is the rationale presented for the selection of acupuncture points? (c) Was the rationale justified? |
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| 5 | Methods | Are the following parameters of needling presented?
(a) Points used (uni/bilateral)
(b) Number of needles inserted
(c) Depth(s) of insertion
(d) Response elicited (e.g., de qi)
(e) Needle stimulation (manual or electrical)
(f) Needle retention time
(g) Needle type (Material and/or manufacturer, gauge, and length) |
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| 6 | Methods | Are the (a) number and (b) frequency of treatments stated? |
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| 7 | Methods | Are details of the acupuncture group cointervention(s) presented? (e.g., moxa, cupping, life-style advice, plum-blossom needling, Chinese herbs) |
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| 8 | Methods | Are descriptions provided of the (a) duration of practitioner training, (b) length of clinical experience, and (c) expertise in specific condition? |
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| 9 | Methods | (a) Is the intended effect of the control or comparison intervention presented? (b) Were the specific explanations given to patients of the treatment and control interventions presented? (c) Are details for the control or comparison intervention presented? (d) Are sources provided, that justify the choice of the control or comparison intervention? |
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| 10 | Methods | Are there statements of (a) specific objectives and (b) hypotheses to be tested? |
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| 11 | Methods | (a) Are primary and (if applicable) secondary outcome measures clearly defined? (b) Are there statements (when applicable), regarding any methods used to enhance the quality of measurements, for example, multiple observers or training of assessors? |
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| 12 | Methods | (a) Is there a statement regarding how the sample size was determined, and (b) if applicable, an explanation of any interim analyses and stopping rules? |
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| 13 | Methods | (a) Is the method presented that was used to generate the random allocation sequence, and (b) if applicable, details of any restriction (e.g., blocking, stratification)? |
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| 14 | Methods | (a) Is the method presented that was used to implement the random allocation sequence, (b) with clarification as to whether the sequence was concealed until interventions were assigned? |
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| 15 | Methods | Are there statements as to (a) who generated the allocation sequence, (b) who enrolled participants, and (c) who assigned participants to their groups? |
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| 16 | Methods | Is it stated whether or not (a) participants, (b) those administering the interventions, and (c) those assessing the outcomes were blinded? and (d) was the success of participant blinding evaluated? |
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| 17 | Methods | (a) Were the statistical methods stated that were used to compare groups for primary outcomes? (b) Were the statistical methods stated that were used for additional analyses such as subgroup or adjusted analyses? |
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| 18 | Results | (a) Is the flow of participants through each stage quantitatively described, and (b) if protocol deviations are reported, were reasons presented? |
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| 19 | Results | (a) Are dates provided that define the period of recruitment? (b) Is the length of followup (on-treatment and posttreatment) reported? |
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| 20 | Results | (a) Are baseline demographics and (b) clinical characteristics presented for each group? |
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| 21 | Results | (a) Is the number of participants in each group included in each analysis? (b) Was the “intention to treat” analysis presented? (c) When feasible, are the results stated in absolute numbers (e.g., 10 of 20, not just 50%)? |
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| 22 | Results | For each primary and (if applicable) secondary outcome, is (a) a summary of results presented for each group, (b) the estimated effect size presented for each between-group difference (e.g., SD), and (c) the precision of the effect size presented for each between-group difference (e.g., confidence interval (CI))? |
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| 23 | Results | If additional subgroup analyses and/or adjusted analyses are reported, is it stated whether they were prespecified or exploratory, that is, not prespecified? |
| 24 | Results | Are all important adverse events or side effects presented for each intervention group? |
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| 25 | Discussion | Is an interpretation of the results presented that takes into account (a) study hypotheses, (b) sources of potential bias or imprecision, and (c) the potential dangers associated with multiple analyses and outcomes? |
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| 26 | Discussion | Is the generalizability (external validity) of the trial findings discussed? |
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| 27 | Discussion | Is a general interpretation of the results presented, in the context of current evidence? |
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