1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Evidence-Based Complementary and Alternative Medicine 3 Table 1: Oregon CONSORT STRICTA instrument (OCSI). Item number Paper section Abstract Introduction/Background Methods Methods Methods Methods Methods Methods Methods Methods Methods Methods Methods Methods Methods Methods Methods Results Results Results Results Question Is there an explicit statement that patients were randomly assigned to interventions? (a) Is scientiﬁc background provided and (b) is the rationale explained? (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? (a) Is the style of acupuncture stated? (b) Is the rationale presented for the selection of acupuncture points? (c) Was the rationale justiﬁed? 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) Are the (a) number and (b) frequency of treatments stated? Are details of the acupuncture group cointervention(s) presented? (e.g., moxa, cupping, life-style advice, plum-blossom needling, Chinese herbs) Are descriptions provided of the (a) duration of practitioner training, (b) length of clinical experience, and (c) expertise in speciﬁc condition? (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? Are there statements of (a) speciﬁc objectives and (b) hypotheses to be tested? (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? (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? (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)? (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? Are there statements as to (a) who generated the allocation sequence, (b) who enrolled participants, and (c) who assigned participants to their groups? 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? (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? (a) Is the ﬂow of participants through each stage quantitatively described, and (b) if protocol deviations are reported, were reasons presented? (a) Are dates provided that deﬁne the period of recruitment? (b) Is the length of followup (on-treatment and posttreatment) reported? (a) Are baseline demographics and (b) clinical characteristics presented for each group? (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%)?