Tukmachi 2004.

Methods	Design: Parallel Blinding: No Attempt to confirm patient blinding for sham control?: Not applicable (no sham control) Drop‐outs/withdrawals: One participant excluded from the analysis due to deviation from protocol CBRG score: 1‐?‐?‐0‐0‐0‐?‐?‐1‐1‐0 Duration: 5 weeks of treatment followed by outcomes assessment, followed by an additional five weeks during which acupuncture was included as an add‐on treatment for all patients in the three arms of this study. We did not extract outcomes data after the 5 week assessment time point because 'acupuncture versus acupuncture' comparisons are not included in our review. Type of analysis reported: One patient was excluded, in all remaining patients missing values were replaced using last value carried forward (therefore, not strictly an intention‐to‐treat analysis).
Participants	Setting: University outpatient clinic (probably, based on context), Birmingham, Great Britain Mean age (+/‐SD or Range): 62 (Range: 42‐77) Men/Women (n/n): 5/24 Recruitment method: Recruited from hospital department of rheumatology Mean pain duration (SD) years: 10 (?SD) For bilateral OA diagnosis, which knee treated/evaluated?: More painful knee Diagnosis of knee OA required to be eligible? (if yes, describe how patients were verified to have OA): Yes, diagnosis was based on clinical and radiological findings Radiologic evidence of knee OA required to be eligible? (if yes, describe requirement): Yes, Kellgren II‐III. (Kellgren IV was mentioned in Box 1, but this is probably an error as it contradicts Table 5, which indicates that all patients were either Kellgren II or III) Minimum duration (and extent) of knee pain required to be eligible: Duration of knee osteoarthritis of six months or more required Hospital inpatients? (Y/N; if Y list number inpatients): Not reported Previous knee surgery? (Y/N; if Y list number with previous knee surgery): Not reported Were people with a history of acupuncture treatment excluded? Yes Other important inclusion criteria: Previous non‐response to inpatient or outpatient treatment Important exclusion criteria: Other type of arthritis (e.g., RA), hemophilia, use of anticoagulants, cortisone or oral corticosteroid medication
Interventions	TEST GROUP INTERVENTION: acupuncture without medication (patients agreed not to take any NSAIDS or analgesics throughout the treatment period, stopping one week before treatment began) N allocated to acupuncture: 10 Style of acupuncture: Chinese Point selection: Formula Points stimulated: Electroacupuncture at SP9, GB34, BL40, 57, two Xiyan points; manual stimulation at GB34; needle insertion only at ST36, LR3, LI4 Total length of treatment period (weeks): 5 Number of sessions target (mean): 10 (?mean) Times per week: 2 Number of points used: 9 Insertion depth: 1‐1.5cm Was De qi reportedly sought?: Yes Duration (mins): 20‐30 Method of stimulation: Manual at GB34 and electrostimulation at SP9, GB34, BL40, BL57, and two Xiyan points (for the other points, there was no method of stimulation) CONTROL GROUP A (sham, if used): symptomatic medication (with acupuncture course added after five weeks) N allocated to control group A: 10 Total length of treatment period: 5 weeks Number of sessions target (mean): NA Times per week: NA (If relevant) Number of points used: NA (If relevant) Insertion depth: NA Was De qi sought?: NA Duration (mins): NA (If relevant) Method of stimulation: NA CONTROL GROUP B: Acupuncture plus continued on medication (same acupuncture procedure as that used for 'acupuncture without medication group described above) N allocated to control group B: 10 Total length of treatment period: 5 weeks Number of sessions target (mean): 10 (?mean) Times per week: 2 Duration (minutes): 20‐30 Any co‐interventions in all groups?: All groups continued with any medications unrelated to their osteoarthritis.
Outcomes	PAIN, FUNCTION, AND OVERALL INDEX OF SYMPTOM SEVERITY OUTCOMES EXTRACTED FROM PUBLICATIONS: MEASUREMENT TIME POINTS Pain: WOMAC Pain: Baseline, after 5 weeks of treatment, and at follow‐up five weeks later (at five weeks all patients were started on acupuncture so post‐five week follow‐up data not included in review) Function: WOMAC function: Not reported Overall index of symptom severity: WOMAC total: Not reported Type of outcome data reported (i.e., post treatment/change from baseline/both): Post‐treatment means and standard deviations for each group, and P values of within group changes Additional outcomes reported in the trial but not abstracted: VAS pain score; patient and practitioner global assessment using the VAS scale Adverse effects: Reported as none
Notes	Comments: Small trial which is in general carefully described. We excluded all outcome measurements that occurred after the patients on the waiting list began acupuncture treatment. All patients received acupuncture after five‐weeks, and therefore, no usable randomized data is available beyond five weeks. For this trial, two arms received acupuncture and one arm was a waiting list control. We used the 'acupuncture plus continued on medication arm' rather than the 'acupuncture without medication arm' for our 'acupuncture versus waiting list comparison' because for all other included trials, the patients in the acupuncture arm were not restricted from using NSAIDs or analgesic medications. Weak points: small sample size; medication regimen of patients not clearly described; minor differences in baseline pain (baseline VAS = 6 for groups A and B and 7 for group C), although there were no statistical tests reported to indicate whether these differences were statistically significant; WOMAC function scale is not presented ‐ only the pain and stiffness subscales. In response to a request for the means and standard deviations of the WOMAC function and WOMAC total scores, the authors provided 34 pages of computer printout of the analyses for the WOMAC scores. However, it was difficult to interpret some of the computer printout, and there were minor discrepancies between the publication and the computer print‐outs for the WOMAC pain data. There was no response to a follow‐up request for clarification, and therefore, we did not include the WOMAC function or WOMAC total scores for this trial. There were no standard deviations of changes from baseline directly reported for the WOMAC pain scores. Therefore, in order to include this trial in the between group changes analysis, we converted the reported P values for the within group comparisons for baseline ‐ week 5 into standard deviations of changes for each group. These recalculated standard deviations of changes for each group were entered into RevMan. We made the following conservative assumptions in extracting these P values for the between group changes analysis: For the 'acupuncture and medication group', the P value was reported only as 'P < .001' so we used P =.001 (i.e., the maximum possible P value) to calculate standard deviation of changes; for the 'medication only' group, the P value was reported only as 'not significant', so we used P = .05 (i.e., the minimum possible P value) to calculate standard deviation of changes. Third author consulted for final decision of data extraction item: For the Jadad scale randomization item, EM scored as 2 and KL scored as 1. EM scored it as 2 because a point was scored for both 'study described as randomized' and 'method of generating randomization sequence appropriate' components. BB agreed with EM and thought we should score this study as 'yes' for item 'method of generating randomization sequence appropriate'. Source of support: Not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	“The randomisation process used block randomisation, in groups of 10, with sealed envelopes containing cards designating the treatment group prepared by a research nurse unconnected with the study.”
Allocation concealment?	Low risk	“The randomisation process used block randomisation, in groups of 10, with sealed envelopes containing cards designating the treatment group prepared by a research nurse unconnected with the study.”
Blinding? Versus sham	High risk	Acupuncture vs. symptomatic medication and Acupuncture plus continued on medication. No sham control.
Incomplete outcome data addressed? Short term	Low risk	“One patient in group A (10) continued taking concomitant analgesic and anti‐inflammatory medication, contrary to the protocol; this patient's data were excluded from the analysis.”
Free of selective reporting?	High risk	“The primary outcome measure was the change in pain as assessed by a 10cm visual analogue scale (VAS). Secondary end points included the WOMAC self‐assessment questionnaire, ... Likert scales, give total scores in the ranges of 0‐25 (pain) and 0‐10 (stiffness). Additionally , patient and practitioner were asked to make a global assessment of the effect at week five and at the final visit, by marking a 10cm visual analogue scale rating labelled 'useless' and 'excellent' at opposite ends.” It appears that the entire WOMAC scale was used, but the WOMAC function results are not reported. Findings reported in Tables 2‐4 and Figure 3, 4.
Free of other bias?	High risk	Baseline of WOMAC and VAS information was not reported. Co‐intervention was not reported. Compliance acceptability was not reported. No ITT analysis was applied.