Sangdee 2002 *.

Methods	Design: Parallel (2x2) Blinding: Clinical outcomes assessors were blinded for all treatment groups and patients were blinded for acupuncture/placebo treatment groups only. Since patients assessed their own outcomes, we considered this trial to have used blinding only for the acupuncture/placebo acupuncture groups for which patients were blinded. Attempt to confirm patient blinding for sham control?: No Drop‐outs/withdrawals: 7 withdrawn from the trial for various medical reasons, none of which were attributable to acupuncture treatment CBRG score: ?‐?‐1‐.5‐0‐.5‐1‐1‐1‐1‐0 (number preceding / is placebo control group score and number following / is medication alone control group score) Duration: 4 weeks of treatment and two additional months of follow‐up for responders Type of analysis reported: only analysis of the 186 completers (intention‐to‐treat analysis also done as sensitivity analysis, but not reported because the results were reportedly not affected by type of analysis due to small number of withdrawals)
Participants	Setting: University outpatient center in Thailand Mean age (+/‐SD or Range): ˜63(7) Men/Women (n/n): 43/150 Recruitment method: Not reported Mean pain duration (SD) years: ˜5(3) years duration of OA For bilateral OA diagnosis, which knee treated/evaluated?: Not reported Diagnosis of knee OA required to be eligible? (if yes, describe how patients were verified to have OA): ACR criteria Radiologic evidence of knee OA required to be eligible? (if yes, describe requirement): No Minimum duration (and extent) of knee pain required to be eligible: more than 3 months as suffering from OA of knee Hospital inpatients? (Y/N; if Y list number inpatients): N Previous knee surgery? (Y/N; if Y list number with previous knee surgery): Not reported Were people with a history of acupuncture treatment excluded?: No, but EA within the last 3 months was an exclusion criteria Other important inclusion criteria: age>40; able to walk; Lequesne functional index greater than or equal to 6 points at baseline; informed consent Important exclusion criteria: underlying inflammatory arthropathy; surgery in future; injury in area affected by OA knee, intraarticular corticosteroid injections or EA in the last 3 months
Interventions	TEST GROUP INTERVENTION: Electroacupuncture plus placebo diclofenac N allocated to acupuncture: 48 Style of acupuncture: Chinese Point selection: Formula Points stimulated: ST35, LR8, EX32 (Xiyan) + 1 Triggerpoint Total length of treatment period (weeks): 4 Number of sessions target (mean): 12 (?mean) Times per week: 3 Number of points used: 4 Insertion depth: not more than .5 inches Was De qi reportedly sought?: No Duration (mins): 20 Method of stimulation: Electrical stimulation (2 Hz) at maximum tolerable level to patient to each pair of needles CONTROL GROUP A (sham, if used): Sham procedure plus placebo diclofenac at 1 tablet 3x/day for 4 weeks. Sham involving patch electrodes attached to the same acupuncture points used in acupuncture group and other end attached to sound producing dummy mode of the same EA machine N allocated to control group A: 47 Total length of treatment period: 4 weeks Number of sessions target (mean): 12 (not reported) Times per week: 3 (If relevant) Number of points used: 4 (If relevant) Insertion depth: Not applicable Was De qi sought?: Not applicable Duration (mins): 20 (If relevant) Method of stimulation: Mock electrostimulation CONTROL GROUP B: Sham procedure plus diclofenac 1 table 3x/day for 4 wks N allocated to control group B: 49 Total length of treatment period: 4 weeks Number of sessions target (mean): Not applicable (3 tablets/day) Times per week: Not applicable (daily) Duration (minutes): Not applicable CONTROL GROUP C: Electroacupuncture plus diclofenac 1 table 3x/day for 4 wks N allocated to control group C: 49 Total length of treatment period: 4 weeks Number of sessions target (mean): 12 plus diclofenac 3x/day Times per week: 3 Duration (minutes): 20 minutes Any co‐interventions in all groups? During the study period, all additional therapies for OA (e.g., oral or topical NSAIDS, intraarticular corticosteroid injection, other analgesics, chondro‐protective, agents, surgical procedures on the knee joint, etc.) were not allowed. However, 2 tablets of 500 mg Paracetamol/day were still prescribed as a rescue analgesic during the study. Other treatments for concomitant diseases could be continued if treatments administered were documented.
Outcomes	PAIN, FUNCTION, AND OVERALL INDEX OF SYMPTOM SEVERITY OUTCOMES EXTRACTED FROM PUBLICATIONS: MEASUREMENT TIME POINTS Pain: WOMAC Pain: Baseline, after 4 week treatment period, and, for responders only, 2 months later Function: WOMAC function: Baseline, after 4 week treatment period, and, for responders only, 2 months later Overall index of symptom severity: WOMAC total: Baseline, after 4 week treatment period, and, for responders only, 2 months later Type of outcome data reported (i.e., post treatment/change from baseline/both): means and standard errors of changes for each group reported in publication Additional outcomes reported in the trial but not abstracted: amount of paracetamol tablets taken/week; 50 feet‐walk time; a patient's global pain as 100 mm VAS; Lesquesne's functional index; and clinician's and patient's overall opinion of change Adverse effects: reported that the "percentage of patients who experienced adverse effects...during the study did not differ between the four groups (data not shown), whereas, local contusions around the knee were more common in the EA and combined group (approximately 45%). However, the contusions usually disappeared within 5‐7 days."
Notes	Comments: Well reported study with 2x2 factorial design. Weak points: Only responders were followed‐up beyond the initial four week treatment period so no randomized long‐term data available This trial did not report standard deviations of post‐treatment scores (because the authors of this trial used a comparison of between group changes for their analysis). For this trial, we used the baseline standard deviations, provided in Table 6, as an estimate for the post‐treatment standard deviation scores. This was the only trial that reported pre‐treatment standard deviations but not post‐treatment standard deviations, and was, therefore, the only trial for which we used pre‐treatment standard deviations to calculate variability. We discussed the use of pre‐treatment standard deviations as estimates for post‐treatment standard deviations with two biostatisticians, who both considered this a reasonable assumption. This trial had a factorial design, and compared electro‐acupuncture versus placebo acupuncture, using either a diclofenac or a placebo diclofenac co‐intervention. This study ID compares acupuncture versus sham using the true diclofenac co‐intervention. The corresponding author was e‐mailed (at csangdee@mail.med.cmu.ac.th) to request review of information extracted from the trial, to obtain further details about the randomization, and to request the SDs of the post‐treatment scores; however, no response was received. Source of support: "This work was supported by the Faculty of Medicine, Chiang Mai University, Thailand."
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	“The patients who had persistent pain and a Lequesne's functional index of at least 6 points at the end of the run‐in period were randomized into the four groups mentioned above.” No more detailed description about randomization. The corresponding author was e‐mailed to obtain further details about the randomization; however, no response was received.
Allocation concealment?	Unclear risk	The method of concealment is not described.
Blinding? Versus sham	Unclear risk	“Clinical assessments in each patient were evaluated by the same physician who was blinded to the treatment.” “The placebo EA was performed by attaching patch electrodes to the selected acupuncture points. Each electrode was connected to the sound producing dummy mode of the same apparatus, as in the true EA treatment. ” No attempt to confirm patient blinding for sham control was reported.
Incomplete outcome data addressed? Short term	Low risk	“Of the 193 study patients, 186 (96.37%) completed the study. The remaining 7 patients were withdrawn from the trial due to flare of pain with joint swelling (2 in the placebo and 1 in the EA group), severe GI side effects (3 in the combined group), and flare of pain from an accidental fall not related to treatment (1 in the EA group).” 45(47), 49(49), 46(48) and 46(49) patients were available at week 4 according to Table 4 and above description.
Free of selective reporting?	Low risk	“Clinical assessments were evaluated for base‐line data at the end of the run‐in period (week 0) and again at the end of the study (week 4). These assessments included the amount of paracetamol tablets taken/week, 50 feet‐walk time, a patient's global pain as 100 mm visual analog scale (VAS) over the previous 3 days, the Western Ontario and McMaster Universities OA Index (WOMAC: score ranging from 0?96) [21], and Lequesne's functional index (score ranging from 0?24) [22]. ?Complete physical examination and non‐directive questioning for adverse events were also performed weekly for 4 weeks in order to acquire a safety assessment. ” Findings reported in Table 6, 4‐6 and Figure 2‐4.
Free of other bias?	High risk	No ITT analysis was applied.