White 2012

Methods	Design: factorial Blinding: yes, participants and outcomes assessor blinding Attempt to confirm participant blinding for sham control?: yes, “Patients were asked at treatment completion, 'Do you think the treatment you had was real' and required to give a yes or no answer.” (page 457 section 2.6, Potential confounders). "A high percentage of patients believed that their treatment had been real; 96% (RA), 93% (SN), and 75% (mock electrical stimulation), which suggests that blinding was successful. These differences between treatments were significant (X2 = 15.486, P = .001).” (page 457 section 3.4, Blinding) Dropouts/withdrawals: 2 in acupuncture group, 6 in Streitberger needle, and 3 in mock electrical stimulation group (Fig. 1 & Table 4) dropped out during the 5 week trial. [For hip OA, there was only one dropout, which was from the Streitberger group.] Duration: 4 weeks treatment and 1 week of follow up, for a total duration of 5 weeks Type of analysis reported: Available case analysis, with intention‐to‐treat was used for participants who completed some pain outcome scores. “Missing data were dealt with by either taking a mean of the values on either side of the missing value or by carrying forward the last entry as appropriate.” (page 457 section 2.7, Sample size and analyses). “Eleven patients (4.9%) dropped out (Table 4); 3 completed some pain scores, and their data were carried forward per intention‐to‐treat analysis and included in the final analysis. Eight did not complete any outcomes and were excluded from analysis.” (page 457 section 3, Results) Stratification for treatment type within each joint: ["We did stratify for treatment type etc within each joint i.e. so for example within all the hips we had equal numbers of acupuncture, streitberger and mock electrical, we had equal numbers of consultation types. Within all the knees we had equal numbers of acupuncture, streitberger and mock electrical, we had equal numbers of consultation types." (2017 Sept 21 e‐mail to Eric Manheimer)]
Participants	Setting: Southampton General and Salisbury District Hospitals (UK) Mean age (±SD or range): 66.75 (8.29) years (page 457 section 3.1, Demographics and baseline measurements) Men/women (n/n): not reported specifically for hip OA; 94/127 for all participants, therefore this ratio was multiplied by the numbers of hip OA only participants to estimate number of male and female for hip OA (i.e. number of males with hip OA was 89 * 94/221 = 38; number of females with hip OA was 89 * 127/221 = 51). Recruitment method: Recruitment was via joint replacement waiting lists Mean pain duration (SD) years: not reported For bilateral OA diagnosis, which hip treated/evaluated?: not reported [The joint that the participant felt was the most painful of the two.] Diagnosis of knee OA required to be eligible? (if yes, describe how participants were verified to have OA): ; not reported [Yes, this was by Orthopaedic Consultant diagnosis, which would have included (without exception) X‐ray.] Radiologic evidence of knee OA required to be eligible? (if yes, describe requirement): not reported [Yes, this was by Orthopaedic Consultant diagnosis, which would have included (without exception) X‐ray.] Minimum duration (and extent) of hip pain required to be eligible: “A minimum mean weekly score of 30 of 100 was an inclusion requirement.” (page 456, section 2.4 and Table 1) Hospital inpatients? (Y/N; if Y list number inpatients): not reported Previous hip surgery? (Y/N; if Y list number with previous hip surgery): no [participants who had previous joint replacement surgery to the hip/knee were excluded but other types of surgery were not excluded] Were people with a history of acupuncture treatment excluded?: yes. “Outcome was not confounded by … previous acupuncture treatment.” Other important inclusion criteria: age 18 to 80 years, suffering chronic osteoarthritic pain from a single joint (hip or knee), awaiting joint replacement surgery, not on any current physical treatment (e.g. physiotherapy) (page 456, Table 1) Important exclusion criteria: pregnancy, serious comorbidity (including severe back pain), history of prolonged or current steroid use, awaiting hip/knee revision (i.e. current prosthesis), needle phobia, allergy to sticking plaster. (page 456, Table 1) How patients grouped for knee/hip subgroup: Eligibility criteria included "Suffering chronic osteoarthritic pain from a single joint (hip or knee)" and "Awaiting joint replacement surgery". They were grouped as hip or knee patients depending on which joint they were waiting to have replaced.
Interventions	TEST GROUP INTERVENTION: acupuncture N allocated to acupuncture: [30] (30 analyzed) Style of acupuncture: described as Western acupuncture approach, but traditional TCM acupoints were used Point selection: flexible formula Points stimulated: not reported [3 or 4 local points, selected from among the following 4: GB 30, GB 31, UB 34, ST 31; 1 or 2 distal points, selected from among the following 3: GB 34, GB 41, UB 60; Plus 1 or 2 ah shi points, if appropriate/evident] Total length of treatment period (weeks): 4 weeks Number of sessions target (mean): 8 Times per week: 2 Number of points used: 6 (reported as mean in the article, but stated as minimum in Peter White’s email) Insertion depth: “with deep needling”; [GB 30 (3 to 6cm), GB 31 (2 to 3cm), UB 34 (2 to 3cm), St 31 (2 to 3cm),GB 34 (2 to 3cm), GB 41 (1 to 2cm), UB60 (1 to 2cm)] Was De qi reportedly sought?: yes Duration (mins): 20 mins Method of stimulation: manual CONTROL GROUP A (sham, if used): Streitberger needle (“The format was exactly the same as those for real acupuncture (RA)”) N allocated to control group A: [29] (28 analyzed) Total length of treatment period: 4 weeks Number of sessions target (mean): 8 Times per week: 2 (If relevant) Number of points used: 6 (reported as mean in the article, but stated as minimum in Peter White’s email) (If relevant) Insertion depth: not applicable Was De qi sought?: not reported Duration (mins): 20 (If relevant) Method of stimulation: manual CONTROL GROUP B (sham, if used): mock electrical stimulation N allocated to control group B: [30] (30 analyzed) Total length of treatment period: 4 weeks Number of sessions target (mean): 8 Times per week: 2 (If relevant) Number of points used: 6 (reported as mean in the article, but stated as minimum in Peter White’s email) (If relevant) Insertion depth: not applicable Was De qi sought?: not applicable Duration (mins): 20 (If relevant) Method of stimulation: mock electrical stimulation was provided to acupoints via electrodes fixed to the surface of the participants' skin. Any cointerventions in all groups? Empathic or non‐empathic consultation (“Patients were first randomised to treatment type and consultation type, and then to specific practitioners.”) Participants were permitted to continue taking analgesia tablets. Acupuncturists’ experience: “Three qualified, experienced (range 3 to 10 years) practitioners were available and funded to provide treatments (physiotherapist, nurse, and licensed acupuncturist). They met frequently throughout the trial to ensure that treatments, including the acupoints used, and consultation types were as comparable and equivalent as possible.”
Outcomes	PAIN, FUNCTION, QUALITY OF LIFE, AND OVERALL INDEX OF SYMPTOM SEVERITY OUTCOMES EXTRACTED FROM PUBLICATIONS: MEASUREMENT TIME POINTS WOMAC pain, function, stiffness were not reported in publication, but information provided by Peter White, the trial’s principal investigator. [For the White 2012 RCT, Peter White provided both post‐treatment outcome scores and change from baseline outcome scores of WOMAC pain, function and stiffness, separately for the knee and hip participants.] Additional outcomes reported in the trial but not extracted: NA Nottingham Health Profile scores (quality of life) were not reported in the publication. The author only stated that "All scores for ... Nottingham Health Profile improved in all groups, with no significant differences between treatment or consultation types." Radiographic joint changes: not reported. Adverse effects: “Three adverse events were recorded, none of which were related to treatment. There were 28 cases of minor side effects (Table 7).” (page 458, section 3.4, Blinding)
Notes	Participants had severe OA, considering they were awaiting joint replacement surgery (for either hip or knee joint). Peter White provided following outcome data specific to patients with hip joint OA used for meta‐analysis (2012 June 20 e‐mail from Peter White to EM): WOMAC scores (range 0‐100 [PW confirmed to EM (2017 Sept 21 e‐mail) that range of WOMAC scales was 0‐100]): pre and post treatment, (sd) Pretreatment; Acupuncture; Streitberger Pain: 57.67 (17.63); 50.86 (15.63) Function: 57.95 (19.46); 55.49 (17.70) Post‐treatment; Acupuncture; Streitberger Pain: 48.83 (23.91); 43.50 (19.00) Function: 52.24 (22.63); 51.44 (17.80) WOMAC change in scores from pre to post treatment, (sd) NB a positive value here represents a fall in WOMAC score of that magnitude from Pre to post i.e. pre scores –post scores WOMAC changes; Acupuncture; Streitberger Pain: 8.84 (14.83); 7.56 (16.15) Function: 4.77 (12.03); 3.10 (14.23) Hip joint patients randomized to acupuncture vs. Streitberger: 30 vs. 29 Hip joint patients analyzed comparing acupuncture vs. Streitberger: 30 vs. 28 Source of support: "P.W. and this study were funded by a Department of Health Postdoctoral Research Award. C.S. was also funded by the same award. G.L.’s post is partially funded by the Rufford Maurice Laing Foundation. The Southampton Complementary Medicine Research Trust contributed funding for this trial. The funders played no role in study design, interpretation, or writing of this paper. All authors have no conflicts of interest to declare and no financial interests related to this study."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	(Information in square brackets below was provided by the first author White P’s email to Eric Manheimer on Jun 20, 2012) “After informed consent and 1‐week baseline pain recording, a 2‐stage randomisation occurred via an independent third party using a computer‐generated list. Patients were first randomised to treatment type and consultation type, and then to specific practitioners.” (page 456, section 2.1, Randomisation)
Allocation concealment (selection bias)	Low risk	“After informed consent and 1‐week baseline pain recording, a 2‐stage randomisation occurred via an independent third party using a computer‐generated list. Patients were first randomised to treatment type and consultation type, and then to specific practitioners.” (page 456, section 2.1, Randomisation) Comment: It seemed to be central randomizations, so the allocation concealment should be assured.
Blinding of participants and personnel (performance bias) All outcomes ‐ participants	Low risk	Sham 1 ‐ Streitberger needle: "The format was exactly the same as those for real acupuncture (RA), but using Streitberger needle (SN) nonpenetrating needles instead of RA needles. These work rather like a stage dagger, have been validated, and patients cannot distinguish them from RA needles." Sham 2 ‐ Mock electrical stimulation: "An electroacupuncture stimulator was used (NOMA Ltd., Southampton, UK) to provide mock transcutaneous electrical stimulation to acupoints via electrodes fixed to the surface of the patient’s skin. The cables were disconnected inside the output plug. All aspects of the intervention were exactly the same as with RA and SN, including time of treatment and checking on patients at regular intervals. This control has previously been well validated." “A high percentage of patients believed that their treatment had been real; 96% (RA), 93% (SN), and 75% (mock electrical stimulation), which suggests that blinding was successful. These differences between treatments were significant (X2 = 15.486, P = .001).” (page 457, section 3.4, Blinding) [For hip OA participants, the percentage of participants who believed that their treatment had been real were 93.3% (RA), 85.7% (SN), and 65.5% (mock electrical stimulation).] A statistical test was conducted and showed that there were no significant difference between RA and SN (P = 0.35), but a significant difference between RA and MES (P = 0.01). The percentage of participants who believed that their treatment had been real was similar between real acupuncture and Streitberger needle, but significantly different between real acupuncture and mock electrical stimulation, which suggested that the blinding between RA and SN was successful, but unclear between RA and SN.
Blinding of participants and personnel (performance bias) All outcomes ‐ personnel	High risk	Acupuncturists could not be blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Since the outcome assessments (WOMAC pain, function and total) were made by the participants themselves using questionnaires, we considered the sham acupuncture arm of this trial to have been both participant and outcomes assessor blinded.
Incomplete outcome data (attrition bias) Short term	Low risk	For hip OA, there was only 1 dropout in the Streitberger needle group, so the degree of 'missingness' would be unlikely to affect the estimate of the treatment effect in this trial. [For hip OA, numbers included in final analysis of the major outcome (pain) were 30/30, 28/29 and 30/30 for WOMAC.]
Selective reporting (reporting bias)	Low risk	[For each of the three treatment groups, WOMAC pain, function and stiffness post‐treatment means and standard deviations, as well as mean changes and standard deviations of changes from baseline, were provided by Peter White.] The result of quality of life (Nottingham Health Profile) score was not reported in the publication but the publication state that "All scores for Western Ontario and McMaster University Osteoarthritis Index and Nottingham Health Profile improved in all groups, with no significant differences between treatment or consultation types.” (page 457, section 3.3, Secondary outcomes) Adverse events and side effects during trial were reported. (page 458, section 3.4, Blinding and Table 7)
Other bias	Low risk	1. The three treatment groups were comparable at baseline in terms of baseline pain VAS, and WOMAC pain, function and stiffness scores, for hip and knee OA separately. There were no comparisons in terms of demographic characteristics reported. (low risk) 2.    Cointervention: empathic or non‐empathic consultation (“Patients were first randomised to treatment type and consultation type, and then to specific practitioners.”) Participants were permitted to continue taking analgesia tablet. (low risk) 3.    Compliance acceptable: Only the target number of treatment sessions, not the mean number of treatment sessions, received by participants was reported. [The mean number (SD) of treatment sessions received by participants with knee OA were 7.67 (0.82) for RA, 7.78 (0.76) for SN and 7.60 (1.11) for MES.] (low risk) 4.    Timing of the outcome assessment similar?: All three groups were assessed for the outcomes at the same time points. (low risk) 5.    Free of interaction?: “ANCOVA at week 5 showed no significant effect on immediate post‐treatment pain of the factors practitioner, treatment, and consultation type, and their first‐order interactions with all of the possible baseline confounders as covariates (age, sex, joint, previous knowledge of acupuncture, credibility, CARE score, and HCAMQ scores).” (low risk)