| Methods |
Design: three group parallel trial
Purpose: examine the effect of acupuncture in patients with osteoarthritis |
| Participants |
Patients: patients with symptomatic osteoarthritis of the knee
Baseline comparability: yes (age, gender, pain duration) |
| Interventions |
Placebo: acupuncture on sites not regarded acupuncture sites
Untreated: no acupuncture
Experimental: acupuncture on sites regarded acupuncture sites
(Co‐intervention: standard medical care (physiotherapy and NSAIDs)). |
| Outcomes |
Success rate (at least 36% change from baseline WOMAC scores)
WOMAC (Western Ontario and McMaster Universities osteoarthritis) index
Physical and mental health (SF‐36)
Global patient assessment |
| Notes |
Patients in the no‐treatment group took more medication, and received more sessions of physiotherapy (median 10) than the other groups (median 6). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'block randomization with block size of 6, stratified by center, was computer‐generated by an independent statistician’ |
| Allocation concealment? |
Low risk |
'Centralised telephone procedure' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/acupressure) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Low risk |
Primary outcome specified in protocol |
| Free of other bias? |
Unclear risk |
See notes |
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
Low risk |
N = 681 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three criteria fulfilled |
