| Methods |
Design: three group parallel trial
Purpose: examine the effect of acupuncture for osteoarthritis of the knee |
| Participants |
Patients: patients with symptomatic osteoarthritis of the knee
Baseline comparability: yes (WOMAC score) |
| Interventions |
Placebo: acupuncture on sites not regarded acupuncture sites
Untreated: no acupuncture
Experimental: acupuncture on sites regarded acupuncture sites
(Co‐intervention: standard medical care. All patients were allowed to take non‐steroid anti‐inflammatory drugs if necessary) |
| Outcomes |
WOMAC (Western Ontario and McMaster Universities osteoarthritis) index
Disability (Pain disability index)
Physical and mental health (SF‐36)
Pain (questionnaire for assessing the emotional aspects of pain)
Depression (ADS depression scale)
Days with limited function
Days in pain (patient diary)
Days with medication in weeks 5‐8 (patient diary) |
| Notes |
Patients in the no‐treatment group took medication on 5.8 days whereas the placebo group did so on 4.6 days (weeks 5 to 8). SE values were provided in the original publication and these values were converted to SD for analysis in the review. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
‘random list generated with Samp Size 2.0’ |
| Allocation concealment? |
Low risk |
'centralised telephone randomisation procedure' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/acupuncture) |
| 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 |
Patients in the no‐treatment group took medication on 5.6 days whereas the placebo group did so on 4.6 days (weeks 5 to 8). |
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 140 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three categories fulfilled |
