| Methods |
Design: three group parallel trial
Purpose: examine the effect of acupuncture on major depression |
| Participants |
Patients: inpatients with depression (score > 17 on 21 item Hamilton depression scale)
Baseline comparability: yes for age and score on Hamilton depression scale; no for gender |
| Interventions |
Placebo: whole body needling in sites not regarded true acupuncture points for 30 minutes 3 times weekly for 4 weeks
Untreated: no acupuncture
Experimental: whole body acupuncture sessions
(Co‐intervention: mianserin at fixed doses; diazepam 'if required' but actual medication the first four weeks was roughly comparable between groups) |
| Outcomes |
Self‐rating scale (Bf‐S)
Global assessment scale (GAS)
Bech‐Rafaelsen melancholia Scale (BRMS)
Clinical global impressions scale (CGI)
Need of diazepam medication |
| Notes |
SD for GAS and Self‐rating scale not reported. Authors were contacted and provided the data. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/acupuncture) |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
SD for GAS and Self‐rating scale not reported. Authors were contacted and provided the data. |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
High risk |
N = 48 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
