| Methods |
Design: three group parallel trial
Purpose: study the effect of acupuncture on migraine |
| Participants |
Patients: out‐patients with migraine headache
Baseline comparability: yes |
| Interventions |
Placebo: needling at places not regarded true acupuncture sites
Untreated: no needling
Experimental: needling at places regarded true acupuncture sites
(Co‐intervention: standard headache treatment according to the guideline of the German Migraine and Headache Society) |
| Outcomes |
Number of headache days of moderate or severe intensity until week 9‐12
Number of migraine headaches
Total number of headache days
Proportion of treatment responders
Number of days with medication
Pain disability index
Scale for assessing the emotional aspects of pain
Algemeine Depressionskalla
SF‐36 |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'random list generated with Sample Size 2.0' |
| Allocation concealment? |
Low risk |
'centralized telephone randomization 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? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
Low risk |
N = 157 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three categories fulfilled |
