| Methods |
Blinding: diary evaluator
Dropouts/withdrawals: substantial bias unlikely (attrition only 10 of 160 participants in 6 months)
Observation period: baseline 2 months; treatment 6 months, no follow‐up
Acupuncturists' assessments: BB different/65% ‐ AW different/55% |
| Participants |
Number of participants included/analysed: 160/150
Condition: migraine without aura (IHS)
Demographics: mean age 38 years; all female
Setting: Women's Headache Center, University of Turin, Italy
Age at onset of headaches: mean 18 years |
| Interventions |
Acupuncture points: LR3, SP6, ST36, CV12, LI4, PC6, GB20, GB14, Taiyang, GV20
Information on acupuncturists; n = 3, "experienced and qualified"
DeChi achieved?: yes
Number of treatment sessions: 12
Frequency of treatment sessions: 1/week for 2 months, then 1/month for 4 months
Control intervention: flunarizine 10 mg (2 months daily, then 20 days per month for 4 months) |
| Outcomes |
Method for outcome measurement: headache diary
Primary outcome: attack frequency
Other outcomes: intensity, use of rescue medication |
| Notes |
Unblinded, but otherwise rigorous trial; additional information provided from author
The paper presents data on attack frequency and analgesics use for 2‐month intervals. For calculating mean differences in this review the means for attack frequency presented in the publication were divided by 2, as all other trials refer to 4‐week periods. The same was done with the standard deviations provided by the study author. For calculation of standardized mean differences we used the 2‐month means presented in the publication. We imputed frequency of response from baseline means and post‐treatment (months 3‐4) and follow‐up (months 5‐6) means and standard deviations |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer program |
| Allocation concealment (selection bias) |
Low risk |
Central telephone procedure (information from author) |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Participants not blinded; diary evaluation blinded |
| Incomplete outcome data (attrition bias)
All outcomes up to 3 month after randomisation |
Low risk |
Only 10 (3 acupuncture, 7 flunarizine) of 160 participants did not complete the study |
| Incomplete follow‐up outcome data (attrition bias)
All outcomes later than 3 months after randomisation |
Low risk |
Only 10 (3 acupuncture, 7 flunarizine) of 160 participants did not complete the study |
| Selective reporting (reporting bias) |
Low risk |
Relevant outcomes presented |
