| Methods |
Blinding: participants, statistician (information from author)
Dropout/withdrawals: no dropouts mentioned in the publication (first author remembers that there were a limited number of participants dropping out from the study, but he did not document the exact number)
Observation period: baseline unclear; treatment 10 weeks; follow‐up only in participants with good response
Acupuncturists' assessments: GA similarly/70% ‐ BB differently/45% |
| Participants |
Number of participants included/analysed: 30?/30
Condition: migraine without aura
Demographics: mean age 40 years; 9 female, 6 male in acupuncture group; 15 female in sham group
Setting: unclear, Italy
Time since onset of headaches: 179 +/‐ 127 months (control group: 226 +/‐ 140) |
| Interventions |
Acupuncture points: BL 2, BL10, BL 60, GB 3, GB 20, GV 11, GV 20, LR 3, CV 13 Ex HN1, ST 8 (on non‐painful side)
Information on acupuncturist: n = 1, trained 3 years
DeChi achieved?: no information
Number of treatment sessions: 10
Frequency of treatment sessions: 1/week
Control intervention: placebo acupuncture (complex procedure without real needling suggesting superficial anaesthesia to the patient) |
| Outcomes |
Method for outcome measurement: headache diary
Primary outcome: at least 50% score reduction
Other outcomes: headache hours, intensity |
| Notes |
Participants were not informed that they might get a placebo; unusual sham technique; sex differences between groups; no interpretable follow‐up data (only follow‐up of responders) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number table (information from author) |
| Allocation concealment (selection bias) |
Low risk |
Numbered envelopes, inclusion and random allocation by different persons (information from author) |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Participants were blinded. The sham procedures differed from true acupuncture but participants were not informed that they might get a placebo. |
| Incomplete outcome data (attrition bias)
All outcomes up to 3 month after randomisation |
Unclear risk |
No dropouts mentioned. The author reports on request that there were a few participants who did not complete the study. |
| Incomplete follow‐up outcome data (attrition bias)
All outcomes later than 3 months after randomisation |
Unclear risk |
Follow‐up only performed in treatment responders |
| Selective reporting (reporting bias) |
Low risk |
Relevant outcomes reported |
