Hesse 1994.
| Methods | Blinding: participants and evaluators Dropouts/withdrawals: bias unlikely (8 of 85 participants dropped out) Observation period: baseline 4 weeks; treatment 17 weeks; no follow‐up Acupuncturists' assessments: GA completely differently/50% ‐ BB different /30% | |
| Participants | Number of participants included/analysed: 85/77 Condition: migraine with or without aura (IHS) Demographics: mean age 45 years; 84% female Setting: outpatient pain clinic in Denmark Time since onset of headaches: mean 23 years | |
| Interventions | Acupuncture points: needling individual trigger points together with placebo tablets Information on acupuncturist: n = 1, no further information DeChi achieved?: no information Number of treatment sessions: individualized Duration of treatment sessions: needling for a few seconds only Control intervention: beta blocker metoprolol 100 mg and placebo stimulation (superficial touch with blunt end of the needle) | |
| Outcomes | Method for outcome measurement: diary Primary outcome: probably attack frequency Other outcomes: severity, duration, global rating, consumption of analgesics | |
| Notes | Rigorous trial; sham acupuncture procedure possibly distinguishable; non‐traditional acupuncture technique (brief needling at trigger points); mean frequency and mean severity of attacks in the last 4 weeks were recalculated from raw data in Figure 1 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No description |
| Allocation concealment (selection bias) | Unclear risk | No description |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | "Blinding was obtained through a double‐dummy technique and by keeping the therapist blinded to the results, whilst both investigator and statistician were blinded to the treatment". Dry needling of individual trigger point was used in the acupuncture group compared to a superficial touch with the blunt end of the needle in the medication/sham acupuncture group at a random selection of points. The success of blinding is not discussed. The way of informing participants about interventions is not reported. No details on the drug placebo reported |
| Incomplete outcome data (attrition bias) All outcomes up to 3 month after randomisation | Low risk | 8 of 85 participants dropped out. Analysis according to intention‐to‐treat principle. |
| Incomplete follow‐up outcome data (attrition bias) All outcomes later than 3 months after randomisation | Unclear risk | Probably rigorous trial with data presented in a manner not feasible for effect size calculation. Authors could not be contacted. Trial ended 17 weeks after randomisation. |
| Selective reporting (reporting bias) | Low risk | Relevant outcomes reported |