A Cochrane review [Abstract] 1 included 11 small RCTs with 209 patients with migraine comparing HBOT vs. sham therapy. Five trials (103 participants) compared HBOT versus sham therapy for acute migraine, two trials evaluated HBOT for cluster headache (29 participants). The risk of bias varied considerably across these trials but in general trial quality was poor to moderate. Data was pooled from three trials, which suggested that HBOT was effective in relieving migraine headaches compared to sham therapy (risk ratio (RR) 6.21, 95% CI 2.41 to 16.00; 58 participants, three trials). The quality of evidence was low. There was no evidence that HBOT could prevent migraine episodes, reduce the incidence of nausea and vomiting, or reduce the requirement for rescue medication. There was no evidence that HBOT was effective for the termination of cluster headache (RR 11.38, 95% CI 0.77 to 167.85; P = 0.08) (one trial), but this trial had low power. No serious adverse effects of HBOT were reported in any of the trials.
Comment: The quality of evidence is downgraded by study quality (inadequate allocation concealment), and imprecise results (few patients and wide confidence intervals).
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