The journal of headache and pain
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Randomized Controlled Trial
No effect of pure oxygen inhalation on headache induced by glyceryl trinitrate.
Inhalation of hyperbaric oxygen has been used as an experimental treatment for migraine and pure oxygen is an established treatment for cluster headache. Intravenous glyceryl trinitrate (GTN) is an established headache model. In the present study the possibility of decreasing the headache by inhalation of pure oxygen was explored in a double-blind crossover design in 18 healthy subjects. ⋯ Sixteen of 18 (89%) subjects experienced GTN-induced headache after O(2)-inhalation and 17/18 (94%) experienced GTN-induced headache after air. The mean peak headache scores were 1.9 and 2.4, respectively, on a numerical scale of 0-10. Oxygen inhalation did not have effect on GTN-induced headache, most likely because the theoretical decrease in NO levels, due to faster metabolism of NO, is too small to be detected in the GTN headache model.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Safety and efficacy of deep brain stimulation in refractory cluster headache: a randomized placebo-controlled double-blind trial followed by a 1-year open extension.
Chronic cluster headache (CCH) is a disabling primary headache, considering the severity and frequency of pain attacks. Deep brain stimulation (DBS) has been used to treat severe refractory CCH, but assessment of its efficacy has been limited to open studies. We performed a prospective crossover, double-blind, multicenter study assessing the efficacy and safety of unilateral hypothalamic DBS in 11 patients with severe refractory CCH. ⋯ No significant change in hormonal functions or electrolytic balance was observed. Randomized phase findings of this study did not support the efficacy of DBS in refractory CCH, but open phase findings suggested long-term efficacy in more than 50% patients, confirming previous data, without high morbidity. Discrepancy between these findings justifies additional controlled studies (clinicaltrials.gov number NCT00662935).
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Randomized Controlled Trial
Tolerability and efficacy of a combination of paracetamol and caffeine in the treatment of tension-type headache: a randomised, double-blind, double-dummy, cross-over study versus placebo and naproxen sodium.
The main aim of this study was to confirm in an Italian population affected by tension-type headache (TTH) the good profile of safety and tolerability of the combination paracetamol 1,000 mg-caffeine 130 mg (PCF) observed in previous studies, by a comparison with naproxen sodium 550 mg (NAP) and placebo (PLA). A secondary objective was to assess the efficacy of PCF in the acute treatment of TTH. This was a multicentre, randomised, double-blind, double-dummy, crossover, placebo-controlled trial. ⋯ Comparing PCF and NAP and PCF and PLA for tolerability, the difference was nonsignificant but the result regarding noninferiority was inconclusive, whilst NAP was noninferior to PLA. As regards SPID and TOTPAR, both PCF and NAP were better than placebo (P < 0.05), but not significantly different from each other. In conclusion, PCF was well-tolerated and effective in the treatment of acute TTH.
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Randomized Controlled Trial Multicenter Study
Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial.
Acupuncture treatment is frequently sought for tension-type headache (TTH), but there is conflicting evidence as to its effectiveness. This randomised, controlled, multicentre, patient-and observer-blinded trial was carried out in 122 outpatient practices in Germany on 409 patients with TTH, defined as > or =10 headache days per month of which < or =1 included migraine symptoms. Interventions were verum acupuncture according to the practice of traditional Chinese medicine or sham acupuncture consisting of superficial needling at nonacupuncture points. ⋯ The relative risk on the primary and secondary response criterion was very similar ( approximately 0.8); the difference in statistical significance may be due to differences in event rate. TTH improves after acupuncture treatment. However, the degree to which treatment benefits depend on psychological compared to physiological effects and the degree to which any physiological effects depend on needle placement and insertion depth are unclear.
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Randomized Controlled Trial Comparative Study
Rizatriptan vs. ibuprofen in migraine: a randomised placebo-controlled trial.
The objective of this study was to compare the efficacy of rizatriptan and ibuprofen in migraine. The study was a randomised placebo-controlled trial in a tertiary care teaching hospital. Migraine patients with <8 attacks/months were included. ⋯ Side effects were noted in 9 patients in rizatriptan, 8 in ibuprofen and 3 in placebo, all of which were nonsignificant. Rizatriptan and ibuprofen are superior to placebo. Rizatriptan is superior to ibuprofen in relieving headache, associated symptoms and functional disability.