Clinical trials in tensiontype headache

Acute treatment of tension-type headache has been investigated in episodic tension-type headache, and in prophylactic treatment of chronic tension-type headache, antidepressant drugs and botulinum toxin have been investigated.

Aspirin and paracetamol are the analgesics used most commonly in the treatment of acute tensiontype headache [76]. In the most recent RCT, 452 patients treated episodes of tension-type headache with aspirin (500 mg or 1000 mg), paracetamol (500 mg or 1000 mg) or placebo. Headache relief after 2 hours was 76% after aspirin 1000 mg and 71% after paracetamol 1000 mg. Both were superior to placebo despite a high placebo response of 55%. The following NSAID were superior to placebo in RCT on the treatment of acute tension-type headache: ibupro-fen [77], ketoprofen [78, 112] naproxen [79, 80] and diclofenac [81]. Caffeine has long been used as an analgesic adjuvant [76]. In a RCT the combination of aspirin and caffeine was superior to paracetamol and placebo [77]; in another RCT, the combination of caffeine and ibuprofen was superior to ibuprofen and placebo [113]. The combination of caffeine, aspirin and paracetamol was more effective than the single substances in one large RCT.

Antidepressants are the drugs most commonly used in chronic tension-type headache [82]. Amitriptyline was superior to placebo in most RCT [82-86] but in the largest RCT there was no effect of amitriptyline and amitriptylinoxide [87]. Mirtazapine 15-30 mg daily was superior to placebo in one RCT [88] whereas the the selective serotonin reuptake inhibitor (SSRI) citalopram was not more effective than placebo [86].

After positive open studies, botulinum toxin has been studied in chronic tension-type headache but the conclusion of these RCT is that botulinum toxin is not more effective than placebo [89].Thus in the most recent large RCT including 298 randomized patients, botulinum toxin A admistered in doses from 50 U to 150 U was not different from placebo [90].

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