Abstract: Objective To observer the efficacy of acupuncture on chronic tension-type headache. Methods Patients with chronic tension-type headache from acupuncture department of Beijing hospital of traditional Chinese medicine were randomized into treatment or control groups according to random number table. Totally 50 patients(27 in treatment group, 23 in control group) completed treatment and 46 patients were interviewed. Patients in treatment group received Verum acupuncture, while those in control group received sham acupuncture (needling on non-acu-puncture points) and took estazolam 0.5 mg per night before going to bed. The medicine was taken for four weeks. Acupuncture and sham acupuncture consisted of 12 sessions and were administered by senior acupuncturists over 4 weeks. All patients were interviewed at the 16th week after randomization. Results After treatment and interview, the proportion of responders, defined as the headache day per month reduced more than 50% compared with that before treatment, in verum acupuncture is higher than that of sham acupuncture plus medicine by per-protocol analysis(P<0.05). The number of headache days and headache hours in the treatment group decreased more than that in control group(P<0.05). Compared with that of patients in control group, the scores of social functioning and general health, two fields of The Medical Outcomes Study 36 Item Short Form Health Survey(Chinese version), were higher in the treatment group(P<0.05). Other outcomes were not found significantly different between groups. Conclusion The acupuncture intervention is effective and safe without serious side-effects in treatment of chronic tension-type headache. This trial witnessed that acupuncture is more effective than sham acupuncture plus medication.

Key words: chronic tension-type headache, acupuncture, estazolam, randomized controlled trial