Forty-eight patients were entered into a placebo (mock TNS) versus acupuncture study to assess the effect of these therapies on headache. Treatment was evaluated by the use of patient diaries; each patient completed a daily diary for 4 weeks prior to treatment during 6 weeks of therapy and for 24 weeks of follow-up. Thirty-nine patients completed treatment and follow-up. At most acupuncture appears to be approximately 20% more effective than a placebo in alleviating headache but no statistically significant difference between these two treatments could be demonstrated. The implications of this result particularly with respect to determining treatment success and study method employed are discussed.