Oct. 24, 2005 — Acupuncture may be helpful for chronic daily headache (CDH), according to the results of a randomized trial published in the October issue of Headache.

"Approximately 4% of adults experience headaches nearly every day," write Remy R. Coeytaux, MD, PhD, from the University of North Carolina at Chapel Hill, and colleagues. "Nonpharmacologic interventions for frequent headaches may be appropriate because medical management alone is often ineffective."

In 74 patients with CDH, the investigators compared medical management provided by neurologists to medical management plus 10 acupuncture treatments. The main endpoints were daily pain severity and headache-related quality of life (QoL).

Patients who received only medical management did not show improvement in any of the standardized measures. Although daily pain severity scores trended downward, they were not different between treatment groups (P = .60). Compared with medical management only, medical management plus acupuncture was associated with an improvement of 3.0 points (95% confidence interval [CI], 1.0 - 4.9) on the Headache Impact Test (HIT) and an increase of at least 8 points on the role limitations caused by physical problems, social functioning, and general mental health domains of the Short Form 36 Health Survey (SF-36). Patients in the acupuncture group were 3.7 times more likely (95% CI, 1.7 - 8.1) to report less pain from headaches at six weeks (absolute risk reduction, 46%; number needed to treat, 2).

"Headache-specialty medical management alone was not associated with improved clinical outcomes among our study population," the authors write. "Supplementing medical management with acupuncture, however, resulted in improvements in health-related QoL and the perception by patients that they suffered less from headaches."

Study limitations include unblinded study design, use of subjective outcomes introducing potential bias, failure to isolate acupuncture as the single causal variable, lack of a sham control, bias inherent in the study design, and inability to evaluate the efficacy of medical care provided by the three study neurologists.

"Additional research is needed to elucidate the extent to which placebo effects associated with acupuncture contribute to clinical benefit, to identify clinical characteristics that predict favorable response to acupuncture, to explore which acupuncture traditions and protocols are most effective for treating the various causes and manifestations of CDH, and to determine whether acupuncture is a cost-effective approach to the treatment of frequent headaches," the authors write.

The National Institutes of Health have disclosed that they funded this study, and the Verne S. Caviness General Clinical Research Center at University of North Carolina School of Medicine also disclosed that they supported it. The Robert Wood Johnson Clinical Scholars Program have disclosed that they supported Dr. Coeytaux during the design phase of the study.

Headache. 2005;45:1113-1123

Clinical Context

Study Highlights

• Inclusion criteria were headache 15 or more times in the previous month, older than 18 years, and English proficiency.
• Exclusion criteria were intracranial surgery, head or neck surgery, or treatment with acupuncture within 6 weeks.
• Patients were paid $80 for completion of headache diaries and follow-up assessments.
• 39 patients were randomized to usual care by the treating neurologist and 35 to usual care and 10 sessions of acupuncture by one provider.
• There was no sham acupuncture group. Patient expectations of acupuncture was not described.
• At baseline health-related QoL was assessed by the HIT using a 6-item questionnaire to assess headache burden from the patient perspective in the past month.
• Health status was also measured using the SF-36, a scale for pain severity from 0 to 10, with 10 being the most severe; and the Beck Depression Inventory (BDI).
• Primary outcomes were change in HIT scores from baseline to the 6-week follow-up visit and daily ratings of pain severity during the 6-week intervention period.
• Patients completed the HIT and BDI at 6 and 12 weeks.
• Adverse effects of acupuncture were elicited from patients.
• Acupuncture was delivered by an experienced physician and acupuncturist trained in Traditional Chinese Medicine (TCM) in the People's Republic of China and who was a diplomate of the National Certification Commission for Acupuncture and Oriental Medicine.
• The acupuncturist interviewed and examined each patient prior to randomization.
• The acupuncturist needled points according to TCM pattern diagnoses and tender points at or near the site of maximal headache pain when indicated for a maximum of 30 needles left in place for up to 30 minutes.
• A total of 10 acupuncture sessions was delivered for 6 weeks.
• Mean age was 44 to 47 years, 77% to 85% were female. 50% were employed full-time, and most had migraine-type headache.
• Average duration of CDH was 1 to 5 years, with more than 80% experiencing near daily headache for at least one year.
• Daily pain severity scores tended downwards for 6 weeks and was not different between the 2 groups.
• Usual medical care plus acupuncture was associated with a 3-point decrease in HIT score for 6 weeks vs usual medical care.
• Medical care plus acupuncture was associated with an improvement of 8 or more points in the role limitations due to physical, social, and general mental health domains of the SF-36, and a decrease of 3.5 points in the BDI relative to usual medical care only.
• At the 12-week follow-up, the acupuncture group experienced an improvement of 7 or more points for the role limitations in the SF-36 due to physical problems, vitality, and social functioning.
• Patients who did not receive acupuncture did not demonstrate improvements in the SF-36 or other outcomes at the 6- or 12-week follow-up.
• In the acupuncture group, 62% reported having less pain from headaches at 6 weeks vs 16% in the usual care group ( P < .001), corresponding to an absolute risk reduction of 46% and number needed to treat of 2.
• Adverse events related to acupuncture were reported in 34 (97%) of 35 patients in the acupuncture group. These included headaches, neck soreness, and difficulty sleeping.

Pearls for Practice

• CDH is a clinical syndrome characterized by the occurrence of headache 15 or more days per month and may include any headache type.
• The use of 10 sessions of acupuncture as an adjunct to usual care is associated with improvements in perceived pain, BDI score, and physical and social functioning in patients with CDH.

CME Test