Background: There is a great deal of controversy in the acupuncture research community regarding whether clinical trials should use individualized treatment protocols, or whether they should use 'formulaic' protocols in which the treatment protocol (e.g., selection of acupuncture points to be needled) are pre-determined. Proponents of individualized treatments argue that the acupuncture diagnoses and appropriate treatments may differ between individuals with the sameWestern diagnosis, while proponents of formulaic treatments argue that clinical trials need to be designed in such a way as to be standardized and replicable.

Objectives: To compare and contrast International Headache Society (IHS) and TCM diagnoses among patients with headache in order to determine whether it is appropriate to use formulaic treatment plans in clinical trials among this patient population. Study Population: Patients with frequent headaches recruited from a university-based headache specialty clinic.

Research Methods: All patients seen in the UNC Headache Clinic over a four-month period were sent an invitation by mail to participate in a clinical trial designed to assess the efficacy of acupuncture as an adjunct to medical care in the treatment of chronic daily headache. Fifty-one patients who met initial eligibility criteria (which included the presence of headache 15 days or more in the past month) were enrolled in the clinical trial. Each of these patients had had their headache syndromes diagnosed according to the IHS classification system by a neurologist. The baseline assessment at the time of enrollment in the clinical trial included a clinical evaluation by a physician and licensed acupuncturist who trained in both Western and traditional Chinese medicine in China. This investigator, who was masked to patients' IHS diagnoses, ascribed one or more TCM diagnoses to each subject. The acupuncture treatments subsequently administered as part of the clinical trial were based on these TCM diagnoses, with some individual variation as indicated.

Results: There were a total of 57 IHS diagnoses and 122 TCM diagnoses ascribed to the 51 patients. Thirty-seven (73%) patients were diagnosed as having migraine, 4 (8%) had tension-type headache, and 16 (31%) carried at least one other IHS diagnosis. Twenty-four (47%) were diagnoses with liver yang rising, 21 (41%) with blood stasis, 19 (37%) with wetness, 16 (31%) with spleen/blood deficiency, 9 (18%) with kidney deficiency, 9 (18%) with heat, 5 (10%) with phlegm, 5 (10%) with wind, 2 (4%) with cold, and 2 (4%) with qi stasis. Among the 37 patients who carried a migraine diagnosis, 20 (54%) were diagnosed with liver yang rising, 17 (46%) had blood stasis, 12 (33%) had wetness, and 10 (27%) had spleen/blood deficiency. Of the 24 patients diagnosed with liver yang rising, 20 (83%) had migraine and none had tension-type headache.

Conclusions: IHS and TCM classification systems for headache disorders appear to be largely independent of each other. With the exception of the TCM diagnosis of liver yang rising, in which group the majority of patients had migraine and none had tension-type headache, there is no clear overlap between the two systems. There appears to be too many TCM diagnoses associated with headache syndromes to permit a single, formulaic set of acupuncture points to be used for all patients who carry a diagnosis of migraine. These findings suggest that clinical trials that include TCM therapeutic modalities should include both Western and TCM diagnoses. Western diagnoses are needed to communicate with Western audiences, and TCM diagnoses are needed to formulate appropriate clinical interventions. Data that pertain to differences in outcomes based on these two different classification systems will be collected and analyzed as part of this ongoing clinical trial. These data, which will be available in December, 2003, may help further inform the discussion of whether individualized or formulaic protocols are most appropriate for clinical trials among headache patients and, perhaps, among other populations defined by Western diagnoses

A comparison of western and traditional Chinese medicine diagnoses among patients with headache