Traditional Acupuncture in Migraine: A Controlled, Randomized Study

Enrico Facco, MD; Aldo Liguori, MD; Filomena Petti, MD; Gastone Zanette, MD; Flaminia Coluzzi, MD; Marco De Nardin, MD; Consalvo Mattia, MD


Headache. 2008;48(3):398-407. 

In This Article

Materials and Methods

A total of 160 patients affected by migraine without aura, with or without tension-type symptoms, were enrolled in the study; the frequency of migraine attacks was 3–8 per month and all the patients had previously received at least one prophylactic treatment for migraine with no improvement.

The diagnosis was performed according to the ICD-10 guide for headaches.[21] The exclusion criteria were: (1) onset of headache or acupuncture treatment less than 1-year before; (2) headache caused by other diseases.

All the patients were allowed to take Rizatriptan to treat the attacks, during the prophylactic treatment with acupuncture or placebo. Rizatriptan wafer was administered at a dose of 10 mg; a second dose was allowed after 2 hours if pain persisted.

The patients were stratified for sex and randomly divided into the following 4 groups of 40 patients each,using the random number generator in Microsoft Excel: (1) group TA, treated with true acupuncture plus Rizatriptan; (2) group RMA, treated with ritualized mock acupuncture plus Rizatriptan; (3) group SMA, treated with standard mock acupuncture plus Rizatriptan; (4) group R, without prophylactic treatment with relief therapy only (Rizatriptan).

All the patients were required to fill in the Italian version of the MIDAS Questionnaire[22] for evaluating disability before treatment (T0), at 3 (T1) and 6 months (T2) from the beginning of treatment; then, the MIDAS Index (MI) was calculated.The total number of Rizatriptan wafers taken in each 90-day period (T1 and T2) was recorded as well. A per-protocol analysis of results was conducted by the first author, who was not involved in the patients' treatment.

Acupuncture Treatment.—Since the Western picture of migraine does not clash with TCM classification of headache, all the patients were clinically evaluated according to the TCM syndrome differentiation and classified into the following, so called, internal or external syndromes:[23–26] (1) exogenous wind-cold attack; (2) exogenous wind-heat attack; (3) exogenous wind-dampness attack; (4) excess of liver yang; (5) obstruction of the middle jiao due to damp-phlegm; (6) deficiency of kidney essence; (7) stagnation of Qi and blood. Each type of syndrome was treated with a specific acupoint selection according to TCM ( Table 1 ), as suggested by Liu Gongwan (Tianjin College of Traditional Chinese Medicine, personal communication); the acupoints were defined according to the WHO standard acupuncture nomenclature.

Twice a week, all the patients were submitted to 2 courses of 10 acupuncture applications each, with a 1-week rest between the 2 courses. Acupuncture was performed with single-use stainless steel filiform needles (according to Chinese manufacturing standards), 25 or 40 mm long and with a Ø of 0.30 mm.

In group TA, after the needle insertion and arrival of Qi, the required method of treatment was applied to each acupoint: the reducing method consisted of a 1 minute stimulation of the needle, obtained with a large rotation (amplitude >360°) at a rate of about 3 rotations/second. The reinforcing method was performed with a small rotation (amplitude >360°) for 1-minute at a rate of about one every 2 seconds. Stimulation was repeated 3 times at intervals of 5 minutes. The session lasted 30 minutes.

In patients belonging to group RMA, the acupuncture was apparently the same as in group TA, but the needles were not inserted. A small cylinder of foam (height and Ø = 1 cm) was applied to the skin by means of a double-adhesive plaster on each acupoint; then, needles with blunted tips were inserted into the cylinder, touching but not penetrating the skin. This allowed the patient to feel a superficial, light pricking-like sensation, thus simulating the needle insertion. A slight pressure was applied on the needle handle 3 times at 3 seconds intervals, in order to simulate the “arrival of Qi.” The reducing or reinforcing methods were also simulated by rotating the needles within the foam cylinder. The protocol for diagnosis as well as acupoint selection according to TCM syndromes was the same as group TA, in order to check possible placebo effects related to the use of the TCM approach.

In patients belonging to group SMA only the Western approach was used for diagnosis and the following standard acupoint selection was used, with the same method of insertion used in group RMA: Touwei (ST8), Xuanlu (GB5), Fengchi (GB20), Dazhui (GV14), Lieque (LU7).

The statistical analysis was conducted by means of factorial ANOVA with groups and time (4 levels and 3 points) and multiple test with Bonferroni adjustment, for a significance level of P < .05, using program R ( Since we did not know what effect size could be expected from the approach to TCM, we did not estimate the sample size based on a power calculation: enrolling 160 patients would have provided at least 30 patients in each group, taking into account possible dropouts.


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