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

Disclosures

Headache. 2008;48(3):398-407. 

In This Article

Abstract and Introduction

Abstract

Objective: To check the effectiveness of a true acupuncture treatment according to traditional Chinese medicine (TCM) in migraine without aura, comparing it to a standard mock acupuncture protocol, an accurate mock acupuncture healing ritual, and untreated controls.
Background: Migraine prevalence is high and affects a relevant rate of adults in the productive phase of their life.Acupuncture has been increasingly advocated and used in Western countries for migraine treatment, but the evidence of its effectiveness still remains weak. A large variability of treatments is present in published studies and no acupoint selection according to TCM has been investigated so far; therefore, the low level of evidence of acupuncture effectiveness might partly depend on inappropriate treatment.
Design and Methods: A prospective, randomized, controlled study was performed in 160 patients suffering from migraine without aura, assessed according to the ICD-10 classification. The patients were divided into the following 4 groups:(1) group TA, treated with true acupuncture (according to TCM) 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). The MIDAS Questionnaire was administered before treatment (T0), at 3 (T1) and 6 months (T2) from the beginning of treatment, and the MIDAS Index (MI) was calculated. Rizatriptan intake was also checked in all groups of patients at T0, T1, and T2. Group TA and RMA were evaluated according to TCM as well; then, the former was submitted to true acupuncture and the latter to mock acupuncture treatment resembling the same as TA. The statistical analysis was conducted with factorial ANOVA and multiple tests with a Bonferroni adjustment.
Results: A total of 127 patients completed the study (33 dropouts): 32 belonged to group TA, 30 to group RMA, 31 to group SMA, and 34 to group R. Before treatment the MI (T0) was moderate to severe with no significant intergroup differences. All groups underwent a decrease of MI at T1 and T2, with a significant group difference at both T1 and T2 compared to T0 (P < .0001). Only TA provided a significant improvement at both T1 and T2 compared to R (P < .0001). RMA underwent a transient improvement of MI at T1. The Rizatriptan intake paralleled the MI in all groups.
Conclusions: TA was the only treatment able to provide a steady outcome improvement in comparison to the use of only Rizatriptan, while RMA showed a transient placebo effect at T1.

Introduction

Migraine prevalence is high and affects a high rate of adults in the productive phase of their life, causing significant disability and loss of daily activities, with relevant social and economic costs.[1–4] Furthermore, the majority of patients suffering from migraine report tension-type symptoms.[5–8] Despite the continuous progress in diagnosis and pharmacologic treatment of migraine, the outcome is still below the expectations: as a result, acupuncture and other non pharmacologic treatments have been increasingly advocated and used in western countries. In 1998 the NIH stated that acupuncture could be a useful adjunct treatment or an acceptable alternative in several disturbances, including headache,[9] while a recent study reported that some 12% of patients attending a neurology outpatient clinic had already tried acupuncture and 73% would be willing to do it.[10]

A growing number of systematic reviews indicates the potential value of acupuncture for the prevention of migraine,[11–15] but evidence still remains weak: the main source for weakness seems to be the large variability of study designs, preventing an accurate data analysis, thus leading the Cochrane review to conclude that there is an urgent need for well-planned, large-scale studies.

Recently, 3 studies with these features have been published,[16–18] 2 of them conclude that acupuncture provides persisting, relevant clinical benefits and health-related quality of life at a small additional cost, suggesting that an increase of acupuncture services in UK should be considered. The third study reports some effectiveness of both true and sham acupuncture at short-term follow-up (12 weeks), when compared to waiting list controls, but no difference between true and sham acupuncture; this gives rise to some concern about the specificity of acupoint selection, at least at a short-term outcome.

Acupuncture involves several specific problems related to research methods, including the problem of placebo (sham acupuncture is far from being a real placebo) and appropriate acupoint selection (see[19] as a review). As far as migraine is concerned, none of the published reviews properly addresses the problem of acupoint selection,[19,20] apart from the Cochrane review. A large variability of treatments was present in the studies quoted in the published systematic reviews, most of which seemed inappropriate according to traditional Chinese medicine (TCM).[20] As the acupoint selection is often skipped, the low level of evidence of acupuncture effectiveness might partly depend on inappropriate treatment,which might have a key role for efficacy (likewise the use of different drugs in Western medicine).

The aim of this controlled study is to check the effectiveness of a true acupuncture treatment according to TCM in migraine without aura, comparing it to a standard mock acupuncture protocol, an accurate mock acupuncture healing ritual, and untreated controls.

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