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

Discussion

Headache is a major public health problem, due to its high prevalence. Despite the great progress in pharmacologic treatment, many patients do not achieve optimal control, or do so only at the expense of unacceptable side-effects. As a result, an increasing use of behavioral as well as non-conventional therapies has occurred in the past 2 decades: acupuncture has been reported to be used by 19% of patients and is perceived as the most effective non-conventional treatment.[27] Similar data have been reported in migraine,[10] where about 12% of patients attending a neurology outpatient clinic reported that they had already tried acupuncture and 73% would be willing to try it. A recent review provides the rationale for traditional acupuncture indication in headache.[28]

Triptans have proved to be very effective drugs in the treatment of migraine attacks and have shown a class I evidence for effectiveness. Among triptans, Rizatriptan, a selective agonist of the 5-HT (1B/1D) receptors, has proved to be effective and well tolerated.[29] Rizatriptan has also been reported to improve the cost-effectiveness ratio, by decreasing migraine-related loss of work productivity.[30] Furthermore, Rizatriptan has been reported to be effective in migraine with tension-type symptoms as well.[7]

The MIDAS Questionnaire is the most extensively studied method for the assessment of headache-related disability[31–35] and has been validated in Italian patients.[22] The MIDAS score can reliably assess the impact of migraine and its changes may serve as an end point in assessing treatment efficacy.[36]

Given its proven mechanisms in analgesia,[28,37,38] acupuncture might provide long-lasting relief in headache with a substantial lack of side effects. The wealth of available data strongly support the value of acupuncture for the prevention of headache,[11–15] but evidence still remains weak; a major source of weakness seems to be the bias introduced by variability of study designs and acupoint selection.

As far as acupoint selection is concerned, it is so variable in the published studies, as to prevent any evaluation of effectiveness.[19,20] Sometimes the authors do not even mention the acupoints they have chosen,[17,18] or only partially report them.[16] The problem of acupoint selection has been skipped in the mentioned systematic reviews, apart from the Cochrane review,[15] where one of the authors (G.Allais) checked the quality of acupuncture: he would have treated only 13 out of 26 studies (50%) in the same or in a similar way and 5 (19%) differently, while no judgment about acupuncture quality was possible with the remaining 8 (31%). Therefore, the appropriateness of acupoint selection remains an essential step for its validation: the studies providing no information on acupoint selection may keep their value in checking overall acupuncture effectiveness (given its correct application), but can say nothing about the quality of treatment.

The aim of this study was to check the effects of traditional acupuncture in migraine, trying to provide reliable information on acupoint selection. This led us to face the TCM classification of syndromes, evaluating patients with both western medicine and TCM and selecting acupoints accordingly. It may seem inappropriate to discuss about TCM in a Western journal, however, we do believe that one cannot but face the paradigm of TCM and try to apply it in the process of acupuncture validation or falsification (in the epistemological sense of this term). To our knowledge, such an effort has never been made so far in Western journals.

As far as the TCM classification of headache is concerned, it is much less standardized than the Western one; furthermore, several symptoms other than pain are taken into account, while the features of pain are not well defined and quantified, as in the DC10 classification. As a result, some variability in symptoms and treatment can be found in different TCM texts:[23–26] in the attempt to find an effective treatment with a limited number of acupoints, we adopted the selection advised by Liu Gongwan (Tianjin College of Traditional Chinese Medicine, personal communication). Among TCM syndromes, the so-called “excess of Liver yang” and “deficiency of Kidney essence” seem to be the ones closer to Western migraine, since they imply throbbing pain, vomiting, and/or worsening with physical activity.[26] These 2 syndromes were found in nearly 50% of cases in our series, while the remaining ones probably reflected the coexistence of migraine and tension-type symptoms, indicating different acupuncture treatments.

In order to tell the difference between acupuncture and placebo effects, we compared true acupuncture to 3 different treatments: no acupuncture, standard mock acupuncture, and a ritualized mock acupuncture. The latter meant treating the patient according to TCM, exactly the same procedure used for true acupuncture. It enabled us to check the effects related to the different physician-patient relationship yielded by TCM. As TCM is more holistic and sensitive to all patient's sources of malaise (including coexisting symptoms other than pain), it might yield some positive results related to the patient's feeling of being better understood and cared for. Even though mock acupuncture has already proven to be a credible placebo (see[19] as a review), we modified the method for mock acupuncture in the attempt to improve its credibility.Touching the skin with a blunted needle tip made it possible to give the patient a light pricking-like sensation, while avoiding the problems related to sham acupuncture.

We did not administer apost hoc questionnaire and this may be a limit of the study; however, the positive result of RMA atT1 suggests a good placebo effect due to a credible ritual,since it showed a lower MI than SMA and R, with SMA laying between group R and RMA.Its credibility is suggested also by the significant increase of Rizatriptan intake in RMA after the end of treatment (that is, from T1 to T2) when it reached the same values as SMA and R.

All groups underwent a sizable decrease of MI, which was below 36% of initial values at both T1 and T2. On average, it might reflect the effectiveness of Rizatriptan in comparison to relief therapy in baseline conditions, of which, unfortunately, we have not collected information: should Rizatriptan have improved relief therapy, the observed decrease of MI might be a mix of therapeutic and placebo effects. If so, it would have helped in making mock acupuncture credible too, since patients might not easily tell its effects from those of Rizatriptan.

TA only was able to provide long-lasting effects, strongly decreasing both MI and Rizatriptan intak e at both T1 and T2, while RMA provided a transient benefit at T1 only, paralleled by changes in Rizatriptan intake. The transient effects observed in group RMA can therefore be assigned to a placebo effect, although the limit between a simple placebo and a true effect may not be so well defined. In fact, one cannot easily rule out that the closer physician-patient relationship yielded by the TCM approach might positively affect the treatment, through an iatroplacebogenesis rather than a simple placebo.[39]

In conclusion, our data suggest that traditional acupuncture is an effective tool for migraine prophylaxis: the syndrome differentiation according to TCM seems to work, although we do not yet know whether all TCM syndromes are so relevant as to call for a specific acupoint selection. Our protocol is the first attempt to check the effects of traditional acupuncture in migraine, providing a detailed report of acupoint selection according to TCM; however, our protocol can only be considered as a first, provisional attempt to merge TCM and Western medicine, in the definition of proper acupuncture treatment for migraine.

We do believe that acupoint selection plays a key role for effectiveness, and we are to face TCM in the process of acupuncture validation. It is the “true” acupuncture, with an enormous store of tradition and empirical knowledge, trickled out over 2,000 years of practice and still routinely used in Chinese hospitals. Western medicine and TCM are 2 deeply different worlds with different paradigms, which seem incompatible at a first glance. A correct approach to TCM has strong epistemological implications, but this cannot prevent us from trying to build a bridge between the 2, which is essential for acupuncture understanding.


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