Treatment in a Randomized Multicenter Trial of Acupuncture for Migraine (ART Migraine)

Abstract

Background: This paper aims to describe the characteristics of physicians and interventions of a large, multicenter randomized trial of acupuncture for migraine (ART Migraine) in order to enable acupuncturists to assess the study interventions. Patients and Methods: 302 patients suffering from migraine were randomized to 12 sessions of semi-standardized acupuncture (6 predefined basic points, recommendations for optional individual choice of additional points given), standardized minimal acupuncture (superficial needling of at least 5 of 10 predefined, distant non-acupuncture points) or a waiting list. 30 physicians trained and experienced in acupuncture from 18 centers in Germany participated in the trial. Results: The median duration of acupuncture training of trial physicians was 500 h (range 140-1350). Physicians had acupuncture experience for 10 (<1 to 25) years and had treated 200 (60 to >1000) patients with acupuncture in the year preceding trial participation. The 6 basic points were needled in 76-93% of sessions. Compliance with treatment instructions varied considerably among centers in the acupuncture group. In contrast, compliance with the minimal acupuncture protocol was very good. 6 of the 30 physicians stated that they would have treated patients somewhat differently outside the trial, 1 completely differently. The trial found a significant effect of those treated with acupuncture compared to those on the waiting list for treatment, but minimal acupuncture was as effective as acupuncture. Conclusions: The treatment protocols for acupuncture and minimal acupuncture in ART Migraine appeared an adequate compromise in the specific situation and for the predefined purposes. However, a relevant minority of participating physicians would have treated patients differently outside the trial.

The Emperors Sham – Wrong Assumption that Sham Needling is Sham

“…h. Superficial needling has been advocated as a treatment technique in its own right [11][12][13] i. Sham acupuncture has been proven to be as effective as verum acupuncture and dedicated analgesics, in headache and migraine [14][15][16][17] j. Sham acupuncture and verum acupuncture have been shown to be more effective than conventional therapeutic interventions in low back pain 18 k. Sham ('placebo') acupuncture was associated with a significantly higher overall pregnancy rate when compared with real acupuncture in IVF treatment. 8 Because of the need to conduct high quality RCTs examining the effects of acupuncture that meet the conventions of good design, different sham acupuncture procedures have been introduced.…”

The Status and Future of Acupuncture Clinical Research

“…The main results of these trials have been published in major journals [1][2][3][4] ; details of the protocols and the treatments actually provided were published in complementary and alternative medicine (CAM) research journals. [5][6][7][8][9][10] Participating physicians had to have at least 140 hours of acupuncture training. About 70% had 350 hours of training or more.…”

“…n November [8][9]2007, the Society for Acupuncture Research (SAR) hosted an international conference to mark the tenth anniversary of the landmark National Institutes of Health (NIH) Consensus Development Conference on Acupuncture. This paper summarizes important invited lectures from the SAR conference in the area of clinical acupuncture research.…”

Clinical acupuncture research in the West

“…Wait-list control was most frequently used in earlier RCTs. In a literature search on RCTs published in 2006-2007 [12,[38][39][40][41][42][43][44][45][46][47][48][49][50][51][52], most outcomes were positive (Table 1). Needless to say, blinding is impossible with this type of control.…”