Diener HC, Kronfeld K, Boewing G, et al. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial

Department of Neurology, University Essen, Essen, Germany.
The Lancet Neurology (Impact Factor: 21.9). 04/2006; 5(4):310-6. DOI: 10.1016/S1474-4422(06)70382-9
Source: PubMed


Our aim was to assess the efficacy of a part-standardised verum acupuncture procedure, in accordance with the rules of traditional Chinese medicine, compared with that of part-standardised sham acupuncture and standard migraine prophylaxis with beta blockers, calcium-channel blockers, or antiepileptic drugs in the reduction of migraine days 26 weeks after the start of treatment.
This study was a prospective, randomised, multicentre, double-blind, parallel-group, controlled, clinical trial, undertaken between April 2002 and July 2005. Patients who had two to six migraine attacks per month were randomly assigned verum acupuncture (n=313), sham acupuncture (n=339), or standard therapy (n=308). Patients received ten sessions of acupuncture treatment in 6 weeks or continuous prophylaxis with drugs. Primary outcome was the difference in migraine days between 4 weeks before randomisation and weeks 23-26 after randomisation. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN52683557.
Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomisation, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analysed in the intention-to-treat popoulation and 443 in the per-protocol population. The primary outcome showed a mean reduction of 2 .3 days (95% CI 1.9-2.7) in the verum acupuncture group, 1.5 days (1.1-2.0) in the sham acupuncture group, and 2.1 days (1.5-2.7) in the standard therapy group. These differences were statistically significant compared with baseline (p<0.0001), but not across the treatment groups (p=0.09). The proportion of responders, defined as patients with a reduction of migraine days by at least 50%, 26 weeks after randomisation, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (p=0.133).
Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.

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Available from: Michael Zenz, Sep 08, 2015
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    • "Recent controversy in the field of acupuncture research has been generated when several large scale RCTs showed no significant differences between acupuncture and minimal or sham acupuncture. But compared to control cases, the clinical effects of acupuncture treatment are significantly positive [6-8]. It claims that deqi is important in creating a positive clinical outcome [5,9]. "
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    ABSTRACT: Deqi is a central concept in traditional Chinese acupuncture. We performed a secondary analysis on data from a larger randomized controlled trial (RCT) in order to assess the effect of acupuncture on deqi traits and pain intensity in primary dysmenorrhea. A total of 60 primary dysmenorrhea patients were enrolled and randomly assigned to one of three treatment groups. Acupuncture was given at SP6, GB39 or nonacupoint. Subjective pain was measured by a 100-mm visual analogue scale (VAS) before and after acupuncture. The Massachusetts General Hospital acupuncture sensation scales (MASS) with minor modification was used to rate deqi sensations during acupuncture. The results showed that VAS scores of pain after acupuncture were significantly decreased comparing to before acupuncture treatment in all three groups (P = 0.000). However, no significant differences were found among three groups at the beginning or end of acupuncture treatment (P = 0.928, P = 0.419). There was no statistical difference among three groups in terms of intensity of deqi feeling. The types of sensation were similar across the groups with only minor differences among them. Trial registration number: ISRCTN24863192.
    Full-text · Article · Feb 2014 · BMC Complementary and Alternative Medicine
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    • "Several studies [15-18] have already reported the encouraging results in the therapy for migraine by acupuncture. A German randomized controlled trial (n = 794) showed that 11 acupuncture treatments given within 6 weeks were at least as effective as a β-blocker taken daily over 6 months [15]. Yang et al. found that acupuncture treatment was more effective and safer than topirmarate [16]. "
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    ABSTRACT: Menstrual-related migraine is a common form of migraine affecting >50% of female migraineurs. Acupuncture may be a choice for menstrual-related migraine, when pharmacological prophylaxis is not suitable. However, the efficacy of acupuncture has not been confirmed. We design and perform a randomized controlled clinical trial to evaluate the efficacy of acupuncture compared with naproxen in menstrual-related migraine patients. This is a multicenter, single blind, randomized controlled clinical trial. A total of 184 participants will be randomly assigned to two different groups. Participants will receive verum acupuncture and placebo medicine in the treatment group, while participants in the control group will be treated with sham acupuncture and medicine (Naproxen Sustained Release Tablets). All treatments will be given for 3 months (menstrual cycles).The primary outcome measures are the change of migraine days inside the menstrual cycle and the proportion of responders (defined as the proportion of patients with at least a 50% reduction in the number of menstrual migraine days). The secondary outcome measures are the change of migraine days outside the menstrual cycle, duration of migraine attack, the Visual Analogue Scale (VAS), and intake of acute medication. The assessment will be made at baseline (before treatment), 3 months (menstrual cycles), and 4 months (menstrual cycles) after the first acupuncture session. The results of this trial will be helpful to supply the efficacy of acupuncture for menstrual-related migraine prophylaxis.Trial registration: ISRCTN: ISRCTN57133712.
    Full-text · Article · Nov 2013 · Trials
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    • "The results of several trials suggest that an enhanced placebo effect impacts the acupuncture effect, which may explain patients’ positive beliefs and expectations of benefit of acupuncture and a benign acupuncturist-patient relationship [18,34-38]. We believe that this trial will demonstrate that the acupuncture effect is not due primarily to the physiological effects of acupoints. "
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    ABSTRACT: The instant-treatment effect of acupuncture for patients with migraines has been corroborated in numerous studies. However, most diseases are chronic and tend to recur, so the long-term effect of acupuncture can verify the existence of sustained efficacy or the placebo effect. Evaluating the efficacy of acupuncture in the prophylaxis of migraine without aura (MWoA) in China is also important because such studies are lacking. This trial is a multicenter, prospective, pragmatic randomized controlled clinical trial. We will randomly allocate 249 participants to three groups of 83. Patients in the individualized acupoint group will be treated with individualized acupuncture point prescriptions. The non-acupoint control group will undergo insertion of acupuncture needles at four bilateral non-points in locations not corresponding to acupuncture points. The waiting-list control group will not undergo treatment but instead will receive 20 acupuncture treatments for free after a waiting period of 24 weeks. Participants in the individualized acupoint group and non-acupoint control group will receive 20 sessions over four weeks and then all participants will receive 20 weeks of follow-up. The results of our trial will help to supply evidence for the long-term acupuncture effect for MWoA in a long follow-up period, and special attention will be paid to comparison with the placebo effect.Trial registration: The trial was registered at (NCT01687660) on 18 September 2012.
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