Acupuncture in migraine prophylaxis: a randomized sham-controlled trial. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial. Acupuncture in migraine prevention: a randomized sham controlled study with 6-months posttreatment follow-up. A controlled trial of the treatment of migraine by acupuncture. Acupuncture in the prophylactic treatment of migraine without aura: a comparison with flunarizine. Acupuncture for patients with migraine: a randomized controlled trial. Traditional acupuncture in migraine: a controlled, randomized study. Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial. Effectiveness and tolerability of acupuncture compared with metoprolol in migraine prophylaxis.
The purpose of the present trial was to evaluate semi-standardized acupuncture efficacy in migraine prophylaxis. Twenty-eight subjects with migraine were randomized to the real or sham acupuncture groups. Semi-standardized and standardized minimal acupuncture were used, respectively, in the two groups of patients. They were all treated with 16 acupuncture sessions in 12 weeks. Both groups exhibited similar reductions in: percentage of patients with reduction of migraine>or=40% and >or=50% regarding frequency of migraine attacks, days with migraine, frequency of migraine attacks, average duration of a migraine attack, rate of rescue medication used, average headache severity rate and other parameters compared with the baseline period. Associated symptoms, such as nausea and vomiting, also showed equal estimates in both groups. These findings showed that semi-standardized acupuncture shows no difference from sham acupuncture in preventing migraine attacks. 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. To assess the efficacy of acupuncture in migraine prophylaxis.
                Thirty-seven patients with migraine were enrolled in a randomized control trial at the Headache clinic located in a University Hospital. Real and sham acupuncture groups received 16 acupuncture sessions over 3 months. Treatment was individualized in the real acupuncture group and minimal acupuncture was used in the sham group. The primary end point was the percentage of patients with a >or=50% reduction in their migraine attack frequency in the second, third, fourth, fifth, and sixth (months) compared with the first one (baseline period). Primary and secondary end points were measured comparing headache diaries.
                Real acupuncture group showed improvement with significant differences compared with the sham acupuncture group in the primary efficacy end point (P=0.021) at the second month of the treatment. Differences also appeared in 2 secondary end points: number of days with migraine per month (P=0.007) in the second month and the percentage of patients with >or=40% reduction in migraine attack frequency in the first (P=0.044) and second months (P=0.004) of the treatment. These differences disappeared in the third (last) month of the treatment as a consequence of the high improvement of the sham acupuncture group. Comparisons within each group showed that several migraine parameters evaluated improved significantly in both groups.
                Individualized treatment based on traditional Chinese medicine plays a role in preventing migraine attacks. Nevertheless, sham acupuncture had similar effects. Major conclusions were limited by the small sample sizes however the observed trends may contribute to design future trials. A randomised controlled trial comparing true and sham acupuncture was conducted on 30 patients suffering from chronic migraine. Diary measures of headache and medication intake were recorded throughout the study, and measures of headache quality, anxiety, and pain behaviour were taken. The credibility of the true and sham treatment procedures was also assessed. True acupuncture was significantly more effective than the control procedure in reducing the pain of migraine headache. Posttreatment reductions in pain scores and medication of 43 and 38%, respectively, were recorded in the true acupuncture group and were maintained at 4-month and 1-year follow-up. In a randomized controlled trial extending over 6 months, we evaluated the effectiveness of acupuncture versus flunarizine in the prophylactic treatment of migraine without aura.
                One hundred sixty women with migraines were randomly assigned to acupuncture treatment (group A, n = 80) or to an oral therapy with flunarizine (group F, n = 80). In group A, acupuncture was carried out in weekly sessions for the first 2 months and then once a month for the next 4 months. The same acupoints were used at each treatment: LR3 Taichong, SP6 Sanyinjiao, ST36 Zusanli, CV12 Zhongwan, LI4 Hegu, PC6 Neiguan, GB20 Fengchi, GB14 Yangbai, EX-HN5 Taiyang, GV20 Baihui. In group F, 10 mg flunarizine were given daily for the first 2 months and then for 20 days per month for the next 4 months.
                The frequency of attacks and use of symptomatic drugs significantly decreased during treatment in both groups. The number of attacks after 2 and 4 months of therapy was significantly lower in group A than in group F, and analgesic consumption was significantly lower in group A at 2 months of treatment. At 6 months no such differences existed between the two treatment groups. Pain intensity was significantly reduced only by acupuncture treatment. Side effects were significantly less frequent in group A.
                Acupuncture proved to be adequate for migraine prophylaxis. Relative to flunarizine, acupuncture treatment exhibited greater effectiveness in the first months of therapy and superior tolerability. Acupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce.
                To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine.
                Three-group, randomized, controlled trial (April 2002-January 2003) involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine headaches, based on International Headache Society criteria. Patients were treated at 18 outpatient centers in Germany.
                Acupuncture, sham acupuncture, or waiting list control. Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks. Patients completed headache diaries from 4 weeks before to 12 weeks after randomization and from week 21 to 24 after randomization.
                Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization.
                Between baseline and weeks 9 to 12, the mean (SD) number of days with headache of moderate or severe intensity decreased by 2.2 (2.7) days from a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting list group. No difference was detected between the acupuncture and the sham acupuncture groups (0.0 days, 95% confidence interval, -0.7 to 0.7 days; P = .96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval; 0.8-2.1 days; P<.001). The proportion of responders (reduction in headache days by at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list group.
                Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control. 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.
                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.
                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.
                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 (T(0)) was moderate to severe with no significant intergroup differences. All groups underwent a decrease of MI at T(1) and T(2), with a significant group difference at both T(1) and T(2) compared to T(0) (P < .0001). Only TA provided a significant improvement at both T(1) and T(2) compared to R (P < .0001). RMA underwent a transient improvement of MI at T(1). The Rizatriptan intake paralleled the MI in all groups.
                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. Acupuncture treatment is frequently sought for tension-type headache (TTH), but there is conflicting evidence as to its effectiveness. This randomised, controlled, multicentre, patient-and observer-blinded trial was carried out in 122 outpatient practices in Germany on 409 patients with TTH, defined as > or =10 headache days per month of which < or =1 included migraine symptoms. Interventions were verum acupuncture according to the practice of traditional Chinese medicine or sham acupuncture consisting of superficial needling at nonacupuncture points. Acupuncture was administered by physicians with specialist acupuncture training. Ten 30-min sessions were given over a six-week period, with additional sessions available for partial response. Response was defined as >50% reduction in headache days/month at six months and no use of excluded concomitant medication or other therapies. In the intent-to-treat analysis (all 409 patients), 33% of verum patients and 27% of sham controls (p=0.18) were classed as responders. Verum was superior to sham for most secondary endpoints, including headache days (1.8 fewer; 95% CI 0.6, 3.0; p=0.004) and the International Headache Society response criterion (66% vs. 55% response, risk difference 12%, 95% CI: 2%-21%; p=0.024).). The relative risk on the primary and secondary response criterion was very similar ( approximately 0.8); the difference in statistical significance may be due to differences in event rate. TTH improves after acupuncture treatment. However, the degree to which treatment benefits depend on psychological compared to physiological effects and the degree to which any physiological effects depend on needle placement and insertion depth are unclear. In a randomized controlled multicenter trial extending over 24 weeks, we investigated whether acupuncture is as effective and safe as metoprolol in the prophylactic treatment of migraine under conditions similar to routine care.
                One hundred fourteen migraine patients could be randomized to treatment over 12 weeks either with acupuncture (8 to 15 sessions) or metoprolol (100 to 200 mg daily). Main outcome measure was the difference in the number of migraine days between baseline and the weeks 9 to 12 after randomization (derived from a headache diary).
                Two of 59 patients randomized to acupuncture withdrew prematurely from the study compared to 18 of 55 randomized to metoprolol. The number of migraine days decreased by 2.5 +/- 2.9 days (baseline 5.8 +/- 2.5 days) in the acupuncture group compared to 2.2 +/- 2.7 days (baseline 5.8 +/- 2.9 days) in the metoprolol group (P= .721). The proportion of responders (reduction of migraine attacks by > or =50%) was 61% for acupuncture and 49% for metoprolol. Both physicians and patients reported fewer adverse effects in the acupuncture group.
                Due to missing the recruitment target (480 patients) and the high drop-out in the metoprolol group the results must be interpreted with caution. Still, they suggest that acupuncture might be an effective and safe treatment option for patients unwilling or unable to use drug prophylaxis.
In the previous version of this review, evidence in support of acupuncture for migraine prophylaxis was considered promising but insufficient. Now, with 12 additional trials, there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of 'true' acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment.