A Randomized Clinical Trial on Acupuncture Versus Best Medical Therapy in Episodic Migraine Prophylaxis: The Acumigran Study

Abstract

BackgroundA large corpus of evidence has reported encouraging results for acupuncture as a prophylaxis therapy of migraine. However, trails investigated the efficacy of acupuncture in comparison to pharmacological treatment in episodic migraine showed conflicting results. The aim of the study was to evaluate if acupuncture is as effective as evidence based pharmacological drugs in episodic migraine prophylaxis. MethodsThis is a randomized controlled clinical study. Patient suffering from migraine without preventive treatment in the past three months were recruited. After the run-in period, episodic migraineurs were assigned randomly to two groups: the acupuncture group (A) was treated with 12 sessions of acupuncture and the pharmacological group (B) was treated with the most appropriate medication for each patient. Headache frequency was compared at baseline and at the end of treatment. Both groups were evaluated 3- and 6-months after treatment.ResultsA total of 148 patients (24 males and 124 females) were enrolled in the study. Out of these, 69 were randomized to A and 66 to B. At baseline no significantly differences were found between the two groups. The 15.5% of patients (21/135) interrupted the treatment, especially those randomized to B. After 4 months, the migraine frequency decreased from 8.58 ± 3.21 to 6.43 ± 3.45 in A and from 8.29 ± 2.72 to 6.27 ± 4.01 in B. Headache frequency decreased significantly after treatment without differences between the two groups (time-effect: p<0.001; group effect: p=0.332; interaction time-group effects: p=0.556). About 34% of patients showed a reduction of headache days by at least 50% after the treatment. The improvements observed at the end of treatment persisted in 57.3% (59/103) after 3 months and in 38.8% (40/103) after 6 months, especially in patients randomized to A.ConclusionsOur trial is the first one comparing acupuncture with the more appropriate pharmacological treatment for migraine prophylaxis. Data suggested that acupuncture could be adopted as a migraine prophylaxis and seem to be slightly superior to pharmacological treatment in compliance and rate of adverse events.

Is Acupuncture Safe and Effective Treatment for Migraine? A Systematic Review of Randomized Controlled Trials

“…Treated patients underwent manual acupuncture (MA), electro-acupuncture (EA), auricular acupuncture (AA), and control patients received no treatment/waiting list, sham acupuncture, or pharmacological medications. Of the 15 trials, seven were conducted in China [ 9 , 11 , 15 - 19 ]; three in Italy [ 20 - 22 ]; three in Iran [ 1 , 2 , 23 ]; one in Australia [ 24 ], and one in Czech Republic [ 25 ]. Seven studies had participants with MWOA only [ 11 , 17 - 21 , 23 ]; two with an acute attack [ 1 , 9 ]; two with chronic migraine [ 2 , 15 ]; four with MWA/MWOA [ 16 , 22 , 24 , 25 ].…”

“…Of the 15 trials, seven were conducted in China [ 9 , 11 , 15 - 19 ]; three in Italy [ 20 - 22 ]; three in Iran [ 1 , 2 , 23 ]; one in Australia [ 24 ], and one in Czech Republic [ 25 ]. Seven studies had participants with MWOA only [ 11 , 17 - 21 , 23 ]; two with an acute attack [ 1 , 9 ]; two with chronic migraine [ 2 , 15 ]; four with MWA/MWOA [ 16 , 22 , 24 , 25 ]. Table 2 summarizes the characteristics of the included studies.…”

“…Treatment duration ranged from 25 to 30 minutes. De-qi sensation (a sensation of soreness, numbness, distention, or radiating that indicates effective needling) was performed in most trials, but three studies did not mention De-qi sensation [ 1 , 20 , 22 ]. Table 3 shows the acupuncture intervention of the included studies based on the standards for reporting interventions in clinical trials of acupuncture (STRICTA) guidelines [ 26 ].…”

“…Of the 10 trials that used MA, one compared MA to no treatment or WL [ 25 ], five studies compared MA to sham acupuncture (needles do not go as deep or inserted in non-acupoint) [ 9 , 16 , 19 , 23 , 24 ], and four studies compared MA to pharmacological medications [ 2 , 15 , 21 , 22 ]. Of the three trials that used EA, one compared EA to SA [ 16 ], another study compared EA to placebo EA [ 17 ] and one study compared EA to SA and no treatment/WL [ 18 ].…”

“…Four trials with 451 participants compared acupuncture with pharmacologic medicine, including botulinum toxin A, topiramate, valproic acid, amitriptyline, beta-blockers, flunarizine, flunarizine + riboflavin, topiramate, pizotifen, duloxetine + coenzyme Q10, riboflavin, and a combination of another nutraceutical drug [ 2 , 15 , 21 , 22 ]. Two trials had participants with chronic migraines, and the other two had MWOA.…”