Evaluating the prophylaxis and long-term effectiveness of acupuncture for migraine without aura: study protocol for a randomized controlled trial

Jiao Chen, Ling Zhao, Hui Zheng, Ying Li, Mingxiao Yang, Xiaorong Chang, Biao Gong, Yinlan Huang, Yanqin Liu, Fanrong Liang, Jiao Chen, Ling Zhao, Hui Zheng, Ying Li, Mingxiao Yang, Xiaorong Chang, Biao Gong, Yinlan Huang, Yanqin Liu, Fanrong Liang

Abstract

Background: 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.

Methods: 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.

Discussion: 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 ClinicalTrials.gov (NCT01687660) on 18 September 2012.

Figures

Figure 1
Figure 1
Trial profile. Participants with a diagnosis of migraine without aura will be recruited at three centers (enrollment areas of Chengdu, Hunan and Chongqing) taking part in the study. All participants should endure a baseline period of four weeks and inappropriate participants will be excluded. A total of 249 participants will be randomized to three groups: individualized acupoint, non-acupoint control, and waiting-list control. Each patient will receive four weeks of treatment and 20 weeks of follow-up. Outcome will be measured before randomization, the week of the last acupuncture session, and 8, 12, 16, 20 and 24 weeks after randomization, except that the acupuncture expectation value will be assessed before randomization, and MSQ, SAS and SDS will be assessed only at four weeks after treatment.

References

    1. Monzon M, Lainez M. Quality of life in migraine and chronic daily headache patients. Cephalalgia. 1998;18:638–643. doi: 10.1046/j.1468-2982.1998.1809638.x.
    1. Diamond M, Dahlöf C, Papadopoulos G, Neto W, Wu SC. Topiramate improves health-related quality of life when used to prevent migraine. Headache. 2005;45:1023–1030. doi: 10.1111/j.1526-4610.2005.05183.x.
    1. Goadsby P, Lipton R, Ferrari M. Migraine - current understanding and treatment. N Engl J Med. 2002;346:257–270. doi: 10.1056/NEJMra010917.
    1. Stewart WF, Lipton RB. The economic and social impact of migraine. Eur Neurol. 1994;34:S12–S17. doi: 10.1159/000119527.
    1. Lipton RB, Scher AI, Steiner TJ, Bigal ME, Kolodner K, Liberman JN. Patterns of health care utilization for migraine in England and in the United States. Neurology. 2003;60:441–448. doi: 10.1212/WNL.60.3.441.
    1. Bigal M, Lipton R. The epidemiology, burden, and comorbidities of migraine. Neurol Clin. 2009;27:321–334. doi: 10.1016/j.ncl.2008.11.011.
    1. Wang S, Liu H, Fuh J, Liu C, Lin K, Chen H, Lin C, Wang P, Hsu L, Wang H, Lin K. Prevalence of headaches in a Chinese elderly population in Kinmen: age and gender effect and cross-cultural comparisons. Neurology. 1997;49:195–200. doi: 10.1212/WNL.49.1.195.
    1. Menken M, Munsat T, Toole J. The global burden of disease study: implications for neurology. Arch Neurol. 2000;57:418–420. doi: 10.1001/archneur.57.3.418.
    1. Lipton R, Stewart W, Cady R. Sumatriptan for the range of headaches in migraine sufferers: results of the spectrum study. Headache. 2000;40:783–791. doi: 10.1046/j.1526-4610.2000.00143.x.
    1. Irimia P, Palma J, Fernandez-Torron R, Martinez-Vila E. Refractory migraine in a headache clinic population. BMC Neurol. 2011;11:94. doi: 10.1186/1471-2377-11-94. article.
    1. Gray R, Goslin R, McCrory D, Eberlein K, Tulsky J, Hasselblad V. Drug Treatments for the Prevention of Migraine Headache: Technical Review 2.3. Rockville, MD: Agency for Health Care Policy and Research Department of Health and Human Services US Public Health Service; 1999.
    1. Li Z. Experimental Acupuncture. Second. Beijing: China’s traditional Chinese medicine press; 2007.
    1. Li Y, Liang F, Yang X, Tian X, Yan J, Sun G, Chang X. Acupuncture for treating acute attacks of migraine: a randomized controlled trial. Headache. 2009;49:805–816. doi: 10.1111/j.1526-4610.2009.01424.x.
    1. Wang L, Zhang X, Guo J. Efficacy of acupuncture for migraine prophylaxis: a single-blinded, double-dummy, randomized controlled trial. Pain. 2011;152:1864–1871. doi: 10.1016/j.pain.2011.04.006.
    1. Vas J, Rebollo A, Perea-Milla E, Méndez C, Font C, Gómez-Río M. Study protocol for a pragmatic randomized controlled trial in general practice investigating the effectiveness of acupuncture against migraine. BMC Complement Altern Med. 2008;8:12. doi: 10.1186/1472-6882-8-12.
    1. Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White A. Acupuncture for migraine prophylaxis. Cochrane Database Syst Rev. 2009;1 DOI: 10.1002/14651858.CD001218.pub2.
    1. Facco E, Liguori A, Petti F. Traditional acupuncture in migraine: a controlled, randomized study. Headache. 2008;48:398–407. doi: 10.1111/j.1526-4610.2007.00916.x.
    1. Alecrim-Andrade J, Maciel-Junior J, Carne X. Acupuncture in migraine prevention: a randomized sham controlled study with six-months posttreatment follow-up. Clin J Pain. 2008;24:98–105. doi: 10.1097/AJP.0b013e3181590d66.
    1. Zhao L, Chen J, Liu CZ, Li Y, Cai DJ, Tang Y, Yang J, Liang FR. A review of acupoint specificity research in china: status quo and prospects. Evid Based Complement Altern Med. 2012;2012:543943.
    1. Li Y, Zheng H, Witt C. Acupuncture for migraine prophylaxis: a randomized controlled trial. Can Med Assoc J. 2012;184:401–410. doi: 10.1503/cmaj.110551.
    1. Vickers A, Rees R, Zollman C, McCarney R, Smith C, Ellis N, Fisher P, Haselen RV. Acupuncture for chronic headache in primary care: large, pragmatic, randomized trial. BMJ. 2004;328:744. doi: 10.1136/bmj.38029.421863.EB.
    1. Headache Classification Subcommittee of the International Headache Society. Guidelines for controlled trials of drugs in migraine: third edition. Cephalalgia. 2011;32:6–38.
    1. Schulz K, Altman D, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. BMJ. 2010;2010(340):698–702.
    1. Headache Classification Subcommittee of the International Headache Society. The international classification of headache disorders. Int Classif Headache Disord. 2004;24:1–150.
    1. Zhang Y, Wang L, Liu H, Li N, Li J, Yi J. The design and protocol of acupuncture for migraine prophylaxis: a multicenter randomized controlled trial. Trials. 2009;10:25. doi: 10.1186/1745-6215-10-25.
    1. Ma T, Yu S, Li Y, Liang F. Immediate effect of acupuncture at Sanyinjiao (SP6) and Xuanzhong (GB39) on uterine arterial blood flow in primary dysmenorrhea. J Altern Complement Med. 2011;12:300–307.
    1. Li Y, Liang F, Yu S, Liu X, Tang Y, Yang X, Tian X, Yan J, Sun G, Chang X, Zheng H, Zhang H, Ma T. Randomized controlled trial to treat migraine with acupuncture: design and protocol. Trials. 2008;9:57. doi: 10.1186/1745-6215-9-57.
    1. De Tommaso M, Sardaro M, Serpino C, Costantini F, Vecchio E, Pia Prudenzano M, Lamberti P, Livrea P. Fibromyalgia comorbidity in primary headaches. Cephalalgia. 2009;29:453–464. doi: 10.1111/j.1468-2982.2008.01754.x.
    1. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutic trials. J Chronic Dis. 1967;20:637–648. doi: 10.1016/0021-9681(67)90041-0.
    1. MacPherson H. Pragmatic clinical trials. Complement Ther Med. 2004;12:136–140. doi: 10.1016/j.ctim.2004.07.043.
    1. Witt C. Efficacy, effectiveness, pragmatic trials - guidance on terminology and the advantages of pragmatic trials. Forschende Komplementärmedizin. 2009;16:292–294. doi: 10.1159/000234904.
    1. Deng Z, Zhou S, Li Y, Zhao L. Thinking on the design scheme of clinical trial with the example of migraine treated by acupuncture. Zhongguo Zhen Jiu. 2012;32:559–562.
    1. Medical Research Council. A Framework for Development and Evaluation of RCTs for Complex Interventions to Improve Health. London: Medical Research Council; 2000.
    1. Diener H, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A, Tegenthoff M, Trampisch H, Zenz M, Meinert R. Efficacy of acupuncture for the prophylaxis of migraine: a multicenter randomized controlled clinical trial. Lancet Neurol. 2006;4:310–316.
    1. Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, Wagenp-feil S, Pfaffenrath V, Hammes M, Weidenhammer W, Willich S, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005;293:2118–2125. doi: 10.1001/jama.293.17.2118.
    1. Kaptchuk T, Stason W, Davis R. Sham device versus inert pill: randomized controlled trial of two placebo treatments. Br Med J. 2006;332:391–397. doi: 10.1136/bmj.38726.603310.55.
    1. Kaptchuk T, Goldman P, Stone D, Stason W. Do medical devices have enhanced placebo effects? J Clin Epidemiol. 2000;53:786–792. doi: 10.1016/S0895-4356(00)00206-7.
    1. Oken B. Placebo effects: clinical aspects and neurobiology. Brain. 2008;131:2812–2823. doi: 10.1093/brain/awn116.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner