Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomised controlled trial

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• 作者：Joo-Hee Kim (1) (2)
  Hyun Jung Jung (3)
  Tae-Hun Kim (1) (4)
  Seunghoon Lee (1) (2)
  Jung-Eun Kim (1)
  Kyung-Won Kang (1)
  So-Young Jung (1)
  Ae-Ran Kim (1)
  Hyo-Ju Park (1)
  Mi-Suk Shin (1)
  Kyung-Min Shin (1)
  Hee-Jung Jung (1)
  Seung-Deok Lee (5)
  Kwon-Eui Hong (6)
  Sun-Mi Choi (1)
  
• 关键词：Hypertension ; Auricular acupuncture ; Effect ; Safety ; Clinical research protocol
• 刊名：Trials
• 出版年：2013
• 出版时间：December 2013
• 年：2013
• 卷：14
• 期：1
• 全文大小：253 KB
• 参考文献：1. Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J: Global burden of hypertension: analysis of worldwide data. / Lancet 2005, 365:217鈥?23.
  2. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ: Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. / Hypertension 2003, 42:1206鈥?252. CrossRef
  3. Woolf KJ, Bisognano JD: Nondrug interventions for treatment of hypertension. / J Clin Hypertens (Greenwich) 2011, 13:829鈥?35. CrossRef
  4. Kjeldsen SE, Oparil S, Narkiewicz K, Hedner T: Should we treat prehypertension? / Blood Press 2009, 18:298鈥?99. CrossRef
  5. Kiely AE, Kwatra SG, Kwatra MM: Treating prehypertension: medically sound and economically viable. / Blood Press 2009, 18:300鈥?03. CrossRef
  6. Diao D, Wright JM, Cundiff DK, Gueyffier F: Pharmacotherapy for mild hypertension. / Cochrane Database Syst Rev 2012., 8: CD006742
  7. Lenzer J: Cochrane review finds no proved benefit in drug treatment for patients with mild hypertension. / BMJ 2012, 345:e5511. CrossRef
  8. Wood MJ, Stewart RL, Merry H, Johnstone DE, Cox JL: Use of complementary and alternative medical therapies in patients with cardiovascular disease. / Am Heart J 2003, 145:806鈥?12. CrossRef
  9. Chiu YJ, Chi A, Reid IA: Cardiovascular and endocrine effects of acupuncture in hypertensive patients. / Clin Exp Hypertens 1997, 19:1047鈥?063. CrossRef
  10. Anshelevich Iu V, Merson MA, Afanas鈥檈va GA: Serum aldosterone level in patients with hypertension during treatment by acupuncture. / Ter Arkh 1985, 57:42鈥?5. Russian
  11. Huang H, Liang S: Acupuncture at otoacupoint heart for treatment of vascular hypertension. / J Tradit Chin Med 1992, 12:133鈥?36.
  12. Jiang X: Effects of magnetic needle acupuncture on blood pressure and plasma ET-1 level in the patient of hypertension. / J Tradit Chin Med 2003, 23:290鈥?91.
  13. Li P, Longhurst JC: Neural mechanism of electroacupuncture鈥檚 hypotensive effects. / Auton Neurosci 2010, 157:24鈥?0. CrossRef
  14. Flachskampf FA, Gallasch J, Gefeller O, Gan J, Mao J, Pfahlberg AB, Wortmann A, Klinghammer L, Pflederer W, Daniel WG: Randomized trial of acupuncture to lower blood pressure. / Circulation 2007, 115:3121鈥?129. CrossRef
  15. Yin C, Seo B, Park HJ, Cho M, Jung W, Choue R, Kim C, Park HK, Lee H, Koh H: Acupuncture, a promising adjunctive therapy for essential hypertension: a double-blind, randomized, controlled trial. / Neurol Res 2007,29(Suppl 1):S98-S103. CrossRef
  16. Macklin EA, Wayne PM, Kalish LA, Valaskatgis P, Thompson J, Pian-Smith MC, Zhang Q, Stevens S, Goertz C, Prineas RJ, Buczynski B, Zusman RM: Stop Hypertension with the Acupuncture Research Program (SHARP): results of a randomized, controlled clinical trial. / Hypertension 2006, 48:838鈥?45. CrossRef
  17. Text book committee of Korean Acupuncture & Moxibustion Society: / The Acupuncture and Moxibustion. 2nd edition. Paju: Jipmoondang; 2008.
  18. Huang L: / Auricular medicine : a complete manual of auricular diagnosis and treatment. Orlando, FL: Auricular International Research & Training Center; 2005.
  19. Yu P, Li F, Wei X, Wu R, Fu C: Treatment of essential hypertension with auriculoacupressure. / J Tradit Chin Med 1991, 11:17鈥?1.
  20. Byun JY, Ahn SG: Effects of the auricular acupuncture on the blood pressure. / J Korean Oriental Med 1996, 17:418鈥?26.
  21. Huang HQ, Liang SZ: Improvement of blood pressure and left cardiac function in patients with hypertension by auricular acupuncture. / Zhong Xi Yi Jie He Za Zhi 1991, 11:654鈥?56. 643鈥?54. (Chinese)
  22. Ahn CH, Bae HS, Roh JH, Moon SK, Ko CN, Joh KH, Kim YS, Lee KS: Effects of aricular acupuncture on the mild hypertension. / J Korean Oriental Med 2000, 20:93鈥?7.
  23. Gaponiuk P, Leonova MV: The clinical efficacy of auricular electroacupuncture in treating hypertension patients. / Vopr Kurortol Fizioter Lech Fiz Kult 1990, 1:13鈥?5. Russian
  24. Gao XY, Zhu B: Analysis on blood-pressure-decreasing effect of electric pulse stimulation of auricular acupoint Jiangyagou in the patient of hypertension. / Zhongguo Zhen Jiu 2005, 25:474鈥?76. Chinese
  25. Lee H, Kim SY, Park J, Kim YJ, Park HJ: Acupuncture for lowering blood pressure: systematic review and meta-analysis. / Am J Hypertens 2009, 22:122鈥?28. CrossRef
  26. Altman DG, Dore CJ: Randomisation and baseline comparisons in clinical trials. / Lancet 1990, 335:149鈥?53. CrossRef
  27. Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ: Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. / Circulation 2005, 111:697鈥?16. CrossRef
  28. Kim MH, Cho YS, Uhm WS, Kim S, Bae SC: Cross-cultural adaptation and validation of the Korean version of the EQ-5D in patients with rheumatic diseases. / Qual Life Res 2005, 14:1401鈥?406. CrossRef
  29. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH: A tutorial on pilot studies: the what, why and how. / BMC Med Res Methodol 2010, 10:1. CrossRef
  30. Hertzog MA: Considerations in determining sample size for pilot studies. / Res Nurs Health 2008, 31:180鈥?91. CrossRef
  31. Julious SA: Sample size of 12 per group rule of thumb for a pilot study. / Pharm Stat 2005, 4:287鈥?91. CrossRef
  32. Sedgwick P: What is intention to treat analysis? / BMJ 2013, 346:f3662-f3662. CrossRef
  33. Sedgwick P: What is per protocol analysis? / BMJ 2013, 346:f3748-f3748. CrossRef
  34. Ohkubo T, Hozawa A, Nagai K, Kikuya M, Tsuji I, Ito S, Satoh H, Hisamichi S, Imai Y: Prediction of stroke by ambulatory blood pressure monitoring versus screening blood pressure measurements in a general population: the Ohasama study. / J Hypertens 2000, 18:847鈥?54. CrossRef
  35. Staessen JA, Thijs L, Fagard R, O鈥橞rien ET, Clement D, de Leeuw PW, Mancia G, Nachev C, Palatini P, Parati G, Tuomilehto J, Webster J: Predicting cardiovascular risk using conventional vs ambulatory blood pressure in older patients with systolic hypertension. Systolic Hypertension in Europe Trial Investigators. / JAMA 1999, 282:539鈥?46. CrossRef
  36. Mancia G, Zanchetti A, Agabiti-Rosei E, Benemio G, De Cesaris R, Fogari R, Pessina A, Porcellati C, Rappelli A, Salvetti A, Trimarco B: Ambulatory blood pressure is superior to clinic blood pressure in predicting treatment-induced regression of left ventricular hypertrophy. SAMPLE Study Group. Study on Ambulatory Monitoring of Blood Pressure and Lisinopril Evaluation. / Circulation 1997, 95:1464鈥?470. CrossRef
  37. Hodgkinson J, Mant J, Martin U, Guo B, Hobbs FDR, Deeks JJ, Heneghan C, Roberts N, McManus RJ: Relative effectiveness of clinic and home blood pressure monitoring compared with ambulatory blood pressure monitoring in diagnosis of hypertension: systematic review. / BMJ 2011, 342:d3621. CrossRef
  38. Lovibond K, Jowett S, Barton P, Caulfield MC, Heneghan C, Hobbs FDR, Hodgkinson J, Mant J, Martin U, Williams B, Wonderling D, McManus RJ: Cost-effectiveness of options for the diagnosis of high blood pressure in primary care: a modelling study. / Lancet 2011,378(9798):1219鈥?230. CrossRef
  39. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R: Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. / Lancet 2002, 360:1903鈥?913. CrossRef
  40. Turnbull F: Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials. / Lancet 2003, 362:1527鈥?535. CrossRef
  41. Garber AM, Tunis SR: Does comparative-effectiveness research threaten personalized medicine? / N Engl J Med 2009, 360:1925鈥?927. CrossRef
  42. Witt CM, Brinkhaus B: Efficacy, effectiveness and cost-effectiveness of acupuncture for allergic rhinitis - An overview about previous and ongoing studies. / Auton Neurosci 2010, 157:42鈥?5. CrossRef
  43. Devilly GJ, Borkovec TD: Psychometric properties of the credibility/expectancy questionnaire. / J Behav Ther Exp Psychiatry 2000, 31:73鈥?6. CrossRef
  44. Kromer TO, de Bie RA, Bastiaenen CH: Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial. / BMC Musculoskelet Disord 2010, 11:114. CrossRef
  45. Yun YJ, Kang KW, Yang JN, Chun MS, Choi JB, Yang JI: Effects of acupuncture on urinary incontinence in premenopausal women: Preliminary study. / Acupunct 2011, 28:55鈥?1.
  46. Kim JE, Kang KW, Kim AR, Kim JH, Kim TH, Park HJ, Shin MS, Lee MH, Lee SH, Lee S, Jung SY, Jung HJ, Hong KE, Choi SM: Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a pilot randomized controlled trial. / Acupunct 2012, 29:109鈥?18.
  47. Kwon HJ, Kim JI, Lee MS, Choi JY, Kang S, Chung JY, Kim YJ, Lee SH, Lee S, Nam D, Kim YS, Lee JD, Choi DY: Acupuncture for sequelae of Bell鈥檚 palsy: a randomized controlled trial protocol. / Trials 2011, 12:71. CrossRef
  
• 作者单位：Joo-Hee Kim (1) (2)
  Hyun Jung Jung (3)
  Tae-Hun Kim (1) (4)
  Seunghoon Lee (1) (2)
  Jung-Eun Kim (1)
  Kyung-Won Kang (1)
  So-Young Jung (1)
  Ae-Ran Kim (1)
  Hyo-Ju Park (1)
  Mi-Suk Shin (1)
  Kyung-Min Shin (1)
  Hee-Jung Jung (1)
  Seung-Deok Lee (5)
  Kwon-Eui Hong (6)
  Sun-Mi Choi (1)
  
  1. Acupuncture, Moxibustion & Meridian Research Group, Medical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea
  2. Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, South Korea
  3. Department of Diagnostics, College of Oriental Medicine, Deagu Hanny University, Daegu-si, South Korea
  4. College of Korean Medicine, Gachon University, Seongnam, South Korea
  5. Department of Acupuncture & Moxibustion, College of Oriental Medicine, DongGuk University, Seoul, South Korea
  6. Department of Acupuncture & Moxibustion, College of Oriental Medicine, Dae-Jeon University, Daejeon, South Korea
  
• ISSN：1745-6215

文摘

Background Hypertension, a worldwide public health problem, is a major risk factor for cardiovascular and kidney disease, and the medical and economic burden of hypertension is increasing. Auricular acupuncture has been used to treat various diseases, including hypertension. Several studies have shown that auricular acupuncture treatment decreases blood pressure in patients with hypertension; however, the scientific evidence is still insufficient. Therefore, we aimed to perform a randomised controlled clinical trial in patients with prehypertension and stage 1 hypertension to evaluate the effect and safety of auricular acupuncture. Methods/designs This on-going study is a two parallel arm, assessor-blinded, randomised controlled trial. Sixty participants with prehypertension and stage 1 hypertension will be recruited and randomly allocated into two groups in a 1:1 ratio. Participants in the auricular acupuncture group will receive auricular acupuncture treatment two times per week for 4 weeks. Participants in the usual care group will not receive any acupuncture treatment during the study period. All participants in both groups will be provided with verbal and written educational materials regarding the dietary and physical activity habits for controlling high blood pressure, and they will self-manage their lifestyle, including diet and exercise, during the study. The primary outcome is the 24-h average systolic and diastolic blood pressure, as measured with an ambulatory monitor. The secondary outcomes are the mean change in the average systolic and diastolic blood pressure during day- and night-time, the circadian rhythm of blood pressure, the mean arterial pressure, the change in blood pressure before and after auricular acupuncture treatment, the EuroQOL-5D (EQ-5D), heart rate variability (HRV), body mass index (BMI) and laboratory examination, including lipid profile and high sensitivity C-reactive protein (hs-CRP). Safety will be assessed at every visit. Discussion This pilot multicentre randomised controlled trial will explore the feasibility of further auricular acupuncture research and provide important clinical evidence for the effect and safety of auricular acupuncture on blood pressure in patients with prehypertension and stage 1 hypertension compared with usual care. Trial registration Clinical Research Information Service: KCT0000169