Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial

Hui Zheng, Xiao-ping Tian, Ying Li, Fan-rong Liang, Shu-guang Yu, Xu-guang Liu, Yong Tang, Xu-guang Yang, Jie Yan, Guo-jie Sun, Xiao-rong Chang, Hong-xing Zhang, Ting-ting Ma, Shu-yuan Yu, Hui Zheng, Xiao-ping Tian, Ying Li, Fan-rong Liang, Shu-guang Yu, Xu-guang Liu, Yong Tang, Xu-guang Yang, Jie Yan, Guo-jie Sun, Xiao-rong Chang, Hong-xing Zhang, Ting-ting Ma, Shu-yuan Yu

Abstract

Background: Acupuncture is widely used in China to treat functional dyspepsia (FD). However, its effectiveness in the treatment of FD, and whether FD-specific acupoints exist, are controversial. So this study aims to determine if acupuncture is an effective treatment for FD and if acupoint specificity exists according to traditional acupuncture meridians and acupoint theories.

Design: This multicenter randomized controlled trial will include four acupoint treatment groups, one non-acupoint control group and one drug (positive control) group. The four acupoint treatment groups will focus on: (1) specific acupoints of the stomach meridian; (2) non-specific acupoints of the stomach meridian; (3) specific acupoints of alarm and transport points; and (4) acupoints of the gallbladder meridian. These four groups of acupoints are thought to differ in terms of clinical efficacy, according to traditional acupuncture meridians and acupoint theories. A total of 120 FD patients will be included in each group. Each patient will receive 20 sessions of acupuncture treatment over 4 weeks. The trial will be conducted in eight hospitals located in three centers of China. The primary outcomes in this trial will include differences in Nepean Dyspepsia Index scores and differences in the Symptom Index of Dyspepsia before randomization, 2 weeks and 4 weeks after randomization, and 1 month and 3 months after completing treatment.

Discussion: The important features of this trial include the randomization procedures (controlled by a central randomization system), a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy.

Trial registration number: Clinical Trials.gov Identifier: NCT00599677.

Figures

Figure 1
Figure 1
Trial flow chart.
Figure 2
Figure 2
Locations of acupoints (acupuncture treatment groups). Acupoints of treatment group 1 are specific acupoints of Stomach meridian. Acupoints of treatment group 2 are non-specific acupoints of Stomach meridian. Acupoints of treatment group 3 are Alarm and transport points. Acupoints of treatment group 4 are acupoints of Gallbladder meridian.
Figure 3
Figure 3
Locations of non-acupoints (acupuncture control group). Descriptions of locations non-acupoints are available at table 2.

References

    1. Talley NJ, Verlinden M, Jones M. Validity of a new quality of life scale for functional dyspepsia: a United States multicenter trial of the Nepean Dyspepsia Index. Am J Gastroenterol. 1999;94:2390–2397. doi: 10.1111/j.1572-0241.1999.01363.x.
    1. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–483. doi: 10.1097/00005650-199206000-00002.
    1. Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, Stanghellini V. Functional gastroduodenal disorders. Gastroenterology. 2006;130:1466–1479. doi: 10.1053/j.gastro.2005.11.059.
    1. El-Serag HB, Talley NJ. Systemic review: the prevalence and clinical course of functional dyspepsia. Aliment Pharmacol Ther. 2004;19:643–654. doi: 10.1111/j.1365-2036.2004.01897.x.
    1. Kang X, Liu Z, Xie B. The incidence of Functional Dyspepsia of parts of citizens in Tianjin. Chinese Journal of Digestion. 2002;22:191–192.
    1. El-Serag HB, Talley NJ. Health-related quality of life in functional dyspepsia. Aliment Pharmacol Ther. 2003;18:387–393. doi: 10.1046/j.1365-2036.2003.01706.x.
    1. Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form. Aliment Pharmacol Ther. 2001;15:207–216. doi: 10.1046/j.1365-2036.2001.00900.x.
    1. Mones J, Adan A, Segu JL, Lopez JS, Artes M, Guerrero T. Quality of life in functional dyspepsia. Dig Dis Sci. 2002;47:20–26. doi: 10.1023/A:1013294815971.
    1. Tebaldi M, Heading RC. Clinical economics review: functional (non-ulcer) dyspepsia. Aliment Pharmacol Ther. 1998;12:11–19. doi: 10.1046/j.1365-2036.1998.00261.x.
    1. Talley NJ. Therapeutic options in nonulcer dyspepsia. J Clin Gastroenterol. 2001;32:286–293. doi: 10.1097/00004836-200104000-00004.
    1. Moayyedi P, Mason J. Clinical and economic consequences of dyspepsia in the community. Gut. 2002;50:iv10–12. doi: 10.1136/gut.50.suppl_4.iv10.
    1. Talley NJ. Helicobacter pylori and dyspepsia. Yale J Biol Med. 1999;72:145–151.
    1. Ouyang H, Chen JD. Review article: therapeutic roles of acupuncture in functional gastrointestinal disorders. Aliment Pharmacol Ther. 2004;20:831–841. doi: 10.1111/j.1365-2036.2004.02196.x.
    1. Takahashi T. Acupuncture for functional gastrointestinal disorders. J Gastroenterol. 2006;41:408–417. doi: 10.1007/s00535-006-1773-6.
    1. Wang YG, Yao SK. [Study on effects of low frequency pulse plus auricular point magnetic therapy on electrogastrogram and clinical therapeutic effect in the patient of functional dyspepsia] Zhongguo Zhen Jiu. 2007;27:245–248.
    1. Chen JY, Pan F, Xu JJ. [Effects of acupuncture on the gastric motivity in patients with functional dyspepsia] Zhongguo Zhong Xi Yi Jie He Za Zhi. 2005;25:880–882.
    1. Luo L, Shou YQ, Chen WJ. Clinical study on acupuncture treatment of functional dyspepsia. Zhongguo Zhen Jiu. 2002;27:89–90.
    1. Li Y, Liang F, Yu S, Liu X, Tang Y, Yang X, Tian X, Yan J, Sun G, Chang X, et al. Randomized controlled trial to treat migraine with acupuncture: design and protocol. Trials. 2008;9:57. doi: 10.1186/1745-6215-9-57.
    1. Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006;130:1377–1390. doi: 10.1053/j.gastro.2006.03.008.
    1. MacPherson H, White A, Cummings M, Jobst KA, Rose K, Niemtzow RC. Standards for Reporting Interventions in Controlled Trials of Acupuncture: The STRICTA Recommendations. The Journal of Alternative & Complementary Medicine. 2002;8:85–89. doi: 10.1089/107555302753507212.
    1. Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C. A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med. 2006;354:832–840. doi: 10.1056/NEJMoa052639.
    1. Assefi NP, Sherman KJ, Jacobsen C, Goldberg J, Smith WR, Buchwald D. A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia. Ann Intern Med. 2005;143:10–19.
    1. Chang CH, Huang JL, Ting CT, Chang CS, Chen GH. Atropine-induced HRV alteration is not amended by electroacupuncture on Zusanli. Am J Chin Med. 2005;33:307–314. doi: 10.1142/S0192415X05002928.
    1. Brinkhaus B, Hummelsberger J, Kohnen R, Seufert J, Hempen CH, Leonhardy H, Nogel R, Joos S, Hahn E, Schuppan D. Acupuncture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized-controlled clinical trial. Allergy. 2004;59:953–960. doi: 10.1111/j.1398-9995.2004.00540.x.
    1. Talley NJ, Haque M, Wyeth JW, Stace NH, Tytgat GN, Stanghellini V, Holtmann G, Verlinden M, Jones M. Development of a new dyspepsia impact scale: the Nepean Dyspepsia Index. Aliment Pharmacol Ther. 1999;13:225–235. doi: 10.1046/j.1365-2036.1999.00445.x.
    1. Wang J. Clinical Epidemiology – design, measurement and evaluation. 2. Shanghai: Shanghai Science and Technology Press; 2001.
    1. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, et al. Acupuncture in patients with tension-type headache: randomised controlled trial. Bmj. 2005;331:376–382. doi: 10.1136/bmj.38512.405440.8F.
    1. Scharf HP, Mansmann U, Streitberger K, Witte S, Kramer J, Maier C, Trampisch HJ, Victor N. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med. 2006;145:12–20.
    1. Hu KM, Wang CP, Xie HJ, Henning J. [Observation on activating effectiveness of acupuncture at acupoint and non-acupoint on different brain regions] Zhongguo Zhen Jiu. 2006;26:205–207.
    1. Maioli C, Falciati L, Marangon M, Perini S, Losio A. Short- and long-term modulation of upper limb motor-evoked potentials induced by acupuncture. Eur J Neurosci. 2006;23:1931–1938. doi: 10.1111/j.1460-9568.2006.04698.x.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi