Acupuncture of different treatment frequency in postprandial distress syndrome: A pilot randomized clinical trial
Yu Wang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorYa-Quan Hou
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorJing-Wen Yang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorLi-Qiong Wang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorJia-Kai Shao
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China
Search for more papers by this authorXuan Zou
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorNa-Na Yang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorJin Huang
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China
Search for more papers by this authorCorresponding Author
Cun-Zhi Liu
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Correspondence
Cun-zhi Liu, Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing 100029, China.
Email: [email protected]
Search for more papers by this authorYu Wang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorYa-Quan Hou
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorJing-Wen Yang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorLi-Qiong Wang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorJia-Kai Shao
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China
Search for more papers by this authorXuan Zou
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorNa-Na Yang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Search for more papers by this authorJin Huang
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China
Search for more papers by this authorCorresponding Author
Cun-Zhi Liu
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Correspondence
Cun-zhi Liu, Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing 100029, China.
Email: [email protected]
Search for more papers by this authorFunding information
Beijing Municipal Science & Technology Commission (No. Z161100000516007).
Abstract
Background
The evidence for different frequencies of acupuncture treatment in postprandial distress syndrome (PDS) is insufficient. This study determined whether 3 sessions per week of acupuncture treatment are superior to 1 session per week for symptomatic outcomes in PDS.
Methods
This 16-week randomized clinical pilot trial was conducted in an outpatient setting in China. Patients with PDS were randomly assigned to receive 3 sessions per week of acupuncture (group H) or 1 session per week of acupuncture (group L) for 4 weeks. The primary outcome was the complete elimination of core symptoms at week 4. Secondary outcomes included overall treatment efficacy, dyspepsia symptoms, quality of life, anxiety, and depression.
Key Results
Sixty patients were randomized of whom 53 (88.3%) completed this trial. The complete elimination rate of core symptoms was 26.7% (95% CI 12.3%-45.9%) in group H and 10.0% (95% CI 2.1%-26.5%) in group L at week 4 (P = .095). There was a significant difference between H and group L at weeks 8, 12, and 16 (P = .038, .02, and .02). All secondary outcomes were better in group H at all time points. No serious adverse events occurred in either groups.
Conclusions
This trial showed that acupuncture, at 3 sessions per week, tended to improve symptoms and the quality of life among patients with PDS as compared to once a week. Acupuncture treatment for 4 weeks was feasible and safe. A larger sample, multicenter, randomized controlled trial of acupuncture for PDS appears to be justified in the future.
CONFLICT OF INTEREST
The authors have no conflict of interest.
Supporting Information
| Filename | Description |
|---|---|
| nmo13812-sup-0001-Appendix.docxWord document, 18.7 KB |
Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
REFERENCES
- 1Tack J, Drossman DA. What's new in Rome IV. Neurogastroenterol Motil. 2017; 29:e13053.
- 2Tack J, Talley NJ, Camilleri M, et al. Functional gastroduodenal disorders. Gastroenterology. 2006; 130: 1466-1479.
- 3Stanghellini V, Chan FK, Hasler WL, et al. Gastroduodenal disorders. Gastroenterology. 2016; 150: 1380-1392.
- 4Drossman DA. Functional gastrointestinal disorders: history, pathophysiology, clinical features, and Rome IV. Gastroenterology. 2016; 150: 1262-1279.e2.
- 5Aziz I, Palsson OS, Törnblom H, Sperber AD, Whitehead WE, Simrén M. Epidemiology, clinical characteristics, and associations for symptom-based Rome IV functional dyspepsia in adults in the USA, Canada, and the UK: a cross-sectional population-based study. Lancet Gastroenterol Hepatol. 2018; 3: 252-262.
- 6Van Den Houte K, Carbone F, Tack J. Postprandial distress syndrome: stratification and management. Expert Rev Gastroenterol Hepatol. 2019; 13: 37-46.
- 7Chuah KH, Mahadeva S. Cultural factors influencing functional gastrointestinal disorders in the East. J Neurogastroenterol Motil. 2018; 24: 536-543.
- 8Matsuzaki J, Suzuki H, Fukushima Y, et al. High frequency of overlap between functional dyspepsia and overactive bladder. Neurogastroenterol Motil. 2012; 24: 821-827.
- 9Aziz I, Palsson OS, Törnblom H, Sperber AD, Whitehead WE, Simrén M. The prevalence and impact of overlapping Rome IV-diagnosed functional gastrointestinal disorders on somatization, quality of life, and healthcare utilization: a cross-sectional general population study in three countries. Am J Gastroenterol. 2018; 113: 86-96.
- 10Matsuzaki J, Suzuki H, Togawa K, et al. Burden of impaired sleep quality on work productivity in functional dyspepsia. United European Gastroenterol J. 2018; 6: 398-406.
- 11Ford AC, Forman D, Bailey AG, Axon AT, Moayyedi P. Effect of dyspepsia on survival: a longitudinal 10-year follow-up study. Am J Gastroenterol. 2012; 107: 912-921.
- 12Chang JY, Locke GR 3rd, McNally MA, et al. Impact of functional gastrointestinal disorders on survival in the community. Am J Gastroenterol. 2010; 105: 822-832.
- 13Camilleri M, Stanghellini V. Current management strategies and emerging treatments for functional dyspepsia. Nat Rev Gastroenterol Hepatol. 2013; 10: 187-194.
- 14Enck P, Azpiroz F, Boeckxstaens G, et al. Functional dyspepsia. Nat Rev Dis Primers. 2017; 3: 17081.
- 15Jung HK, Lee KJ, Choi MG, et al. Efficacy of DA-9701 (Motilitone) in functional dyspepsia compared to pantoprazole: a multicenter, randomized, double-blind, non-inferiority study. J Neurogastroenterol Motil. 2016; 22: 254-263.
- 16Moayyedi P, Soo S, Deeks J, Delaney B, Innes M, Forman D. Pharmacological interventions for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2006; CD001960.
- 17Ouyang H, Chen JD. Review article: therapeutic roles of acupuncture in functional gastrointestinal disorders. Aliment Pharmacol Ther. 2004; 20: 831-841.
- 18Hiyama T, Yoshihara M, Matsuo K, et al. Meta-analysis of the effects of prokinetic agents in patients with functional dyspepsia. J Gastroenterol Hepatol. 2007; 22: 304-310.
- 19Suzuki H, Kusunoki H, Kamiya T, et al. Effect of lansoprazole on the epigastric symptoms of functional dyspepsia (ELF study): a multicentre, prospective, randomized, double-blind, placebo-controlled clinical trial. United European Gastroenterol J. 2013; 1: 445-452.
- 20Bektas M, Soykan I, Altan M, Alkan M, Ozden A. The effect of Helicobacter pylori eradication on dyspeptic symptoms, acid reflux and quality of life in patients with functional dyspepsia. Eur J Intern Med. 2009; 20: 419-423.
- 21Talley NJ. Functional dyspepsia: advances in diagnosis and therapy. Gut Liv. 2017; 11: 349-357.
- 22Moayyedi P, Lacy BE, Andrews CN, Enns RA, Howden CW, Vakil N. ACG and CAG clinical guideline: management of dyspepsia. Am J Gastroenterol. 2017; 112: 988-1013.
- 23Tack J, Van den Houte K, Carbone F. The unfulfilled promise of prokinetics for functional dyspepsia/postprandial distress syndrome. Am J Gastroenterol. 2019; 114: 204-206.
- 24Suzuki H, Hibi T. Acotiamide (Z-338) as a possible candidate for the treatment of functional dyspepsia. Neurogastroenterol Motil. 2010; 22: 595-599.
- 25Altan E, Masaoka T, Farré R, Tack J. Acotiamide, a novel gastroprokinetic for the treatment of patients with functional dyspepsia: postprandial distress syndrome. Expert Rev Gastroenterol Hepatol. 2012; 6: 533-544.
- 26Takahashi T. Acupuncture for functional gastrointestinal disorders. J Gastroenterol. 2006; 41: 408-417.
- 27Kim KN, Chung SY, Cho SH. Efficacy of acupuncture treatment for functional dyspepsia: a systematic review and meta-analysis. Complement Ther Med. 2015; 23: 759-766.
- 28Ma T, Zeng F, Li Y, et al. Which subtype of functional dyspepsia patients responses better to acupuncture? A retrospective analysis of a randomized controlled trial. Forsch Komplementmed. 2015; 22: 94-100.
- 29Pang B, Jiang T, Du YH, et al. Acupuncture for functional dyspepsia: what strength does it have? A systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med. 2016; 2016: 1-17.
- 30Ho R, Chung V, Wong C, Wu J, Wong S, Wu I. Acupuncture and related therapies used as add-on or alternative to prokinetics for functional dyspepsia: overview of systematic reviews and network meta-analysis. Sci Rep. 2017; 7: 10320.
- 31Sun N, Tu JF, Lin LL, et al. Correlation between acupuncture dose and effectiveness in the treatment of knee osteoarthritis: a systematic review. Acupunct Med. 2019; 37: 261-267.
- 32White A, Cummings M, Barlas P, et al. Defining an adequate dose of acupuncture using a neurophysiological approach–a narrative review of the literature. Acupunct Med. 2008; 26: 111-120.
- 33Armour M, Smith CA. Treating primary dysmenorrhoea with acupuncture: a narrative review of the relationship between acupuncture 'dose' and menstrual pain outcomes. Acupunct Med. 2016; 34: 416-424.
- 34MacPherson H, Maschino AC, Lewith G, et al. Characteristics of acupuncture treatment associated with outcome: an individual patient meta-analysis of 17,922 patients with chronic pain in randomised controlled trials. PLoS ONE. 2013; 8:e77438.
- 35Yan LI. Study on the time-effect relationship of acupuncture between needle retaining time and the interval time of acupuncture. Liaoning J Tradit Chin Med. 2013; 2013(03): 160-162.
- 36Zhong YT, Huang DL, Gao M. Research on the effect that frequency do to the curative effect of acupuncture. J Liaoning Univ Tradit Chin Med. 2012; 14(10): 132-133.
- 37Suzuki H. The application of the Rome IV criteria to functional esophagogastroduodenal disorders in Asia. J Neurogastroenterol Motil. 2017; 23: 325-333.
- 38Suzuki H, Mori H. Helicobacter pylori: Helicobacter pylori gastritis–a novel distinct disease entity. Nat Rev Gastroenterol Hepatol. 2015; 12: 556-557.
- 39Xie X, Zhu H, Wu X, Chen Q, Liang F. Regularity of acupoints’ application in acupuncture and moxibustion clinical trials for functional dyspepsia. J Chengdu Univ TCM. 2008; 31: 1.
- 40Peng C, Cunzhi L, Guiling W, et al. Experienced ten acupoints” from “golden needle” Wang Leting. World Chinese Medicine. 2012; 7(05): 430-431.
- 41Zhou K, Fang J, Wang X, et al. Characterization of de qi with electroacupuncture at acupoints with different properties. J Altern Complement Med. 2011; 17: 1007-1013.
- 42Ang D, Talley NJ, Simren M, Janssen P, Boeckxstaens G, Tack J. Review article: endpoints used in functional dyspepsia drug therapy trials. Aliment Pharmacol Ther. 2011; 33: 634-649.
- 43 U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006; 4: 79.
- 44 Design of Treatment Trials Committee, Irvine EJ, Whitehead WE, et al. Design of treatment trials for functional gastrointestinal disorders. Gastroenterology. 2006; 130: 1538-1551.
- 45Tan VP, Liu KS, Lam FY, Hung IF, Yuen MF, Leung WK. Randomised clinical trial: rifaximin versus placebo for the treatment of functional dyspepsia. Aliment Pharmacol Ther. 2017; 45: 767-776.
- 46Iwakiri R, Tominaga K, Furuta K, et al. Randomised clinical trial: rabeprazole improves symptoms in patients with functional dyspepsia in Japan. Aliment Pharmacol Ther. 2013; 38: 729-740.
- 47Zeng F, Qin W, Ma T, et al. Influence of acupuncture treatment on cerebral activity in functional dyspepsia patients and its relationship with efficacy. Am J Gastroenterol. 2012; 107: 1236-1247.
- 48Tian X, Li Y, Ma T, Liang FR. Review of efficacy index of acupuncture for functional dyspepsia. Liaoning J Tradit Chin Med. 2008; 25: 1584.
- 49Veldhuyzen van Zanten SJ, Jones MJ, Verlinden M, Talley NJ. Efficacy of cisapride and domperidone in functional (nonulcer) dyspepsia: a meta-analysis. Am J Gastroenterol. 2001; 96: 689-696.
- 50van Zanten SV, Armstrong D, Chiba N, et al. Esomeprazole 40 mg once a day in patients with functional dyspepsia: the randomized, placebo-controlled "ENTER" trial. Am J Gastroenterol. 2006; 101: 2096-2106.
- 51Chiba N, Van Zanten SJ, Sinclair P, Ferguson RA, Escobedo S, Grace E. Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: the Canadian adult dyspepsia empiric treatment-Helicobacter pylori positive (CADET-Hp) randomised controlled trial. BMJ. 2002; 324: 1012-1016.
- 52Matsueda K, Hongo M, Tack J, Saito Y, Kato H. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut. 2012; 61: 821-828.
- 53Tian XP, Li Y, Liang FR, et al. Translation and validation of the Nepean Dyspepsia Index for functional dyspepsia in China. World J Gastroenterol. 2009; 15: 3173-3177.
- 54Talley NJ, Haque M, Wyeth JW, et al. Development of a new dyspepsia impact scale: the Nepean Dyspepsia Index. Aliment Pharmacol Ther. 1999; 13: 225-235.
- 55Aro P, Talley NJ, Ronkainen J, et al. Anxiety is associated with uninvestigated and functional dyspepsia (Rome III criteria) in a Swedish population-based study. Gastroenterology. 2009; 137: 94-100.
- 56White IR, Carpenter J, Horton NJ. Including all individuals is not enough: lessons for intention-to-treat analysis. Clin Trials. 2012; 9: 396-407.
- 57Zheng H, Xu J, Sun X, et al. Electroacupuncture for patients with refractory functional dyspepsia: a randomized controlled trial. Neurogastroenterol Motil. 2018; 30:e13316.
- 58Corazziari E, Bytzer P, Delvaux M, et al. Clinical trial guidelines for pharmacological treatment of irritable bowel syndrome. Aliment Pharmacol Ther. 2003; 18: 569-580.
- 59Jones M, Talley NJ. Minimum clinically important difference for the Nepean Dyspepsia Index, a validated quality of life scale for functional dyspepsia. Am J Gastroenterol. 2009; 104: 1483-1488.
- 60Aro P, Talley NJ, Agréus L, et al. Functional dyspepsia impairs quality of life in the adult population. Aliment Pharmacol Ther. 2011; 33: 1215-1224.
- 61Haag S, Senf W, Häuser W, et al. Impairment of health-related quality of life in functional dyspepsia and chronic liver disease: the influence of depression and anxiety. Aliment Pharmacol Ther. 2008; 27: 561-571.
- 62Tomita T, Oshima T, Miwa H. New approaches to diagnosis and treatment of functional dyspepsia. Curr Gastroenterol Rep. 2018; 20: 55.
- 63Janssen P, Harris MS, Jones M, et al. The relation between symptom improvement and gastric emptying in the treatment of diabetic and idiopathic gastroparesis. Am J Gastroenterol. 2013; 108: 1382-1391.
Citing Literature
