Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial

Sai Ho Sin, Jing Wu, Yuchen Kang, Kar Hung Kevin Yip, Ngo Suet Kong, Hei Wan, Bacon Fung Leung Ng, Haiyong Chen, Sai Ho Sin, Jing Wu, Yuchen Kang, Kar Hung Kevin Yip, Ngo Suet Kong, Hei Wan, Bacon Fung Leung Ng, Haiyong Chen

Abstract

Background: Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally regarded as the Wei-Pi syndrome, and Banxia Xiexin decoction (BXD) has been used in the empirical treatment of the same for a long time. The current study aims to evaluate the efficacy of modified BXD in the management of Wei-Pi syndrome.

Methods/design: A randomized, waitlist-controlled trial will be conducted. A total of 84 patients with Wei-Pi syndrome will be randomized into the BXD or waitlist control group in a ratio of 1:1. The patients in the BXD group will receive the semi-individualized BXD on the basis of the syndrome differentiation in CM, for a duration of 3 weeks and will be under follow-up for further 3 weeks after the completion of therapy. Conversely, the patients in the waitlist control group will undergo the same intervention and follow-up after a 3-week waiting period. In the current study, the primary outcome will be the variation in the scores pertaining to the global scale of the Quality of Life Questionnaire for Functional Digestive Disorders after 3 weeks. The secondary outcomes include the variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests.

Discussion: This trial will assess the efficacy of modified BXD in improving the clinical symptoms and quality of life of the patients suffering from Wei-Pi syndrome.

Trial registration: ClinicalTrials.gov NCT04398888 . Registered on May 21, 2020.

Keywords: Banxia Xiexin decoction; Chinese medicine; Functional dyspepsia; Postprandial distress syndrome; Quality of life; Randomized controlled trial; Study protocol; Wei-Pi syndrome.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of patient recruitment

References

    1. Futagami S, Yamawaki H, Agawa S, Higuchi K, Ikeda G, Noda H, et al. New classification Rome IV functional dyspepsia and subtypes. Transl Gastroenterol Hepatol. 2018;3:70. doi: 10.21037/tgh.2018.09.12.
    1. Mahadeva S, Ford AC. Clinical and epidemiological differences in functional dyspepsia between the East and the West. Neurogastroenterol Motil. 2016;28(2):167–174. doi: 10.1111/nmo.12657.
    1. Hu W, Wong WM, Lam C, Lam K, Hui W, Lai K, et al. Anxiety but not depression determines health care-seeking behaviour in Chinese patients with dyspepsia and irritable bowel syndrome: a population-based study. Aliment Pharmacol Ther. 2002;16(12):2081–2088. doi: 10.1046/j.1365-2036.2002.01377.x.
    1. Cheng C, Hui WM, Lam SK. Psychosocial factors and perceived severity of functional dyspeptic symptoms: a psychosocial interactionist model. Psychosom Med. 2004;66(1):85–91. doi: 10.1097/01.PSY.0000106885.40753.C1.
    1. Moayyedi P, Mason J. Clinical and economic consequences of dyspepsia in the community. Gut. 2002;50(Suppl 4):iv10–iv12.
    1. Lacy BE, Weiser KT, Kennedy AT, Crowell MD, Talley NJ. Functional dyspepsia: the economic impact to patients. Aliment Pharmacol Ther. 2013;38(2):170–177. doi: 10.1111/apt.12355.
    1. Cheng S. Huangdi’s internal classic. Beijing: People’s Medical Publishing House; 2006.
    1. Zhang SS, Qin DP, Zhou Q, Ji YX, Li JX, Tang XD, et al. A clinical practice guideline for functional dyspepsia in Chinese medicine (primary care doctor version). China J Tradit Chinese Med Pharm. 2019;(8):75.
    1. Zhang SS, Zhao RQ. A diagnosis and treatment of functional dyspepsia: a consensus 2017. China J Tradit Chinese Med Pharm. 2017;(6):2595–8.
    1. Chung KF, Yeung WF, Leung FCY, Yu BYM. When east meets west: understanding the traditional Chinese medicine diagnoses on insomnia by Western medicine symptomatology. Eur J Integr Med. 2018;17:129–134. doi: 10.1016/j.eujim.2017.12.007.
    1. Yeung WF, Chung KF, Zhang NL, Zhang SP, Yung KP, Chen PX, et al. Identification of Chinese medicine syndromes in persistent insomnia associated with major depressive disorder: a latent tree analysis. Chin Med. 2016;11(4):4. doi: 10.1186/s13020-016-0076-y.
    1. Liu F, Fan YH, Wei YL. A review on the pathology and disease mechanisms of functional dyspepsia. J China-Japan Fridenship Hospital. 2007;21(5):303–305.
    1. Li YH. Banxia Xiexin decoction for Pi syndrome: an analysis of 159 cases. Beijing J Tradit Chinese Med. 1991;10(5):11.
    1. Feng H, Zang L, Zhang D-Z. Influence of Banxia Xiexin decoction on substance P in the blood serum and calcitonin gene-related peptide in the gastric antrum mucosa of patients with functional dyspepsia. J Nanjing Univ Tradit Chinese Med. 2015;31(4):310–13.
    1. He RH, Xie XL. Mosapride combined with Banxia Xiexin decoction in the treatment of functional dyspepsia and its effect on plasma motilin. J New Chinese Med. 2012;44(4):39–40.
    1. US Food Drug Administration . Guidance for industry drug-induced liver injury: premarketing clinical evaluation. 2009.
    1. US Food Drug Administration . Pharmacokinetics in patients with impaired renal function—study design, data analysis, and impact on dosing and labeling. 2010.
    1. Chassany O, Marquis P, Scherrer B, Read NW, Finger T, Bergmann JF, et al. Validation of a specific quality of life questionnaire for functional digestive disorders. Gut. 1999;44(4):527–533. doi: 10.1136/gut.44.4.527.
    1. Feng-Bin L, Yong-Xing J, Yu-Hang W, Zheng-Kun H, Xin-Lin C. Translation and psychometric evaluation of the Chinese version of functional digestive disorders quality of life questionnaire. Dig Dis Sci. 2014;59(2):390–420. doi: 10.1007/s10620-013-2897-1.
    1. Hou ZK, Mi H, Liu FB, Chen ZQ, Chen XL, Wu YH, et al. Interpreting the Chinese version of quality of life questionnaire for functional digestive disorders. J Gastroenterol Hepatol. 2018;33(4):869–877. doi: 10.1111/jgh.14025.
    1. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002;52(2):69–77. doi: 10.1016/S0022-3999(01)00296-3.
    1. Leung CM, Wing YK, Kwong PK, Lo A, Shum K. Validation of the Chinese-Cantonese version of the hospital anxiety and depression scale and comparison with the Hamilton Rating Scale of Depression. Acta Psychiatr Scand. 1999;100(6):456–461. doi: 10.1111/j.1600-0447.1999.tb10897.x.
    1. Mahadeva S, Wee HL, Goh KL, Thumboo J. The EQ-5D (Euroqol) is a valid generic instrument for measuring quality of life in patients with dyspepsia. BMC Gastroenterol. 2009;9:20. doi: 10.1186/1471-230X-9-20.
    1. Shetty AJ, Balaraju G, Shetty S, Pai CG. Quality of life in dyspepsia and its subgroups using EQ-5D (EuroQol) questionnaire. Saudi J Gastroenterol. 2017;23(2):112–116.
    1. National Center for Complementary and Integrative Health. Adverse event forms [Available from: . Accessed 25 Jan 2021.
    1. Chen XX, Lin WL, Yeung WF, Song TH, Lao LX, Zhang YB, et al. Quality and safety control of tumor-shrinking decoction (TSD): a Chinese herbal preparation for the treatment of uterine fibroids. Biotechnol Appl Biochem. 2017;64(1):126–133. doi: 10.1002/bab.1460.
    1. Song J, Yang L, Su S, Piao MY, Li BL, Yu Y, et al. Agreement of gastroenterologists in traditional Chinese medical differential diagnosis of functional dyspepsia compared with traditional Chinese medical practitioners: a prospective, multicenter study. J Dig Dis. 2020;21(7):399–405. doi: 10.1111/1751-2980.12873.
    1. Chu MHK, Wu IXY, Ho RST, Wong CHL, Zhang AL, Zhang Y, et al. Chinese herbal medicine for functional dyspepsia: systematic review of systematic reviews. Ther Adv Gastroenterol. 2018;11:1756284818785573. doi: 10.1177/1756284818785573.
    1. Moayyedi PM, Lacy BE, Andrews CN, Enns RA, Howden CW, Vakil N. ACG and CAG Clinical Guideline: management of dyspepsia. Am J Gastroenterol. 2017;112(7):988–1013. doi: 10.1038/ajg.2017.154.
    1. Zhang X, Tian R, Zhao C, Tang X, Lu A, Bian Z. Placebo design in WHO-registered trials of Chinese herbal medicine need improvements. BMC Complement Altern Med. 2019;19(1):299. doi: 10.1186/s12906-019-2722-2.

Source: PubMed

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