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Journal of Traditional Chinese Medicine ›› 2024, Vol. 44 ›› Issue (6): 1254-1267.DOI: 10.19852/j.cnki.jtcm.20240806.005

• Research Articles • Previous Articles     Next Articles

Clinical efficacy and safety evaluation of Buzhongyiqi pills (补中益气丸) on appetite improvement in patients with colorectal cancer receiving chemotherapy: a pilot randomized cross-over clinical trial

QIAN Jianan1,2, XU Yan3, HU Hongyi4(), ZHAO Aiguang3()   

  1. 1 Department of Gastroenterology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China
    2 Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    3 Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    4 Department of Gastroenterology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
  • Received:2023-05-02 Accepted:2023-09-02 Online:2024-12-15 Published:2024-08-06
  • Contact: HU Hongyi,ZHAO Aiguang
  • About author:ZHAO Aiguang, Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. aiguangzhao@qq.com Telephone: +86-18918799919; +86-13661472241
    HU Hongyi, Department of Gastroenterology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. hongyihu2003@shutcm.edu.cn;
  • Supported by:
    Shanghai Municipal Administrator of Traditional Chinese Medicine-funded Project: Ding’s Clinical Medicine Huang Wendong Base Li Dongyuan "Yin Fire" Theory Inheritance and Innovation Team(2021LPTD-009)

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Abstract:

OBJECTIVE: To evaluate the clinical efficacy and safety of Buzhongyiqi pills (BZYQP, 补中益气丸) in improving the appetite of patients with colorectal cancer (CRC) receiving chemotherapy.

TRIAL DESIGN: A pilot, randomized, single-blind cross-over clinical trial was conducted on diagnosed stage II-IV CRC patients receiving chemotherapy.

METHODS: Patients were randomly assigned to either the BZYQP-placebo or placebo-BZYQP groups. The BZYQP-placebo group received BZYQP for 1-2 d before the first cycle of chemotherapy and continued until the end of the third cycle. A 7-day washout followed, after which they received a placebo until the end of the sixth cycle. The placebo-BZYQP group followed the opposite treatment order. The oral dose of BZYQP and placebo was ten pills three times daily. A total of 12 visit points were scheduled in this study, with each visit point carried out before and after each of the six cycles of chemotherapy. The Simplified Nutrition Appetite Questionnaire (SNAQ), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0), and the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, V5.0) were used to evaluate patient appetite, quality of life, and drug safety.

RESULTS: Totally 62 patients completed the study, and baseline characteristics were balanced between the BZYQP-placebo and placebo-BZYQP groups. The primary outcome, as assessed by SNAQ scores, demonstrates a statistically significant difference between the two groups during the first three cycles of chemotherapy, with the mean SNAQ score of the BZYQP-placebo group consistently higher than that of the placebo-BZYQP group from V1 (P < 0.001). After the washout period, the SNAQ score of the BZYQP-placebo group decreased from V7, and the difference in SNAQ scores between the two groups gradually became more significant after the intersection at V9. Secondary outcomes showed that during the first three cycles of chemotherapy, the BZYQP-placebo group had significantly lower scores in physical, role, emotional, cognitive, and social functioning domains, as well as in fatigue, loss of appetite, and diarrhea symptoms, compared to the placebo-BZYQP group (P < 0.001). Scores for physical, role, emotional, cognitive, and social functioning in the BZYQP-placebo group remained lower (P < 0.05) at V11. The chemotherapy-induced adverse events (AEs) in the BZYQP-placebo group were significantly lower than those in the placebo-BZYQP group at V5, mainly in nausea and vomiting (9.1% vs 62.1%, P < 0.001), diarrhea (12.1% vs 44.8%, P = 0.004), and anemia (15.2% vs 41.4%, P = 0.021). No drug-related events were reported in this study.

CONCLUSION: BZYQP is feasible and safe to effectively improve the appetite of patients with CRC receiving chemotherapy and help them with better quality of life.

Key words: colorectal neoplasms, appetite, quality of life, adverse events, pilots, cross-over studies, randomized controlled trials, Buzhongyiqi pills

Cite this article

QIAN Jianan, XU Yan, HU Hongyi, ZHAO Aiguang. Clinical efficacy and safety evaluation of Buzhongyiqi pills (补中益气丸) on appetite improvement in patients with colorectal cancer receiving chemotherapy: a pilot randomized cross-over clinical trial[J]. Journal of Traditional Chinese Medicine, 2024, 44(6): 1254-1267.