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
作者机构：Department of Gastroenterology， Longhua Hospital， Shanghai University of Traditional Chinese Medicine Institute of Digestive Diseases， Longhua Hospital， Shanghai University of Traditional Chinese Medicine Department of Oncology， Longhua Hospital， Shanghai University of Traditional Chinese Medicine
出 版 物：《Journal of Traditional Chinese Medicine》 (中医杂志(英文版))
年 卷 期：2024年
核心收录：
学科分类：1006[医学-中西医结合] 100602[医学-中西医结合临床] 10[医学]
摘 要：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 *** DESIGN: A pilot， randomized， single-blind cross-over clinical trial was conducted on diagnosed stage II-IV CRC patients receiving ***: Patients were randomly assigned to either the BZYQP-placebo or placebo-BZYQP groups. The BZYQP-placebo group received BZYQP for 1-2 days 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 ***: 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
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