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