Clinical Efficacy of Huayu Tongbian Decoction in Patients With Functional Constipation: A Randomized Controlled Trial With Exploratory Analysis of Serum VIP and 5-HT Levels
Abstract
Decoction (HTD) is a traditional Chinese herbal formula that has been applied in the management of chronic constipation, although evidence
from randomized studies and related biological investigations remains limited. Methods: This study was designed as a single-center randomized controlled trial. Sixty patients meeting diagnostic criteria for FC were randomly assigned to receive HTD (n = 30) or mosapride citrate
(n = 30) for 2 weeks. Symptom severity was assessed using the Constipation Scoring System (CSS) as the primary outcome. TCM symptom
scores were evaluated as secondary outcomes. Serum vasoactive intestinal peptide (VIP) and serotonin (5-hydroxytryptamine, 5-HT) levels
were measured before and after treatment by (ELISA as exploratory outcomes. Results: Fifty-five patients completed the study. CSS scores
improved significantly from baseline in both groups after treatment (P < 0.01). After treatment, CSS scores were significantly lower in the
HTD group compared with the control group (P < 0.01). TCM symptom scores decreased significantly in the HTD group (P < 0.05) but not
in the control group. Serum VIP and 5-HT levels decreased after treatment in both groups, with significantly lower post-treatment levels observed in the HTD group than in the control group (P < 0.05). Conclusions: HTD improved constipation symptoms in patients with functional
constipation and was associated with changes in serum VIP and 5-HT levels. Further studies with larger sample sizes and longer follow-up are
warranted to confirm these findings and to explore potential biological pathways.
Keywords
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DOI: http://dx.doi.org/10.70711/pmr.v3i4.8803
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