This randomized controlled trial enrolled 102 women with uterine fibroids. The observation group received Huayu Xiaozheng Decoction (HYXZD) combined with triptorelin and mifepristone, while the control group received only triptorelin plus mifepristone. The study followed participants for 12 months.
The group receiving the HYXZD combination showed a higher total effective rate (P < 0.05). Greater reductions in menstrual flow, fibroid volume, sex hormone levels (LH, E, FSH), hemorheologic parameters (BVH, BVL, PAGT), and serum tumor markers (CA125, CEA) were observed in the HYXZD group (all P < 0.05). Improvements in uterine artery hemodynamics (PI, RI, S/D) were also better in the observation group (P < 0.05). The 1-year recurrence rate was 7.84% (4/51) in the HYXZD group versus 11.76% (6/51) in the control group, a difference that was not statistically significant (P = 0.505).
Safety data indicated a lower adverse reaction rate in the observation group receiving the HYXZD combination. Key limitations include the lack of reported effect sizes and confidence intervals for most outcomes. The composition, standardization, and dosing of the herbal decoction (HYXZD) were not described. The clinical relevance is restrained to this specific population and regimen, and the non-significant recurrence rate difference tempers conclusions about long-term benefit.
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OBJECTIVE: To expound the efficacy of Huayu Xiaozheng Decoction (HYXZD) combined with triptorelin and mifepristone in the treatment of uterine fibroids, with a particular focus on its effect on uterine artery hemodynamics.
METHODS: A total of 102 women with uterine fibroids were enrolled and randomly allocated into a control group and an observation group. The control group received triptorelin plus mifepristone, while the observation group was additionally treated with HYXZD. Both groups were treated for 3 months. Clinical efficacy was compared, and the following parameters were measured before and after treatment: menstrual flow, fibroid volume, sex hormone levels (LH, E, FSH), uterine artery hemodynamics (PI, RI, S/D), hemorheologic parameters (BVH/BVL, PAGT), serum tumor markers (CA125, CEA), adverse reactions, and 1-year recurrence rate.
RESULTS: The total effective rate was higher in the observation group relative to the control group (P < 0.05). Before treatment, no notable differences existed between groups in menstrual flow, fibroid volume, LH, E, FSH, PI, RI, S/D, BVH, BVL, PAGT, CA125, or CEA (P > 0.05). Following treatment, both groups showed reductions in menstrual flow, fibroid volume, LH, E, FSH, BVH, BVL, PAGT, CA125, and CEA, with greater reductions in the observation group (P < 0.05); PI, RI, and S/D increased in both groups, with better improvements in the observation group (P < 0.05). The adverse reaction rate was lower in the observation group versus the control group (P = 0.013). At the 1-year follow up, recurrence occurred in 11.76% (6/51) of patients in the control group and 7.84% (4/51) of patients in the observation group (P = 0.505).
CONCLUSION: HYXZD combined with triptorelin and mifepristone improves clinical outcomes in uterine fibroid treatment by reducing fibroid size, optimizing hormone levels and hemodynamics, lowering tumor markers, and maintaining safety.