A clinical study on the efficacy of a novel herbal medicine cocktail in enhancing HIFU treatment for adenomyosis: a pilot randomized controlled trial

Objective: To investigate the clinical efficacy and potential mechanisms of Traditional Chinese Medicine (TCM) combined with High-Intensity Focused Ultrasound (HIFU) in the treatment of adenomyosis, providing evidence-based support for optimizing clinical treatment strategies. Methods: In this prospective randomized trial, 66 patients were assigned to a control group (HIFU alone) or an observation group (HIFU plus a “Yiqi Huoxue, Huayu Sanjie” TCM formula) for 12 weeks. The Visual Analog Scale (VAS) for pain as the primary endpoint, and the Pictorial Blood Loss Assessment Chart (PBAC) for menstrual blood loss, uterine/lesion volumes, and serum carbohydrate antigen 125 (CA125), interleukin-6 (IL-6) as exploratory outcomes were assessed. Results: The results showed that the VAS scores in the observation group were significantly lower than those in the control group after treatment (p < 0.05). The reduction in uterine volume and lesion volume was greater in the observation group compared to the control group (p < 0.05). Serum levels of CA125 and IL-6 decreased more significantly in the observation group (p < 0.05), and no significant abnormalities were observed in safety indicators. Conclusion: The combination of TCM and HIFU treatment suggests a possible benefit in alleviating dysmenorrhea and promoting lesion absorption in patients with adenomyosis. The observed changes in inflammatory status and CA125 levels hint at a potential link with the therapeutic effect. However, these findings should be considered exploratory, and further studies are needed to validate TCM as an adjunctive therapy to HIFU treatment.