High-intensity focused ultrasound combined with syndrome differentiation-based individualized herbal therapy and 12-month outcomes in patients with adenomyosis: a prospective non-randomized study

Abstract

Objective To evaluate the association of high-intensity focused ultrasound (HIFU) combined with syndrome differentiation-based individualized traditional Chinese medicine (TCM) herbal therapy with 12-month clinical outcomes compared with HIFU monotherapy in patients with adenomyosis (AM). Methods This prospective non-randomized, patient-preference, parallel-controlled study enrolled 88 patients with adenomyosis between November 2021 and November 2023; 87 completed 12-month follow-up and were analyzed (HIFU, n = 45; HIFU+TCM, n = 42). TCM prescriptions tailored for damp-heat and blood stasis obstruction, qi stagnation, or cold coagulation syndromes were administered for 3 months after HIFU. The primary outcome was the 12-month dysmenorrhoea numerical rating scale (NRS) score. Secondary outcomes were uterine volume, lesion volume, serum CA125, adverse events, and symptom recurrence. The primary analysis used multivariable-adjusted linear mixed-effects models. Stabilized inverse probability of treatment weighting (IPTW), with 1st/99th percentile trimming, was used as a sensitivity analysis; baseline balance was assessed using standardized mean differences. Results At 1 month, the adjusted between-group NRS difference was not significant ( P = 0.174). From 3 to 12 months, the HIFU+TCM group had lower adjusted NRS scores than the HIFU group (all P < 0.05). Uterine volume was smaller at 6, 9, and 12 months, and lesion volume at 9 and 12 months. IPTW sensitivity analyses supported these findings. Serum CA125 did not differ significantly between groups at any time point (12 months, P = 0.362). Adverse events were mild and comparable. Symptom recurrence occurred in 4/45 (8.89%) patients receiving HIFU and 6/42 (14.29%) receiving HIFU+TCM ( P = 0.492). Conclusion In this prospective non-randomized study, HIFU combined with syndrome differentiation-based individualized TCM herbal therapy was associated with greater improvement in dysmenorrhoea and greater reductions in uterine and lesion volumes over 12 months than HIFU alone, but not with lower symptom recurrence. These preliminary associations require confirmation in adequately powered randomized controlled trials.