Key Takeaways & Executive Findings
- •• HIFU ablation achieves significant fibroid volume reduction (45.2% at 6 months) with fewer adverse events compared to myomectomy. • Symptom severity and quality of life improvements are comparable between HIFU and surgery. • HIFU is a non-invasive option with shorter recovery time and lower complication rates. • Patient selection and tumor characteristics are critical for optimal HIFU outcomes.
Abstract
Background: High-intensity focused ultrasound (HIFU) is a non-invasive therapeutic modality for uterine fibroids. However, its efficacy and safety compared with conventional surgery remain debated. Methods: In this multicenter, randomized, controlled trial, we randomly assigned 200 women with symptomatic uterine fibroids to undergo HIFU ablation (n=100) or myomectomy (n=100). The primary endpoint was the reduction in fibroid volume at 6 months. Secondary endpoints included symptom severity score, quality of life, and adverse events. Results: At 6 months, the mean reduction in fibroid volume was 45.2% in the HIFU group versus 58.7% in the surgery group (P<0.001). Symptom severity scores improved significantly in both groups, with no significant difference between groups (P=0.32). Quality of life scores were comparable. Adverse events were fewer in the HIFU group (12% vs. 28%, P=0.004). Conclusion: HIFU is a safe and effective alternative to surgery for symptomatic uterine fibroids, offering comparable symptomatic relief with fewer adverse events, despite a smaller reduction in fibroid volume.
1. Introduction
Uterine fibroids are the most common benign tumors of the female reproductive system, affecting up to 70% of women of reproductive age. While many women are asymptomatic, a significant proportion experience heavy menstrual bleeding, pelvic pain, and reproductive dysfunction. Conventional treatments include myomectomy and hysterectomy, which are invasive and associated with surgical risks and prolonged recovery. In recent years, high-intensity focused ultrasound (HIFU) has emerged as a non-invasive therapeutic modality that ablates fibroids through targeted ultrasound energy, offering the potential for reduced morbidity and faster return to normal activities.
Despite its promise, the clinical adoption of HIFU has been limited by a lack of robust comparative data against standard surgical approaches. Previous studies have been mostly single-center with small sample sizes and short follow-up. Therefore, we conducted a multicenter, randomized controlled trial to rigorously evaluate the efficacy and safety of HIFU compared with myomectomy in women with symptomatic uterine fibroids. Our aim was to provide high-quality evidence to guide clinical decision-making and patient counseling.
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ZHANG Wei, LI Ming, WANG Fang, CHEN Jing, LIU Yang, ZHAO Lei, SUN Hong, ZHOU Qiang, WU Na, XU Lin, HUANG Mei, YANG Jun, GAO Peng, TANG Rui, HE Xia, FENG Yu, DENG Tao, CAO Min, XIE Bin, LUO Xin (2025). A Randomized Controlled Trial of High-Intensity Focused Ultrasound for the Treatment of Uterine Fibroids: A Multicenter Study. Chinese Journal of New Drugs. https://doi.org/pub_80__articleID_236
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Frequently Asked Questions
What is high-intensity focused ultrasound (HIFU) for uterine fibroids?
HIFU is a non-invasive procedure that uses focused ultrasound waves to heat and destroy fibroid tissue, without incisions. It is performed under MRI or ultrasound guidance and offers a shorter recovery time compared to surgery.
How does HIFU compare to myomectomy in terms of fibroid volume reduction?
In our trial, HIFU resulted in a mean fibroid volume reduction of 45.2% at 6 months, while myomectomy achieved 58.7%. Although surgery had a greater reduction, HIFU still provided significant symptomatic improvement.
Is HIFU as effective as surgery in relieving symptoms?
Yes, our study found that symptom severity scores improved significantly in both groups, with no statistically significant difference between HIFU and myomectomy. Quality of life also improved comparably.
What are the advantages of HIFU over surgery?
HIFU is non-invasive, resulting in fewer adverse events (12% vs. 28% in our study), no incisions, less pain, and faster recovery. It also preserves the uterus and may be suitable for women who wish to avoid surgery.
Are there any limitations of HIFU treatment?
HIFU may not be suitable for all fibroids, particularly those with high signal intensity on T2-weighted MRI or those located near the bowel or bladder. The procedure also requires specialized equipment and expertise, and long-term durability of symptom relief needs further study.
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