Oxytocin-Augmented and Non-Sedating High-Intensity-Focused Ultrasound (HIFU) for Uterine Fibroids Showed Promising Outcome As Compared To HIFU Alone or Uterine Artery Embolization.

The use of a modified energy transmission protocol and oxytocin augmentation is being proposed as a high-intensity-focused ultrasound (HIFU) treatment for uterine fibroids, to aim for an effective and well-tolerable treatment to be given as an out-patient procedure without anesthesia or sedation. The objective of this study was to evaluate the safety and treatment effectiveness of this new protocol. The treatment outcomes of 9 consecutive patients (study group) were compared with those of 51 patients (control group) who had been randomized (1:1) to receive HIFU (n = 24) or uterine artery embolization ([UAE] n = 27). There was no major adverse event. At 3 mo, the median proportion of fibroid volume compared with the baseline was 51.1% in the study group, significantly smaller than that in the control groups (HIFU 76.6%, UAE 66.2%). At 6 mo, all patients in the study group became symptom free (9/9, 100%), a result significantly better than that of both control groups. The proportion of patients with good quality of life was significantly higher in the study group (5/7, 71.4%) compared with the control groups (HIFU 3/24, 12.5%; UAE 7/27, 25.9%). Within 24 mo, none of the patients in the study HIFU group required re-intervention, a result significantly better than that in the control HIFU group (15/24, 62.5%). The treatment could result in a very promising long-term imaging and clinical outcome that may be better than those of UAE; however, a randomized control trial of larger scale is required for further evaluation of this treatment.

RCT Entities:   Population Interventions Outcomes