This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 In a case series of 42 women (51 fibroadenomas) treated by high-intensity focused ultrasound (HIFU), 63% (29/46) of the fibroadenomas had reduced in size by 30% at 2 months, 67% (32/48) had reduced by 50% at 6 months and 87% (40/46) had reduced by 60% at 12 months. In a non-randomised controlled study of 40 women, in which 20 were treated by HIFU and 20 were in a control group, fibroadenoma size was statistically significantly reduced by 17% at 2 weeks (standard deviation [SD] 19%, p=0.021) and by 31% at 3 months (SD 53%, p=0.022) in the HIFU group. In the same study, fibroadenoma size reduction was statistically significantly different in women treated by HIFU (44%, SD 39%, p=0.016) compared with women in the control group (5%, SD 46%, p=0.53) at 6‑month follow-up; complete fibroadenoma reduction was reported in 33% (4/20) of women in the HIFU group at 12‑month follow-up. In a case series of 10 patients treated by HIFU, fibroadenoma diameter was reduced by 50% in 100% (10/10) of patients at 3‑month follow-up. In a case series of 9 patients treated by magnetic resonance-guided HIFU, fibroadenomas size was reduced to 1.3 cm3 (mean, SD 1.1 cm3) from a baseline of 1.9 cm3 (mean, SD 1.5 cm3) in 50% (6/12) of treatments at 6‑month follow-up. In a case series of 20 patients, fibroadenoma size was statistically significantly reduced in patients treated only once by HIFU from 0.78 ml (0.35 ml to 2.24 ml) at baseline to 0.35 ml (0.06 ml to 1.21 ml, p<0.001) at 2‑year follow-up, and in patients treated twice from 2.66 ml (0.52 ml to 3.01 ml) to 0.21 ml (0.09 ml to 1.66 ml, p=0.003) at 2‑year follow-up.
4.2 In the non-randomised controlled study of 40 women, 10% (2/20) of fibroadenomas treated by HIFU did not change in size at 6‑month follow-up.
4.3 In the case series of 9 patients treated by magnetic resonance-guided HIFU, technical failure was reported in 42% (5/12) of fibroadenoma treatments.
4.4 In the case series of 42 women, 61% (31/51) of the fibroadenomas had caused discomfort before the procedure, which had resolved in 100% of the women at 12‑month follow-up. In the same study, at baseline, 35% (18/51) of fibroadenomas were associated with pain, which had resolved in 100% of patients at 12‑month follow-up. In the non-randomised controlled study of 40 women, complete pain reduction was reported by 75% (6/8) of women treated by HIFU at 6‑month follow-up.
4.5 In the case series of 20 patients treated by HIFU, for symptom disappearance, 45% (9/20) of patients were completely satisfied, and satisfaction was high in 50% (10/20) and low in 5% (1/20) of patients. In the same case series, for cosmetic results, 95% (19/20) of patients were completely satisfied and satisfaction was high in 5% (1/20) of patients.
4.6 The specialist advisers listed key efficacy outcomes as reduction in lesion size, relief or resolution of symptoms, cost effectiveness, recurrence of symptoms in the short and long term, and time taken to do the procedure.