Discussion
This meta-analysis aimed to evaluate the effectiveness of MRI-HIFU on patients with uterine fibroids. The results showed that there was an overall decrease in NPV% and tSSS% change. The health-related quality of life among patients with uterine fibroids also improved with follow-up; however, this was seen only in three studies and needs to be assessed further. Studies involved in the meta-analysis have also proclaimed improved reproductive outcomes. It has come to light that reintervention was needed in 18-24% of patients. This meta-analysis has included studies that have focussed on complete ablation for looking at the overall effect of MR-HIFU.
The overall level of data, which was low to moderate, affected all of the outcome criteria examined in this study. For inclusion, only non-randomized, non-comparative trials were available. The sources of a high risk of prejudice are linked to the sample designs themselves: insufficient documentation of loss of follow-up and the possibility of selection bias.
Increased expertise improves care effectiveness by reducing technical errors and treatment time in extended patient cohorts. Xu et al. registered the shortest sonication duration, suggesting that the Chongqing method could increase treatment effectiveness. The pooled NPV percent immediately after MR-HIFU was 70.24 percent, which is higher than other reviews14,18, owing to the lack of stringent treatment protocols. The distribution of dispersed points into two classes showed a remarkable asymmetry in our findings. Unfortunately, we were unable to provide a complete explanation. Through bowel-interference avoidance methods, only a minor disparity was discovered, meaning that this may lead to a higher NPV percent.
The pooled tSSS declined on average and continued to increase during follow-up. There was no data available for more than a year. MR-HIFU was not linked to other therapeutic choices in any of the trials included. At a 3-months follow-up, Jacoby et al. compared MRgFUS to placebo21 and found that the MRgFUS community had a more significant tSSS decline, -31 vs. -13 points. We looked for other uterine fibroid studies that used the UFS-QoL questionnaire to equate the tSSS of MR-HIFU to other treatment alternatives (UAE, hysterectomy, and myomectomy). Similarly, studies by Spies JB30 and Manyonda IT31 have also reported a decrease in tSSS% change in myomectomy and hysterectomy, and the present meta-analysis has indicated an overall tSSS% change of 49.27, which is comparable to hysterectomy and myomectomy. Few studies reported health-related quality of life, but the enrolled studies have improved uterine fibroid-related quality of life.
Fibroid shrinkage was shown in all the studies, and the percentage of shrinkage ranged over time, indicating that fibroids will continue to shrink in volume for at least a year. The relationship between fibroid shrinkage and NPV percent was marginally significant, implying that a higher NPV percent could lead to more fibroid shrinkage. Please keep in mind that a follow-up MRI exam is costly and mostly needless.
The reintervention has seen in Tan et al.20, Mindjuk et al.19, and Chen et al.16 was 9%, 12.7%, and 0.9%, respectively, while other studies did not report the need for reintervention on the follow-up period. This particular result pointed at the efficacy of the procedure. The procedure of MR-HIFU is non-invasive and does not indicate any effect on the reproductive outcome of the patients after the treatment. None of the studies has included the reproductive outcome and hence raised concern. However, studies by Lee JS32 and Cheung VY33have shown no effect on the Anti-Mullerian Hormone, indicating that women can try for pregnancy after treating uterine fibroids.
Just two SAEs were identified in older studies24,39, which may be clarified by a slight learning curve effect when MR-HIFU was first used in clinical practice [13]. As AE was stratified by method, trials using the Sonalleve system had slightly more AE than trials using the ExAblate device 14,15,17,22. Two Ex-Ablate reports, on the other hand, reported ‘no unforeseen or major AE,’ implying under-reporting16,27. Furthermore, there is no agreement about how to define AE in the context of MR-HIFU. For example, although irregular vaginal discharge is often classified as AE, fibroid expulsion was identified as a common finding in 21% of ExAblate patients 19. Surprisingly, a Sonalleve study classified constitutional symptoms as AE, although none of the other studies did 22. Although a reporting bias may clarify the disparity in AE between Sonalleve and ExAblate, more research is needed in the future.
These treatment modalities may have shown to be cost effective34-38 but not included in this analysis. MR-HIFU can be considered a cost-effective treatment for patients ready to pay.
Methodological flaws were to blame for the meta-analysis’s flaws. Standard deviations were often estimated. There was a lack of follow-up in some trials, and some sub-studies had different sample sizes41. As a consequence, the findings should be viewed with caution. Furthermore, since the findings are based on published means rather than actual patient records, the ecological fallacy may have influenced the results. We questioned if we should generalize our findings because of the significant and often mysterious heterogeneity in each outcome parameter. However, since we used a random-effects model for meta-analysis40, this approach is accurate.
Even though MR-HIFU has been used to treat uterine fibroids for 14 years, it is still not widely used or reimbursed worldwide. The gold standard for obtaining reimbursement is a randomized clinical experiment, and one is currently underway to compare UAE and MR-HIFU42. However, they had difficulty selecting volunteers, and some patients refused to be randomly assigned. As a result, randomized experiments are challenging to perform and face statistical difficulties. More extensive retrospective randomized cohort trials with longer follow-up are needed to establish the role of MR-HIFU in the management of symptomatic uterine fibroids before it can be used in routine clinical care.