Validation of the translated Bengali version of Uterine Fibroid Symptom Quality of Life questionnaire (UFS-QOL) & open observational trial to evaluate effectiveness of individualized homoeopathic treatment of symptomatic uterine fibroids

Uterine fibroids (myomas, fibromyomas or leiomyomas) are the most common, benign, monoclonal tumours of the smooth muscle cells and extracellular matrix proteins collagen and elastin found in the human uterus and are identified as the most common diagnosis associated with a hysterectomy. Uterine fibroids lead to nearly 600,000 hysterectomies performed each year in the USA and 37,000 myomectomies performed annually, nevertheless, epidemiological data on fibroid prevalence and incidence are limited and reliable population-based research is lacking. Therapeutic options include medical therapy, surgical interventions like hysterectomy (abdominal, vaginal and laparoscopic) and myomectomy (laparotomy, laparoscopic and hysteroscopic), and newer approaches, such as myolysis, focused ultrasound, transvaginal cryomyolysis and uterine artery embolisation (UAE). All conservative management options allow the possibility for new leiomyomas to form, and pre-existing small or undetected leiomyomas may exhibit significant growth, necessitating another treatment. The most frequently consulted alternative therapist for uterine fibroids is a homeopath; however, there is an acute paucity of published research. In this open, observational, multicentric, pre-post comparison clinical trial, 100 patients will be given individualized homoeopathic medicines to examine treatment effect over 6 months. Prior to that, psychometric validity of the translated Bengali version of the Uterine Fibroids Symptoms Quality of Life (UFS-QOL) questionnaire will be tested. Results will be published in scientific journals.