Abstract
Background: Uterine leiomyomas, commonly known as fibroids, are the most prevalent benign tumors in women of reproductive age and a major contributor to gynecological morbidity. Although surgery and hormonal therapies are standard treatments, their associated side effects have prompted the search for safer, non-hormonal alternatives. Oligo-fucoidan, a sulfated polysaccharide derived from brown seaweed, has demonstrated anti-fibrotic and estrogen-regulating effects in preclinical models, but its clinical potential remains largely unexplored. Methods: In this randomized, double-blind, placebo-controlled pilot trial, 16 women diagnosed with uterine leiomyomas by ultrasound were enrolled and randomly assigned to receive either oligo-fucoidan (4 g/day) or placebo for six months (n = 8 per group). The primary endpoints were changes in the number of leiomyomas and quality of life, assessed using the World Health Organization Quality-of-Life Scale (WHOQOL-BREF) and Menstrual Distress Questionnaire (MDQ). Hormonal and safety parameters were also monitored. Results: Compared with the placebo group, participants receiving oligo-fucoidan exhibited a statistically significant reduction in fibroid number and reported improvements in quality-of-life domains. No serious adverse events occurred, and no clinically significant changes were noted in safety-related laboratory parameters. Conclusions: This pilot study provides preliminary clinical evidence that oligo-fucoidan may be a safe, well-tolerated, and potentially effective functional food-based approach for managing uterine fibroids. Larger trials are warranted to confirm these findings.