Non-surgical management of uterine fibroids with a classical siddha formulation, Rasaganthi Mezhugu – an open pilot trial
Paper Details
Non-surgical management of uterine fibroids with a classical siddha formulation, Rasaganthi Mezhugu – an open pilot trial
Abstract
Uterine fibroids are the most common non-cancerous growth among women of reproductive age and elderly women, and this is highly concerned with affecting women’s quality of life. The treatment procured in conventional medicine is of either medicinal management or surgical, which may lead to several complications. As a matter of considering the limitations of other conventional management, Rasaganthi Mezhugu (RGM), a classical Siddha formulation, has been selected to validate its clinical role in the management of Karuppai Sathai Kattigal/ Karuppai Naarthasai Kattigal (Uterine Fibroids). The objective of this study was to determine the safety and efficacy of RGM in patients with uterine fibroids. The study was designed as an open pilot single-arm clinical trial with a sample size of 20 patients. Women aged 25-55 years with clinical symptoms of uterine fibroids and the presence of fibroids confirmed with Trans-vaginal Ultra sonogram were included in the study. The trial drug, RGM was administered orally in 500 mg capsule twice a day for a period of 90 days and followed up at month 6 and month 9. Among 20 patients, complete disappearance of Intramural fibroids was noted in 7 patients (35%) and there was a positive significant difference in the size of fibroids from baseline compared to day 90, month 6 and month 9 at a 5% level of significance. The patients were also symptomatically relieved. Also, there were no significant differences observed in the haematological indexes of the recruited subjects, substantiating the safety profile.
Donnez J, Dolmans MM. 2016. Uterine fibroid management: From the present to the future, Human Reproduction Update 22(6), 665–686.
Dr. Shanmugavel M. 2006. Noinaadal Noi muthalnaadal Thirattu. Directorate of Indian Medicine and Homeopathy, Chennai, India, Part 2.
Dutta DC. 2013. Dc Dutta’s Textbook of Gynaecology. Jaypee Brothers Medical Publishers (P) Ltd, 6th Edition.
Elizabeth AP, David JV, Jonathan SB, William P, Ronald F, Jacqueline F, David LO. 2015. The prevalence of occult leiomyosarcoma at surgery for presumed uterine fibroids: A meta-analysis. Gynecological Surgery 12, 165–177.
Geethamala K, Murthy VS, Vani BR, Rao S. 2016. Uterine Leiomyomas: An ENIGMA. Journal of Mid-Life Health 7(1), 22–27.
Gurusamy KS, Vaughan J, Fraser IS, Best LMJ, Richards T. 2016. Medical Therapies for Uterine Fibroids – A Systematic Review and Network Meta-Analysis of Randomised Controlled Trials. PLoS ONE, 11(2).
Kalaiselvi R, Brundha MP. 2016. Prevalence of Hysterectomy in South Indian Population. Research Journal of Pharmacy and Technology 9(11).
Khan AT, Shehmar M, Gupta JK. 2014. Uterine fibroids: Current perspectives. International Journal of Women’s Health 6, 95–114.
Lethaby A, Vollenhoven B, Sowter M. 2001. Pre-operative GnRH analogue therapy before hysterectomy or myomectomy for uterine fibroids. The Cochrane Database of Systematic Reviews (2), CD000547–CD000547.
Murugesa Mudhaliyar KS. 2008. Gunapadam-Mooligai Vaguppu, Directorate of Indian Medicine and Homeopathy, Chennai, 2nd Edition.
Pavone D, Clemenza S, Sorbi F, Fambrini M, Petraglia F. 2018. Epidemiology and Risk Factors of Uterine Fibroids. Best Practice & Research Clinical Obstetrics & Gynaecology 46, 3–11.
Ramachandhiran SP (Ed.). 1999. Pulippani Vaithiyam -500 (1st Edition). Thamarai Noolagam, Chennai.
Riyasdeen A, Periasamy VS, Paul P, Alshatwi A, Akbarsha MA. 2012. Chloroform Extract of Rasaganthi Mezhugu, a Siddha Formulation, as an Evidence-Based Complementary and Alternative Medicine for HPV-Positive Cervical Cancers. Evidence-Based Complementary and Alternative Medicine, 1–10.
Sabry M, Al-Hendy A. 2012. Innovative Oral Treatments of Uterine Leiomyoma. Obstetrics and Gynecology International. Hindawi Publishing Corporation 2012, Article ID 943635, 10 pages. http://dx.doi.org/10.1155/2012/9436351–10.
Sambasivam Pillai TV. 1994. Dictionary of Medicine, Chemistry, Botany and Allied Sciences, Madras, Govt. Central Press, 5.
Shyamala Rajkumar, Vijaya Kumar V, Ponmuthu Rani C, Gopakumar K, Ramaswamy RS. 2015. Management of Fibroid Uterus with a Traditional Siddha Formulation – A Review. International journal of multidisciplinary health sciences 1(1).
Song H, Lu D, Navaratnam K, Shi G. 2013. Aromatase inhibitors for uterine fibroids. In The Cochrane Library. John Wiley & Sons, Ltd.
Stewart E, Cookson C, Gandolfo R, Schulze-Rath R. 2017. Epidemiology of Uterine fibroids: A Systematic Review. BJOG: An International Journal of Obstetrics & Gynaecology 124(10), 1501–1512.
Tanos V, Brölmann H, De Wilde RL, O’Donovan P, Symeonidou E, Campo R. 2017. Survey among ESGE members on leiomyosarcoma morcellation incidence. Gynecological Surgery 14(1).
Taylor M. 2001. Psychological consequences of surgical menopause. The Journal of Reproductive Medicine 46(3), 317–324.
Tharakan ST, Kuttan G, Kuttan R, Kesavan M, Rajagopalan K. 2010. Toxicity Studies of Siddha Medicine- Rasagandhi Mezhugu. The Open Toxicology Journal 4(1).
The Siddha Formulary of India. 1992. 1st Edition, Govt. of India Press, Chennai. Yugi Vaidya Chinthamani, 1998, Directorate of Indian Medicine and Homeopathy, 1st Edition, Chennai.
Zhang Y, Peng W, Clarke J, Liu Z. 2010. Acupuncture for uterine fibroids. The Cochrane Database of Systematic Reviews (1), CD007221.
Shyamala Rajkumar, A. Faridha, Eugene Wilson, M. Kannan4, S. Vinayak, 2023. Non-surgical management of uterine fibroids with a classical siddha formulation, Rasaganthi Mezhugu – an open pilot trial. Int. J. Biosci., 23(4), 28-37.
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