Clinical Study to Compare the Efficacy and Adverse Effects of Nona Roguy Herbal Formulation and Gonadotrophin Releasing Hormone Agonist (GnRH) in the Treatment of Uterine Fibroids

Accession number;06A0032857
Title;Clinical Study to Compare the Efficacy and Adverse Effects of Nona Roguy Herbal Formulation and Gonadotrophin Releasing Hormone Agonist (GnRH) in the Treatment of Uterine Fibroids
Author; HAZLINA NH N (Universiti Sains Malaysia, Mys) PAZUDIN I M. (Universiti Sains Malaysia, Mys) ALIZA AG NOR (Universiti Sains Malaysia, Mys) MOHSIN SAHIL J S. (Universiti Sains Malaysia, Mys)
Journal Title;Int Med J
Journal Code:L4914A
ISSN:1341-2051
VOL.12;NO.4;PAGE.295-302(2005)
Figure&Table&Reference;FIG.4, TBL.2, REF.19
Pub. Country;Japan
Language;English
Abstract;Objective: This study was designed to compare the reduction of the uterine and fibroids volume between the herbal treatment (Nona Roguy herbal product) and the GnRH agonist treatment (Leuprolide acetate 3.75mg depot, Lucrin) and also to compare the possible side-effects of both treatments. Methodology: This prospective randomized control trial was conducted in Gynaecology clinic, Hospital Universiti Sains Malaysia (HUSM) from February 2002 until January 2003. Thirty five patients with uterine fibroids were randomly allocated into the two groups of treatment. The effectiveness in the reduction of uterine / fibroid volume and side-effects of treatment in each group was analysed and compared. Results: 18 patients (51%) received herbal treatment and 17 patients (49%) received GnRH agonist treatment. There is no significant difference in the overall changes of mean uterine and fibroids volume between the herbal and GnRH agonist groups, p value 0.29 and 0.63 respectively. However, there is a significant reduction of mean uterine and fibroids volume within the same groups of treatment, p value = 0.004 and < 0.001 respectively within the first 3 to 4 months of treatment. The maximum reduction of fibroid volume in GnRH agonist group (57% reduction) occurred at the 5th month (Visit 5), two months after the last injection. The maximum reduction in herbal group (41% reduction) occurred at the 3rd month (Visit 3) and the fibroid regrow in size rapidly in the next 2 months inspite of patient continuing the treatment. There is marked suppression of oestrogen in the GnRH group (p = 0.001) but there is only mild suppression in the herbal group (p = 0.46). There is a significant difference in the side-effects profile between the two groups of treatment (p value < 0.0001) with GnRH agonist treatment causing more side-effects.... (author abst.)