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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
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. Conclusion: There is no significant difference in the overall reduction of uterine and fibroids volume between the herbal and GnRH agonist groups. However there is a significant reduction of the fibroid and uterine volume within the same group. More adverse events were seen in the GnRH agonist group and this was related to the hypo-oestrogenic state of the patients. © 2005 Japan International Cultural Exchange Foundation.
Background. Chinese medicine (CM) has been used to relieve symptoms relevant to uterine fibroids. Objective. This study investigated the association between the use of CM and the incidence of uterine surgery in women with uterine fibroids. Subjects and Methods. This retrospective cohort study extracted records for 16,690 subjects diagnosed with a uterine fibroid between 2000 and 2003 from the National Health Insurance reimbursement database. The risk factors for surgery were examined via Cox proportional hazard analysis, and the difference in incidence of surgery between CM users and nonusers was compared using incidence rate ratios (IRRs) derived from Poisson's models. Results. After an average follow-up period of 4.5 years, the cumulative incidence of uterine surgery was significantly lower in CM users than CM nonusers (P < 0.0001). Compared to CM nonusers, CM users were more unlikely to undergo uterine surgery (adjusted hazard ratio = 0.18, 95% confidence interval (CI) = 0.17, 0.19). The incidence of surgery in CM users was dramatically different from that for CM nonusers (IRR = 0.17, 95% CI = 0.16, 0.18). Conclusion. The risk of uterine surgery among fibroid patients who used CM was significantly decreased, implying an effective treatment of fibroid-related symptoms provided by CM.
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