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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
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.
Many randomised controlled trials (RCTs) of herbal interventions have been conducted in the ASEAN Communities. Good quality reporting of RCTs is essential for assessing clinical significance. Given the importance ASEAN placed on herbal medicines, the reporting quality of RCTs of herbal interventions among the ASEAN Communities deserved a special attention.
To systematically review the quality of reporting of RCTs of herbal interventions conducted in the ASEAN Plus Six Countries.
Searches were performed using PubMed, EMBASE, The Cochrane Library, and Allied and Complementary Medicine (AMED), from inception through October 2013. These were limited to studies specific to humans and RCTs. Herbal species search terms were based on those listed in the National List of Essential Medicines [NLEM (Thailand, 2011)]. Studies conducted in the ASEAN Plus Six Countries, published in English were included.
Seventy-one articles were identified. Thirty (42.25%) RCTs were from ASEAN Countries, whereas 41 RCTs (57.75%) were from Plus Six Group. Adherence to the recommended CONSORT checklist items for reporting of RCTs of herbal interventions among ASEAN Plus Six Countries ranged from 0% to 97.18%. Less than a quarter of the RCTs (18.31%) reported information on standardisation of the herbal products. However, the scope of our interventions of interest was limited to those developed from 20 herbal species listed in the NLEM of Thailand.
The present study highlights the need to improve reporting quality of RCTs of herbal interventions across ASEAN Plus Six Communities.
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.
Background:
Uterine fibroids are the most common non-malignant growths in women of childbearing age. They are associated with heavy menstrual bleeding and subfertility. Herbal preparations are commonly used as alternatives to surgical procedures.
Objectives:
To evaluate the effectiveness and safety of Chinese herbal medicine for treatment of uterine fibroids.
Search methods:
The authors with the guidance of the Trials Search Coordinator searched the following electronic databases: the Trials Registers of the Cochrane Menstrual Disorders and Subfertility Group and the Cochrane Complementary Medicine Field, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 4), MEDLINE, EMBASE, the Chinese Biomedical Database, the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), AMED, and LILACS. The searches were up to 11 September 2012.
Selection criteria:
Randomised controlled trials comparing herbal preparations with no intervention, placebo, medical treatment, or surgical procedures in women with uterine fibroids. We included trials of herbal preparations with or without conventional therapy.
Data collection and analysis:
Two review authors collected data independently. We assessed trial risk of bias according to our methodological criteria. We presented dichotomous data as risk ratios (RR) and continuous outcomes as mean differences (MD), both with 95% confidence intervals (CI).
Main results:
We included 21 randomised trials (involving 2222 women) and the majority of them had unclear or high risk of bias. There were several different herbal preparations used within the included trials. The average treatment duration was three to six months. The primary outcome of uterine fibroid related symptoms was not reported in any of the included trials. The majority of the trials reported fibroid volume and size of the uterus.Compared with mifepristone, Tripterygium wilfordii extract was associated with a greater reduction in the fibroid volume (MD -23.03 cm(3), 95% CI -28.39 to -17.67; 2 trials) and in uterine size (MD -51.25 cm(3), 95% CI -77.70 to -24.80; 2 trials). There was no evidence of a significant difference between Nona Roguy herbal product and gonadotropin-releasing hormone (GnRH) agonist on the average fibroid volume or the uterine size. The combination of Guizhi Fuling formula and mifepristone was associated with a greater reduction in the fibroid volume (-1.72 [-2.42, -1.02] 7 trials) and in uterine size (MD -31.63 [95% CI -54.58, -8.68] 3 trials)) compared with mifepristone alone. Only 13/21 trials reported on adverse events and no serious adverse effects from herbal preparations were reported.
Authors' conclusions:
Current evidence does not support or refute the use of herbal preparations for treatment of uterine fibroids due to insufficient studies with large sample sizes and of high quality. Further high quality trials evaluating clinically relevant outcomes are warranted.
Buserelin acetate, a luteinizing hormone-releasing hormone agonist, is known to be effective in the shrinkage of uterine fibroids. A prospective trial was undertaken (1) to compare the efficacy of intranasal (IN) and subcutaneous (SC) administration of buserelin acetate and (2) to assess if tumor regression correlated with fibroid size and/or patient age. Forty patients were randomly allocated to receive 6 months of either IN buserelin acetate (n = 21) or SC buserelin acetate (n = 19). Four patients did not complete the study and were excluded from statistical analysis. Fibroid regression occurred in all 36 patients. Overall regression to 66% or less of the initial fibroid volume occurred in 70% of subjects. There was no significant difference in fibroid shrinkage between the two administration routes. A significant positive correlation was found between initial fibroid size and subsequent fibroid regression, with larger tumors being more likely to shrink than smaller fibroids. No correlation was found between the patient's age and the extent of fibroid regression.
Thirteen premenopausal women with uterine fibroids were treated for a maximum of 6 months with a long-acting agonist of luteinizing hormone-releasing hormone (LH-RH), goserelin (Zoladex depot, ICI Pharmaceuticals, Macclesfield, UK) 3.6 mg, administered subcutaneously every 28 days. A 55% reduction (range, 38% to 84%) in uterine volume assessed by ultrasound was obtained. The greatest reduction (30%) was apparent within the first treatment cycle regardless of whether treatment was started in the early follicular or the luteal phase. Fibroid regression was inversely correlated with urinary estrogen concentration. Treatment was well tolerated and only one subject withdrew from the study before its scheduled completion. Following cessation of therapy, ovulatory menstruation returned within 3 months in the majority of the subjects, but this was accompanied by a rapid regrowth of the fibroids. This medical approach to the management of fibroids merits further investigation but as yet cannot be regarded as an alternative to surgery.
To compare the effect of the gonadotrophin-releasing hormone agonist leuprorelin and progestin lynestrenol, given prior to surgical treatment of symptomatic uterine myomas, on the pre-operative symptoms, tolerance, and operative blood loss.
Fifty-six women were randomly selected to receive, during 16 weeks, either monthly subcutaneous injections of leuprorelin 3.75 mg sustained release (n=33) or lynestrenol 5 mg two tabs per day (5th to the 25th menstrual cycle) (n=23).
Intent-to-treat analysis of the main efficacy criterion, namely ultrasonographic reduction of myoma(s) diameter, showed a significant difference in favour of leuprorelin (P=0.02) with a mean decrease of 26.5+/-4.5% (n=29) as opposed to 7.3+/-5% in the lynestrenol group (n=17). Clinical improvement was satisfactory in both groups. Hematocrit decrease between the preoperative value and the value measured 48 h postoperatively was significantly lower in the leuprorelin group than in the lynestrenol one (P=0.02) (for hemoglobin: P=0.07).
Leuprorelin was more effective than lynestrenol because of its more intense antigonadotropic activity. The tolerance was good, reflecting each drug mechanism of action.