01.04.2016

Bmc complementary and alternative medicine online nov 5 2013

This study assessed the efficacy and safety of Guizhi Fuling Formula for the treatment of uterine fibroids.MethodsPubMed, Cochrane CENTRAL, EMBASE, and four Chinese databases were searched through May 2013.
We included randomised controlled trials (RCTs) that tested Guizhi Fuling Formula for uterine fibroids, compared with no intervention, placebo, pharmaceutical medication, or other Chinese patent medicines approved by the State Food and Drug Administration of China. No serious adverse events were reported.ConclusionsGuizhi Fuling Formula appears to have additional benefit based on mifepristone treatment in reducing volume of fibroids. However, due to high risk of bias of the trials, we could not draw confirmative conclusions on its benefit. When fibroids are symptomatic, they present in a variety of ways such as menstrual problems, pain, pressure symptoms, and infertility. Current treatments include surgical approaches such as hysterectomy, myomectomy, uterine artery embolization (UAE) and magnetic resonance imaginga€“guided focused ultrasound surgery (MRgFUS), pharmacologic options such as hormonal therapies and gonadotropin-releasing hormone (GnRH) agonists [4]. GnRH agonists can relieve both bleeding and bulk-related symptoms but might cause significant menopausal side effects [5, 6].
Progesterone antagonists, such as mifepristone and asoprisnil, seem to be effective in inducing fibroid regression without major adverse events. However, progesterone antagonists and other hormonal therapies that alter oestrogen and progesterone production or function may affect fertility [7].
So safer therapy is needed for uterine fibroids.In China, traditional Chinese herbal medicine is a prevalent treatment for uterine fibroids.
Guizhi Fuling Formula consists of five herbs: Ramulus Cinnamomi, Poria, Semen Persicae, Radix Paeoniae Rubra or Radix Paeoniae Alba, and Cortex Moutan[8].
Its traditional effects (actions) are invigorating blood, dissolving stasis, and resolving masses [9]. A bibliometrics study of modern literature analysing the names of diseases that are treated by Guizhi Fuling pills revealed that the highest frequency of traditional Chinese medicine (TCM) diseases was abdominal mass (zheng jia) and the highest frequency of western medicine diseases was uterine fibroids [10].A Cochrane systematic review [11] assessing herbal preparations for uterine fibroids included ten clinical trials of Guizhi Fuling Formula. Results showed that the combination of Guizhi Fuling Formula and mifepristone was associated with a greater reduction in fibroid volume and in uterine size compared with mifepristone alone. Conference proceedings and dissertations were also searched from CNKI and Wanfang databases for unpublished trials.
Modified Guizhi Fuling Formula prescribed according to TCM syndrome differentiation was acceptable, and was defined by practitioners as adding no more than five herbs to the five original herbs, resulting in nearly the same actions as the original Guizhi Fuling Formula.
The controls could be no intervention, placebo, medication, or other Chinese patent medicines approved by the State Food and Drug Administration of China. Any disagreements were resolved through discussion with a third author (JPL).Assessment of risk of biasTwo authors (NNC, MH) independently assessed the quality of included trials using the Cochrane risk of bias tool [12].
The following items were assessed: random sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other bias. Sample size estimate, comparable baseline characteristic, inclusion and exclusion criteria were considered when we judged the other bias. We used risk ratios (RR) with 95% confidence intervals (CI) for binary outcomes or mean difference (MD) with 95% CI for continuous outcomes.


When different measurement scales were used, standardised mean difference (SMD) analyses were performed. Heterogeneity was assessed using both the Chi-squared test and the I-squared statistic with an I-squared value greater than 50% indicative of substantial heterogeneity. Funnel plots were generated to detect publication bias when more than ten trials were identified.
Sample sizes varied from 39 to 195 participants, with an average of 100.42 participants per trial. One of the two trials [14, 15] with three arms had two comparisons, which we counted twice.
Preparations of Guizhi Fuling Formula were capsules or pills in all the included trials and were patent medicines approved by the State Food and Drug Administration of China.For outcome measures, 34 trials reported fibroid volume and 12 trials reported uterus volume, and the volume was measured by ultrasonography. Five trials reported improvement of fibroid-related symptoms such as heavy menstrual bleeding, prolonged menstrual bleeding, vaginal bleeding at times other than menstruation, distention pain of the lower back and abdomen, and dysmenorrhea.
No trial reported quality of life.Of the 34 trials which reported fibroid volume, 21 trials reported different parameters to represent the volume of uterine fibroids. Among the 21 trials, 13 trials reported average volume of maximum fibroids, two trials reported total volume of multiple fibroids, four trials reported average volume of multiple fibroids, and two trials reported average diameter of fibroids.
To confirm the parameters representing the volume of fibroids in the remaining trials that did not provide such information, we attempted to contact the authors of these trials and only the authors of two trials [16, 17] provided detailed information.
The effect of Guizhi Fuling Formula on volume of uterine fibroids are summarised in TableA 1.
In a three-arm trial [15], increased and common dosages of Guizhi Fuling capsules were designed to compare with mifepristone. No significant difference was found between the common dosage of Guizhi Fuling capsules and mifepristone on reducing volume of fibroids (pa€‰=a€‰0.22). One trial [31] showed mifepristone had better effect in reducing volume of fibroids (pa€‰=a€‰0.01).
Two trials [47, 48] reported number of participants with shrinkage of fibroids based on different standards.
So we considered that heterogeneity may have resulted from the particularity of included participants.SafetyNo trial reported serious adverse events. Nine trials (one meta-analysis) showed that Guizhi Fuling Formula plus mifepristone may be more effective than mifepristone alone in reducing the volume of the uterus. The two findings were consistent with the Cochrane review [11], but our systematic review included more trials. Another trial [24] found Guizhi Fuling Formula plus mifepristone had better effect than mifepristone on number of participants with improvement of dysmenorrhea. Two trials (one meta-analysis) [27, 30] showed Guizhi Fuling Formula was potentially safer than mifepristone, and 11 trials (one meta-analysis) showed Guizhi Fuling Formula plus mifepristone resulted in fewer adverse events than mifepristone alone.Strengths and limitationsThere are several strengths in this study.
The search for eligible trials was comprehensive and most of the included RCTs identified in Chinese databases were not found in English databases.


We had a standard protocol registration in PROSPERO, an international prospective register of systematic reviews, and published the protocol. Moreover, we rigorously assessed the methodological quality of included trials.Our study also has several limitations.
The majority of trials did not report randomization procedures and all trials lacked information on blinding. Additionally, intention-to-treat analysis and pre-trial sample size estimate were not applied.
We failed to perform a funnel plot analysis due to insufficient number of included trials in meta-analysis, so there may be potential publication bias. Though we endeavored to contact trial authors to clarify the missing information, responses were not satisfactory. In terms of Chinese medicine actions, the formula invigorates blood, dissolves stasis, and resolves masses [9].Implications for further studyMost of included trials lacked detailed information on methodology, since the reporting of most RCTs published in the Chinese literature did not follow the CONSORT statement.
Furthermore, the low number of telephone or e-mail responses of original authors did not provide some of the missing information we needed.
Although there is no standard in reporting fibroid volume, the volume of the maximum fibroid could be a good choice as it is easier to carry out and is more accurate.
Clinically relevant outcomes, such as fibroid-related symptoms, quality of life, should be addressed and measured using validated instruments, such as a pictorial blood-loss assessment chart, Short-Form McGill Pain Questionnaire or visual-analogue scale for pain, and the uterine fibroid symptoms quality of life (UFS-QOL) questionnaire. In addition, composite outcomes are not preferred and we recommend each outcome should be reported individually with clear definition or judgment.
Finally, future trials should pay more attention to adverse events, especially long-term safety of the therapy being investigated.
Adverse events should be recorded and reported completely, using international standard medical terms.ConclusionsThe findings of the current trials suggest that Guizhi Fuling Formula plus mifepristone may be more effective than mifepristone alone for the treatment of uterine fibroids in reducing the volume of fibroids or uterus. However, due to poor methodological quality, we could not draw confirmative conclusions on the beneficial effect of Guizhi Fuling Formula plus mifepristone for uterine fibroids.
Authors were supported by the Program of Innovative Research Team of Beijing University of Chinese Medicine (2011-CXTD-09). Dazheng Ma for their professional advice and Nissi Wang and Xun Li for suggestions on manuscript revision. We also thank those original authors providing information we needed by answering our telephone or e-mail.



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