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Letrozole, Berberine, Or Their Combination For BMJ Open: first published as 10.1136/bmjopen-2013-003934 on 25 November 2013. Downloaded from Open Access Protocol Letrozole, berberine, or their combination for anovulatory infertility in women with polycystic ovary syndrome: study design of a double- blind randomised controlled trial Yan Li,1 Hongying Kuang,1 Wenjuan Shen,1 Hongli Ma,1 Yuehui Zhang,1 Elisabet Stener-Victorin,2 Ernest Hung Yu Ng,3 Jianping Liu,4 Haixue Kuang,5 Lihui Hou,1 Xiaoke Wu1 To cite: Li Y, Kuang H, ABSTRACT and is the most common endocrine disorder et al Shen W, . Letrozole, Introduction: Letrozole is being used as an alternative in women of reproductive age as it affects berberine, or their to clomiphene citrate in women with polycystic ovary 5–10% of premenopausal women.1 Insulin combination for anovulatory syndrome (PCOS) requiring ovulation induction. infertility in women with resistance has been implicated in the patho- Berberine, a major active component of Chinese herbal polycystic ovary syndrome: genesis of anovulation and infertility in medicine rhizoma coptidis, has been used to improve study design of a double- PCOS and abnormalities in insulin action insulin resistance to facilitate ovulation induction in blind randomised controlled have been noted in a variety of reproductive trial. BMJ Open 2013;3: women with PCOS but there is no study reporting the e003934. doi:10.1136/ live birth or its potential as a complementary treatment tissues from women with PCOS and may bmjopen-2013-003934 to letrozole. We aim to determine the efficacy of explain the pleiotropic presentation and 2 letrozole with or without berberine in achieving live multiorgan involvement of the syndrome. fi ▸ Prepublication history and births among 660 infertile women with PCOS in The rst-line medical treatment for ovula- additional material for this Mainland China. tion induction in PCOS women is clomi- paper is available online. To Methods and analysis: This study is a multicentre phene citrate (CC), which can result in an view these files please visit randomised, double-blind trial. The randomisation ovulation rate of 60–85% but a conception http://bmjopen.bmj.com/ – the journal online scheme is coordinated through the central mechanism rate of only about 20%.3 6 Antioestrogenic (http://dx.doi.org/10.1136/ and stratified by the participating site. Participants are bmjopen-2013-003934). effects of CC on the endometrium and randomised into one of the three treatment arms: (1) cervix mucus are thought to cause the low letrozole and berberine, (2) letrozole and berberine Received 31 August 2013 conception rate.7 Also, CC may have a placebo, or (3) letrozole placebo and berberine. Berberine Revised 12 October 2013 number of side effects including hot flushes, Accepted 15 October 2013 is administered three times a day (1.5 g/day) for up to 24 weeks, starting on day 1 after a spontaneous period breast discomfort, abdominal distension, or a withdrawal bleeding. Either letrozole or letrozole nausea, vomiting, nervousness, sleeplessness, on September 25, 2021 by guest. Protected copyright. placebo 2.5 mg is given daily from day 3 to day 7 of the headache, mood swings, dizziness, hair loss first three cycles and the dose is increased to 5 mg/day in and disturbed vision.6 Letrozole, an aroma- the last three cycles, if not pregnant. The primary tase inhibitor, traditionally applied for hypothesis is that the combination of berberine and oestrogen-dependent carcinoma, has been letrozole results in a significantly higher live birth rate used for ovulation induction for about a than letrozole or berberine alone. decade.89The effectiveness of letrozole Ethics and dissemination: The study was approved versus CC for ovulation induction has been by the ethics committee of the First Affiliated Hospital of reviewed by two meta-analyses.10 11 In both Heilongjiang University of Chinese Medicine. Study meta-analyses that included six randomised findings will be disseminated through peer-reviewed publications and conference presentations. controlled trials, it was concluded that even Trial registration: ClinicalTrials.gov identifier: though letrozole was associated with a lower NCT01116167. number of mature follicles per cycle, there was no significant difference in the ovulation For numbered affiliations see end of article. rate per cycle or the pregnancy, multiple BACKGROUND pregnancy or miscarriage rates between letro- Correspondence to Polycystic ovary syndrome (PCOS) is charac- zole and CC. No difference was found in the Prof. Xiaoke Wu; terised by anovulation, hyperandrogenism live birth rate, although it was only assessed 11 [email protected] and polycystic ovaries (PCOs) on scanning in one meta-analysis. Li Y, Kuang H, Shen W, et al. BMJ Open 2013;3:e003934. doi:10.1136/bmjopen-2013-003934 1 BMJ Open: first published as 10.1136/bmjopen-2013-003934 on 25 November 2013. Downloaded from Open Access Based on the above two meta-analyses, letrozole the degree of insulin resistance and androgen synthesis appears to be at least as effective as CC in ovulation in cultured insulin-resistant ovaries, indicating that ber- induction with some potential advantages over CC. berine may have a favourable effect on fertility in Although side effects reported by patients in the group women with PCOS.25 receiving CC were higher, while no complication was However, there is only one study investigating the noted in the group receiving letrozole,12 large sample effect of berberine in women with PCOS.26 Eighty-nine sized clinical trials are still needed. As far as we know, Chinese women with PCOS with insulin resistance were two large randomised multicentre studies, the randomised to one of the three treatment groups: ber- Pregnancy in Polycystic Ovary Syndrome II (PPCOSII)13 berine+cyproterone acetate (CPA; n=31), metformin trial and the Assessment of Multiple Intrauterine +CPA (n=30) and placebo+CPA (n=28) for 3 months. Gestations from Ovarian Stimulation (AMIGOS)14 trial The author concluded that berberine showed similar are ongoing and can provide definitive evidence for metabolic effects on the amelioration of insulin sensitiv- pregnancy outcome with the use of CC versus letrozole. ity and the reduction of hyperandrogenaemia, when Insulin sensitising agents are commonly used as compared to metformin. Berberine also appeared to adjunctive medications for women with have a greater effect on the changes in body compos- PCOS and metformin is widely chosen.15 Although a ition and dyslipidemia. That study was limited by its newly published meta-analysis showed that there was no small sample size, incomplete description of the meth- evidence that metformin improved live birth rates in odology and use of surrogate outcomes (anthropometric combination with CC (pooled OR 1.16, 95% CI 0.85 to measures and hormonal and metabolic value changes). 1.56; 7 trials and 907 women), the clinical pregnancy There is also an ongoing trial (NCT01138930) rates were higher for the combination of metformin and testing the efficacy of berberine on insulin resistance in CC than CC alone (pooled OR 1.51, 95% CI 1.17 to women with PCOS as measured by a hyperinsulinaemic- 1.96; 11 trials and 1208 women).15 Furthermore, metfor- euglycaemic clamp. Berberine was thought to be safe min was associated with a higher incidence of gastro- during clinical use.19 The side effects were commonly intestinal disturbances than placebo (pooled OR 4.27, gastrointestinal discomforts including constipation, diar- 95% CI 2.4 to 7.59; 5 trials and 318 women), which ham- rhoea, nausea and abdominal distension. Constipation pered its clinical compliance with high dropout rates.16 was one of the most common gastrointestinal discom- Recent studies suggest that several Chinese herbal forts, but it is predictable since berberine had a long medicines could be beneficial as an adjunct to the con- history of being used to treat diarrhoea in China. ventional medical management of PCOS, but the evi- We aim to determine the efficacy of letrozole with or dence is limited due to the poor methodology of without berberine in achieving live births among women existing trials.17 Berberine, the major active component with PCOS seeking pregnancy in Mainland China. The of rhizoma coptidis, exists in a number of medicinal plants primary hypothesis is that the combination of berberine http://bmjopen.bmj.com/ and displays a broad array of pharmacological effects.18 and letrozole results in a significantly higher live birth In Chinese medicine, berberine has a long history for its than letrozole or berberine alone. We report the study antidiabetic effect. A recent meta-analysis compared dif- design of our ongoing study. ferent oral hypoglycaemics including metformin, glipi- zide or rosiglitazone with berberine, and found no priority over glycaemic control but a mild antidyslipi- MATERIALS AND METHODS demic effect following berberine.19 The mechanism of This is a multicentre, double-blind, randomised con- its hypolipidemic effect was studied using human hepa- trolled clinical trial. A total of 660 women with PCOS on September 25, 2021 by guest. Protected copyright. toma cells. Berberine acts differently from that of statin seeking pregnancy (or 220 per each treatment arm) will drugs as it could upregulate low-density lipoprotein be enrolled at one of 18 participating sites and randomly receptor expression independent of sterol regulatory assigned to three treatment arms. element-binding proteins, but dependent on extracellu- Written informed consent will be obtained from each lar signal-regulated kinase activation.20 patient prior to her participation in the study. The trial A series of basic research also implicated that berber- is registered at clinicaltrials.gov (NCT01116167). ine could have beneficial effects in women with PCOS. In insulin-resistant theca cells, berberine increased Primary and secondary outcomes glucose transporter type 4, decreased peroxisome The primary outcome is that combination of berberine proliferator-activated receptor δ mRNA levels, increased and letrozole results in a significantly higher live birth – glucose uptake, and reduced insulin resistance.21 23 than letrozole or berberine alone.
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