Investigation of the reproductive effects of Chinese herbal medicine in humans as measured by 3D ultrasound and blood serum

• Main Author: Wing, Trevor
• Published: University of Portsmouth 2009
• Subjects: 615.53; Biomedical Sciences : Pharmacy
• Online Access: http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.545846

Aim: To establish whether Chinese Herbal Medicine (CHM) has any positive effect on human endometrial receptivity to embryo implantation. Design: A prospective interventional clinical study. The measurements used in this study were: serum follicle stimulating hormone (FSH), serum progesterone, endometrial thickness (ET), sub endometrial 3D-PDA ultrasound indices; vascularisation index (VI), flow index (FI), vascularisation flow index (VFI) and pregnancy outcome. Setting: A private London natural female heath practice specialising in treating infertility with Naturopathic and Traditional Chinese Medicine (TCM). The study period was between November 2005 and April 2008. Patient(s): Fifty primary or secondary infertile women who had failed at least two In Vitro Fertilisation (IVF) treatment cycles (the treatment group) with no pathological cause after investigation by infertility specialists and diagnosed as suffering with unexplained infertility. In addition, a reference group of fifty normal healthy volunteer women (the reference group) randomised and double blinded who received either placebo or treatment. Interventions: Both the treatment group and the reference group received CHM for three menstrual cycles. The reference group on a randomised basis received either CHM or placebo. All staff at the clinic and the reference group volunteers were double blinded to who received placebo or treatment until the end of the study. ii Results: The treatment group results indicated that there was a statistically significant positive difference between pre and post treatment for all variables examined (p < 0.001). The reference group results were not as significant but never the less, still indicated that the improvement was statistically significant between the two arms (treatment and placebo) for all measures, with the exception of sub endometrial FI, where there was no significant difference between groups. The number of pregnancies achieved in the treatment group at 6 months post commencement of the last patient was 17 pregnancies, 10 live births, 2 miscarriages and 5 ongoing pregnancies (34% overall pregnancy rate). Conclusions: The study demonstrated that within the treatment group of 50 failed IVF patients CHM did improve all the 6 physiological parameters known to affect endometrial receptivity by a statistically significant amount and provided a 34% pregnancy outcome. The findings of this study show that administration of CHM did have a positive effect on the endometrial receptivity measures used in this study and that the pregnancy rate achieved in the treatment group was encouraging, however without a control arm it is impossible to attribute the pregnancy rate outcome to treatment or reduced stress from the placebo effect of receiving treatment. The study also demonstrated statistically significant improvement in treatment arm of the reference group whilst the placebo arm showed no significant improvement in the same parameters. None of the participants in the study experienced any adverse reactions or side effects from treatment.