Hussain, Nik Hazlina Nik, Kadir, Azidah Abdul, Bebakar, Wan Mohamad Wan, Mohd, Dayang Marshitah, Shukor, Norlela, Kamaruddin, Nor Azmi, and Mohamud, Wan Nazaimoon Wan
Background: Amongst the most important issues in women's health are the risks and benefits of estrogen replacement therapy. However, continual uncertainty and lack of consensus of standard estrogen replacement therapy has driven many women to seek alternative sources of estrogen, including herbal remedies. To date, there has been no clinical study to look at the effects of Labisia pumila var. alata (Kacip Fatimah) on post- menopausal women. In view of the initial evidence from animal studies that the plant contains phytoestrogens and exert androgenic and estrogenic activities, it is postulated that Labisia pumila may be beneficial to these women. BioLabisia™ is a water extract of Labisia pumila var. alata, produced using a patented technology developed by a group of Malaysian scientists. The objectives of this study were to determine the effects of varying doses of BioLabisia™ a standardized sprayed-dried water extract of Labisia pumila var. alata on the safety profiles such as haematological indices, liver and renal function and the cardiovascular effects from body mass index, waist hip ratio, the effects on blood pressure, chest x-ray and ECG changes. Methodology: This is a randomized, double-blind, placebo-controlled study comparing the effects of BioLabisia™, at 140, 280 or 560 mg/day, given for 6 months, in a group of post-menopausal, but otherwise healthy, Malay women aged 48-55 years old. Ethical approval from participating hospitals were obtained prior to the study. 70 eligible participants were divided into four groups. Group 1 received 140 mg/day BioLabisia™, Group 2 received 280 mg/day BioLabisia™, Group 3 received 560 mg/day BioLabisia™ and group 4 received placebo (maltodextrine). Pre study screening and assessment was done and if the subject was eligible, informed consent was taken and baseline investigations including hematological, liver and renal function tests, chest x-ray and electrocardiography (ECG) were performed. Those respondents with normal baseline investigations were invited to participate in this study. The study duration was six months and all participants were required to come to the clinic for clinical examination two monthly. During each visit the participants were asked regarding any side effects of medication. The participants were also required to come for a supply of medication each month and the investigator team had to ensure that all participants complied with the medication and scheduled visits. On visit 4, all blood investigations, blood pressure, chest x-ray and ECG were repeated again. Results: There was no significant difference seen in demographic profile between the four groups of post-menopausal women. No significant changes were seen in the measurement of body mass index and the waist hip ratio at the end of study period. In terms of haematological indices, liver and renal function, no significant changes were seen in each of the four groups. Other investigations such as blood pressure, chest x-ray and ECG were all normal. Conclusion: In summary, based on the clinical and laboratory evidence, daily intake of BioLabisia™ up to 560 mg/day for 6 months, was found to be safe and has not been shown to cause any adverse effect to the body. [ABSTRACT FROM AUTHOR]