Pilot study on the safety and cardiovascular effects of BioLabisia™ on post-menopausal women

Nik Hazlina Nik Hussain, Azidah Abdul Kadir, Wan Mohamad Wan Bebakar, Dayang Marshitah Mohd, Norlela Shukor, Nor Azmi Kamaruddin, Wan Nazaimoon Wan Mohamud

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)137-148
Number of pages12
JournalInternational Medical Journal
Volume16
Issue number2
Publication statusPublished - Jun 2009

Fingerprint

Electrocardiography
Safety
Thorax
X-Rays
Estrogen Replacement Therapy
Waist-Hip Ratio
Blood Pressure
Kidney
Body Mass Index
Placebos
Phytoestrogens
Water
Liver
Liver Function Tests
Women's Health
Insurance Benefits
Informed Consent
Uncertainty
Estrogens
Research Personnel

Keywords

  • Bio-Labisia
  • Cardiovascular risk factors
  • Post-menopausal
  • Safety profiles

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Hussain, N. H. N., Kadir, A. A., Bebakar, W. M. W., Mohd, D. M., Shukor, N., Kamaruddin, N. A., & Mohamud, W. N. W. (2009). Pilot study on the safety and cardiovascular effects of BioLabisia™ on post-menopausal women. International Medical Journal, 16(2), 137-148.

Pilot study on the safety and cardiovascular effects of BioLabisia™ on post-menopausal women. / Hussain, Nik Hazlina Nik; Kadir, Azidah Abdul; Bebakar, Wan Mohamad Wan; Mohd, Dayang Marshitah; Shukor, Norlela; Kamaruddin, Nor Azmi; Mohamud, Wan Nazaimoon Wan.

In: International Medical Journal, Vol. 16, No. 2, 06.2009, p. 137-148.

Research output: Contribution to journalArticle

Hussain, NHN, Kadir, AA, Bebakar, WMW, Mohd, DM, Shukor, N, Kamaruddin, NA & Mohamud, WNW 2009, 'Pilot study on the safety and cardiovascular effects of BioLabisia™ on post-menopausal women', International Medical Journal, vol. 16, no. 2, pp. 137-148.
Hussain, Nik Hazlina Nik ; Kadir, Azidah Abdul ; Bebakar, Wan Mohamad Wan ; Mohd, Dayang Marshitah ; Shukor, Norlela ; Kamaruddin, Nor Azmi ; Mohamud, Wan Nazaimoon Wan. / Pilot study on the safety and cardiovascular effects of BioLabisia™ on post-menopausal women. In: International Medical Journal. 2009 ; Vol. 16, No. 2. pp. 137-148.
@article{f78b53fed0d94fb6a08cce2ab82c594b,
title = "Pilot study on the safety and cardiovascular effects of BioLabisia™ on post-menopausal women",
abstract = "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.",
keywords = "Bio-Labisia, Cardiovascular risk factors, Post-menopausal, Safety profiles",
author = "Hussain, {Nik Hazlina Nik} and Kadir, {Azidah Abdul} and Bebakar, {Wan Mohamad Wan} and Mohd, {Dayang Marshitah} and Norlela Shukor and Kamaruddin, {Nor Azmi} and Mohamud, {Wan Nazaimoon Wan}",
year = "2009",
month = "6",
language = "English",
volume = "16",
pages = "137--148",
journal = "International Medical Journal",
issn = "1341-2051",
publisher = "Japan International Cultural Exchange Foundation",
number = "2",

}

TY - JOUR

T1 - Pilot study on the safety and cardiovascular effects of BioLabisia™ on post-menopausal women

AU - Hussain, Nik Hazlina Nik

AU - Kadir, Azidah Abdul

AU - Bebakar, Wan Mohamad Wan

AU - Mohd, Dayang Marshitah

AU - Shukor, Norlela

AU - Kamaruddin, Nor Azmi

AU - Mohamud, Wan Nazaimoon Wan

PY - 2009/6

Y1 - 2009/6

N2 - 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.

AB - 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.

KW - Bio-Labisia

KW - Cardiovascular risk factors

KW - Post-menopausal

KW - Safety profiles

UR - http://www.scopus.com/inward/record.url?scp=67651247393&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=67651247393&partnerID=8YFLogxK

M3 - Article

VL - 16

SP - 137

EP - 148

JO - International Medical Journal

JF - International Medical Journal

SN - 1341-2051

IS - 2

ER -