The Effects of Tualang Honey on Postmenopausal Women
Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
Despite evidence supporting the benefits of hormone replacement therapy (HRT), only 15% of
postmenopausal women currently use HRT (1). The leading reasons why women refuse or
discontinue HRT are fear of malignancy, side effects such as vaginal bleeding, weight gain,
depressed mood, and breast tenderness, and social reasons such as regarding menopause as a
natural transition, not as a disease that requires treatment. Millions of women expressed
their concern on the safety of hormone replacement therapy since the data from the Women's
Health Initiative (WHI) study was released, which reported an increased risk of
cardiovascular disease, breast cancer, stroke and thromboembolic disease with conjugated
equine estrogen plus medroxyprogesterone acetate compared with placebo (2). The study has
also demonstrated that quality of life (3) and cognition (4) were no better in the HRT group
than the placebo group. In view of these problems, women are increasingly turning to
alternative therapies in an effort to manage their menopausal symptoms (1).
Menopause is associated with decreasing sex steroid levels. The effect of menopause on
circulating androgen levels has been studied by several investigators with variable findings.
The levels of testosterone and androstenedione appear to show a small but significant
decrease just before or within the first 2 years after menopause, with a decrease in
testosterone amounting to approximately 15% (5,6). Unlike the abrupt decrease in estradiol
levels associated with menopause, circulating testosterone, DHEA, and DHEAS levels decrease
more gradually, beginning in the years before menopause and continuing thereafter (6,7). As a
consequence, some women may experience symptoms of androgen decrease in the period before
cessation of menses. By giving Tualang Honey to these postmenopausal women, it is postulated
that the symptoms of androgen deficiency or menopausal symptoms should be reduced.
The investigators have also reported that tualang honey given to ovariectomised rats, an
animal model for postmenopausal states for two weeks significantly increased the free
testosterone and progesterone plasma levels, but no significant effect was seen in the
beta-estradiol level. There were significant increased in the thickness of vaginal epithelium
and vaginal epithelial-muscular layers. Proliferation of the squamous epithelium with
vacuolation of some of the squamous cells were noted in the honey treated animals implying
that there were increased in mucopolysacharide content. Uterine weight, endometrial and
circular muscle thickness were significantly increased in honey treated animal with cystic
changes noted over the glands (8).
To date, there are no clinical studies looking at the effects of Tualang Honey on
perimenopausal women. In view of the initial evidence that it is a phytoestrogen from animal
studies and has androgenic properties as well, it should have a beneficial effect to these
women in terms of improvement in their menopausal symptoms, changes in their endogenous
hormonal profile and increase in bone mineral density.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Universiti Sains Malaysia University of Science Malaysia