The Effects of Tualang Honey on Postmenopausal Women

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universiti Sains Malaysia; University of Science Malaysia
• Treatments: Dydrogesterone; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Age more than 45 and less than 65 years old

• No present active medical, surgical and gynaecological problems

• Body mass index 18-35 kg / m2

• Not on hormone replacement therapy for more than 3 months

• Subject who has given written informed consent to participate in the study and understand the nature of the study

• Not illiterate

Exclusion Criteria:

• Taking any form of herbal extract in the last 3 months before study entry.

• History of drug or alcohol abuse.

• Following ovariectomy.

• History of breast or cervical carcinoma.

• Taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant and methotrexate.

• Clinical relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult.

• Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.

• Evidence of uncooperative attitude, including poor compliance

• Inability to attend follow-up visit.

• Subject with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.

• Endometrial thickness more than 0.5 cm detected from pelvic ultrasonography.