The Effects of Tualang Honey on Postmenopausal Women

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.

Conditions

• Postmenopausal Syndrome

Interventions

DRUG

Tualang honey

This was a randomized, prospective, clinical study to evaluate the effect of Tualang honey in comparison with HRT. Subjects will be confined to healthy postmenopausal women who were naturally menopause for more than one year. The study period was four months. A total of 79 patients were recruited. Group 1: Subjects receiving 20 g/day of Tualang honey. The honey used was from a single batch honey supplied by Federal Agricultural Marketing Authorities (FAMA), Malaysia, evaporated by FAMA to achieve a water content of about 20%, submitted to Sterile Gamma company at Shah Alam, Selangor for sterilization at 25 kGy and packed in 20 g sachet in collaboration with School of Pharmaceutical Sciences laboratory. Group 2: Subjects receiving hormonal replacement therapy (Femoston®), also known as Femo conti 1/5 (contain 1 mg Estradiol valerate and 5 mg Dydrogesterone) supplied by Solvay Pharma Malaysia.

Sponsors & Collaborators

• Universiti Sains Malaysia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2010-01-31

Completion

2010-06-30

Countries

• Malaysia

Study Locations