The Effects of Tualang Honey on Postmenopausal Women

NCT01300676 | Completed Phase 2 DMC

• 1 other identifier: (USMKK/PPP/JEPeM (198.3(11))
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tualang honey; HRT; safety profiles; cardiovascular parameters; hormonal levels; bone changes; postmenopausal women

Outcome Measures

Primary Outcomes (3)

• changes in haematological function

  To evaluate the safety profile of honey in term of haematological and biochemical profile

  4 months

• changes in liver function

  To evaluate the safety profile of honey in term of haematological and biochemical profile

  4 months

• changes in renal function

  To evaluate the safety profile of honey in term of haematological and biochemical profile

  4 months

Secondary Outcomes (3)

• changes in cardiovascular parameters

  4 months

• changes in hormonal level

  4 months

• changes in bone density

  4 months

Study Arms (2)

Tualang Honey

ACTIVE COMPARATOR

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.

Drug: Tualang honey

Group 2

NO INTERVENTION

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.

Drug: Tualang honey

Interventions

Tualang honey DRUG

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.

Also known as: Femo conti 1/5 (contain 1 mg Estradiol valerate and 5 mg Dydrogesterone)

Group 2; Tualang Honey

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Clinical Trial Unit, Hospital USM

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Interventions

Estradiol; Dydrogesterone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienes; Pregnanes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: February 23, 2011
• Study Start: March 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 23, 2011

Record last verified: 2007-11

Locations

MY (1)