Tuesday December 20 2011
The study only involved 48 women
A hormone pill “may help women through the menopause and give their sex lives a boost,” according to the Daily Mail. The newspaper reported that the hormone pill, called DHEA, could become an alternative to the current Hormone Replacement Therapy (HRT) for easing menopausal problems such as hot flushes and night sweats. DHEA is a steroid hormone naturally produced by the body’s adrenal gland and used in the production of sex hormones, but the synthetic version is not currently licensed for use in menopause.
The Mail’s news is based on a trial that compared DHEA against two existing treatments, looking at how women who had recently been through the menopause rated their sexual function before and after treatment. They found that standard hormone replacement therapy, a drug called tibolone, an HRT pill containing an oestrogen, and DHEA all decreased menopause symptoms and improved sexual function after one year of treatment.
It is important to note that this was a small study with just 12 women receiving each treatment. Furthermore, there are a wide variety of hormone therapies used in the treatment of menopausal symptoms, which have various potential adverse effects and cautions for use. Treatment must be prescribed on an individual basis, as not all therapies are suitable for all women. Women currently taking HRT will have been prescribed the drug preparation that is most appropriate for them.
As the Daily Mail rightly pointed out, further larger trials are needed to see whether DHEA is a safe and effective treatment to be used for menopausal symptoms in some women.
Where did the story come from?
The study was carried out by researchers from The University of Pisa, Italy, and received no additional funding. It was published in the peer-reviewed medical journal, Climacteric.
This research was reported on well by the Daily Mail, which highlighted that as the study was small, larger trials of DHEA would be needed to see if it could provide an alternative to standard HRT treatments for menopause symptoms. Although DHEA does not have a licence to treat menopause symptoms, some people may have already received DHEA ‘off licence’ in the UK (that is, at their doctor’s discretion), to help with menopause symptoms.
What kind of research was this?
This was a randomised controlled trial comparing DHEA against two existing treatments for menopause symptoms. In total, 48 women were randomly assigned into three groups designated to receive:
- A standard daily HRT pill containing an oestrogen (estradiol) in combination with a progestogen (dihydrogesterone).
- A type of drug called tibolone, which is a unique drug with oestrogen, progestogen and weak androgen (male hormone) properties.
- The new type of hormone: DHEA (dehydroepiandrosterone), which is not currently licensed in the UK. It is a synthetic version of the steroid hormone naturally produced by the body’s adrenal gland and used in the production of sex hormones. Some of the women did not want to take hormone treatments, so were treated with oral vitamin D treatments instead.
The researchers were interested in how these three treatments, particularly DHEA, would affect the women’s sexual function, which can be affected when going through the menopause. Oral oestrogen therapy can help with blood flow to the vagina and lubrication and the researchers suggest that it may help other sexual factors such as clitoral sensitivity, orgasm rates and sexual activity. However, sexual desire, or libido, is not thought to be governed by oestrogen levels.
However, while oestrogen may offer these improvements, it does not come without risks. In women who have an intact uterus – that is, all those who have not had a hysterectomy – oestrogen cannot be given in the long term without being in combination with a progestogen. This is because it can overstimulate the growth of the uterus lining (the endometrium). It can also increase the risk of endometrial cancer if its effects are not balanced with a progestogen.
The researchers suggested that DHEA that affects levels of sex hormones might play a role in governing sexual desire pre- and post-menopause.
What did the research involve?
The researchers recruited 48 post-menopausal Italian women (aged 50 to 60 years). All of the women had natural menopause, were healthy and had no previous or current hormone disorders (such as thyroid or adrenal problems). The women also had no heart problems, high blood pressure, psychiatric disorders, pelvic or breast disease and were non-smokers.
Natural menopause was defined as over 12 consecutive months without a natural menstrual period. The age at menopause was defined as age at last menstruation.
The women’s medical history was taken to determine if there was anything other than menopause that could have contributed to sexual function problems.
The researchers used validated self-administered questionnaires to properly diagnose sexual symptoms and to gain information on any sexual relationship.
The women were then randomised to receive:
- DHEA: 10mg daily (12 women)
- Femoston Conti HRT: oral estradiol (1mg) plus dihydrogesterone (5mg) daily (12 women)
- Livial: oral tibolone (2.5mg) daily (12 women)
Additionally, 12 women not wishing to use hormone therapies received oral vitamin D (400 IU) plus calcium carbonate (1,250mg).
The women had clinical and hormonal evaluations three, six and 12 months into their treatment.
What were the basic results?
The severity of menopausal symptoms was assessed at the start of the study (known as the ‘baseline’) and after 12 months. This was done using a recognised system called the ‘Greene Climacteric Scale’. At baseline, the women in the DHEA, HRT and tibolone groups had similar severity of menopause symptoms. The women who had chosen not to receive hormone therapies had lower baseline menopause symptoms. After 12 months, symptoms improved in women treated in each of the three hormone groups from baseline (DHEA, HRT and tibolone). There was no change from baseline in the vitamin D group.
At baseline, the women in each of the groups had a similar score on the sexual function questionnaire and had sex similarly often. When the researchers looked at how they changed since baseline they found that:
- Women receiving DHEA or HRT had a greater average score on the sexual function questionnaire. These DHEA and HRT average scores were greater than the women who received vitamin D. Women taking tibolone also had an increased score, though the difference from baseline was not significant.
- There was no difference in a relationship score in any of the groups.
- Frequency of sex in the past four weeks increased in the women treated with DHEA, HRT and tibolone. The increases in these three groups were comparable. The frequency of having sex was greater in the three hormone groups compared to the vitamin D group.
How did the researchers interpret the results?
The researchers say their research shows that women receiving one year of oral DHEA therapy at a daily dose of 10mg improved their hormone symptoms to a similar extent to women receiving HRT or tibolone.
All of the hormone treatments improved the quality of sexual life in the women, which the researchers say ‘supports the hypothesis that hormonal changes during reproductive ageing negatively affect sexual function’. They further add that this finding was achieved in healthy women who would not be considered to have sexual dysfunction, but who opted for hormone treatments to reduce their menopause symptoms.
This small, randomised controlled trial found that both menopause symptoms and measures of sexual function could be improved by three types of hormone therapy. The study compared a form of HRT, tibolone (a unique drug with oestrogen, progestogen and male hormone activity) and another type of hormone therapy called DHEA, which is not currently licensed for use in the UK. One group of women received vitamin D but no hormone therapies.
The study was small, including 48 women in total and 12 in each group. This means there is a higher likelihood the findings are due to chance. Additionally, although the women saw improvements in sexual function, they had normal sexual function at the start of the study and did not have a clinical diagnosis of sexual dysfunction. It is not known whether these hormone treatments would have any effect for women with more severe sex problems.
It is important to note that there are a wide variety of hormone therapies used in the treatment of menopausal symptoms, which have various potential adverse effects and cautions for use. Treatment must be prescribed on an individual basis, as not all therapies are suitable for all women. The women in this study had all gone through a natural menopause, had not had periods for over 12 months and were otherwise healthy.
Different treatments may be prescribed for women who have undergone hysterectomy (with or without removal of their ovaries), or for women who are around the time of menopause but who are still experiencing some irregular bleeding (for example, tibolone is unsuitable for use in women who are within 12 months of their last period).
Women currently taking HRT or other hormone therapies will have been prescribed the drug preparation that is most appropriate for them.
As the Daily Mail highlights, it is not clear from this small study whether DHEA is as safe or effective as HRT therapies or other hormone therapies that are currently available. Larger trials would be needed to see if this is the case.