Primary care screening to identify symptomatic menopausal women
Research type
Research Study
Full title
The use of a screening tool in primary care to identify menopausal and perimenopausal women who could benefit from Hormone replacement therapy
IRAS ID
265355
Contact name
Rod Tucker
Contact email
Sponsor organisation
Rotherham Doncaster & South Humber Foundation Trust
ISRCTN Number
ISRCTN13287757
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
Research Summary
The menopause represents a normal physiological change that occurs on average occurs in women age 50. Though not strictly an illness, the low levels of oestrogen associated with the menopause commonly results in vasomotor symptoms such as hot flushes and night sweats. In addition, some also experience sleep disturbance, depression, mood changes, musculoskeletal pain, vaginal dryness and low libido.
Menopausal symptoms can be easily managed with hormone replacement therapy (HRT) however the potential increased risk of breast and other cancers, although very slight, has led to concerns among many women so that uptake of HRT is relatively low and women remain symptomatic.
The purpose of the present study is to make use of a validated screening tool to identify women eligible for treatment with HRT and who, according to the screening tool, experience moderate to severe menopausal symptoms. These women will be offered an appointment with a practice pharmacist to discuss the benefits and any possible risks from using HRT to enable them to make an informed choice on whether they wish to manage their symptoms with treatment.
We are interested in exploring the proportion of eligible symptomatic women who subsequently decide to use HRT and the extent to which the symptom burden is reduced by treatment.Summary of Results
Introduction Climacteric symptoms experienced by women during the menopausal transition can be managed using hormonal replacement therapy (HRT). However, the use of HRT has become maligned due to concerns over higher cancer risks which are largely unfounded. Consequently, many women are likely to experience an unnecessary climacteric burden that could be resolved with HRT. The current study examined the impact of HRT on women identified with a moderately severe climacteric burden.
Method
Women aged 47 to 53 years were asked to complete the menopause rating scale (MRS) which assessed climacteric severity burden. Women with at least moderate severity were invite to consult with a clinical pharmacist based at their GP practice to discuss the use of HRT. The primary outcome of interest was the change from baseline in MRS score at 3 months. The main secondary outcome was the change from baseline in the subdomains (psychological somatic and urogenital) of the MRS.Results
A total of 64 women with a mean age of 50.63 years were recruited into the study. All completed a baseline MRS score and 57.8% completed a three- month follow-up MRS score.
The mean baseline and follow-up MRS scores were 21.64 and 18.54 respectively (p= 0.008). There were also significant improvements in psychological (p = 0.046), somatic (p = 0.014) and urogenital (p = 0.003) symptoms.Conclusion
Women undergoing the menopausal transition and experiencing moderately burdensome climacteric symptoms, appear to gain a significant improvement in their symptomology across all domains with hormone replacement therapy.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0745
Date of REC Opinion
23 Mar 2020
REC opinion
Further Information Favourable Opinion