Women's Health - Keeping HRT

    Women's Health - Keeping HRT, World of Irish Nursing, Vol 10 (9), October 2002 p 24-26 

In the wake of the  recent controversy, the need for a clear understanding of the role of HRT has never been greater, writes Ails n Riain

The WHI study provides strong evidence that long-term HRT does not preserve health and prevent disease. HRT is likely to be primarily employed for relatively short-term use in the treatment of menopausal symptoms and more selective longer term use where a significant risk of osteoporosis has been established.

Absolute contraindications to HRT
  • Acute phase myocardial infarction, pulmonary embolism or DVT
  • Active endometrial or breast cancer
  • Uninvestigated breast lump
  • Uninvestigated abnormal vaginal bleeding
  • Pregnancy
  • Severe, active liver disease with abnormal liver function tests

Strengths and weaknesses of HRT formulations
Formulation Strengths Weaknesses
 Systemic
Oral (tablets)
  • Easy to take
  • Generally well tolerated
  • Range of drugs available in tablet form
  • Relatively inexpensive
  • Require daily compliance
  • Some people do not like to take tablets
  • Blood levels less certain due to variation in absorption from gut
  • Drug interactions may occur
Transdermal (patches)
  • Avoid first pass effect
  • Some regard them as more ‘natural’
  • Once or twice weekly application may  increase compliance 
  • May cause skin reactions
  • Patches visible
  • Adhesion may be a problem 
  • More expensive
Transdermal (foam, gel, cream, intranasal spray)
  • Avoid first pass effect 
  • Some regard them as more ‘natural’
  • Invisible
  • Only oestrogen is available
  • May cause skin reactions
  • Some consider them ‘messy’
  • Daily compliance required
  • Dose may be variable 
  • More expensive
Subcutaneous (implant)
  • Avoid first pass effect
  • Compliance not generally a problem (duration of action – 6 months) 
  • Greater dose range of oestrogen available
  • Only oestrogen is available
  • Not commonly initiated in general practice as small surgical procedure involved
  • Tachyphylaxis
Local 
Vaginal pessary
  • Indicated for treatment of vaginal atrophy 
  • Little systemic effect although long-term use not advised

The recent publication of the results of the prematurely concluded trial of hormone replacement therapy by the Women’s Health Institute has prompted clinicians to review their prescribing. The WHI study demonstrates that HRT is not effective in the primary prevention of cardiovascular disease in postmenopausal women and otherwise generally confirms the known risks and benefits.

While it has provided clear information in the area of cardiovascular disease prevention, the surrounding publicity has contributed to existing levels of uncertainty amongst both the public and healthcare professionals about the role of HRT in the future.

Combining this uncertainty with an apparently ever-increasing choice of preparations and formulations, choosing a suitable preparation for women who wish to take HRT is more difficult than ever.

HRT is the treatment of choice for menopausal symptoms and remains underused in this capacity. It also continues to play a useful role in the prevention and treatment of osteoporosis in women. Before treatment is initiated, an individualised risk-benefit analysis should be carried out and the woman then advised of her options accordingly.

Emerging evidence is likely to influence the level of investigation of individual risk. It is also likely to focus both women and healthcare professionals on more structured monitoring of HRT and making continuation a matter for active consideration at review visits.

The majority of women with menopausal symptoms are candidates for HRT. A small number of women with absolute contraindications (see Table 1) are excluded and further investigation or specialist advice should be sought in the case of relative contraindications. For the remaining majority, most formulations will suit most women.

However, for some women, none of the standard preparations will meet their needs or keep them free of side effects. In such cases, an individualised regimen may be required and specialist referral may be necessary.

Regimens

Oestrogen alone is sufficient for a woman who has had a hysterectomy, except in the case of endometriosis where combined HRT is recommended to prevent pelvic recurrences.

Combined sequential preparations (daily oestrogen with 12-14 days progestogen per month) are suitable for the peri-menopausal woman with an intact uterus. This usually results in a regular, monthly bleed.

Continuous combined preparations (with oestrogen and a small amount of progestogen in every dose) are suitable for the post-menopausal woman with an intact uterus. These ‘no bleed’ preparations usually cause no regular menstrual bleeding once the woman is truly post-menopausal on initiation of therapy and has been taking the preparation for about six months. While spotting or irregular bleeding in the early months of use are a relatively common reason for discontinuation, they are not a cause for medical concern.

Depending on the indication for use, alternatives to HRT such as tibolone, raloxifene or the bisphosphonates may be considered.

Lifestyle issues such as nutritional intake, smoking and exercise need to be addressed, irrespective of the choice of medication. It is important not to overlook the contraceptive needs of perimenopausal women as HRT doses of oestrogen are not contraceptive. 

Formulations

The options include systemic (tablets, patches, gels and implants) and local preparations. Each has strengths and weaknesses (see Table 2). Choice is determined by patient preference, doctor familiarity and cost in the majority of cases.

Medical indications for a particular formulation exist in relatively few cases (see Table 3) and the evidence is relatively weak. Provided equivalent doses of hormone are given, all routes of administration appear to be equally effective in preventing osteoporosis.

A number of other options are likely to be available in the near future. Progestogen is currently available in a progestogen-releasing IUCD (Mirena) although this is not yet licensed in Ireland as a component of HRT. Vaginal rings impregnated with hormones are in advanced stages of development.

The usual first lines of treatment are tablets or patches. Active involvement of the woman in deciding on her route of treatment will minimise the possibility of disillusionment and consequent HRT discontinuation.

Developing a personal formulary

Conjugated oestrogens, oestradiol valerate and micronised oestradiol are widely used in HRT. Their effect is comparable to that of 17-oestradiol, the natural oestrogen. There is currently no evidence that any form of oestrogen is better than another, either in the treatment of symptoms or the prevention of osteoporosis.

The progestogens most commonly used in HRT are divided essentially into the C-21 progesterone derivatives (eg. Dydrogesterine, medroxyprogesterone acetate) and the C-19 nortestostrone derivatives (eg. norethisterone, norgestrel) with differing androgenicity and endometrial potencies(see Table 4)

Faced with an apparently bewildering choice of preparations, clinicians may develop their own personal formulary of preparations with which they are familiar.

Criteria for inclusion in such a formulary may include a range of all three regimens(oestrogen alone, sequential combined and continuous preparations); a range of formulations (tablets, patches, etc); a range of different doses of oestrogen and a range of progestogens to allow logical selection and switching of HRT in individual clinical circumstances.

Cost implications, local specialist prescribing and patient preference should also be considered in developing this formulary.

Active decision making

Active decisions should be made about whether a woman needs HRT, whether she is a suitable candidate, the form best fitted to her personal needs and the level of investigation and monitoring required.

HRT selection benefits form the advice of Maimonides, a 12th century Egyptian physician who stated that one should always consider the particular patient, the particular time in the patient’s life and the patient’s particular constitution. His essential point was: Do not treat everybody as if they were the same!

Women need to feel confident with their treatment and their healthcare team. This requires doctors and nurses taking the time to inform themselves on the best option and then taking the same time to inform and involve women in decisions about their treatment.

Patient satisfaction is the ultimate determinant. However, it is to be accepted that some patients will not feel better on HRT, despite adequate trials of a verity of therapeutic manoeuvres.


Dr. Ailis ni Riain is director of the Irish College of GPs' Women's Health Programme

References on request

 



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