New Guidelines for the use of Hormone Therapy

NEW data emerging from the Women’s Health Initiative study into the use of hormone therapy (HT) for menopausal women has prompted the South African Menopause Society to revise its guidelines for medical practitioners and women wanting to make informed health choices.

 It’s been five years since the American study ended and, in that time, a re-analysis has taken place of the various subsections of the WHI trials and more information has emerged – all of it pertaining to the use of HT in relation to cardio-vascular disease, cancer and osteoporosis.

 When one of the trials in the study was suspended suddenly in 2002 because the health risks appeared to outweigh the benefits, it triggered a panicky rejection of HT by many women – and their healthcare providers.  However the latest scientific response to the data reflects a guarded shift back to a middle ground of HT use for younger menopausal women.

 Said SAMS president, Dr Tobie de Villiers: “The Society has revised its position statement on hormone therapy because it’s become clear that the risk versus benefit profile differs depending on when and how HT is used.”

 One of the main differences between SAMS’ revised guidelines and those it issued three years ago has to do with the use of estrogen only (ET) compared with estrogen plus progestin (EPT). In the estrogen only arm of WHI, no increase in breast cancer was seen over the seven-plus years of the study. In addition, the younger patients (between 50 and 59) who took part in this trial showed a decrease in overall cardiac events.

 Explained Dr Mike Davey, SAMS’ vice-president: “This has lead to a window of opportunity theory which suggests that early use of estrogen is beneficial to blood vessels. If however ET is delayed and used in an older woman in whom vascular damage has already occurred, the effect could be detrimental.”

When the ET and EPT arms of the WHI study were combined and analysed, researchers found a 30% lower mortality rate in the women using hormones compared with non-users – provided that the HT was initiated less than ten years after the onset of menopause. (The average age of menopause is 51.)

HT in relation to osteoporosis also gets a nod of approval. In line with a WHI publication on bone density, the new SAMS statement indicates that hormone use should be considered a first line of treatment for younger menopausal women with osteoporosis.

 Included in the SAMS guidelines is the considered use of HT for:

 ·        Treatment of hot flushes, night sweats and sleeps disorders. “HT remains the only treatment that consistently has a greater effect than placebo in published controlled trials,” the guidelines state.

·        Preventing and treating urinary problems and vaginal conditions such as dryness, atrophy and painful intercourse. For less severe symptoms, local ET is favoured (usually in the form of a vaginal cream or tablet).

 
The previous SAMS guidelines pointed to a four to five year safety period for the use of HT. The new statement however does not stipulate a timeline for stopping hormone use. The duration should be assessed according to the individual needs of every woman and be reviewed annually. The statement goes on to say that, in general, HT should not be started after a woman has passed the age of 60.

 As with its 2004 position statement, SAMS remains committed to the “principle of the lowest effective dose” as this has been effective in symptom control and the prevention of bone loss.

 The revising of the guidelines by no means gives a green light to the application of HT for every woman going through her menopausal years. Concerns remain around the following :

 ·         Breast cancer. The use of estrogen combined with a progestin for more than five years may be associated with a small increase in the risk of invasive breast cancer. It’s possible that the hormone therapy does not cause the cancer but stimulates pre-existing malignancy. 

·         It’s also recommended that all women undergo breast screening as well as a pelvic examination before starting HT. SAMS maintains that all menopausal women should have regular mammography.

·         There is a small increased risk of blood clot formation but this possibility decreases after the first year of treatment. The risk for thrombosis maybe less if transdermal (through the skin) estrogens are used instead of the oral variety.

·         Stroke. While the WHI study revealed an increased risk for thrombotic stroke, the SAMS statement notes that “there is not enough evidence to support any firm conclusion regarding the effect of HT on stroke”. The document states that smaller doses may be protective and larger doses harmful.

·         Endometrial cancer. There is less risk of developing this cancer when progestogen is included in the HT.

 The SAMS’ statement points out that research into the use of plant estrogens and herbal formulations has not produced results from which confident recommendations can be made for treating menopausal symptoms  - and no published data is presently available on the use of traditional African medicine.

 Decision-making around menopause management is complex. It not only involves the decision of whether or not to use HT but also the hormonal formula and the method of delivery. And one of the crucial elements in judging whether or not a woman should use HT is quality of life which can only be judged by the patient herself – weighing up relief from acute symptoms with long-term risks and the possible discomfort of side-effects.

 A woman’s general state of health is also important. So the SAMS guidelines recommend that the menopausal transition be used as an opportunity to look at all the health matters concerning women in their mid and later lives. Lifestyle modifications that could be addressed include stress reduction, weight management, exercise, smoking cessation as well as monitoring for diabetes, hypertension (high blood pressure), bone density, breast and arterial health. 

Said Dr de Villiers: “Gaps remain in our present knowledge so undertaking HT must be a joint decision between the healthcare provider and an informed patient, based on relevant clinical factors and ongoing scientific evidence.”

·         Read the SAMS Position Statement on the website:

       www.samenopause.co.za