On Tuesday, July9, 2002, the Data and Safety Monitoring Board (DSMB) recommended stopping a major study of synthetic hormone replacement therapy (HRT: conjugated equine oestrogens and medroxyprogesterone) on the risks and benefits of combined oestrogen and progestin in healthy postmenopausal women. This is the first randomised controlled primary trial (planned duration 8.5 years) in which 16,608 post-menopausal women aged 50-79 years with an intact uterus at baseline were recruited by 40 American clinical centers in 1993-1998.This study was halted after researchers for the Women’s Health Initiative (WHI) cited an increased risk of invasive breast cancer, coronary heart disease (CHD), stroke and pulmonary embolism.
This is the latest of many reports released over the last few years, that have offered conflicting reports regarding the benefits and risks of synthetic HRT.Long-term use of HRT had been thought to aid in the prevention of heart disease and osteoporosis. However, as in this particular case, after five years of the scheduled eight and a half year study, it was determined that the risks associated with synthetic HRT outweighed the positive results of the therapy. The positive outcomes were a decrease in the risk of colon cancer and reduced fractures.
Numbers of overall deaths in the oestrogen/progestin and placebo groups were statistically and clinically similar in this short-duration study. Most adverse outcomes began appearing within 1 to 2 years, but increased breast cancer risk did not begin until 3 years. Results were remarkably consistent in subgroup analyses, suggesting that there is not a subgroup that the drug benefits. The DSMB did not recommend stopping the other portion of the hormone replacement trial, which compared oestrogen alone with placebo in women with hysterectomies, so it is reasonable to assume that to date, oestrogen alone may be safer than combination oestrogen/progestin. [Ref: JAMA.Vol.288 No.3, July 2002]
HOW COMPOUNDING PHARMACISTS CAN HELP FIND A SOLUTION
It is important to differentiate between synthetic hormone replacement therapy cited in the study and Natural (Bio-Identical) hormone replacement therapy offered by compounding pharmacists. A compounding pharmacist, pursuant to a doctor’s prescription can prepare customised bio-identical hormone replacement therapy for women as an alternative to synthetic hormone replacement therapy.
As a customer of Australian Compounding Pharmacy, we would like to re-inforce the following positives about our service just in case some of your friends taking synthetic HRT ask you about Natural or Bio-Identical HRT.
1. Bio-identical hormones including oestriol, oestrone, oestradiol (Tri-est) and progesterone were NOT part of the halted NIH study. For years, health physicians have been prescribing bio-identical hormone replacement therapy as an alternative for women concerned with the use of a synthetic hormone replacement therapy.
2. A benefit of bio-identical hormone replacement therapy is that they can be customised, in strength and dosage form, to exactly suite individual’s specific needs.
3. The decision on whether to use bio-identical hormone replacement therapy should be determined on an individual basis only after appropriate consultation with a physician and pharmacist.
So, you are way ahead of others who have chosen the synthetic pathway to control hormonal balance. Thank you for allowing this compounding pharmacy to be part of your decision to select a more natural, albeit, lesser known solution to better health.
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