Menopause breather as US FDA drops warning from hormone replacement (HRT) therapy: Gynaecologists decode if this is safe

What’s the trouble with HRT?
Although hormone therapy has been around, prescriptions plummeted after 2003. This followed the WHI findings of 2002, demonstrating that HRT increased the risk of breast cancer, heart disease and stroke. The study concluded that the benefits associated with HRT did not outweigh these risks.

However, follow-up research challenged the study, saying it had methodological flaws. The study had exclusively studied women who were ten years post-menopause, with an average age of 63, who the researchers felt were already vulnerable to cardiovascular issues. Besides, the study, critics said, evaluated only one delivery method — a daily pill combining estrogen and progestin — which has now been replaced with more effective options like transdermal patches, vaginal rings and topical gels, as well as different amounts and types of hormones.

“Unfortunately, the study was done in the wrong cohort of women. So a lot of women, who actually required hormonal replacement, were bereft of the treatment in these years because of the WHI study. From that time, analysis has been done and guidelines have been published again,” says Dr Meenakshi Ahuja, senior director, obstetrics and gynaecology, Fortis, Le Femme. Current medical literature suggests that HRT can be beneficial for women within 10 years of menopause or in the under-60 group. Many doctors are even recommending early treatment in perimenopause to maximise benefits and avoid complications. “There have been many large community and population registry-based studies. India has data on symptoms and the onset of menopausal age,” says Dr Ruma Satwick, senior consultant and professor of reproductive medicine, Sir Ganga Ram Hospital, Delhi. “The structure of newer drugs is similar to that of natural estrogen and progesterone; they are analogues. HRT patches or those meant to be applied topically allow absorption of hormones through the skin to the systemic circulation. This pattern of absorption bypasses the liver so there is a more consistent blood level of hormone than via the oral route,” she adds.

What are benefits of HRT?
HRT reduces severe cases of hot flashes, palpitations, frequent UTIs and improves concentration, focus and sleep. “Clinical trials have shown HRT is effective in preventing osteoporotic fractures. It slows down bone loss. And with menopause, there is a rapid decay in bone mass. The risk of fractures is three times higher in women than men in their 70s. HRT slows down cognitive decline, the risk of which is again higher in women. And it controls heavy flow periods in the irregular phase of perimenopause,” says Dr Satwick.

Who qualifies for HRT?
“It should be the first line therapy for menopausal women who have been screened for contraindications. Now it’s established that HRT therapy should be given for the least possible time in the least possible dose for four clear indications, which include premature ovarian failure that is menopause before 40 years, vasomotor issues  like hot flashes and night sweats which interfere with good quality of life, genitourinary syndrome which leads to urinary infections as well as for prevention of osteoporosis. The sooner menopausal therapy is started in the first 10 years of menopause, it gives excellent results, and this is known as the golden period of starting HRT,” says Dr Ahuja. HRT can improve quality of life in menopausal women when used judiciously at the right time, for the right duration and at the right dosage, she argues.

Of course, this can be done once the contraindications have been ruled out and regular screening for these women has been done. Dr Satwick did a survey of her women patients in the 40 to 60 age group. “I found that 10 per cent had severe symptoms, 15 to 20 had moderate symptoms and the rest did not experience any symptoms at all. So, HRT is clearly not for everybody, only those with severe symptoms. Nobody should use it, begin or end it without consulting their doctors and getting a complete health assessment done,” she says.

On HRT in India
“From the available Indian data, it is hypothesized that an early age of menopause predisposes a woman to chronic health disorders a decade earlier than a Caucasian woman. It is reported that osteoporotic fractures occur 10–20 years earlier in Indians compared to Caucasians.The first myocardial infarction (MI) attack occurs in 4.4% of Asian women at a younger age than in European women In India, type 2 diabetes occurs a decade earlier than the Caucasians. Breast cancer is the most common cancer in Indian women, and the incidence peaks before the age of 50 years,” says Dr Ahuja.

Who should not take HRT?
Women who have a family history of cancer, high risk for breast cancer, have active endometrial and gynecological hormone-dependent cancers, severe active liver disease with impaired/abnormal liver function, deep vein thrombosis, heart disease or an increased risk of one, pregnancy, and undiagnosed and abnormal vaginal bleeding.