Updated Guidelines Will Help Pharmacists Standardize Hormone Therapy for Menopause and Perimenopause

Updated Guidelines Will Help Pharmacists Standardize Hormone Therapy for Menopause and Perimenopause

Updated Guidelines Will Help Pharmacists Standardize Hormone Therapy for Menopause and PerimenopauseUpdated Guidelines Will Help Pharmacists Standardize Hormone Therapy for Menopause and Perimenopause

The long history of hormone replacement therapy resembles a wild roller coaster ride, with highs when HRT medication was the most frequently prescribed drug in the United States, lows as hormone use plunged after studies revealed adverse effects, and plenty of twists-and-turns in the form of ongoing debates about safety.

In 2013, a group of experts came together for the first time to develop recommendations for the administration of HRT. Now they’ve released a Revised Global Consensus Statement on Menopausal Hormone Therapy. While their guidelines are important for pharmacists, it’s also interesting to note the group’s other message—that the debate is over and that experts are in agreement.

Solidarity Statement from The North American Menopause Society

An article published by The North American Menopause Society began by saying that the debate triggered by the first results of the Women’s Health Initiative gave women the impression that the experts didn’t agree on the topic of hormone therapy.1 This “solidarity statement”—jointly endorsed by The North American Menopause Society, the American Society for Reproductive Medicine, and The Endocrine Society—is intended to show that the experts do agree on key points. Here are the recommendations they support:

  • Menopausal hormone therapy (MHT) – Still the most effective treatment for symptoms like hot flashes and vaginal dryness.
  • Low doses of vaginal estrogen – To help address vaginal dryness or painful intercourse if they are the only symptoms present.
  • Higher doses of oral estrogen therapy – If hot flashes are the primary complaint.
  • Progesterone along with estrogen – for prevention of uterine cancer. Duration of five years or less is recommended, but the length of MHT should be determined individually.
  • Estrogen alone – May be used in women without a uterus. This group may also be able to use it longer than five years.

Risks to consider:

  • Blood clots – The risk of blood clots in the legs and lungs increases with estrogen alone and estrogen with progestogen, but the risk is rare in women aged 50 to 59 years.
  • Breast cancer with combined therapy – Increased risk of breast cancer exists with five or more years of continuous estrogen/progestogen therapy—the risk decreases after hormone therapy is stopped.
  • Breast cancer with estrogen alone – Based on the Women’s Health Initiative, use of estrogen alone for an average of seven years did not increase the risk of breast cancer.

Global Consensus Statement Released August 2016

If the solidarity statement sounds a bit generic, rest assured that the actual revised consensus statement provides more details, such as grades for recommendations and levels of evidence.3 A short overview of relevant information includes:

  • The risk-benefit ratio differs for perimenopausal women compared with older, postmenopausal women. The benefits outweigh the risks if therapy is started before the age of 60 or within 10 years after menopause.
  • MHT recommendations include tibolone, ospemifene and the combination of conjugated equine estrogens and bazedoxifene.
  • Increasing evidence shows MHT initiated around the time of menopause helps prevent bone loss and osteoporotic fractures.
  • Benefits for preventing heart disease remain controversial—hormone therapy is likely harmful when started more than 10 years after menopause, but protective when started early.
  • The increased risk for breast cancer with combination therapy is less than 1 per 1,000 women per year of use—a risk similar to or lower than in factors such as obesity and alcohol consumption.
  • Evidence to date doesn’t support an association between MHT and weight gain.
  • Hormone replacement is recommended to treat vulvodynia
  • Risk of ischemic stroke increases with oral MHT, but it’s rare before age 60.
  • Transdermal therapy and low-dose estrogen may lower the risk of stroke and venous thromboembolism.
  • Use of custom-compounded hormone therapy is not recommended based on concerns over lack of standardization and safety/purity testing.

When MHT is contraindicated for treating vasomotor symptoms, the group recommends selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors such as paroxetine, escitalopram, venlafaxine and desvenlafaxine. Alternately, gabapentin is another effective option.

In addition to The North American Menopause Society and The Endocrine Society, the revised global consensus statement was endorsed by five other groups: The International Menopause Society, The European Menopause and Andropause Society, The Asia Pacific Menopause Federation, The International Osteoporosis Foundation and The Federation of Latin American Menopause Societies.

Lifestyle Considerations Are Part of the Strategy 

Lifestyle affects a woman’s quality of life at any stage, but it makes a significant difference during peri- and post-menopause, as this is a time when bone loss escalates, aging causes loss of lean muscle mass, and hormonal changes increase the risk of weight gain. When MHT is being considered, the discussion should also include diet and exercise, with the goal of developing healthy habits to carry them through menopause and beyond. The consensus guidelines also specifically recommend an evaluation of lifestyle habits when MHT is being considered to prevent osteoporosis.

When you have the opportunity to counsel women, they may welcome lifestyle tips to help make menopausal symptoms more tolerable:4

  • Hot flash relief – Dress in layers and drink a cold glass of water.
  • Avoid hot flash triggers – Women may not be aware that hot flashes are sometimes triggered by hot beverages, caffeine, spicy foods, alcohol, and stress.
  • Smoking cessation – In addition to boosting the risk of heart disease, stroke, osteoporosis and cancer, smoking may also increase hot flashes.
  • Relieve vaginal discomfort – Advise women to use water-based vaginal lubricants and to avoid those containing glycerin, which may cause burning or irritation.

The consensus report did not delve into alternative therapies, but you can offer some guidance to patients based on a systematic review published in June 2016 in JAMA. While the studies reviewed were heterogeneous and not up to rigorous standards overall, the experts were able to reach a conclusion: phytoestrogens such as soy isoflavones were associated with a modest decrease in hot flashes and vaginal dryness, but didn’t relieve night sweats.5 Red clover may help with night sweats, but didn’t affect other symptoms, and black cohosh didn’t yield any benefits.6

Pharmacists Guide Women Through the Maze of Choices

Hormone therapy is a personal decision that requires sorting through a maze of treatment options, risk factors, and family history. These details are worked out between women and their doctors, but pharmacists will still face questions. At the very least, you will help monitor for adverse effects when hormones are prescribed. With knowledge of the latest consensus guidelines, you’ll be better prepared to counsel your patients facing menopause.

Pharmaceutica North America provides prescription drug products and a diverse line of bulk active pharmaceutical ingredients to treat multiple aging-related issues. Contact us today to talk about how we can support your pharmaceutical needs.

Show 6 footnotes

  1. “The Experts Do Agree About Hormone Therapy,” August 2016, https://www.menopause.org/for-women/menopauseflashes/menopause-symptoms-and-treatments/the-experts-do-agree-about-hormone-therapy
  2. “The Experts Do Agree About Hormone Therapy,” August 2016, https://www.menopause.org/for-women/menopauseflashes/menopause-symptoms-and-treatments/the-experts-do-agree-about-hormone-therapy
  3. “Revised Global Consensus Statement on Menopausal Hormone Therapy,” June 2016, http://www.imsociety.org/manage/images/pdf/fd28270c02bdca95a58a471e1719e9b4.pdf
  4. “Menopause: Lifestyle and Home Remedies,” January 2015, http://www.mayoclinic.org/diseases-conditions/menopause/basics/lifestyle-home-remedies/con-20019726
  5. “Use of Plant-Based Therapies and Menopausal Symptoms,” June 2016, http://jama.jamanetwork.com/article.aspx?articleid=2529629
  6. “Plant-Based Remedies Helpful in Reducing Some Menopausal Symptoms,” June 2016, https://www.uspharmacist.com/article/plantbased-remedies-helpful-in-reducing-some-menopausal-symptoms
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