The 2023 NonHormone Therapy Position Statement of the North American Menopause Society

Source: Menopause: The Journal of The North American Menopause Society. Vol. 30, No. 6, pp. 573-590. DOI: 10.1097/GME.0000000000002200

In June 2023, the North American Menopause Society (NAMS) released an update (with expanded information) to their 2015 NonHormone Management of Menopause-Associated Vasomotor Symptoms: Position Statement.

For this update NAMS selected an advisory panel of clinicians and research experts in women’s health to review and evaluate the literature published since their 2015 Position Statement was published.

This new information was used to reach consensus on updated recommendations in the following five categories of therapy:

1. Lifestyle
2. Mind-body techniques
3. Prescription therapies
4. Dietary supplements
5. Acupuncture, other treatments, and technologies

It is important to realize that NAMS recommendations are based on scientific evidence. If NAMS does not recommend these treatments, it does not mean that there are no benefits, just no scientific evidence that they improve perimenopause symptoms.

Summary conclusions of the update are as follows:

Recommended

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Recommended therapies to treat perimenopause symptoms, particularly vasomotor symptoms (hot flashes & night sweats):

  • cognitive-behavioral therapy
  • clinical hypnosis
  • selective serotonin reuptake inhibitors (SSRIs) / serotonin-
  • norepinephrine reuptake inhibitors (SNRIs)
  • gabapentin
  • fezolinetant (Veozah)
  • oxybutynin
  • weight loss
  • stellate ganglion block

Not Recommended

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Not recommended therapies (therapies that are not supported by scientific evidence) include:

  • paced respiration
  • supplements/herbal remedies
  • cooling techniques
  • avoiding triggers
  • exercise
  • yoga
  • mindfulness-based intervention
  • relaxation
  • suvorexant
  • soy foods and soy extracts
  • soy metabolite equol
  • cannabinoids
  • acupuncture
  • calibration of neural oscillations
  • chiropractic interventions
  • clonidine
  • dietary modification
  • pregabalin
  • This expert panel used the strength of scientific evidence in published papers to assign a level of support.
    Level 1 = good and consistent support
    Level 2 = limited or inconsistent evidence
    Level 3 = no published evidence, support is by means of consensus and medical expert opinion


    Lifestyle
    Therapy NameRecommended (Y / N)Evidence Level
    Cooling techniques
    • Clothing adjustments (dressing layers, avoiding pullover sweaters, etc.)

    • Environmental controls (fans, cold packs, lower room temperature, etc.)

    N – research has found no measurable changes in the number or duration of hot flashes & night sweats based on these cooling techniquesLvl 2
    Avoiding Triggers
    • Alcohol, caffeine, spicy foods, etc.

    N – There are no clinical trials assessing the effects of avoiding specific triggers for the alleviation of VMS.Lvl 2
    Exercise and YogaN – there are other health benefits associated with exercise or yoga, but little evidence supporting them for the treatment of VMS.Lvl 2
    Dietary modificationN – credible research evaluating the relationship of diet and VMS is limited, although individual studies have shown some reductions in the severity of hot flashes & night sweats from dietary modification.Lvl 3
    Weight LossY – Evidence suggests that the role of adiposity (fat) and weight loss may vary depending on age or menopause stage. Specifically, being overweight seems to be a greater risk factor for hot flashes & night sweats during perimenopause and early postmenopause but not when women are older or are later in post-menopause. This means weight loss may have greater effects in reducing VMS when women are earlier in the transition.Lvls 2 – 3


    Mind-Body Techniques
    Therapy NameRecommended (Y / N)Level of Evidence (1-3)
    Cognitive-Behavioural Therapy (CBT)Y – studies support CBT reducing the bother and interference of hot flashes & night sweats for both survivors of breast cancer and menopausal women.Lvl 1
    Mindfulness-based interventions
    • meditation practices; approaching thoughts, feelings, and bodily sensations in an accepting, nonjudgmental manner; mindfulness-based stress reduction (MBSR)
    N – studies generally show positive effects in reducing menopause symptoms broadly, with mixed effects for hot flashes & night sweats specifically.
    However, these studies are limited by small size and/or limited control groups and most were not designed to consider menopausal symptoms (so perimenopausal women were not specifically enrolled). Future rigorously designed trials are needed to test the efficacy of MBI for menopausal symptoms.
    Lvl 2
    Hypnosis
    • With a trained provider

    • Through a smartphone app
    Y – studies show that clinical hypnosis is significantly better at reducing the frequency and severity of hot flashes and improving mood and sleep compared to no treatment.Lvl 1
    Paced Respiration
    • taking six to eight slow, deep breaths per minute while inhaling through the nose and exhaling through the mouth
    N – one study (of only three) had women use a chest device to guide their slow, deep breathing practice at home for at least 15 minutes per day. This showed significantly less benefit than a control group assigned to music listening. The other studies showed no effect.Lvl 2
    RelaxationN – Evidence is limited and inconsistent on relaxation for hot flashes & night sweatsLvl 2


    Prescription Therapies
    Therapy NameRecommended (Y / N)Level of Evidence (1-3)
    Selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI)Y – Evidence exists that SSRIs and SNRIs are associated with mild to moderate improvements in hot flashes & night sweats, regardless of whether menopause is natural or surgical.Lvl 1
    GabapentinoidsY – FDA approved as an antiepileptic drug, however, several studies show that gabapentinoids improve the frequency and severity of hot flashes & night sweats.Lvl 1
    PregabalinN – FDA approved for the management of neuropathic pain and seizures. One study showed improvements in hot flashes & night sweats but an increase in dizziness and cognitive difficulties.Lvl 3
    ClonidineN – studies have shown modest benefits for hot flashes & night sweats compared to a placebo (nothing) but less beneficial than SSRIs, SNRIs, and gabapentin in reducing VMS. It is used infrequently because of side effects including low blood pressure, lightheadedness, headache, dry mouth, dizziness, sedation, and constipation. Sudden cessation can lead to significant elevations in blood pressure.Lvls 1, 2, 3
    OxybutyninY – used for the treatment of overactive bladder and urinary urge incontinence. Studies have shown that use significantly improves moderate to severe hot flashes & night sweats. Note that long-term use may be associated with cognitive decline.Lvls 1, 2
    SuvorexantN – used to reduce the severity of insomnia. One small study showed that it led to reductions in night sweats compared to a placebo and was well tolerated. Suvorexant did not improve daytime hot flashes. These limited results do not support its use for hot flashes & night sweats.Lvl 2
    Neurokinin B antagonists
    (Fezolinetant (Veozah))
    Y – Fezolinetant (Veozah) is the only FDA approved drug in this class, however, elinzanetant is currently in the approval process. These nonhormonal drugs directly target the neural mechanism underlying hot flashes & night sweats.Lvl 1


    Dietary Supplements
    • There are few credible clinical studies to evaluate supplements and there is no government regulation ensuring the purity and safety of supplements. Despite this, these over-the-counter products are widely marketed directly to the consumer. Specific claims of alleviating individual symptoms are allowed, even with limited or no evidence as long as the marketing doesn’t claim to provide relief from the broader condition or disease – in this case, perimenopause and menopause.
    Therapy NameRecommended (Y / N)Level of Evidence (1-3)
    Soy foods and soy extractsN – most widely used isoflavone- containing food. Isoflavones are a type of phytochemical that bind to estrogen receptors (ERs) in animals and human beings. Research findings are mixed, with some studies showing improvements, some showing no change, and some showing less benefit than other treatments.
    – Note that few studies have considered whether study participants can actually metabolize soy, which is critical for its potential positive effects and only 35% of North American women can metabolize isoflavone into equol – the substance that is helpful as an estrogenic substance (a substance that binds to estrogen receptors, helpful as women’s estrogen levels are dropping during perimenopause).
    Lvl 2
    Soy metabolite equolN – Equol is a nonsteroidal estrogen that is produced from metabolizing (breaking down) soy food or supplement products. Few studies have considered whether study participants can actually metabolize soy, which is critical for its potential positive effects and only 35% of North American women can metabolize isoflavone into equol. Women who cannot produce equol after ingesting soy do not benefit from soy but would be expected to benefit from taking equol directly. Lvl 2
    Pollen extractN – A proprietary extract made from flower pollen has been available under the brand names Relizen, Serelys, Femal, and Femalen. One small study found that women showed a significant decrease in hot flashes & night sweats after 12 weeks’ use of pollen extract. However, expert opinion and limited research support a finding of ‘not recommended’.Lvl 3
    Ammonium succinateN – ammonium succinate is a water-soluble, colourless crystal with an acid taste. It is used to produce medicine, the manufacture of lacquers, to make perfume, and to prepare a highly efficient rust remover for as a chemical intermediate, in medicine outdoor construction steel and stone. Two small studies on the use of ammonium succinate found improvements in perimenopause symptoms such as poor sleep, fatigue, loss of interest in sex, joint and muscle pain, hot flashes & night sweats, and a decrease in anxiety compared with the placebo group. However, these results are based on manufacturer-sponsored clinical trials.Lvl 2
    Lactobacillus acidophilusNLactobacillus acidophilus is the most commonly used probiotic. The only small study done showed that quality of life (based on the Kupperman Index) improved after 12 weeks of use. The study has not been replicated.Lvl 2
    RhubarbN – Siberian rhubarb (Rheum rhaponticum) is eaten and is used as a medicinal plant for constipation, diarrhea, and other gastrointestinal complaints. One study reported that at 12 weeks, the Menopause Rating Scale (MRS – a diagnostic tool that measures the severity of perimenopause symptoms) total score and each symptom within the scale (including hot flashes & night sweats) significantly improved compared to no treatment. These conclusions are limited because of the study design and low numbers of women completing the full study. Lvl 2
    Black cohoshNActaea racemosa L. (previously Cimicifugae racemosae), is the most purchased botanical for menopause symptoms. The active ingredients in black cohosh extract are unknown, and how it works in the body is unclear. Reports of possible liver damage have resulted in all black cohosh products carrying a warning statement: “Discontinue use and consult a healthcare practitioner if you have a liver disorder or develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice.” Only a few studies have looked specifically at black cohosh, all with contradictory results.Lvl 1
    Wild yamN – One clinical trial found no significant benefit to yam cream, which is unsurprising because tested yam creams often do not contain any yam extract. Many contain unidentified steroids, including estrogens and progesterone. These additives may be harmful and studies do not support using yam cream. Lvl 2
    Dong quaiN – The small studies done to date do not support Dong quai helping hot flashes & night sweats. There are safety concerns including possible sensitivity to light and sunlight, blood thinning and cancer causing properties. Lvl 2
    Evening primroseN – There has only been one published study and no benefit was found compared to a placebo.Lvl 2
    MacaN – Four studies showed improvements in scores from the Greene Climacteric Scale or the Kupperman Index. However, these studies had design, quality, and sample sizes issues and there was limited reporting of study data, so the existing evidence is not strong enough to support the use of maca for hot flashes & night sweats.Lvl 2
    GinsengN – Researchers from two separate studies found no significant effect of ginseng on hot flashes & night sweats compared to no treatment.Lvl 1
    Labisia pumila / Eurycoma longifolia (Nu-FemmeTM)N – The roots of these plants are used in many different herbal remedies treating sexual dysfunction, ageing, malaria, cancer, diabetes, anxiety, aches, constipation, exercise recovery, fever, increased energy, increased strength, leukemia, osteoporosis, stress, syphilis, glandular swelling, erectile dysfunction (ED), male infertility, increasing sexual desire in healthy people, and boosting athletic performance. There is little research on how it works for any of these conditions. For hot flashes & night sweats, no significant differences have been found between treatment and no treatment groups. Lvl 1
    Chasteberry (Vitex Agnus-Castus)N – Plants from the genus Vitex (including chasteberry) are known to have estrogenic properties. However, studies done on chasteberry used different ingredients in the compounds making it impossible to conclude that it was chasteberry alone that improved hot flashes & night sweats. Lvl 2
    Milk thistleN – This herb is often used to treat fever and for kidney and spleen disease. A single study showed improvement in hot flashes and night sweats, but there were problems with the study design. Lvl 2
    Omega-3 fatty acidN – these supplements contain polyunsaturated fatty acids. Study results have been mixed or inconclusive and cannot support recommended usage for hot flashes & night sweats.Lvl 2
    Vitamin EN – There is very little evidence for vitamin E having significant benefit in reducing hot flashes & night sweats.Lvl 1
    CannabinoidsN – Despite the fact that one-quarter of women report having used or currently using marijuana to treat their menopause symptoms, research data is very limited. Because of this, its use cannot be recommended.Lvl 2


    Other Treatments & Technologies
    Therapy NameRecommended (Y / N)Level of Evidence (1-3)
    AcupunctureNResearch studies have shown that acupuncture does improve some menopause-related symptoms such as mood, sleep, and pain based on improvements in diagnostic tools including the Kupperman Index and the Greene Climacteric Scale, and improvement in quality-of-life measurements such as the Menopause-specific Quality of Life (MSQOL) survey. There was no difference found between treatment and no treatment for hot flashes & night sweats for natural or surgical menopause.Lvl 1
    Stellate ganglion blockY – Stellate ganglion blockade is a widely used treatment for pain management, including for migraine and complex regional pain syndrome. It involves injecting an anaesthetic agent into the spine at the front of the neck. How it works for hot flashes & night sweats is unclear. Despite this, studies show that it improves hot flash & night sweat frequency and severity. This is a procedure that involves risks and side effects.Lvls 2, 3
    Calibration of neural oscillationsN – This is an acoustic stimulation neurotechnology where scalp sensors and software algorithms translate specific brain frequencies into audible tones of varying pitch in real time. These tones are immediately mirrored back via earbuds, allowing the brain to “listen to itself ” in an acoustic mirror. There is a total lack of controlled trials, so this treatment is not recommended.Lvl 2
    Chiropractic interventionN – There have been no clinical trials of chiropractic interventions for hot flashes & night sweats and survey data do not show an association between use of chiropracty and hot flashes & night sweats and VMS.Lvl 2

    NAMS 2022 Updated Hormone Therapy Position Statement

    Source: Menopause: The Journal of The North American Menopause Society. Vol. 29, No. 7, pp. 767-794. DOI: 10.1097/GME.0000000000002028

    In July 2022, the North American Menopause Society (NAMS) released an update to the 2017 Hormone Therapy Position Statement. NAMS used an Advisory Panel of experts in the fields of women’s health and menopause (both clinicians and researchers) to review the 2017 Position Statement, evaluate new literature, assess the evidence, and reach consensus on updated recommendations.

    Highlights from this update include:

  • Hormone therapy remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM) and has been shown to prevent bone loss and fracture.
  • The benefits of hormone therapy outweigh the risks for most healthy symptomatic women who are aged younger than 60 years and within 10 years of menopause onset.
  • The decision to use MHT should be a shared decision between a woman and her healthcare provider. The decision should be re-evaluated periodically over the course of treatment as a woman ages to ensure the use of appropriate doses, durations, and routes of administration required to manage a woman’s symptoms and to meet treatment goals.
  • Risks should be assessed using both age and time since menopause.
  • Transdermal (through the skin) routes of administration and lower doses of hormone therapy may decrease risk of blood clots and stroke.
  • Women with primary ovarian insufficiency (POI) and premature or early menopause have higher risks of bone loss, heart disease, and cognitive or affective disorders associated with estrogen deficiency. It is recommended that hormone therapy can be used until at least the mean age of menopause unless there is a strong reason not to use MHT.
  • There are not enough randomized, controlled trial data to be definitive about the risks of extended duration of hormone therapy in women aged older than 60 or 65 years. Observational studies suggest there is a potentially rare risk of breast cancer with increased duration of hormone therapy.
  • For some survivors of breast and endometrial cancer that do not find any relief of their GMS menopausal transition symptoms from non-hormone therapy, observational data show that of low dose vaginal estrogen therapy appears safe and greatly improves quality of life for many.
  • Breast cancer risk does not increase with short-term use of estrogen-progestogen therapy and may be decreased using estrogen alone (ET) therapy.
  • There are safety concerns with the use of compounded bioidentical hormone therapy including minimal government regulation and monitoring, the risk of overdosing or underdosing, the presence of impurities, a lack of scientific data on effectiveness and safety, and poor or absent risk labelling.
  • Hormone therapy does not need to be routinely discontinued in women aged older than 60 or 65 years and can be considered for continuation beyond age 65 for persistent VMS, quality-of-life issues, or prevention of osteoporosis after appropriate evaluation and counseling of benefits and risks.
  • For women with GSM, vaginal estrogen or other non-estrogen therapies may be used at any age and for extended duration, if needed.
  • NAMS 2015 Updated NonHormone Therapy Position Statement

    Source: Menopause: The Journal of The North American Menopause Society. Vol. 22, No. 11, pp. 1155-1172. DOI: 10.1097/GME.0000000000000546

    In 2015, the North American Menopause Society (NAMS) released a position statement on non-hormonal management of the most common perimenopause symptoms called Vasomotor Symptoms (VMS). This position statement is aimed at clinicians, to keep them informed about what the scientific evidence shows with respect to the many non-hormonal (naturopathic) management options. The goal is to provide evidence-based guidance that can prevent the use of inappropriate or ineffective therapies and to support the use of effective ones.

    NAMS Recommended:

  • Cognitive behavioral therapy (CBT), a common form of talk therapy, and clinical hypnosis have been shown to be effective in reducing vasomotor symptoms (VMS).
  • Paroxetine salt is the only non-hormonal medication approved by the US Food and Drug Administration for the management of VMS, although other selective serotonin reuptake/norepinephrine reuptake inhibitors (SSRIs), gabapentinoids, and clonidine show evidence of efficacy.
  • NAMS Recommended with caution:

  • weight loss
  • mindfulness-based stress reduction
  • S-equol derivatives of soy isoflavones, and stellate ganglion block (additional studies of these therapies are warranted)
  • NAMS Does not recommend at this time:

    There are negative, insufficient, or inconclusive data suggesting the following should not be recommended as proven (ie scientifically supported and guaranteed) therapies for managing VMS, although many may help individual women:

  • cooling techniques
  • avoidance of triggers such as alcohol and spicy food
  • exercise
  • yoga
  • paced respiration
  • relaxation
  • over-the-counter supplements and herbal therapies
  • acupuncture, calibration of neural oscillations
  • chiropractic interventions
  • Note that these recommendations are for vasomotor symptoms only. There are no recommendations from governing or licensing bodies on the use of naturopathic treatments for menopausal symptoms other than vasomotor symptoms.