Hrt reviews: Here’s The Current Thinking On Hormone Therapy (It’s Not What You Heard 20 Years Ago)
Here’s The Current Thinking On Hormone Therapy (It’s Not What You Heard 20 Years Ago)
Many doctors don’t discuss the option of hormone therapy with menopausal patients.
Menopause symptoms aren’t only uncomfortable, but they can also impact a woman’s health, relationships and career. Although hormone therapy can reduce or eliminate menopause symptoms, most menopausal women don’t take advantage of hormones because of a decades-old study that warned of serious health risks. Although the thinking on hormones has changed, some women remain confused and afraid, and some medical doctors refuse to prescribe hormones. Now, the CEO of a telehealth startup, celebrities, medical doctors and others are trying to raise awareness about how the thinking on hormone therapy has evolved over the last twenty years.
Oncologist Avrum Bluming and social psychologist Carol Tavris are among those trying to raise awareness. They wrote amazon.com/Estrogen-Matters-Hormones-Menopause-Well-Being-ebook/dp/B078W61N8Z/ref=tmm_kin_swatch_0?_encoding=UTF8&qid=&sr=”>Estrogen Matters to clarify some of the misunderstandings surrounding hormone therapy. “Our goal in writing the book and subsequently answering the dozens of emails we receive from women around the world is to educate women and the medical profession about the symptoms and medical ramifications of the menopause—and, in particular, the role of estrogen in ameliorating symptoms and prolonging women’s lives,” Bluming says.
Alicia Jackson, Evernow founder and CEO, also wants to help alleviate the confusion surrounding hormone therapy and other treatments for menopause symptoms. She started the telehealth company which focuses on menopause care to provide women easy access to doctors who are experts on menopause. “I really want women to know that they need to be the CEO of their own health care. They should be seeking out practitioners who are true experts, who want to partner with them and give them the tools and the information that they need to make good decisions for their health,” Jackson explains. Evernow’s physicians can help women decide if hormones are the best choice for them, and, if appropriate, they can often be prescribed after a virtual visit.
In early April, Evernow received over $28 million in investment, and Gwyneth Paltrow, Cameron Diaz, Drew Barrymore and other celebrities are serving as angel investors. These celebrities invested in Evernow, not only to help the company reach more women but also because they are also committed to raising awareness about menopause, menopause symptoms and potential treatments like hormone therapy.
The Current Thinking On Hormone Therapy
The reason these individuals and others are making efforts to raise awareness regarding the current thinking on hormone therapy is that the current thinking is dramatically different than it was twenty years ago. Over twenty years ago, the Women’s Health Initiative (WHI) study, which randomized women to receive either hormone therapy or a placebo, set out to assess the benefits and risks of hormone therapy. In 2002, the WHI study was abruptly halted because the researchers found that women taking a combination of estrogen and progestin had an increased risk of breast cancer, heart attacks, stroke, and blood clots. Headlines blasted the news that hormone therapy was unsafe, and the use of hormone therapy in the United States plummeted by about 80%.
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Later analysis of the WHI study data focused on the age of the participants. This analysis found that primarily older women were at high risk from the use of these hormones, and that the benefits of hormone therapy generally outweighed the risks for healthy women who are under 60 years old and within ten years of the onset of menopause. Despite the good news, many women and doctors are still relying on the original warnings to guide their decisions regarding hormones.
An 18-year follow-up study of the participants in the WHI study provides more reassurance on the safety of hormones. The report found that women who took hormones did not have a greater chance of dying in the subsequent 18 years than those who did not. The researchers report in JAMA that hormone therapy use (estrogen alone or estrogen plus progestin) for five to seven years “was not associated with risk of all-cause, cardiovascular, or cancer mortality during a cumulative follow-up of 18 years.”
In the same article, the authors conclude, “Observational studies, which include primarily women who initiate hormone therapy in early menopause, have generally demonstrated lower mortality among women using hormone therapy compared with nonusers.” In other words, according to these studies, women who started hormone therapy in early menopause tended to live longer than women who didn’t take hormones.
In fact, a pooled statistical analysis of thirty clinical trials found that women who began hormone therapy before age 60 had a 39% lower risk of death than women who didn’t take hormones.
With all of this new information, why is there still so much resistance surrounding hormone therapy? JoAnn Manson, a Harvard Medical School professor at Brigham and Women’s Hospital and one of the lead researchers on the WHI study, says it’s been difficult to get the word out about follow-up studies showing that benefits outweigh risks for younger women with menopause symptoms.
“There were all these alarm bells that went off in 2002. And once a bell is rung, it cannot be unrung,” Manson explains. “It’s taking a very long time to make it clear that there were differences by age and that hormone therapy is still an appropriate treatment for women in early menopause who have moderate to severe symptoms. The results are all out there in prominent journals read by clinicians,” she says.
Newer formulations of hormones, not widely used when the WHI study began, may further minimize risks. Manson says that preliminary data from studies examining these newer hormone formulations including transdermal estrogen (delivered through the skin via a patch) and micronized progesterone are promising. Transdermal estrogen doesn’t go through the liver and may also reduce the chances of blood clots and stroke compared to oral estrogen. And Bluming and Tavris write, “When women take estrogen combined with natural, micronized progesterone, no increased risk of breast cancer has thus far been observed in any study. ”
Although some of these new FDA-approved formulations are promising, all of the experts I spoke to caution against the use of compounded hormones. Compounded hormones are not regulated by the Food and Drug Administration (FDA), and these compounds have not been shown to be safe or effective and can have impurities and inconsistent dosing. As evidence of the lack of reliable information available to women, 35% of women currently on hormone therapy take these unregulated compounds. How do you know if your hormones are compounded? If the hormones are produced by a pharmaceutical company that is recognized and approved by the FDA, then they are not compounded.
Another concern for those considering hormone therapy is the risk of dementia. In her book, XX Brain, Lisa Mosconi, director of the Women’s Brain Initiative and associate director of the Alzheimer’s Prevention Clinic weill.cornell.edu/clinical-services/alzheimers-disease-memory-disorders-program/alzheimers-prevention-clinic”> at Weill Cornell Medical College, points out that brain imaging studies suggest that the decrease of estrogen at menopause likely plays a role in explaining why women have a greater risk than men for Alzheimer’s. But that doesn’t necessarily mean that hormone therapy reduces that risk for all women. Mosconi writes that there is some evidence that for younger women who begin hormone therapy within five years of menopause, these hormones may be helpful in fighting off cognitive decline. However, in women older than 60 years, or more than five years past menopause, there is some evidence that hormone therapy may increase the risk of dementia. Also, for those women already showing early signs of dementia, hormones likely won’t help and could make things worse. More research is clearly needed in this area to determine how to best use hormones to ward off dementia.
For women with menopause symptoms who are not good candidates for hormone therapy or who are reluctant to take hormones, there are other potential remedies. For example, Evernow also offers SSRIs as an option. SSRIs, typically prescribed as anti-depressants, have been shown to relieve hot flashes and other menopausal symptoms.
Menopause Symptoms Impact Health And Work
Menopause symptoms aren’t limited to hot flashes and night sweats. Other symptoms of menopause include difficulty sleeping, difficulty concentrating, mood swings, depression, headaches, racing heart, vaginal dryness, decreased recent memory and decreased energy. For some women, these symptoms begin years before menopause.
Hot flashes are uncomfortable, but they are also related to other issues. Hot flashes can disrupt sleep and may cause mood changes, difficulty concentrating, and impairment of short-term memory. In one study, frequent hot flashes and night sweats were associated with a 50% increased risk of cardiovascular disease. And, if these hot flashes and night sweats persisted over time, then there was a 77% increased risk of later cardiovascular disease.
Menopause symptoms can also impact relationships and careers. The British Medical Association surveyed female doctors of menopause age and found that “a significant number have reduced their hours, left management roles or intend to leave medicine altogether, despite enjoying their careers, because of the difficulties they faced when going through menopause.” Over a third (36%) of the doctors surveyed had made changes to their working lives due to menopause, and an additional 9% intended to make changes. Another study found that about a third of working, post-menopausal women report that their job performance was negatively impacted by symptoms of menopause, and yet another found a startling 83% of respondents who had experienced menopause said it negatively affected their work.
Given the health and career impact of menopause symptoms, it’s a problem that many clinicians are not well-informed on the current thinking regarding hormone therapy. Bluming explains that part of the problem stems from the fact that menopause education is currently offered to less than 25% of residents studying obstetrics/gynecology. This may also explain why some practitioners still refuse to prescribe hormones. Given that over 50 million women in the United States are over the average age of menopause (51 years), one would think menopause care would be a higher priority.
Each woman has unique needs and finding a knowledgeable healthcare professional is key to figuring out what’s best for her health. For those women who have doctors that are not trained in menopause treatments or refuse to discuss hormone therapy, there are still options. These women can either take the telehealth route and speak to trained professionals virtually, or they can access the North American Menopause Society (NAMS) web page to find a NAMS Certified Menopause Practitioner in their area.
HRT: Follow-up Assessments | Doctor
HRT – Follow-up Assessments
In this article
- HRT reviews
- HRT assessment
- Management of HRT side-effects
- Switching from cyclical HRT to continuous combined HRT
- HRT referral
- Stopping HRT
Arrange to review the woman after three months if HRT has been started or changed, then at least annually thereafter, unless there are clinical indications for an earlier review (such as treatment ineffectiveness or adverse effects). At each review:
- Reinforce information and lifestyle advice.
- Assess the efficacy and tolerability of treatment(s).
- Assess for bothersome adverse effects or persistent symptoms, and offer to adjust the HRT dose or preparation if appropriate. Options include:
- Reduce the dose of oestrogen.
- Change the dose or type of progestogen.
- Alter the route of administration – for example, switch from oral to transdermal.
- Switch to a combined oestrogen/bazedoxifene acetate preparation (a selective oestrogen receptor modulator), if progestogen-containing therapy is not appropriate.
- If there is a sudden change in menstrual pattern, intermenstrual bleeding, postcoital bleeding, or postmenopausal bleeding – assess appropriately and arrange an urgent two-week referral if a gynaecological cancer is suspected.
- If there are persistent symptoms despite adjustment of the HRT dose or preparation, consider an alternative cause for symptoms.
Review the duration of HRT treatment:
- If HRT was started in the perimenopause, discuss the option of changing the treatment regimen and/or reducing the dose of oestrogen.
- Support the woman to make an individual decision on when and how to stop HRT. Advise that:
- HRT should be continued for as long as benefits of symptom control and improved quality of life outweigh any risks, and there is no arbitrary limit for duration of HRT use.
- For vasomotor symptoms, most women require 2-5 years of treatment, but some women may need longer.
- Women with premature menopause or premature ovarian insufficiency (POI) should take HRT up to 50 years in the UK, after which the need for ongoing HRT should be reassessed.
- HRT may be gradually reduced over 3-6 months, or stopped suddenly, depending on the woman’s preferences. However, gradual reduction is preferable (see ‘Stopping HRT’ below).
- Symptoms may recur in the short term after stopping treatment, particularly if HRT is stopped suddenly.
- If troublesome symptoms recur, options include restarting HRT at a low dose, or considering alternative non-hormonal treatments.
- Vaginal oestrogen preparations may be required long term, but regular attempts to stop treatment, such as annually, can be made.
Components to a follow-up assessment:
- A three-month trial of HRT is suggested to achieve maximum effect.
- Improvement of symptoms should be noted and women should be asked about any residual symptoms.
Where a patient remains symptomatic, consider:
- Poor absorption – for example, due to bowel disorder.
- Drug interactions reducing bio-available oestrogen – for example, carbamazepine and phenytoin.
- Problems with patch adhesion.
- Incorrect diagnosis – hypothyroidism or diabetes may mimic some features of menopause.
- Patient expectations – these may also need to be addressed.
- The dose of oestrogen in HRT may be too low.
Altering the HRT product or delivery method may help address some of these problems. The oestrogen dose may need to be increased. For example, vaginal oestrogen cream can be added if urogenital symptoms are poorly controlled.
A regular review should include the following:
- Check for side-effects – eg, breast tenderness or enlargement, nausea, headaches or bleeding – and manage appropriately (see ‘Management of side-effects’, below).
- Check blood pressure and weight.
- Encourage breast awareness and participation in screening mammography and also cervical screening if appropriate for age.
- A review and discussion of an individual’s risk:benefit ratio concerning HRT should occur at least annually.
- If appropriate, consider switching from cyclical HRT to continuous combined HRT (see below).
The decision on whether to advise continuation of HRT should be based on symptoms and ongoing risks and benefits, rather than a set minimum or maximum duration of therapy. Cessation of HRT leads to recurring symptoms for up to 50% of women. Consider the potential impact of these symptoms on quality of life.
The merits of long-term HRT use should be assessed for each individual woman, and the lowest dose of HRT which controls symptoms should be used.
Management of HRT side-effects
Side-effects may be oestrogen-related (occurring continuously or randomly through a cycle) or progestogen-related (occurring cyclically during the progestogen phase).
These are usually transient and may resolve spontaneously with increasing duration of use. Encourage patients to persist with a particular therapy for at least 12 weeks. Side-effects are more likely to occur or be problematic where there has been a longer interval since ovarian failure.
Oestrogen-related side-effects include:
- Breast tenderness or enlargement – this usually settles after 4-6 weeks of taking HRT. The oestrogen dose could be reduced and then increased very gradually. A change in progestogen can sometimes be beneficial. Evening primrose oil is no longer recommended.
- Leg cramps – suggest exercise and calf stretching.
- Nausea and dyspepsia – adjust time of dose and administer with food.
- Headaches – try transdermal oestrogen, as this usually produces more stable oestrogen levels.
These may be more problematic and are usually connected to the type, duration and dose of progestogen.
Progestogen-related side-effects include:
- Fluid retention.
- Headaches or migraine.
- Breast tenderness.
- Mood swings and depression.
- Symptoms of premenstrual syndrome.
- Lower abdominal and back pain.
Again encourage perseverance, as symptoms may improve over three months. If there is no improvement at that point strategies include:
- If bleeding is heavy or irregular on sequential combined HRT then the dose of progestogen can be doubled or increased in duration to 21 days. Alternatively the type of progestogen can be changed.
- Erratic bleeding can be common in the first three to six months after starting HRT.
- Women with progestogen side-effects (eg, fluid retention, mood swings, weight gain) can have the progestogen dose halved or the duration of taking progestogen reduced to seven to ten days.
- Fewer progestogenic side-effects occur with progesterone and dydrogesterone. The intrauterine system (IUS) can be used as an alternative for endometrial protection. Its licence for this use is four years.
- Drospirenone has anti-androgenic and anti-mineralocorticoid properties.
- Micronised progesterone:
- Is a natural, ‘body-identical’ progestogen, devoid of any androgenic as well as glucocorticoid activities but being slightly hypotensive due to anti-mineralocorticoid activity.
- It may be the optimal progestogen in terms of cardiovascular effects, blood pressure, venous thromboembolism (VTE), probably stroke and even breast cancer, but these data are from observational studies only and they have a higher risk of endometrial hyperplasia.  There is only one currently available to prescribe in the UK.
- Micronised progesterone can be prescribed with oral or transdermal oestrogen. It is commonly prescribed at a dose of 200 micrograms a day for two weeks followed by a two-week break for those women who are still having periods.
- For ‘continuous’ micronised progesterone use, the dose recommended in the BNF is days 1-25, with a 3-day break, rather than continuous use. This may reduce the chances of breakthrough bleeding compared to continuous use. However continuous is commonly used in practice, is generally well tolerated, and is easier for women to remember.
This is often given as a major reason for why women discontinue HRT but there is no randomised controlled trial evidence of HRT-induced weight gain. Reassure the patient that weight gain is common at this time of life and counter with dietary and lifestyle advice.
Monthly sequential preparations should produce regular, predictable and acceptable bleeds starting towards the end, or soon after, the progestogen phase. This pattern may be altered by:
- Drug interaction.
- Gastrointestinal upset.
Breakthrough bleeding is common in the first three to six months of continuous combined and long-cycle HRT regimens. Unscheduled bleeding in the first six months of HRT use does not need investigation, but investigate new-onset or persistent bleeding to exclude pelvic disease.
Where pelvic pathology is excluded, strategies for tackling bleeding problems include:
- Heavy or prolonged bleeding – increase dose, duration or type of progestogen. Consider the use of the levonorgestrel-releasing IUS (LNG-IUS) combined with oral or transdermal oestrogen.
- Bleeding early in the progestogen phase – increase the dose or change the type of progestogen.
- It can be useful for some women with bleeding when taking a continuous combined regime to revert back to a cyclical regime for a few months.
- Painful bleeding – change the type of progestogen.
- Irregular bleeding – change the regimen or increase progestogen.
- No bleeding – this occurs in 5% of women and is due to an atrophic endometrium. It is necessary to exclude pregnancy in perimenopausal women and to ensure compliance with the progestogen element of the HRT regimen.
Switching from cyclical HRT to continuous combined HRT
Women should be prescribed cyclical/sequential combined HRT if their last menstrual period was less than one year previously, or if they are significantly symptomatic but still having periods.
Cyclical HRT can be changed to continuous combined HRT when the woman is considered to be postmenopausal. This is advantageous to the woman as it removes the risk of endometrial hyperplasia. The woman may also no longer want to have to deal with a bleed.
Women can be prescribed continuous combined HRT if they have received sequential combined HRT for at least one year; or it has been at least one year since their last menstrual period.
A woman may be reasonably sure that she is postmenopausal by the age of 54 years. The problem with starting continuous combined HRT before a woman is postmenopausal is the increased frequency of irregular bleeding, which may need further investigation, such as ultrasound assessment of endometrial thickness.
At the time of review, consider arranging referral to a healthcare professional with expertise in menopause if:
- The woman has ongoing symptoms and lifestyle measures, hormonal, non-hormonal, or non-drug treatments are ineffective.
- The woman has persistent, troublesome adverse effects from treatment.
- There is uncertainty about the most suitable treatment option – for example, if the woman has comorbidities and/or contra-indications to treatment.
- The woman has persistent altered sexual function and hormonal and/or non-hormonal, or non-drug treatments are ineffective:
- Seek specialist advice regarding the use of testosterone supplementation.
- Consider referral for psychosexual counselling, depending on the woman’s wishes.
- There is a sudden change in menstrual pattern, intermenstrual bleeding, postcoital bleeding, or postmenopausal bleeding – assess appropriately and arrange an urgent two-week referral if a gynaecological cancer is suspected.
Menopausal symptoms (hot flushes and sweats) last on average between two to five years but there is considerable individual difference and symptoms may last decades in some women.
A trial of withdrawal of HRT could be considered:
- In those women symptom-free on HRT after one to two years.
- In women who have been on HRT for longer than five years.
- After the age of 51 for women who were started on HRT for premature menopause.
Alternatives to HRT are discussed in the separate Menopause and its Management article.
Abrupt cessation or gradual withdrawal of HRT?
When stopping HRT, it is generally recommended that the dose of HRT should be reduced gradually over three to six months, to minimise the chance of oestrogen deficiency symptoms returning.
On initial cessation of therapy, symptoms may return fairly soon but then resolve. Ideally, staying off treatment for two to three months should be considered before deciding whether or not to recommence.
However, if the vasomotor symptoms are severe after stopping HRT, restarting treatment may be the most appropriate course of action. The lowest dose to improve symptoms should be given.
Reasons HRT must be stopped
Hormone replacement therapy should be stopped (pending investigation and treatment) if any of the following occur.
- Sudden severe chest pain (even if not radiating to the left arm).
- Sudden breathlessness (or cough with blood-stained sputum).
- Unexplained swelling or severe pain in the calf of one leg.
- Severe stomach pain.
- Serious neurological effects including:
- Unusual severe, prolonged headache, especially if for the first time or that is getting progressively worse.
- Sudden partial or complete loss of vision.
- Sudden disturbance of hearing.
- Other perceptual disorders or dysphasia.
- Bad fainting attack or collapse or first unexplained epileptic seizure.
- Weakness, motor disturbances.
- Very marked numbness suddenly affecting one side or one part of body.
- Hepatitis, jaundice, liver enlargement.
- Blood pressure above systolic 160 mm Hg or diastolic 95 mm Hg.
- Prolonged immobility after surgery or leg injury.
- Detection of a risk factor which contra-indicates treatment.
HRT – Guide; British Menopause Society (2020)
Cobin RH, Goodman NF; American Association of Clinical Endocrinologists and American College of Endocrinology Position Statement on Menopause – 2017 Update. Endocr Pract. 2017 Jul23(7):869-880. doi: 10.4158/EP171828.PS.
Menopause; NICE CKS, September 2022 (UK access only)
Menopause: diagnosis and management; NICE Guideline (November 2015 – last updated December 2019)
Suspected cancer: recognition and referral; NICE guideline (2015 – last updated December 2021)
Palacios S, Castelo-Branco C, Currie H, et al; Update on management of genitourinary syndrome of menopause: A practical guide. Maturitas. 2015 Nov82(3):308-13. doi: 10.1016/j.maturitas.2015.07.020. Epub 2015 Jul 26.
Panay N; Body identical hormone replacement. Post Reprod Health. 2014 May 2220(2):69-72.
Sussman M, Trocio J, Best C, et al; Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records. BMC Womens Health. 2015 Aug 1315:58. doi: 10.1186/s12905-015-0217-y.
British National Formulary (BNF); NICE Evidence Services (UK access only)
Bicycle inner tubes
Bicycle inner tubes
HAPPY2023 (5% discount from 5.000r) Free shipping (from 7.000r)
HAPPY2023 (5% discount from 5.000r) Free shipping (from 7.000r)
HAPPY2023 (5% discount from 5.000r) Free shipping (from 7.000r)
Camera Kenda, 10″, Schrader, curved nipple
HRT chamber nipple extension, presta 60 mm, without valve, aluminum alloy, black
HRT chamber nipple extension, presta 40 mm, without valve, aluminum alloy, black
Camera Horst (H. R.T), 20×1.95-2.125″, 32mm, Schrader
Camera Horst (H.R.T), 26×1.95-2.125″, 32mm, Schrader
Camera Kenda, 12×1.75-2.125″, Schrader, curved nipple
Camera Kenda, 8″, Schrader, curved nipple
Camera Kenda, 14×1.75-2.125″,Schrader
Camera Kenda, 16×1.5-1.75″, Schrader
Camera Kenda, 16×1.75-2.125″, Schrader
Camera Kenda, 18×1.75-2.125″, Schrader
Camera Kenda, 10″, Schrader, straight nipple
Camera Kenda, 26×1. 75-2.125″, 32mm, Schrader
Camera Kenda, 20×1.75-2.125″, 32mm, Schrader
Camera Kenda, 26×1.75-2.125″, 32mm, Schrader (OEM without packaging)
Camera Kenda, 26×2.125-2.35″, 32mm, Schrader
Camera Kenda, 29×1.9-2.35″, 32mm, Schrader
Camera Kenda, 700×28/45c, 32mm, Schrader
Camera Kenda, 20×2.125-2.35″, 32mm, Schrader
Camera Kenda, 700×28/45c, 32mm, Presta
Camera 8-1/2″x2. 0″, Schrader 22mm, for scooters, compatible with Xiaomi 365 / Ninebot, steel cord
Camera Maxxis WelterWeight, 26×1.9/2.125″, 60mm, Presta
Camera Maxxis WelterWeight, 24×1.9/2.125″, 32mm, Schrader
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HRT Snowmobile Suit
HRT is a young but promising Russian brand owned by the famous Bask company.
Under this brand, a collection of clothing and textile accessories has entered the market, creating maximum comfort for professional hunters and fishermen. The key differences between the products of this brand and the model range of the parent company are that the product models are designed to be worn in the temperature conditions of the middle and polar geographic zones.
The cooperation of the company’s management with competent clothing designers made it possible to create accessories, the high comfort of which does not affect reliability in any way, thanks to which the brand’s products are in demand.
Each item is designed with specific use in mind. The founders of this brand set strict requirements for quality standards. Therefore, the most modern materials (fabrics and accessories) are used for production, the declared characteristics of which are confirmed by the relevant certificates.
Functionality, quality and wear resistance of each product are mandatory tested before the line is put into mass production. This procedure is established by the parent company Bask, which has a special production workshop in which new samples are sewn, then all things are tested and, if necessary, finalized. This algorithm predates the launch of HRT branded production model lines.
Despite its young age, the HRT brand has successfully taken a leading position in its segment of the outdoor accessories market, thanks to a competent production and marketing policy.
The company’s management has chosen a course for the maximum use of modern innovative technologies. In production, the latest technological solutions are used, which, together with innovative materials, ensure the maximum quality of products. Therefore, in clothes from HRT it is impossible to freeze, as well as overheat.
HRT currently produces a wide range of all-season men’s and women’s clothing. The position of the brand is growing and strengthening thanks to Bask’s many years of experience in designing reliable clothing for extreme conditions.