Menopause is more than Hot Flashes: What is Missing in Homeopathic Research? A Narrative Review

Homeopathy ◽  
2021 ◽  
Author(s):  
Emma Macías-Cortés
Keyword(s):  
Health Outcomes ◽  
Hot Flashes ◽  
Daily Practice ◽  
Vasomotor Symptoms ◽  
Double Blind ◽  
High Quality Research ◽  
Risk Of Mortality ◽  
Increased Risk ◽  
Menopausal Women ◽  
Important Health

Abstract Background Menopausal complaints are frequently treated with homeopathy in daily practice worldwide. Recently, vasomotor symptoms have been understood to have implications as predictors of other important and long-term outcomes, causing increased risk of mortality and/or disability. Methods A comprehensive search of the literature was conducted to investigate whether homeopathic treatments for menopausal women with vasomotor symptoms have a positive effect on other important health outcomes associated with menopause, such as cardiovascular disease, neurocognitive impairment, metabolic and mood disorders, or osteoporosis. Results Though observational studies have shown encouraging results in reducing the severity and frequency of hot flashes in women treated with homeopathy, few randomized controlled trials have shown positive results. In most of the studies using homeopathy, the primary outcome is reduction in the frequency and severity of hot flashes, and other menopausal complaints are assessed secondarily as a part of the symptoms evaluated in the menopausal scales. Quality of life improves with homeopathic treatments for hot flashes, but there is scarce evidence of the effect of homeopathy on other health outcomes associated with menopause. Limited evidence exists in the case of menopausal women treated with individualized homeopathy for depression and metabolic disorders. Conclusion A more comprehensive approach for treating menopause in routine homeopathic practice constitutes a valuable opportunity to increase knowledge and high-quality research in this field. Future homeopathic research for menopause should be focused on well-designed, double-blind, placebo-controlled, randomized trials as well as on pragmatic trials to show whether homeopathic treatments for vasomotor symptoms can also improve outcomes that are well-known to increase the risk of mortality and/or disability.

scholarly journals Comparative Efficacy of Zolpidem and Nigella Sativa in Treatment of Sleep Disorder and Vasomotor Symptoms in Menopausal Women of Women’s General Hospital

2020 ◽  
Author(s):  
Mojgan Asadi ◽  
Fatemeh Molavi ◽  
Mostafa Qorbani ◽  
Fatemeh Davari Tanha
Keyword(s):  
Sleep Quality ◽  
Postmenopausal Women ◽  
Nigella Sativa ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Vasomotor Symptoms ◽  
Double Blind ◽  
Menopausal Women ◽  
Night Sweats ◽  
Group B

Objective: To evaluate the efficacy of Zolpidem and Nigella sativa compared to placebo in treatment of sleep disturbance in healthy postmenopausal women. Menopause is a period that diagnosed after 12 months of amenorrhea and is characterized by a group of symptoms that include irregular menses; vasomotor and urogenital symptoms. The effects of non-hormonal therapies are being widely researched on menopause symptoms. There has been no study to compare Zolpidem and Nigella sativa versus placebo. Materials and methods: In this double-blind, placebo controlled trial, we compared the effect of Zolpidem with Nigella sativa and placebo in reducing sleep quality in 60 menopausal women. The prior and the later results were compared. We divided the patients into three groups after history taking and physical examination and filling the Pittsburgh questionnaire. Each group received their medication as the following order: Group A: Zolpidem, Group B: Nigella sativa, Group C: placebo. The first group received Zolpidem with the dose of 5 mg for 8 weeks. The second group received Nigella sativa with the dose of 600 mg for 8 weeks. The third group received placebo for 8 weeks. After two months, the Pittsburg questionnaire was filled again. Results: In the nigella sativa group, we had not significant improvement in sleep quality (p =0.07), hot flashes (p =0.15), palpitation (p =0.56) and night sweets (p =0.08).  In zolpidem group, we have seen lack of improvement of hot flashes (p =0.73), and palpitation (p =0.36), which are nonsignificant statistically according to p values, but in zolpidem group, we had significant improvement in sleep quality (p =0.01), and night sweats (p =0.049). Conclusion: It seems that zolpidem has some effect on improving the quality of sleep in postmenopausal women. zolpidem also is good for night sweats. Nigella sativa was not effective in vasomotor symptoms and sleep quality.

scholarly journals OR11-03 NT-814, a Non-Hormonal Dual Neurokinin 1,3 Receptor Antagonist Markedly Improves Vasomotor Symptoms in Post-Menopausal Women; Results of a Randomised, Double-Blind, Placebo-Controlled, Dose-Finding Study (SWITCH-1)

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
James Simon ◽  
Richard A Anderson ◽  
Elizabeth Ballantyne ◽  
Hadine Joffe ◽  
Mary Kerr ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Dose Finding ◽  
Vasomotor Symptoms ◽  
Phase 3 ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Vasomotor symptoms (VMS), caused by declining estrogen in menopausal women, are common and debilitating. Hormone therapy is effective in many women but carries risks and may be contraindicated. Biological and clinical evidence shows a modulatory role for neurokinin (NK) receptor antagonists acting primarily via hypothalamic KNDy (kisspeptin, NK, dynorphin) neurons on VMS. NT-814 is an oral non-hormonal dual NK1,3 receptor antagonist which has previously been shown to cause rapid and marked improvements in VMS in post-menopausal women. This Phase-2b trial (SWITCH-1) was undertaken to further evaluate efficacy and safety and to establish the optimum dose(s) for Phase 3 studies. Methods: SWITCH-1 was a double-blind, placebo-controlled, adaptive-randomization, dose-finding trial in 199 post-menopausal women. After a 2-week single-blind placebo run-in to establish symptom stability, women (40 to 65 years) with ≥7 moderate and/or severe VMS per day at baseline were randomized to 12 weeks of once daily treatment with placebo or one of 4 doses of NT-814: 40 mg, 80 mg, 120 mg, 160 mg. Subjects recorded the frequency and severity of VMS in electronic diaries twice daily throughout the study. Patient-reported measures of quality-of-life, sleep and mood were collected periodically. Adverse events (AEs) were recorded at each clinic visit. Results: VMS frequency was reduced in all treatment groups, including placebo. VMS reductions were significantly greater with the 2 higher NT-814 doses at most time-points, as early as the first week of treatment. Least squares mean reductions from baseline in moderate/severe VMS per day at week 4 were: placebo, 2.7; 40 mg, 4.3 (p=0.161 vs placebo); 80 mg, 4.1 (p=0.326); 120 mg, 6.7 (p<0.0001); 160 mg, 5.5 (p=0.007). In week 12 the reductions were: placebo, 4.7; 40 mg, 6.5 (p=0.185); 80 mg, 5.6 (p=0.599); 120 mg, 7.8 (p=0.009); 160 mg, 6.6 (p=0.109). At the 160 mg dose the median reduction in week 12 was significantly greater than placebo (6.9 vs 4.4, p=0.0023), indicating an effect of high outliers on the mean. Average HF severity was also improved in a dose-related manner, with greater reductions compared to placebo with the 2 higher NT-814 doses. Improvements in HF were accompanied by statistically significant benefits on sleep (assessed using the Insomnia Severity Index and Pittsburgh Sleep Quality Index), mood (measured using the Beck Depression Inventory), and all four domains of the MenQoL menopause-specific quality-of-life instrument. NT-814 was well-tolerated; most AEs were mild or moderate and there were no serious AEs related to treatment. Conclusions: NT-814, a once daily non-hormonal NK antagonist, at doses of 120 & 160 mg reduced the frequency and severity of VMS and significantly improved quality of life, mood and sleep, in postmenopausal women. NT-814 was well tolerated, with a safety profile that supports further evaluation in Phase 3 trials.

The Widowhood Effect: Explaining the Adverse Outcomes After Spousal Loss Using Physiological Stress Theories, Marital Quality, and Attachment

2020 ◽  
Vol 28 (3) ◽  
pp. 241-246 ◽  
Author(s):  
Jeffrey Ennis ◽  
Umair Majid
Keyword(s):  
Health Outcomes ◽  
Marital Quality ◽  
Physiological Stress ◽  
Adverse Outcomes ◽  
Loved One ◽  
Spousal Loss ◽  
Adverse Health Outcomes ◽  
Physical Health Outcomes ◽  
Risk Of Mortality ◽  
Increased Risk

The loss of a loved one is one of the most ubiquitous life experiences. There have been multiple reviews that have found adverse health outcomes for individuals experiencing spousal loss, particularly the widowhood effect that characterizes an increased risk of mortality after loss. However, there is a lack of clarity on the relationship between physiological stress and the widowhood effect. This commentary uses the literature on stress, marital quality, and attachment to explain the widowhood effect and other adverse physical health outcomes. We discuss three points: (1) the chronic nature of stress may be the source of adverse outcomes, (2) the quality and quantity of available resources may moderate the effects of stress, and (3) the level and style of attachment may explain why these outcomes may persist many years after spousal loss.

A Review of Paroxetine for the Treatment of Vasomotor Symptoms

2014 ◽  
Vol 28 (3) ◽  
pp. 266-274 ◽  
Author(s):  
Rachel M. Slaton ◽  
Megan N. Champion ◽  
Kayla B. Palmore
Keyword(s):  
Clinical Trial ◽  
Trial Design ◽  
English Language ◽  
Hormone Replacement ◽  
Hot Flashes ◽  
Clinical Trial Design ◽  
Vasomotor Symptoms ◽  
Search Process ◽  
Mesh Terms ◽  
Menopausal Women

Background: Studies in recent years have exposed concerns about the safety of hormone replacement therapy (HRT) in the treatment of vasomotor symptoms (VMS) in menopausal women. Numerous studies have examined the use of antidepressants for relief of VMS. Despite recommendations to deny approval of paroxetine mesylate (Brisdelle™) for the treatment of VMS, the Food and Drug Administration (FDA) recently granted it approval for this indication. Objective: To evaluate all published literature examining use of paroxetine salts (mesylate and hydrochloride) in the treatment of menopausal VMS. Methods: Both PubMed and International Pharmaceutical Abstracts (IPA) were searched using the keywords hot flashes, vasomotor symptoms, menopause, and paroxetine. In PubMed, MeSH terms were used for paroxetine, menopause, and hot flashes. Searches were limited to humans, English language, and clinical trial design. The references for each study identified in this search process were examined in order to locate any additional relevant articles. Results: Compared with placebo, paroxetine salts offer a modest benefit in the treatment of menopausal VMS reducing the frequency and severity of weekly hot flashes. Conclusion: Paroxetine (mesylate or hydrochloride) is an effective alternative to HRT for the reduction in VMS in menopausal women. Future head-to-head studies with active medications are needed in order to identify the best algorithm of treatment for this condition.

Burden of menopausal vasomotor symptoms on work productivity and daily-activity in a cohort of peri/post-menopausal women in daily practice in Spain

Maturitas ◽  
2015 ◽  
Vol 81 (1) ◽  
pp. 181-182
Author(s):  
Pluvio J. Coronado ◽  
Rafael Sanchez-Borrego ◽  
Miguel A. Ruiz ◽  
Laura Baquedano ◽  
Sonia Sanchez ◽  
...  
Keyword(s):  
Daily Activity ◽  
Work Productivity ◽  
Daily Practice ◽  
Vasomotor Symptoms ◽  
Menopausal Women ◽  
Post Menopausal

scholarly journals Does hormone replacement therapy benefit post-menopausal women? – a scoping review

2019 ◽  
Vol 13 (2) ◽  
pp. 52-57
Author(s):  
Vinodkumar Mugada ◽  
Raj Kiran Kolakota ◽  
Sujana Bhargavi Jadda ◽  
Urmila Kotapadu ◽  
Mounika Veesam
Keyword(s):  
Hormone Replacement Therapy ◽  
Replacement Therapy ◽  
Scoping Review ◽  
English Language ◽  
Hormone Replacement ◽  
Hot Flashes ◽  
Screening Process ◽  
Increased Risk ◽  
Menopausal Women ◽  
Post Menopausal

Post-menopausal women experience symptoms such as irregular periods, lower fertility, vaginal dryness, hot flashes and night sweats. Hormone replacement therapy (HRT) relieves menopausal symptoms. The aim of this review was to assess the benefits and risks of HRT in post-menopausal women. A scoping review was conducted for original peer-reviewed English language papers using the electronic databases of PUBMED, JAMA, BMC and TRIP. The papers were subjected to a three-stage screening process. The type of study, year of study, age, participants, type of therapy and the aim of the study defined the inclusion and exclusion criteria. HRT was associated with reduced risk and prevalence of end-stage kidney disease, gastric esophageal reflex disease (GORD) symptoms, periodontal disease and associated with the increased risk of overall cancers. The benefits of HRT depend on the duration of therapy, formulation, route of administration, time of initiating therapy (age <60 years) and type of therapy. Post-menopausal symptomatic women mostly benefited with hormone replacement therapy. To reduce risks of adverse events, HRT should be initiated with appropriate monitoring.

scholarly journals Treatment of Menopausal Vasomotor Symptoms With Fezolinetant, a Neurokinin 3 Receptor Antagonist: A Phase 2a Trial

2019 ◽  
Vol 104 (12) ◽  
pp. 5893-5905 ◽  
Author(s):  
Herman Depypere ◽  
Dirk Timmerman ◽  
Gilbert Donders ◽  
Peter Sieprath ◽  
Steven Ramael ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Outcome ◽  
Gastrointestinal Disorder ◽  
Controlled Study ◽  
Vasomotor Symptoms ◽  
Electronic Diary ◽  
Double Blind ◽  
Menopausal Women ◽  
Neurokinin 3 Receptor

Abstract Context The thermoregulatory center in the hypothalamus is stimulated by neurokinin 3 receptor (NK3R) activation and inhibited by estrogen-negative feedback. This balance is disrupted in menopause, producing vasomotor symptoms (VMSs). Objective To evaluate safety and efficacy of the NK3R antagonist fezolinetant in menopausal VMSs. Design Twelve-week, double-blind, randomized, placebo-controlled study. Setting Eight Belgian centers from September 2015 to October 2016. Participants Generally healthy menopausal women aged 40 to 65 years with moderate/severe VMSs. Interventions Subjects were randomized (1:1) to 90 mg of fezolinetant twice daily or placebo for 12 weeks. Main Outcome Measures Subjects captured VMS severity and frequency using an electronic diary. The primary outcome was change from baseline to week 12 in total VMS score with fezolinetant vs placebo. Secondary outcomes included timing of changes in frequency and severity of moderate/severe VMSs and quality-of-life assessments at weeks 4, 8, and 12. Pharmacodynamic and pharmacokinetic effects were assessed, as were safety and tolerability. Results Of 122 subjects screened, 87 were randomized and 80 (92%) completed the study. At week 12, fezolinetant significantly reduced total VMS score vs placebo (−26.5 vs −12.2, P < 0.001) and decreased mean frequency of moderate/severe VMSs by five episodes per day vs placebo. Severity and frequency of moderate/severe VMSs were reduced from the first day of treatment. Improvements were achieved in all quality-of-life measures. Fezolinetant was well tolerated. The most common fezolinetant-related adverse event was gastrointestinal disorder (n = 6). Conclusions Fezolinetant rapidly and significantly reduced moderate/severe VMSs, supporting its potential as an effective nonhormonal treatment option for menopausal women.

scholarly journals Efficacy of a Homeopathic Medicine of Capsicum frutescens L. (Solanaceae) in the Treatment of Hot Flashes in Menopausal Women: A Phase-2 Randomized Controlled Trial

Homeopathy ◽  
2019 ◽  
Vol 108 (02) ◽  
pp. 102-107 ◽  
Author(s):  
Débora Andrade ◽  
Fabio Carmona ◽  
Mateus Angelucci ◽  
Edson Martinez ◽  
Ana Pereira
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Hormone Replacement ◽  
Hot Flashes ◽  
Well Being ◽  
Capsicum Frutescens ◽  
Phase 2 ◽  
Double Blind ◽  
Homeopathic Medicine ◽  
Menopausal Women

Background Hot flashes are common in women during menopause, and are an important cause of discomfort, increasing the number of medical appointments. Hormone replacement therapy is an effective treatment, but it can bring undesirable consequences. Alternative treatments exist but they are not universally accepted or effective. The ingestion of malagueta peppers (popular name for fruits of Capsicum frutescens L., Solanaceae) causes sensations similar to those experienced by women during hot flashes. Using the homeopathic law of similars (let like be cured by like), we hypothesized that a homeopathic remedy made of malagueta peppers can be effective in alleviating menopausal hot flashes. We named this remedy Malagueta. Methods This randomized, placebo-controlled, double-blind, phase-2 clinical trial was designed to test the hypothesis that, in menopausal women, the homeopathic medicine Malagueta (30 CH), compared with placebo, will significantly reduce the intensity of hot flashes, after 4 weeks of treatment. The primary outcome was the intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument. A total of 40 women were enrolled in the study, 20 in each group. Results The effect of Malagueta on the primary outcome, the intensity of hot flashes, assessed by MYMOP, was superior to that of placebo over the 4 weeks of treatment, with worsening in both groups after treatment was interrupted (after week 4, p < 0.001 in ordinal logistic regression). The odds ratio for treatment response (reduction of at least three MYMOP categories) was 2.78 (95% confidence interval, 0.77 to 10.05). Treatment with Malagueta, compared with placebo, also reduced the intensity of the secondary symptoms (p = 0.001) and improved level of activity (p = 0.025) and well-being (p = 0.008). Conclusion The homeopathic medicine of Capsicum frutescens (Malagueta) was superior to placebo in reducing the intensity of hot flashes in menopausal women after 4 weeks of treatment.

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