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.

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 Comparing the Effect of Face-to-Face with Phone Counselling Based on Cognitive-Behavioral Therapy on Vasomotor Symptoms in Postmenopausal Women: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Nasim Sadeghi Joola ◽  
Pourandokht Afshari ◽  
Maryam Gholamzadeh Jefreh ◽  
Mitra Tadayon ◽  
Mohammad Hossein Haghighizadeh
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Postmenopausal Women ◽  
Behavioral Therapy ◽  
Hot Flashes ◽  
Night Sweat ◽  
Cognitive Behavioral ◽  
Vasomotor Symptoms ◽  
Face To Face ◽  
Night Sweats ◽  
Phone Counseling

Abstract Background: Hot flash and night sweat (HF/NS) are the most common complication in menopause that affects the quality of life of women. The present study was conducted with the aim of comparing the effectiveness of the phone with face-to-face counseling based on cognitive-behavioral therapy for vasomotor symptoms of postmenopausal women.Methods: The present study was a randomized clinical trial. In this study, 40 eligible postmenopausal women were randomly assigned to one of face-to-face or phone counseling methods using the block randomization. Six counseling sessions were weekly held for each person and women requested to record their hot flashes and night sweat in a diary. Data were analyzed using chi-square, ANCOVA, and independent t-test.Results: Thirty- six women completed the study. Women in two groups showed a significant improvement in the frequency, severity, and duration of hot flashes and the frequency and severity of night sweats after the intervention (P <0.001). Weekly means of hot flashes and night sweats, decreased after the intervention in both groups (face-to-face group: HF frequency from 31.92±7.98 to 18.83±7.35, HF severity from 2.24±0.28 to 1.21±0.23, HF duration from 4.22±1.17 min to 2.79±0.91min, NS frequency from 2.34±0.31 to 1.21±0.24 and NS severity from 1.70±0.34 to 1.03±0.29 and also in phone counseling group: HF frequency from 33.32±7.77 to 19.53±7.7, HF severity from 2.23±0.24 to 1.20±0.18, HF duration from 4.29±1.23 min to 2.68±0.95min, NS frequency from 2.33±0.31 to 1.14±0.16 and NS severity from 1.59±0.34 to 1.01±0.30). There was no significant difference between groups after the intervention in terms of HF frequency, severity, and duration, as well as NS frequency, and severity (p>0.05). Conclusion: Based on the results of this study, using of face-to-face and phone counseling methods based on cognitive-behavioral therapy had a similar effect on the reducing of frequency, severity and duration of hot flashes as well as the frequency and severity of night sweats. Using phone counseling in women who have difficulty to attend the clinic is recommended.Trial registration number: IRCT20180918041065N1 Website: https://www.irct.ir/login

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.

scholarly journals Effect of acupuncture on menopausal vasomotor symptoms (VMS): A study protocol for a randomized controlled clinical trial

2019 ◽  
Author(s):  
Anna Bogachko ◽  
Shanshan Li ◽  
Tian Li ◽  
Xuan Yin ◽  
Ping Yin ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Hot Flashes ◽  
Vasomotor Symptoms ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Acupuncture Points ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Menopausal Women ◽  
Pattern Differentiation

Abstract Background During menopause, many women are troubled by vasomotor symptoms (VMS) when hot flashes, night sweats, or both, interfere with normal daily life. Both hormone therapy (HT) and taking antidepressants are common ways to reduce VMS but they have associated health risks such as breast cancer and thromboembolic events. Acupuncture is found to be a safe treatment option to reduce VMS and recent studies have demonstrated positive results applying personalized selections of acupuncture points. Hence, we hypothesize acupuncture, according to Chinese Medicine's basic principle of pattern differentiation, can reduce both frequency and severity of VMS in menopausal women. We designed a randomized controlled trial to test the hypothesis using a wait-list group as a control group and pattern differentiation to find an optimal therapeutic treatment. Method/Design The study is a single-center, pragmatic, randomized control trial with two parallel arms, to assess the effectiveness of acupuncture in 60 women in the Shanghai international and Chinese community with peri- and postmenopausal VMS. Eligible participants will be randomly assigned into two groups on a ratio 1:1. An acupuncture group of 30 women will twice weekly receive totally 12 acupuncture treatments and we will follow their treatment response through their VMS self-rating journal entries recorded at baseline, during intervention and twice post intervention as primary outcome. A waitlisted control group will record the same self-ratings of their VMS for purposes of comparison. After the six-week wait period is over, they will receive the same 12 sessions acupuncture treatment. As a second outcome, menopause-specific quality of life indicators will be assessed at baseline and twice post intervention by all participants. Discussion If the outcome of this study confirms acupuncture to be an effective and safe management method to reduce VMS in menopausal women, we expect further investigations and trials to clinically find optimal acupuncture treating strategies.

scholarly journals 0498 Effect of Lavender Essential Oil on Sleep in Postmenopausal Women with Insomnia: Double-Blind Randomized Controlled Trial

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A190-A191 ◽  
Author(s):  
L R Lucena ◽  
J G Santos-Junior ◽  
S Tufik ◽  
H Hachul
Keyword(s):  
Randomized Controlled Trial ◽  
Essential Oil ◽  
Sleep Quality ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Menopausal Symptoms ◽  
Sleep Pattern ◽  
Double Blind ◽  
Randomized Controlled

Abstract Introduction Sleep is essential for women’s health and its deprivation leads to serious physiological consequences. In addition, insomnia is a common complaint in postmenopausal women. Thus, the present study aimed to evaluate the effect of Lavandula angustifolia essential oil inhalation on sleep and menopausal symptoms in postmenopausal women with insomnia. Methods Experimental, double-blind, randomized controlled trial composed by 33 women (48 - 65 years) with clinical diagnosis of insomnia divided in two groups that inhaled different oils before sleep during 29 days: Placebo Group - PG (sunflower oil) and Aroma Group - AG (Lavandula angustifolia essential oil). Both groups received sleep hygiene guidelines and were followed weekly. To assess the effect of the intervention on menopausal symptoms the Menopause Rating Scale (MRS) and the Hospital Anxiety and Depression Scale (HADS) were used and for sleep evaluation the Insomnia Severity Index (ISI) and the Pittsburgh Sleep Quality Index (PSQI) were used. Additionally, polysomnography were used to assess sleep pattern. All outcomes were evaluated before and after intervention. Statistical analysis was performed using SPSS 22 through Generalized Estimed Equations test with significance set at p≤ 0.05. Results Comparing the pre and post-intervention periods, AG participants had a significant decrease in sleep onset latency, depression level, hot flashes, menopausal symptoms and a significant increase in sleep quality. Polysomnography data showed increased sleep efficiency and decreased wakefulness after sleep onset on AG participants. After the intervention, all volunteers presented improvement in all outcomes of sleep and menopausal symptoms measured by questionnaires. Conclusion The intervention was effective in improving the sleep pattern of AG participants, but was not significant when compared to PG participants. In addition, sleep hygiene instructions were essential to improve the sleep pattern of all volunteers. Therefore, inhalation of lavender essential oil is a safe, low-cost practice that should be considered as a complementary option to conventional treatments, whether medical, psychological or other integrative and complementary practices. Support This research was supported by fellowships from Associação Fundo de Incentivo à Pesquisa (AFIP), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) - Finance Code 001 and Conselho Nacional de Pesquisa (CNPq).

scholarly journals SAT-001 Clinically Meaningful Effects of E2/P4 Oral Capsule in Treating Vasomotor Symptoms

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Ginger Constantine ◽  
Shelli Graham ◽  
Dennis A Revicki ◽  
Risa Kagan ◽  
Sebastian Mirkin
Keyword(s):  
Controlled Trial ◽  
Clinical Importance ◽  
Vasomotor Symptoms ◽  
Life Questionnaire ◽  
Double Blind ◽  
Exact Test ◽  
Menopausal Women ◽  
Patient Reported ◽  
Hormonal Therapies

Abstract Hormonal therapies effectively reduce the frequency and severity of vasomotor symptoms (VMS) in menopausal women; however, whether the effect is clinically meaningful to women is typically not determined. Oral estradiol/progesterone (E2/P4; mg/mg) 1/100 and 0.5/100 significantly improved moderate to severe VMS versus placebo at weeks 4 and 12. The objective of these analyses was to determine the clinical importance (meaningfulness) of E2/P4 treatment versus placebo in menopausal women. REPLENISH, a phase 3, randomized, double-blind, placebo-controlled trial, evaluated the safety and efficacy of E2/P4 oral capsules in symptomatic, postmenopausal women with a uterus. Clinically meaningful reductions in weekly VMS frequency were determined using 3 patient-reported outcomes as anchors (VMS severity score, clinical global impression [CGI], and question 1 from the vasomotor domain of the menopause-specific quality of life questionnaire). The proportion of women who had a clinically important response with 0.5/100 was compared with placebo using the Fisher’s exact test. Spearman correlations were also performed across the 3 anchors. Clinically meaningful reductions in weekly VMS frequency ranged from 32 to 43 at week 4, and from 32 to 48 at week 12. Significantly more responders were observed with 0.5/100 than with placebo for all 3 anchors at both weeks 4 (all, P&lt;0.05) and 12 (all, P≤0.002). All 3 anchors were correlated, supporting their acceptability as appropriate anchors. Treatment with E2/P4 0.5/100 provided consistent clinically meaningful improvements in the weekly frequency of moderate to severe VMS in menopausal women, similar to what has been observed with the CGI-anchor for E2/P4 1/100.

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