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 Thyroid Hormone Replacement for Central Hypothyroidism: A Randomized Controlled Trial Comparing Two Doses of Thyroxine (T4) with a Combination of T4 and Triiodothyronine

2007 ◽  
Vol 92 (11) ◽  
pp. 4115-4122 ◽  
Author(s):  
Marc Slawik ◽  
Björn Klawitter ◽  
Edith Meiser ◽  
Marcus Schories ◽  
Oliver Zwermann ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Hormone Replacement ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Well Being ◽  
Double Blind ◽  
Central Hypothyroidism ◽  
Beneficial Effects ◽  
Serum T3 ◽  
Free Serum

Abstract Background: Dosage of T4 in central hypothyroidism is primarily guided by the free serum T4 level (fT4). However, the optimum fT4 range is ill defined, and subtle hypothyroidism might be missed using this approach. Objectives: Our aim was to investigate the effects of a body weight (bw)-adapted T4 treatment, alone or in combination with T3, on metabolism, well-being, and cognitive function in comparison to a regimen leading to normal fT4. Design: This was a placebo-controlled trial (double-blind, crossover). Patients: A total of 29 patients (age 52 ± 2 yr; females/males, 8/21) with hypopituitarism, including TSH deficiency, participated in the study. Interventions: Three regimens were compared (5 wk each): “EMPIRICAL-T4,” empirical T4 dosage (1 ± 0.05 μg/kg bw) leading to normal fT4; BW-ADAPTED-T4 (1.6 μg/kg bw T4); and “BW-ADAPTED-T3T4,” bw-adapted combination of T3 and T4 (ratio of 1:10). Results: BW-ADAPTED-T4 administration increased mean fT4 concentrations to the upper limit of the normal range (peak levels). Compared with EMPIRICAL-T4, BW-ADAPTED-T4 treatment resulted in a lower body mass index (BMI) (29.0 ± 0.7 vs. 29.5 ± 0.7 kg/m2; P &lt; 0.03), lower total cholesterol (198 ± 9 vs. 226 ± 7 mg/dl; P &lt; 0.01), and lower low-density lipoprotein (LDL) cholesterol (116 ± 5 vs. 135 ± 7 mg/dl; P &lt; 0.01). BW-ADAPTED-T3T4 treatment was associated with additional beneficial effects on ankle reflex time and working memory but resulted in supraphysiological free serum T3 (fT3) levels. Limitations: Long-term side effects may have been missed. Conclusions: Using a dose of 1.6 μg/kg bw improved markers commonly associated with central hypothyroidism. This suggests that T4 dosage based on bw and aiming at fT4 in the upper reference range is superior to titration of T4 aiming at middle normal fT4 concentrations in those patients.

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 Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

2021 ◽  
pp. svn-2021-000942
Author(s):  
Jingyi Liu ◽  
Ximing Nie ◽  
Hongqiu Gu ◽  
Qi Zhou ◽  
Haixin Sun ◽  
...  
Keyword(s):  
Placebo Group ◽  
Tranexamic Acid ◽  
Intracerebral Haemorrhage ◽  
Intracranial Haemorrhage ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intracerebral Haematoma ◽  
Spot Sign ◽  
Double Blind ◽  
Risk Of Death

BackgroundStudies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.MethodsWe did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days.ResultsOf the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth, death and dependency.ConclusionsAmong patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

scholarly journals Neurokinin 3 receptor antagonism as a novel treatment for menopausal hot flushes: A phase 2, randomised, double-blind, placebo controlled trial

Maturitas ◽  
2017 ◽  
Vol 100 ◽  
pp. 142-143
Author(s):  
Julia Prague ◽  
Rachel Roberts ◽  
Alexander Comninos ◽  
Sophie Clarke ◽  
Channa Jayasena ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Hot Flushes ◽  
Phase 2 ◽  
Double Blind ◽  
Receptor Antagonism ◽  
Double Blind Placebo ◽  
Novel Treatment ◽  
Neurokinin 3 Receptor
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