scholarly journals Randomized, double blind, placebo controlled clinical study to assess efficacy and safety of NRL/MW/201901 in subjects suffering from erectile dysfunction

2020 ◽  
Vol 11 (3) ◽  
pp. 2790-2801
Author(s):  
Omkar Kulkarni ◽  
Anuj Agarwal ◽  
Priya Khare ◽  
Gayatri Ganu
Keyword(s):  
Quality Of Life ◽  
Erectile Dysfunction ◽  
Holistic Approach ◽  
Serum Testosterone ◽  
Well Being ◽  
Serum Levels ◽  
Treated Group ◽  
Double Blind ◽  
Resting Metabolism

Sex is an integral part of a well-being. Sexual satisfaction is the most important component of the quality of life. In management of ED overall sexual potential and quality of life needs to be taken care of as a holistic approach to management. The aim of the study was to clinically validate effect of NRL/MW/201901 a polyhedral Nutraceutical product in ED. The clinical efficacy of NRL/MW/201901 in patients suffering from erectile dysfunction was evaluated by assessing Quality of Erection Questionnaire and sexual encounter profile with Intra-vaginal ejaculation latency time, serum testosterone and anthropometric analysis etc. NRL/MW/201901 was effective in increasing erection function, orgasmic function, intercourse satisfaction, overall satisfaction and sexual desire. There is marked increase in number of sexual encounters in NRL/MW/201901 treated group. Serum levels of testosterone were increased after treatment of NRL/MW/201901 than in placebo group. It was evident from the anthropometric analysis of the subjects that there was significant increase in resting metabolism and % skeletal muscle content in NRL/MW/201901 treated group. There were no evident adverse events related to drug. Thus it could be concluded that NRL/MW/201901 is safe and effective in the treatment of mild to moderate erectile dysfunction.

scholarly journals Evaluation of the Use of Sterilized and Non-Sterilized Peruibe Black Mud in Patients with Knee Osteoarthritis

2021 ◽  
Vol 18 (4) ◽  
pp. 1666 ◽  
Author(s):  
Paulo Fávio Macedo Gouvêa ◽  
Zélia Maria Nogueira Britschka ◽  
Cristina de Oliveira Massoco Salles Gomes ◽  
Nicolle Gilda Teixeira de Queiroz ◽  
Pablo Antonio Vásquez Salvador ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Knee Osteoarthritis ◽  
Short Form ◽  
Serum Levels ◽  
Double Blind ◽  
Sf 36 ◽  
Radiographic Grade ◽  
Physical Functions ◽  
Kellgren And Lawrence

This study aimed to evaluate the effects of treatment with Peruíbe Black Mud (PBM) on the clinical parameters and quality of life of patients with knee osteoarthritis and to compare the effects of PBM samples simply matured in seawater and PBM sterilized by gamma radiation. A controlled, double-blind trial was conducted with 41 patients divided into two treatment groups composed of 20 and 21 patients: one group was treated with matured PBM and the other with sterilized PBM. Evaluations were done using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) questionnaires, the Kellgren and Lawrence (KL) radiographic scale, and the quantification of the serum levels of inflammatory biomarkers. An improvement in pain, physical functions, and quality of life was observed in all of the patients who underwent treatment with both simply matured and sterilized PBM. Nine patients showed remission in the KL radiographic scale, but no statistically significant differences were observed in the serum levels of inflammatory mediators before or after treatment. Peruíbe Black Mud proves to be a useful tool as an adjuvant treatment for knee osteoarthritis (OA), as shown by the results of the WOMAC and SF-36 questionnaires and by the remission of the radiographic grade of some patients on the Kellgren and Lawrence scale.

scholarly journals Efficacy of Lactobacillus paracasei HA-196 and Bifidobacterium longum R0175 in Alleviating Symptoms of Irritable Bowel Syndrome (IBS): A Randomized, Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1159 ◽  
Author(s):  
Erin D. Lewis ◽  
Joseph M. Antony ◽  
David C. Crowley ◽  
Amanda Piano ◽  
Renu Bhardwaj ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Irritable Bowel Syndrome ◽  
Bifidobacterium Longum ◽  
Well Being ◽  
Lactobacillus Paracasei ◽  
Controlled Study ◽  
Double Blind ◽  
Gi Symptoms ◽  
Irritable Bowel

Specific probiotic strains can alleviate the gastrointestinal (GI) symptoms and psychiatric comorbidities of irritable bowel syndrome (IBS). In this randomized, double-blind, placebo-controlled study, the efficacy of Lactobacillus paracasei HA-196 (L. paracasei) and Bifidobacterium longum R0175 (B. longum) in reducing the GI and psychological symptoms of IBS was evaluated in 251 adults with either constipation (IBS-C), diarrhea (IBS-D), or mixed-pattern (IBS-M). Following a 2-week run-in period, participants were randomized to one of three interventions: L. paracasei (n = 84), B. longum (n = 83) or placebo (n = 81). IBS symptoms, stool frequency and consistency and quality of life were assessed by questionnaires. The differences from baseline in the severity of IBS symptoms at 4 and 8 weeks were similar between groups. Participants in this study were classified, after randomization, into subtypes according to Rome III. Within the L. paracasei group, complete spontaneous and spontaneous bowel movement frequency increased in participants with IBS-C (n = 10) after 8 weeks of supplementation (both p < 0.05) and decreased in participants with IBS-D (n = 10, p = 0.013). Both L. paracasei and B. longum supplementation improved the quality of life in emotional well-being and social functioning compared with baseline (all p < 0.05). In conclusion, L. paracasei and B. longum may reduce GI symptom severity and improve the psychological well-being of individuals with certain IBS subtypes.

The effect of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: A double-blind placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9062-9062
Author(s):  
Egidio Del Fabbro ◽  
Rony Dev ◽  
David Hui ◽  
J. Lynn Palmer ◽  
Eduardo Bruera
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Advanced Cancer ◽  
Interim Analysis ◽  
Controlled Trial ◽  
Well Being ◽  
Test Statistic ◽  
Double Blind ◽  
Edmonton Symptom Assessment Scale

9062 Background: Patients with advanced cancer experience anorexia and weight loss which impairs their quality of life. Prior studies suggest melatonin, a frequently used integrative medicine may attenuate weight loss, anorexia, fatigue, and depression. These studies were limited by a lack of blinding and absence of placebo controls. The primary objective of this study was to compare melatonin to placebo for appetite in patients with cachexia. Methods: A randomized, double-blind, 28 day trial of melatonin 20mg vs. placebo in patients with advanced lung or gastrointestinal cancer, appetite scores >3 on a 0 to 10 scale (10 = worst appetite) and a history of weight loss ≥ 5% within 6 months. Patients unable to maintain oral intake, thyroid or adrenal dysfunction, or with a karnofsky <40 were excluded from the study. The assessments included weight, symptom severity by Edmonton Symptom Assessment Scale (ESAS) and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT).Differences between groups from baseline to day 28 were analyzed using one-sided two sample t tests (appetite, pain and well-being) or Wilcoxon two-sample tests for the other variables. Interim analysis at half point had a Lan-DeMets monitoring boundary with an O’Brien-Fleming stopping rule. The decision boundaries for the interim test was to accept the null hypothesis of no treatment difference (futility) if the test statistic Z < 0.39 (p ≥ 0.348). Results: After interim analysis of 48 patients, the study was closed by the Data Safety Monitoring Board for futility. There were no significant differences between groups in appetite (p=0.78), weight (p= 0.17), FAACT score (p=0.95), insomnia (p=0.62) or other symptoms measured by the ESAS from baseline to day 28.No significant toxicities were observed. Conclusions: In cachectic patients with advanced cancer, 20mg oral Melatonin at night does not improve appetite, weight or quality of life compared to placebo.

Tadalafil improves erectile dysfunction and quality of life in men with cirrhosis: a randomized double blind placebo controlled trial

2021 ◽  
Author(s):  
Rakesh Kumar Jagdish ◽  
Ahmed Kamaal ◽  
Saggere Muralikrishna Shasthry ◽  
Jaya Benjamin ◽  
Rakhi Maiwall ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Erectile Dysfunction ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals What contributes the most to the breast cancer patients’ quality of life during the therapy - clinical factors, functional and affective state or social support?

2021 ◽  
pp. 24-24
Author(s):  
Ivana Novakov ◽  
Svetlana Popovic-Petrovic ◽  
Sonja Ilincic-Zlatar ◽  
Milanka Tatic ◽  
Mirjana Sevo
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Social Support ◽  
Repeated Measures ◽  
Affective State ◽  
Holistic Approach ◽  
Well Being ◽  
Hierarchical Regression ◽  
Breast Cancer Patients

Background/Aim. As significant advances in cancer treatment have occurred over the decades, the crucial questions in oncology nowadays are not related only to the treatment of illness, but also to the quality of life (QOL) of patients. The goal of our study was to explore which set of determinants (clinical, functional, affective, or social) has the greatest impact on explaining QOL in women who live with diagnosis of breast cancer in Serbia. Methods. The research was conducted on 64 women (Mage=58.36, SD=11.30) while undergoing radiation therapy at Oncology institute of Vojvodina. QOL-BC was used as a measure of physical, psychological, social, spiritual and general well-being, UEFI was applied for the assessment of the upper extremity function, DASS-21 was used for measuring symptoms of depression, anxiety and stress, MOS-SSS served as a measure of social support, while demographic and clinical data were also collected. Results. ANOVA with repeated measures, F(2.03, 127.80 )=20.24, p<.001, showed that in our sample, physical QOL was significantly better from all other domains, while social QOL was significantly lower from both physical and psychological aspect. A hierarchical regression analysis, F(8, 55)=7.16, p<.001, R2=.51, showed that patients who received adjuvant chemotherapy, who experienced high levels of stress and poor social support, tend to have diminished general QOL. Intoduction of affective-related variables, ?R2=.16, p(?F)<.01, and social support, ?R2=.05, p(?F)<.05, led to a significant increase in proportion of explained variance over and above clinical and functional variables. Conclusion. Our results indicate that psychological and social resources are more important in predicting QOL, compared to clinical and funcitonal factors. At the same time, social, psychological and spiritual well-being of patients is significantly worse compared to physical QOL, meaning that there is still much left to be done regarding the progress from a purely somatic to a holistic approach in treatment of breast cancer.

scholarly journals Acne: Advocating for holistic support

2021 ◽  
Vol 47 (1) ◽  
Author(s):  
Aryan Riahi ◽  
David Jung
Keyword(s):  
Quality Of Life ◽  
Holistic Approach ◽  
Well Being ◽  
Complex Interplay ◽  
Health Practitioners ◽  
Critical Patients ◽  
Suboptimal Health

As health practitioners, having a holistic approach to patients is critical. Patients are a complex interplay of physical, emotional, and social well-being. Limiting treatments to only some of these domains will inevitably yield suboptimal health and reduced quality of life. Thus, it is imperative that we advocate for acne-prone individuals so that they can receive the well-rounded care they deserve.

scholarly journals Effects of standard glucocorticoid replacement therapies on subjective well-being: a randomized, double-blind, crossover study in patients with secondary adrenal insufficiency

2012 ◽  
Vol 167 (5) ◽  
pp. 679-685 ◽  
Author(s):  
Sven Benson ◽  
Pia Neumann ◽  
Nicole Unger ◽  
Manfred Schedlowski ◽  
Klaus Mann ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Well Being ◽  
Healthy Controls ◽  
Subjective Well Being ◽  
Secondary Adrenal Insufficiency ◽  
Double Blind ◽  
Sf 36 ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

Objective For secondary adrenal insufficiency (SAI), established biochemical parameters for dosage control are lacking and no optimal substitution dosage and daily distribution have been determined yet. Therefore, in clinical practice, the individual total dose is often adjusted based on patients' subjective well-being. Design Effects of three standard glucocorticoid replacement regimens on psychological variables were assessed in patients with SAI based on a randomized double-blind study design. Methods SAI patients (n=18) were treated with three different established glucocorticoid replacement regimens in a randomized, double-blind, crossover study (treatment A, hydrocortisone 10 mg-placebo-5 mg-placebo; treatment B, hydrocortisone 10 mg-5 mg-placebo-5 mg; and treatment C, prednisone 5 mg-placebo-placebo-placebo). Following each 4-week replacement regimen, quality of life (SF-36) and emotional distress (brief symptom inventory (BSI)) were assessed along with diurnal changes in current well-being (Bf-S) and alertness (Stanford Sleepiness Scale (SSS)) using validated questionnaires, and additionally compared with patient (patients with pituitary disease and adrenal sufficiency) and healthy control groups. Results SAI patients showed improvements in physical quality of life (i.e. SF-36 physical function, P<0.05; physical role function, P<0.05) and current well-being (at 1800 h, P<0.05) under treatment A (hydrocortisone 10-0-5-0 mg) compared with the other replacement regimens. Quality of life and current well-being were significantly impaired compared with healthy controls but did not differ from patient controls. Conclusions Although the observed improvements in psychological parameters were comparatively small, our results indicate beneficial effects of a 10-0-5-0 mg hydrocortisone replacement regimen. Nevertheless, treatment effects were insufficient to restore subjective health compared with healthy controls, indicating the need for improved replacement regimens and supportive psychosocial interventions in SAI patients.

Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small-cell lung cancer: a randomized placebo-controlled, double-blind phase III study of the Cancer and Leukemia Group B.

1994 ◽  
Vol 12 (6) ◽  
pp. 1113-1120 ◽  
Author(s):  
M P Kosty ◽  
S B Fleishman ◽  
J E Herndon ◽  
K Coughlin ◽  
A B Kornblith ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Performance Status ◽  
Treated Group ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Hydrazine Sulfate ◽  
Double Blind ◽  
Phase Iii Study

PURPOSE To assess the chemotherapy regimen of cisplatin, vinblastine, and hydrazine sulfate administered to patients with non-small-cell lung cancer (NSCLC) in a randomized, placebo-controlled double-blind phase III study. PATIENTS AND METHODS Between July 25, 1989 and February 1, 1991, 291 patients with stage IIIB or IV NSCLC and performance status 0 or 1 were randomized to receive cisplatin 100 mg/m2 intravenously (IV) every 28 days, vinblastine 5 mg/m2 IV per week times five, then every 2 weeks; and either hydrazine sulfate 60 mg three times per day orally or placebo. The concurrent use of corticosteroids, medroxyprogesterone, or other appetite stimulants was not permitted. Treatment groups were comparable for known prognostic variables. The primary end point of this study was survival; however, the influence of hydrazine sulfate on nutritional status, performance status, and quality of life was also assessed. RESULTS Analysis of 266 eligible patients showed a median survival duration of 7.78 months for the hydrazine sulfate-treated group compared with 7.70 months for the placebo-treated group (P = .65, log-rank). Objective response rates were similar for the two groups, with 4% complete responses, 20% partial responses, and 2% regressions in those treated with hydrazine sulfate; 3% complete responses, 23% partial responses, and 2% regressions in those who received placebo. The major toxicity was severe or life-threatening neutropenia, which occurred in 65% of hydrazine sulfate patients and 63% of placebo patients. There were no differences noted between the two groups in degree of anorexia, weight gain or loss, or overall nutritional status. Sensory and motor neuropathy occurred significantly more often in patients treated with hydrazine sulfate. Quality of life was significantly worse in patients who received hydrazine sulfate. CONCLUSION This study suggests no benefit from the addition of hydrazine sulfate to an effective cytotoxic regimen.

Improving the Sexual Quality of Life of Couples Affected by Erectile Dysfunction: A Double‐Blind, Randomized, Placebo‐Controlled Trial of Vardenafil

2005 ◽  
Vol 2 (5) ◽  
pp. 699-708 ◽  
Author(s):  
William A. Fisher ◽  
Raymond C. Rosen ◽  
Martin Mollen ◽  
Gerald Brock ◽  
Gary Karlin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Erectile Dysfunction ◽  
Controlled Trial ◽  
Double Blind ◽  
Sexual Quality Of Life
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