Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep: Randomized, controlled, double-blind pilot study

2007 ◽  
Vol 23 (2) ◽  
pp. 117-122 ◽  
Author(s):  
Carmela Rotem ◽  
Boris Kaplan
Keyword(s):  
Pilot Study ◽  
Hot Flushes ◽  
Quality Of Sleep ◽  
Double Blind ◽  
Randomized Controlled ◽  
Night Sweats

Opipramol Improves Subjective Quality of Sleep the Night Prior to Surgery: Confirmatory Testing of a Double-Blind, Randomized Clinical Trial

2011 ◽  
Vol 64 (1) ◽  
pp. 24-31 ◽  
Author(s):  
Michael Hueppe ◽  
David Hartge ◽  
Klaus-Dieter Stoll ◽  
Andrea Ros ◽  
Peter Schmucker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Subjective Quality ◽  
Quality Of Sleep ◽  
Double Blind ◽  
Confirmatory Testing

scholarly journals A Randomized Controlled Trial of the Efficacy of Systemic Enzymes and Probiotics in the Resolution of Post-COVID Fatigue

Medicines ◽  
2021 ◽  
Vol 8 (9) ◽  
pp. 47
Author(s):  
Abhijit Rathi ◽  
Swati B. Jadhav ◽  
Neha Shah
Keyword(s):  
Treatment Efficacy ◽  
Controlled Trial ◽  
Placebo Treatment ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Time Points ◽  
Randomized Controlled ◽  
Cognitive Disturbances ◽  
Oral Supplements

Muscle fatigue and cognitive disturbances persist in patients after recovery from acute COVID-19 disease. However, there are no specific treatments for post-COVID fatigue. Objective: To evaluate the efficacy and safety of the health supplements ImmunoSEB (systemic enzyme complex) and ProbioSEB CSC3 (probiotic complex) in patients suffering from COVID-19 induced fatigue. A randomized, multicentric, double blind, placebo-controlled trial was conducted in 200 patients with a complaint of post-COVID fatigue. The test arm (n = 100) received the oral supplements for 14 days and the control arm (n = 100) received a placebo. Treatment efficacy was compared using the Chalder Fatigue scale (CFQ-11), at various time points from days 1 to 14. The supplemental treatment resulted in resolution of fatigue in a greater percentage of subjects in the test vs. the control arm (91% vs. 15%) on day 14. Subjects in the test arm showed a significantly greater reduction in total as well as physical and mental fatigue scores at all time points vs. the control arm. The supplements were well tolerated with no adverse events reported. This study demonstrates that a 14 days supplementation of ImmunoSEB + ProbioSEB CSC3 resolves post-COVID-19 fatigue and can improve patients’ functional status and quality of life.

scholarly journals Fermented Soy Supplementation Improves Quality of Life Indicators: A Randomized, Placebo-Controlled, Double-Blind Trial in Adults Experiencing Heartburn

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1124-1124
Author(s):  
Asmaa Fatani ◽  
Kadi Vaher ◽  
Karima Alabasi ◽  
Wendy Dahl
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Rating Scale ◽  
Gastrointestinal Symptoms ◽  
Lactobacillus Delbrueckii ◽  
Soy Flour ◽  
Life Questionnaire ◽  
Double Blind ◽  
Symptom Intensity

Abstract Objectives The aim of this pilot study was to determine the effects of a fermented soy supplement on heartburn relief, gastrointestinal symptoms, and quality of life. Methods A 5-week, randomized, double-blind pilot study was conducted with adults (n = 51; 37F/14 M, 31 ± 12y) experiencing mild or moderate heartburn. Following a 1-week baseline, participants self-treated heartburn symptoms with up to 3, 1 g sachets of a non-GMO soy flour fermented by Lactobacillus delbrueckii ssp. delbrueckii Rosell-187 or placebo (maltodextrin) sachets per incident for 3 weeks followed by a 1-week washout. Differences from baseline between treatments were compared using the Wilcoxon Signed Rank test (alpha 0.05). Symptom intensity at 5, 15 and 30-min post administration was assessed using a Likert-like scale (1, no symptoms to 5, severe discomfort). The Gastrointestinal Symptoms Rating Scale (GSRS) (1-no discomfort to 7-very severe discomfort) and Gastro-oesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL) (4-strongly disagree to 0-strongly agree) were administered during baseline, intervention, and washout. Results No significant differences between intervention groups were seen for heartburn severity or frequency, GSRS syndromes or GERD-QOL domains. However, individual QOL items related to inconvenience of taking medications (−1.0 ± 1.3 vs −0.04 ± 1.8, P < 0.05), fear of eating (−1.4 ± 1.3 vs −0.2 ± 1.7, P < 0.05), inability to concentrate at work (−0.9 ± 1.6 vs −0.3 ± 1.0, P < 0.05), and disturbance of after-meal activities and rest (−1.6 ± 1.5 vs −0.7 ± 1.5, P < 0.05) significantly improved with fermented soy compared to control. In addition, the frequency of heartburn (0.3 ± 0.3 vs 0.1 ± 0.3, P < 0.05) and the GSRS symptoms of diarrhea (0.3 ± 1.4 vs −0.3 ± 1.2, P < 0.05) and bloating (0.7 ± 1.7 vs 0.1 ± 1.3, P < 0.05) were significantly improved during washout vs. baseline for the fermented soy group, demonstrating a possible carryover effect over time. Conclusions Further research is suggested to test the effect of daily supplementation of fermented soy on heartburn frequency, gastrointestinal symptoms and QOL in a trial of longer duration. Funding Sources Lallemand Bio-Ingredients

scholarly journals Effects of a multispecies synbiotic on glucose metabolism, lipid marker, gut microbiome composition, gut permeability, and quality of life in diabesity: a randomized, double-blind, placebo-controlled pilot study

2019 ◽  
Vol 59 (7) ◽  
pp. 2969-2983 ◽  
Author(s):  
Angela Horvath ◽  
Bettina Leber ◽  
Nicole Feldbacher ◽  
Norbert Tripolt ◽  
Florian Rainer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Type 2 Diabetes ◽  
Pilot Study ◽  
Glucose Metabolism ◽  
Life Assessment ◽  
Gut Permeability ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Purpose Diabesity, the combination of obesity and type 2 diabetes, is an ever-growing global health burden. Diabesity-associated dysbiosis of the intestinal microbiome has gained attention as a potential driver of disease and, therefore, a possible therapeutic target by means of pro- or prebiotic supplementation. This study tested the effects of a multispecies synbiotic (i.e. a combination of probiotics and prebiotics) on glucose metabolism, gut microbiota, gut permeability, neutrophil function and quality of life in treatment-experienced diabesity patients. Methods A randomized, double-blind, placebo-controlled pilot study with 26 diabesity patients was conducted in which patients received a daily dose of a multispecies probiotic and a prebiotic (or a placebo) for 6 months. Results There were no changes in glucose metabolism or mixed meal tolerance test responses throughout the study. The analysis of secondary outcomes revealed beneficial effects on hip circumference [− 1 (95% CI − 4; 3) vs +3 (− 1; 8) cm, synbiotics vs. placebo, respectively, p = 0.04], serum zonulin [− 0.04 (− 0.2; 0.1) vs +0.3 (− 0.05; 0.6) ng/ml, p = 0.004)] and the physical role item of the SF36 quality of life assessment [+ 5.4 (− 1.7; 12.5) vs − 5.0 (− 10.1; 0.2) points, p = 0.02] after 3 months of intervention, and lipoprotein (a) [− 2.1 (− 5.7; 1.6) vs +3.4 (− 0.9; 7.9) mg/dl, p = 0.02] after 6 months. There were no significant differences in alpha or beta diversity of the microbiome between groups or time points. Conclusions Glucose metabolism as the primary outcome was unchanged during the intervention with a multispecies synbiotic in patients with diabesity. Nevertheless, synbiotics improved some symptoms and biomarkers of type 2 diabetes and aspects of quality of life suggesting a potential role as adjuvant tool in the management of diabesity. Graphic abstract

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