scholarly journals An Extract ofGlycyrrhiza glabra(GutGard) Alleviates Symptoms of Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Kadur Ramamurthy Raveendra ◽  
Jayachandra ◽  
Venkatappa Srinivasa ◽  
Kadur Raveendra Sushma ◽  
Joseph Joshua Allan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Functional Dyspepsia ◽  
Global Assessment ◽  
Short Form ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Secondary Outcome Measure ◽  
Double Blind ◽  
Double Blind Placebo

A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of GutGard, an extract ofGlycyrrhiza glabra, in patients with functional dyspepsia. The primary outcome variables of the study were the change in the severity symptoms and the global assessment of efficacy. The quality of life was evaluated as a secondary outcome measure. The patients received either placebo or GutGard (75 mg twice daily) for 30 days. Efficacy was evaluated in terms of change in the severity of symptoms (as measured by 7-point Likert scale), the global assessment of efficacy, and the assessment of quality of life using the short-form Nepean Dyspepsia Index. In comparison with placebo, GutGard showed a significant decrease (P≤.05) in total symptom scores on day 15 and day 30, respectively. Similarly, GutGard showed marked improvement in the global assessment of efficacy in comparison to the placebo. The GutGard group also showed a significant decrease (P≤.05) in the Nepean dyspepsia index on day 15 and 30, respectively, when compared to placebo. GutGard was generally found to be safe and well-tolerated by all patients. GutGard has shown significant efficacy in the management of functional dyspepsia.

scholarly journals Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years

2018 ◽  
Vol 36 (6) ◽  
pp. 563-571 ◽  
Author(s):  
Julie Lemieux ◽  
Michael D. Brundage ◽  
Wendy R. Parulekar ◽  
Paul E. Goss ◽  
James N. Ingle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Aromatase Inhibitor ◽  
Short Form ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Change Scores ◽  
Sf 36 ◽  
Cancer Trials

Purpose MA.17R was a Canadian Cancer Trials Group–led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor–positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL.

scholarly journals Preventive Efficacy and Safety of Yiqi-Wenjing-Fang Granules on Oxaliplatin-Induced Peripheral Neuropathy: A Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Zhancheng Gu ◽  
Guoli Wei ◽  
Liangjun Zhu ◽  
Lingjun Zhu ◽  
Jing Hu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Group I ◽  
Preventive Efficacy

Background. Oxaliplatin-induced peripheral neuropathy (OIPN) is one of the most common side effects of oxaliplatin, which can cause reduction and cessation of oxaliplatin-based chemotherapy and significantly affect patients’ quality of life. However, no drug has got recognition to prevent or treat OIPN. Yiqi-Wenjing-Fang (YWF) is a joint name of Chinese medicine prescriptions with similar effects of tonifying qi and warming meridians, represented by Huangqi Guizhi Wuwu decoction (HGWD) and Danggui Sini decoction (DSD), both from “Treatise on Cold Pathogenic and Miscellaneous Diseases.” YWF granules, including HGWD granules and DSD granules, have been, respectively, demonstrated to be effective in preventing OIPN in previous small-sample observations. The purpose of this study is to enlarge the sample size for further evaluation of the preventive efficacy and safety of YWF granules on OIPN. Methods and Analysis. This study is a randomized, double-blind, placebo-controlled, and multicenter clinical trial. 360 postoperative patients with stage IIa-IIIc colorectal cancer will be randomly assigned into placebo-control group, intervention group I, and intervention group II, taking the mimetic granules of YWF as placebo, HGWD granules and DSD granules, respectively. All subjects will receive oxaliplatin-based chemotherapy regimen at the same time. EORTC QLQ-CIPN20 will be used to assess the degree of OIPN as the primary outcome measure. The grades of OIPN, quality of life, chemotherapeutic efficacy, and the number of completed chemotherapy cycles are selected as the secondary outcome measures. Discussion. Based on the condition of no recognized effective drugs in preventing OIPN, evidence-based medical study will be conducted for seeking a breakthrough in the field of Chinese herb medicine. This protocol could provide reliable and systemic research basis about the efficacy of YWF granules and the differentiation of two classical prescriptions of YWF on preventing OIPN objectively. Trial Registration. This study was registered at ClinicalTrials.gov on 26 December 2020 (ID: https://clinicaltrials.gov/ct2/show/NCT04690283).

Effects of dehydroepiandrosterone sulphate (DHEAS) replacement on insulin action and quality of life in hypopituitary females: a double-blind, placebo-controlled study

2012 ◽  
Vol 77 (3) ◽  
pp. 423-429 ◽  
Author(s):  
Claire M. McHenry ◽  
Patrick M. Bell ◽  
Steven J. Hunter ◽  
Christopher J. Thompson ◽  
C. H. Courtney ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Insulin Action ◽  
Controlled Study ◽  
Dehydroepiandrosterone Sulphate ◽  
Double Blind ◽  
Double Blind Placebo
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