Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of H. pylori Eradication in H. pylori-Infected Patients with Functional Dyspepsia

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.

Download Full-text

Correction to: A double-blind placebo controlled study of acotiamide hydrochloride for efficacy on gastrointestinal motility of patients with functional dyspepsia

Journal of Gastroenterology ◽

10.1007/s00535-020-01758-9 ◽

2021 ◽

Vol 56 (2) ◽

pp. 191-191

Author(s):

Kumiko Nakamura ◽

Toshihiko Tomita ◽

Tadayuki Oshima ◽

Haruki Asano ◽

Takahisa Yamasaki ◽

...

Keyword(s):

Functional Dyspepsia ◽

Gastrointestinal Motility ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo

Download Full-text

Efficacy of Cisapride in Functional Dyspepsia Resistant to Domperidone or Metoclopramide: A Double-Blind, Placebo-Controlled Study: General Discussion

Scandinavian Journal of Gastroenterology ◽

10.3109/00365529309098328 ◽

1993 ◽

Vol 28 (sup195) ◽

pp. 47-53 ◽

Cited By ~ 30

Author(s):

M. van Outryve ◽

N. De Nutte ◽

P. van Eeghem ◽

J. P. Gooris

Keyword(s):

Functional Dyspepsia ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo

Download Full-text

Effect of GutGard in the Management ofHelicobacter pylori: A Randomized Double Blind Placebo Controlled Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/263805 ◽

2013 ◽

Vol 2013 ◽

pp. 1-8 ◽

Cited By ~ 10

Author(s):

Sreenivasulu Puram ◽

Hyung Chae Suh ◽

Seung Un Kim ◽

Bharathi Bethapudi ◽

Joshua Allan Joseph ◽

...

Keyword(s):

Repeated Measures ◽

Treated Group ◽

Controlled Study ◽

Root Extract ◽

Double Blind ◽

Exact Probability ◽

Double Blind Placebo ◽

Significant Difference ◽

The Difference ◽

H Pylori

A randomized, double blind placebo controlled study was conducted to evaluate the efficacy of GutGard (root extract ofGlycyrrhiza glabra) in the management ofHelicobacter pylori(H. pylori) gastric load. Participants diagnosed withH. pyloriinfection were randomly assigned to two groups to orally receive 150 mg of GutGard (n=55) or placebo (n=52) once daily for 60 days.H. pyloriinfection was assessed using13C-urea breath test (13C-UBT) at days 0, 30, and 60. Stool Antigen test (HpSA) was also performed on days 0, 30, and 60. Repeated measures of analysis of variance (RMANOVA), chi-square, and Fisher's exact probability tests were used to compare the treatment outcomes. A significant interaction effect between group and time (P=0.00) and significant difference in mean Delta Over Baseline (DOB) values between GutGard (n=50) and placebo (n=50) treated groups after intervention period were observed. On day 60, the results of HpSA test were negative in 28 subjects (56%) in GutGard treated group whereas in placebo treated group only 2 subjects (4%) showed negative response; the difference between the groups was statistically significant. On day 60, the results of13C-UBT were negative in 24 (48%) in GutGard treated group and the difference between the groups was statistically significant. The findings suggest GutGard is effective in the management ofH. pylori.

Download Full-text