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

Kadur Ramamurthy Raveendra, Jayachandra, Venkatappa Srinivasa, Kadur Raveendra Sushma, Joseph Joshua Allan, Krishnagouda Shankargouda Goudar, Hebbani Nagarajappa Shivaprasad, Kudiganti Venkateshwarlu, Periasamy Geetharani, Gopalakrishna Sushma, Amit Agarwal, Kadur Ramamurthy Raveendra, Jayachandra, Venkatappa Srinivasa, Kadur Raveendra Sushma, Joseph Joshua Allan, Krishnagouda Shankargouda Goudar, Hebbani Nagarajappa Shivaprasad, Kudiganti Venkateshwarlu, Periasamy Geetharani, Gopalakrishna Sushma, Amit Agarwal

Abstract

A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of GutGard, an extract of Glycyrrhiza 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.

Figures

Figure 1
Figure 1
Flow chart of disposition of patients.

References

    1. Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C. A placebo-controlled trial of itopride in functional dyspepsia. The New England Journal of Medicine. 2006;354(8):832–840.
    1. Adam B, Liebregts T, Saadat-Gilani K, Vinson B, Holtmann G. Validation of the gastrointestinal symptom score for the assessment of symptoms in patients with functional dyspepsia. Alimentary Pharmacology and Therapeutics. 2005;22(4):357–363.
    1. Holtmann G, Adam B, Haag S, Collet W, Grünewald E, Windeck T. Efficacy of artichoke leaf extract in the treatment of patients with functional dyspepsia: a six-week placebo-controlled, double-blind, multicentre trial. Alimentary Pharmacology and Therapeutics. 2003;18(11-12):1099–1105.
    1. Qu Y, Gan HQ, Mei QB, Liu L. Study on the effect of Jia-Wei-Xiao-Yao-San decoction on patients with functional dyspepsia. Phytotherapy Research. 2010;24(2):245–248.
    1. Mahadeva S, Goh KL. Epidemiology of functional dyspepsia: a global perspective. World Journal of Gastroenterology. 2006;12(17):2661–2666.
    1. Haycox A, Einarson T, Eggleston A. The health economic impact of upper gastrointestinal symptoms in the general population: results from the Domestic/International Gastroenterology Surveillance Study (DIGEST) Scandianavian Journal of Gastroenterology. 1999;34(231):38–47.
    1. Moayyedi P, Mason J. Clinical and economic consequences of dyspepsia in the community. Gut. 2002;50(supplement 4):iv10–iv12.
    1. Chang L. Review article: epidemiology and quality of life in functional gastrointestinal disorders. Alimentary Pharmacology and Therapeutics. 2004;20(supplement 7):31–39.
    1. Heikkinen M, Färkkilä M. What is the long-term outcome of the different subgroups of functional dyspepsia? Alimentary Pharmacology and Therapeutics. 2003;18(2):223–229.
    1. Agréus L, Svärdsudd K, Talley NJ, Jones MP, Tibblin G. Natural history of gastroesophageal reflux disease and functional abdominal disorders: a population-based study. American Journal of Gastroenterology. 2001;96(10):2905–2914.
    1. Saad RJ, Chey WD. Review article: current and emerging therapies for functional dyspepsia. Alimentary Pharmacology and Therapeutics. 2006;24(3):475–492.
    1. Brook RA, Kleinman NL, Choung RS, Melkonian AK, Smeeding JE, Talley NJ. Functional dyspepsia impacts absenteeism and direct and indirect costs. Clinical Gastroenterology and Hepatology. 2010;8(6):498–503.
    1. Hikino H. Recent research on oriental medicinal plants. In: Wagner H, Hikino H, Farnsworth NR, editors. Economic and Medicinal Plant Research. London: Academic Press; 1985. pp. 53–85.
    1. Lata S, Kakkar S, Srivastava VK, Saxena KK, Saxena RS, Kumar A. Comparative antipyretic activity of Ocimum sanctum, Glycyrrhiza glabra and aspirin in experimentally-induced pyrexia in rats. Indian Journal of Pharmacology. 1999;31(1):71–75.
    1. Wittschier N, Faller G, Hensel A. Aqueous extracts and polysaccharides from Liquorice roots (Glycyrrhiza glabra L.) inhibit adhesion of Helicobacter pylori to human gastric mucosa. Journal of Ethnopharmacology. 2009;125(2):218–223.
    1. Vaya J, Belinky PA, Aviram M. Antioxidant constituents from licorice roots: isolation, structure elucidation and antioxidative capacity toward LDL oxidation. Free Radical Biology and Medicine. 1997;23(2):302–313.
    1. van Marle J, Aarsen PN, Lind A, van Weeren-Kramer J. Deglycyrrhizinised liquorice (DGL) and the renewal of rat stomach epithelium. European Journal of Pharmacology. 1981;72(2-3):219–225.
    1. Aly AM, Al-Alousi L, Salem HA. Licorice: a possible anti-inflammatory and anti-ulcer drug. AAPS PharmSciTech. 2005;6(1, article 13):E74–E82.
    1. Fukai T, Marumo A, Kaitou K, Kanda T, Terada S, Nomura T. Anti-Helicobacter pylori flavonoids from licorice extract. Life Sciences. 2002;71(12):1449–1463.
    1. Jafarian MM, Ghazvini K. In vitro susceptibility of Helicobacter pylori to licorice extract. The Iranian Journal of Pharmaceutical Research. 2007;6(1):69–72.
    1. Bennett A, Clark-Wibberley T, Stamford IF, Wright JE. Aspirin-induced gastric mucosal damage in rats: cimetidine and deglycyrrhizinated liquorice together give greater protection than low doses of either drug alone. Journal of Pharmacy and Pharmacology. 1980;32(2):p. 151.
    1. Habibullah CM, Chandra V, Padmanabham C, Datla R. A double blind trial of deglycyrrhizinated liquorice in peptic ulcer. The Indian Practitioner. 1979;32(2):119–122.
    1. Larkworthy W, Holgate PFL. Deglycyrrhizinized liquorice in the treatment of chronic duodenal ulcer. A retrospective endoscopic survey of 32 patients. The Practitioner. 1975;215(1290):787–792.
    1. Murray MT, Pizzorno JE., Jr. Glycyrrhiza glabra. In: Murray MT, Pizzorno JE Jr., editors. Textbook of Natural Medicine. 2nd edition. London, UK: Churchill Livingstone; 1999. pp. 767–773.
    1. Chandrasekaran CV, Deepak HB, Thiyagarajan P, et al. Dual inhibitory effect of Glycyrrhiza glabra (GutGard) on COX and LOX products. Phytomedicine. 2011;18(4):278–284.
    1. Mukherjee M, Bhaskaran N, Srinath R, et al. Anti-ulcer and antioxidant activity of GutGard. Indian Journal of Experimental Biology. 2010;48(3):269–274.
    1. Rome Foundation, 2006, .
    1. van Zanten SJOV, Chiba N, Armstrong D, et al. Validation of a 7-point Global Overall Symptom scale to measure the severity of dyspepsia symptoms in clinical trials. Alimentary Pharmacology and Therapeutics. 2006;23(4):521–529.
    1. Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form. Alimentary Pharmacology and Therapeutics. 2001;15(2):207–216.
    1. Mahadeva S, Wee HL, Goh KL, Thumboo J. The EQ-5D (Euroqol) is a valid generic instrument for measuring quality of life in patients with dyspepsia. BMC Gastroenterology. 2009;9, article 20
    1. Dell RB, Holleran S, Ramakrishnan R. Sample size determination. ILAR Journal. 2002;43(4):207–213.
    1. Zar JH. Biostatistical Analysis. (Singapore) Pte. Ltd: Pearson Education; 2003. More on dichotomous variables; pp. 516–570.
    1. Coon JT, Ernst E. Systematic review: herbal medicinal products for non-ulcer dyspepsia. Alimentary Pharmacology and Therapeutics. 2002;16(10):1689–1699.
    1. Gupta YK, Katyal J, Kumar G, et al. Evaluation of antitussive activity of formulations with herbal extracts in sulphur dioxide (SO2) induced cough model in mice. Indian Journal of Physiology and Pharmacology. 2009;53(1):61–66.
    1. Dehpour AR, Zolfaghari ME, Samadian T, Kobarfard F, Faizi M, Assari M. Antiulcer activities of liquorice and its derivatives in experimental gastric lesion induced by ibuprofen in rats. International Journal of Pharmaceutics. 1995;119(2):133–138.
    1. Gundermann KJ, Godehardt E, Ulbrich M. Efficacy of a herbal preparation in patients with functional dyspepsia: a meta-analysis of double-blind, randomized, clinical trials. Advances in Therapy. 2003;20(1):43–49.
    1. Melzer J, Iten F, Reichling J, Saller R. Iberis amara L. and Iberogast—results of a systematic review concerning functional dyspepsia. Journal of Herbal Pharmacotherapy. 2004;4(4):51–59.
    1. Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GNJ. Functional gastroduodenal disorders. Gut. 1999;45(supplement 2):II37–II42.
    1. Bortolotti M, Coccia G, Grossi G, Miglioli M. The treatment of functional dyspepsia with red pepper. Alimentary Pharmacology and Therapeutics. 2002;16(6):1075–1082.
    1. Miller FG, Brody H. What makes placebo-controlled trials unethical? The American Journal of Bioethics. 2002;2(2):3–9.
    1. Lau JTF, Mao J, Woo J. Ethical issues related to the use of placebo in clinical trials. Hong Kong Medical Journal. 2003;9(3):192–198.
    1. Aoki F, Nakagawa K, Kitano M, et al. Clinical safety of Licorice Flavonoid Oil (LFO) and pharmacokinetics of glabridin in healthy humans. Journal of the American College of Nutrition. 2007;26(3):209–218.
    1. Isbrucker RA, Burdock GA. Risk and safety assessment on the consumption of Licorice root (Glycyrrhiza sp.), its extract and powder as a food ingredient, with emphasis on the pharmacology and toxicology of glycyrrhizin. Regulatory Toxicology and Pharmacology. 2006;46(3):167–192.

Source: PubMed

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