Treatment of Functional Dyspepsia with a Herbal Preparation
Madisch A.a · Holtmann G.b · Mayr G.c · Vinson B.d · Hotz J.†,e
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial
aMedical Department I, Technical University Hospital Dresden; bDivision of Gastroenterology and Hepatology, University Hospital, Essen; cPFK International, Kaufbeuren; dResearch Department, Steigerwald Arzneimittelwerk GmbH, Darmstadt, and eDepartment of Gastroenterology, General Hospital, Celle, Germany
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Background: We aimed to assess the efficacy and safety of a herbal preparation STW 5-II containing extracts from bitter candy tuft, matricaria flower, peppermint leaves, caraway, licorice root and lemon balm for the treatment of patients with functional dyspepsia. Methods: 120 patients with functional dyspepsia were randomly assigned to 1 of 4 treatment groups. Each patient received the treatment for three consecutive 4-week treatment blocks. The first two treatment blocks were fixed. For the third treatment period, medication was based upon the investigator’s judgement of symptom improvement during the preceding treatment period. In patients without adequate control of symptoms, the treatment was switched, or if symptoms were controlled, the treatment was continued. The primary outcome measure was the improvement of a standardized gastrointestinal symptom score (GIS). Findings: During the first 4 weeks, the GIS significantly decreased in subjects on active treatment compared to the placebo (p < 0.001). During the second 4-week period, symptoms further improved in subjects who continued on active treatment or who switched to the active treatment (p < 0.001), while symptoms deteriorated in subjects who switched to placebo. After 8 weeks 43.3% on active treatment and 3.3% on placebo reported complete relief of symptoms. (p < 0.001 vs. placebo). Conclusion: In patients with functional dyspepsia, the herbal preparation tested improved dyspeptic symptoms significantly better than placebo.
© 2004 S. Karger AG, Basel
Talley NJ, Colin-Jones D, Koch KL, Koch M, Nyrén O, Stanghellini V: Functional dyspepsia: A classification with guidelines for diagnosis and management. Gastroenterol Int 1991;4:145–160.
- Barbara L, Camilleri M, Corinaldesi R, Crean GP, Heading RC, Johnson AG, et al: Definition and investigation of dyspepsia: Consensus of an international ad hoc working party. Dig Dis Sci 1989;34:1272–1276.
Richter JE: Dyspepsia: organic causes and differential characteristics from functional dyspepsia. Scand J Gastroenterol 1991;182(suppl):11–16.
Talley NJ, Holtmann G: Approach to the patient with dyspepsia and related functional gastrointestinal complaints; in Yamada T, Alpers DH, Laine L, Owyang C, Powell DW (eds): Textbook of Gastroenterology, ed 3. Philadelphia, Lippincott Williams & Wilkins, 1999, pp 660–682.
- Talley NJ, Phillips SF: Nonulcer dyspepsia: Potential causes and pathophysiology. Ann Intern Med 1988;108:865–879.
Talley NJ: Drug treatment of functional dyspepsia. Scand J Gastroenterol 1991;182 (suppl):47–60.
- Madisch A, Melderis H, Mayr G, Sassin I, Hotz J: Commercially available herbal preparation and its modified dispense in patients with functional dyspepsia. Results of a double-blind, placebo-controlled, randomized multicenter trial. Z Gastroenterol 2001;39:511–517.
- Holtmann G, Gschossmann J, Mayr P, Talley NJ: A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia. Aliment Pharmacol Ther 2002;16:1641–1648.
Holtmann G, Gschossmann J, Karaus M, Fischer T, Becker B, Mayr P, et al: Randomised double-blind comparison of simethicone and cisapride in functional dyspepsia. Aliment Pharmacol Ther 1999;13:1459–1464.
Drossman DA, Whitehead WE, Corazziari E, Richter JE, Talley NJ, Thompson WG: The functional gastrointestinal disorders and their diagnosis: A coming of age; in Drossman DA, Richter JE, Talley NJ, Thompson WG, Corazziari E, Whitehead WE (eds): The Functional Gastrointestinal Disorders. Boston, Little, Brown, 1994, pp 1–23.
- O’Brien PC: Procedures for comparing samples with multiple endpoints. Biometrics 1991;47:511–521.
- Rösch W: Cisapride in non-ulcer dyspepsia: Results of a placebo-controlled trial. Scand J Gastroenterol 1987;22:161–164.
Stephens CJ, Lever L, Hoare AM: Dicyclomine for idiopathic dyspepsia. Lancet 1988;i:1004.
Talley NJ, McNeil D, Hayden A, Piper DW: Randomized, double-blind, placebo-controlled crossover trial of cimetidine and pirenzepine in non-ulcer dyspepsia. Gastroenterology 1986;91:149–156.
- Talley NJ, Meineche-Schmidt V, Pare P, Duckworth M, Räisänen P, Pap A, et al: Efficacy of omeprazole in functional dyspepsia: Double-blind randomised placebo-controlled trials. Aliment Pharmacol Ther 1998;12:1055–1065.
Talley NJ, Lauritsen K: The potential role of acid suppression in functional dyspepsia: The BOND, OPERA, PILOT, and ENCORE studies. Gut 2002;suppl 4:iv36–41.
- Bolling-Sternevald E, Lauritsen K, Aalykke C, Havelund T, Knudsen T, Unge P, et al: Effect of profound acid suppression in functional dyspepsia: A double-blind, randomized, placebo-controlled trial. Scand J Gastroenterol 2002;37:1395–1402.
Otu AA: Perforated peptic ulcer in south-eastern Nigeria 1973–1982. Scand J Gastroenterol 1986;124(suppl):219–222.
Azpiroz F, Malagelada JR: Isobaric intestinal distension in humans: Sensorial relay and reflex gastric relaxation. Am J Physiol 1990;258:G202–G207.
- Holtmann G, Talley NJ: Functional dyspepsia: Current treatment recommendations. Drugs 1993;45:918–930.
Talley NJ: Dyspepsia: How to manage and how to treat? (review article) Aliment Pharmacol Ther 2002;16(suppl 4):95–104.
- Talley NJ, Vakil N, Ballard DE, Fennerty B: Absence of benefit of eradicating Helicobacter pylori in patients with non-ulcer dyspepsia. N Engl J Med 1999;341:1106–1111.
- Blum AL, Talley NJ, O’Morain C, Van Zanten SV, Labenz J, Stolte M, et al: Lack of effect of treating Helicobacter pylori infection in patients with nonulcer dyspepsia: Omeprazole plus Clarithromycin and Amoxicillin Effect One Year after Treatment (OCAY) Study Group. N Engl J Med 1998;339:1875–1881.
Veldhuyzen van Zanten SJ, Talley NJ, Bytzer P, Klein KB, Whorwell PJ, Zinsmeister AR: Design of treatment trials for functional gastrointestinal disorders. Gut 1999;45(suppl 2):69–77.
- Talley NJ, McNeil D, Hayden A, Colreavy C, Piper DW: Prognosis of chronic unexplained dyspepsia: A prospective study of potential predictor variables in patients with endoscopically diagnosed nonulcer dyspepsia. Gastroenterology 1987;92:1060–1066.
- Bensoussan A, Talley NJ, Hing M, Menzies R, Guo A, Ngu M: Treatment of irritable bowel syndrome with Chinese herbal medicine: A randomized controlled trial. JAMA 1998;280:1585–1589.
Madisch A, Holtmann G, Plein K, Mayr G, Sassin I, Hotz J: Benefit of a herbal preparation in patients with irritable bowel syndrome: Results of a double-blind, randomized, placebo-controlled multicenter trial. Gastroenterology 2000;118:A4440.
- May B, Köhler S, Schneider B: Efficacy and tolerability of a fixed peppermint oil and caraway oil in patients suffering from functional dyspepsia. Aliment Pharmacol Ther 2000;14:1671–1677.
Madisch A, Heydenreich C-J, Wieland V, Hufnagel R, Hotz J: Equivalence of a fixed peppermint oil and caraway oil combination preparation as compared with cisapride in functional dyspepsia: A multicenter, double-blind, randomized trial. Drug Res 1999;49:925–932.
Duthie HL: The effect of peppermint oil on colonic motility in man. Br J Surg 1981;68:820–824.
- Hills JM, Aaronson PI: The mechanism of action of peppermint oil on gastrointestinal smooth muscle: An analysis using patch clamp electrophysiology and isolated tissue pharmacology in rabbit and guinea pig. Gastroenterology 1991;101:55–65.
- Finney JS, Kinnersley N, Hughes M, O’Bryan-Tear CG, Lothian J: Meta-analysis of antisecretory and gastrokinetic compounds in functional dyspepsia. J Clin Gastroenterol 1998;26:312–320.
- Talley NJ, Meineche-Schmidt V, Pare P, Duckworth M, Raisanen P, Pap A, et al: Efficacy of omeprazole in functional dyspepsia: Double-blind, randomized, placebo-controlled trials (the Bond and Opera studies). Aliment Pharmacol Ther 1998;12:1055–1065.
- Jones RH, Baxter G: Lansoprazole 30 mg daily versus ranitidine 150 mg b.d. in the treatment of acid-related dyspepsia in general practice. Aliment Pharmacol Ther 1997;11:541–546.
- Blum AL, Arnold R, Stolte M, Fischer M, Koelz HR: Short course acid suppressive treatment for patients with functional dyspepsia: results depend on Helicobacter pylori status. Gut 2000;47:473–480.
Okpanyi SN, Mark M, Wahl MA: Gastrointestinal motility modulation with Iberogast®. Acta horticulturae 1993;3332:227–235.
Simmen U, Kelber O, Jäggi R, Büter B, Okpanyi SN, Weiser D: Relevance of the herbal combination of STW 5 for its binding affinity to the muscarinic M3 receptor. Arch Pharmacol 2003;367(suppl 1; A):R22.
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