Safety and efficacy of a traditional herbal medicine (Throat coat®) in symptomatic temporary relief of pain in patients with acute pharyngitis: A multicenter, prospective, randomized, double-blinded, placebo-controlled study

Journal of Alternative and Complementary Medicine

Volumn 9, Issue 2, 2003, Pages 285-298

  Brinckmann, Josef ^a   Sigwart, Herbert ^b   Taylor, Leslie Van Houten ^c  

^a Traditional Medicinals Inc   (United States)

^b Narayana Research GmbH   (Germany)

^c Dean Foundation for Health   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLYCYRRHIZA EXTRACT; HERBACEOUS AGENT; PLACEBO; THROATCOAT; TRADITIONAL MEDICINALS;

ADULT; ANALGESIA; AREA UNDER THE CURVE; ARTICLE; BARK; BARLEY; CHERRY; CHICORY; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; GLYCYRRHIZA; HEADACHE; HEARING DISORDER; HERBAL MEDICINE; HUMAN; LUNG TOXICITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUROTOXICITY; ORANGE (FRUIT); PAIN; PHARYNGITIS; PRIMARY HEALTH CARE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RHIZOME; SINUSITIS; SWALLOWING; TEA; TREATMENT OUTCOME; UNITED STATES; VESTIBULAR DISORDER; VISUAL DISORDER;

EID: 0037396233     PISSN: 10755535     EISSN: None     Source Type: Journal    
DOI: 10.1089/10755530360623400     Document Type: Article

References (34)

1. Benrimoj SI, Langford JH. Efficacy and tolerability of the anti-inflammatory throat lozenge flurbiprofen 8.75 mg in the treatment of sore throat: A randomized, double-blind, placebo-controlled study. Clin Drug Invest 2001;21:183-193.
2. Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins CW, Rister RS, eds. Klein S, Rister RS transl. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin, TX: American Botanical Council, 1998:161-162, 167.
3. Braun R, Surmann P, Wendt R, Wichtl M, Ziegenmeyer J, eds. German Standard Licenses for Prepared Medicines - Text and Commentary, 11th Supplement [in German]. Stuttgart, Germany: Deutscher Apotheker Verlag, February 1996; Nr.:1309.99.99, Nr.: 8899.99.99.
4. Butler CC, Rollnick S, Pill R, Maggs-Rapport F, Stott N. Understanding the culture of prescribing: Qualitative study of general practitioners' and patients' perceptions of antibiotics for sore throats. Br Med J 1998;317:637-642.
5. Carroll K, Reimer L. Clinical diagnosis of streptococcal pharyngitis is unreliable. Clin Infect Dis 1996;23:442-448.
6. Catterall W, Mackie K. Local anesthetics. In: Hardman J, Limbird L, eds. Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed. New York: McGraw-Hill, 1996:337-338.
7. Chamberlain JJ, Abolnik IZ. Letter to the editor: Pulmonary edema following a licorice binge. West J Med 1997;167:184-185.
8. de Klerk GJ, Nieuwenhuis MG, Beutler JJ. Hypokalaemia and hypertension associated with use of liquorice flavoured chewing gum. Br Med J 1997;314:731-732.
9. Del Mar CB, Glasziou PP, Spinks AB. Antibiotics for sore throat (Cochrane Review). Cochrane Database Syst Rev 2000;2:CD000023.
10. Desjardins PJ, Norris LH, Cooper SA, Reynolds DC. Analgesic efficacy of intranasal butorphanol (Stadol NS) in the treatment of pain after dental impaction surgery. J Oral Maxillofac Surg 2000;58(10 Suppl 2):19-26.
11. Eriksson JW, Carlberg B, Hillörn V. Life-threatening ventricular tachycardia due to liquorice-induced hypokalaemia. J Int Med 1999;245:307-310.
12. European Pharmacopoeia, 4th edition 2002. Strasbourg, France: Council of Europe, 2002:1478-1479, 1529.
13. Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining the clinically important difference in pain outcome measures. Pain 2000;88:287-294.
14. Food and Drug Administration. Over-the-counter oral health care and discomfort drugs; establishment of a monograph. Federal Register 1982;47:22916.
15. Food and Drug Administration. §172.510: Althea root; §182.10: Cassia bark, Fennel fruit; §182.20: Cassia bark, Fennel fruit, Sweet orange peel, Wild cherry bark; §184.1408: Licorice and licorice derivatives. In: Code of Federal Regulations. Washington, DC: Office of the Federal Register National Archives and Records Administration. 1998:49-52, 427-489.
16. Graham A, Fahey T. Sore throat: diagnostic and therapeutic dilemmas. Br Med J 1999;319:173-174.
17. Health Canada Drugs Directorate. Drugs Directorate Guideline: Traditional Herbal Medicines (revised). Ottawa, ON: Health Canada Drugs Directorate, October 1995.
18. Health Canada Therapeutic Products Programme. Traditional Medicinals® Throat Formula Herbal Tea; Drug Identification Number: 00659797. In: Drug Product Database (DPD). Ottawa, ON: Health Canada Therapeutic Products Programme. Updated November 29, 2002.
19. Hersh EV, Levin LM, Cooper SA, Doyle G, Waksman J, Wedell D, Hong D, Secreto SA. Ibuprofen liquigel for oral surgery pain. Clin Ther 2000;22:1306-1318.
20. Government of India Ministry of Health and Family Welfare. Liquorice. In: Indian Pharmacopoeia 1996, Vol. I. Delhi, India: The Controller of Publications, 1996:440-442.
21. Leung AY, Foster S. Encyclopedia of common natural ingredients used in food, drugs, and cosmetics, 2nd ed. New York: John Wiley & Sons, Inc., 1996:299-300.
22. Little P, Gould C, Williamson I, Warner G, Gantley M, Kinmonth AL. Reattendance and complications in a randomised trial of prescribing strategies for sore throat: The medicalising effect of prescribing antibiotics. Br Med J 1997a;315:350-352.
23. Little P, Williamson I, Warner G, Gould C, Gantley M, Kinmonth AL. Open randomised trial of prescribing strategies in managing sore throat. Br Med J 1997b; 314:722.
24. Marvez-Valls EG, Ernst AA, Gray J, Johnson WD. The role of betamethasone in the treatment of acute exudative pharyngitis. Acad Emerg Med 1998;5:567-572.
25. O'Brien JF, Meadle JL, Falk JL. Dexamethasone as adjuvant therapy for severe acute pharyngitis. Ann Emerg Med 1993;22:212-215.
26. Pharmacopoeia Commission of the People's Republic of China. Radix Glycyrrhizae; Extractum Glycyrrhizae; Mel. In: Pharmacopoeia of the People's Republic of China (English Edition 1997), Vol. I. Beijing, China: Chemical Industry Press, 1997:114-115, 153-154, 274-275.
27. Schachtel BF, Fillingim JM, Lane AC, Thoden WR, Baybutt RI. Caffeine as an analgesic adjuvant. Arch Intern Med 1991;151:733-737.
28. Schmidgall J, Schnetz E, Hensel A. Evidence for bioadhesive effects of polysaccharides and polysaccharide-containing herbs in an ex vivo bioadhesion assay on buccal membranes. Planta Med 2000;66:48-53.
29. Therapeutic Goods Administration. Honey - Scientific Report of the Complementary Medicines Evaluation Committee. Woden, Australia: Therapeutic Goods Administration Office of Complementary Medicines, December 1998.
30. Tichy J, Novak J. Detection of antimicrobials in bee products with activity against viridans streptococci. J Alt Comp Med 2000;6:383-389.
31. Traditional Medicinals. Throat Coat®. In: Product Safety Document. Sebastopol, CA: Traditional Medicinals Research and Development Department, June 2001.
32. United States Pharmacopoeial Convention. "USP" vs. "NF." USP Quality Rev Rockville, MD: United States Pharmacopoeial Convention, April 1999, No. 65.
33. United States Pharmacopoeial Convention. Elm USP. In: United States Pharmacopoeia, 25th revision - The National Formulary, 20th ed. Rockville, MD: United States Pharmacopoeial Convention, Inc., 2002.
34. World Health Organization. Radix Glycyrrhizae. In: WHO Monographs on Selected Medicinal Plants, vol. 1. Geneva, Switzerland: World Health Organization, 1999:183-194.