Zeitschrift für Phytotherapie 2009; 30(6): 275-285
DOI: 10.1055/s-0030-1247118
Forschung

© Hippokrates Verlag in MVS Medizinverlage Stuttgart GmbH & Co. KG

Eine Kombination von Salbei/Echinacea oder Chlorhexidin/Lidocain zur Behandlung akuter Halsschmerzen

Eine randomisierte, doppelblinde StudieAndreas Schapowal, Daniel Berger, Peter Klein, Andy Suter
Further Information

Publication History

Publication Date:
12 January 2010 (online)

Zusammenfassung

Ziel der Studie: Beurteilung der Nichtunterlegenheit eines Salbei/Echinacea-Sprays gegenüber einem Chlorhexidin/Lidocain-Spray bei der Behandlung akuter Halsschmerzen. Design: Multizentrische, randomisierte, doppelblinde, doppeldummykontrollierte Studie in 11 allgemeinmedizinische Praxen in der Schweiz. Studienteilnehmer: 154 Patienten (133 als Per-Protocol-Kollektiv analysiert), mindestens 12 Jahre alt mit akuten Halsschmerzen seit höchstens 72 Stunden vor Studieneinschluss und mit einem Rachen-Score von 6 oder höher. Interventionen: 2 Sprühstöße Echinacea/Salbei-Spray oder Chlorhexidin/Lidocain-Spray alle 2 Stunden, doppeldummy-verblindet, bis zu 10-mal täglich bis Symptomfreiheit erreicht wird. Anwendung maximal 5 Tage lang. Hauptzielkriterien: Vergleich der Ansprechraten in den ersten 3 Tagen, wobei Ansprechen als Abnahme der Gesamtsymptome um mindestens 50% verglichen mit den Ausgangswerten definiert war. Ergebnisse: Die Echinacea/Salbei-Behandlung war der Behandlung mit Chlorhexidin/Lidocain hinsichtlich der Symptomreduktion bei Halsentzündung in den ersten 3 Tagen nicht unterlegen [P(X<Y) = 0,5083]. Die Ansprechraten nach 3 Tagen betrugen 63,8% in der Echinacea/Salbei-Gruppe und 57,8% in der Chlorhexidin/Lidocain-Gruppe. Hinsichtlich aller sekundären Parameter wie Zeit bis zur Symptomfreiheit, Halsschmerzen und Gesamtbeurteilung der Wirksamkeit durch Arzt und Patient wurden keine Unterschiede zwischen den beiden Behandlungen festgestellt. Beide Behandlungen waren sehr gut verträglich. Schlussfolgerung: Ein Echinacea/Salbei-Spray ist bei der Behandlung akuter Halsschmerzen genauso wirksam und gut verträglich wie ein Chlorhexidin/Lidocain-Spray.

Summary

A combination of sage/echinacea or chlorhexidine/lidocaine in the treatment of acute sore throats. A randomized double-blind controlled trial

Goal: Assessment of the relative efficacy of a sage/echinacea spray and a chlorhexidine/lidocaine spray in the treatment of acute sore throats. Design: Multicenter, randomized, double-blind, double-dummy controlled trial carried out in eleven general practices in Switzerland. Patients: A total of 154 patients (133 analyzed in per protocol collective) at least 12 years old with acute sore throat present for not more than 72 hours prior to inclusion and with a throat score ≥6 participated in the study. Treatments: Either an echinacea/sage spray or a chlorhexidine/lidocaine spray with two puffs every 2 hours, in a double-dummy blinded manner, up to 10 times daily until they were symptom-free, for a maximum of 5 days. Primary parameter: Comparison of response rates during the first three days. A response was defined as a decrease of at least 50% of the total symptoms compared to baseline. Results: The echinacea/sage treatment exhibited similar efficacy to the chlorhexidine/lidocaine treatment in reducing sore throat symptoms during the first 3 days [P(x<Y) = .5083]. Response rates after 3 days were 63.8% in the echinacea/sage group and 57.8% in the chlorhexidine/lidocaine group. For all secondary parameters, such as time to becoming symptom free, throat pain, and global assessments of efficacy by the physician and patient, no difference between the two treatments was seen. They were both very well tolerated. Conclusion: An echinacea/sage preparation is as efficacious and well tolerated as a chlorhexidine/lidocaine spray in the treatment of acute sore throats.

Literatur

  • 1 Wei JL, Kasperbauer JL, Weaver AL, Boggust AJ. Efficacy of single-dose dexamethasone as adjuvant therapy for acute pharyngitis.  Laryngoscope. 2002;  112 87-93
  • 2 Stephenson K. Acute and chronic pharyngitis across the lifespan.  Lippincott’s Primary Care Practice. 2000;  4 471-489
  • 3 Vincent MT, Celestin N, Hussain AN. Pharyngitis.  Am Fam Physician. 2004;  69 1465-1470
  • 4 Scottish Intercollegiate Guidelines Network (SIGN) .Management of sore throat and indications for tonsillectomy. Edinburgh; SIGN Publication No. 34 1999
  • 5 Eccles R, Loose I, Jawad M, Nyman L. Effects of acetylsalicylic acid on sore throat pain and other pain symptoms associated with acute upper respiratory tract infection.  Pain Med. 2003;  4 118-124
  • 6 Bertin L, Pons G, d’Athis P, et al.. Randomized, double-blind, multicenter, controlled trial of ibuprofen versus acetaminophen (paracetamol) and placebo for treatment of symptoms of tonsillitis and pharyngitis in children.  J Pediatr. 1991;  119 811-814
  • 7 Weckx LL, Ruiz JE, Duperly J, et al.. Efficacy of celecoxib in treating symptoms of viral pharyngitis: a double-blind, randomized study of celecoxib versus diclofenac.  J Int Med Res. 2002;  30 185-194
  • 8 Moshrefi A. Chlorhexidine.  J West Soc Periodontol Periodontal Abstr. 2002;  50 5-9
  • 9 Shah SA, Sander S, White CM, et al.. Evaluation of echinacea for the prevention and treatment of the common cold: a metaanalysis.  Lancet Infect Dis. 2007;  7 473-480
  • 10 Gertsch J, Schoop R, Kuenzle U, Suter A. Echinacea alkylamides modulate TNF-alpha gene expression via cannabinoid receptor CB2 and multiple signal transduction pathways.  FEBS Lett. 2004;  577 563-569
  • 11 Hinz B, Woelkart K, Bauer R. Alkamides from Echinacea inhibit cyclooxygenase-2 activity in human neuroglioma cells.  Biochem Biophys Res Commun. 2007;  360 441-446
  • 12 Hudson J, Altamirano M. The application of DNA micro-arrays (gene arrays) to the study of herbal medicines.  J Ethnopharmacol. 2006;  108 2-15
  • 13 ESCOP .Salviae officinalis folium, Sage leaf. ESCOP Monographs. 2nd ed. Exeter: ESCOP Stuttgart, New York; Thieme 2003: 452-455
  • 14 Bereznoy VV, Riley DS, Wassmer G, Heger M. Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized, double-blind, placebo-controlled trial.  Altern Ther Health Med. 2003;  9 68-79
  • 15 Wei LJ, Lachin JM. Two-sample asymptotically distribution-free tests for incomplete multivariate observations.  J Am Statistical Assoc. 1984;  79 653-661
  • 16 Hirschmann JV. Antibiotics for common respiratory tract infections in adults.  Arch Intern Med. 2002;  162 256-264
  • 17 European Medicines Agency (EMEA) .ICH Topic E 9 Statistical Principles for Clinical Trials. Note for guidance on statistical principles for clinical trials (CPMP/ICH/363/96). London; EMEA 1998
  • 18 Rowbotham MC, Davies PS, Fields HL. Topical lidocaine gel relieves postherpetic neuralgia.  Ann Neurol. 1995;  37 246-253
  • 19 Finnerup NB, Biering-Sørensen F, Johannesen IL, et al.. Intravenous lidocaine relieves spinal cord injury pain: a randomized controlled trial.  Anesthesiology. 2005;  102 1023-1030
  • 20 Hara K, Maruyama K. Effect of additives in lidocaine spray on postoperative sore throat, hoarseness and dysphagia after total intravenous anaesthesia.  Acta Anaesthesiol Scand. 2005;  49 463-467
  • 21 Morrell DF, Chappel WA, White IW. Topical analgesia of the upper airway with lignocaine. Absorption and its relationship to toxic and anti-arrhythmic levels.  S Afr Med J. 1982;  61 551-553
  • 22 Balit CR, Lynch AM, Gilmore SP, et al.. Lignocaine and chlorhexidine toxicity in children resulting from mouth paint ingestion: a bottling problem.  J Paediatr Child Health. 2006;  42 350-353
  • 23 Burght van der M, Schønemann NK, Laursen JK, et al.. Onset and duration of hypoalgesia following application of lidocaine spray on genital mucosa.  Acta Obstet Gynecol Scand. 1994;  73 809-811
  • 24 Holst A, Evers H. Experimental studies of new topical anaesthetics on the oral mucosa.  Swed Dent J. 1985;  9 185-191
  • 25 Wonnemann M, Helm I, Stauss-Grabo M, et al.. Lidocaine 8 mg sore throat lozenges in the treatment of acute pharyngitis. A new therapeutic option investigated in comparison to placebo treatment.  Arzneimittelforschung. 2007;  57 689-697
  • 26 Baricevic D, Sosa S, Della Loggia R, et al.. Topical anti-inflammatory activity of Salvia officinalis L. leaves: the relevance of ursolic acid.  J Ethnopharmacol. 2001;  75 125-132
  • 27 Feres M, Figueiredo LC, Barreto IM, et al.. In vitro antimicrobial activity of plant extracts and propolis in saliva samples of healthy and periodontally-involved subjects.  J Int Acad Periodontol. 2005;  7 90-96
  • 28 Tierra M. Echinacea: an effective alternative to antibiotics.  J Herb Pharmacother. 2007;  7 79-89
  • 29 Sharma M, Anderson SA, Schoop R, Hudson JB. Induction of multiple pro-inflammatory cytokines by respiratory viruses and reversal by standardized Echinacea, a potent antiviral herbal extract.  Antiviral Res. 2009;  83 165-170
  • 30 Woelkart K, Marth E, Suter A, et al.. Bioavailability and pharmacokinetics of Echinacea purpurea preparations and their interaction with the immune system.  Int J Clin Pharmacol Ther. 2006;  44 401-408
  • 31 Woelkart K, Dittrich P, Beubler E, et al.. Pharmacokinetics of the main alkamides after administration of three different Echinacea purpurea preparations in humans.  Planta Med. 2008;  74 651-656
  • 32 Brinkeborn RM, Shah DV, Degenring FH. Echinaforce and other Echinacea fresh plant preparations in the treatment of the common cold. A randomized, placebo controlled, double-blind clinical trial.  Phytomedicine. 1999;  6 1-6
  • 33 Hubbert M, Sievers H, Lehnfeld R, Kehrl W. Efficacy and tolerability of a spray with Salvia officinalis in the treatment of acute pharyngitis – a randomised, double-blind, placebocontrolled study with adaptive design and interim analysis.  Eur J Med Res. 2006;  11 20-26
  • 34 Schulten B, Bulitta M, Ballering-Brühl B, et al.. Efficacy of Echinacea purpurea in patients with a common cold. A placebo-controlled, randomised, double-blind clinical trial.  Arzneimittelforschung. 2001;  51 563-568
  • 35 Goel V, Lovlin R, Barton R, et al.. Efficacy of a standardized Echinacea preparation (Echinilin) for the treatment of the common cold: a randomized, double-blind, placebocontrolled trial.  J Clin Pharm Ther. 2004;  29 75-83
  • 36 Sperber SJ, Shah LP, Gilbert RD, et al.. Echinacea purpurea for prevention of experimental rhinovirus colds.  Clin Infect Dis. 2004;  38 1367-1371
  • 37 Bräunig B, Dorn M, Knick E. Echinaceae purpureae radix: zur Stärkung der körpereigenen Abwehr bei grippalen Infekten.  Z Phytother. 1992;  13 7-13
  • 38 Schoop R, Klein P, Suter A, Johnston SL. Echinacea in the prevention of induced rhinovirus colds: a meta-analysis.  Clin Ther. 2006;  28 174-183
  • 39 Summers A. Sore throats.  Accid Emerg Nurs. 2005;  13 15-17
  • 40 Thomas M, Del Mar C, Glasziou P. How effective are treatments other than antibiotics for acute sore throat?.  Br J Gen Pract. 2000;  50 817-820
  • 41 Goossens H. Antibiotic consumption and link to resistance.  Clin Microbiol Infect. 2009;  15 (Suppl. 3) 12-15
  • 42 McIsaac WJ, White D, Tannenbaum D, Low DE. A clinical score to reduce unnecessary antibiotic use in patients with sore throat.  CMAJ. 1998;  158 75-83
  • 43 Moore N, Le Parc JM, Ganse van E, et al.. Tolerability of ibuprofen, aspirin and paracetamol for the treatment of cold and flu symptoms and sore throat pain.  Int J Clin Pract. 2002;  56 732-734
  • 44 Hamre HJ, Fischer M, Heger M, et al. Anthroposophic vs. conventional therapy of acute respiratory and ear infections: a prospective outcomes study.  Wien Klin Wochenschr. 2005;  117 256-268
  • 45 Barnes P, Powell-Griner E, McFann K, Nahin R. Complementary and alternative medicine use among adults. United States; CDC Advance Data Report #343 2004

PD Dr. med. Dr. h.c. Andreas Schapowal

Facharzt für Hals-Nasen-Ohren-Heilkunde

Hochwangstr. 3

CH-7302 Landquart

Schweiz

Email: andreas@schapowal.ch

Daniel BergerDr. pharm. 

CH-3054 Schüpfen

Schweiz

Peter KleinDipl.-Mathematiker 

d.s.h. statistical services GmbH

85296 Rohrbach

Deutschland

Andy Suter

Leiter Abt. Medizin

A. Vogel Bioforce AG

CH-9325 Roggwil

Schweiz

Email: a.suter@bioforce.ch

    >