Myrtol

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Myrtol is a registered word mark for a herbal medicinal product with a mixed distillate of rectified eucalyptus oil , rectified sweet orange oil, rectified myrtle oil and rectified lemon oil (ratio 66: 32: 1: 1), which, according to the manufacturer, contains no less than 25 percent lime , 25 percent cineole and contains 6.7 percent (+) - α- pinene . This mixture of substances has a density of 0.895 g / cm 3 . It has an expectorant effect and promotes expectoration and is therefore used in acute and chronic bronchitis as well as in sinusitis .

Indication and type of application

Soft gelatin capsules with myrtol

Myrtol is used to dissolve mucus and make it easier to cough up in acute and chronic bronchitis and to dissolve mucus in inflammation of the paranasal sinuses (sinusitis). Myrtol is in the form of enteric soft gelatin capsules administered to the Myrtol if correctly used only in the small intestine to release.

Scientific data

About 100 preclinical studies on pharmacodynamics, pharmacokinetics and toxicity as well as 27 clinical studies with about 6200 patients exist for Myrtol. Myrtol is considered to be the essential oil-based drug whose effectiveness has been best demonstrated by modern clinical studies.

Effects / pharmacodynamics

The following effects are attributed to Myrtol:

  • Mucolytic (expectorant) effect: In vitro sputum samples from patients with bronchial asthma , chronic bronchitis and cystic fibrosis were examined in a study. After adding Myrtol, the viscoelasticity of the mucus decreased by about 10 to 16%. These values ​​are comparable to the effects of N - acetylcysteine .
  • secretomotor effect (increasing ciliary beat frequency): The cilia ( cilia ) of certain mucosal cells make with their wavy coordinated movements for the removal of mucus. The beat frequency of these cilia is accelerated by Myrtol, so that the transit time of the mucus is shortened. In one study, for example, the ciliary beat frequency of mucosal tissue samples was recorded with a microscope and a connected high-speed camera. Myrtol significantly increased the ciliary beat frequency at doses equivalent to the usual human dose. Myrtol tended to be more effective than N -acetylcysteine. In another study, the frequency of ciliary beats under Myrtol was increased by a factor of 2 compared to a dummy preparation ( placebo ) and the transit time of the mucus was shortened by more than 5 minutes.
  • Secretolytic (mucus-thickening) effect: In mice it has been found that an increasing mucus-thinning effect occurs with increasing Myrtol dose. In a direct comparison with untreated animals, the secretolytic effect with Myrtol was increased by 32% and by 21% when treated with a pure eucalyptus oil preparation.
  • Increase in mucociliary clearance : Due to the mentioned mucolytic, secretolytic and secretomotor effects, the natural cleaning mechanism of the mucous membranes is supported, i.e. H. Mucus and inhaled particles are increasingly removed (technical language: Mucociliary-Clearance-Enhancer, MCC). This effect may prevent the formation of bacterial biofilms . It is believed that such biofilms can cause chronic sinus infections. Biofilms protect the pathogenic bacteria from the body's own defenses and from antibiotics and form a permanent bacterial reservoir. The effect of increased mucociliary clearance has been proven experimentally and in humans several times.
  • Antioxidant effects: Antioxidants are compounds that protect substances from unwanted oxidation and thus from the formation of potentially harmful free radicals . Natural antioxidants are mainly found in plants. The antioxidant effects of Myrtol have been tested in various systems. Myrtol in the SIN system (3-morpholinosydnonimine) inhibits the formation of ethylene by more than half. This was confirmed by the Fenton reaction with inhibition of ethylene formation by 82%. Myrtol interacts with aggressive oxygen species and thus weakens the oxidative attack by infectious agents or environmental factors. This property could be responsible for preventing tissue damage, such as that which occurs after a bacterial infection with Pseudomonas aeruginosa .
  • Anti- inflammatory effects: Inflammation of the respiratory tract, as in acute and chronic bronchitis or bronchial asthma , is caused by various inflammatory cells and messenger substances ( inflammation mediators ). In experiments, Myrtol has led to a reduced production of inflammatory mediators in inflammatory cells. Myrtol inhibits, among other things, 5-lipoxygenase, a key enzyme in the inflammation cascade.
  • bronchospasmolytic effect: Myrtol has an antispasmodic effect on the smooth muscles of the bronchi ( spasmolytic ). In experiments with standardized myrtol , histamine- induced bronchospasm could be prevented in a dose-dependent manner.
  • Antimicrobial effect: Under experimental conditions, Myrtol inhibited various types of bacteria, such as pneumococci and Haemophilus influenzae, depending on the dose used. These are considered to be the most important bacteria in acute bronchitis and in the acute flare-up of chronic bronchitis. Even if in principle most acute infections of the upper and lower respiratory tract aretriggeredby viruses ,bacterial colonization can occurin the further course of a respiratory tract infection, especially with impaired mucociliary clearance.

In summary, the mixed herbal distillate Myrtol can be described as a primarily expectorant herbal medicinal product with several additional effects. The various aspects of action for strengthening mucociliary clearance and the antioxidant effects (radical scavengers) should be emphasized. Accordingly, the herbal medicinal product is primarily used for respiratory diseases such as acute and chronic sinusitis and acute and chronic bronchitis.

Clinical studies

Myrtol has been used for decades and has been tested in clinical studies. Randomized, double-blind, placebo-controlled multicenter studies were carried out according to the international GCP ( Good Clinical Practice ) standard with the aim of demonstrating the effectiveness and tolerability according to the principles of evidence-based medicine . These clinical studies were supplemented by observational and non-interventional studies .

Acute sinusitis

In a study, Myrtol and an essential oil were administered to a total of 331 adults with acute sinus infections (acute sinusitis) for about a week and compared with a dummy drug (placebo). In order to rule out bias, neither investigators nor patients knew what kind of preparation was administered in each individual case ( double blinding ) and the allocation to the three groups was carried out at random ( randomization ). The comparison of the total symptom scores of the study participants showed a statistically significant superiority of the myrtol and the essential oil compared to the patients treated with placebo, i.e. the patients recovered faster, especially with regard to the core symptoms of headache, pain when stooping and tenderness over certain nerve exit points in the face . Antibiotic treatments were less necessary in the Myrtol group after this therapy phase than in the placebo group (23% versus 40%).

Chronic sinusitis

In a study based on the international GCP standard (see above), 48 adults with chronic sinusitis (chronic sinusitis) had taken either Myrtol three times a day or a dummy preparation (placebo) for a total of three months. Computed tomography (CT) scans of the paranasal sinuses were performed for all participants , which confirmed the diagnosis and documented the course of the disease, in particular with the help of a CT score. Before starting treatment, this score averaged about 9 points in both groups. After the end of treatment, this point value was unchanged in the placebo group (no treatment effect). In the study group treated with Myrtol, however, the value fell by a statistically significant 41% (improvement). Approx. 90% of the participating patients as well as the doctors certified that Myrtol was tolerated well to very well.

Acute bronchitis

In an acute bronchitis study, Myrtol was compared with two antibiotics and a dummy drug (placebo) for a period of 14 days. The total of 676 participants in the study were randomly divided into the treatment groups (randomization); neither investigators nor patients knew what they were being treated with (double blinding). After two weeks, Myrtol proved to be just as tolerable as placebo, but the effect of Myrtol was statistically significantly superior. The treatment effect of Myrtol was on the whole comparable to that of antibiotic treatment, with several parameters showing a slight superiority over the antibiotics. However, since acute bronchitis is mainly caused by viruses, the usefulness of antibiotic therapy for this disease is in question.

The cough, which is often excruciating for bronchitis patients, is also quickly and significantly relieved with Myrtol; there are fewer nocturnal sleep disorders compared to a sham treatment, according to the result of a randomized and double-blind study with 413 participants. With regard to adverse events, there was no difference between the placebo and Myrtol groups.

Chronic bronchitis

In the long-term treatment of chronic bronchitis, Myrtol is just as well tolerated as a placebo, but superior in effectiveness: The intensity and frequency of acute exacerbations of chronic bronchitis are statistically significantly and significantly reduced with Myrtol, as is the need for antibiotics. In a study with 246 patients with chronic bronchitis, the quality of life, assessed according to their general condition and the impairment caused by cough and sputum, was significantly improved after six months of therapy in the winter time. The treatment resulted in an exacerbation peak typical of the placebo group for the time of year between the 2nd and 4th month of treatment (mostly December to February) in the Myrtol group. The quality of this study has been assessed by the Cochrane Airways Group with 4 out of 5 possible points.

In summary, Myrtol has recognized proven efficacy in both acute and chronic infections of the upper and lower respiratory tract.

Guideline recommendations

Based on the scientific literature, several medical societies recommend the use of Myrtol for both sinusitis and chronic bronchitis.

Finished medicinal products

GeloMyrtol ( AT , DE ) / 300 mg (AT) / -forte (DE), GeloDurat (CH).

Side effects

Occasional side effects of Myrtol are gastrointestinal complaints, rarely nausea , vomiting or diarrhea may occur. In rare cases, hypersensitivity reactions can also occur.

literature

  • Volker Schulz, Rudolf Hänsel, Mark Blumenthal, VE Tyler: Rational Phytotherapy . 5th ed., Springer, 2004, ISBN 978-3-540-40832-1 , pp. 207-208; 5th German edition, 2004, ISBN 3-540-00983-3 , pp. 222-223.
  • Thomas Wittig: Myrtol standardized - a clinical documentation . 4th edition, 2005, Results-Verlag, ISBN 9783879160679

Individual evidence

  1. ↑ Register information from the German Patent and Trademark Office (DPMA)
  2. ^ GWA Milne: Drugs: Definitions & Properties , Ashgate Publ Co., Brookfield, Vt, 2000, p. 1280.
  3. ^ V. Schulz, R. Hansel: Rationale Phytotherapie 5th ed. 2004, p. 222.
  4. ↑ EM App: Importance of mucus clearance for the bronchial system - pathophysiology and therapeutic approaches. R. Meister (Ed.): Inflammatory diseases of the bronchial system, Springer Verlag, pages 27 - 53 in T. Wittig: Myrtol standardized - a clinical documentation. Results-Verlag (2010) 5: 25.
  5. ↑ F. Begrow et al .: Effect of Myrtol standardized and other substances on respiratory tract: ciliary beat frequency and mucociliary clearance as parameters . In: Adv Ther (2012) 29 (4): 350-358.
  6. ↑ a b R.P. Kwok: The effects of Gelomyrtol forte® on human ciliary beat frequency and intracellular cyclic adenosine monophosphate in vitro. Dissertation for the degree of Master of Research in Medicine. Division of Respiratory Medicine, Department of Medicine, Queen Mary Hospital, Hong Kong, 2007.
  7. ↑ H. Lenders: Pharmacodynamic detection methods for the effect of essential oils on the upper respiratory tract. In: K. Mees: The unspecific rhino-sinusitis. Springer-Verlag Berlin Heidelberg 1996, pp. 40-51.
  8. ↑ a b F. Begrow et al .: Effect of Myrtol standardized and other substances on respiratory tract: ciliary beat frequency and mucociliary clearance as parameters. Adv Ther (2012) 29 (4): 350-358.
  9. ↑ H. Lenders et al., Suitability of various methods as pharmacodynamic models for the investigation of the efficacy of mucolytic agents on the maxillary sinus, Naunyn-Schmiederberg's Arch. Pharmacol. (1996) 353 (Suppl.) R151 in T. Wittig: Myrtol standardized - a clinical documentation. Results-Verlag (2010) 5: 26.
  10. ↑ F. Beuscher et al .: Myrtol standardized in treatment of sinusitis and bronchitis - Pharmacodynamics and pharmacokinetics, Journal for Phytotherapy , abstract volume , Congress of the Society for Phytotherapy (1997) pages 9-10 .
  11. ↑ a b c d e f T. Wittig: Myrtol standardized - a clinical documentation. Results-Verlag (2010) 5: 23.
  12. ↑ WJ Fokkens et al .: European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinology Suppl 23: 2012: 60, 64-65,134.
  13. ↑ H. Behrbohm, O. Kaschke, K. Sydow: The influence of a secretolytic drug on mucociliary clearance of the maxillary sinus, J. Rhinol. (1997) 4 (1): 29-33.
  14. ↑ P. Dorow et al .: Influence of a secretolytic agent and a combination of pinene, limonene and cineole on mucociliary clearance in patients with chronic obstructive airways disease. Arzneimittel-Forsch / Drug Res. (1987) 37 (II) 12: 1378-1381.
  15. ↑ D. Han et al .: The effect of myrtol standardized on human nasal ciliary beat frequency and mucociliary transport time, Am J Rhinol Allergy (2009) 23: 610-614.
  16. ↑ a b c L. Cao et al .: Effect of Myrtol standardized on mucus hypersecretion and clearance of Pseudomonas aeruginosa in a rat model of chronic obstructive pulmonary disease. Medic.-Forsch / Drug Res (2011) 62 (12): 685-692.
  17. ^ J. Graßmann et al .: Antioxidant Properties of Essential Oils. Arzneimittel-Forsch./Drug Res (2000) 50 (1): 135-39.
  18. ↑ S. Hippeli et al .: Free radicals in the pathogenesis and therapy of inflammatory diseases of the bronchial system In: R. Meister: Inflammatory diseases of the bronchial system. Springer Verlag 1st edition (2000): 1-25.
  19. ↑ a b Rantzsch et al .: Anti-inflammatory effects of Myrtol standardized and other essential oils on alveolar macrophages from Chronic Obstructive Pulmonary Disease. Eur J Med Res (2009) 14 (Supp. IV): 205-209.
  20. ↑ a b N. Beuscher et al .: Interference of Myrtol Standardized with inflammatory and Allergic Mediators. Pharmaceutical Research (1998) 48 (I), 10, 985-989.
  21. ↑ F. Beuscher et al .: Myrtol standardized in treatment of sinusitis and bronchitis - Pharmacodynamics and pharmacokinetics, Journal for Phytotherapy, abstract volume, Congress of the Society for Phytotherapy (1997) pages 9-10.
  22. ^ Medicines Commission of the German Medical Association: Respiratory Infections. Medication prescription in practice. 3rd edition 2013.
  23. ↑ P. Federspil et al .: standardized effects of Myrtol in the treatment of acute sinusitis - results of a double-blind, randomized multicenter study against placebo. Laryngo-Rhino-Otol. (1997) 76: 23-27.
  24. ^ H. Matthys et al .: Efficacy and Tolerability of Myrtol Standardized in Acute Bronchitis. Medicinal Research / Drug Res. (2000) 50 (II), 8, 700-711.
  25. ↑ A. Gillissen et al .: A Multi-center, Randomised, Double-blind, Placebo-controlled Clinical Trial on the Efficacy and Tolerability of GeloMyrtol® forte in Acute Bronchitis. Drug Res. (2013) 63: 19-27.
  26. ↑ R. Meister et al .: Standardized effectiveness and tolerability of Myrtol in the long-term treatment of chronic bronchitis. Arzneimittel-Forsch./Drug Res. (1999) 49 (I) 4: 351-358.
  27. ^ P. Poole, PN Black, CJ Cates: Mucolytic agents for chronic bronchitis or chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Aug 15; 8: CD001287.
  28. ^ S2 rhinosinusitis guideline of the German Society for ENT Medicine, Head and Neck Surgery. AWMF Register No. 017/049, as of March 2011.
  29. ↑ Rhinosinusitis Guideline of Dt. Society for General Medicine and Family Medicine (DEGAM) AWMF Register No. 053/012.
  30. ↑ WJ Fokkens et al .: European Position Paper on Rhinosinusitis and Nasal Polyps. Rhinology (2012) 50, Suppl. 23.
  31. ↑ COPD guideline of Dt. Respiratory league. Pneumology (2002) 56: 704-738.
  32. ↑ Specialist information on GeloMyrtol ® forte, November 2007.