- Efficacy and safety of Herbion ivy surup in patients with cough in acute bronchitis
Efficacy and safety of Herbion ivy surup in patients with cough in acute bronchitis
Uranic Natasa, Barbic–Zagar Breda
The purpose of the study was to compare the efficacy and safety of Herbion ivy syrup with a product having a similar composition in patients with cough in acute bronchitis.
Materials and methods: 126 patients were included in the randomized, open, parallel, comparative, multicentre study. 63 patients were randomized to receive the reference product, another 63 patients used Herbion ivy syrup. Both products were taken orally for 7 days in accordance with the established dosage regimen every day — 5 ml of syrup three times a day. Efficacy and safety appraisal was performed after 7 days of therapy. In addition, on the 4th and 14th day of therapy (one week after the end of therapy), a safety and tolerability assessment was performed.
Results: Cough relief was observed in 98.4% of patients taking Herbion and in 96.8% of patients taking the reference product. There was no statistically significant intergroup difference (Fisher's exact test, p=1.00, lower limit of 95% confidence interval, 3.8%). The total disappearance of cough was noted in 16.1% of patients in Herbion group and 11.1% in the reference group. Both products significantly (p<0.001) lowered the frequency and severity of cough compared to baseline. The point estimates of the mean change in the frequency of cough when taking Herbion ivy syrup and the reference product were 2.03 and 1.86, respectively; the point estimates of the severity of cough with the intake of Herbion syrup ivy and the reference product were -43.6 mm and -42.9 mm, respectively. There was no statistically significant difference between the two groups. Both products had the good tolerability. Adverse reactions were observed in 1.6% of patients in the group receiving the reference products and 3.2% in Herbion group. The difference was not statistically significant.
Conclusions: Herbion ivy syrup has demonstrated the same efficacy and safety in the treatment of cough in patients with acute bronchitis as the reference product.
Key words: acute bronchitis, productive cough, expectorant, ivy syrup, Hedera helix.
1. Landgrebe H, Matusch R, Runkel F, Hecker M. (1999). Effectiveness and use of an old medicinal plant. Pharmazeutische Zeitung. 35: 11—5.
2. EMA: Committee on herbal medicinal products (HMPC) Community herbal monograph on Hedera helix l. folium, internet. European Medicines Agency, London, 2011. cited 2012 Nov 22. Available from: http://www.ema.europa.eu/ema/
3. Buechi S. Ivy (2002). Schweiz Apoth Ztgю 140(20): 700—1.
4. Runkel F, Prenner L, Haberlein H. (2005). In vitro studies: contribution about the mechanism of effects of ivy. Pharm Ztg. 150(4): 1—6.
5. ESCOP Monographs. (2003). 2th edition: 241—7.
6. Hecker M. (1999). Efficacy and tolerance of ivy extract in patients suffering from respiratory tract diseases. Naturamed. 14: 28—33.
7. Fazio S, Pouso J, Dolinsky D, Fernandez A, Hernandez M, Clavier G et al. (2009). Tolerance, safety and efficacy of Hedera helix extract in inflammatory bronchial diseases under clinical practice conditions: a prospective, open, multicentre postmarketing study in 9657 patients. Phytomedicine. 16: 17—24. https://doi.org/10.1016/j.phymed.2006.05.003; https://doi.org/10.1016/j.phymed.2008.06.004; PMid:16860549
8. Beden AB, Perko J, Tercelj R, Kreft S. (2011). Potek zdravljenja akutne okuzbe dihal pri slovenskih otrocih s sirupom, ki vsebuje izvlcek listov brsljana. Zdrav Vestn. 80: 276—84.