Efficacy and tolerability of myrtol standardized in long-term treatment ofchronic bronchitis - A double-blind, placebo-controlled study

This multicenter, placebo-controlled, double-blind, randomized parallel-gro up trial was conducted to investigate the efficacy and tolerability of myrt ol standardized (Mk'S, Gelomyrtol(R) forte, 3 x 300 mg) in the long-term tr eatment of patients with chronic bronchitis during the winter. 246 patients received the investigational treatments (MYS: 122, placebo: 124) for at le ast 1 month; 215 subjects (110 under MYS and 105 under placebo) were evalua ble in terms of efficacy (exacerbation rate, the need for antibiotics, symp tom scores and general well-being) for the protocol-defined 6 months of tre atment. Statistically significantly (p < 0.01) more patients remained without acute exacerbation in the myrtol standardized group (72%) compared to the placeb o group (53%). In the placebo group, there was an evident peak in the incid ence of exacerbations during the third month of treatment, which was not ob served in the active treatment group. In the MYS group, 51.6% of the patien ts with an acute exacerbation required antibiotics vs. 61.2% under placebo. 62.5% of the patients treated with anitbiotics in the MYS group required t hem for less than or equal to 7 days, whereas 76.7% of the patients in the placebo group treated with antibiotics for exacerbation needed antibiotics for >7 days. Well-being (assessed in terms of general health and health imp airment by cough and expectoration) was significantly better under treatmen t with MYS. The overall therapeutic efficacy evaluation scored higher for M YS. Therefore, it is concluded that long-term treatment with MYS is equally wel l tolerated as placebo but is clearly superior in efficacy in terms of prot ecting against acute exacerbations in patients with chronic bronchitis: it reduces the frequency and intensity of acute exacerbations, the need of ant ibiotics for them and the health impairment by cough and expectoration.