Efficacy and safety of a combination herbal medicinal product containing Tropaeoli majoris herba and Armoraciae rusticanae radix for the prophylactic treatment of patients with respiratory tract diseases: a randomised, prospective, double-blind, placebo-controlled phase III trial.

OBJECTIVE: The aim of this ICH-GCP study was to investigate the efficacy and safety of a prophylactic administration of a combination herbal medicinal product (CHMP) in two dosages compared to placebo with respect to the incidence of new occurring infections of the respiratory tract (RTI). Clinical experience of prophylactic treatment of respiratory tract infections with the marketed CHMP containing horseradish root (Armoraciae rusticanae radix) and nasturtium (Tropaeoli majoris herba) has existed for decades. METHODS: The study was performed as a phase III, multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel-group trial. All groups received two film coated tablets three times a day. Group 1 received the CHMP tablets 3 × 2 per day, group 2 the CHMP tablets 2 × 2 and placebo tablets 2 × 1 per day and group 3 received placebo tablets 3 × 2 per day. Maximum duration of treatment was 84 days. The primary efficacy criterion was the comparison of the incidences of new occurring RTIs between the treatment groups during the prophylactic treatment. In addition the character of occurring infections, number of sick days and severity of infections were compared. Further criteria were subjects' well being, the satisfaction of subjects with the respective treatments and severity and incidence of the observed adverse events (AE) and serious adverse events (SAE) during the study period. TRIAL REGISTRATION: EudraCT No. 2010-023227-26. RESULTS: From 371 subjects screened, a total of 351 subjects of both sexes from 18 to 75 years were randomly allocated to one of the three groups. In order to achieve scientifically and medically impeccable results it was necessary to address acute infections of the respiratory tract occurring during the normal incubation period. Early infections (≤day 7) were excluded from the data set in a sensitivity analysis. In the intention to treat (ITT) population excluding early infections ≤day 7 (n = 344) the infection rates were 13.3% for CHMP 3 × 2 (n = 113), 18.4% for CHMP 2 × 2 (n = 114) and 25.6% for placebo (n = 117). The statistical trend test showed significant results (p = 0.0171). For the per protocol (PP) population - also excluding infections ≤day 7 (n = 334) - infection rates were: CHMP 3 × 2 (n = 110) 12.7%, CHMP 2 × 2 (n = 113) 18.6% and placebo (n = 111) 24.3% (p = 0.0266). Secondary parameters of infections (infection diagnosis, intensity, duration) showed no relevant differences between the treatment groups. The study medication was well tolerated. LIMITATIONS: This was the first clinical ICH-GCP study with the CHMP conducted in this indication and with a sufficient number of subjects. The study population comprised subjects from 18 to 75 years and covered different diagnoses of RTIs. The results show a benefit when using 3 × 2 film tablets of CHMP for prophylaxis of RTIs. However, no data are available on use of the CHMP in this indication in children, adolescents and the elderly (over 75 years). CONCLUSION: This trial demonstrates the efficacy and safety of the combination herbal medicinal product as the treatment of first choice in the prophylactic treatment of episodes of respiratory tract infections. Clinical experience was confirmed in an ICH-GCP study.

Efficacy and tolerability of a Rhodiola rosea extract in adults with physical and cognitive deficiencies.

During a 12-wk drug monitoring study, the efficacy and safety of a Rhodiola rosea extract given in combination with vitamins and minerals (vigodana(R)) were tested in 120 adults (83 women and 37 men, ages 50-89 y) with physical and cognitive deficiencies. Two different dosage regimens were chosen. One group of 60 patients (group 1) took 2 capsules orally in the morning after breakfast, and the other group (group 2) took 1 capsule after breakfast and 1 after lunch. Three medical examinations were performed during the course of the study (at baseline, after 6 wk, and after 12 wk). The evaluated symptoms were divided into physical disturbances such as exhaustion, decreased motivation, daytime sleepiness, decreased libido, sleep disturbances, and cognitive complaints (eg, concentration deficiencies, forgetfulness, decreased memory, susceptibility to stress, irritability). A statistically highly significant improvement (P<.001) in physical and cognitive deficiencies was observed in the overall group, as well as in the separately evaluated groups 1 and 2. In addition, the time needed to complete a digit connection test decreased significantly in all groups (P<.001). Improvements in group 1 were more pronounced than in group 2, however, indicating that the intake of 2 capsules after breakfast is more effective than the intake of 1 capsule after breakfast and 1 after lunch. Global assessment of efficacy revealed that treatment was "very good" or "good" for 81% of patients, as reported by physicians, and for 80%, as reported by patients. Ninety-nine percent of patients and physicians rated safety as "good" or "very good." No adverse events occurred during the course of the study. The results of this drug monitoring study are very promising, but they still need to be corroborated by future placebo-controlled clinical trials.