ABSTRACT
1) Faculty Therapy No. 2, National Medical University, Kiev, Ukraine
2) University of New Mexico Medical School, Santa Fe, New Mexico
3) Department of Clinical Research, Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany,
4) Loacker Remedia, Prato all’Isarco (BZ)
The proprietary extract EPs is produced from the root of the South African wild geranium Pelargonium sidoides (Geraniaceae). The results of two randomized, double blind, placebo-controlled, multicenter clinical studies are reported to demonstrate the efficacy and safety of the herbal medicine EPs in the treatment of the common cold in adult patients. The aim of the studies were to evaluate the efficacy of a liquid herbal drug preparation from the roots of Pelargonium sidoides compared with placebo in adult patients with the common cold. The two multi-center, prospective, randomized, double-blind placebo-controlled clinical trials investigated the change of the Sum of Symptom Intensity Differences (SSID) of the Cold Intensity Score (CIS) under EPs treatment versus placebo. A significant improvement of the SSID was found for EPs in contrast to placebo. First study (Explore 2007; 3:573-584) took place in eight outpatient departments affiliated with hospitals. One hundred three male and female adult patients with at least two major and one minor or with one major and three minor cold symptoms (maximum symptom score of 40 points), present for 24 to 48 hours were randomized to receive either 30 drops (1.5 mL) of the liquid herbal drug preparation EPs or placebo three times a day. Patients received randomized treatment for a maximum period of 10 days. The primary outcome criterion was the sum of symptom intensity differences (SSID) of the cold intensity score (CIS) from day one to day five. The CIS consists of the following 10 cold symptoms: nasal drainage, sore throat, nasal congestion, sneezing, scratchy throat, hoarseness, cough, headache, muscle aches, and fever. Results: From baseline to day five, the mean SSID improved by 14.6 ± 5.3 points in the EPs group compared with 7.6 ± 7.5 points in the placebo group. This difference was statistically significant (P ≤ .0001). The mean CIS decreased by 10.4 ± 3.0 points and 5.6 ± 4.3 points in EPs and placebo-treated patients, respectively. After 10 days, 78.8% versus 31.4% in the EPs versus placebo group were clinically cured (CIS equals zero points or complete resolution of all but a maximum of one cold symptom; P ≤ .0001). The mean duration of inability to work was significantly lower in the EPs treatment group (6.9±1.8 days) than in the placebo group (8.2 ± 2.1 days; P ≤.0003). Treatment outcome (rates of complete recovery or major improvement from disease) was assessed better in the EPs treatment group than in the placebo group by both the investigator and the patient on day five (P ≤ .0001). Adverse events occurred in three of 103 patients (2.9%), with two of 52 (3.8%) and one of 51 (2.0%) patients in the EPs and placebo group, respectively. All adverse events were assessed as nonserious. At the end of treatment, all patients (100%) in the active treatment group judged the subjective tolerability of EPs as good or very good. Conclusions: EPs represents an effective treatment of the common cold. It significantly reduces the severity of symptoms and shortens the duration of the common cold compared with placebo. The herbal drug is well tolerated.