[Traditional Chinese Pharmacotherapy in Patients with Chronic Rhinosinusitis - an Observational Trial Considering the Origin of Medicinal Drugs].

BACKGROUND:The use of Chinese medicinal drugs is becoming more common in Germany. However, the import from China results in aggravated quality controls and potentially jeopardized therapeutic safety. Therefore, in 1999 the Bavarian Department for Agriculture has initiated an interdisciplinary research project to cultivate and analyze important Chinese herbal plants. Currently 16 Bavarian-produced Chinese drugs are in use and distributed to patients by pharmacies. Despite a comparable quality of Bavarian pharmaceutical products, there are concerns remaining as the Bavarian medical drugs have been used for treatment purposes on patients since 2006, without their effect having been compared to the Chinese products. Therefore we performed an observational trial using a parallel group design on patients with chronic rhinosinusitis. METHODS:The duration of the trial was 4 weeks. After a 4-week follow-up, the patients were interviewed via telephone. During the trial the patients were given 2 × 50 ml of a decoction of Chinese medicinal herbs, either (a) from Bavarian controlled cultivation (Bavaria group) or (b) from Chinese production (China group). The therapeutic success was evaluated using numerical rating scales. RESULTS:In total, 64 patients completed the observational trial (31 Bavaria group, 33 China group). Both groups showed significant improvements in the main symptom scores of chronic rhinosinusitis as well as in secondary symptoms, such as the overall state of health or the tendency to catch a cold. There were no significant differences between the groups concerning the main symptoms scores. Overall the herbal decoctions had no severe side effects. CONCLUSION:This observational trial shows that Chinese herbal drugs from Bavarian cultivation are as effective as medicinal herbs imported from China, but the effects of concomitant therapies must be considered as well. The symptom score improvements during the treatment period were obvious and should stimulate further investigation on the efficacy of this herbal formula in the treatment of chronic rhinosinusitis.