Hummelsberger Josef, Friedl Fritz, Gaus Wilhelm, Kohnen Ralph, Heuberger Heidi, Seidenberger Rebecca, Aidelsburger Pamela, Bauer Rudolf, Heubl Günther
Societas Medicinae Sinensis, Mx00FC;nchen, Deutschland.
Forsch Komplementmed. 2015;22(5):312-9. doi: 10.1159/000440658. Epub 2015 Sep 11.
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.
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.
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.
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.
中药在德国的使用日益普遍。然而,从中国进口导致质量控制更加严格,治疗安全性也可能受到威胁。因此,1999年巴伐利亚州农业部启动了一个跨学科研究项目,旨在种植和分析重要的中草药。目前,有16种巴伐利亚生产的中药可供使用,并由药店分发给患者。尽管巴伐利亚州的药品质量相当,但仍有人担心,因为自2006年以来,巴伐利亚州的药品已用于患者的治疗目的,但其效果尚未与中国产品进行比较。因此,我们对慢性鼻窦炎患者进行了一项采用平行组设计的观察性试验。
试验为期4周。在4周的随访期后,通过电话对患者进行访谈。在试验期间,患者服用2×50毫升的中药汤剂,要么(a)来自巴伐利亚州的受控种植(巴伐利亚组),要么(b)来自中国生产(中国组)。使用数字评分量表评估治疗效果。
共有64名患者完成了观察性试验(巴伐利亚组31名,中国组33名)。两组在慢性鼻窦炎的主要症状评分以及次要症状(如整体健康状况或感冒倾向)方面均有显著改善。两组在主要症状评分方面没有显著差异。总体而言,中药汤剂没有严重的副作用。
这项观察性试验表明,巴伐利亚州种植的中草药与从中国进口的草药效果相同,但同时也必须考虑伴随疗法的效果。治疗期间症状评分的改善很明显,应该促使对这种草药配方治疗慢性鼻窦炎的疗效进行进一步研究。