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Fixed herbal drug combination with and without butterbur (Ze 185) for the treatment of patients with somatoform disorders: Randomized, placebo-controlled pharmaco-clinical trial

Fixed herbal drug combination with and without butterbur (Ze 185) for the treatment of patients with somatoform disorders: Randomized, placebo-controlled pharmaco-clinical trial

ARTICLE IN PRESS 216 Abstracts / European Journal of Integrative Medicine 1 (2009) 181–221 OP-021 Professional development in complementary medicine...

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ARTICLE IN PRESS 216

Abstracts / European Journal of Integrative Medicine 1 (2009) 181–221

OP-021 Professional development in complementary medicine/ homeopathy

cooperation with the central Society of Homeopathy and Otto-von-Guericke-University, Magdeburg. 10.1016/j.eujim.2009.08.140

K. Werwick, M. Reed, M. Herrmann Institut fu¨r Allgemeinmedizin, Medizinische Fakulta¨t, Magdeburg, Germany

Introduction: Because of growing patient demand for complementary medical services as well as new ways of financing these from statutory health insurance, specialist doctors, especially in general practice, are finding they need to acquire additional qualifications in, amongst other things, homeopathy. We investigated how doctors arrange their professional development in these areas and also we undertook a survey amongst medical students of their needs and interest in learning complementary medicine. Methods: The questionnaire examined how and when the teaching of complementary medicine should take place in the course of medical studies from the perspective of both students and doctors. We looked at biographical influences, as well as prior knowledge and expectations of students and doctors about complementary medicine. To process it we used a multi-method approach that combined quantitative methods of data ascertainment (standardized questionnaires) as well as qualitative methods (narrative interviews). Using these we questioned students and doctors about how they choose to further develop their understanding of complementary medicine. Results: Both quantitative and qualitative analysis showed that students – no matter what age, sex or prior knowledge – would like more diversified teaching in the area of complementary medicine. They consider this to be integral to a holistic view of the patient. It became clear through the statistical analysis of their needs and interests that the greater their experience with complementary medicine, the greater was their holistic appreciation of their patients. This was also correlated with greater self-reflective behaviour. It seems that attention to complementary medicine before and after studying helps to foster a professional understanding of this field that is additional to the traditional medical studies. Discussion: Through this optional teaching in the area of complementary medicine, interested students may receive the opportunity of early exposure, which may facilitate their further education in complementary medicine. Conclusion: Homeopathy should be included as an optional addition to medical studies. The evaluation results assisted us in the conception of two clinical elective subjects: homeopathy and TCIM. Furthermore we are in the process of developing of a master’s degree course in the integrated practice of homeopathy, in

OP-022 Fixed herbal drug combination with and without butterbur (Ze 185) for the treatment of patients with somatoform disorders: Randomized, placebo-controlled pharmaco-clinical trial J. Melzera,b, E. Schraderc, A. Brattstro¨md, R. Schellenberge, R. Sallera a

Institute of Complementary Medicine, Zurich, Switzerland b Clienia Schloessli, Clinic for Psychiatry and Psychotherapy, Oetwil at Lake, Switzerland c Clinical Drug Research, Pohlheim, Germany d Max Zeller Sons Inc., Romanshorn, Switzerland e Clinical Physiology, Huettenberg, Germany Herbals drugs – single or in combination – are often used in patients with somatoform disorders, yet the available evidence is limited. Aim of the present short-term study was to evaluate in a pharmaco-clinical trial the additional benefit of butterbur in a fixed herbal drug combination (Ze 185 ¼ 4-combination versus 3-combination without butterbur versus placebo) in patients with somatoform disorders. A total of 182 patients were randomized for a 3-arm trial (butterbur root, valerian root, passionflower herb, lemon balm leaf versus valerian root, passionflower herb, lemon balm leaf versus placebo) for a 2-week treatment in patients with somatisation disorder (F45.0) and undifferentiated somatoform disorder (F45.1). Anxiety (visual analogue scale—VAS) and depression (Beck’s Depression Inventory—BDI) served as primary parameters, Clinical Global Impression (CGI) was a secondary parameter. The 4-combination was significantly superior to the 3combination and placebo (4 combination 43 combination 4placebo) in all the primary and secondary parameters (PP-population). Analysis of the ITT population confirmed these results. As to safety no serious adverse events (AE) occurred. In total 9 non-serious AE were documented but the distribution did not differ significantly between the treatment groups. Butterbur had an additional benefit on the short-term treatment in patients with somatoform disorders. Thus the herbal 4-combination (Ze185) showed to be efficacious and safe. 10.1016/j.eujim.2009.08.138