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May 2024

Kombinationspräparate in der Phytotherapie

Journal/Book: Ärztezeitschrift für Naturheilverfahren. 1990; 31/2: 88/93.

Abstract: For purposeful (!) fixed combinations the "pro arguments" are prevailing in case of phytopharmaceuticals and the application of such drugs may be called a rational therapeutical measure. The criteria as determined by the Commision E are suited for the critical evaluation whether a combination is purposeful or nonsensical or non-scientific, respectively. These criteria are a scientifically justifiable compromise. On the part of the manufacturers of phytopharmaceuticals these criteria are deemed to be too strictand, on the other hand, oon the part of pharmacologists and clinicians without phytotherapeutical experiencethey are considered to be inadequate and non-scientific. In comparing the pro and contra argumentsit is obvious that the recommending arguments primarily result form the medical experience whereas the nature of the declining arguments is more or less theoretical and that such arguments is more or less theoretical and that such arguments are by no means proved experimentally or clinically. For the benefit of the patients the realizable and understandablemedical experience should/ must rank prior to theory! The eligibility of a fixed phyto-combination to be repaid for cannot be considered to depend on the number of combination partners which are determined by legislature "at the desk" (-six combination partners for phyto-pharmaceuticals are suggested in the draught of the negative list -). The following fundamental rules should rather apply to the assessment: 1. Unobjectionableness of the combination (this is in many cases more or less known through many years´ prescription). 2, The combination must be easy to oversee ( a combination with 8 or even 10 partners can by all means still be overlooked). 3. Consideration of galenic incmpatibilities. 4. No synthetic but also no homoeopathic combination partners are allowed to be presented in phyto-pharmaceuticals; any isolated pure natural substance (e.g. beta-aescin) not being considered "different in kind" or even a synthetic substance, respectively. The number of cumbination partners is anyway limiting itself by the analytical requirements pertaining to a drug according to §§ 22 (2) as well as § 10 (1), 8 of the Acto on Drugs of the 24th of August, 1976. The preceding general fundamental considerations are explained in detail on the basis of cuncrete cases as examples.


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