An overview of formal methodological requirements for controlled clinical trials

An overview of formal methodological requirements for controlled clinical trials

114 ified alternation as an alternative to stratified randomization is outlined; this could be of interest to researchers when designing controlled cl...

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114 ified alternation as an alternative to stratified randomization is outlined; this could be of interest to researchers when designing controlled clinical trials. The Berlin Journal on Research in Homceopathy 1991;1:129-31 The current edition of the Homint R & D Newsletter, unfortunately incorrectly numbered, comprises three contributions reprinted from elsewhere and a short correspondence on 'biased publication bias' by Kleijnen and Bol. Two items are worthy of brief mention. Treatment of pollinosis with the hom~eopathic preparation galphimia glauca M. W I E S N A U E R , W. GAUS, S. HAUSSLER The authors concluded from a 1990 placebo controlled double blind trial on 201 subjects that patients with hay fever syndrome who took the remedy Galphimia 2c showed a greater improvement than patients who took a placebo. Eye and nose symptoms were marked by a GP according to a four point scale. Surprisingly, however, no pollen counts are taken during the study to relate observed reactions to the strength of the stimulus. H o m l n t R & D Newsletter 1991;2(4) An experimental approach to the concept of hormesis and the hom~eopathic similia law R. VAN WIJK et al. Notice is given of a paper, presently in press, that will provide a molecular basis for understanding the effects of low doses of toxicants inreducing the adverse effects of a harmful stressor. The incomplete reference yields no clue as to when and where the final article will appear. H o m l n t R & D Newsletter 1991;2(4) Assessment of cytogenetic damage in X-irradiated mice, and its alteration by oral administration of a potentized hom~eopathic drug, Ginseng 30 A. R. K H U D A - B U K H S H and S. BANIK A paper from India reports on the effects of administering a hom~eopathic drug on cytogenetic damage induced by X-irradiated mice. Ginseng 200x was orally administered to batches of mice exposed at two intensities of radiation over three different durations of time; the results were assessed using methods based on protocols of chromosome aberration and micronuclei (MNT) testing. The authors report that the drug appeared to

British Homceopathic Journal

produce a 'spectacular protective action' when compared with controls, but they are unable to suggest a possible mechanism. It is concluded from this study, and from previous studies using 6x and 30x potencies, that Ginseng may be recommended as a potential drug for anti-radiation activity. The Berlin Journal on Research in Homaeopathy 1991;1:254~53 Alterations of cytogenic effects by oral administration of a hom~eopathic drug, Ruta graveolens, in mice exposed to sub-lethal X-irradiation A. R. K H U D A - B U K H S H and S. BANIK In a second, similar study, Ruta 30x and Ruta 200x were tested for possible radio-protective action. 'Sperm-head' abnormality and mitotic index studies were used in addition to chromosome aberration and MNT. The results demonstrate that Rata has good potential for being considered as a radio protective drug. The Berlin Journal on Research in Homveopathy 1991 ;1:264-74 Synergism of action between indolacetic acid (IAA) and highly diluted solutions of CaCO 3 on the growth of oat coleoptiles C. B O R N O R O N I Papers on agricultural aspects of hom~eopathy appear infrequently, and this contribution from Italy is very welcome. The work was conducted to assess the effect of Calc. carb. potencies on the growth of oat coleoptiles stimulated by 100 ~m of the growth hormone IAA. It is concluded that the specimens pretreated with Calc. carb 5x prior to the addition of I A A exhibited a statistically significant increase in growth as compared with the hormone alone. The drug had no effect on the growth of coleoptile segments when applied witout IAA, proving that its action was synergistic. A reduction in the growth effect resulted when it was heated to 60~ before application. The mechanism may have involved interaction between Ca ++ ions and IAA. The Berlin Journal on Research in Homwopathy 1991 ;1:275-78 An overview of formal methodological requirements for controlled clinical trials J. H O R N U N G In this paper the Editor lists the most important features in organizing, carrying out, evaluating and documenting a controlled clinical trial. The list is of a general nature, more suited to allo-

Volume 81, Number 2, April 1992 pathic testing. No mention is made of the special problems encountered when such standard methods are applied to hom~eopathic trials, and of the suspicion raised when variations were introduced. The Berlin Journal on Research in Hom~eopathy 1991;1:288-97 A critical appraisal of scientific arguments regarding basic research in hom~eopathy: a comprehensive examination of Francophone literature M. MAJERUS In his doctoral thesis Michael Majerus analyses French literature on basic research in hom~eopathy, and this critical review represents an English translation of the introductory chapter. The scope of the paper is limited to medicines with precisely defined chemical structures, e.g. Sulphur, Phosphorus, Argent. nit., Kali phos., and thus the great majority of hom~eopathic medicines are excluded. There are 149 references cited from French language publications, with a further 38 having German and English language origins, covering a period from 1926 to 1988. Sections include the concepts and history of homoeopathy, theoretical foundations, and research. The Berlin Journal on Research in Homeeopathy

115 1991 ;1:301-24 Research by the Central Council for Research in Hom~eopathy (CCRH) in India D.P. R A S T O G I Clinical research activities, including research in tribal areas, is being conducted in 51 facilities of the CCRH all over India, ranging from clinical verficiation and collection of medicinal plants, to drug research and standardization. Three units are for drug provings, and 29 drugs hve been proved. This interesting report outlines the work of the CCRH, and it is refreshing to read of the 'back to basics' type of clinical research being carried out to identify effective medicines for the treatment of 21 different diseases. The Berlin Journal on Research in Homveopathy 1991 ;1:349-55 The September/December issue of the Berlin Journal on Research in Homoepathy (Numbers 4/5) completes the first volume. It appears that the Journal has now exhausted its funds and unfortunately its future is in considerable doubt, no new sponsor having been found. The mix of papers was developing well and it would be a pity if publication were to cease now. We wish the Editor, Prof. Hornung, well in his quest for funds.