Conforti Anita, Bellavite Paolo, Bertani Simone, Chiarotti Flavia, Menniti-Ippolito Francesca, Raschetti Roberto
Department of Medicine-Public Health, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro, 33100 Verona, Italy.
BMC Complement Altern Med. 2007 Jan 17;7:1. doi: 10.1186/1472-6882-7-1.
One of the cardinal principles of homeopathy is the "law of similarities", according to which patients can be treated by administering substances which, when tested in healthy subjects, cause symptoms that are similar to those presented by the patients themselves. Over the last few years, there has been an increase in the number of pre-clinical (in vitro and animal) studies aimed at evaluating the pharmacological activity or efficacy of some homeopathic remedies under potentially reproducible conditions. However, in addition to some contradictory results, these studies have also highlighted a series of methodological difficulties.The present study was designed to explore the possibility to test in a controlled way the effects of homeopathic remedies on two known experimental models of acute inflammation in the rat. To this aim, the study considered six different remedies indicated by homeopathic practice for this type of symptom in two experimental edema models (carrageenan- and autologous blood-induced edema), using two treatment administration routes (sub-plantar injection and oral administration).
In a first phase, the different remedies were tested in the four experimental conditions, following a single-blind (measurement) procedure. In a second phase, some of the remedies (in the same and in different dilutions) were tested by oral administration in the carrageenan-induced edema, under double-blind (treatment administration and measurement) and fully randomized conditions. Seven-hundred-twenty male Sprague Dawley rats weighing 170-180 g were used. Six homeopathic remedies (Arnica montana D4, Apis mellifica D4, D30, Atropa belladonna D4, Hamamelis virginiana D4, Lachesis D6, D30, Phosphorus D6, D30), saline and indomethacin were tested. Edema was measured using a water-based plethysmometer, before and at different times after edema induction. Data were analyzed by ANOVA and Student t test.
In the first phase of experiments, some statistically significant effects of homeopathic remedies (Apis, Lachesis and Phosporus) were observed (the reduction in paw volume increase ranging from 10% to 28% at different times since edema induction). In the second phase of experiments, the effects of homeopathic remedies were not confirmed. On the contrary, the unblinded standard allopathic drug indomethacin exhibited its anti-inflammatory effect in both experimental phases (the reduction in paw volume increase ranging from 14% to 40% in the first phase, and from 18% to 38% in the second phase of experiments).
The discrepancies between single-blind and double-blind methods in animal pharmacological research are noteworthy and should be better investigated, also in non-homeopathic research.
顺势疗法的一项基本原则是“相似律”,即通过给予在健康受试者身上进行测试时会引发与患者自身症状相似症状的物质来治疗患者。在过去几年中,旨在评估某些顺势疗法药物在潜在可重复条件下的药理活性或疗效的临床前(体外和动物)研究数量有所增加。然而,除了一些相互矛盾的结果外,这些研究还凸显了一系列方法学上的困难。本研究旨在探索以可控方式测试顺势疗法药物对大鼠急性炎症的两种已知实验模型的影响的可能性。为此,该研究在两种实验性水肿模型(角叉菜胶和自体血液诱导的水肿)中,针对此类症状,采用两种给药途径(足底注射和口服),考虑了六种顺势疗法实践中指出的不同药物。
在第一阶段,按照单盲(测量)程序在四种实验条件下测试不同的药物。在第二阶段,在双盲(给药和测量)及完全随机条件下,通过口服给药在角叉菜胶诱导的水肿中测试一些药物(相同和不同稀释度)。使用了720只体重170 - 180克的雄性斯普拉格 - 道利大鼠。测试了六种顺势疗法药物(山金车蒙大拿D4、蜜蜂D4、D30、颠茄D4、北美金缕梅D4、拉切西斯D6、D30、磷D6、D30)、生理盐水和吲哚美辛。在诱导水肿前及水肿诱导后的不同时间,使用基于水的体积描记器测量水肿情况。数据通过方差分析和学生t检验进行分析。
在实验的第一阶段,观察到一些顺势疗法药物(蜜蜂、拉切西斯和磷)有统计学上显著的效果(自水肿诱导后不同时间,爪体积增加的减少幅度在10%至28%之间)。在实验的第二阶段,顺势疗法药物的效果未得到证实。相反,未设盲的标准对抗疗法药物吲哚美辛在两个实验阶段均显示出其抗炎效果(在第一阶段爪体积增加的减少幅度在14%至40%之间,在第二阶段实验中为18%至38%)。
动物药理研究中单盲和双盲方法之间的差异值得关注,并且在非顺势疗法研究中也应进行更好的调查。