Vickers A J, van Haselen R, Heger M
Royal London Homoeopathic Hospital, England, United Kingdom.
J Altern Complement Med. 2001 Apr;7(2):141-8. doi: 10.1089/107555301750164208.
To pilot a method for determining whether homeopathically prepared mercury causes more symptoms (a "drug proving") in healthy volunteers than placebo.
One hundred and eighteen (118) healthy volunteers ages 18 to 65 were recruited by local advertising. Subjects unfamiliar with homeopathy undertook a 1-week single-blind placebo run-in, a 1-week of double-blind, randomized treatment on either homeopathically prepared mercury 12C or placebo, and a third week of placebo run-out. Each day, symptoms were recorded on a checklist that included both true mercury symptoms and symptoms not expected to be caused by mercury (false symptoms). Additional symptoms were assessed by open reporting. Outcome was assessed by calculating a score for each day as the number of true symptoms minus the number of false symptoms. The mean score during placebo was then subtracted from the mean score for weeks two and three of the trial.
Fourteen (14) subjects dropped out during placebo run-in. The remaining 104 completed the trial. Baseline comparability was good. Mean difference score was -0.125 (SD 3.47) for mercury and -0.221 (SD 3.01) for placebo (p > 0.2). No significant differences between groups were found for the number of subjects meeting predefined criteria for a drug-proving reaction.
This pilot study failed to find evidence that mercury 12C causes significantly more symptoms in healthy volunteers than placebo. Questionnaires with a limited number of gross symptoms do not seem to be an appropriate methodological technique in drug proving research. If drug-proving phenomena exist, they appear to be rare.
试行一种方法，以确定顺势疗法制备的汞制剂在健康志愿者身上引起的症状是否比安慰剂更多（即“药物验证”）。
通过当地广告招募了118名年龄在18至65岁之间的健康志愿者。不熟悉顺势疗法的受试者进行了为期1周的单盲安慰剂导入期、为期1周的双盲、随机接受顺势疗法制备的12C汞制剂或安慰剂治疗，以及第三周的安慰剂洗脱期。每天，在一份清单上记录症状，该清单既包括真正的汞中毒症状，也包括预计不会由汞引起的症状（假症状）。通过开放式报告评估其他症状。通过计算每天的得分（真正症状数减去假症状数）来评估结果。然后从试验的第二周和第三周的平均得分中减去安慰剂期间的平均得分。
14名受试者在安慰剂导入期退出。其余104名完成了试验。基线可比性良好。汞制剂组的平均差异得分为-0.125（标准差3.47），安慰剂组为-0.221（标准差3.01）（p>0.2）。在达到药物验证反应预定义标准的受试者数量方面，两组之间未发现显著差异。
这项初步研究未能找到证据表明12C汞制剂在健康志愿者身上引起的症状比安慰剂明显更多。症状数量有限的问卷在药物验证研究中似乎不是一种合适的方法技术。如果存在药物验证现象，它们似乎很罕见。
