Fuller R K, Williford W O, Lee K K, Derman R
Control Clin Trials. 1984 Sep;5(3):263-73. doi: 10.1016/0197-2456(84)90030-8.
Disulfiram treatment of alcoholism has been difficult to evaluate in controlled studies because the study design must contend with problems unique to this drug. The therapeutic effect may be a result of the patient's fear of the disulfiram-ethanol reaction rather than a direct pharmacological effect on the craving for alcohol. Good outcome may not be directly related to compliance with the drug regimen; a patient may remain abstinent even if he does not take his medication. The Veterans Administration Cooperative Study "Disulfiram in the Treatment of Alcoholism," is a multicenter, randomized, blinded, controlled clinical trial designed to evaluate the efficacy of disulfiram while addressing these issues. Two control groups are used. The members of one control group will not receive disulfiram and will be told they are not receiving disulfiram. The members of the other control group will be given disulfiram and will be told they are receiving disulfiram; however, the dose of their disulfiram will be measured by doing pill counts and obtaining urine specimens at each clinic visit and measuring urinary diethylamine, a metabolite of disulfiram, and riboflavin (a medication marker).
在对照研究中，双硫仑治疗酒精中毒的效果一直难以评估，因为研究设计必须应对这种药物所特有的问题。治疗效果可能是患者对双硫仑 - 乙醇反应的恐惧所致，而非对酒精渴望的直接药理作用。良好的治疗结果可能与是否遵守药物治疗方案没有直接关系；即使患者不服药，也可能保持戒酒状态。退伍军人管理局合作研究项目“双硫仑治疗酒精中毒”是一项多中心、随机、双盲、对照临床试验，旨在评估双硫仑的疗效，同时解决这些问题。该研究使用了两个对照组。一个对照组的成员不会接受双硫仑，并会被告知他们没有接受双硫仑。另一个对照组的成员会被给予双硫仑，并会被告知他们正在接受双硫仑；然而，他们的双硫仑剂量将通过每次门诊就诊时清点药丸数量、采集尿液样本，并测量双硫仑的代谢产物二乙胺和核黄素（一种药物标记物）来确定。
