International Circulation: What are your opinions on the SIMPLICITY-3 trial? What will this trial add to the conversation in places like Europe where this procedure is already in use?
Prof. Bohm: My personal opinion is that the SIMPLICITY 3 trial will confirm SIMPLICTY 1 and 2. However, it is important that we have at least one set of data using a sham-operated group. It is not really possible in some countries, because doing a sham-operation and analgesia in patients without performing the intervention is a little questionable.
《国际循环》:您对SIMPLICITY-3试验如何平均,它会对欧洲RND的临床实践产生什么影响?
Bohm教授:我个人的观点是SIMPLICITY-3将确SIMPLICITY-1和2的结果。不过,重要的是我们至少能有一组假手术的数据。在某些国家,这样的数据是不可能获得的,因为对患者实施麻醉和假手术,而不做干预会产生问题。
International Circulation: But you do feel that the sham procedure is important?
Prof. Bohm: I believe that the trial results will be similar because the sham-procedure is simply trying to rule out the placebo effect. However, there is a blood pressure reduction over 36 months, which would make it the longest placebo effect known. It is not a placebo effect. Still, it is important to have at least one data set showing that this is indeed important.
《国际循环》:您认为假手术很重要吗?
Bohm教授:我相信临床试验的结果将会是相同的,因为假手术只是为了排除安慰剂效应。然而,(试验显示)血压降低的效益持续超过36个月,这会是我们所知的最长的安慰剂效应?当然这不可能是安慰剂效应。尽管如此,能够有一组数据表明这不是安慰剂效应仍然是非常重要的。
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