统计问题第58问：关于安慰剂的一道多选题

Question

Researchers undertook a randomised, double blind, placebo controlled trial to assess whether calcium supplementation was associated with adverse cardiovascular events. Healthy postmenopausal women were recruited and randomly assigned to receive five tablets a day of either 200 mg of elemental calcium or identical placebo. The occurrence of adverse cardiovascular events over a five year period was recorded. Calcium supplementation in healthy postmenopausal women was associated with increased rates of adverse cardiovascular events.

Which of the following statements, if any, are true?

a) The placebo was an inert treatment with no known active therapeutic effects

b) The use of a placebo allowed the assessment of contextual benefits associated with trial participation aside from those of receiving calcium supplementation

c) The use of a placebo allowed the assessment of the therapeutic effects of calcium supplementation

d) The use of a placebo facilitated blinding

提示：这是一道多选题。

Answers

Answers a, b, c, and d are all true.

The placebo was an inert treatment with no known active therapeutic effects (answera). However, giving a placebo is not the same as not giving treatment because its administration can induce physiological changes.

The response of the placebo group is quantified as the placebo effect (answerb). The placebo effect is the contextual benefits received excluding those of receiving calcium supplementation. Contextual benefits include the patient’s response to the patient-doctor consultation and being in a trial and perhaps receiving additional specialist medical attention, plus the belief of receiving therapeutic care. By quantifying the placebo effect, it can be removed from the response of the calcium supplementation group to provide an estimate of the therapeutic effects of calcium supplementation alone (answer c).

The use of a placebo facilitated the double blind design of the trial (answerd). The placebo was identical in appearance, taste, and feel to calcium supplementation; therefore, it was possible to blind trial participants to their treatment allocation. The use of a placebo meant that it was also possible to blind assessors to treatment, resulting in a double blind trial.

The term “placebo” is typically used in pharmacological studies, whereas “sham treatment” is used for non-pharmacological studies, including those of devices and of psychological and physical treatments.

所以答案是选择 a b c d

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