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Trial Design: Pain Sections
Author Bio
Introduction
Currently selected section: Placebo Effects
Single Dose Trials
Repeated Dose Trials
Explanatory Versus Pragmatic
Dose-Response
Parallel Group Versus Crossover
Conclusion
 

 

Chapter 1: Clinical Trials of Pain Treatment: Placebo Effects: Problem 2.1
 
.......What is a reasonable conclusion?

You answered:

Selection A
The data strongly suggest efficacy, as the proportion of patients improving is well above the usual 30% placebo response.

INCORRECT

In fact, these data say little about efficacy of epidural steroids. The common statement that one can expect 30% of patients to get pain relief from a placebo is not correct (Turner et al., 1994). The frequency of placebo effects varies among analgesic studies from zero to more than 60% (Turner et al., 1994); Moore et al, 1998. Efforts to identify and exclude "placebo responders" from analgesic trials have not succeeded; given repeated opportunities, most people will manifest a placebo response.

Patients in most chronic pain studies show some improvement, even when treated with placebo. One cannot tell whether this represents "regression to the mean" or placebo effect unless one includes a no treatment group to compare to the group given a placebo.

Comparison to a placebo injection will let one infer how much of the pain relief was due to the steroid and how much to the suggestive value of the procedure.

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