For years, we’ve known about the “placebo effect”—that a patient, simply by believing that a treatment is effective, may experience a beneficial effect from a clinically ineffectual treatment. Of course, the ethics of deceiving patients into falsely believing that a placebo is an effective treatment are questionable—so researchers have recently turned their attention toward open-label placebos.
Randomized Controlled Study: OLP vs TAU Group
A recent Pain article chronicled a randomized controlled study of open-label placebo treatment for chronic low back pain. Ninety-seven patients were divided into two groups: One continued treatment as usual (TAU), while the other group received open-label placebo pills (OLP). Before embarking on the study, patients were told that the human body can automatically and powerfully respond to taking placebo pills—and all patients were aware of whether they were in the TAU or the OLP group.
At the study’s end, patients in the OLP group showed significant reductions in both pain and disability—in other words, knowing full well that they were taking a placebo pill, the patients still reported an improvement in their chronic low back pain.
But what does that mean for central nervous system (CNS) clinical trials?
The Importance of Rater Training in Clinical Trials
In this study, the efficacy of the placebo pill can largely be chalked up to the nurturing approach of the rater and investigator, who repeatedly stressed the positive potential of the placebo effect. In CNS trials—especially when it comes to pain management—rater training is absolutely essential to avoid the increasing placebo response rate.
Solution: A Supportive Treatment Environment
That’s why Worldwide Clinical Trials employs a four-stage certification process for raters, assessing their experience and knowledge and calibrating them to the standard scoring conventions and protocol specific study criteria at the beginning of each study. Raters need to know that simply being in a therapeutic environment can heighten placebo effect—so a “research” atmosphere, rather than a “therapeutic” one, should always be the goal. Interaction with site staff should be controlled, and not unintentionally create a non-specific supportive treatment environment. Staff also needs to know that they should have no expectations of drug response, either positive or negative, and should communicate the same to patients.
Learn How Rater Training Can Benefit Pain Management Treatments
The placebo effect is no replacement for effective pain-management treatments. By properly training raters to be well aware of the placebo effect and evaluate each participant in CNS clinical trials consistently, we can more effectively continue the search for treatments for lower back pain, neuropathic pain, osteoarthritic pain, and other areas of Worldwide’s CNS expertise.
