Open-Label Placebo Works As Well As Double-Blind Placebo in Irritable Bowel Syndrome

Open-label placebo works as well as double-blind placebo
in irritable bowel syndrome

First-of-its-kind study compares performance of open-label placebo to blinded
placebo
Date:
March 30, 2021
Source:
Beth Israel Deaconess Medical Center
Summary:
In a randomized clinical trial, researchers found participants with moderate to severe irritable
bowel syndrome (IBS) who were knowingly treated with a pharmacologically inactive pill --
referred to as an honest or open-label placebo -- reported clinically meaningful
improvements in their IBS symptoms.

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FULL STORY
For decades, the power of the placebo effect was thought to lie in patients'
belief that they were -- or at least, could be -- receiving a pharmacologically
active treatment. A new study by physician-researchers at Beth Israel
Deaconess Medical Center (BIDMC) suggests that patients don't need to be
deceived to receive benefit from treatment with placebo.
In a randomized clinical trial published in the journal PAIN, researchers found participants with
moderate to severe irritable bowel syndrome (IBS) who were knowingly treated with a
pharmacologically inactive pill -- referred to as an honest or open-label placebo -- reported clinically
meaningful improvements in their IBS symptoms. People who received the open-label placebo
experienced improvements that were significantly greater than those reported by participants
assigned to a no-pill control group. There was no difference in symptom improvement between those
who received open-label or double-blind placebos. The results build on the research team's previous
findings and challenge the long-held notion that concealment or deception are key elements in the
placebo effect.
"The clinical response to open-label placebo in this six-week trial was high, with 69 percent of
participants who received open-label placebo reporting a clinically meaningful improvement in their
symptoms," said first and corresponding author Anthony J. Lembo, MD, Professor of Medicine in the
Division of Gastroenterology at BIDMC. "IBS is one of the most common reasons for healthcare
consultations and absenteeism from work or school. Effective treatment options for IBS are limited,
and we hypothesized it may be possible to ethically harness the placebo effect for clinical benefit."
For the rigorously designed clinical trial, researchers enrolled 262 adult participants, 18 to 80 years
old with at least moderately severe irritable bowel syndrome, as measured by the validated IBS-
Severity Scoring System (IBS-SSS), which measures frequency and severity of abdominal pain and
distention, quality of life and other relevant factors across a scale of 0-500. Participants were
examined, filled out baseline questionnaires and were randomized into one of three study arms;
open-label placebo; double-blind (which included double-blind placebo or double-blind peppermint
oil); or no-pill control. During their examinations, all participants discussed the placebo effect, the
trial and its aims with their physicians.
The open-label group received pill bottles labeled "open-label placebo," and were told that the pills
inside were pharmacologically inert, but could make them feel better through the placebo effect. The
double-blind group received pill bottles labeled "double-blind placebo or peppermint oil." Participants
in the double-blind group received either a placebo or an identical pill containing peppermint oil, but
neither they nor the research team knew which they received. All participants who received pills
were instructed to take one pill three times a day, 30 minutes before meals. The no-pill control group
received no pills but otherwise followed identical study protocol. During return visits three and six
weeks into the study, all participants completed questionnaires, were verbally asked about adverse
events and briefly met with a study physician.
Lembo and colleagues -- including senior author, Ted J. Kaptchuk, Director of the Program in
Placebo Studies and the Therapeutic Encounter at BIDMC -- found that improvement in IBS-SSS
scores from baseline to the six-week endpoint was significantly greater in the open-label placebo
group compared to the no-pill control group. Additionally, participants in the double-blind placebo
group also saw superior symptom improvement compared to the no-pill control group, but the
double-blind and open-label groups were not different from each other.

Open-Label Placebo Works As Well As Double-Blind Placebo in Irritable Bowel Syndrome

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Open-Label Placebo Works As Well As Double-Blind Placebo in Irritable Bowel Syndrome

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Open-label placebo works as well as double-blind placebo

in irritable bowel syndrome

March 30, 2021

Beth Israel Deaconess Medical Center

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