BOSTON-For decades, it has been believed that the power of placebo action lies in patients believing that they are or at least maybe receiving pharmacologically active treatments. A new study by physician-researchers at Beth Israel Deaconess Medical Center (BIDMC) shows that patients can benefit from placebo treatment without deceiving patients.
In a randomized clinical trial published in the journal “PAIN”, researchers found that subjects known to have moderate to severe irritable bowel syndrome (IBS) received pill treatment without pharmacological effects. Known as an honest or open-label placebo-it is reported to have clinically significant improvement in IBS symptoms. The improvement for those who received the open-label placebo was significantly greater than the improvement reported by the participants assigned to the drug-free control group. There was no difference in symptom improvement among those who received the open-label or double-blind placebo. This result builds on the previous findings of the research team and challenges the long-standing notion that hiding or deception is a key factor in the effect of placebos.
"In the six-week trial, the clinical response to the open-label placebo was high, and 69% of the participants who received the open-label placebo reported a clinically meaningful improvement in their symptoms,” the first author and corresponding author Anthony J. Lembo, MD said. Professor of Medicine, Department of Gastroenterology, BIDMC. "IBS is one of the most common reasons for medical consultation and absenteeism while going to work or school. Effective treatment options for IBS are limited, and we believe that placebo effects can be used ethically to obtain clinical benefits."
In a rigorously designed clinical trial, the researchers recruited 262 adult participants from 18 to 80 years old with at least moderate irritable bowel syndrome, which passed the validated IBS-Severity Scoring System (IBS -SSS), the system can measure the frequency and severity of pain and discomfort in the abdomen, quality of life and other related factors, ranging from 0-500. Participants were checked, filled out a baseline questionnaire, and randomly divided into one of three study groups; open-label placebo; double-blind (including double-blind placebo or double-blind peppermint oil); or no pill control. During the examination, all participants discussed the placebo effect, the trial, and its purpose with the doctor.
The open-label team accepted the medicine bottle labeled "open-label placebo" and was told that the inside was pharmacologically inert, but the placebo could make them feel better. The double-blind group received a medicine bottle labeled "double-blind placebo or peppermint oil." Participants in the double-blind group received either a placebo or the same pill containing peppermint oil, but neither they nor the research team knew which one they received. Instruct all participants who received the pill to take three meals a day and take one pill 30 minutes before meals. The drug-free control group did not receive any drugs but followed the same research protocol. During the three- to the six-week return visit of the study, all participants completed the questionnaire survey.
Lembo and colleagues-including senior author Ted J. Kaptchuk, director of the placebo study program and treatment of BIDMC En-found, from baseline to six-week endpoint, IBS-SSS score The improvement is significantly greater. The open-label placebo group was compared with the drug-free control group. Also, compared with the drug-free control group, participants in the double-blind placebo group improved their symptoms better, but there was no difference between the double-blind group and the open-label group.
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