https://doi.org/10.55788/f55f95c5
A pilot study of 30 pediatric patients with abdominal pain found that nearly three-quarters of the children reported a 30% improvement in pain, and half experienced a 50% improvement in pain when placebos were prescribed, researchers report in JAMA Pediatrics. Both the children and their parents were told in advance that the treatment they would be receiving was a placebo.
"It's fascinating to me," said the study's first author, Dr. Samuel Nurko, director of the Center for Motility and Functional Gastrointestinal Disorders and director of the Functional Abdominal Pain Program at Boston Children's Hospital and a professor of pediatrics at Harvard Medical School. "This was an open-label placebo trial and the family and the kids were told it was inert and not a medicine and they still got better. That's the most impressive thing from this study."
Dr. Nurko and his colleagues do not know exactly how, for some of the children, placebos reduced pain and the need for rescue medication.
But, he said, "it's been shown before that there is something about the placebo that affects people unconsciously and changes the way the brain works. We don't understand it. But we would like to harness it to make the pain go away."
For some kids the placebo effect was strong enough that they continued to have less pain even after the study was done. For others, the pain returned and their parents requested that their children be given placebos again. "We went to the (institutional review board) and they approved a placebo prescription for a year," Dr. Nurko said.
The study was a crossover randomized clinical trial conducted between 2015 and 2018 at two U.S. medical centers. To be included in the study, children needed to be between ages 8 and 18 and have functional abdominal pain or IBS. All the children had normal lab results and none was lactose intolerant.
The 30 children were randomly assigned to receive either a placebo plus their regular treatment (Group 2) or regular treatment alone (Group 1). For three weeks Group 2 got the placebo treatment, an inert suspension, along with a supply of the rescue medication, hyoscyamine, to use for pain if needed. The children were also asked to keep a daily symptom diary. The Group 1 children (controls) received their normal care along with a supply of the rescue medication and were asked to keep a daily symptom diary.
For the following three weeks, Group 2 then received normal care along with a supply of the rescue medication and a new daily diary, while Group 1 got the placebo treatment, along with a supply of the rescue medication to use for pain if needed.
Overall, 22 of 30 patients (73%) reported that the placebo treatment improved their pain score by more than 30% and 15 patients (50%) reported the placebo treatment improved their pain score by more than 50%.
When it came to the children who received the placebo treatment in the first part of the study, among "those that responded, in some, the good effect was persistent, others relapsed and pain got worse," Dr. Nurko said.
Future research will be geared to trying to understand what happens when placebos work in those with functional abdominal pain and IBS, he added.
The new study "is interesting and well designed," said Dr. Shaija Kutty, an assistant professor and head of the Gastro-Intestinal Functional Treatment (GIFT) clinic at Johns Hopkins Medicine in Baltimore, Maryland. "An important part of the study is physician-patient relationships and how much patients trust their physicians. These findings should be independently replicated in a large trial with long duration to show how physicians can use placebo effects."
Brain imaging studies have shown that the placebo response has neurobiological and psychobiological properties along the gut-brain axis, Dr. Kutty, who was not involved in the study, told Reuters Health by phone. "We might be able to augment drug treatment using the placebo effect."
The findings show that "open-label placebo can provide relief for young people with chronic pain associated with disorders of gut-brain interaction (DGBI)," said Dr. Kari Baber, a pediatric psychologist in the division of gastroenterology, hepatology and nutrition at the Children's Hospital of Philadelphia, who also was not involved in the study.
"As a psychologist who works with young people with DGBIs and their families, I'm most struck by the finding that placebo effectiveness appeared to be relatively independent of patients' or their caregivers' expectations for placebo to help," Dr. Baber told Reuters Health by email. "This suggests that the placebo effect - like DGBIs themselves - reflect complex biopsychosocial interactions."
These findings offer another treatment avenue for children and their caregivers who have difficulty making regular visits, according to Dr. Jennifer Webster, an assistant professor of clinical psychiatry at the University of Pennsylvania's Perelman School of Medicine.
"Open-label placebo - administered at home, by caregivers who have received instruction but no specialized training - could offer an especially promising advance for patients who are unable to access non-pharmacologic treatments like cognitive behavior therapy, biofeedback or clinical hypnosis, which typically require regularly scheduled visits with trained professionals," Dr. Webster, who did not take part in the study, told Reuters Health by email. "Future research comparing the effectiveness of placebo to these interventions will make important contributions to our care for patients with DGBIs."
"It will be essential to understand whether the effects of open-label placebo are lasting, and also whether these effects can be achieved for patients from minoritized groups, those with limited health literacy and other groups who are especially vulnerable to the ill effects of chronic pain," Dr. Webster said.
SOURCE: https://bit.ly/3gcWkZl JAMA Pediatrics, online January 31, 2022.
By Linda Carroll
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