Placebos are essential in any controlled clinical trial, providing a yardstick against which the test drug is measured. Placebos are even starting to be used as a treatment in their own right, as studies show that they make people feel better via a "mind-body" healing effect. But do parents find placebos acceptable for their children? A study led by Boston Children's Hospital found the answer is mostly yes, provided ethical guidelines are followed. Findings will appear online November 15 in The Journal of Pediatrics.
"The question of placebos is more complex when it comes to children, since parents must make medical decisions on their behalf," says Vanda Faria, PhD, a research fellow at Boston Children's Hospital's Center for Pain and the Brain. "Large placebo responses have been seen in a variety of pediatric conditions, and parent's perceptions can influence how well placebos work. At the same time, little is still known about the potential harms of prolonged drug therapy on children's development. Sometimes, the best intervention might not involve pharmacotherapy."
The researchers used an online survey to ask 1,000 U.S. parents about their attitudes toward placebos. Their findings:
- 91.5 percent of parents agreed, at least somewhat, that use of placebo in clinical trials is vital for advancing new treatments.
- 86 percent of parents felt that giving their child a placebo is acceptable in some clinical care situations, while 5.7 percent said the use of placebos in children is always unacceptable.
- 48.5 percent agreed that placebos can cause physical changes in the body; another 32.8 percent "somewhat" agreed with this statement. In total, 83 percent believed a person's mind can affect their health.
- While 80 percent agreed that taking advantage of the placebo response could improve children's care, 96.5 percent felt it imperative to create ethical guidelines around this practice.
- 52 percent felt it inacceptable for doctors to prescribe a placebo while calling it a real drug.
- 71 percent found it unacceptable not to explain that the treatment is a placebo.
When parents were given a list of 17 conditions, a majority considered placebo acceptable for only seven: the common cold, ear infection, occasional pain, anxiety disorders, mood disorders, sleep disturbance and ADHD.
As the researchers note, the study had a number of limitations. The survey respondents were mostly white, half were college graduates and nearly all of their children were in good health. Also, the survey did not distinguish between honesty toward parents or honesty toward the children in disclosing that the treatment is placebo; parents might have different views on that.
"We need to refresh traditional pediatric therapeutic models to best support parental decisions around the potential use of placebos," says Faria. "Open-label placebo seems to be a promising adjuvant therapy with the potential to improve pediatric care, as acknowledged by the great majority of the parents we surveyed. Future studies should continue to investigate its therapeutic role."
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David Borsook, MD, PhD, co-director of the Center for Pain and the Brain, was senior author on the paper. Co-authors were Joe Kossowsky, PhD, Ted J. Kaptchuk, Irving Kirsch, PhD, and Alyssa Lebel, MD, PhD, of Boston Children's Department of Anesthesiology, Perioperative and Pain Medicine, and Mike Petkov of the Center for Pain and the Brain. Faria, Kaptchuk, Kirsch and Kossowsky are also affiliated with the Program in Placebo Studies at Beth Israel Deaconess Medical Center. The study was supported by the Swedish Research Council, the Swiss National Science Foundation and the National Institutes of Health (NIH)/National Center for Complimentary and Integrative Health (NCCIH).
Boston Children's Hospital is home to the world's largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 1,100 scientists, including seven members of the National Academy of Sciences, 11 members of the Institute of Medicine and 10 members of the Howard Hughes Medical Institute comprise Boston Children's research community. Founded as a 20-bed hospital for children, Boston Children's today is a 404-bed comprehensive center for pediatric and adolescent health care. Boston Children's is also the primary pediatric teaching affiliate of Harvard Medical School. For more, visit our Vector and Thriving blogs and follow us on our social media channels: @BostonChildrens, @BCH_Innovation, Facebook and YouTube.
Journal
The Journal of Pediatrics