Parents Pass Placebos
Is it ethical to use placebo controls in pediatric clinical trials? Most parents say, “yes”
The ethics around placebos have been discussed for some time in the medical community, but it’s an even more hotly debated subject when it comes to clinical trials involving children, despite evidence suggesting that placebo effects in pediatrics are significant. Clearly, children require special consideration and a trial can’t go ahead without parental consent, so it’s important to understand what parents think.
Until recently, data has been lacking but now researchers from Harvard Medical School have conducted a survey to assess parental attitudes regarding placebo usage in pediatric, randomized controlled trials and clinical care (1). “Our aim was to further understand the obstacles related to children enrolment in a placebo randomized controlled trial and to understand the feasibility of clinical opportunities, such as placebo therapy, which can maintain the therapeutic benefits and decrease the use of medication with potential side effects,” said Vanda Rocha Faria, lead author of the study and Research Fellow in Anesthesia at Boston’s Children’s Hospital.
The researchers found that the majority of surveyed parents considered the use of placebos acceptable in both pediatric care (86 percent) and pediatric trials (91.5 percent), while only 5.7 percent of parents reported the use of placebos in children as unacceptable. Respondents’ judgment and acceptance were influenced by the doctors’ certainty about the therapeutic benefits of placebo treatment, the pediatric conditions for placebo usage (mostly psychological), transparency, safety, and purity of placebos.
Interestingly, the researchers also found that more than two-thirds of parents would rather have their child enrol in a clinical study to test the effectiveness of a new drug against a placebo without pharmacologic side effects than in a study testing the new drug against an already existing drug with possible pharmacologic side effects. Most parents also indicated that they would like to be informed about clinical trials results and, if results suggest that certain drugs do not work better than placebo, do not believe it acceptable for a doctor to prescribe those drugs to children.
“In out study, we found that parents seem to be quite positive towards placebo use,” says Rocha Faria. “However, if deception is involved, then their attitudes change.”
Rocha Faria also pointed out that a number of parents spontaneously left positive comments at the end of the survey. “Some said they would like to read more on the topic, others that they would like to see our recommendations implemented in clinical practice... I think it shows there’s a genuine interest in the topic.”
- V Faria, “Parental attitudes about placebo use in children”, J Pediatr [Epub ahead of print] (2016). PMID: 27863847.
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