Research has shown that pain is a major symptom of IBS, which could be due to the connection between the gut and the brain. That may explain why people with IBS respond well to placebos as a pain treatment — the fake pills can have a psychological effect and help patients feel less pain. Typically, however, placebos are given to people who believe they are receiving real medicine. “Knowing that the placebo effect is so important, particularly in patients with IBS, we decided to test the hypothesis of what happens if we actually tell families [and children] that they are getting a placebo,” says Samuel Nurko, MD, director of the Center for Motility and Functional Gastrointestinal Disorders at Boston Children’s Hospital. In the study, Dr. Nurko and colleagues looked at 30 children (average age 14) with functional abdominal pain or IBS, who underwent a three-week control period and another three-week placebo period of receiving sugar pills twice daily. Hyoscyamine (a drug used to relieve pain in the gastrointestinal tract) was allowed as a rescue medication for quick, short-term relief as needed. They found that participants reported less pain when they were taking open-label placebos — fake pills that are openly prescribed so that patients are fully aware they are not receiving real medication. Mean pain scores were significantly lower (39.9) during the open-label placebo period, compared with the control period (45). Overall, 14 study participants (46.7 percent) reported that they experienced overall improvement during the open-label placebo period, whereas nine participants (30 percent) said that they felt better overall during the control period. While researchers noted that this was not a significant difference, it contributes to evidence that placebos may have a beneficial effect. In addition, 21 of the 30 participants (70 percent) reported higher pain scores during the control period than during the open-label placebo period. During the control period, participants also took nearly twice as many hyoscyamine tablets — a mean of 3.8 pills, compared with two pills during the open-label placebo period.
Less Medication Means Fewer Potential Side Effects
Shikib Mostamand, MD, a pediatric gastroenterologist at Stanford Children’s Health in Palo Alto, California, who was not involved in the study, pointed out that hyoscyamine tablets can have side effects, whereas placebos have none. “The anti-spasmodic [hyoscyamine] used in the study is known to cause unwanted side effects such as constipation,” said Dr. Mostamand. “Sometimes the very treatments used to alleviate a symptom can actually worsen the underlying problem. This is why providers try to not use rescue therapies or treatments as long-term Band-Aids.” The study also underscored the fact that there was no difference in bowel movement habits between the open-label placebo period and the control period, suggesting that the improvements observed were associated with changes in pain modulation. As far as any limitations of the research are concerned, Mostamand noted that the study population was small at 30 participants and a more expansive investigation would be needed to help support these preliminary results. “For scientific data to be a meaningful and effective agent of change, it has to be easily reproduced or replicated,” he said. “I think larger multicenter studies are needed to support this initial paper.” Although this type of placebo treatment for people with IBS or functional abdominal pain is not currently a part of standard medical care, Mostamand sees its potential. “I think prior to this paper, there really was no sound evidence-based data to support this approach,” he said. “What is surprising to me is that even with an open-label placebo where patients and their parents are told that this is a placebo, they still had statistically significant improvement in their pain scores.” While the findings show promise, Nurko says that more research is needed to better understand the mechanisms responsible for high placebo response rates among children. Results also suggest that open-label placebos can be used in an ethical way to harness the placebo effect as a therapeutic tool in the clinic; they also offer the added bonus of being inexpensive, easy-to-administer, and safe. “We found that with placebos, the effect on the brain and the gut is so related that you can modulate pain by using this treatment,” he said. “If people believe in something occurring, you can change the way your brain works.”
