Although placebos are known to be beneficial in patients with subjective symptoms, they are impractical in a clinical setting because they are thought to require deception during administration, which violates the ethics of patient autonomy and informed consent.
“Everyone assumed that you need lying (‘I’m giving you a powerful medication’) or concealment (‘you may or may not be getting a real medication’) for a placebo effect to happen,” said lead researcher Associate Professor Ted Kaptchuk, director of Complementary Specialties at Beth Israel Deaconess Medical Center in Boston, Massachusetts, US and Associate Professor of Medicine at the Harvard Medical School.
“Our working hypothesis is that placebo (like the mind-body symbolic intervention that it is) will primarily modulate the experience of symptoms and not the basic pathophysiology.”
In the first randomized controlled trial of its kind, 80 patients with IBS were randomized to receive no treatment or open-label placebos described as “placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes.”
[PLoS One 2010 Dec 22;5(12):e15591]
Patients who received the open-label placebo had higher average scores on the IBS Global Improvement Scale after 11 and 21 days compared to those receiving no treatment (5.2±1.0 vs. 4.0±1.1, P<0.001; p="0.002)." p="0.08).">The researchers noted that open-label placebo had comparable response rates to those of IBS patients in clinical trials treated with established drugs.
However, the response rate to placebo in this trial was somewhat higher than response rates in placebo controlled double blind IBS trials, which the researchers attributed to the open-label placebo status coupled with persuasive treatment rationale.
“It may be that 100 percent certainty that one is receiving the ‘treatment of interest’ (in this case open-label placebo) is more placebogenic than a 50 percent probability of receiving an inactive control,” Kaptchuk said.
He also highlighted the importance of ritual in therapy, in this case, taking a pill. Participants were given precise directions about how to take their open-label placebo. Kaptchuk suspects that such acts may be a potent part of the healing process.
Demonstrable efficacy of an open-label placebo removes the ethical conundrum that makes them inconvenient to use in clinical practice, although Kaptchuk noted that many physicians will prescribe treatments with no effect that are tantamount to placebos.
[BMJ 2008 Oct 23;337:a1938. doi: 10.1136/bmj.a1938]
“We can hypothesize that it may be possible, if more evidence supports our trial, that physicians can try to honestly prescribe placebo as a first line of treatment,” Kaptchuk said. “At a minimum, it allows nature to take its course and maybe even have salubrious effects.”
Patients who received the open-label placebo had higher average scores on the IBS Global Improvement Scale after 11 and 21 days compared to those receiving no treatment (5.2±1.0 vs. 4.0±1.1, P<0.001; p="0.002)." p="0.08).">The researchers noted that open-label placebo had comparable response rates to those of IBS patients in clinical trials treated with established drugs.
However, the response rate to placebo in this trial was somewhat higher than response rates in placebo controlled double blind IBS trials, which the researchers attributed to the open-label placebo status coupled with persuasive treatment rationale.
“It may be that 100 percent certainty that one is receiving the ‘treatment of interest’ (in this case open-label placebo) is more placebogenic than a 50 percent probability of receiving an inactive control,” Kaptchuk said.
He also highlighted the importance of ritual in therapy, in this case, taking a pill. Participants were given precise directions about how to take their open-label placebo. Kaptchuk suspects that such acts may be a potent part of the healing process.
Demonstrable efficacy of an open-label placebo removes the ethical conundrum that makes them inconvenient to use in clinical practice, although Kaptchuk noted that many physicians will prescribe treatments with no effect that are tantamount to placebos.
[BMJ 2008 Oct 23;337:a1938. doi: 10.1136/bmj.a1938]
“We can hypothesize that it may be possible, if more evidence supports our trial, that physicians can try to honestly prescribe placebo as a first line of treatment,” Kaptchuk said. “At a minimum, it allows nature to take its course and maybe even have salubrious effects.”
Radha Chitale
