Patients who knowingly took a placebo in
conjunction with traditional treatment for lower back pain saw more
improvement than those given traditional treatment alone, suggested a paper published in the journal Pain.
Conventional medical wisdom has long held that placebo effects depend
on patients' belief they are getting pharmacologically active
"These findings turn our understanding of the placebo effect on its
head," said joint senior author Ted Kaptchuk, director of the Program
for Placebo Studies and the Therapeutic Encounter at Beth Israel
Deaconess Medical Center and an associate professor of medicine at
Harvard Medical School.
‘Patients who knowingly took a placebo in conjunction with traditional treatment for lower back pain saw more improvement than those given traditional treatment alone.’
"This new research demonstrates that the placebo
effect is not necessarily elicited by patients' conscious expectation
that they are getting an active medicine, as long thought. Taking a pill
in the context of a patient-clinician relationship - even if you know
it's a placebo - is a ritual that changes symptoms and probably
activates regions of the brain that modulate symptoms."
Kaptchuk, with colleagues at Instituto Superior de Psicologia
Aplicada (ISPA) in Lisbon, Portugal, studied 97 patients with chronic
lower back pain (cLBP), which causes more disability than any other
medical condition worldwide. After all participants were screened and
examined by a registered nurse practitioner and board certified pain
specialist, the researchers gave all patients a 15-minute explanation of
the placebo effect. Only then was the group randomized into one of two
groups; the treatment-as-usual (TAU) group or the open-label placebo
The vast majority of participants in both groups (between 85 and 88%) were already taking medications - mostly non-steroidal
anti-inflammatories (NSAIDS) - for their pain. (Patients taking opioid
medications were excluded from the trial.) Participants in both the TAU
and OLP groups were allowed to continue taking these drugs, but were
required not to change dosages or make any other major lifestyle
changes, such as starting an exercise plan or new medication, which
could impact their pain.
In addition, patients in the OLP group were given a medicine bottle
labeled "placebo pills" with directions to take two capsules containing
only microcrystalline cellulose and no active medication twice daily.
At the end of their three-week course of pills, the OLP group
overall reported 30% reductions in both usual pain and maximum
pain, compared to 9% and 16% reductions, respectively, for
the TAU group. The group taking placebo pills also saw a 29%
drop in pain-related disability. Those receiving treatment as usual saw
almost no improvement by that measure.
"It's the benefit of being immersed in treatment: interacting with a
physician or nurse, taking pills, all the rituals and symbols of our
healthcare system," Kaptchuk said. "The body responds to that."
"Our findings demonstrate the placebo effect can be elicited without
deception," said lead author, Claudia Carvalho of ISPA. "Patients
were interested in what would happen and enjoyed this novel approach to
their pain. They felt empowered."
Kaptchuk speculates that other conditions with symptoms and
complaints that are based on self-observation (like other kinds of pain,
fatigue, depression, common digestive or urinary symptoms) may also be
modulated by open-label treatment.
"You're never going to shrink a tumor or unclog an artery with
placebo intervention," he said. "It's not a cure-all, but it makes
people feel better, for sure. Our lab is saying you can't throw the
placebo into the trash can. It has clinical meaning, it's statically
significant, and it relieves patients. It's essential to what medicine
"Taking placebo pills to relieve symptoms without a warm and
empathic relationship with a health-care provider relationship probably
would not work," noted Carvalho.