A new study published in Pain found that individuals being treated with open-label placebos showed significant reductions in pain and disability, even when compared to individuals receiving treatment as usual. The authors of the study – which is the first to show potentially clinically significant benefits of open-labels placebos for this type of condition – make an argument for innovative treatments, which include this ethical, rather than deceptive, distribution of placebos.
“Recent studies have demonstrated that some commonly prescribed front-line therapies for LBP are actually not superior to placebo controls in double-blind randomized clinical trials (RCTs) or are of only marginal increased efficacy.”
The prevalence of chronic pain in the U.S. is increasing, with upwards of 25 million individuals reporting experiencing some form of it. Lower back pain, specifically, “causes more disability than any other medical condition worldwide”, the authors write. Despite warnings against it, clinicians still often prescribe opioids for pain, which can be highly problematic.
Additionally, anxiety, depression, and stress can influence pain severity; therefore antidepressants are also often prescribed, although benefits for reduction of lower back pain are unproven and side effects can be high. Further, in prior randomized control trials, other commonly prescribed medications have not been found to be superior to placebo, leaving researchers and providers in need of innovative treatments.
Placebos, in fact, have been shown to have benefits, although most studies regarding these were blinded (i.e. individuals did not know they were taking placebos). However, placebo administration presents what the authors call an “ethical conundrum” to physicians who do not want to deceive patients. Although some studies have already found benefits in open-label placebo prescriptions (i.e. administrating placebos honestly), these studies have been fairly small.
For this study, which was conducted in Portugal, the researchers aimed to understand if adding an open-label placebo treatment to treatment as usual could benefit patients with chronic lower back pain. For this, the researchers recruited 83 adults who completed a 3-week randomized clinical trial comparing a group receiving their current treatment plus open-label placebo (OLP) to a group just receiving current treatment, also known as treatment as usual (TAU).
Receiving OLP along with TAU resulted in significantly greater reductions in pain and disability. “The amount of additional pain reduction produced by OLP was approximately 30% of baseline pain and disability ratings,” the researchers write. In addition, participants in the TAU group were offered the opportunity to receive OLP at the conclusion of the main study, for which 30 individuals signed up. These participants also showed significant pain relief and a decrease of back pain-related disability.
Regardless of limitations, such as a small sample size and a short trial duration, the researchers present an alternative with almost no adverse events and without the negative side effects often produced by opioids and antidepressants. More notably, they demonstrate that ethical, honest prescribing of placebos can be effective. Their findings present new possibilities for the treatment of not just lower back pain, but other chronic pain conditions.
Carvalho, C., Caetano, J. M., Cunha, L., Rebouta, P., Kaptchuk, T. J., & Kirsch, I. (2016). Open-label placebo treatment in chronic low back pain: A randomized controlled trial. Pain, 1-7. (Abstract)