Open-label placebo treatment in chronic low back pain: a randomized controlled trial

Abstract

This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland–Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P < 0.001), with moderate to large effect sizes. Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (−0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P < 0.001), with a large effect size. Improvement in disability scores was 2.9 (1.7-4.0) in the OLP group and 0.0 (−1.1 to 1.2) in the TAU group. After being switched to OLP, the TAU group showed significant reductions in both pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain.

Placebo disclosure does not result in negative changes in mood or attitudes towards health care or the provider

“…For example, a recent study compared treatment as usual to treatment as usual plus open label placebo pill for individuals with low back pain of greater than three months duration [57]. The treatment as usual plus placebo pill group received chemically inert pills (containing microcrystalline cellulose) in a container labeled 'placebo. '…”

“…An interesting alternative to the deceptive use of placebo is the use of "pure" placebo treatments without deception [56,57]. For example, a recent study compared treatment as usual to treatment as usual plus open label placebo pill for individuals with low back pain of greater than three months duration [57].…”

An Over-the-Counter Central Sensitization Therapy: A Chronic Back Pain Registry Study of Pain Relief, Medication Use and Their Adverse Effects

“…This 40% figure was chosen to account for a lack of a placebo control and reflects the fact that the two RCTs using this device reported placebo effects of 7 and 3%, respectively [26,27]. Although the understanding of placebo has changed substantially and is now seen as being related to patient's perception of treatment, ways are being investigated to incorporate the placebo effect into medical treatment [30]. At this 40% effectiveness threshold, 52% of subjects reported effective pain relief and averaged a 66% reduction in their mean VAS scores.…”

Los Siete Secretos Mágicos De La Efectividad Terapéutica

“…En otras palabras, saben que la pastilla que ingieren no posee ningún principio activo. Y sorprendentemente, aun así provoca efectos beneficiosos (Carvalho, Caetano, Cunha, Rebouta, Kaptchuk, y Kirsch, 2016;Charlesworth et al, 2017). Les estamos diciendo a los pacientes que la pluma no es mágica, pero la pluma sigue teniendo efecto.…”