Regression to the mean in treated versus untreated chronic pain

Abstract

The course of pain associated with temporomandibular disorders (TMD) and other chronic pain conditions is typically episodic. Its expression may influence when a person seeks treatment, for example, when the level of pain flares up or exceeds its characteristic severity. Improvement in pain status subsequent to entering treatment may be due to: (1) specific effects of treatment; (2) non-specific effects of treatment (‘placebo effects’); or (3) regression to the mean. Due to regression to the mean, uncontrolled evaluation of treatment in persons self-selected by a pain flare-up may lead to erroneous conclusions concerning effects of treatment by patients, providers, and/or researchers. For this report, the magnitude of regression to the mean due to self-selection for treatment is estimated by comparing subjects who sought treatment for TMD pain (n = 147) to a random sample of subjects with TMD pain not seeking treatment (n = 95. Among subjects seeking treatment, a significant 14.7-point reduction in VAS pain intensity was observed at 1-year follow-up. A control group of TMD subjects not seeking treatment showed no mean reduction in pain intensity but reported lower pain intensity at baseline than the group seeking care. When both groups of subjects were stratified on baseline VAS pain values, the reduction in pain increased as the baseline pain level increased, but no differences between comparable treated and untreated cases in the extent of improvement were observed. The before-after differences in both groups may be attributed to regression to the mean. We conclude that before-after differences in pain intensity can be large and that such improvement may be largely due to regression to the mean. This suggests the need for research which differentiates change due to regression to the mean (due to homeostatic processes, random within-subject variation, or measurement error) from change due to specific and non-specific effects of treatment. In clinical practice, the personal experience of patients and clinicians who observe improvement after initiation of treatment should be regarded as an unreliable guide to treatment efficacy due to regression to the mean. This phenomenon may contribute to the proliferation and continued use of treatments of unproven efficacy for pain management and suggests caution in the use of costly or risky pain treatments the efficacy of which is unknown.