STUDY DESIGN: A subanalysis of data derived from a randomized clinical trial was performed. OBJECTIVE: To evaluate the association of a patient's expectation for benefit from a specific treatment with improved functional outcome. SUMMARY OF BACKGROUND DATA: Psychosocial factors, ambiguous diagnoses, and lack of a clearly superior treatment have complicated the management of patients with chronic low back pain. The authors hypothesized that patient expectation for benefit from a specific treatment is associated with improved functional outcomes when that treatment is administered. METHODS: In a randomized trial, 135 patients with chronic low back pain who receivedacupuncture or massage were studied. Before randomization, study participants were asked to describe their expectations regarding the helpfulness of each treatment on a scale of 0 to 10. The primary outcome was level of function at 10 weeks as measured by the modified Roland Disability scale. RESULTS: After adjustment for baseline characteristics, improved function was observed for 86% of the participants with higher expectations for the treatment they received, as compared with 68% of those with lower expectations (P = 0.01). Furthermore, patients who expected greater benefit from massage than from acupuncture were more likely to experience better outcomes with massage than with acupuncture, and vice versa (P = 0.03). CONCLUSIONS: The results of this study suggest that patient expectations may influence clinical outcome independently of the treatment itself. In contrast, general optimism about treatment, divorced from a specific treatment, is not strongly associated with outcome. These results may have important implications for clinical trial design and recruitment, and may help to explain the apparent success of some conventional and alternative therapies in trials that do not control for patient expectations. The findings also may be important for therapy choices made in the clinical setting.
RCT Entities:
STUDY DESIGN: A subanalysis of data derived from a randomized clinical trial was performed. OBJECTIVE: To evaluate the association of a patient's expectation for benefit from a specific treatment with improved functional outcome. SUMMARY OF BACKGROUND DATA: Psychosocial factors, ambiguous diagnoses, and lack of a clearly superior treatment have complicated the management of patients with chronic low back pain. The authors hypothesized that patient expectation for benefit from a specific treatment is associated with improved functional outcomes when that treatment is administered. METHODS: In a randomized trial, 135 patients with chronic low back pain who received acupuncture or massage were studied. Before randomization, study participants were asked to describe their expectations regarding the helpfulness of each treatment on a scale of 0 to 10. The primary outcome was level of function at 10 weeks as measured by the modified Roland Disability scale. RESULTS: After adjustment for baseline characteristics, improved function was observed for 86% of the participants with higher expectations for the treatment they received, as compared with 68% of those with lower expectations (P = 0.01). Furthermore, patients who expected greater benefit from massage than from acupuncture were more likely to experience better outcomes with massage than with acupuncture, and vice versa (P = 0.03). CONCLUSIONS: The results of this study suggest that patient expectations may influence clinical outcome independently of the treatment itself. In contrast, general optimism about treatment, divorced from a specific treatment, is not strongly associated with outcome. These results may have important implications for clinical trial design and recruitment, and may help to explain the apparent success of some conventional and alternative therapies in trials that do not control for patient expectations. The findings also may be important for therapy choices made in the clinical setting.
Authors: Karen J Sherman; Daniel C Cherkin; Laura Ichikawa; Andrew L Avins; Kristin Delaney; William E Barlow; Partap S Khalsa; Richard A Deyo Journal: Spine (Phila Pa 1976) Date: 2010-07-01 Impact factor: 3.468
Authors: Eric Manheimer; Ke Cheng; L Susan Wieland; Li Shih Min; Xueyong Shen; Brian M Berman; Lixing Lao Journal: Cochrane Database Syst Rev Date: 2012-05-16