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Submission Deadline: January 15, 2020
Sample Abstract Format
The impact of patients’ expectations on clinical response: Re-analysis of data from the Hypericum Depression Trial Study Group
J. Chen J, G.I. Papakostas, S.J. Youn, L. Baer, A.J. Clain, M. Fava, D. Mischoulon
Depression Clinical and Research Program, Dept. of Psychiatry, Massachusetts General Hospital, Harvard Medical School
Background: Patient belief about assigned double-blind treatment may influence outcome. We reanalyzed data from the Hypericum Depression Trial Study Group’s placebo-controlled trial of St. John’s wort (SJW) versus sertraline for major depressive disorder (MDD) to determine whether patients who believed they were receiving active therapy rather than placebo obtained greater improvement, independent of assigned treatment.
Methods: 340 adults with MDD and baseline HAM-D-17 scores of ≥20 were randomized to either SJW 900-1500 mg/d, sertraline 50-100 mg/d, or placebo for 8 weeks. At week 8, patients were asked to guess their assigned treatment. 243 subjects met intent-to-treat criteria. Univariate ANOVA was used to determine whether treatment assignment moderated the effect of belief on clinical improvement. Logistic regression examined whether treatment assignment moderated the effect of belief on response (≥50% decrease in HAM-D-17 score) and remission (final HAM-D-17 score <8).
Results: Significant differences in improvement were found for belief in SJW (p<0.001) or sertraline (p=0.001) versus placebo, with strongest improvement in the SJW-believing group. Response rates were significantly stronger for subjects guessing active treatments (p<0.001 for SJW and sertraline) versus placebo, and for subjects guessing SJW versus sertraline (Fisher’s p=0.049). Association between belief and improvement remained significant when controlling for assigned treatment (p<0.001). A significant association with response was seen only for treatment guess (p=0.003, 95% CI=0.588), but not for assigned treatment. No significant associations were found for remission rates.
Conclusions: Patient expectations regarding treatment may exert a greater influence on clinical outcome than the actual medication received.