Association between physician beliefs regarding assigned treatment and clinical response: Re-analysis of data from the Hypericum Depression Trial Study Group

Abstract

Background We have previously shown an association between patient belief and treatment response in the Hypericum Depression Trial Study Group's 2002 study. We re-examined these data to determine whether clinical improvement was associated with physician belief about assigned therapy. Methods 340 adults with major depression and baseline scores ≥20 on the 17-item Hamilton Depression Scale (HDRS-17) were randomized to Hypericum 900-1500 mg/d, sertraline 50-100 mg/d, or placebo for 8 weeks. At week 8, physicians guessed their patients' treatment. We analyzed 277 subjects with at least one post-baseline visit and physician guess data. We examined association between guess and improvement in HDRS-17 and whether treatment assignment moderated the effect of belief on remission (final HDRS-17 score <8). Results Patient and doctor guesses agreed at 53% for sertraline, 68% for Hypericum, and 52% for placebo (kappa = 0.37). Doctors guessed placebo correctly (38%) more than sertraline (18%) or Hypericum (19%) (p = 0.001). Adverse event scores were significantly greater among subjects for which the clinicians guessed Hypericum (p < 0.001) or sertraline (p = 0.005) compared to placebo. Significant improvements in HDRS-17 score were found when comparing the Hypericum-guess (p < 0.001) or the sertraline-guess group (p < 0.001) against the placebo-guess group. Remission rates were significantly greater for subjects whose clinicians guessed sertraline (p < 0.001) or Hypericum (p < 0.001) versus placebo. Conclusion Doctors tended to guess placebo more easily than Hypericum or sertraline, and their guesses tended to favor active therapies when improvement was more robust. Results show association but not causation, and merit more careful investigation.

Building an Evidence Base in Complementary and Integrative Healthcare for Child and Adolescent Psychiatry

“…11 Similarly, in a recently published study 49 investigating of the efficacy of St. John’s wort in minor depression, the placebo response rate was comparable with the response rates for either St. John’s wort or the active control, citalopram. On the other hand, a recent reanalysis of the 2002 Hypericum Depression Trial Study Group study 50 suggested that patients who believed that they were receiving St. John’s wort as opposed to sertraline (active control) or placebo seemed to have better outcomes, regardless of treatment received.…”

Paprastųjų Jonažolių Naudojimas Gydant Sunkią Depresiją

“…Taip pat, nepriklausomai nuo to, placebą, jonažolę ar sintetinius antidepresantus gauna tiriamasis, gydymo rezultatus reikšmingai lemia tai, ką pacientas pats mano gaunąs. Tokiu atveju tiek paciento įsitikinimu gaunamų jonažolių, tiek sintetinių antidepresantų jaučiamas teigiamas poveikis yra reikšmingai didesnis nei jaučiamas pacientų, kurie mano gaunantys placebą [28].…”

Novel Approaches to Study Design and Intervention for Residual Symptoms of MDD

“…Although more patients guessed acupuncture correctly, this did not lead to a significant advantage for acupuncture, suggesting that the patients may not have been so influenced by their belief. In a recent investigation 23 of patient beliefs about treatment received, we found that believing that one was receiving an active intervention seemed to correlate with clinical improvement more so than which intervention was actually received.…”