Guest guest Posted August 10, 2000 Report Share Posted August 10, 2000 I have included below an article from a recent issue of JAMA. the key point that caught my attention was " The placebo effect, thought to be due to the diagnosis, time, and attention paid by staff who are conducting clinical trials, has been well demonstrated in multiple trials of depression and other anxiety disorders." That just acknowledging what happened to gurukulis on a one to one basis, and a systematic acknowledgement by authorities is in itself very theraputic. JAMA. 2000;283:1837-1844. To the Editor: The study by Dr Brady and colleagues1 of sertraline treatment of posttraumatic stress disorder (PTSD) is a welcome addition to the sparse literature on therapeutic options for this common condition. Moreover, their conclusion that the benefit of sertraline occurred predominantly within the first 2 to 4 weeks of treatment may have important clinical implications. However, a closer examination of the data (Tables 3 and 4), using effect size calculations (modified Cohen d values estimated from the SDs provided), suggests an alternative explanation for the observed treatment effects. Large effect sizes were demonstrated for both sertraline and placebo groups for total Clinician Administered PTSD, Part 2 (CAPS-2) (sertraline, d = 1.45 vs placebo, d = 1.0), total Impact of Event (sertraline, d = 0.97 vs placebo, d = 0.74), and Clinical Global Impression-Severity (sertraline, d = 1.18 vs placebo, d = 0.83), as well as for CAPS-2 intrusion (sertraline, d = 1.05 vs placebo, d = 0.76), avoidance (sertraline, d = 1.35 vs placebo, d 0.95), and arousal (sertraline, d = 1.27 vs placebo, d = 0.85) scales. In taking the customary difference between the 2 groups by subtracting the placebo effect size, the net sertraline treatment effects are much smaller, ranging from 0.24 to 0.45 for the above measures. To explain these findings, we speculate that the vigorous assessment protocol used in this study is responsible for most of the treatment effect. The primary outcome measures were obtained during 9 distinct interviews and secondary data from 7 of these visits during the course of the 12-week design. In these follow-up interviews, patients repeatedly responded to many PTSD-related questions that could have invoked an element of exposure and desensitization. Moreover, frequent contacts with the researchers and the questionnaires would likely decrease patient avoidance behavior. Thus, instead of a placebo response, we believe that the protocol represented covert cognitive-behavioral therapy. In a comparison of prolonged exposure, stress inoculation training, and a combination of the 2 treatments for PTSD2 and in our treatment research of imagery rehearsal to target the intrusion symptom of nightmares in PTSD,3 large net treatment effect sizes have been demonstrated after subtracting the effect sizes of wait-list control subjects. Thus, in the study by Brady et al, it might be important to consider the effects of covert exposure and desensitization on the treatment gains for this group of patients. Barry Krakow, MD Michael Hollifield, MD Teddy D. Warner, PhD University of New Mexico Health Sciences Center Albuquerque 1. Brady K, Pearlstein T, Asnis GM, et al. Efficacy and safety of sertraline treatment of posttraumatic stress disorder: a randomized controlled trial. 2. Foa EB, Dancu CV, Hembree EA, Jaycox LH, Meadows EA, Street GP. A comparison of exposure therapy, stress inoculation training, and their combination for reducing posttraumatic stress disorder in female assault victims. J Consult Clin Psychol. 1999;67:194-200. MEDLINE 3. Krakow B, Hollifield M, Schrader R, et al. A controlled study of imagery rehearsal for chronic nightmares in sexual assault survivors with PTSD: a preliminary report. J Trauma Stress. In press. In Reply: Dr Krakow and colleagues hypothesize that the act of completing weekly PTSD rating scales might have constituted "covert cognitive-behavioral therapy" due to "an element of exposure and desensitization." We agree that this is a credible hypothesis and have considered it as an explanation for the placebo effect observed in this chronically ill group of patients. However, we believe that completing weekly rating scales is not a potent form of cognitive-behavioral therapy. The placebo effect, thought to be due to the diagnosis, time, and attention paid by staff who are conducting clinical trials, has been well demonstrated in multiple trials of depression and other anxiety disorders. A placebo effect is not unexpected in this multicenter trial of patients with PTSD and has been demonstrated in a recent pharmacological trial of PTSD, which failed to show efficacy.1 Krakow et al also note that being placed on a waiting list represents a weaker means of controlling for nonspecific treatment effects than double-blind, parallel treatment with placebo.2 As a result, effect sizes may appear spuriously high. The problem is further compounded by the use of relatively small sample sizes and few research sites in most cognitive-behavioral PTSD treatment studies. As a result, the confidence interval around the putative effect size can be large. In general, however, we believe that Krakow et al make a valuable point. Effective treatment of PTSD frequently consists of a combination of pharmacotherapy and psychotherapy. Studies exploring the interface of effective psychotherapy and pharmacotherapy techniques should provide valuable information concerning optimal treatment. Kathleen T. Brady, MD, PhD Medical University of South Carolina Charleston Terri Pearlstein, MD Butler Hospital Providence, RI Gregory M. Asnis, MD Montefiore Medical Center Bronx, NY Dewleen Baker, MD Cincinnati Veterans Affairs Medical Center Cincinnati, Ohio Barbara Rothbaum, PhD Emory University Atlanta, Ga Carolyn R. Sikes, PhD Gail M. Farfel, PhD Pfizer Inc New York, NY 1. Baker DG, Diamond BI, Gillette G, et al. A double-blind, randomized, placebo-controlled, multi-center study of brofaromine in the treatment of post-traumatic stress disorder. Psychopharmacology (Berl). 1995;122:386-389. MEDLINE 2. Robinson LA, Berman JS, Neimeyer RA. Psychotherapy for the treatment of depression: a comprehensive review of controlled outcome research. Psychol Bull. 1990;108:30-49. MEDLINE Letters Section Editors: Stephen J. Lurie, MD, PhD, Contributing Editor; Phil B. Fontanarosa, MD, Deputy Editor. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.