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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.

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