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5428Re: Sertraline (Zoloft) Re: [Bioethics] Defending psychiatry (was Re:US Drug Usage Explodes_327% increase in Children

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  • Jack Noble
    Aug 1, 2002
      Rosemary,
          You post an impressive string of articles showing a difference for Zoloft greater than the placebo. More germane than a placebo contrast is the measured effects (benefiicial and adverse) of Zoloft compared to other "standard" treatments of the conditions for which Zoloft has been tried. It is no secret that placebo studies are favored because they offer the best chance of getting FDA approval of yet one more drug whose effects may well be equivalent to other "standard" treatments (which if a generic drug is dramatically less profitable in the marketplace). By "standard treatment," I am not referring to "no treatment" by any means, although some have made that argument intemperately, IMHO. The upshot of FDA approval of several drugs claiming efficacy for the same condition is to encourage prescription of drug cocktails that combine a number of drugs (unless there are strong prior contraindications) in the hope that at least one will work. (This was recently reported by a source that escapes me at the moment. Vera Sharav can probably supply the citation) . Moreoever, this is being done without benefit of randomized control trials (RCTs).
          So, the challenge is not simply to cite studies with titles that stake a claim, but to analyze their internal and external validity and then draw inferences within the involved constraints of Type I and Type II type error. To do less is to indulge in "my ___ is bigger than yours" rhetoric, IMHO.
          --JHN
      ----- Original Message -----
      Sent: Wednesday, July 31, 2002 8:46 PM
      Subject: Sertraline (Zoloft) Re: [Bioethics] Defending psychiatry (was Re:US Drug Usage Explodes_327% increase in Children

      Timothy H Lillie wrote: <
      > I recently heard of a study in which the drug Zoloft was about as useful in treating depression as a
      >placebo.  This would seem to contradict any "scientific" evidence that it works, eh?  Thus, those
      >psychiatrists dispensing Zoloft for depression are ALSO using "superstitious" methods, arent' they?
      I take Zoloft (well, the generic form: sertraline), with enormous benefit, which I doubt is placebo since I was hostile to the concept of antidepressant medication and started taking it only because otherwise I would be denied disability benefits.
       
      So I was surprised when the study you mention hit the headlines. But let's not forget that there are many other studies which have shown a benefit to Zoloft (why do you think anyone bothers prescribing it?):
      • Sertraline better than placebo for depressed recently abstinent alcoholics. Biol Psychiatry 1998 Oct 1;44(7):633-7 Placebo-controlled study of sertraline in depressed recently abstinent alcoholics. Roy A. Psychiatry Service, Department of Veterans Affairs Medical Center, East Orange, NJ 07019, USA.

      • Sertraline more effective than placebo for people with depression after mild traumatic brain injury. J Neuropsychiatry Clin Neurosci 2000 Spring;12(2):226-32 Sertraline in the treatment of major depression following mild traumatic brain injury. Fann JR, Uomoto JM, Katon WJ. Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle 98195, USA.

      • People with Alzheimers and major depression respond better to sertraline than placebo. Am J Psychiatry 2000 Oct;157(10):1686-9 Randomized, placebo-controlled, double-blind clinical trial of sertraline in the treatment of depression complicating Alzheimer's disease: initial results from the Depression in Alzheimer's Disease study. Lyketsos CG, Sheppard JM, Steele CD, Kopunek S, Steinberg M, Baker AS, Brandt J, Rabins PV. Department of Psychiatry and Behavioral Sciences, School of Medicine, Johns Hopkins University, Baltimore, USA.

      • Sertraline better than placebo in treating dysthymia. J Clin Psychiatry 2000 Nov;61(11):821-7 Treatment of dysthymia with sertraline: a double-blind, placebo-controlled trial in dysthymic patients without major depression. Ravindran AV, Guelfi JD, Lane RM, Cassano GB. Department of Psychiatry, University of Ottawa, Ontario, Canada.

      • Sertraline produces rapid improvement in PTSD compared to placebo. J Clin Psychiatry 2002 Jan;63(1):59-65 Posttraumatic stress disorder and quality of life: results across 64 weeks of sertraline treatment. Rapaport MH, Endicott J, Clary CM. Department of Psychiatry, University of California, San Diego, La Jolla, CA 92037, USA. Another PTSD study: JAMA 2000 Apr 12;283(14):1837-44 Efficacy and safety of sertraline treatment of posttraumatic stress disorder: a randomized controlled trial. Brady K, Pearlstein T, Asnis GM, Baker D, Rothbaum B, Sikes CR, Farfel GM. Department of Psychiatry, Medical University of South Carolina, Charleston 29425, USA.

      • Sertraline more effective than placebo in preventing relapse in pts with OCD. Am J Psychiatry 2002 Jan;159(1):88-95 Efficacy of sertraline in the long-term treatment of obsessive-compulsive disorder. Koran LM, Hackett E, Rubin A, Wolkow R, Robinson D. Department of Psychiatry, Stanford University, CA 94305, USA.  Also works for children with OCD: JAMA 1998 Nov 25;280(20):1752-6 Sertraline in children and adolescents with obsessive-compulsive disorder: a multicenter randomized controlled trial. March JS, Biederman J, Wolkow R, Safferman A, Mardekian J, Cook EH, Cutler NR, Dominguez R, Ferguson J, Muller B, Riesenberg R, Rosenthal M, Sallee FR, Wagner KD, Steiner H. Department of Psychiatry, Duke University Medical Center, Durham, NC 27710, USA.

      • Sertraline produced significant improvement in children with generalized anxiety disorder. Am J Psychiatry 2001 Dec;158(12):2008-14 Placebo-controlled trial of sertraline in the treatment of children with generalized anxiety disorder. Rynn MA, Siqueland L, Rickels K. Mood and Anxiety Disorders Section, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA 19104, USA.

      • People with PTSD are 6 times more likely to relapse if given placebo rather than sertraline. Am J Psychiatry 2001 Dec;158(12):1974-81 Efficacy of sertraline in preventing relapse of posttraumatic stress disorder: results of a 28-week double-blind, placebo-controlled study. Davidson J, Pearlstein T, Londborg P, Brady KT, Rothbaum B, Bell J, Maddock R, Hegel MT, Farfel G. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA. And here's another study showing sertraline helps PTSD: Arch Gen Psychiatry 2001 May;58(5):485-92 Multicenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder. Davidson JR, Rothbaum BO, van der Kolk BA, Sikes CR, Farfel GM. Anxiety and Traumatic Stress Program, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA.

      • Sertraline works better than placebo for people with panic disorder. Acta Psychiatr Scand 2001 Oct;104(4):289-98 Sertraline treatment of panic disorder: results of a long-term study. Rapaport MH, Wolkow R, Rubin A, Hackett E, Pollack M, Ota KY. Department of Psychiatry, University of California at San Diego and Psychiatric Service San Diego Veterans, Affairs Healthcare System, 8950 Villa La Jolla Dr., La Jolla, CA 92037, USA. Int Clin Psychopharmacol 2000 Nov;15(6):335-42 The efficacy of sertraline in panic disorder: combined results from two fixed-dose studies. Sheikh JI, Londborg P, Clary CM, Fayyad R. Department of Psychiatry, Stanford University School of Medicine, CA 94305-5723, USA. Br J Psychiatry 1998 Jul;173:54-60 Sertraline in the treatment of panic disorder. A multi-site, double-blind, placebo-controlled, fixed-dose investigation. Londborg PD, Wolkow R, Smith WT, DuBoff E, England D, Ferguson J, Rosenthal M, Weise C. Summit Research Network, Seattle, Washington 98104, USA. Arch Gen Psychiatry 1998 Nov;55(11):1010-6 Sertraline in the treatment of panic disorder: a flexible-dose multicenter trial. Pollack MH, Otto MW, Worthington JJ, Manfro GG, Wolkow R. Anxiety Disorders Program, Department of Psychiatry, Massachusetts General Hospital, Boston 02114-3117, USA. Am J Psychiatry 1998 Sep;155(9):1189-95 Sertraline in the treatment of panic disorder: a double-blind multicenter trial. Pohl RB, Wolkow RM, Clary CM. Department of Psychiatry and Behavioral Neurosciences, Wayne State University, Detroit, USA.

      • Sertraline significantly better than placebo for people with generalized social phobia. Br J Psychiatry 2001 Jul;179:23-30 Randomised controlled general practice trial of sertraline, exposure therapy and combined treatment in generalised social phobia. Blomhoff S, Haug TT, Hellstrom K, Holme I, Humble M, Madsbu HP, Wold JE. Department of Psychosomatic and Behavioural Medicine, National Hospital, Oslo, Norway. Am J Psychiatry 2001 Feb;158(2):275-81 Sertraline treatment of generalized social phobia: a 20-week, double-blind, placebo-controlled study. Van Ameringen MA, Lane RM, Walker JR, Bowen RC, Chokka PR, Goldner EM, Johnston DG, Lavallee YJ, Nandy S, Pecknold JC, Hadrava V, Swinson RP. Anxiety Disorders Clinic, McMaster University Medical Centre, Hamilton, Canada.

      • Sertraline reduces binge eating disorder more than placebo. Am J Psychiatry 2000 Jun;157(6):1004-6 Placebo-controlled trial of sertraline in the treatment of binge eating disorder. McElroy SL, Casuto LS, Nelson EB, Lake KA, Soutullo CA, Keck PE Jr, Hudson JI. Biology Psychiatry Program, Department of Psychiatry, University of Cincinnati College of Medicine, OH 45267-0559, USA.

      • Sertraline better than placebo in treating premenstrual dysphoric disorder. J Clin Psychiatry 2000 Feb;61(2):101-9 Psychosocial functioning in women with premenstrual dysphoric disorder before and after treatment with sertraline or placebo. Pearlstein TB, Halbreich U, Batzar ED, Brown CS, Endicott J, Frank E, Freeman EW, Harrison WM, Haskett RF, Stout AL, Yonkers KA. Butler Hospital and Brown University, Providence, RI 02906, USA. Arch Fam Med 1999 Jul-Aug;8(4):328-32 Luteal phase sertraline treatment for premenstrual dysphoric disorder. Results of a double-blind, placebo-controlled, crossover study. Jermain DM, Preece CK, Sykes RL, Kuehl TJ, Sulak PJ. Department of Pharmacy, Scott & White Memorial Hospital, Temple, Tex., USA. J Clin Psychiatry 1998 Feb;59(2):76-80 Treatment of premenstrual dysphoric disorder with sertraline during the luteal phase: a randomized, double-blind, placebo-controlled crossover trial. Young SA, Hurt PH, Benedek DM, Howard RS. Department of Psychiatry, Walter Reed Army Medical Center, Washington, D.C., USA.

      I am getting tired of leafing through Medline, but you get the picture. Prescribing Zoloft is based on more than just "superstition".
       
      Peace,
      Rosemary


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