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Fluoxetine in the Treatment of Bulimia Nervosa: A Multicenter, Placebo-Controlled, Double-blind Trial

Fluoxetine in the Treatment of Bulimia Nervosa: A Multicenter, Placebo-Controlled, Double-blind... Abstract • Bulimia nervosa represents a serious public health problem in the United States. We performed an 8-week, double-blind trial comparing fluoxetine hydrochloride (60 and 20 mg/d) with placebo in 387 bulimic women treated on an outpatient basis. Fluoxetine at 60 mg/d proved superior to placebo in decreasing the frequency of weekly binge-eating and vomiting episodes at end point. Fluoxetine at 20 mg/d produced an effect between that of the 60mg/d dosage and that of placebo. Depression, carbohydrate craving, and pathologic eating attitudes and behaviors also improved significantly with fluoxetine, with the higher dosage again showing a more robust effect than the lower dosage. Several adverse events (ie, insomnia, nausea, asthenia, and tremor) occurred significantly more frequently with fluoxetine (60 or 20 mg/d) than with placebo. However, there was no statistically significant difference among treatment groups in the proportion of patients discontinuing the study because of adverse events. References 1. American Psychiatric Association, Committee on Nomenclature and Statistics. Diagnostic and Statistical Manual of Mental Disorders—Revised Third Edition . Washington, DC: American Psychiatric Association; 1987. 2. Shotte DE, Stunkard AJ. Bulimia vs bulimic behaviors on a college campus . JAMA . 1987;258:1213-1215.Crossref 3. Thelen MH, McLaughlin L, Pruitt J, Smith M. Bulimia: prevalence and component factors in college women . J Psychosomat Res . 1987;31:73-78.Crossref 4. Pope HG Jr, Hudson JI, Yurgelun-Todd D. Anorexia nervosa and bulimia among 300 suburban women shoppers . Am J Psychiatry . 1984;141:292-294. 5. Pope HG Jr, Champoux RF, Hudson JI. Eating disorder and socioeconomic class: anorexia nervosa and bulimia in nine communities . J Nerv Ment Dis . 1987;175:620-623.Crossref 6. Mitchell JE, Seim HC, Colon E, Pomeroy C. Medical complications and medical management of bulimia . Ann Intern Med . 1987;107:71-77.Crossref 7. Herzog DB, Copeland PM. Eating disorders . N EnglJ Med . 1985;313:295-303.Crossref 8. Palmer EP, Guay AT. Reversible myopathy secondary to abuse of ipecac in patients with major eating disorders . N Engl J Med . 1985;314:1457-1459.Crossref 9. Pope HG Jr, Hudson JI, Nixon RA, Herridge PL. The epidemiology of ipecac abuse . N Engl J Med . 1986;314:245-246. 10. Pope HG Jr, Hudson JI, Jonas JM, Yurgelun-Todd D. Bulimia treated with imipramine: a placebo-controlled, doubleblind study . Am J Psychiatry . 1983;140:554-558. 11. Hughes PL, Wells LA, Cunningham CJ, Ilstrup DM. Treating bulimia with desipramine: a placebo-controlled double-blind study . Arch Gen Psychiatry . 1986;43:182-186.Crossref 12. Agras WS, Dorian BG, Kirkley BG, Arnow B, Bachman J. Imipramine in the treatment of bulimia: a double-blind controlled study . Int J Eating Disorders . 1987;6:29-38.Crossref 13. Kaplan AS, Garfinkel PE, Garner DM. Bulimia treated with carbamazepine and imipramine. Presented at the American Psychiatric Association Annual Meeting; May 13, 1987; chicago, Ill. 14. Barlow J, Blouin J, Blouin A, Perez E. Treatment of bulimia with desipramine: a double-blind crossover study . Can J Psychiatry . 1988;33:129-133. 15. Price WA, Babai MR. Antidepressant drug therapy for bulimia: current status revisited . J Clin Psychiatry . 1987;48:385. 16. Walsh BT, Gladis M, Roose SP, Stewart JW, Stetner F, Glassman AH. Phenelzine vs placebo in 50 patients with bulimia . Arch Gen Psychiatry . 1988;45:471-475.Crossref 17. Kennedy SH, Piran N, Warsh JJ, Prendergast P, Mainprize E, Whynot C, Garfinkel PE. A trial of isocarboxazid in the treatment of bulimia nervosa . J Clin Psychopharmacol . 1988;8:391-396.Crossref 18. Horne RL, Ferguson JM, Pope HG Jr, Hudson JI, Lineberry CG, Ascher J, Cato A. Treatment of bulimia with bupropion: a multicenter controlled trial . J Clin Psychiatry . 1988; 49:262-266. 19. Pope HG Jr, Keck PE Jr, McElroinSM, Hudson JI. A placebo-controlled study of trazodone in bulimia nervosa . J Clin Psychopharmacol . 1989;9:254-259.Crossref 20. Mitchell JE, Groat R. A placebo-controlled, double-blind trial of amitriptyline in bulimia . J Clin Psychopharmacol . 1984; 4:186-193.Crossref 21. Sabine EJ, Yonace A, Farrington AJ, Barratt KH, Wakeling A. Bulimia nervosa: a placebo-controlled double-blind therapeutic trial of mianserin . Br I Clin Pharmacol . 1983; 15( (suppl) ):195S-202S.Crossref 22. Pope HG Jr, Hudson JI. Antidepressant drug therapy of bulimia: current status . J Clin Psychiatry . 1986;47:339-345. 23. Pope HG Jr, Hudson JI, Jonas JM. Antidepressant treatment of bulimia: preliminary experience and practical recommendations . J Clin Psychopharmacol . 1983;3:274-281. 24. Chouinard G. A double-blind controlled clinical trial of fluoxetine and amitriptyline in the treatment of outpatients with major depressive disorder . J Clin Psychiatry . 1985;46:32-37. 25. Feighner JP. Clinical efficacy of the new antidepressants . J Clin Pharmacol . 1981;1:235-265. 26. Cohn JB, Wilcox C. A comparison of fluoxetine, imipramine, and placebo in patients with major depressive disorder . J Clin Psychiatry . 1985;46:26-31. 27. Stark P, Hardison CD. A review of multicenter controlled studies of fluoxetine vs imipramine and placebo in outpatients with major depressive disorder . J Clin Psychiatry . 1985;46:53-58. 28. Leibowitz SF, Brown O, Tretter JR, Kirschgessner A. Norepinephrine, clonidine, and tricyclic antidepressants selectively stimulate carbohydrate ingestion through noradrenergic system of the paraventricular nucleus . Pharmacol Biochem Behav . 1985;23:541-550.Crossref 29. Berken GH, Weinstein DO, Stern WC. Weight gain: a side effect of tricyclic antidepressants . J Affective Disord . 1984;7:133-138.Crossref 30. Fernstrom MD, Krowinski RL, Kupfer DJ. Chronic imipramine treatment and weight gain . Psychiatry Res . 1986; 17:269-273.Crossref 31. Ferguson JM, Feighner JP. Fluoxetine-induced weight loss in overweight nondepressed humans . Int J Obesity . 1987;11( (suppl) ):179S-184S. 32. Levine LR, Rosenblatt S, Bosomworth JC. Use of serotonin reuptake inhibitor, fluoxetine, in the treatment of obesity . IntJ Obesity . 1987;11( (suppl) ):185S-190S. 33. Pope HG Jr, Hudson JI. New Hope for Binge Eaters: Advances in the Understanding and Treatment of Bulimia . New York, NY: Harper & Row Publishers Inc; 1984. 34. Freeman CPL, Hampson M. Fluoxetine as a treatment for bulimia nervosa . Int J Obesity . 1987;11( (suppl) ):171S-177S. 35. Freeman CP, Munro JK. Drug and group treatments for bulimia/bulimia nervosa . J Pychosom Res . 1988;32:647-660.Crossref 36. Levine LR, Enas GG, Thompson WL, Byyny RL, Dauer AD, Kirby RW, Kreindler TG, Levy B, Lucas CP, Mcllwain HH, Nelson EB. Use of fluoxetine, a selective serotonin-uptake inhibitor, in the treatment of obesity: a dose-response study . Int J Obesity . 1989;13:635-645. 37. Metropolitan Life Insurance Company. Height and weight tables . Metropolitan Life Foundation Statistical Bulletin . 1983;64:62. 38. Hamilton M. A rating scale for depression . J Neurol Neurosurg Psychiatry . 1960;23:56-65.Crossref 39. Garner DM, Olmstead MP, Polivy J. Development and validation of a multidimensional eating disorder inventory for anorexia nervosa and bulimia . Int J Eating Disorders . 1983;2:15-34.Crossref 40. Garner DM, Olmstead MP, Bohr Y, Garfinkel PE. The eating attitude test: psychometric features and clinical correlates . Psychol Med . 1982;12:871-878.Crossref 41. Wurtman JJ, Wurtman RJ. Suppression of carbohydrate intake from snacks and meals by d-fenfluramine and tryptophan . In: Garrattini S, ed. Anorectic Agents: Mechanisms of Action and Tolerance . New York, NY: Raven Press; 1981:169-181. 42. US Food and Drug Administration. COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms . 2nd ed. Rockville, Md: Food and Drug Administration; 1985. 43. SAS/STAT User's Guide, Version 5 Ed. Cary, NC: SAS Institute Inc; 1985:2. 44. Cramer JA, Mattson RH, Prevey ML, Scheyer RD, Ouellette VL. How often is medication taken as prescribed? A novel assessment technique . JAMA . 1989;261:3273-3277.Crossref 45. Lemberger L, Bergstrom RF, Wolen RL, Farid NA, Enas GG, Aronoff GR. Fluoxetine: clinical pharmacology and physiologic disposition . J Clin Psychiatry . 1985;46:14-19. 46. Wernicke JF, Dunlop SR, Dornseif BG, Zerbe RL. Fixed dose fluoxetine therapy for depression . Psychopharmacol Bull . 1987;23:164-168. 47. Wurtman JJ, Wurtman RJ. Drugs that enhance central serotonergic transmission diminish elective carbohydrate consumption by rats . Life Sci . 1980;24:825-826. 48. Kaye WH, Gwirtsman HE, Brewerton TD, George DT, Wurtman RJ. Bingeing behavior and plasma amino acids: a possible involvement of brain serotonin in bulimia nervosa . Psychiatry Res . 1988;23:31-43.Crossref 49. Fernstrom JD, Wurtman RJ. Brain serotonin content: increase following ingestion of carbohydrate diet . Science . 1971;174:1023-1025.Crossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of General Psychiatry American Medical Association

Fluoxetine in the Treatment of Bulimia Nervosa: A Multicenter, Placebo-Controlled, Double-blind Trial

Archives of General Psychiatry , Volume 49 (2) – Feb 1, 1992
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Publisher
American Medical Association
Copyright
Copyright © 1992 American Medical Association. All Rights Reserved.
ISSN
0003-990X
eISSN
1598-3636
DOI
10.1001/archpsyc.1992.01820020059008
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Abstract

Abstract • Bulimia nervosa represents a serious public health problem in the United States. We performed an 8-week, double-blind trial comparing fluoxetine hydrochloride (60 and 20 mg/d) with placebo in 387 bulimic women treated on an outpatient basis. Fluoxetine at 60 mg/d proved superior to placebo in decreasing the frequency of weekly binge-eating and vomiting episodes at end point. Fluoxetine at 20 mg/d produced an effect between that of the 60mg/d dosage and that of placebo. Depression, carbohydrate craving, and pathologic eating attitudes and behaviors also improved significantly with fluoxetine, with the higher dosage again showing a more robust effect than the lower dosage. Several adverse events (ie, insomnia, nausea, asthenia, and tremor) occurred significantly more frequently with fluoxetine (60 or 20 mg/d) than with placebo. However, there was no statistically significant difference among treatment groups in the proportion of patients discontinuing the study because of adverse events. References 1. American Psychiatric Association, Committee on Nomenclature and Statistics. Diagnostic and Statistical Manual of Mental Disorders—Revised Third Edition . Washington, DC: American Psychiatric Association; 1987. 2. Shotte DE, Stunkard AJ. Bulimia vs bulimic behaviors on a college campus . JAMA . 1987;258:1213-1215.Crossref 3. Thelen MH, McLaughlin L, Pruitt J, Smith M. Bulimia: prevalence and component factors in college women . J Psychosomat Res . 1987;31:73-78.Crossref 4. Pope HG Jr, Hudson JI, Yurgelun-Todd D. Anorexia nervosa and bulimia among 300 suburban women shoppers . Am J Psychiatry . 1984;141:292-294. 5. Pope HG Jr, Champoux RF, Hudson JI. Eating disorder and socioeconomic class: anorexia nervosa and bulimia in nine communities . J Nerv Ment Dis . 1987;175:620-623.Crossref 6. Mitchell JE, Seim HC, Colon E, Pomeroy C. Medical complications and medical management of bulimia . Ann Intern Med . 1987;107:71-77.Crossref 7. Herzog DB, Copeland PM. Eating disorders . N EnglJ Med . 1985;313:295-303.Crossref 8. Palmer EP, Guay AT. Reversible myopathy secondary to abuse of ipecac in patients with major eating disorders . N Engl J Med . 1985;314:1457-1459.Crossref 9. Pope HG Jr, Hudson JI, Nixon RA, Herridge PL. The epidemiology of ipecac abuse . N Engl J Med . 1986;314:245-246. 10. Pope HG Jr, Hudson JI, Jonas JM, Yurgelun-Todd D. Bulimia treated with imipramine: a placebo-controlled, doubleblind study . Am J Psychiatry . 1983;140:554-558. 11. Hughes PL, Wells LA, Cunningham CJ, Ilstrup DM. Treating bulimia with desipramine: a placebo-controlled double-blind study . Arch Gen Psychiatry . 1986;43:182-186.Crossref 12. Agras WS, Dorian BG, Kirkley BG, Arnow B, Bachman J. Imipramine in the treatment of bulimia: a double-blind controlled study . Int J Eating Disorders . 1987;6:29-38.Crossref 13. Kaplan AS, Garfinkel PE, Garner DM. Bulimia treated with carbamazepine and imipramine. Presented at the American Psychiatric Association Annual Meeting; May 13, 1987; chicago, Ill. 14. Barlow J, Blouin J, Blouin A, Perez E. Treatment of bulimia with desipramine: a double-blind crossover study . Can J Psychiatry . 1988;33:129-133. 15. Price WA, Babai MR. Antidepressant drug therapy for bulimia: current status revisited . J Clin Psychiatry . 1987;48:385. 16. Walsh BT, Gladis M, Roose SP, Stewart JW, Stetner F, Glassman AH. Phenelzine vs placebo in 50 patients with bulimia . Arch Gen Psychiatry . 1988;45:471-475.Crossref 17. Kennedy SH, Piran N, Warsh JJ, Prendergast P, Mainprize E, Whynot C, Garfinkel PE. A trial of isocarboxazid in the treatment of bulimia nervosa . J Clin Psychopharmacol . 1988;8:391-396.Crossref 18. Horne RL, Ferguson JM, Pope HG Jr, Hudson JI, Lineberry CG, Ascher J, Cato A. Treatment of bulimia with bupropion: a multicenter controlled trial . J Clin Psychiatry . 1988; 49:262-266. 19. Pope HG Jr, Keck PE Jr, McElroinSM, Hudson JI. A placebo-controlled study of trazodone in bulimia nervosa . J Clin Psychopharmacol . 1989;9:254-259.Crossref 20. Mitchell JE, Groat R. A placebo-controlled, double-blind trial of amitriptyline in bulimia . J Clin Psychopharmacol . 1984; 4:186-193.Crossref 21. Sabine EJ, Yonace A, Farrington AJ, Barratt KH, Wakeling A. Bulimia nervosa: a placebo-controlled double-blind therapeutic trial of mianserin . Br I Clin Pharmacol . 1983; 15( (suppl) ):195S-202S.Crossref 22. Pope HG Jr, Hudson JI. Antidepressant drug therapy of bulimia: current status . J Clin Psychiatry . 1986;47:339-345. 23. Pope HG Jr, Hudson JI, Jonas JM. Antidepressant treatment of bulimia: preliminary experience and practical recommendations . J Clin Psychopharmacol . 1983;3:274-281. 24. Chouinard G. A double-blind controlled clinical trial of fluoxetine and amitriptyline in the treatment of outpatients with major depressive disorder . J Clin Psychiatry . 1985;46:32-37. 25. Feighner JP. Clinical efficacy of the new antidepressants . J Clin Pharmacol . 1981;1:235-265. 26. Cohn JB, Wilcox C. A comparison of fluoxetine, imipramine, and placebo in patients with major depressive disorder . J Clin Psychiatry . 1985;46:26-31. 27. Stark P, Hardison CD. A review of multicenter controlled studies of fluoxetine vs imipramine and placebo in outpatients with major depressive disorder . J Clin Psychiatry . 1985;46:53-58. 28. Leibowitz SF, Brown O, Tretter JR, Kirschgessner A. Norepinephrine, clonidine, and tricyclic antidepressants selectively stimulate carbohydrate ingestion through noradrenergic system of the paraventricular nucleus . Pharmacol Biochem Behav . 1985;23:541-550.Crossref 29. Berken GH, Weinstein DO, Stern WC. Weight gain: a side effect of tricyclic antidepressants . J Affective Disord . 1984;7:133-138.Crossref 30. Fernstrom MD, Krowinski RL, Kupfer DJ. Chronic imipramine treatment and weight gain . Psychiatry Res . 1986; 17:269-273.Crossref 31. Ferguson JM, Feighner JP. Fluoxetine-induced weight loss in overweight nondepressed humans . Int J Obesity . 1987;11( (suppl) ):179S-184S. 32. Levine LR, Rosenblatt S, Bosomworth JC. Use of serotonin reuptake inhibitor, fluoxetine, in the treatment of obesity . IntJ Obesity . 1987;11( (suppl) ):185S-190S. 33. Pope HG Jr, Hudson JI. New Hope for Binge Eaters: Advances in the Understanding and Treatment of Bulimia . New York, NY: Harper & Row Publishers Inc; 1984. 34. Freeman CPL, Hampson M. Fluoxetine as a treatment for bulimia nervosa . Int J Obesity . 1987;11( (suppl) ):171S-177S. 35. Freeman CP, Munro JK. Drug and group treatments for bulimia/bulimia nervosa . J Pychosom Res . 1988;32:647-660.Crossref 36. Levine LR, Enas GG, Thompson WL, Byyny RL, Dauer AD, Kirby RW, Kreindler TG, Levy B, Lucas CP, Mcllwain HH, Nelson EB. Use of fluoxetine, a selective serotonin-uptake inhibitor, in the treatment of obesity: a dose-response study . Int J Obesity . 1989;13:635-645. 37. Metropolitan Life Insurance Company. Height and weight tables . Metropolitan Life Foundation Statistical Bulletin . 1983;64:62. 38. Hamilton M. A rating scale for depression . J Neurol Neurosurg Psychiatry . 1960;23:56-65.Crossref 39. Garner DM, Olmstead MP, Polivy J. Development and validation of a multidimensional eating disorder inventory for anorexia nervosa and bulimia . Int J Eating Disorders . 1983;2:15-34.Crossref 40. Garner DM, Olmstead MP, Bohr Y, Garfinkel PE. The eating attitude test: psychometric features and clinical correlates . Psychol Med . 1982;12:871-878.Crossref 41. Wurtman JJ, Wurtman RJ. Suppression of carbohydrate intake from snacks and meals by d-fenfluramine and tryptophan . In: Garrattini S, ed. Anorectic Agents: Mechanisms of Action and Tolerance . New York, NY: Raven Press; 1981:169-181. 42. US Food and Drug Administration. COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms . 2nd ed. Rockville, Md: Food and Drug Administration; 1985. 43. SAS/STAT User's Guide, Version 5 Ed. Cary, NC: SAS Institute Inc; 1985:2. 44. Cramer JA, Mattson RH, Prevey ML, Scheyer RD, Ouellette VL. How often is medication taken as prescribed? A novel assessment technique . JAMA . 1989;261:3273-3277.Crossref 45. Lemberger L, Bergstrom RF, Wolen RL, Farid NA, Enas GG, Aronoff GR. Fluoxetine: clinical pharmacology and physiologic disposition . J Clin Psychiatry . 1985;46:14-19. 46. Wernicke JF, Dunlop SR, Dornseif BG, Zerbe RL. Fixed dose fluoxetine therapy for depression . Psychopharmacol Bull . 1987;23:164-168. 47. Wurtman JJ, Wurtman RJ. Drugs that enhance central serotonergic transmission diminish elective carbohydrate consumption by rats . Life Sci . 1980;24:825-826. 48. Kaye WH, Gwirtsman HE, Brewerton TD, George DT, Wurtman RJ. Bingeing behavior and plasma amino acids: a possible involvement of brain serotonin in bulimia nervosa . Psychiatry Res . 1988;23:31-43.Crossref 49. Fernstrom JD, Wurtman RJ. Brain serotonin content: increase following ingestion of carbohydrate diet . Science . 1971;174:1023-1025.Crossref

Journal

Archives of General Psychiatry – American Medical Association

Published: Feb 1, 1992

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