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Relapse ctm submitted final.pdf

Six-month Depression Relapse Rates among Women Treated with Acupuncture SUBMITTED FOR REVIEW—PLEASE DO NOT CITE OR DISTRIBUTE
Department or institution to which the work should be attributed: Department of Psychology University of Arizona, PO Box 210068 Tucson, AZ 85721-0068 Until June 30, 2001
After July 1, 2001
the published version of this manuscript) Phone, FAX, and email at any time
(520) 626-5401 Voice, (425) 940-5948 FAX
Email: jallen@u.arizona.edu

Source of Support
: Grant R21-RR09492-01 from the National Institutes of Health
Office of Alternative Medicine.
Running Head: DEPRESSIVE RELAPSE FOLLOWING ACUPUNCTURE
Abstract
Conventional treatments for Major Depression, although reasonably effective, leave many without lasting relief. Alternative approaches would therefore be welcome for both short- and long-term treatment of depression. Thirty-eight women were randomized to one of three treatment conditions in a double-blind randomized controlled trial of acupuncture in depression 1. All participants eventually received eight weeks of acupuncture treatment specifically for depression. From among the 33 women who completed treatment, 79% were interviewed at six-month follow-up. Relapse rates were comparable to those of established treatments, with 24% of those who achieved full remission at the conclusion of treatment experiencing a relapse six months later. Compared to other empirically validated treatments, acupuncture designed specifically to treat major depression produces results that are comparable in terms of rates of response and of relapse or recurrence. These results suggest a larger trial of acupuncture in the acute- and maintenance-phase treatment of depression is warranted. Key Words : Major Depression, Treatment, Acupuncture, Relapse, Recurrence
Introduction
Depression frequently recurs, even among those successfully treated with pharmacotherapy, psychotherapy or combined treatments. Following acute treatment, naturalistic follow up across six to 36 months reveal relapse and recurrence rates ranging from approximately 20% to 80% 2-4. Even with continued treatment a substantial proportion (10% to 34%) of treatment responders re-experience depression regardless of the type of treatment received 3 5-12, with larger rates of re-emergence (52%- 70%) during long-term treatment for more severe depression 9 13. Cognitive and interpersonal therapies for depression may provide some benefit in maintaining treatment gains, but are not immune from the specter of relapse. Relapse rates with maintenance psychotherapies range from 17% with weekly visits over 8 months to 60% with monthly These data highlight the recurrent nature of depression, even during the course of long-term treatment, and underscore the importance of developing alternative approaches for both short- and long-term treatment of depression. Initial evidence from a small-scale study 1 found support for the efficacy of acupuncture specifically designed to treat depression, with response rates similar to established well-researched treatments. The longer-term prognosis of these acupuncture responders is unknown, and is the focus of Methods and Results
Participants: As detailed in the acute phase report 1, 38 women aged 18 to 45 were enrolled, all with a current, non-chronic, major depressive episode based on DSM- IV14 criteria. Exclusion criteria were: 1) any other current Axis I disorder; 2) history of mania, hypomania, or psychosis; 3) substance abuse or dependence within the past 4 months; 4) concurrent treatment; 5) endocrine abnormalities, CNS lesions, or any medical disorder or treatment that could cause depressive symptoms; 6) pregnancy; and, 7) active and imminent suicidal potential. Experimental procedures were approved by the university committee on human subjects research. During the acute phase, the severity of participants’ depression was rated using a modified 19-item 1 version of the Hamilton Rating Scale for Depression (HRSD). During acute and follow-up phases, clinical status was assessed by blind clinical raters using the depression module of the Structured Clinical Interview for the DSM (SCID-P) 15. Five women dropped out before completing the entire acute-phase treatment, leaving 33 women in the final sample for possible follow-up. Study Design. In the first eight-week acute treatment phase of the study, participants were randomly assigned to one of three groups: acupuncture specifically designed to address depressive symptoms (specific treatment), acupuncture for a condition other than depression (non-specific treatment), or wait list. All women eventually received eight-weeks of specific treatment. The nonspecific treatment provided an active but hypothetically ineffective treatment for depression, controlling for expectation of treatment effects. With the intent of blinding treatment providers, the following strategies were employed 1 16: 1) An assessing acupuncturist devised for each participant a unique set of points that were individually tailored to address her signs and symptoms according to a manualized protocol 16; 2) Acupuncture treatment plans (specific and nonspecific alike) all involved active and credible constellations of points; 3) Treating acupuncturists did not assess participants to identify the full signs and symptoms of their presentation, and were therefore unlikely to determine whether points would address a given participant’s configuration. It appeared that this design could be considered double-blind since neither provider nor participant expectations of effectiveness differed between specific and nonspecific treatments 1. As reported previously 1, symptom reduction (mean ± s.d. on the 19-item HRSD) in the specific group (-11.7±7.3) exceeded that of the nonspecific group (-2.9±7.9), and there was a nonsignificant trend for symptom reduction in the specific group to exceed that of the waitlist group (-6.1±10.9). Following 8 weeks of treatment, participants in the nonspecific treatment group and those in the wait list received 8 weeks of specific treatment, whereas participants in the specific treatment group discontinued treatment. After completing specific treatment, 22 of the 33 women experienced full remission Follow-up Phase. Participants were interviewed six months after completing specific treatment, using the depression module of the SCID. The interviewer inquired about the worst two-week period during the follow-up period to identify any recurrence or relapse that may have transpired. Data were available for 26 of the original 33 completers (79%). Five of the seven who did not participate in the follow-up phase were fully remitted at acute phase end; nonparticipants did not differ in terms of clinical status at the end of treatment from those who did participate (17/26 remitted at acute phase end; Results. Full remission was defined as the absence of both core symptoms of depression (depressed mood, anhedonia) as determined by the SCID. Among those who had achieved full remission after treatment, 24% had fully relapsed within six months. Remission status at study exit predicted clinical status at six months (chi-square = 4.62, p = .04); whereas 24% of those in remission at the conclusion of treatment had a full depressive relapse during follow-up period, 67% of those without full remission after treatment met criteria for major depressive episode at some point during the six-month follow-up period. Similarly, symptom severity at study exit also predicted clinical status at six months (F[1,25]=3.74, p [one-tailed] = .033). Participants depressed at follow-up had an average HRSD score (19 items) after treatment of 15.5±10.1 (mean±s.d.); participants not depressed at follow-up had HRSD of 9.3±6.3 after treatment. Discussion
The results of the acute-phase study 1 and the present follow-up study indicate that response rates and relapse rates with acupuncture are similar to those reported with other empirically validated treatments 4, suggesting that a larger clinical trial of acupuncture for depression is warranted. These results suggest that acupuncture may be a promising alternative for those who reject traditional treatments, for those who do not show adequate response to traditional treatment, or for those for whom pharmacokinetics are a concern (e.g., the frail elderly, pregnant women)17-24. Acupuncture may also hold promise as a cost-effective long-term maintenance treatment for depression, regardless of the initial treatment modality. These questions will remain for future studies to examine. Acknowledgements
This work was supported, in part, by an Exploratory/Development Grant from the National Institutes of Health (1 R21 RR09492-01), through the Office of Alternative Medicine. The authors wish to thank Della Estrada, Leslie McGee, Bob Stagnitto, and MaryAnn Tully for their tireless efforts and for making the controlled study of the efficacy of acupuncture possible. The authors also thank Varda Shoham and Karen Moriah for their assistance in the planning of this project, and Cindy McGahuey and Jim Cavender for their assistance with recruitment. Address correspondence to John J.B. Allen, Department of Psychology, P.O. Box 210068, University of Arizona, Tucson, AZ, 85721-0068 (Email: jallen@u.arizona.edu). References
1. Allen JJB, Schnyer RN, Hitt SK. The efficacy of acupuncture in the treatment of major depression in women. Psychological Science 1998;9(5):397-401. 2. Blackburn IM, Eunson KM, Bishop S. A two-year naturalistic follow-up of depressed patients treated with cognitive therapy, pharmacotherapy and a combination of both. J Affect Disord 1986;10(1):67-75. 3. Evans MD, Hollon SD, DeRubeis RJ, Piasecki JM, Grove WM, Garvey MJ, et al. Differential relapse following cognitive therapy and pharmacotherapy for depression. Arch Gen Psychiatry 1992;49(10):802-8. 4. Shea MT, Elkin I, Imber SD, Sotsky SM, Watkins JT, Collins JF, et al. Course of depressive symptoms over follow-up. Findings from the National Institute of Mental Health Treatment of Depression Collaborative Research Program. Arch Gen Psychiatry 1992;49(10):782-7. 5. Belsher G, Costello CG. Relapse after recovery from unipolar depression: A critical review. Psychological Bulletin 1988;104(1):84-96. 6. Doogan DP, Caillard V. Sertraline in the prevention of depression [see comments]. Br 7. Frank E, Kupfer DJ, Perel JM, Cornes C, Jarrett DB, Mallinger AG, et al. Three-year outcomes for maintenance therapies in recurrent depression. Arch Gen Psychiatry 8. Montgomery SA, Dufour H, Brion S, Gailledreau J, Laqueille X, Ferrey G, et al. The prophylactic efficacy of fluoxetine in unipolar depression [see comments]. Br J 9. Prien RF, Kupfer DJ, Mansky PA, Small JG, Tuason VB, Voss CB, et al. Drug therapy in the prevention of recurrences in unipolar and bipolar affective disorders. Report of the NIMH Collaborative Study Group comparing lithium carbonate, imipramine, and a lithium carbonate-imipramine combination. Arch Gen 10. Prien RF, Kupfer DJ. Continuation drug therapy for major depressive episodes: how long should it be maintained? Am J Psychiatry 1986;143(1):18-23. 11. Robinson DS, Lerfald SC, Bennett B, Laux D, Devereaux E, Kayser A, et al. Continuation and maintenance treatment of major depression with the monoamine oxidase inhibitor phenelzine: a double-blind placebo-controlled discontinuation study. Psychopharmacol Bull 1991;27(1):31-9. 12. Thase ME. Relapse and recurrence in unipolar major depression: short-term and long- term approaches. J Clin Psychiatry 1990;51 Suppl:51-7; discussion 58-9. 13. Glen AI, Johnson AL, Shepherd M. Continuation therapy with lithium and amitriptyline in unipolar depressive illness: a randomized, double-blind, controlled trial. Psychol Med 1984;14(1):37-50. 14. American Psychiatric Association. Diagnostic and statistical manual of mental disorders (4th ed.). Washington, DC, USA: Author, 1994. 15. Spitzer RL, Williams JBW, Gibbon M, First MB. Structured Clinical Interview for DSM-III-R (SCID). Washington, D.C.: American Psychiatric Press, 1990. 16. Schnyer RN, Allen JJB, Hitt SK, Manber R. Acupuncture in the Treatment of Major Depression: A Manual for Research and Practice. London: Harcourt-Brace 17. NIH Consensus Development Panel on Depression in Late Life. JAMA 18. Laghrissi-Thode F, Pollock BG, Miller MC, Mulsant BH, Altieri L, Finkel MS. Double-blind comparison of paroxetine and nortriptyline on the postural stability of late-life depressed patients. Psychopharmacol Bull 1995;31(4):659-63. 19. Liu BA, Mittmann N, Knowles SR, Shear NH. Hyponatremia and the syndrome of inappropriate secretion of antidiuretic hormone associated with the use of selective serotonin reuptake inhibitors: a review of spontaneous reports [published erratum appears in Can Med Assoc J 1996 Oct 15;155(8):1043]. CMAJ 20. Newhouse PA. Use of serotonin selective reuptake inhibitors in geriatric depression. J Clin Psychiatry 1996;57 Suppl 5:12-22. 21. American Psychiatric Association. Practice guideline for major depressive disorder in adults. American Psychiatric Association [see comments]. Am J Psychiatry 22. Coverdale JH, Chervenak FA, McCullough LB, Bayer T. Ethically justified clinically comprehensive guidelines for the management of the depressed pregnant patient. Am J Obstet Gynecol 1996;174(1 Pt 1):169-73. 23. Robert E. Treating depression in pregnancy [editorial; comment]. N Engl J Med 24. Ramin SM, Bertis B, Little MA, Gilstrap LCI. Psychotropics in pregnancy. In: Gilstrap LC, Little BB, editors. Drugs and Pregnancy. New York: Elsevier

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