Benzodiazepine - Discontinuation of Benzodiazepine...

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Unformatted text preview: Discontinuation of Benzodiazepine Treatment: Efficacy of Cognitive-Behavioral Therapy for Patients With Panic Disorder Michael W. Otto, Ph.D., Mark H. Pollack, M.D., Gary S. Sachs, M.D., Stewart R. Reiter, M.D., Samantha Meltzer-Brody, 3.5., and Jerrold F. Rosenbaum, M.D. The primary disadvantage of high-potency benzodiazepine treatment for panic disorder is the difficulty of discontinuing the treatment. During treatment discontinuation, new symptoms may emerge and anxiety may return, preventing many patients from success- fully discontinuing their treatment. In this controlled, randomized trial the authors investi- gated the efficacy of a cognitive-behavioral program for patients with panic disorder who were attempting to discontinue treatment with high-potency benzodiazepines. Method; Outpatients treated for panic disorder with alprazolam or clonazepam for a minimum of 6 months and expressing a desire to stop taking the medication (N=33) were randomly assigned to one of two taper conditions: a slow taper condition alone or a slow taper condition in conjunction with 10 weeks of group cognitive-behavioral therapy. Results; The rate of successful discon- tinuation of benzodiazepine treatment was significantly higher for the patients receiving the cognitive-behavioral program (13 of 17,- 76%) than for the patients receiving the slow taper program alone (four of 1 6,- 25%). There was no difference in the likelihood of discontinuation success between the patients treated with alprazolam and those who received clonazepam. At the 3-month follow-up evaluation, 77% of the patients in the cognitive-behavioral program ’ who successfully discontinued benzodiazepine treatment remained benzodiazepine free. Can; plasmas; These findings support the efficacy of cognitive-behavioral interventions in aiding benzodiazepine discontinuation for patients with panic disorder. (Am J Psychiatry 1993; 150:1485-1490) he ease of initiating treatment of panic disorder with high-potency benzodiazepines is frequently offset by subsequent difficulties in discontinuing such treatment. Moderate to severe symptoms are associated with abrupt withdrawal of benzodiazepine treatment (1), and although gradual tapering diminishes symp- toms, they continue to be a major problem for many patients (2—4). The discontinuation of alprazolarn therapy for pa- tients being treated for panic disorder has been the fo- cus of particular attention (3). For example, Fyer et al. (5) reported that among panic disorder patients under- going alprazolam withdrawal, with a reduction of 10% Received Nov. 3, 1992; revision received Feb. 25, 1993; accepted March 19, 1993. From the Behavior Therapy and Clinical Psycho- pharmacology Units, Massachusetts General Hospital and Harvard Medical School. Address reprint requests to Dr. Otto, WACC-815, Massachusetts General Hospital, 15 Parkman St., Boston, MA 02144. Supported in pan by NIMH Faculty Scholar Award MH-19600 to Dr. Pollack and a grant from Roche Laboratories, a Division of Hoff- man laRoche, Inc. Copyright 0 1993 American Psychiatric Association. Am 1 Psychiatry 150.40, October 1993 of the starting dose every 3 days, only four (24%) of the 17 patients completed the withdrawal program. Fur- thermore, 15 of the 17 patients experienced increased panic attacks and nine of the 17 experienced other withdrawal symptoms. Fourteen of the 15 patients with more panic attacks had been panic free before the taper. Similar rates of recurrent panic attacks during alprazo- lam discontinuation (74%) were reported by Noyes et al. (6); 64% of their patients were unable to stop taking their medication, and 60% reported anxiety symptoms during taper that were as bad as or worse than those before treatment. These difficulties are not limited to high-potency benzodiazepines (4, 7). For example, Noyes et al. (6) reported that 58% of patients with panic disorder who were treated with diazepam were unable to discontinue treatment, and 60% experienced a return of panic. Approximately 60% of their benzo- diazepine-treated patients developed novel symptoms during discontinuation. Various interventions have been used to decrease the difficulties associated with benzodiazepine discontinu- ation. As noted, a gradual rather than rapid taper may 1485 DISCONTINUATION OF BENZODIAZFJ’INE TREATMENT reduce but not eliminate discontinuation symptoms (2- 4). Studies evaluating adjunctive medication strategies have found no significant benefits with buspirone treat- ment (8) but a possible benefit with carbamazepine (9, 10), although systematic investigation of the utility of carbamazepine for this use is pending. The substitution of a longer—acting high-potency benzodiazepine (i.e., clonazepam) for a shorter-acting agent (i.e., alprazo- lam) to facilitate discontinuation has received anecdo- tal support (11, 12), although this relative advantage may be obviated by slowing the rate of taper (4). Cognitive-behavioral interventions offer an altema- tive approach that may be particularly helpful for un- derstanding and treating difficulties associated with benzodiazepine discontinuation. Reports from uncon- trolled studies (13—16) suggest that cognitive-behav- ioral interventions may help patients discontinue their benzodiazepine treatment. However, these studies did not exclusively target patients with panic disorder and did not use the most current cognitive-behavioral in- terventions. Most cognitive-behavioral approaches posit that panic disorder is maintained because an individual de- velops fear of somatic sensations associated with panic attacks (17-21). Anxiety itself becomes a phobic stimu- lus, and anxious apprehension about the possibility of a panic episode directs attention to feared bodily sensa- tions associated with anxiety (e.g., tachycardia), en- sures that these sensations will be experienced, and helps evoke another panic episode. Although both cog- nitive-behavioral and pharmacological treatments are effective in decreasing anxiety and blocking panic, pharmacological treatments do not address the fear and catastrophic misinterpretation of the somatic sensa- tions associated with panic. This untreated fear may set the stage for discontinuation difficulties. Benzodiazepine discontinuation, even with slow ta- per, is associated with the emergence of anxiety symp- toms (4). As a result, the discontinuation process en- sures that patients are exposed to increased anxiety and somatic sensations associated with panic. This occurs at a time when the patients are vigilant about the re- emergence or worsening of anxiety and panic due to the rem0val of treatment. Given this model of discontinu- ation difficulties, interventions to facilitate medication discontinuation should treat the tendency to cata- strophically misinterpret somatic sensations of anxiety, so that the emergence of these sensations during and after discontinuation will not provoke panic episodes (22). To achieve this goal, informational and cognitive interventions are combined with interoceptive exposure (exposure to somatic sensations of anxiety) and somatic symptom management interventions that are currently used to treat panic disorder itself (23-25 ). 1n the discon- tinuation program, these interventions target the sensa- tions arising from benzodiazepine discontinuation. In this randomized, controlled study we examined the efficacy of a short-term cognitive-behavioral intervention for panic disorder patients wishing to discontinue benzo- diazepine therapy. We made the following hypotheses. 1486 1 . A significant proportion of the patients (more than 50%) would be unable to discontinue their benzodiaz- epine treatment when using a conservative taper sched- ule and clinical support alone. 2. More patients would be able to discontinue taking clonazepam, which has a longer half-life, than alprazo- lam, but this advantage would disappear by 3-month follow-up. 3. Concomitant cognitive-behavioral treatment would result in a significantly greater rate of successful discon- tinuation of alprazolam or clonazepam treatment. 4. At 3-month follow-up, a significantly greater pro- portion of patients receiving cognitive-behavioral treat- ment would have, remained free of medication than pa- tients receiving the standard taper alone. METHOD Subject Selection and Assignment Outpatients treated for panic disorder with alprazolam or clona- upam for a minimum of 6 months and seeking to discontinue this treatment were selected for the study. In most cases, the patients had attempted dose reducrions on their own and were self- or clinician- referred for additional treatment interventions. The reasons for dis- continuation included dissatisfaaion with the effects of the medica~ tion, planned pregnancy, and intention to reassess clinical status or control panic without the use of medication. Patients were excluded from participation if they had previously undergone behavioral treat- ment for panic disorder, concurrently used psychoactive medications other than alprazolam, clonazepam, or antidepressant medications, were psychotic or currently suicidal, or had a history of seizure dis- order. Patients were block randomized to one of two treatment pro- grams, taper as usual or taper plus cognitive-behavioral treatment, according to the following characteristics: 1) alprazolam or donate- pam, 2) concurrent use of antidepressant medication, and 3) daily use of more than 3.0 mg of alprazolam or the equivalent dose of clona- aepam (1.5 mg). All patients provided informed consent. Procedure 11m taper as usual condition included information on discontinu- adon effects, a slow taper schedule, weekly clinical monitoring, and general encouragement and support regarding discontinuation diffi- culties. The withdrawal schedule for patients taking alprazolam was a reduction of the daily dose by 0.25 mg every 2 days for doses above 2.0 mg. For patients starting at 2.0 mg or below and for patients reaching this level during their nper, the alprazolam dose was re- duced by 0.125 mg every 2 days. According to this schedule, the taper was approximately 5 weeks for patients taking a daily dose of 2.0 mg and 7 weeks for patients taking 4.0 mg. Patients taking clonazepam followed a similar taper schedule adjusted for the approximate 2:1 difference in potency and available pill size (0.5 mg) for clonazepam. Patients taking more than 1.0 rug/day of clonaupam decreased the dose by 0.25 mg every 4 days, and they then reduced it by 0.25 every 8 days for doses of 1.0 mg or less. According to this schedule, the taper lasted approximately 7 weeks for a patient taking a daily dose of 2 mg of clonazepam. For the initial doses encountered in this study, the alprazolam taper schedule for doses above 0.5 mg is roughly equivalent to a weekly 25% reduction in dose and, thus, similar to that used in previous studies (4, 5), and this taper schedule is substan- tially slower than the taper rate suggested by the manufacturer of alprazolam and approved by the us. Food and Drug Administration. Whereas a slower taper schedule could have been used, the rate cho- sen strikes a balance between an ultraslow taper and discontinuation in a reasonable time frame. The medication reductions were struc- tured for each participant by a written withdrawal schedule that Am J Psychiatry 150:10, October 1993 specified the scheduled daily dose and provided space for the patient to mord the actual doses taken. Consistent with recommendations for successful taper (26), the use of occasional extra doses (as needed) was permitted during the taper schedule as long as the taper failure criteria were not met (described in the following section). The pa- n'ents were scheduled to meet with their study physicians weekly dur- ing medication wid’rdrawal. A decision not to proceed with scheduled dose reductions was made by individual patients in conjunction with their study physician. Participants receiving taper plus cognitive-behavioral u'eatrrient re- ceived all the elements of taper as usual, including identical taper schedules, but also received 10 sessions of cognitive-behavioral ther- apy in weekly group sessions of 90 minutes’ duration for the first five sessions and 60 minutes for the last five sessions. Before the initiation of treatment, the patients met individually with the behavior therapist (M.W.O.) to complete evaluations of their anxiety and panic difficul- ties. The cognitive-behavioral treatment was based on current treat- ments reported to yield marked success in the treatment of panic dis- order (23-25) and included the following. 1. Identification of symptoms of both withdrawal and panic, re- view of behavioral patterns in panic, identification of atastrophic interpretations of symptoms, and review and rehearsal of more adap- tive interpretations and cognitive coping strategies. 2. Structured exposure to somatic sensations of anxiety and panic (interoceptive exposure) and rehearsal of coping strategies as the pa- tients experienced anxiety or withdrawal symptoms. Self-directed ex- posure to avoided situations was encouraged in later sessions. Intero- ceptive exposure exercises, designed to induce somatic sensations similar to anxiety, panic, and withdrawal symptoms, included activi- ties such as hyperventilation, head rolling, and running up stairs. 3. Teaching and practice of somatic coping skills (muscle relaxa- tion and diaphragmatic breathing techniques). The pretreatment assessment included five self-report measures that were used as predictors of withdrawal success or failure: fre- quency of panic snacks, severity of generalized anxiety as assessed with the Beck Anxiety Inventory (27), fear of anxiety symptoms as assessed with the Anxiety Sensitivity Index (28, 29), level of avoid- ance as indicated by the Fear Questionnaire total score (30), and se- verity of depressed mood as assessed with the Beck Depression Inven- tory (31). Weekly assessments consisted of a daily diary of panic frequency, mood, and medication and alcohol use and, at die weekly clinical visit, assessment of anxiety with the Beck Anxiety Inventory and measurement of withdrawal symptoms with the clinician-rated Benzodiazepine Withdrawal Checklist (32). After selection, random assignment, and completion of the pre- treatment assessment measures, the patients completed the daily and weekly assessment measures over a 2-week baseline period. They were then asked to continue their daily and weekly assessments for the duration of the taper program and for 2 weeks after discontinu- ation. The patients receiving taper as usual initiated the taper at the next scheduled session (between 1 and 3 weeks after the baseline visits). The patients receiving the cognitive-behavioral treatment were scheduled for the behavior therapy group and beyn the taper process after the third group session. Outcome Criteria The principal dependent measure was the proportion of patients successfully completing the scheduled taper. Successful discontinu- ation was defined a priori as completion of the taper as scheduled without substantial deviation and no use of benzodiazepine medica- tions beyond “minimal p.r.n. use“ during the 2 postdiscontinuation evaluation weeks. Substantial deviation from the taper schedule in- cluded 1) failure to make a scheduled dose decrease for 10 days, 2) falling more than 14 days behind the taper schedule for any consecu- tive 3 days, or 3) continued benzodiazepine use beyond 14 days from the scheduled zero-dose date. Patients deviating from the taper schedule as indicated were considered treatment failures for the pur- pose of data analyses. Minimal benzodiaaepine use was defined as use of no more than two doses of medication as needed (each not to exceed 0.5 mg of alprazolam or clonaaepam) during the 2 weeks after discontinuation to ensure that patients taking small doses as needed for extraordinary circumstances or relatively rare phobic Am J Psychiatry 1 50:1 0, October 1993 OTTO, POLLACK, SACHS, ET A]... events (e.g., a trip to the dentist or a yearly plane trip) were not considered taper failures. To be included in the primary outcome analyses a patient must have completed the baseline assessment and must have been sched- uled for at least one dose reduction at the time of dropout. One pa- tient assigned to taper plus cognitive-behavioral treatment who met these criteria was tapering on schedule but moved out of the state during the program and was lost to follow-up. This patient was re- placed in the randomization. One patient assigned to taper as usual refused to initiate her taper because of fears of increased symptoms. As no taper was actually attempted, this patient was excluded from the analyses so as to ensure a conservative test of the advantage of taper plus cognitive-behavioral treatment over taper alone. This pa- tient was not replaced in the randomization. Baseline Patient Characteristics Thirty-three patients (22 women and 11 men) completed the base- line assessment and were scheduled for taper; 17 received taper plus cognitive-behavioral treatment and 16 were given taper as usual alone. The subjects‘ ages ranged from 27 to 55 years, and the mean age was 38.2 years (SDs7.4). The mean Fear Questionnaire total score of the patients given taper plus cognitive-behavioral treatment (mean-30.6, SD=16.6) did not differ significantly from that of the patients given taper alone (mean=28.7, SD:21.2). Similarly, there were no significant differences in baseline scores on the Beck Anxiety Inventory (mean:14.3, SDs$.5 versus mean-14.3, SD:11.4) or Ben- aodiazepine Withdrawal Checklist (mean=23.1, 50:15.2 versus mean:16.5, SDxIZJ). Thirteen (39%) of the 33 patients were panic free during the 2 weeks of baseline evaluation. At baseline the mean number of panic attacks per week was 3.5 (SD:6.3) for the patients given taper plus cognitiveobehavioral treatment and 1.8 (SD:2.3) for the patients given taper as usual, and this difference was not significant. Twenty patients were taking clonuepam, and 13 were taking al- prazolam. Eight (62%) of the alprazolam-treated patients and nine (45 %) of the clonazepam-treated patients were assigned to taper plus cognitive-behavioral treatment. Because of this nonsignificant trend toward a higher proportion of alprazolam-treated patients being as- signed to taper plus cognitive-behavioral treatment, in all tests of treatment differences this differential assignment was accounted for by using Mantel-Haenszel chi-square procedures. The mean dose of clonazepam was 1.5 mg/day (SD:1.1), and the mean dose of alprazolam was 1.3 myday (SD=1.1). Because of the different potencies of alprazolarn and clonaaepam (33), the patients taking clonazepam were receiving, on average, twice the equivalent dose of the alprazolam-treated patients. The mean doses of benzodi- aaepine medication, expressed as alprazolam-equivalent doses, were not significantly different between the two treatment groups: 2.15 (SD:2.03) for the patients given taper plus cognitive-behavioral treat- ment and 2.68 (SD:2.06) for the patients given taper as usual alone. Four patients given taper plus cognitive-behavioral treatment and two patients in the group given taper alone were taking antidepres- sant medications at baseline and centinued their stable doses of these medications throughout the taper period. RESULTS Of the 17 patients receiving taper plus cognitive—be- havioral treatment, 13 (76%) successfully discontin- ued their benzodiazepine treatment. Of the 16 patients receiving taper alone, four (25%) successfully discon- tinued treatment. This difference was significant ac- cording to direct analysis with Fisher’s exact test (two- tailed, p<0.005 ) and a Mantel-Haenszel chi-square test controlling for the two medication conditions (x2=7.61, df=l, p<0.01 Eight (40%) of the 20 patients treated with clonaze- 1487 DISCONTINUATION OF BENZODIAZEPINE TREATMENT FIGURE 1. Pmic Attack anueneyand Scores on the lack Anxiety inventory and Ianudianpine Withdrawal Checklist In! Panic Disor- davPatientaWhoWereWithdmn From Ienndiaupinasvmiflaper As Usual or Taper Plus Copiitiwsahaviaral Therapy —-o— hummus! Seaman “mm ; pam and nine (69%) of the 13 patients treated with alprazolam suCCessfully discontinued medication. There was no significant difference between these rates as evaluated with Fisher’s exact test (p<0.16) or the more appropriate Mantel-Haenszel test controlling for treatment assignment (Mantel-Haenszel x2=1.78, df=1, p<0.19). Similarly, no effect of concurrent treatment with antidepressant medication was evident (p<0.42 and p<0.65 for Pearson and Mantel-Haenszel chi- square tests, respectively). Three of the four patients taking antidepressant medications in the group given taper plus cognitive-behavioral treatment successfully 1488 discontinued their benzodiaupine medications; one of the two patients given taper as usual who were taking antidepressants achieved discontinuation. The 16 patients who were unable to discontinue tak- ing their medications attributed their failure in part to increased panic attacks (N=11), increased anticipatory anxiety (N=15), increased phobic avoidance (N=8), and new symptoms during taper (N:5). No patient re- ported new symptoms as the only reason for failing discontinuation. The dependent measures for these analyses were the weekly measures of generalized anxiety (Beck Anxiety Inventory) and withdrawal symptoms (Benzodiazepine Withdrawal Checklist) and the daily diary items (i.e., number of panic episodes) that allowed examination of discontinuation distress at selected evaluation points: initial dose reduction, 50% reduction, final week of ta~ per, and first and second weeks without medication. The differences between the groups at each evaluation point were analyzed with Mann-Whitney U tests. These analyses were compromised by patients who failed to continue their medication taper and by missing values for some subjects who did not complete or return ques- tionnaires. In addition, among the patients who did not maintain the taper program, at the point of failure most patients increased their medication, thereby reducing distress ratings during the week of taper failure. The results are de icted graphically in figure 1. For the com- pleters at eac assessment period, there were no signifi- cant differences between groups, but by the end of the second week after discontinuation, the patients com- pleting the taper (primarily patients given taper plus cognitive-behavioral treatment) had significantly less severe anxiety than at baseline, as indicated by scores on the Beck Anxiety Inventory (t=2.67, df=14, p<0.03) and the Benzodiazepine Withdrawal Checklist (t=2.35, df=14, p<0.05); there were similar although nonsignifi- cant trends for the Fear Questionnaire scores (t=1.97, df=11, p<0.08) and panic frequency (p<0.12, Wilcoxon test). Five baseline measures were selected for the predic- tion of taper success—panic frequency and scores on the Beck Anxiety Inventory, Fear Questionnaire, Anxi- ety Sensitivity Index, and Beck Depression Inventory— and were examined by using logistic regression proce- dures appropriate to the dichotomous outcome vari- able of discontinuation success. Regardless of whether treatment assignment was included in the regression equation (significant in all cases), none of these baseline variables significantly increased the predictability of discontinuation success. The patients‘ use of benzodiazepine medications was evaluated 3 months after the scheduled discontinuation date. Of the 13 patients who were given taper plus cog- nitive-behavioral treatment and discontinued medica- tion successfully in the acute trial, 10 remained benzo- diazepine free at the 3-month follow-up. Of the four patients given taper plus cognitive-behavioral treat- ment who failed treatment discontinuation during the trial, two were known to still be receiving benzodiaze- Am ] Psychiatry 150:10, October 1993 pine treatment and two were unavailable for follow-up. Of the four patients given taper as usual who success- fully discontinued taking their medication, all remained benzodiazepine free, although one patient sought be- havioral treatment for recurrence of anxiety and panic. Three patients in the taper as usual program who failed their discontinuation attempts subsequently received group cognitive-behavioral therapy, and two of the three had successfully discontinued high-potency ben- zodiazepine treatment by the follow-up assessment. One patient subsequently discontinued high—potency benzodiazepine treatment without cognitive-behavioral treatment, and two were lost to follow-up; the remain- ing six patients were known to have continued taking their high-potency benzodiazepines. DISCUSSION This study was designed to examine the efficacy of a cognitive-behavioral program as an adjunct to the con- servative taper and regular monitoring recommended for benzodiazepine discontinuation. As in previous studies (5, 6), we found a high rate of discontinuation failure (75%) in patients undergoing the standard clini- cal program. In contrast, the majority of patients receiv- ing adjunctive cognitive-behavioral treatment (76%) were successful in achieving medication discontinu- ation. Successful discontinuation in either program was generally associated with decreased levels of anxiety symptoms and global distress. Evaluation of medica- tion and symptom status 3 months after discontinu- ation indicated that most of the patients (77%) who received cognitive—behavioral treatment and success- fully discontinued benzodiazepine treatment remained benzodiazepine free. In addition, two of three patients given taper as usual who failed the acute taper and sub- sequently enrolled in group cognitive-behavioral treat- ment successfully discontinued their benzodiazepine medication during the follow-up period. No significant differences in discontinuation between alprazolam and clonazepam were found. Although there was a weak trend toward a greater rate of success- ful discontinuation in alprazolam-treated patients, this finding must be considered within the context of the higher alprazolam-equivalent doses taken by the pa- tients receiving clonazepam. Nonetheless, this study does not support the hypothesis that clonazepam is eas- ier to withdraw than alprazolam under the conditions of slow taper. It is possible that differences between these agents may have emerged with a faster taper or that an overall increase in the success rate may have been achieved with an even slower taper. Nonetheless, the results provide strong support for the efficacy of the cognitive-behavioral program in aiding patients who wish to discontinue benzodiazepine treatment and use a moderate rate of taper. This study included patients with different baseline levels of panic severity; only 39% of the subjects were panic free at baseline. This rate is comparable to that Am 1 Psychiatry 150:10, October 1993 OTTO, POLLACK, SACHS, ET AL. reported in longitudinal studies of panic disorder, and thus our group of patients seeking to discontinue ben- zodiazepine treatment appears similar to the general population of medication-treated patients. The longitu- dinal studies (34-36), using follow-up assessments ranging from 1.5 to 6.0 years after the initiation of medication treatment, indicate that approximately 40% of patients continue to experience panic attacks and that 50% to 80% remain symptomatic. in our group the baseline severity of illness—as indicated by separate assessments of panic frequency, generalized anxiety, degree of avoidance, and degree of fear of anxi- ety symptoms (anxiety sensitivity)—was not associated with discontinuation success. The finding that cognitive-behavioral treatment maintained low panic severity over the course of dis- continuation is consistent with the efficacy of these in- terventions in the treatment of panic disorder (23—25). We used interventions similar to those applied to un- treated patients, but we modified the procedures to tar- get reactions to discontinuation-related symptoms (22). lnteroceptive exposure (exposure to somatic sen- sations of anxiety) and cognitive interventions were used to decrease fears and catastrophic misinterpreta- tions of emergent panic sensations and withdrawal symptoms, preparing patients for symptoms they might encounter during and after the discontinuation procedure. Symptom management skills, i.e., breath- ing retraining and relaxation procedures, were taught to help patients decrease the intensity of these symp- toms should they occur. 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This note was uploaded on 08/12/2008 for the course PSY 364 taught by Professor Telch during the Fall '06 term at University of Texas at Austin.

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Benzodiazepine - Discontinuation of Benzodiazepine...

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