Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study.

OBJECTIVE: Chronic low back pain (CLBP) is a widespread ailment. The aim of this study was to assess the efficacy of topiramate in the treatment of CLBP and the changes in anger status and processing, body weight, subjective pain-related disability and health-related quality of life during the course of treatment. METHODS: We conducted a 10-week, randomized, double-blind, placebo-controlled study of topiramate in 96 (36 women) patients with CLBP. The subjects were randomly assigned to topiramate (n=48) or placebo (n=48). Primary outcome measures were changes on the McGill Pain Questionnaire, State-Trait Anger Expression Inventory, Oswestry Low Back Pain Disability Questionnaire and SF-36 Health Survey scales, and in body weight. RESULTS: In comparison with the placebo group (according to the intent-to-treat principle), significant changes on the pain rating index of McGill Pain Questionnaire (Ps<0.001), State-Trait Anger Expression Inventory Scales (all Ps<0.001), Oswestry Low Back Pain Disability Questionnaire (P<0.001), and SF-36 Health Survey scales (all P<0.001, except on the role-emotional scale) were observed after 10 weeks in the patients treated with topiramate. Weight loss was also observed and was significantly more pronounced in the group treated with topiramate than in those treated with placebo (P<0.001). Most patients tolerated topiramate relatively well but 2 patients dropped out because of side effects. DISCUSSION: Topiramate seems to be a relatively safe and effective agent in the treatment of CLBP. Significantly positive changes in pain sensitivity, anger status and processing, subjective disability, health-related quality of life, and loss of weight were observed.

Change in instrumental activities of daily living disability in female senior patients with musculosceletal pain: a prospective, randomized, controlled trial.

Previous studies found that depressive symptoms and low functional self-efficacy are associated with the occurrence of disabling musculoskeletal pain, and diminished quality of life in elderly people. The target of this study was to consider the change in instrumental activities of daily living (IADL) disability and health related quality of life after integrative psychotherapeutic treatment program of depressive symptoms in senior female patients with musculoskeletal pain. In an 8-week outpatient-based, random, prospective, controlled trial, 36 female patients between 70 and 79 with a history of clinically evident musculoskeletal pain and afflicted with depressive symptoms, but who were able to bathe, walk, dress, and transferring inside the house were evaluated. The study was performed using the Center for Epidemiological Studies Depression Scale (CES-D), IADL, and the Health Survey (SF-36). In comparison with the untreated group, according to the intent-to-treat principle, significant changes on the CES-D (P < 0.01), IADL (P < 0.01), and all scales of SF-36 were observed after eight weeks in the treated subjects. The treatment of moderate depression with integrative psychotherapy may be efficacious in improving of IADL disability and health related quality of life in affected senior female patients with musculoskeletal pain.

Changes in instrumental activities of daily living disability after treatment of depressive symptoms in elderly women with chronic musculoskeletal pain: a double-blind, placebo-controlled trial.

BACKGROUND AND AIMS: The purpose of this study was to assess the effect of antidepressant therapy on changes in instrumental activities of daily living disability in elderly female patients with musculoskeletal pain in a controlled study comparing active drugs with a placebo. METHODS: In an 8-week double-blind, placebo-controlled outpatient trial, 30 female patients (response rate 90.0%) between 70 and 79 were examined. They all had a history of clinically evident musculoskeletal pain, were afflicted with depressive symptoms, and could independently bathe, walk, dress, and transfer (e.g., from a chair) inside the house. The study was performed using the Center for Epidemiological Studies Depression Scale (CES-D), and Instrumental Activities of Daily Living (IADL). RESULTS: Compared with the placebo-group, significant changes in the CES-D (p<0.01) and IADL (p<0.01) scales were observed after eight weeks in the active drug-treated subjects. CONCLUSION: Treatment of depressive symptoms may be efficacious in reducing IADL disability in elderly female patients afflicted with musculoskeletal pain.

Mirtazapine treatment of social phobia in women: a randomized, double-blind, placebo-controlled study.

Social phobia is an anxiety disorder characterized by extreme fear and phobic avoidance of social and performance situations and by a relatively poor health-related quality of life. The goal of this study was to compare the efficacy of mirtazapine versus placebo in the treatment of patients with social phobia. In 2004, we conducted a randomized, double-blind, placebo-controlled study of mirtazapine in 66 female subjects from the general population meeting the criteria for social phobia. The subjects were randomly assigned in a 1:1 manner to mirtazapine (n = 33) or placebo (n = 33). The treatment lasted 10 weeks. Seven patients dropped out. Primary outcome measures were self-reported changes on the Social Phobia Inventory, Liebowitz Social Anxiety Scale, and Health Survey (SF-36). In comparison with the placebo group and according to the intent-to-treat principle, significant differences on the Social Phobia Inventory and Liebowitz Social Anxiety Scale scales (all P < 0.001), as well as on most (5 from 8) scales of SF-36 (all P < 0.001), were observed in the mirtazapine-treated subjects. All patients tolerated mirtazapine relatively well. Mirtazapine appears to be an effective agent in the treatment of social phobia in women and in the improvement of their health-related quality of life.

Topiramate treatment in bulimia nervosa patients: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: The aim of the current study was to test the influence of topiramate on behavior, body weight, and health-related quality of life (HRQOL) in bulimic patients. METHOD: Thirty patients with bulimia nervosa were treated with topiramate in a 10-week randomized, double-blind, placebo-controlled study. The subjects were randomly assigned to receive topiramate (topiramate group [TG]; n = 30) or a placebo (control group [CG]; n = 30). Primary outcome measures were changes in the frequency of binging/purging, in body weight, and on the SF-36 Health Survey (SF-36) scales. RESULTS: In comparison to the CG group (according to the intent-to-treat principle), significant changes in the frequency of binging/purging (a > 50% reduction: TG, n = 11 [36.7%]; CG, n = 1 [3.3%]; p < .001), body weight (difference in weight loss between the two groups: 3.8 kg, 95% confidence interval [CI] = -5.4 to -2.1; p < .001), and SF-36 (all ps < .001) could be seen. All patients tolerated topiramate well. CONCLUSION: Topiramate appears to safe and effective in influencing the frequency of binging/purging, body weight, and HRQOL in bulimic patients.

Lamotrigine treatment of aggression in female borderline-patients: a randomized, double-blind, placebo-controlled study.

Anger and aggression are typical in borderline patients. The goal of this study was to compare the efficacy of lamotrigine versus placebo in the treatment of aggression in women meeting the criteria for borderline personality disorder (BPD). We conducted a randomized, double-blind, placebo-controlled study of lamotrigine in 24 female subjects meeting Structured Clinical Interview for DSM-IV (SCID) criteria for BPD. The subjects were randomly assigned in a 2: 1 manner ratio to lamotrigine (n = 18) or placebo (n = 9). Treatment duration was 8 weeks. Primary outcome measures were self-reported changes on the anger scales of the Trait Anger Expression Inventory (STAXI). In comparison with the placebo group, and according to the intention-to-treat principle, highly significant (p < 0.01) changes on four STAXI scales (State-Anger, Trait-Anger, Anger-Out, Anger-Control) were observed in those subjects treated with lamotrigine after 8 weeks. The only exception (p < 0.05) was found on the Anger-In scale, where a difference of only 8.5% (p < 0.2) was found. All the patients tolerated lamotrigine relatively well. Lamotrigine appears to be a safe and effective agent in the treatment of anger in women with criteria-defined BPD as defined by SCID criteria. It did not produce any clinically significant effect on body weight.

Recovering the ability to function socially in elderly depressed patients: a prospective, controlled trial.

Among elderly patients with depressive disorders, restrictions of the ability to function socially apparently linger long after the depressive symptoms abate. In a 16-week long, prospective, controlled study on 30 elderly, depressed patients who were still living at home (response rate, 93.3%), we wanted to find out whether recovering the ability to function socially takes a different course through integrative treatment than it does subsequent to purely psychopharmacological therapy. We used the Beck Depression Inventory (BDI) and the Social Adaptation Self-Evaluation Scale (SASS) to measure our results. Both forms of therapy did afford a relatively rapid reduction of depressive symptoms, however, the integrative treatment not only led to a more expeditious reduction of the BDI score [in the fourth week (P<0.05) and starting with the eighth week (P<0.01)] but was also the only one that led to a significant improvement in the ability to function socially [in the 12th week, P<0.05; in the 16th week, P<0.01]. These findings could contribute to improved treatment and rehabilitation of elderly patients, thereby prolonging the periods in their lives in which they can live independently.

Influence of topiramate on olanzapine-related adiposity in women: a random, double-blind, placebo-controlled study.

The aim of this study was to compare the efficacy of topiramate versus a placebo in the treatment of adiposity in women undergoing olanzapine therapy. We also assessed changes health-related quality of life, the patient's actual state of health, and psychologic impairments. The 10-week, random, double-blind, placebo-controlled study included 43 women who had been treated with olanzapine (mean dose 7.8 +/- 3.6 in the topiramate group and 7.2 +/- 3.1 in the placebo group) and had gained weight as a side effect. The subjects were randomly assigned to topiramate (n = 25) or a placebo (n = 18). Primary outcome measures were weight checks and self-reported changes on the scales of the SF-36 Health Survey, Bf-S Scale of Well-Being, and the Adjective Checklist EWL-60-S. Weight loss was observed and was significantly more pronounced in the topiramate-treated group (difference in weight loss between the 2 groups: 5.6 kg, 95% CI = -8.5, -3.0, P < 0.001). In comparison with the placebo group, significant changes on 7 (7/8) scales of SF-36 Health Survey (all P < 0.001), on all 6 scales of the EWL-60-S, and on the Bf-S were observed in the topiramate-treated subjects after 10 weeks. All patients tolerated topiramate well. Topiramate appears to be a safe and effective agent in the treatment of weight gain that occurred during olanzapine treatment. Significantly positive changes in health-related quality of life, the patient's actual state of health, and psychologic impairments were observed.

Treatment of aggression with topiramate in male borderline patients: a double-blind, placebo-controlled study.

BACKGROUND: Borderline personality disorder (BPD) is a complex mental disease associated with severe serious functional impairment, affective instability, and impulsive aggression. The aim of this study was to compare the efficacy of topiramate versus placebo in the treatment of aggression in men with borderline personality disorder. METHODS: We conducted an 8-week, double-blind, placebo-controlled study of topiramate in 42 male subjects (42 of 44) meeting DSM-IV criteria for BPD. The Structured Clinical Interview (SCID I and II) was carried out. The subjects were randomly assigned to topiramate (n = 22) or placebo (n = 20). RESULTS: Significant changes on four STAXI scales (State Anger, p < .01; Trait Anger, p < .05; Anger Out, p < .01; Anger Control, p < .01) were observed in the subjects treated with topiramate. A nonsignificant difference was found on the Anger In scale (p = .86). Additional significant weight loss was observed (difference in weight loss between the both groups was 5.0 kg, p < .01, 95% confidence interval = [-6.5 to 3.4]). All subjects tolerated topiramate relatively well. CONCLUSIONS: Topiramate appears to be an effective agent in the treatment of anger in men with BPD. Mild weight loss can be expected.

Topiramate treatment of aggression in female borderline personality disorder patients: a double-blind, placebo-controlled study.

OBJECTIVE: The goal of this study was to compare the efficacy and safety of topiramate versus placebo in the treatment of aggression in women who meet the criteria for borderline personality disorder. METHOD: We conducted a double-blind, placebo-controlled study of topiramate in 29 female subjects (response rate 93.5%) meeting SCID (Structured Clinical Interview for DSM-IV) criteria for borderline personality disorder. The subjects were randomly assigned in a 2:1 ratio to topiramate (N = 21, analysis based on N = 19) or placebo (N = 10). Treatment lasted 8 weeks (November 2003-January 2004). Primary outcome measures were self-reported changes on the anger subscales of the State-Trait Anger Expression Inventory (STAXI). RESULTS: Significant improvements on 4 subscales of the STAXI (state-anger, trait-anger, anger-out, anger-control) were observed in the topiramate-treated subjects after 8 weeks, in comparison with the placebo group. The difference in improvement in score between the 2 groups for state-anger, trait-anger, and anger-out ranged from 21% to 24%, and the difference for anger-control was -13%. As an exception, a difference of only 8.5% (p < .2) was found on the anger-in subscale. Significantly greater weight loss was observed in the topiramate-treated group than in those treated with placebo (difference in weight loss between the 2 groups: 2.3 kg [5.1 lb] [3.2%]; 95% CI = 1.3% to 4.4%, p < .01). All patients tolerated topiramate well. CONCLUSIONS: Topiramate appears to be a safe and effective agent in the treatment of anger in women with borderline personality disorder as defined by SCID criteria. Additionally, significant weight loss can be expected.