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Rinie Geenen - One of the best experts on this subject based on the ideXlab platform.
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Body image in patients with Somatoform Disorder
BMC psychiatry, 2018Co-Authors: Mia Scheffers, Hanneke Kalisvaart, J.t. Van Busschbach, Ruud J Bosscher, M. A. J. Van Duijn, S. Van Broeckhuysen-kloth, Robert A. Schoevers, Rinie GeenenAbstract:Although body-related problems are common in patients with Somatoform Disorder, research focusing on how patients with Somatoform Disorder perceive and evaluate their body is scarce. The present study compared differences in body image between patients with Somatoform Disorder and respondents from a general population sample. It also examined differences within the Somatoform Disorder group between men and women and between the diagnostic subgroups conversion Disorder, pain Disorder and undifferentiated Somatoform Disorder. Data were obtained from 657 patients (67.5% female) with Somatoform Disorder (DSM-IV-TR 300.7, 300.11, 300.81, 300.82) and 761 participants (58.6% female) from the general population. The Dresden Body Image Questionnaire (DBIQ) was used to assess body image in five domains: body acceptance, vitality, physical contact, sexual fulfilment, and self-aggrandizement. Confirmatory factor analysis and analyses of variance were performed. Since differences in age and sex were found between the Somatoform Disorder sample and the comparison sample, analyses were done with two samples of 560 patients with Somatoform Disorder and 351 individuals from the comparison sample matched on proportion of men and women and age. Patients scored significantly lower than the comparison sample on all DBIQ domains. Men scored higher than women. Patients with conversion Disorder scored significantly higher on vitality and body acceptance than patients with undifferentiated Somatoform Disorder and pain Disorder. The mostly large differences in body image between patients with Somatoform Disorder and the comparison sample as well as differences between diagnostic subgroups underline that body image is an important feature in patients with Somatoform Disorder. The results indicate the usefulness of assessing body image and treating negative body image in patients with Somatoform or somatic symptom Disorder.
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body drawings as an assessment tool in Somatoform Disorder
Arts in Psychotherapy, 2018Co-Authors: Hanneke Kalisvaart, J.t. Van Busschbach, Saskia Van Broeckhuysenkloth, Rinie GeenenAbstract:Abstract As part of the assessment of Somatoform Disorder, body drawings may provide complementary information to augment self-report questionnaires. This study examined the psychometric quality of observer ratings of objective characteristics of 180 own body drawings made by persons referred to treatment for Somatoform Disorder and 67 post-treatment drawings. Physical features of the drawings such as eyes, hands, size and angle of perception, were scored. These observer ratings were correlated with participants’ responses on the Dresden Body Image Questionnaire (DBIQ-35) and with a single assessment by art therapists of the clients’ relationships to their bodies. Changes in the observer ratings before and after therapy were evaluated. Inter-rater reliability was adequate to excellent for ten observer ratings and the art therapist ratings. Categorical principal components analysis of observer ratings indicated a 2-factor structure comprising details (factor 1, α = 0.76) and basic elements (factor 2, α = 0.73). Both factors correlated with the art therapists’ rating (Spearman’s ρ = −0.53 and ρ = −0.36) but not with DBIQ-35 scales. Factor scores improved after therapy. Assessment of objective characteristics of body drawings in clients with Somatoform Disorder indicates reliability, sensitivity to change and initial validity. These assessments may help to improve evaluation of client characteristics and treatment effectiveness.
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personalized treatment outcomes in patients with Somatoform Disorder a concept mapping study
Journal of Psychosomatic Research, 2018Co-Authors: Sonja Klemm, Saskia Van Broeckhuysenkloth, Sanne Van Vliet, Lummy Oosterhuis, Rinie GeenenAbstract:Abstract Objective From a patient-centered perspective, treatment outcome measures in Somatoform Disorder need to be (1) personalized to the patient, (2) fit core problems that are targeted in therapy, and (3) reflect one's ability to adapt and self-manage anticipated deterioration. The aim of this study was to identify an encompassing set of treatment outcome variables in patients with Somatoform Disorder. Methods In-depth interviews yielded a comprehensive overview of 60 treatment outcomes that were sorted in a card sorting task according to similarity of meaning by 30 patients. Hierarchical cluster analysis (squared Euclidean distances, Ward's method) was used to obtain a structured overview of treatment outcomes unbiased by subjective interpretations of researchers. Perceived importance and personal change were examined using descriptive statistics. Results The hierarchical structure of treatment outcomes showed seven clusters, classified in two broad categories: self-other relationships (comprising social support, health care use, and self-confidence) and self-management (comprising physical balance, psychological adjustment, symptom acceptance, and resilience). Ratings of the importance of the clusters showed large individual differences. Most participants retrospectively perceived positive personal change. Conclusion The wide variety of treatment outcomes and the observation that patients attach different importance to the outcome measures supports the value of developing new personalized outcome measures for effect studies. In clinical practice, the clusters of outcomes can be used in shared decision making during intake, to define treatment goals, and to map and evaluate change on a personalized set of outcome measures.
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Predictors of response to psychological treatment in Somatoform Disorder and somatic symptom Disorder: A meta-analysis
Journal of Psychosomatic Research, 2018Co-Authors: S.e. Lieftink, Marc J. Diener, S.a.m. Van Broeckhuysen, Rinie GeenenAbstract:Aims: Somatoform Disorder and somatic symptom Disorder are associated with substantial psychosocial and functional impairment. Meta-analysis can clarify whether this group of Disorders tends to be difficult to treat and whether effects of therapy depend on specific variables. The main aim of the present meta-analysis was to examine whether type of intervention and type of outcome variable predicted response to treatment. Methods: Included were studies evaluating a psychological intervention given to patients diagnosed with Somatoform Disorder or somatic symptom Disorder. Of 2,655 initially identified records, 22 studies were eligible for quantitative analysis, involving 3,160 patients. Outcome domains were somatic symptoms, psycho-behavioral features (e.g., psychopathology) and illness consequences (e.g., mental and physical well-being and functioning). Results: An overall medium-to-large pre-post effect size across 27 intervention conditions (d = 0.77) and a medium pre-post effect size across 10 control conditions (d = 0.49) was obtained. Psychological interventions were significantly superior to control conditions for illness consequences but not for somatic symptoms or psycho-behavioral features. Pre-post effect sizes for cognitive-behavioral therapy (CBT) did not significantly differ from those of other psychological interventions. Longer symptom duration, younger age and lower methodological quality predicted larger effect sizes. Conclusion: Overall, the present findings suggest that psychological interventions are effective in improving illness consequences but may not yield larger amounts of change when compared to control conditions in terms of symptoms or psychopathology. Effects of CBT did not prove superior to effects of other psychological interventions. Relatively modest effects of treatment and the difficulty of identifying modifiable predictors of treatment effects, such as type of treatment, provide support for previous suggestions in the literature that Somatoform Disorder is difficult to treat.
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Self-compassion in Somatoform Disorder.
Psychiatry research, 2017Co-Authors: Charlotte Dewsaran-van Der Ven, Saskia Van Broeckhuysen-kloth, Shiva Thorsell, Ron Scholten, Véronique De Gucht, Rinie GeenenAbstract:‘Third wave’ cognitive-behavioral therapies have given a boost to the study of resilience factors, such as self-compassion. To get an indication of the potential clinical relevance of self-compassion for Somatoform Disorder, this study examined whether self-compassion in patients with Somatoform Disorder is lower than in the general population, and whether self-compassion is associated with number of symptoms and health-related quality of life. Two-hundred-and-thirty-six participants with Somatoform Disorder and 236 subjects from the general population, matched on sex and age, filled out questionnaires regarding self-compassion (SCS), number of symptoms (PSC) and health-related quality of life (EQ-5D). The difference in self-compassion between the patient group (Mean 3.53, SD 0.96) and the general population (Mean 4.16, SD 0.98) was significant with a medium effect size (d = −0.65). Multiple regression analyses showed that having a Somatoform Disorder and low self-compassion were independently associated with number of symptoms and reduced health-related quality of life. The lower level of self-compassion in Somatoform Disorder and its association with more physical symptoms and lower health-related quality of life, indicate that self-compassion is a potential clinically relevant factor that may influence therapy outcome and that can be a therapeutic target in patients with Somatoform Disorder.
Frank Rohricht - One of the best experts on this subject based on the ideXlab platform.
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group body psychotherapy for the treatment of Somatoform Disorder a partly randomised controlled feasibility pilot study
BMC Psychiatry, 2019Co-Authors: Frank Rohricht, Heribert Sattel, Christian Kuhn, Claas LahmannAbstract:Clinical outcomes for patients with heterogeneous Somatoform Disorder (bodily distress Disorder, including medically unexplained symptoms) are suboptimal, new treatments are required to improve acceptance. Body-oriented psychological therapy approaches have been identified as potentially beneficial additions to the portfolio of treatments. This study was aiming to assess the acceptability, the potential benefits, and associated change processes of manualised group body psychotherapy (BPT) for outpatients with Somatoform Disorder. A randomized controlled feasibility trial was carried out with follow-up at 6 months after baseline assessments using the Primary Health Questionnaire (PHQ), Somatic Symptom Screening Scale (SOMS-7), quality of life ratings (Short-Form Health Survey-36; SF-36) and body image measures (Dresden Body Image Questionnaire). Acceptance was assessed with the Helping Alliance Scale (HAS). A total of 24 patients were recruited to participate. Sixteen patients were randomly assigned to receive either manualised BPT or TAU, eight patients were directly assigned to BPT. Drop-out rates were acceptable, patients reported to be highly satisfied with the group intervention. Somatic symptom levels reduced significantly in the BPT group. Additionally, a significant effect on self-acceptance and the mental component of quality of life was observed. Group body psychotherapy is a feasible and acceptable treatment for patients with Somatoform Disorder and a larger trial studying the effectiveness of BPT in these patients should be conducted. Retrospectively registered SRCTN12277345 ; Trial Registraton Date: 27/03/2019.
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Group body psychotherapy for the treatment of Somatoform Disorder - a partly randomised-controlled feasibility pilot study
BMC, 2019Co-Authors: Frank Rohricht, Heribert Sattel, Christian Kuhn, Claas LahmannAbstract:Abstract Background Clinical outcomes for patients with heterogeneous Somatoform Disorder (bodily distress Disorder, including medically unexplained symptoms) are suboptimal, new treatments are required to improve acceptance. Body-oriented psychological therapy approaches have been identified as potentially beneficial additions to the portfolio of treatments. This study was aiming to assess the acceptability, the potential benefits, and associated change processes of manualised group body psychotherapy (BPT) for outpatients with Somatoform Disorder. Methods A randomized controlled feasibility trial was carried out with follow-up at 6 months after baseline assessments using the Primary Health Questionnaire (PHQ), Somatic Symptom Screening Scale (SOMS-7), quality of life ratings (Short-Form Health Survey-36; SF-36) and body image measures (Dresden Body Image Questionnaire). Acceptance was assessed with the Helping Alliance Scale (HAS). Results A total of 24 patients were recruited to participate. Sixteen patients were randomly assigned to receive either manualised BPT or TAU, eight patients were directly assigned to BPT. Drop-out rates were acceptable, patients reported to be highly satisfied with the group intervention. Somatic symptom levels reduced significantly in the BPT group. Additionally, a significant effect on self-acceptance and the mental component of quality of life was observed. Conclusion Group body psychotherapy is a feasible and acceptable treatment for patients with Somatoform Disorder and a larger trial studying the effectiveness of BPT in these patients should be conducted. Trial registration Retrospectively registered SRCTN12277345; Trial Registraton Date: 27/03/2019
Claas Lahmann - One of the best experts on this subject based on the ideXlab platform.
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group body psychotherapy for the treatment of Somatoform Disorder a partly randomised controlled feasibility pilot study
BMC Psychiatry, 2019Co-Authors: Frank Rohricht, Heribert Sattel, Christian Kuhn, Claas LahmannAbstract:Clinical outcomes for patients with heterogeneous Somatoform Disorder (bodily distress Disorder, including medically unexplained symptoms) are suboptimal, new treatments are required to improve acceptance. Body-oriented psychological therapy approaches have been identified as potentially beneficial additions to the portfolio of treatments. This study was aiming to assess the acceptability, the potential benefits, and associated change processes of manualised group body psychotherapy (BPT) for outpatients with Somatoform Disorder. A randomized controlled feasibility trial was carried out with follow-up at 6 months after baseline assessments using the Primary Health Questionnaire (PHQ), Somatic Symptom Screening Scale (SOMS-7), quality of life ratings (Short-Form Health Survey-36; SF-36) and body image measures (Dresden Body Image Questionnaire). Acceptance was assessed with the Helping Alliance Scale (HAS). A total of 24 patients were recruited to participate. Sixteen patients were randomly assigned to receive either manualised BPT or TAU, eight patients were directly assigned to BPT. Drop-out rates were acceptable, patients reported to be highly satisfied with the group intervention. Somatic symptom levels reduced significantly in the BPT group. Additionally, a significant effect on self-acceptance and the mental component of quality of life was observed. Group body psychotherapy is a feasible and acceptable treatment for patients with Somatoform Disorder and a larger trial studying the effectiveness of BPT in these patients should be conducted. Retrospectively registered SRCTN12277345 ; Trial Registraton Date: 27/03/2019.
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Group body psychotherapy for the treatment of Somatoform Disorder - a partly randomised-controlled feasibility pilot study
BMC, 2019Co-Authors: Frank Rohricht, Heribert Sattel, Christian Kuhn, Claas LahmannAbstract:Abstract Background Clinical outcomes for patients with heterogeneous Somatoform Disorder (bodily distress Disorder, including medically unexplained symptoms) are suboptimal, new treatments are required to improve acceptance. Body-oriented psychological therapy approaches have been identified as potentially beneficial additions to the portfolio of treatments. This study was aiming to assess the acceptability, the potential benefits, and associated change processes of manualised group body psychotherapy (BPT) for outpatients with Somatoform Disorder. Methods A randomized controlled feasibility trial was carried out with follow-up at 6 months after baseline assessments using the Primary Health Questionnaire (PHQ), Somatic Symptom Screening Scale (SOMS-7), quality of life ratings (Short-Form Health Survey-36; SF-36) and body image measures (Dresden Body Image Questionnaire). Acceptance was assessed with the Helping Alliance Scale (HAS). Results A total of 24 patients were recruited to participate. Sixteen patients were randomly assigned to receive either manualised BPT or TAU, eight patients were directly assigned to BPT. Drop-out rates were acceptable, patients reported to be highly satisfied with the group intervention. Somatic symptom levels reduced significantly in the BPT group. Additionally, a significant effect on self-acceptance and the mental component of quality of life was observed. Conclusion Group body psychotherapy is a feasible and acceptable treatment for patients with Somatoform Disorder and a larger trial studying the effectiveness of BPT in these patients should be conducted. Trial registration Retrospectively registered SRCTN12277345; Trial Registraton Date: 27/03/2019
Changsu Han - One of the best experts on this subject based on the ideXlab platform.
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paroxetine for patients with undifferentiated Somatoform Disorder a prospective open label 8 week pilot study
Current Therapeutic Research-clinical and Experimental, 2008Co-Authors: Changsu Han, David M Marks, Chiun Pae, Bun Hee Lee, Prakash S Masand, Ashwin A Patkar, In Kwa JungAbstract:Background: Forty-eight percent of somatic symptoms encountered in the primary care setting are medically unexplained. Such symptoms have been associated with negative impact on quality of life and with functional impairment. Objective: The aim of this study was to assess the potential utility and tolerability of paroxetine for the treatment of undifferentiated Somatoform Disorder (USD), using the 15-item Patient Health Questionnaire (PHQ-15) to assess the severity of somatic symptoms. Methods: A prospective, open-label, 8-week pilot study of paroxetine was conducted in outpatients with USD. Data were collected at baseline and at weeks 1, 2, 4, and 8. The primary measure was the mean change in PHQ-15 total score from baseline to the end of treatment. Secondary effectiveness measures included mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire from baseline to end of treatment. A physical examination, electrocardiography, complete blood count, blood chemistry, urinalysis, and pregnancy test (for women of childbearing potential) were performed at baseline and the end of treatment. Vital signs were measured during each visit. Adverse events (AEs) were recorded during the study and included those determined using the Systematic Assessment for Treatment Emergent Events-General Inquiry. Results: Forty-three Korean patients were screened for the study. Twenty-two patients (13 women, 9 men; mean [SD] age, 37.4 [12.4] years) were enrolled and 20 completed the study; 2 patients were lost to follow-up. The mean total score on the PHQ-15 from baseline to the end of treatment was significantly decreased (17.2 vs 4.3; P = 0.001), as was the mean total BDI score (12.8 vs. 6.3; P < 0.001). Overall, paroxetine was well-tolerated. Nausea and dry mouth were the most commonly reported treatment-emergent AEs (both, 5 [22.7%]); no serious AEs were reported. No abnormal laboratory results were observed. Conclusion: This open-label pilot study found that paroxetine had potential utility in the treatment of USD and was generally well-tolerated. These results suggest that adequately-powered, double-blind, placebo-controlled trials are warranted to more fully assess the efficacy and safety of paroxetine in the treatment of USD.
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fluoxetine versus sertraline in the treatment of patients with undifferentiated Somatoform Disorder a randomized open label 12 week parallel group trial
Progress in Neuro-psychopharmacology & Biological Psychiatry, 2008Co-Authors: Changsu Han, Chiun Pae, Bun Hee Lee, Prakash S Masand, Ashwin A Patkar, In Kwa JungAbstract:The present study was conducted to compare the effectiveness and tolerability of fluoxetine and sertraline in the treatment of undifferentiated Somatoform Disorder (USD), using the Patient Health Questionnaire (PHQ-15), which was specifically designed for assessing the severity of somatic symptoms. A randomized, 12-week, open-label trial of fluoxetine (10-60 mg/d) and sertraline (25-350 mg/d) in patients with USD was conducted. Six visits, at baseline and weeks 1, 2, 4, 8, and 12, were scheduled. Assessments for effectiveness and tolerability were conducted at each visit. The primary effectiveness measure was the mean change in PHQ-15 total score, from baseline to the end of treatment. Secondary effectiveness measures were the mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire (GHQ-12), from baseline to the end of treatment. A total of 45 subjects were enrolled; of them, 28 were randomly assigned to receive fluoxetine and 17 to receive sertraline. The total score on the PHQ-15 from baseline to the end of treatment significantly decreased in the fluoxetine (-10.7, p<0.0001) and sertraline (-10.3, p<0.0001) treatment groups, with no between-group difference (F=0.0701, p=0.7924). Overall, both treatments were well tolerated and no serious adverse event was reported. This study suggests that both agents may have a potential role in the treatment of USD. A double-blind, placebo-controlled trial and/or head-to-head comparison study with larger samples are required to draw more definite conclusions.
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venlafaxine versus mirtazapine in the treatment of undifferentiated Somatoform Disorder a 12 week prospective open label randomized parallel group trial
Clinical Drug Investigation, 2008Co-Authors: Changsu Han, Chiun Pae, Bun Hee Lee, Prakash S Masand, Ashwin A Patkar, Sook Haeng Joe, In Kwa JungAbstract:Objective: We set out to compare the efficacy and tolerability of mirtazapine versus venlafaxine in patients with undifferentiated Somatoform Disorder (USD) using the Patient Health Questionnaire-15 (PHQ-15). Methods: This was a 12-week prospective, open-label, randomized, parallel-group trial. The trial consisted of six visits that included baseline and weeks 1, 2, 4, 8 and 12. The primary effectiveness measure was the mean change in PHQ-15 total score from baseline to the end of treatment. Secondary effectiveness measures included the mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire (GHQ) from baseline to the end of treatment. Ninety-five subjects were randomized to either mirtazapine (n = 50) or venlafaxine (n = 45); 71 subjects completed the study (mirtazapine: n = 39/50 [78%]; venlafaxine: n = 32/45 [71%]). Results: The mean total score on the PHQ-15 decreased by 34.7% (−8.4, p < 0.0001) from baseline to endpoint in the mirtazapine group and by 26.6% (−6.1, p < 0.0001) in the venlafaxine group. A marginally significant between-group difference was observed for the mean change in total score on the PHQ-15 from baseline to endpoint (F = 4.126, p = 0.046). The mean total scores on the GHQ-12 and BDI from baseline to endpoint decreased by −4.9 (29.4%, p < 0.0001) and −13.5 (55.9%, p < 0.0001), respectively, in the mirtazapine group, and by −4.3 (26.2%, p = 0.001) and −9.02 (46.0%, p < 0.0001), respectively, in the venlafaxine group. No between-group difference was observed for the mean changes in total scores on the secondary effectiveness measures from baseline to endpoint. Both treatments were well tolerated. Conclusion: Our findings suggest that both mirtazapine and venlafaxine may be effective and well tolerated in the treatment of patients with USD. Double-blind, placebo-controlled and/or head-to-head comparison studies are required to allow definite conclusions to be drawn.
In Kwa Jung - One of the best experts on this subject based on the ideXlab platform.
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paroxetine for patients with undifferentiated Somatoform Disorder a prospective open label 8 week pilot study
Current Therapeutic Research-clinical and Experimental, 2008Co-Authors: Changsu Han, David M Marks, Chiun Pae, Bun Hee Lee, Prakash S Masand, Ashwin A Patkar, In Kwa JungAbstract:Background: Forty-eight percent of somatic symptoms encountered in the primary care setting are medically unexplained. Such symptoms have been associated with negative impact on quality of life and with functional impairment. Objective: The aim of this study was to assess the potential utility and tolerability of paroxetine for the treatment of undifferentiated Somatoform Disorder (USD), using the 15-item Patient Health Questionnaire (PHQ-15) to assess the severity of somatic symptoms. Methods: A prospective, open-label, 8-week pilot study of paroxetine was conducted in outpatients with USD. Data were collected at baseline and at weeks 1, 2, 4, and 8. The primary measure was the mean change in PHQ-15 total score from baseline to the end of treatment. Secondary effectiveness measures included mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire from baseline to end of treatment. A physical examination, electrocardiography, complete blood count, blood chemistry, urinalysis, and pregnancy test (for women of childbearing potential) were performed at baseline and the end of treatment. Vital signs were measured during each visit. Adverse events (AEs) were recorded during the study and included those determined using the Systematic Assessment for Treatment Emergent Events-General Inquiry. Results: Forty-three Korean patients were screened for the study. Twenty-two patients (13 women, 9 men; mean [SD] age, 37.4 [12.4] years) were enrolled and 20 completed the study; 2 patients were lost to follow-up. The mean total score on the PHQ-15 from baseline to the end of treatment was significantly decreased (17.2 vs 4.3; P = 0.001), as was the mean total BDI score (12.8 vs. 6.3; P < 0.001). Overall, paroxetine was well-tolerated. Nausea and dry mouth were the most commonly reported treatment-emergent AEs (both, 5 [22.7%]); no serious AEs were reported. No abnormal laboratory results were observed. Conclusion: This open-label pilot study found that paroxetine had potential utility in the treatment of USD and was generally well-tolerated. These results suggest that adequately-powered, double-blind, placebo-controlled trials are warranted to more fully assess the efficacy and safety of paroxetine in the treatment of USD.
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fluoxetine versus sertraline in the treatment of patients with undifferentiated Somatoform Disorder a randomized open label 12 week parallel group trial
Progress in Neuro-psychopharmacology & Biological Psychiatry, 2008Co-Authors: Changsu Han, Chiun Pae, Bun Hee Lee, Prakash S Masand, Ashwin A Patkar, In Kwa JungAbstract:The present study was conducted to compare the effectiveness and tolerability of fluoxetine and sertraline in the treatment of undifferentiated Somatoform Disorder (USD), using the Patient Health Questionnaire (PHQ-15), which was specifically designed for assessing the severity of somatic symptoms. A randomized, 12-week, open-label trial of fluoxetine (10-60 mg/d) and sertraline (25-350 mg/d) in patients with USD was conducted. Six visits, at baseline and weeks 1, 2, 4, 8, and 12, were scheduled. Assessments for effectiveness and tolerability were conducted at each visit. The primary effectiveness measure was the mean change in PHQ-15 total score, from baseline to the end of treatment. Secondary effectiveness measures were the mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire (GHQ-12), from baseline to the end of treatment. A total of 45 subjects were enrolled; of them, 28 were randomly assigned to receive fluoxetine and 17 to receive sertraline. The total score on the PHQ-15 from baseline to the end of treatment significantly decreased in the fluoxetine (-10.7, p<0.0001) and sertraline (-10.3, p<0.0001) treatment groups, with no between-group difference (F=0.0701, p=0.7924). Overall, both treatments were well tolerated and no serious adverse event was reported. This study suggests that both agents may have a potential role in the treatment of USD. A double-blind, placebo-controlled trial and/or head-to-head comparison study with larger samples are required to draw more definite conclusions.
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venlafaxine versus mirtazapine in the treatment of undifferentiated Somatoform Disorder a 12 week prospective open label randomized parallel group trial
Clinical Drug Investigation, 2008Co-Authors: Changsu Han, Chiun Pae, Bun Hee Lee, Prakash S Masand, Ashwin A Patkar, Sook Haeng Joe, In Kwa JungAbstract:Objective: We set out to compare the efficacy and tolerability of mirtazapine versus venlafaxine in patients with undifferentiated Somatoform Disorder (USD) using the Patient Health Questionnaire-15 (PHQ-15). Methods: This was a 12-week prospective, open-label, randomized, parallel-group trial. The trial consisted of six visits that included baseline and weeks 1, 2, 4, 8 and 12. The primary effectiveness measure was the mean change in PHQ-15 total score from baseline to the end of treatment. Secondary effectiveness measures included the mean changes in total scores on the Beck Depression Inventory (BDI) and the 12-item General Health Questionnaire (GHQ) from baseline to the end of treatment. Ninety-five subjects were randomized to either mirtazapine (n = 50) or venlafaxine (n = 45); 71 subjects completed the study (mirtazapine: n = 39/50 [78%]; venlafaxine: n = 32/45 [71%]). Results: The mean total score on the PHQ-15 decreased by 34.7% (−8.4, p < 0.0001) from baseline to endpoint in the mirtazapine group and by 26.6% (−6.1, p < 0.0001) in the venlafaxine group. A marginally significant between-group difference was observed for the mean change in total score on the PHQ-15 from baseline to endpoint (F = 4.126, p = 0.046). The mean total scores on the GHQ-12 and BDI from baseline to endpoint decreased by −4.9 (29.4%, p < 0.0001) and −13.5 (55.9%, p < 0.0001), respectively, in the mirtazapine group, and by −4.3 (26.2%, p = 0.001) and −9.02 (46.0%, p < 0.0001), respectively, in the venlafaxine group. No between-group difference was observed for the mean changes in total scores on the secondary effectiveness measures from baseline to endpoint. Both treatments were well tolerated. Conclusion: Our findings suggest that both mirtazapine and venlafaxine may be effective and well tolerated in the treatment of patients with USD. Double-blind, placebo-controlled and/or head-to-head comparison studies are required to allow definite conclusions to be drawn.
