Beate Herpertz-Dahlmann1, Reinhild Schwarte2, Melanie Krei2, Karin Egberts3, Andreas Warnke3, Christoph Wewetzer4, Ernst Pfeiffer5, Christian Fleischhaker6, André Scherag7, Kristian Holtkamp8, Ulrich Hagenah2, Katharina Bühren2, Kerstin Konrad9, Ulrike Schmidt10, Carmen Schade-Brittinger11, Nina Timmesfeld12, Astrid Dempfle12. 1. Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of the RWTH Aachen, Aachen, Germany. Electronic address: bherpertz-dahlmann@ukaachen.de. 2. Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of the RWTH Aachen, Aachen, Germany. 3. Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Würzburg, Würzburg, Germany. 4. Department of Child and Adolescent Psychiatry and Psychotherapy, Kliniken der Stadt Köln, Cologne, Germany. 5. Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité, Berlin, Germany. 6. Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Centre, Freiburg, Freiburg, Germany. 7. Institute of Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany. 8. Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, DRK Fachklinik Bad Neuenahr, Bad Neuenahr, Germany. 9. Child Neuropsychology Section, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of the RWTH Aachen, Aachen, Germany. 10. King's College London, Institute of Psychiatry, London, UK. 11. Coordinating Centre for Clinical Trials, Philipps-University Marburg, Marburg, Germany. 12. Institute of Medical Biometry and Epidemiology, Philipps-University Marburg, Marburg, Germany.
Abstract
BACKGROUND: In-patient treatment (IP) is the treatment setting of choice for moderately-to-severely ill adolescents with anorexia nervosa, but it is costly, and the risks of relapse and readmissions are high. Day patient treatment (DP) is less expensive and might avoid problems of relapse and readmission by easing the transition from hospital to home. We investigated the safety and efficacy of DP after short inpatient care compared with continued IP. METHODS: For this multicentre, randomised, open-label, non-inferiority trial, we enrolled female patients (aged 11-18 years) with anorexia nervosa from six centres in Germany. Patients were eligible if they had a body-mass index (BMI) below the tenth percentile and it was their first admission to hospital for anorexia nervosa. We used a computer-generated randomisation sequence to randomly assign patients to continued IP or DP after 3 weeks of inpatient care (1:1; stratified for age and BMI at admission). The treatment programme and treatment intensity in both study groups were identical. The primary outcome was the increase in BMI between the time of admission and a 12-month follow-up adjusted for age and duration of illness (non-inferiority margin of 0·75 kg/m(2)). Analysis was done by modified intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Number Register, number ISRCTN67783402, and the Deutsches Register Klinischer Studien, number DRKS00000101. FINDINGS: Between Feb 2, 2007, to April 27, 2010, we screened 660 patients for eligibility, 172 of whom we randomly allocated to treatment: 85 to IP and 87 to DP. DP was non-inferior to IP with respect to the primary outcome, BMI at the 12-month follow-up (mean difference 0·46 kg/m(2) in favour of DP (95% CI, -0·11 to 1·02; pnon-inferiority<0·0001). The number of treatment-related serious adverse events was similar in both study groups (eight in the IP group, seven in the DP group). Three serious adverse events in the IP group and two in the DP group were related to suicidal ideation; one patient in the DP attempted suicide 3 months after she was discharged. INTERPRETATION:DP after short inpatient care in adolescent patients with non-chronic anorexia nervosa seems no less effective than IP for weight restoration and maintenance during the first year after admission. Thus, DP might be a safe and less costly alternative to IP. Our results justify the broad implementation of this approach. FUNDING: German Ministry for Education and Research.
RCT Entities:
BACKGROUND: In-patient treatment (IP) is the treatment setting of choice for moderately-to-severely ill adolescents with anorexia nervosa, but it is costly, and the risks of relapse and readmissions are high. Day patient treatment (DP) is less expensive and might avoid problems of relapse and readmission by easing the transition from hospital to home. We investigated the safety and efficacy of DP after short inpatient care compared with continued IP. METHODS: For this multicentre, randomised, open-label, non-inferiority trial, we enrolled female patients (aged 11-18 years) with anorexia nervosa from six centres in Germany. Patients were eligible if they had a body-mass index (BMI) below the tenth percentile and it was their first admission to hospital for anorexia nervosa. We used a computer-generated randomisation sequence to randomly assign patients to continued IP or DP after 3 weeks of inpatient care (1:1; stratified for age and BMI at admission). The treatment programme and treatment intensity in both study groups were identical. The primary outcome was the increase in BMI between the time of admission and a 12-month follow-up adjusted for age and duration of illness (non-inferiority margin of 0·75 kg/m(2)). Analysis was done by modified intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Number Register, number ISRCTN67783402, and the Deutsches Register Klinischer Studien, number DRKS00000101. FINDINGS: Between Feb 2, 2007, to April 27, 2010, we screened 660 patients for eligibility, 172 of whom we randomly allocated to treatment: 85 to IP and 87 to DP. DP was non-inferior to IP with respect to the primary outcome, BMI at the 12-month follow-up (mean difference 0·46 kg/m(2) in favour of DP (95% CI, -0·11 to 1·02; pnon-inferiority<0·0001). The number of treatment-related serious adverse events was similar in both study groups (eight in the IP group, seven in the DP group). Three serious adverse events in the IP group and two in the DP group were related to suicidal ideation; one patient in the DP attempted suicide 3 months after she was discharged. INTERPRETATION:DP after short inpatient care in adolescent patients with non-chronic anorexia nervosa seems no less effective than IP for weight restoration and maintenance during the first year after admission. Thus, DP might be a safe and less costly alternative to IP. Our results justify the broad implementation of this approach. FUNDING: German Ministry for Education and Research.
Authors: Leslie K Anderson; Erin E Reilly; Laura Berner; Christina E Wierenga; Michelle D Jones; Tiffany A Brown; Walter H Kaye; Anne Cusack Journal: Curr Psychiatry Rep Date: 2017-08 Impact factor: 5.285
Authors: Manuel Föcker; Katharina Bühren; Nina Timmesfeld; Astrid Dempfle; Susanne Knoll; Reinhild Schwarte; Karin Maria Egberts; Ernst Pfeiffer; Christian Fleischhaker; Christoph Wewetzer; Johannes Hebebrand; Beate Herpertz-Dahlmann Journal: Eur Child Adolesc Psychiatry Date: 2014-08-27 Impact factor: 4.785
Authors: Sarah E Strandjord; Erin H Sieke; Miranda Richmond; Arjun Khadilkar; Ellen S Rome Journal: Eat Weight Disord Date: 2015-11-23 Impact factor: 4.652