Self-help treatments for disorders of recurrent binge eating: a systematic review.

OBJECTIVE: To evaluate self-help interventions for patients with binge eating disorder (BED) and bulimia nervosa (BN), tested in randomized controlled trials, and compared with waiting list or any other type of control group. METHODS: A systematic review including quality appraisal was conducted of randomized controlled trials, using self-help techniques in patients with BED and/or BN. Six databases were searched during the period between January 1994 and June 2004. RESULTS: A total of 2686 articles were identified, 1701 abstracts were evaluated in detail and, nine studies fulfilled the inclusion criteria for this review. All studies indicated that patients treated with active interventions had a reduced number of binge eating episodes at end of treatment. CONCLUSION: The results support self-help interventions but shall be interpreted with caution. Because of the small number of studies using self-help techniques for BED and BN, further larger randomized, multi-center controlled studies that apply standardized inclusion criteria, evaluation instruments and self-help materials, are needed.

Antidepressants for anorexia nervosa.

BACKGROUND: Anorexia Nervosa (AN) is an illness characterised by extreme concern about body weight and shape, severe self-imposed weight loss, and endocrine dysfunction. In spite of its high mortality, morbidity and chronicity, there are few intervention studies on the subject. OBJECTIVES: The aim of this review was to evaluate the efficacy and acceptability of antidepressant drugs in the treatment of acute AN. SEARCH STRATEGY: The strategy comprised of database searches of the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register, MEDLINE (1966 to April 28th, 2005), EMBASE (1980 to week 36, 2004), PsycINFO (1969 to August week 5, 2004), handsearching the International Journal of Eating Disorders and searching the reference lists of all papers selected. Personal letters were sent to researchers in the field requesting information on unpublished or in-progress trials. SELECTION CRITERIA: All randomised controlled trials of antidepressant treatment for AN patients, as defined by the Diagnostic and Statistical Manual, fourth edition (DSM-IV) or similar international criteria, were selected. DATA COLLECTION AND ANALYSIS: Quality ratings were made giving consideration to the strong relationship between allocation concealment and potential for bias in the results; studies meeting criteria A and B were included. Trials were excluded if non-completion rates were above 50%. The standardised mean difference and relative risk were used for continuous data and dichotomous data comparisons, respectively. Whenever possible, analyses were performed according to intention-to-treat principles. Heterogeneity was tested with the I-squared statistic. Weight change was the primary outcome. Secondary outcomes were severity of eating disorder, depression and anxiety symptoms, and global clinical state. Acceptability of treatment was evaluated by considering non-completion rates. MAIN RESULTS: Only seven studies were included. Major methodological limitations such as small trial size and large confidence intervals decreased the power of the studies to detect differences between treatments, and meta-analysis of data was not possible for the majority of outcomes. Four placebo-controlled trials did not find evidence that antidepressants improved weight gain, eating disorder or associated psychopathology. Isolated findings, favouring amineptine and nortriptyline, emerged from the antidepressant versus antidepressant comparisons, but cannot be conceived as evidence of efficacy of a specific drug or class of antidepressant in light of the findings from the placebo comparisons. Non-completion rates were similar between the compared groups. AUTHORS' CONCLUSIONS: A lack of quality information precludes us from drawing definite conclusions or recommendations on the use of antidepressants in acute AN. Future studies testing safer and more tolerable antidepressants in larger, well designed trials are needed to provide guidance for clinical practice.

Psychotherapy for bulimia nervosa and binging.

BACKGROUND: Bulimia nervosa and related syndromes such as binge eating disorder are common in young Western women. A specific manual-based form of cognitive behaviour therapy (CBT) has been developed for the treatment of bulimia nervosa (CBT-BN). Other psychotherapies, some from a different theoretical framework, and some modifications of CBT are also used. OBJECTIVES: To evaluate the efficacy of CBT and CBT-BN and compare them with other psychotherapies in the treatment of adults with bulimia nervosa or related syndromes of recurrent binge eating. SEARCH STRATEGY: A handsearch of The International Journal of Eating Disorders since its first issue; database searches of MEDLINE, EXTRAMED, EMBASE, PsycInfo, CURRENT CONTENTS, LILACS, SCISEARCH, CENTRAL and the The Cochrane Collaboration Depression, Anxiety & Neurosis Controlled Trials Register; citation list searching and personal approaches to authors were used. SELECTION CRITERIA: All studies that have tested any form of psychotherapy for adults with non-purging bulimia nervosa, binge eating disorder and/or other types of eating disorders of a bulimic type (eating disorder, not otherwise specified, or EDNOS), and which applied a randomised controlled and standardised outcome methodology. DATA COLLECTION AND ANALYSIS: Data were analysed using the Review Manager software program. Relative risks were calculated for binary outcome data. Standardized mean differences were calculated for continuous variable outcome data. A fixed effects model was used to analyse the data. Sensitivity analyses of a number of measures of trial quality were conducted. Data were not reported in such a way to permit subgroup analyses, but the effects of treatment on depressive symptoms, psychosocial and/or interpersonal functioning, general psychiatric symptoms and weight were examined where possible. Funnel plots were drawn to investigate the presence of publication bias. MAIN RESULTS: The review supported the efficacy of cognitive-behavioural psychotherapy (CBT) and particularly CBT-BN in the treatment of people with bulimia nervosa and also (but less strongly due to the small number of trials) related eating disorder syndromes. CBT was also shown to be effective in group settings. Other psychotherapies were also efficacious, particularly interpersonal psychotherapy in the longer-term. Self-help approaches that used highly structured CBT treatment manuals, were promising albeit with more modest results generally, and their evaluation in bulimia nervosa merits further research. Exposure and Response Prevention did not appear to enhance the efficacy of CBT.Psychotherapy alone is unlikely to reduce or change body weight in people with bulimia nervosa or similar eating disorders. REVIEWERS' CONCLUSIONS: There is a small body of evidence for the efficacy of cognitive-behaviour therapy in bulimia nervosa and similar syndromes, but the quality of trials is very variable and sample sizes are often small. More trials of CBT are needed, particularly for binge eating disorder and other EDNOS syndromes. Trials evaluating other psychotherapies and less intensive psychotherapies should also be conducted.

Anticholinergics for neuroleptic-induced acute akathisia.

BACKGROUND: Neuroleptic-induced akathisia is one of the most common and distressing early-onset adverse effects of conventional antipsychotic drugs, being associated with poor compliance with treatment, and thus, ultimately, with an increased risk of relapse. This review assesses the role of anticholinergic drugs as an adjunct to standard antipsychotic medication in the pharmacological treatment of this problem. OBJECTIVES: To determine the clinical effects of anticholinergic drugs for neuroleptic-induced acute akathisia. SEARCH STRATEGY: The reviewers undertook electronic searches of Biological Abstracts (1982-1999), CINAHL (1982-1999), Cochrane Library (Issue 4 1999), Cochrane Schizophrenia Group's Register (October 1999), EMBASE (1980-1999), LILACS (1982-1999), MEDLINE (1966-1999) and PsycLIT (1974-1999). References of all identified studies were inspected for more trials and first authors contacted. Each included study was sought as a citation on the Science Citation Index database. SELECTION CRITERIA: All randomised clinical trials of anticholinergic drugs versus placebo for people with neuroleptic-induced acute akathisia. DATA COLLECTION AND ANALYSIS: Two reviewers, working independently, selected, quality assessed and extracted data. These data were then analysed on an intention-to-treat basis. For homogeneous dichotomous data the fixed effects relative risk (RR), the 95% confidence intervals (CI) and, where appropriate, the number needed to treat (NNT) were calculated on an intention-to-treat basis. For continuous data, reviewers calculated weighted mean differences. MAIN RESULTS: No randomised controlled trials could be included. REVIEWER'S CONCLUSIONS: At present, there is no reliable evidence to support or refute the use of anticholinergics for people suffering from neuroleptic-induced acute akathisia. Akathisia is a most distressing movement disorder that remains highly prevalent, both in the developed and developing world. This review highlights the need for well designed, conducted and reported clinical trials to address the claims of open studies as regards the effects of the anticholinergic group of drugs for akathisia.

Antidepressants versus placebo for people with bulimia nervosa.

BACKGROUND: Bulimia Nervosa (BN) represents an important public health problem and is related to serious morbidity and even mortality. This review attempted to systematically evaluate the use of antidepressant medications compared with placebo for the treatment of bulimia nervosa. OBJECTIVES: The primary objective of this review was to determine whether using antidepressant medications was clinically effective for the treatment of bulimia nervosa. The secondary objectives were:(i) to examine whether there was a differential effect for the various classes/types of antidepressants with regard to effectiveness and tolerability(ii) to test the hypothesis that the effect of antidepressants on bulimic symptoms was independent of its effect on depressive symptoms SEARCH STRATEGY: (1) electronic searches of MEDLINE (1966 to December 2002), EMBASE (1980-December 2002), PsycINFO (to December 2002), LILACS & SCISEARCH (to 2002)(2) the Cochrane Register of Controlled Trials and the Cochrane Depression, Anxiety and Neurosis Group Register - ongoing(3) inspection of the references of all identified trials(4) contact with the pharmaceutical companies and the principal investigator of included trials(5) inspection of the International Journal of Eating Disorders - ongoing INCLUSION CRITERIA: every randomised, placebo-controlled trial in which antidepressant medications were compared to placebo to reduce the symptoms of bulimia nervosa in patients of any age or gender.Quality criteria: reports were considered adequate if they were classified as A or B according to the Cochrane Manual. The Jadad scale, with a cut off of 2 points, was applied to check the validity of the above referred criterion but was not used as an inclusion criterion. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers for each included trial. Dichotomous data were evaluated by the relative risk with 95% confidence intervals (CI) around this measure, based on the random effects model; continuous data were evaluated by the standardised mean difference with the 95% CI. NNT was calculated using the inverse of the absolute risk reduction. MAIN RESULTS: Currently the review includes 19 trials comparing antidepressants with placebo: 6 trials with TCAs (imipramine, desipramine and amitriptyline), 5 with SSRIs (fluoxetine), 5 with MAOIs (phenelzine, isocarboxazid, moclobemide and brofaromine) and 3 with other classes of drugs (mianserin, trazodone and bupropion). Similar results were obtained in terms of efficacy for these different groups of drugs. The pooled RR for remission of binge episodes was 0.87 (95% CI 0.81-0.93; p<0,001) favouring drugs. The NNT for a mean treatment duration of 8 weeks, taking the non-remission rate in the placebo controls of 92% as a measure of the baseline risk was 9 (95% CI 6 - 16). The RR for clinical improvement, defined as a reduction of 50% or more in binge episodes was 0.63 (95% CI 0.55-0.74) and the NNT for a mean treatment duration of 9 weeks was 4 (95% CI 3 - 6), with a non-improvement rate of 67% in the placebo group. Patients treated with antidepressants were more likely to interrupt prematurely the treatment due to adverse events. Patients treated with TCAs dropped out due to any cause more frequently that patients treated with placebo. The opposite was found for those treated with fluoxetine, suggesting it may be a more acceptable treatment. Independence between antidepressant and anti-bulimic effects could not be evaluated due to incomplete published data. REVIEWER'S CONCLUSIONS: The use of a single antidepressant agent was clinically effective for the treatment of bulimia nervosa when compared to placebo, with an overall greater remission rate but a higher rate of dropouts. No differential effect regarding efficacy and tolerability among the various classes of antidepressants could be demonstrated.

Individual psychotherapy in the outpatient treatment of adults with anorexia nervosa.

BACKGROUND: Anorexia nervosa is a disorder of high morbidity and significant mortality. It is commonest in young adult women, in whom the incidence may be increasing. The focus of treatment has moved to an outpatient setting and a number of differing psychotherapies are presently used in treatment. OBJECTIVES: The aim of the present review was to evaluate the evidence from randomised controlled trials for the efficacy of outpatient psychotherapies used in the treatment of older adolescents and adults with anorexia nervosa SEARCH STRATEGY: The strategy comprised database searches of MEDLINE, EXTRAMED, EMBASE,PSYCLIT, CURRENT CONTENTS, Cochrane Collaboration Controlled Trials Register and the Depression and Anxiety Neuroses Cochrane Group (CCDAN), a hand-search of The International Journal of Eating Disorders, and he reference lists of all papers selected. Personal letters were sent to identified notable researchers published in the area, requesting information on trials that are unpublished or in progress. SELECTION CRITERIA: All randomised controlled trials of adult individual outpatient therapy for anorexia nervosa as defined by the DSM-IV or similar international criterion. Quality ratings were made according to the CCDAN criteria and in addition, whether the trial had examined treatment integrity. DATA COLLECTION AND ANALYSIS: A range of outcome variables were selected, including physical state, severity of eating disorder attitudes and beliefs, interpersonal function, and general psychiatric symptom severity. Continuous outcome data comparisons were made with the standardized mean difference statistic, and binary outcome comparisons made with the relative risk statistic. Reliability of data extraction and quality ratings were made with the kappa statistic. Sensitivity analyses to evaluate the effects of trial quality and subgroup analyses to explore specific questions of treatment effects from different settings, frequency and duration of therapies were planned. MAIN RESULTS: Six small trials only, two of which included children or adolescents, were identified from the search and aggregation of data was not possible. Bias was possible due particularly to lack of blinding of outcome assessments. The results in two trials suggested that 'treatment as usual' or similar may be less efficacious than a specific psychotherapy. No specific treatment was consistently superior to any other specific approach. Dietary advice as a control arm had a 100% non-completion rate in one trial. REVIEWER'S CONCLUSIONS: No specific approach can be recommended from this review. It is unclear why 'treatment as usual' performed so poorly or why dietary advice alone appeared so unacceptable as the reasons for non-completion were not reported. There is an urgent need for large well-designed trials in his area.

Psychotherapy for bulimia nervosa and binging.

BACKGROUND: Bulimia nervosa and like syndromes, such as binge eating disorder, are common in young Western women. A specific manual based psychotherapy, cognitive behaviour therapy (CBT) has been developed for the treatment of bulimia nervosa (CBT-BN). Other psychotherapies, some from a different theoretical framework, and some modifications of CBT are also used. OBJECTIVES: To evaluate the efficacy of psychotherapeutic treatments for those with binge eating syndromes, that have been tested in randomised controlled trials. The efficacy of CBT in the specific treatment of bulimia nervosa and binge eating disorder was evaluated. CBT therapy was compared with waiting list or a non-treatment group, any other psychotherapy, CBT in a "pure self-help" form and CBT augmented by exposure and response therapy. In addition, the review aimed to evaluate the evidence for the efficacy of other psychotherapies when compared to a no treatment control group and to evaluate the evidence for the efficacy of other psychotherapies when compared to a 'placebo' therapy. SEARCH STRATEGY: A handsearch of The International Journal of Eating Disorders since its first issue; database searches of MEDLINE, EXTRAMED, EMBASE, PSYCHLIT, CURRENT CONTENTS, LILACS, SCISEARCH, The Cochrane Collaboration Controlled Trials Register and the Cochrane Depression, Anxiety and Neurosis Controlled Trials Register; citation list searching and personal approaches to authors were used. SELECTION CRITERIA: All studies that have tested any form of psychotherapy for adult patients with non-purging bulimia nervosa, binge eating disorder and/or EDNOS of a bulimic type, and which have applied a randomised controlled and standardized outcome methodology, were sought for the purpose of this review. DATA COLLECTION AND ANALYSIS: Data were entered into a spreadsheet programme, and into the REVMAN analysis program. Relative risk analyses were conducted of binary outcome data. The relative risk analysis was used rather than the odds ratio as the outcome measures proposed were not measuring a rare event (such as death) and the total number of studies was small. Standardized mean difference analyses were conducted of continuous variable outcome data, as the continuous outcome measures were not consistent across studies. Sensitivity analyses were conducted of a number of measures of trial quality. Data were not reported in such a way to permit subgroup analyses, but the effects of treatment on depressive symptoms, psychosocial and/or interpersonal functioning, general psychiatric symptoms and weight were examined where possible. Chi-square tests for homogeneity were done, at 5% level of significance, using a fixed effects model. Funnel plots to evaluate presence of publication bias were completed and are available in a text file upon request. MAIN RESULTS: To date, more than 1365 trials have been generated by searching and over 100 trials have been evaluated in detail. Because of a relatively high number of original exclusions (n=12) the trial inclusion criteria were broadened to include those with non-blinded outcome assessment, providing 34 trials for analyses. Because of incomplete published and available data, at best up to 12 studies had data available for any single analysis. The maximum number of total patients included in a single analysis was 602. The majority of studies evaluated patients with bulimia nervosa of a purging type. The review supported the efficacy of cognitive-behavioural psychotherapy (CBT) and particularly CBT-BN in the treatment of people with bulimia nervosa and also (but less strongly due to the small number of trials) like eating disorder syndromes. CBT had been used with efficacy in group settings. Other psychotherapies were also efficacious, particularly interpersonal psychotherapy in the longer-term. Self-help approaches that used highly structured CBT treatment manuals, were promising albeit with more modest results generally, and their evaluation in bulimia nervosa approach merits further research. Exposure and response prevention did not appear to enhance the efficacy of CBT. Psychotherapy alone is unlikely to reduce or change body weight in people with bulimia nervosa or similar eating disorders. REVIEWER'S CONCLUSIONS: There was a small body of evidence for the efficacy of cognitive-behaviour therapy in bulimia nervosa and similar syndromes, but the quality of trials was very variable (e.g. the majority were not blinded) and sample sizes were often small in comparison to pharmacotherapy trials. More trials are needed, particularly for binge eating disorder and other EDNOS syndromes, and trials evaluating other psychotherapies and less intensive psychotherapies.

Anticholinergics for neuroleptic-induced acute akathisia.

BACKGROUND: Neuroleptic-induced akathisia is one of the most common and distressing early-onset adverse effects of conventional antipsychotic drugs, being associated with poor compliance with treatment, and thus, ultimately, with an increased risk of relapse. This review assesses the role of anticholinergic drugs as an adjunct to standard antipsychotic medication in the pharmacological treatment of this problem. OBJECTIVES: To determine the clinical effects of anticholinergic drugs for neuroleptic-induced acute akathisia. SEARCH STRATEGY: The reviewers undertook electronic searches of Biological Abstracts (1982-1999), CINAHL (1982-1999), Cochrane Library (Issue 4 1999), Cochrane Schizophrenia Group's Register (October 1999), EMBASE (1980-1999), LILACS (1982-1999), MEDLINE (1966-1999) and PsycLIT (1974-1999). References of all identified studies were inspected for more trials and first authors contacted. Each included study was sought as a citation on the Science Citation Index database. SELECTION CRITERIA: All randomised clinical trials of anticholinergic drugs versus placebo for people with neuroleptic-induced acute akathisia. DATA COLLECTION AND ANALYSIS: Two reviewers, working independently, selected, quality assessed and extracted data. These data were then analysed on an intention-to-treat basis. For homogeneous dichotomous data the fixed effects relative risk (RR), the 95% confidence intervals (CI) and, where appropriate, the number needed to treat (NNT) were calculated on an intention-to-treat basis. For continuous data, reviewers calculated weighted mean differences. MAIN RESULTS: No randomised controlled trials could be included. REVIEWER'S CONCLUSIONS: At present, there is no reliable evidence to support or refute the use of anticholinergics for people suffering from neuroleptic-induced acute akathisia. Akathisia is a most distressing movement disorder that remains highly prevalent, both in the developed and developing world. This review highlights the need for well designed, conducted and reported clinical trials to address the claims of open studies as regards the effects of the anticholinergic group of drugs for akathisia.

Benzodiazepines for neuroleptic-induced acute akathisia.

BACKGROUND: Neuroleptic-induced akathisia is one of the most common and distressing early-onset adverse effects of antipsychotic drugs, being associated with poor compliance with treatment, and thus, ultimately, to an increase risk of relapse. This review assesses the role of benzodiazepines in the pharmacological treatment of this problem. OBJECTIVES: To determine the effects of benzodiazepines versus placebo for people with neuroleptic-induced acute akathisia. SEARCH STRATEGY: Biological Abstracts (January 1982-March 1999), The Cochrane Library (Issue 3 1999), The Cochrane Schizophrenia Group's Register (May 2001), EMBASE (January 1980-March 1999), LILACS (January 1982-March 1999), MEDLINE (January 1964-March 1999), PsycLIT (January 1974-March 1999), and SCISEARCH were searched. Further references were sought from published trials and their authors. SELECTION CRITERIA: All randomised clinical trials comparing benzodiazepines with placebo for people with antipsychotic-induced acute akathisia. DATA COLLECTION AND ANALYSIS: Two reviewers, working independently, selected, quality assessed and extracted data. These data were then analysed on an intention-to-treat basis. For homogeneous dichotomous data the fixed effects relative risk (RR), the 95% confidence intervals (CI) and, where appropriate, the number needed to treat (NNT) were calculated on an intention-to-treat basis. For continuous data, reviewers calculated weighted mean differences. MAIN RESULTS: Two small (total N=27) randomised controlled trials were included. By seven to 14 days, there was a reduction in symptoms for those patients receiving clonazepam compared with placebo (2 RCTs, N=26, RR 0.09 CI 0.01 to 0.6, NNT 1.2 CI 0.9 to 1.5). No significant difference was found for adverse events (2 RCTs, N=26, RR 3.00 CI 0.2 to 62) or the need for anticholinergic medication (2 RCTs, N=26, RR 1.56 CI 0.9 to 2.7). No one left the two studies early. Data on mental, social and family outcomes could not be pooled and there was little or no data on user satisfaction, deaths, violence, criminal behaviour and costs. REVIEWER'S CONCLUSIONS: Over a short follow-up period, the use of benzodiazepines may reduce the symptoms of antipsychotic-induced acute akathisia. This review highlights the need for well designed, conducted and reported clinical trials to address the claims of open studies.

Efficacy and safety of risperidone oral solution in agitation associated with dementia in the elderly.

BACKGROUND: Behavioral and psychological symptoms in dementia (BPSD) contribute to caregiver burden and institutionalization of elderly. Neuroleptics are prescribed to control agitation. Side effects of typical neuroleptics are harmful, making atypical neuroleptics an indication. OBJECTIVES: To evaluate efficacy and tolerability of risperidone oral solution (ROS) given once daily to demented elderly outpatients with BPSD (agitation). METHOD: Patients (n=26), 76.35+/-8.63 years, Diagnostic and Statistical Manual of Mental Disorders 4th ed. (DSM-IV) criteria for dementia. RSO was given, starting dose of 0.25 mg and increments of 0.25 mg every week. Mini-Mental State Examination (MMSE) assessed cognitive status, Behavioral and Emotional Activities Manifested in Dementia (BEAM-D) and Clinical Global Impression (CGI) measured BPSD, Extrapiramidal Symptom Rating Scale (ESRS) evaluated extrapyramidal symptoms. Cardiovascular side effects were evaluated clinically. RESULTS: There was a 26% reduction in agitation and no cardiovascular side effects in the range from 1.0 to 1.25 mg. Side effects were more prevalent above 2.5 mg. CONCLUSION: Risperidone oral solution improved agitation with good tolerability from 0.5 to 1.25 mg. A single dose with increments of 0.25 mg may be more acceptable to patients and caregivers.

Psychotherapy for bulimia nervosa and binging.

BACKGROUND: Bulimia nervosa and like syndromes, such as binge eating disorder, are common in young Western women. A specific psychotherapy, cognitive behaviour therapy (CBT) has been developed for the treatment of bulimia nervosa. Other psychotherapies, some from a different theroretical framework and some which are modifications of CBT are also used. OBJECTIVES: The review aims to evaluate the psychotherapeutic treatments for those with binge eating syndromes, that have been tested in randomised controlled trials. Specifically, CBT therapy is compared with waiting list or a non-treatment group, any other psychotherapy, CBT in a "pure self-help" form and CBT augmented by exposure and response therapy. As well, the review aims to evaluate the evidence for the efficacy of other psychotherapies when compared to a no treatment control group and to evaluate the evidence for the efficacy of other psychotherapies when compared to a 'placebo' therapy. SEARCH STRATEGY: Handsearch of The International Journal of Eating Disorders since its first issue; database searches of MEDLINE, EXTRAMED, EMBASE, PSYCHLIT, CURRENT CONTENTS, LILACS, SCISEARCH, The Cochrane Collaboration Controlled Trials Register and the Cochrane Depression, Anxiety and Neurosis Group Database of Trials; citation list searching and personal approaches to authors communication are used. SELECTION CRITERIA: All studies that have tested any form of psychotherapy for adult patients with non-purging bulimia nervosa, binge eating disorder and/or EDNOS of a bulimic type, and which have applied a randomised controlled and standardized outcome methodology, are sought for the purpose of this review. DATA COLLECTION AND ANALYSIS: Data are entered into a spreadsheet programme, and into the REVMAN analysis program. Relative risk analyses are conducted of binary outcome data. The relative risk analysis is used rather than the odds ratio as the outcome measures proposed are not measuring a rare event (such as death) and the total number of studies is small. Standardized mean difference analyses are conducted of continuous variable outcome data, as the continuous outcome measures are not consistent across studies. Sensitivity analyses are conducted of a number of measures of trial quality. Data were not reported in such a way to permitsubgroup analyses, but the effect of treatment on depressive symptoms, psychosocial and/or interpersonal functioning, general psychiatric symptoms and weight is examined where possible. Chi-square tests for homogeneity are done, at 5% level of significance, using a fixed effects model. Funnel plots to evaluate presence of publication bias are completed and available in a text file upon request. MAIN RESULTS: To date, more than 1365 trials have been generated by searching and 64 trials have been evaluated in detail. Because of a relatively high number of original exclusions (n=12) the trial inclusion criteria were broadened to include those with non-blinded outcome assessment, providing 27 trials for analyses. Because of incomplete published and available data, at best up to 10 studies had data available for any single analysis. The maximum number of total patients included in a single analysis is 543. The majority of studies (21) evaluate patients with bulimia nervosa of a purging type. CBT is superior to waiting list controls with respect to abstinence from binge eating (RR 0.64 CI.53-.78). CBT just fails to be significantly superior to other psychotherapies with respect to abstinence from binge eating (RR.79, CI.61-1.04). CBT in a full or less intensive form is not significantly superior to CBT in a pure self-help form. Augmentation of CBT with exposure therapy is not more effective than CBT alone. Non CBT-psychotherapies also have significantly greater abstinence rates in comparisons with wait-list controls, but there is a paucity of such studies (RR 0.67, CI.56-.81, n=3 studies). Funnel plots suggest a bias towards publication of positive outcome studies only. REVIEWER'S CONCLUSIONS: There is small body of evidence for the efficacy of cognitive-behaviour therapy in bulimia nervosa and similar syndromes, but the quality of trials is very variable (e.g. the majority are not blinded) and sample sizes are often very small. More trials are needed, particularly for binge eating disorder and other EDNOS syndromes, and evaluating other psychotherapies and less intensive psychotherapies.

Antidepressants versus psychological treatments and their combination for bulimia nervosa.

BACKGROUND: Psychotherapeutic approaches, mainly cognitive behavior therapy, and antidepressant medication are the two treatment modalities that have received most support in controlled outcome studies of bulimia nervosa. OBJECTIVES: The primary objective was to conduct a systematic review of all RCTs comparing antidepressants with psychological approaches or comparing their combination with each single approach for the treatment of bulimia nervosa. SEARCH STRATEGY: (1) electronic searches of MEDLINE (1966 to December 2000), EMBASE (1980-December 2000), PsycLIT (to December 2000), LILACS & SCISEARCH (to 1999) (2) the Cochrane Register of Controlled Trials and the Cochrane Depression, Anxiety and Neurosis Group Register - ongoing (3) handsearches of the references of all identified trials (4) contact with the pharmaceutical companies and the principal investigator of each included trial (5) handsearch of the International Journal of Eating Disorders - ongoing INCLUSION CRITERIA: every randomized controlled trial in which antidepressants were compared with psychological treatments or the combination of antidepressants with psychological approaches was compared to each treatment alone, to reduce the symptoms of bulimia nervosa in patients of any age or gender. Quality criteria: reports were considered adequate if they were classified as A or B according to the Cochrane Manual. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers for each included trial. The main outcome for efficacy was full remission of bulimic symptoms, defined as 100% reduction in binge or purge episodes from baseline to endpoint. Dichotomous data was evaluated by the relative risks and 95% confidence intervals around this measure, based on the random effects model; continuous data was evaluated by the average difference and the 95% confidence interval. Number needed to treat (NNT) and number needed to harm (NNH) were calculated using the inverse of the absolute risk reduction. MAIN RESULTS: Five trials were included in comparison one (antidepressants versus psychological treatments), five in comparison two (antidepressants versus the combination) and seven in comparison three (psychological treatments versus the combination). Remission rates were 20% for single antidepressants compared to 39% for single psychotherapy (DerSimonian-Laird Relative Risk = 1.28; 95% Confidence Interval = 0.98;1.67). Dropout rates were higher for antidepressants than for psychotherapy (DerSimonian-Laird Relative Risk = 2.18; 95% Confidence Interval = 1.09;4.35). The NNH for a mean treatment duration of 17.5 weeks was 4 (95% confidence interval = 3;11). Comparison two found remission rates of 42% for the combination versus 23% for antidepressants (DerSimonian-Laird Relative Risk = 1.38; 95% Confidence Interval = 0.98;1.93). Comparison three showed a 36% pooled remission rate for psychological approaches compared to 49% for the combination (DerSimonian-Laird Relative Risk = 1.21; 95% Confidence Interval = 1.02;1.45). The NNT for a mean treatment duration of 15 weeks was 8 (95% Confidence Interval = 4;320). Dropout rates were higher for the combination compared to single psychological treatments (DerSimonian-Laird Relative Risk = 0.57; 95% Confidence Interval = 0.38;0.88). The NNH was 7 (95% Confidence Interval = 4;21). REVIEWER'S CONCLUSIONS: Using a more conservative statistical approach, combination treatments were superior to single psychotherapy. This was the only statistically significant difference between treatments. The number of trials might be insufficient to show the statistical significance of a 19% absolute risk reduction in efficacy favouring psychotherapy or combination treatments over single antidepressants. Psychotherapy appeared to be more acceptable to subjects. When antidepressants were combined to psychological treatments, acceptability of the latter was significantly reduced.

Antidepressants versus placebo for people with bulimia nervosa.

BACKGROUND: Bulimia Nervosa (BN) represents an important public health problem and is related to serious morbidity and even mortality. This review attempted to systematically evaluate the use of antidepressant medications compared with placebo for the treatment of bulimia nervosa. OBJECTIVES: The primary objective of this review was to determine whether using antidepressant medications was clinically effective for the treatment of bulimia nervosa. The secondary objectives were: (i) to examine whether there was a differential effect for the various classes/types of antidepressants with regard to effectiveness and tolerability (ii) to test the hypothesis that the effect of antidepressants on bulimic symptoms was independent of its effect on depressive symptoms SEARCH STRATEGY: (1) electronic searches of MEDLINE (1966 to December 2000), EMBASE (1980-December 2000), PsycLIT (to December 2000), LILACS & SCISEARCH (to 1997) (2) the Cochrane Register of Controlled Trials and the Cochrane Depression, Anxiety and Neurosis Group Register - ongoing (3) inspection of the references of all identified trials (4) contact with the pharmaceutical companies and the principal investigator of each included trial (5) inspection of the International Journal of Eating Disorders - ongoing INCLUSION CRITERIA: every randomized, placebo-controlled trial in which antidepressant medications were compared to placebo to reduce the symptoms of bulimia nervosa in patients of any age or gender. Quality criteria: reports were considered adequate if they were classified as A or B according to the Cochrane Manual. The Jadad scale, with a cut off of 2 points, was applied to check the validity of the above referred criterion but was not used as an inclusion criterion. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers for each included trial. Dichotomous data were evaluated by the relative risk with 95% confidence intervals (CI) around this measure, based on the random effects model; continuous data were evaluated by the standardised mean difference with the 95% CI. NNT was calculated using the inverse of the absolute risk reduction. MAIN RESULTS: Currently the review includes 16 trials comparing antidepressants with placebo: 6 trials with TCAs (imipramine, desipramine and amitryptiline), 3 with SSRIs (fluoxetine), 4 with MAOIs (phenelzine, isocarboxazid and brofaromine) and 3 with other classes of drugs (mianserine, trazodone and bupropion). Similar results were obtained in terms of efficacy for these different groups of drugs. The pooled RR for remission of binge episodes was 0.88 (95% CI 0.83-0.93; p<0,001) favoring drugs. The NNT for a mean treatment duration of 8 weeks, taking the non-remission rate in the placebo controls of 92% as a measure of the baseline risk was 9 (95% CI 6 - 16). The RR for clinical improvement, defined as a reduction of 50% or more in binge episodes was 0.63 (95% CI 0.55-0.74) and the NNT for a mean treatment duration of 9 weeks was 4 (95% CI 3 - 6), with a non-improvement rate of 67% in the placebo group. Patients treated with antidepressants were more likely to interrupt prematurely the treatment due to adverse events. Patients treated with TCAs dropped-out due to any cause more frequently that patients treated with placebo. The opposite was found for those treated with fluoxetine, suggesting it may be a more acceptable treatment. Independence between antidepressant and antibulimic effects could not be evaluated due to incomplete published data. REVIEWER'S CONCLUSIONS: The use of a single antidepressant agent was clinically effective for the treatment of bulimia nervosa when compared to placebo, with an overall greater remission rate but a higher rate of dropouts. No differential effect regarding efficacy and tolerability among the various classes of antidepressants could be demonstrated.

Psychotherapy for bulimia nervosa and binging.

BACKGROUND: Bulimia nervosa and like syndromes, such as binge eating disorder, are common in young Western women. A specific psychotherapy, cognitive behaviour therapy (CBT) has been developed for the treatment of bulimia nervosa. Other psychotherapies, some from a different theroretical framework, some modifications of CBT are also used. OBJECTIVES: The review aims to evaluate the psychotherapeutic treatments for those with binge eating syndromes, that have been tested in randomised controlled trials. Specifically, CBT therapy is compared with waiting list or a non-treatment group, any other psychotherapy, CBT in a "pure self-help" form and CBT augmented by exposure and response therapy. As well, the review aims to evaluate the evidence for the efficacy of other psychotherapies when compared to a no treatment control group and to evaluate the evidence for the efficacy of other psychotherapies when compared to a 'placebo' therapy. SEARCH STRATEGY: Handsearch of The International Journal of Eating Disorders since its first issue; database searches of MEDLINE, EXTRAMED, EMBASE, PSYCHLIT, CURRENT CONTENTS, LILACS, SCISEARCH, The Cochrane Collaboration Controlled Trials Register and the Cochrane Depression, Anxiety and Neurosis Group Database of Trials; citation list searching and personal approaches to authors communication are used. SELECTION CRITERIA: All studies that have tested any form of psychotherapy for adult patients with non-purging bulimia nervosa, binge eating disorder and/or EDNOS of a bulimic type, and which have applied a randomised controlled and standardized outcome methodology, are sought for the purpose of this review. DATA COLLECTION AND ANALYSIS: Data are entered into a spreadsheet programme, and into the REVMAN analysis program. Relative risk analyses are conducted of binary outcome data. The relative risk analysis is used rather than the odds ratio as the outcome measures proposed are not measuring a rare event (such as death) and the total number of studies is small. Standardized mean difference analyses are conducted of continuous variable outcome data, as the continuous outcome measures are not consistent across studies. Sensitivity analyses are conducted of a number of measures of trial quality. Data were not reported in such a way to permitsubgroup analyses, but the effect of treatment on depressive symptoms, psychosocial and/or interpersonal functioning, general psychiatric symptoms and weight is examined where possible. Chi-square tests for homogeneity are done, at 5% level of significance, using a fixed effects model. Funnel plots to evaluate presence of publication bias are completed and available in a text file upon request. MAIN RESULTS: To date, more than 1360 trials have been generated by searching and 63 trials have been evaluated in detail. Because of a relatively high number of exclusions (n=12) the trial inclusion criteria were broadened to include those with non-blinded outcome assessment, providing 25 trials for analyses. Because of incomplete published and available data, at best up to 10 studies had data available for any single analysis. The maximum number of total patients included in a single analysis is 543. The majority of studies (21) evaluate patients with bulimia nervosa of a purging type. CBT is superior to waiting list controls with respect to abstinence from binge eating (RR 0.64 CI.53-.78). CBT just fails to be significantly superior to other psychotherapies with respect to abstinence from binge eating (RR.79, CI.61-1.04). CBT in a full or less intensive form is not significantly superior to CBT in a pure self-help form. Augmentation of CBT with exposure therapy is not more effective than CBT alone. Non CBT-psychotherapies also have significantly greater abstinence rates in comparisons with wait-list controls, but there is a paucity of such studies (RR 0.67, CI.56-.81, n=3 studies). Funnel plots suggest a bias towards publication of positive outcome studies only. REVIEWER'S CONCLUSIONS: There is small body of evidence for the efficacy of cognitive-behaviour therapy in bulimia nervosa and similar syndromes, but the quality of trials is very variable (e.g. the majority are not blinded) and sample sizes are often very small. More trials are needed, particularly for binge eating disorder and other EDNOS syndromes, and evaluating other psychotherapies and less intensive psychotherapies.

Psychotherapy for bulimia nervosa and binging.

OBJECTIVES: The review aims to evaluate the psychotherapeutic treatments for those with binge eating syndromes, that have been tested in randomised controlled trials. Specifically, cognitive-behavioural(CBT) therapy is compared with waiting list or a non-treatment group, any other psychotherapy, CBT in a "pure self-help" form and CBT augmented by exposure and response therapy. As well, the reveiw aims to evaluate the evidence for the efficacy of other psychotherapies when compared to a no treatment control group and to evaluate the evidence for the efficacy of other psychotherapies when compared to a 'placebo' therapy. SEARCH STRATEGY: Handsearch of The International Journal of Eating Disorders since its first issue; database searches of MEDLINE, EXTRAMED, EMBASE, PSYCHLIT, CURRENT CONTENTS, LILACS, SCISEARCH, The Cochrane Collaboration Controlled Trials Register and the Cochrane Depression, Anxiety and Neurosis Group Database of Trials; citation list searching and personal approaches to authors communication are used. SELECTION CRITERIA: All studies that have tested any form of psychotherapy for adult patients with non-purging bulimia nervosa, binge eating disorder and/or EDNOS of a bulimic type, and which have applied a randomised controlled and standardized outcome methodology, are sought for the purpose of this review. DATA COLLECTION AND ANALYSIS: Data are entered into a spreadsheet programme, and into the REVMAN analysis program. Relative risk analyses are conducted of binary outcome data. The relative risk analysis is used rather than the odds ratio as the outcome measures proposed are not measuring a rare event (such as death) and the total number of studies is small. Standardized mean difference analyses are conducted of continuous variable outcome data, as the continuous outcome measures are not consistent across studies. Sensitivity analyses are conducted of a number of measures of trial quality. Data were not reported in such a way to do subgroup analyses, but the effect of treatment on depressive symptoms, psychosocial and/or interpersonal functioning, general psychiatric symptoms and weight is examined where possible. Chi-square tests for homogeneity are done, @ 5% level of significance, using a fixed effects model. Funnel plots to evaluate presence of publication bias are completed and available in a text file upon request. MAIN RESULTS: To date, 1360 trials have been generated by searching and 58 trials have been evaluated in detail. Because of a relatively high number of exclusions (n=12) the trial inclusion criteria were broadened to include those with non-blinded outcome assessment, providing 20 trials for analyses. Because of incomplete published and available data, at best up to 10 studies had data available for any single analysis. The maximum number of total patients included in a single analysis is 396. The majority of studies (18) evaluate patients with bulimia nervosa of a purging type. CBT is superior to waiting list controls with respect to abstinence from binge eating (RR 0.64 CI.53-.78). CBT is not superior to other psychotherapies with respect to abstinence from binge eating (RR.79, CI.54-1.17). CBT in a full or less intensive form is not significantly superior to CBT in a pure self-help form. Augmentation of CBT with exposure therapy is not more effective than CBT alone. NonCBT-psychotherapies also have significantly greater abstinence rates in comparisons with wait-list controls, but there is a paucity of such studies (RR 0.67, CI.56-.81, n=3 studies). Funnel plots suggest a bias towards publication of positive outcome studies only. REVIEWER'S CONCLUSIONS: There is small body of evidence for the efficacy of cognitive-behaviour therapy in bulimia nervosa and similar syndromes, but the quality of trials is very variable (e.g. the majority, 12, are not blinded) and sample sizes are often very small. More trials are needed, particularly for binge eating disorder and other EDNOS syndromes, and evalu

Antidepressants versus placebo for the treatment of bulimia nervosa: a systematic review.

OBJECTIVE: The objective of this study was to valuate the effectiveness, tolerability and acceptability of various classes of antidepressants compared with placebo in the treatment of bulimia nervosa. METHOD: A meta-analysis including 16 randomised controlled trials and 1300 bulimic patients was performed. Dichotomous outcomes were analysed by calculating relative risks, and continuous outcomes by calculating effect sizes. Methodological quality, heterogeneity in the results and selective publication were assessed. RESULTS: Short-term remission in bulimic symptoms was statistically more likely on antidepressants than placebo (Relative Risk=0.88, 95% CI=0.83-0.94, p<0.0001). Drop-out rates were high but no statistical difference was found between treatment groups (34.6% and 31.4% for drug and placebo; RR=1.03, 95% CI=0.80-1.32, p=0.8). No difference in efficacy could be demonstrated among different classes of antidepressants. CONCLUSIONS: The use of a single antidepressant agent was clinically effective for the treatment of bulimia nervosa when compared with placebo, with an overall greater remission rate and a higher rate of drop-outs. No differential effect regarding efficacy and tolerability among the various classes of antidepressants could be demonstrated.

Combination of antidepressants and psychological treatments for bulimia nervosa: a systematic review.

UNLABELLED: This review assessed the effect of a combination of antidepressants plus psychological approaches compared to each single treatment for bulimia nervosa. METHOD: Trials were included in two meta-analyses: single antidepressants versus combination and single psychological approaches versus combination. Methodological quality and homogeneity of results were assessed. Dichotomous outcomes were analysed by calculating relative risks (RR). RESULT: Five trials were included in meta-analysis 1 and 7 in meta-analysis 2. Remission rates were 42% for combination versus 23% for antidepressants (RR = 1.38; 95% CI=0.98-1.93; P=0.06) and 36% for psychological approaches compared to 49% for combination (RR= 1.21; P=0.03). Drop-out rates were 16% for psychological approaches and 30% for combination (RR =0.57; 95% CI = 0.38-0.088; P=0.11). CONCLUSION: Efficacy of combined treatments was superior to single approaches. When antidepressants were combined to treatment, acceptability of psychological approaches was significantly reduced.

A pilot study of topiramate in children with Lennox-Gastaut syndrome.

We conducted an open, add-on study with topiramate (TPM) as adjunctive therapy in Lennox-Gastaut syndrome (LGS), to assess the long-term efficacy and safety and to evaluate quality of life (QL) measurements in the chronic use of TPM. We studied 19 patients (11 male; age ranging from 4 to 14 years) with uncontrolled seizures receiving 2-3 anti-epileptic drugs. Patients were followed up to 36 months of treatment. A questionnaire was used to query parents about QL. Seven patients completed the study at 36 months and seizure frequency was reduced > or = 75% in 4, and < 50% in 3 patients. Two children became seizure free for more than 24 months. Most side effects were CNS related, with the most frequent being somnolence and anorexia. These were generally transient. One patient dropped-out due to powder in the urine. None of the patients required hospitalization. At 36 months, patients' alertness (2/7), interaction with environment (5/7), ability to perform daily activities (5/7), and verbal performance (6/7) improved on TPM. We conclude that TPM may be useful as adjunctive therapy in the treatment of LGS. The efficacy of TPM was maintained in long-term treatment in more than 40% of patients, long term safety was confirmed and QL improved on TPM.

A pilot study of topiramate in children with Lennox-Gastaut syndrome

We conducted an open, add-on study with topiramate (TPM) as adjunctive therapy in Lennox-Gastaut syndrome (LGS), to assess the long-term efficacy and safety and to evaluate quality of life (QL) measurements in the chronic use of TPM. We studied 19 patients (11 male; age ranging from 4 to 14 years) with uncontrolled seizures receiving 2-3 anti- epileptic drugs. Patients were followed up to 36 months of treatment. A questionnaire was used to query parents about QL. Seven patients completed the study at 36 months and seizure frequency was reduced = 75 per cent in 4, and < 50 per cent in patients. Two children became seizure free for more than 24 months. Most side effects were CNS related, with the most frequent being somnolence and anorexia. These were generally transient. One patient dropped-out due to powder in the urine. None of the patients required hospitalization. At 36 months, patients' alertness (2/7), interaction with environment (5/7), ability to perform daily activities (5/7), and verbal performance (6/7) improved on TPM. We conclude that TPM may be useful as adjunctive therapy in the treatment of LGS. The efficacy of TPM was maintained in long-term treatment in more than 40 per cent of patients, long term safety was confirmed and QL improve on TPM.