Scandinavian Journal of Psychology, 2004, 45, 247252

Review of studies evaluating psychotherapy in bulimia nervosa: The inuence of research methods
Blackwell Publishing Ltd

LOA CLAUSEN
Department of Psychology, Aarhus University, Denmark and Eating Disorder Centre, Aarhus University Hospital, Denmark

Clausen, L. (2004). Review of studies evaluating psychotherapy in bulimia nervosa: The inuence of research methods. Scandinavian Journal of Psychology, 45, 247252. The purpose of the study was to test if design and research methods of studies predict outcome results of bulimia nervosa. Fifty-seven articles on outcome of bulimia nervosa were found through MEDLINE and PSYCHINFO databases and 25 were included in the statistical analysis. Percentages of patients with a good outcome ranged from 24% to 74% with a mean of 51.1%. The variables best predicting outcome were time to follow-up and number of symptoms evaluated in denition of good outcome whereas dropout, design of studies, treatments, and sample characteristics did not predict signicantly. The implications of these ndings are discussed. Key words: Bulimia nervosa, outcome studies, predictor of outcome, research methods. L. Clausen, Aarhus University, Department of Psychology, Asylvej 4, 8240 Risskov, Denmark. E-mail: loa.clausen@post.tele.dk

Bulimia nervosa is one of two main eating disorders known to hamper the life of, predominantly, young women. It is characterized by regular loss of control of eating, resulting in eating signicantly larger amounts of food than other people would do in a discrete period of time (bingeing). As a consequence they have recurrent inappropriate compensatory behavior, for example, vomiting, misuse of laxatives, fasting, or excessive exercise. Lastly, self-evaluation are signicantly inuenced by body and weight (American Psychiatric Association, 1994). Reviews of studies investigating the outcome of patients with bulimia nervosa treated with psychotherapy show that approximately 50% of the patients have a good outcome (Hsu, 1995; Keel and Mitchell, 1997; Mitchell, Hoberman, Peterson, Mussell & Pyle, 1996). However, the percentage with good outcome varies between 24% and 74% (Fichter and Quadieg, 1997; Abraham, 1998). A range as large as 50 needs elucidation, and it is necessary to consider several substantial aspects when looking for explanations of this variance. Sample characteristics, treatments and methodology have all been found to have an inuence on results of outcome studies. Starting with the methodology this includes, among other things, decisions on how to evaluate patients, who to evaluate, how to dene and operationalize outcome, how to design the study etc. Different methods and designs have been applied in previous outcome studies on bulimia nervosa. To clarify the consequences of methods and designs on outcome results of studies on bulimia nervosa four aspects of these areas will get special attention: (1) The way of dening a good outcome varies on two aspects. First, the number of symptoms evaluated differ: some studies only evaluate behavior, that is, bingeing and purging, while others additionally evaluate psychological symptoms, that is, the

inuence of body shape and weight on self-evaluation. Second, the degree of abstinence required varies: good outcome criteria for some studies include patients having no more than one binge per month whereas others demand total abstinence of symptoms. (2) The period of evaluation varies, that is, some studies evaluate symptoms over the last 2 weeks, others 4, 12 or more weeks. One study found that 9% of patients were reclassied into a moderate outcome group instead of a good outcome group if duration of abstinence required change from 1 to 12 months (Keel, Mitchell, Davis, Fieselman & Crow, 2000a). (3) Design of the study varies and randomized controlled trials are found to get better outcome results than naturalistic follow-up studies within the rst 5 years after initial assessment (Keel and Mitchell, 1997). (4) Different methods are used to assess outcome (e.g. interviews, questionnaires, and eating disorder scales) resulting in different validity and reliability of information. Other aspects have been found to affect the outcome of follow-up studies. Time to follow-up varies from a few weeks to several years and longer follow-up time seems to predict better outcome for bulimic patients (Keel and Mitchell, 1997). Dropout is a variable that needs attention in all studies for its inuence on results. Lastly, types of treatment given (Fairburn, Jones, Peveler, Hope & OConnor, 1993b) and different samples of patients (Vaz, 1998) affect outcome results. The focus of this article will be on outcome studies investigating patients with bulimia nervosa treated with psychotherapy or counselling. The range in outcome results will be analysed in relation to the following predictors: (1) time to follow-up, (2) denition of good outcome (i.e. symptoms evaluated: behavioral vs behavioral/-psychological), (3) period of evaluation, (4) dropout, (5) design of study (i.e. randomized controlled trails, longitudinal prospective follow-up studies, and retrospective follow-up studies), (6) treatment

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Scand J Psychol 45 (2004) follow-up studies (ROS). Treatments were coded as inpatient, outpatient and daycare only. More specic information was too heterogeneous to group and analyze. The following sample characteristics were coded: mean age at assessment and mean duration of illness. Mean age at onset and mean number of binges and purging behavior were not coded as only four studies included this information.

conditions (i.e. inpatient, daycare, or outpatient), and (7) sample characteristics (i.e. age and severity of illness). Other relevant variables such as method of assessment, psychiatric co-morbidity, and more specic types of treatment such as behavioral vs interpersonal, will not be tested because of lack of information or the level of heterogeneous information making grouping impossible.

Method of analysis MATERIALS AND METHOD Retrieval and inclusion of studies

Relevant studies were found using MEDLINE and PSYCHINFO databases under the term outcome and bulimia nervosa for the period 19902000. Furthermore, secondary references were used from these articles. Inclusion criteria were: (1) language of articles English, German, or French, (2) patients diagnosed with bulimia nervosa according to DSM-III, DSM-IIIR, or DSM-IV, (3) sample size of at least 20 patients, and (4) results reported categorically, i.e. percentage of patients with good outcome. Correlation analysis (Pearsons correlation coefcient, two-tailed) was used for continuous independent variables, and the t-test was used for categorical independent variables. Correlations and differences being at least signicant on a trend level were added to a regression analysis. Trend correlations and differences were dened as p < 0.15 because of the small number of studies. Calculations were done with the SPSS program package.

RESULTS Table 2 displays means and standard deviations for all continuous variables and number of studies within categorical variables. Mean follow-up time for the 18 groups of patients was 4.1 years 4.1, mean good outcome was 51.1% 12.6, and mean dropout was 15.2% 12.7. As seen in Table 3 analysis of correlations revealed only trend correlations with percentage of good outcome, i.e. dropout ( p = 0.064) and time to follow-up ( p = 0.144). Analysis showed correlation between age at assessment and duration of illness ( p = 0.004) but neither of these variables correlated with outcome (assessment: p = 0.349, duration: p = 0.156). Time to follow-up and period of evaluation correlated signicantly ( p = 0.043), i.e. studies with longer follow-up time evaluated symptoms for a longer period at follow-up than studies with shorter follow-up time. Outcome was 43.1% 8.4 and 55.1% 12.6 when grouped by denition of outcome (Group A vs. B). The difference was signicant (t = 2.397, p = 0.031) indicating that studies evaluating psychological as well as behavioral symptoms had fewer patients with a good outcome compared to studies evaluating only behavioral symptoms. Further investigation showed that N was 6 and 12 respectively, time to follow-up was 6.4 years 3.8 and 3.0 years 3.9 respectively (t = 1.797, p = 0.091), number of patients that was followed was 106.2 61.4 and 46.4 30.0 (t = 2.253, p = 0.064), period of evaluation was longer for Group A, and more than half of the studies in Group B were RCT while only one of Group A was. Differences in percentages of good outcome between design of studies, i.e. ROS with 55.7% 16.5, RCT with 51.7% 10.1 and LPOS with 45.6% 12.4 were, however, non-signicant. ROS had the longest follow-up time and the biggest dropout whereas RCT had the shortest follow-up time and a medium dropout. The only signicant difference in design was between RCT and ROS in time to follow-up (t = 2.764, p = 0.041). All but one RCT used behavioral denitions of outcome whereas ROS and LPOS included studies with behavioral denitions and studies with diagnostic denitions almost equally.

Studies included
Using the method mentioned above 57 articles were located, all English. The inclusion criteria led to exclusion of 32 articles due to the following reasons: 12 reported results as continuous data, 11 had under 20 subjects, 5 reported results from survival analysis without nal outcome, 2 mixed results of patients with anorexia nervosa and bulimia nervosa, one reported outcome only on social functioning, and another reported absence of bingeing and purging separately but not the number of patients being free of both symptoms. Thus, 25 articles were included in the analysis covering 15 studies, 18 groups of patients, and 33 follow-ups in total. Table 1 shows the following: studies included, number of patients at each follow-up (i.e. completers and number included at admission), outcome results, years to follow-up, denition of outcome (including number of weeks evaluated and the present authors grouping of studies), methodological design of studies, treatment, and assessment tests.

Selection and grouping of information

Articles referring to the same sample were classied as one study. In studies with more than one follow-up, the longest follow-up time was chosen. The percentage of good outcome for completers was coded as dependent variable. To test the inuence of denition of good outcome on results, denition of outcomes was categorized into two groups according to the number of diagnostic criteria included in evaluation: Group A included studies evaluating all diagnostic criteria for bulimia nervosa (i.e. bingeing, compensating behavior, and obsession with weight or shape) and demanding all symptoms to be absent, and Group B included studies evaluating behavioral criteria for bulimia nervosa only (i.e. bingeing and compensation behavior) or studies accepting a light symptomatology (i.e. bingeing and /or compensation behavior present, but less than twice a week). Two studies used cutoff scores on behavioral scales for bulimia nervosa (Fahy and Russell, 1993; Reas, Williamson, Martin & Zucker, 2000); these were included in Group B. Design of studies were coded as randomized control trails (RCT), longitudinal prospective follow-up studies (LPOS), and retrospective

2004 The Scandinavian Psychological Associations/Blackwell Publishing Ltd.

Table 1. Studies included Completers N (N included) 44 (50) Good outcome (%) 46 Years to follow-up 9.8 Denition of outcome, weeks of evaluation (group of denition) (A) All BN symptoms nonpathological for 52 weeks

2004 The Scandinavian Psychological Associations/Blackwell Publishing Ltd.

Scand J Psychol 45 (2004)

Literature included Collings & King (1994), Reiss & Johnson-Sabina (1995), Johnson-Sabina et al. (1992) Keel et al. (1999, 2000) Fairburn et al. (1986, 1991, 1993a, 1993b, 1995), Jones et al. (1993) Fallon et al. (1991, 1994) Fahy & Russell (1993) Bulik et al. (1998a, 1998b)

Design LPOS

Treatment Outpatient Later: mixed

Assessment EAT, semi-structured interview

91 (100) 173 (222) 89 (99) 46 (52) 39 (43) 37 (43) 106 (111) 95 (111) 35/33/39 (111) 32/39 (83) 32/39 (83) 32/39 (83) 98 (98) 184 (196) 187 (196) 44 (97)

66 46.8 33.3 53.9 39.1 46.2 56.8 52.8 54.7 65/44/43 34.4/25.6 65.6/43.6 65.6/43.6 29 24.5 43.9 72.7

3.5 11.5 1 5.8 4.5 0.3 1 0.2 0.5 1 1.2 2.2 3.2 1 2 6 2

(A) All symptoms nonpathological for 8 weeks (A) All BN symptoms nonpathological for 12 weeks (A) PSR < 3 for 8 weeks (B) BITE < 6 no bulimic behavior for 12 weeks (B) Binge/purge = 0 for 2 weeks 12 weeks in one follow-up for total sample in parenthesis (B) Binge/purge = 0 for 4 weeks

ROS RCT

Outpatient group therapy Later: not reported Outpatient CBT, BT or IPT Later: mixed Inpatient Later: mixed Outpatient Later: not reported Outpatient CBT, BT or Relaxation therapy inpatient psychodynamic or outpatient family therapy Mixed Inpatient Later: not reported Outpatient Later: mixed Day treatment including CBT and family therapy Not reported Self-help manual plus supervision by social worker Day treatment Outpatient CBT

EDQ, BSQ, SCID-I EDE, EAT

ROS RCT RCT

EAT, EDI, GAF, Structured interview BITE, EAT EDE (partly), GAF

Jger et al. (1996)

RCT

EDI, EAT, ANIS Structured interview

Research methods in outcome studies on bulimia nervosa 249

Herzog & Sacks (1993) Fichter & Quadieg (1997) Reas et al. (2000)

(A) PSR < 3 for 8 weeks (A) PSR < 3 number of weeks not reported (B) MEAD no elevation on behavioral scale number of weeks not reported (B) Binge/purge = 0 for 4 weeks (B) No eating disorder number of weeks not reported (B) Binge/purge = 0 for 4 weeks (B) Binge/purge = 0 for 4 weeks (B) Binge/purge = 0 for 4 weeks

LPOS LPOS ROS

LIFE-EAT II EDI, SIAB Structured interview MEAD

Maddocks et al. (1992) Abraham (1998) Cooper et al. (1996) de Groot et al. (1995) Agras et al. (2000)

86 (86) 35 (43) 43 (48) 50 (82) 31 (37) 140 (194)

55.8 45.7 74.4 64 45.2 41.4

0.2 2 12.5 1 0.2 0.3

ROS ROS LPOS LPOS RCT

EDI, EAT Interview EDE EDE, BSQ EDE, EDI EDE, SCID-I

Notes: Denition of outcome: A: all diagnostic criteria (including psychological), B: behavioral criteria, BN: bulimia nervosa, PSR: Psychiatric status rating scale. Design: LPOS: longitudinal prospective follow-up study, ROS: retrospective follow-up studies, RCT: randomized control trails. Treatment: CBT: cognitive behavioral therapy, BT: behavior therapy, IPT: interpersonal therapy. Assessment: ANIS: anorexia nervosa inventory for self-rating, BITE: bulimic investigatory test, BSQ: body shape questionnaire, EAT: eating attitude test, EDE: eating disorder examination, EDI: eating disorder inventory, EDQ: eating disorder questionnaire, GAF: global assessment of functioning, LIFE EAT-II: the longitudinal interval follow-up evaluation, MEAD: multiaxial assessment of eating disorders symptoms, SCID-I: structured clinical interview for DSM-III-R axis I disorders, SIAB: structured interview for anorexia and bulimia.

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Table 2. Descriptive statistics of follow-up studies Mean Patients with good outcome (%) Number of patients followed Time to follow-up (years) Length of evaluation (weeks) Dropout (%) Denition of outcome A) Denition of outcome B) Randomized controlled trails Prospective follow-up studies Retrospective follow-up studies Inpatient treatment Daycare Outpatient treatment Mixed treatment Age at assessment (years) Duration of illness (years) 51.1 66.3 4.1 10.7 15.2 SD 12.6 50.3 4.1 12.0 12.7 6 12 8 5 5 3 2 9 1 25.2 6.7 1.4 1.7 N

Fig. 1. Outcome in relation to years of follow-up and denition of outcome.

Three samples had inpatient treatment, two had daycare treatment, and nine had outpatient treatment. The percentage of patients with good outcome was 49.5% 14.1 for inpatient treatment, 45.5% 0.4 for daycare treatment, and 50.9% 9.3 for outpatient treatment. These differences were not signicant. Figure 1 displays the distribution in outcome for the two groups with different denition of outcome in relation to time to follow-up. The range was large particularly with follow-ups for the rst three years. Regression analysis showed that time to follow-up was a signicant predictor ( = 0.620, p = 0.010) when controlling for the denition of good outcome (Group A vs. B) ( = 0.691, p = 0.006) and dropout ( = 0.091, p = 0.656). Together, time to follow-up and denition of outcome explained 52% of the variance.

DISCUSSION Three variables were signicant or approached signicance as predictors of percentage of good outcome, that is, time to follow-up, denition of outcome and dropout. The percentages of patients with a good outcome grew as time to followup was prolonged, as dropout increased, and in cases where denition of outcome focussed on behavioral symptoms without including psychological symptoms.
Table 3. Correlation between continuous variables Outcome Time to follow-up Length of evaluation Dropout Age Duration 0.359*** 0.052 0.446** 0.283 0.386 Follow-up

Time to follow-up has in earlier studies been found to predict outcome (Keel and Mitchell, 1997). The maximum of 74.4% patients with a good outcome could indicate that a group of approximately 20% will continue to be ill no matter the time to follow-up, as found with anorexia nervosa (Pike, 1998; Theander, 1985). One study on bulimic patients showed a steady growth of patient recovery, up to approximately 70%, within the rst 125 weeks after initial assessment, in contrast to the period between week 125 and week 200 where no further patients recovered (Keller, Herzog, Lavori, Bradburn & Mahoney, 1992). Another study found a continuous accumulation of patients recovering in the rst 250 weeks, however with a rate of recovery getting smaller as follow-up time increases (Herzog et al. 1999). Further studies have to clarify if there is a certain amount of chronicity in bulimia nervosa and if the rate of recovery is decreasing as time to follow-up reaches a certain maximum. The inuence of time to followup cannot be seen as mere dropout, as time to follow-up and dropout did not correlate between studies. Grouping by denition of outcome (behavioral symptoms vs. behavioral as well as psychological symptoms) resulted in signicant differences in outcome results and denition was also signicant in regression analysis. If diagnostic criteria are clinically meaningful the distinction between the two denitions in outcome studies is crucial and needs more attention. An illustration of this has been shown in studies on anorexia nervosa where corresponding different denitions

Evaluation

Dropout

Age

0.528* 0.240 0.479** 0.128

0.225 0.315 0.209

0.374 0.204

0.734*

Notes: Pearsons correlation coefcient used. *p < 0.05, **p < 0.10, ***p < 0.15. 2004 The Scandinavian Psychological Associations/Blackwell Publishing Ltd.

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Research methods in outcome studies on bulimia nervosa 251 made it impossible to go further into the analysis on treatments and sample characteristics, resulting in a lack of knowledge about how much these two variables actually contribute to the range in outcome results. Denition of outcome, design of studies, weeks of evaluation, and time to follow-up all seem to interact in ways that (1) makes comparison of studies difcult and (2) brings methodological issues into focus of discussion. There seem to be different methods between the different study designs. Studies with RCT design had longer periods of evaluation and shorter time to follow-up compared to naturalistic follow-up studies. Furthermore, RCT mainly used behavioral denitions of outcome whereas follow-up studies used both evaluation of behavioral as well as behavioral and psychological criteria in denition of good outcome. The reason for this is probably due to the fact that follow-up studies are often linked closely to clinical departments resulting in clinical judgments and evaluations. RCT is often linked to the more positivistic and objective research in which observed and quantiable data is preferred, compared to data including judgements and interpretations. There seems to exist a lack of consensus on how long a period of time symptoms should be evaluated. It has been proposed that outcome must be evaluated for at least 2 months (Keel et al., 2000a). However, it seems more logical to evaluate up to 3 months to make it comparable to the diagnostic requirements. The small number of studies included in this review makes the interpretation of results problematic. Furthermore, the inclusion of categorical outcome and the exclusion of continuous outcome led to the exclusion of several studies, thereby depreciating the power of analysis. However, the procedure was chosen because of the lack of well-dened cutoff scores for healthy vs. pathological ratings on the different tests used for these continuous outcome studies. Furthermore studies using continuous outcome did not always report pretreatment ratings, why it was not possible to calculate effect sizes which again made comparison difcult. All this leads to a recommendation of more homogeneity in data reporting between studies so further investigation of the inuence of method and design of studies on outcome results is possible.

of outcome on the same population were found to alter outcome as much as 1825% (Pla and Toro, 1999; Schork, Eckert & Halmi, 1994). If the parametric estimation in the present analysis on bulimia nervosa can be conrmed in further studies approximately equivalent correction can be made in comparisons between different denitions of outcome on bulimia nervosa. Additionally, the differences shown by denition of outcome could indicate that symptoms decrease in different stages, with behavioral symptoms vanishing rst. Further studies have to conrm this. The third hypothesis, predicting that shorter periods of evaluation would get a better outcome than longer as found by Keel et al. (2000a), was not conrmed, indicating that symptom relapse and variations at follow-up are small within 13 months of evaluation. Dropout correlated on a trend level with outcome results but was non-signicant when time to follow-up and denition of outcome were controlled for. Dropout always needs attention in itself but can also be seen as a variable that gathers and reects important aspects of sample as well as method and design, that is, it is known that some types of patients are more compliant than others, LPOS can have more compliance than other methods because patients have accepted the follow-up from the beginning of treatment, and also time to follow-up can in some countries complicate the possibilities of nding patients, etc. The fth hypothesis predicting RCTs to have better outcome results than follow-up studies as found by Keel and Mitchell (1997) was not conrmed. RCT seems (albeit nonsignicantly) to get a better outcome than LPOS but worse than ROS. However, caution is needed in inference because ROS had longer follow-up times and a bigger dropout rate, which could be the reason for the outcome results of ROS being better than RCT. Sample characteristics such as severity of illness have in some studies been shown to be a signicant predictor of outcome (Keel and Mitchell, 1997). In this study severity was illustrated by duration of illness and age of assessment but no correlations were found with outcome results, perhaps because duration of illness was too imprecise a variable to accurately reect severity. Two of the studies included showed that different treatments resulted in different outcomes (Bulik, Sullivan, Carter, McIntosh & Joyce., 1998b; Jger, Liedtke, Kunsebeck, Lempa, Kersting & Seide, 1996) but this could not be conrmed by the present analysis between studies. However, the grouping of treatment (i.e. inpatient, outpatient, daycare) and the low number of studies could be responsible for the lack of positive results. Outcome results uctuate considerably during the rst years of follow-up whereas results from longer follow-ups are more homogeneous when denition of outcome is taken into account. This could indicate that differences in samples and treatments add signicance to outcome in the short run but little in the long run. The reviewed studies lack of information on severity, co-morbidity etc.

CONCLUSION The review of outcome studies on bulimia nervosa published between 1990 and 2000 reveals that 2474% of patients have a good outcome. Time to follow-up and denition of outcome are the variables that seem to explain most of the uctuation in outcome results. Methodological aspects such as dropout and design of studies need further attention to clarify their contribution to the outcome. Sample characteristics and treatments could not explain the uctuation in outcome though they are impossible to eliminate. The analysis shows that methodology needs serious consideration when

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outcome studies are reviewed and compared and that more consensus on methods and data reporting would be useful.

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