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ORIGINAL ARTICLES |
From the School of Psychiatry and Behavioural Science (F.C., E.G., J.R., B.T.) and Section of Gastrointestinal Science (D.G.T.), University of Manchester, Manchester, UK; and University of Sheffield Centre for Human Nutrition, Northern General Hospital, Manchester, UK (L.F., N.R.); all on behalf of the North of England IBS Research Group (Chris Babbs, Joe Barlow, Chandu Bardhan, Francis Creed, David Dawson, Lakshmi Fernandez, Elspeth Guthrie, Stephanie Howlett, Linda McGowan, Jane Martin, Jim Moorey, Kierran Moriarty, Stephen Palmer, Joy Ratcliffe, Nicholas Read, Christine Rigby, Irene Sadowski, David Thompson, Barbara Tomenson).
Address correspondence and reprint requests to Francis Creed, FRCP, School of Psychiatry and Behavioural Science, Rawnsley Building, Oxford Road, Manchester M13 9WL, UK. E-mail: francis.creed{at}manchester.ac.uk
| ABSTRACT |
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Methods: IBS patients entering a treatment trial who reported prior sexual abuse were compared with the remainder in terms of symptom severity and health-related quality of life (SF-36) at trial entry and 15 months later. Analyses used ANCOVA with age, sex, marital status, and treatment group as covariates. We assessed possible mediators using multiple regression analysis.
Results: Of 257 patients with severe IBS, 31 (12.1%) reported a history of rape and 28 (10.9%) reported forced, unwanted touching. People who reported abuse were more impaired than the remainder on the SF-36 scales for pain (adjusted p = .023) and physical function (p = .029); these relationships followed a "dose-response" relationship and were mediated by SCL-90 somatization score. At 15 months follow-up, the associations between reported abuse and SF-36 scores were lost because people with reported abuse, especially rape, improved more than the remainder when treated with psychotherapy or paroxetine (selective serotonin reuptake inhibitor antidepressant); this improvement was mediated by change in SCL-90 somatization score.
Conclusions: In severe IBS, the association between self-reported sexual abuse and impaired functioning is mediated by a general tendency to report numerous bodily symptoms. A reported history of abuse is associated with a marked improvement following psychological treatment.
Key Words: irritable bowel syndrome outcome health-related quality of life sexual abuse somatization psychotherapy
Abbreviations: IBS = irritable bowel syndrome; SF-36 = Short Form 36; SSRI = selective serotonin reuptake inhibitor; SCL-90 = Symptom Checklist (90 items); SPSS = Statistical Package for the Social Sciences; SEM = standard error of the mean; ANOVA = analysis of variance; ANCOVA = analysis of covariance.
| INTRODUCTION |
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In a randomized controlled trial including patients with severe IBS, we found that a history of sexual abuse reported at trial entry predicted a beneficial response to psychotherapy and antidepressant medication at follow-up 15 months later (17). To understand this finding, we have performed further analyses on the data from this trial to examine possible links between a reported history of sexual abuse and outcome. On the basis of previous work, we tested the hypothesis that, after controlling for confounders, a history of sexual abuse would be associated with 1) more severe pain and other symptoms of IBS and 2) greater impairment of health-related quality of life. We tested these associations both at the time of entry to the trial and 15 months later (12 months after the end of treatment). We examined as possible mediators depression, anxiety, number of somatic symptoms, alcohol use, and number of other medical conditions. Since SF-36 physical component score improved significantly more in the patients treated with psychotherapy or paroxetine compared with treatment as usual, we assessed whether a change in somatization, depression, or anxiety mediated this change. This report only concerns sexual abuse as the relevant mediators of the association between physical abuse and outcome might be different from those concerning sexual abuse.
| METHODS |
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All clinic patients who fulfilled ROME I criteria for IBS (18), with severe abdominal pain (60 or more on a 0 to100 visual analogue scale) and whose symptoms had not responded to "usual" medical treatment were invited to join the trial. Patients were excluded if they had a psychotic disorder, severe personality disorder, active suicidal ideation, or consumed more than 50 U of alcohol per week, but patients with other psychiatric disorders were included (19).
Ethics committee approval was obtained from each hospital taking part in the study, and all participants signed written consent after full explanation before entering the study. Before randomization, the following assessments were made by an independent researcher:
Abdominal pain and bowel symptoms were assessed using a visual analogue scale taken from the McGill Pain Questionnaire (20). Patients also completed a daily diary recording the severity of 10 IBS symptoms for 14 days before trial entry and before follow-up assessment. The mean daily symptom severity score was used; a high score indicates more severe IBS symptoms.
Psychiatric symptoms were recorded by a trained psychiatrist using the Hamilton rating scale for depression (21), and each patient completed the SCL-90 (22).
Assessment of history of sexual abuse. The Sexual and Physical Abuse Questionnaire (23) was given to patients to complete in the presence of the female psychiatrist performing the assessment. Discussion was not encouraged (as this could have interfered with our trial), but support was provided if necessary. The questionnaire asks whether the respondent has experienced any physical or sexual abuse either as an adult or as a child. This report only concerns reported sexual abuse. The categories quoted in this report are those involving 1) forced touching (either some part of the breasts or genitals) or 2) forced penetration (rape). The questionnaire has been widely used in gastroenterology and has good test-retest reliability (24).
Health-related quality of life was measured using the Short Form-36 (SF-36) (25). This has 8 subscales; low scores indicate poor health status. In IBS, the SF-36 has been shown to discriminate between different degrees of severity (26,27). In our trial of psychological treatments, we found marked improvement occurred in the physical component summary score; this includes the subscales of physical function, role limitation (physical), bodily pain, and general health perception (28). The results of these scales are included in the present report.
The research staff involved in the pre- and post-treatment and follow-up assessments worked independently of the clinicians who delivered the treatments (psychotherapy or antidepressants). Treatment allocation and compliance were not revealed to the researchers conducting the baseline and follow-up assessments until after the study was completed and all data had been entered into the database and verified.
Data Analysis
All data were entered and analyzed on SPSS, version 11.5. In a preliminary analysis, we compared the three abuse groups (none, forced touching, rape) in terms of socio-demographic characteristics using ANOVA or chi square tests. Following this we compared the three abuse groups in terms of the main outcomes (IBS symptoms and SF-36 scores) using ANCOVA with age, sex, and marital status as covariates for the baseline data. This analysis was repeated using the follow-up data, when treatment group and baseline values were included as additional covariates. The follow-up results are displayed by treatment group; the psychotherapy and paroxetine groups are combined because of small numbers. Repeated-measures analysis was used to test for the linear trend across the three time points (baseline, 3 months, and 15 months), and the interaction of this with the three abuse groups.
Multiple regression analyses with mean substitution for missing data were performed to identify possible mediators between reported abuse and the baseline SF-36 scores that were significantly associated with reported abuse, physical function and bodily pain. These analyses used the method of Baron and Kenny (29) to assess whether SCL-90 somatization, anxiety, and depression scores mediated the association between reported abuse and poor outcome. To fulfill the requirements of mediation according to this method, the following three associations should be significant in multiple regression equations: 1) reported abuse and outcome variable (SF-36 score), 2) reported abuse and mediating variable (SCL somatization score), and 3) mediating variable and outcome variable (Figure 1). For SCL somatization score to be regarded as a mediating variable, its addition to the linear regression analysis "1" above renders the association between reported abuse and outcome nonsignificant.
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The first multiple regression analysis included SF-36 physical function score as dependent variable with the following as independent variables: age, sex, years of education, marital status (as two dummy variables), Hamilton depression score, and reported abuse. In the second analysis, we added the SCL-90 somatization score and noted whether this rendered the previous association between reported abuse and SF-36 physical function score nonsignificant. These analyses were repeated using SF-36 bodily pain score as the dependent variable.
Similar multiple regression analyses were then used to assess whether the change in SF-36 physical component summary score (between trial entry and follow-up) was also mediated by change in somatization, anxiety, or depression scores. The SF-36 physical component summary change score was used as the dependent variable. This analysis included the same independent variables as before but also included baseline SCL-90 somatization score, baseline SF-36 physical component score, and change in SCL-90 somatization (or depression or anxiety) score.
Power of the Study and Multiple Testing
The size of the sample included in this study was determined by the power calculation of the original trial; the planned sample size of 85 patients in each group was based on the improvement of abdominal pain found in a previous study (17). Consequently, this current study could be underpowered for analysis of the three subgroups based on a history of sexual abuse. Thus, the nonsignificant results in Table 4 need to be read in the knowledge that the size of the subgroups would need to be 22 to obtain a power of 80%. The power of the multiple regression analysis in model 2, Table 6, however, is more than 99% using Cohens method of calculating power from f2.
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Despite the large number of analyses performed (Tables 14), results are reported without Bonferroni adjustments for the following reasons. The 7 demographic variables analysed in Table 1 were used simply to identify which covariates should be considered in later analyses. The variables analyzed in Table 2 are so diverse in their range, covering all aspects of the patients illness, costs and life-style factors, that we felt that it would be unreasonable to adjust for the 15 variables being analysed (30). None of the measures showed significant differences at follow-up, so it would not be relevant to apply Bonferroni adjustments to those. Bonferroni adjustments are not required for the multiple regression analyses because all variables have been analyzed simultaneously.
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| RESULTS |
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The IBS was chronic (median duration, 8 years) and severe (mean typical pain score, 67.4 of 100). The disorder led to restricted activities on a mean of 12.1 (SD, 11.8) days per month before baseline assessment. Seventy patients (27.2%) were unemployed through illness and 37 (14.6%) received invalidity benefits. The mean Hamilton rating scale for depression score was 11.28 (SD, 6.2) and the mean SCL-90 global severity index was 0.90 (SD, 0.63).
Fifty-nine patients (23%) reported that they had experienced some form of sexual abuse: 31 (12.1%) reported rape and 28 (10.9%) reported unwanted touching of the genitalia. Of the 59, 27 reported abuse during childhood. Twenty percent had never disclosed the abuse to anyone, 29% had spoken with a professional counsellor about it, and the remainder had disclosed it only to a family member or a friend.
Socio-demographic and Psychological Features of People With Reported History of Sexual Abuse
Patients with a reported history of sexual abuse were more likely to be female and to be separated or divorced than the remainder (Table 1). Subsequent analyses controlled for these variables and age (which was significantly correlated with SF-36 scores). Table 2 (lower part) shows that those who reported sexual abuse had significantly higher SCL-90 scores for somatization and anxiety but not depression. They did not consume significantly more alcohol (Table 2).
Pattern and Severity of IBS Symptoms and Health-Related Quality of Life
After adjustment for age, sex and marital status, there was no significant association between a reported history of abuse and severity of IBS (Table 2), but the abused groups had significantly lower (more impaired) SF-36 scores for bodily pain and physical function than the remainder (Table 2), and these relationships followed a "dose-response" relationship with lowest scores (greatest impairment) for the reported rape group.
Outcome at 15 Months
At follow-up, there remained no significant association between reported abuse and severity of IBS symptom severity (data not shown). The significant associations between reported abuse and SF-36 pain and physical function scores found at baseline were lost at follow-up because the abused groups made marked improvements between baseline and follow-up (highlighted in Table 3). The patients who had reported rape made a considerable improvement and had a slightly higher physical component summary score at follow-up (Table 3).
This pattern of improvement was found only in those patients who received active treatment (psychotherapy or antidepressants); patients in the treatment as usual group showed little or no change (Table 4). The SF-36 physical component score showed a significant difference with the subjects who had reported rape having the highest (least impaired) score (Table 4). The individual SF-36 scores, which comprise the physical component summary score, are shown in Figure 2 for those patients who received active treatment (psychotherapy or antidepressants). It can be seen that the low scores (greatest impairment) for the reported sexual abuse groups at baseline improved markedly at follow-up.
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SCL-90 somatization scores showed no difference across the three abuse groups at follow-up because the reported abuse groups, who received active treatment, tended to improve more from baseline (Table 4). The greater improvement in SF-36 physical component score observed in the "rape" group occurred between the end of treatment and the follow-up assessment (adjusted improvement in SF-36 physical component score at end of treatment, 3.7; [SEM, 3.1]; and at 15 months follow-up, = 10.6 [SEM, 2.9]), indicating that the improvement was delayed and not immediate.
Possible Intervening Variables
With baseline SF-36 physical function score as the dependent variable, only SCL-90 somatization score fulfilled all the criteria as a possible mediator (Figure 1). Reported sexual abuse was associated with both SF-36 physical function score and SCL-90 somatization score (Table 2). The last two variables were correlated with each other (r = 0.49, p < .001). Table 5 shows the results of the multiple regression analysis. Reported abuse was a significant predictor of SF 36 physical function score in model 1. When SCL-90 somatization score was added to the linear regression equation, the association between reported abuse and SF-36 physical function score became nonsignificant (model 2 in Table 5), indicating that somatization score acted as a mediator between reported abuse and SF-36 physical function score.
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When SF-36 bodily pain score was used as the dependent variable, exactly the same pattern held. Reported abuse was associated significantly with SF-36 bodily pain score in the first model (p = .010; data not shown) but ceased to be significantly associated when SCL-90 somatization score was included in the model (p = .10).
In the multiple regression analyses with change in SF-36 physical component summary score as the dependent variable, reported abuse was a significant predictor (model 1 in Table 6) until change in SCL-90 somatization score was also entered when it became nonsignificant (model 2 in Table 6). Neither change in SCL-90 anxiety nor depression acted as a mediator in this way, i.e., reported abuse remained a significant predictor of the SF-36 physical component change score even after SCL-90 anxiety or depression scores were added (models 3 and 4 in Table 6).
Figure 3 shows the scores for SF-36 physical and mental component scores and the SCL-90 somatization score at three time points: baseline, at the end of 3 months of treatment, and at 15 months follow-up (1 year after the end of treatment). A significant linear effect across the three interviews was found for the mental and physical component scores (Figure 3A, B). The interaction between abuse group and linear trend across time was not significant on any measure. However, Figure 3 does show the marked improvement in SCL-90 score between baseline and 3 months for treated patients who had reported a history of rape or forced touching (Figure 3C), which is mirrored in the improved SF-36 physical and mental scores (Figure 3A, B) and which continues between 3 and 15 months in the rape group.
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| DISCUSSION |
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Thus, our main hypothesis was partly supported. For 2 of the 8 SF-36 subscale scores, the association between reported sexual abuse and impaired health-related quality of life was significant, after controlling for confounders, and fit a "dose-response" relationship. There was no significant association between abuse and IBS symptom severity. This appears to conflict with previous studies. It may be explained by the fact that other studies often only considered a single category of severe abuse, rape, and this was associated with worse abdominal pain in our study. The exception is the paper by Leserman et al., which shows markedly worse pain in the rape group rather than the forced touch group (3). It may also reflect the fact that our sample had particularly severe IBS, with worse pain and higher SCL-90 scores than the comparable longitudinal study (12) and worse SF-36 scores than the other studies that used this scale (26,27), reflecting our selection of people with severe IBS.
The prevalence of abuse in this study was similar to an European study (9) but lower than that recorded in previous studies in North America (3,13), which probably results from the selection of samples and different definitions. In two other studies using a detailed interview, which uses a stringent definition of childhood sexual abuse, we have shown a similar association between sexual abuse and impairment of health-related quality of life in patients with upper abdominal pain and a variety of other illnesses seen in medical clinics (31,32), so this association is not specific to IBS. It is probably not appropriate, therefore, to invoke a specific link between abuse and IBS on the basis that both involve the pelvic area (23).
Most previous work has been cross-sectional, but one other longitudinal study has been reported. This showed that, in the absence of treatment, the principal predictors of poor health-related quality of life at 1-year follow-up were the severity of abuse and the patients perception that they could not control their symptoms (12). We have shown that, in the presence of active treatment, the patients with reported sexual abuse did particularly well, especially those who had reported a history of rape. We did not measure coping, but the change in the role limitation (physical) score of this group (Figure 2) demonstrated that they felt that their symptoms were interfering much less with their daily lives, even though their reports of abdominal pain showed little change (top line of Table 4).
This is one of the few treatment trials that has attempted to examine the effect of a reported history of abuse on outcome in a prospective manner. In our main trial, we had hypothesized that patients who reported sexual abuse would have a poor outcome (17), but this proved to be the opposite of our findings for those receiving psychotherapy, which allows these subjects to discuss and resolve their previous and current interpersonal difficulties (17). A recent study of chronic depression also reported the effect of a history of abuse on outcome; those treated with cognitive behavior therapy made such a marked improvement that there was no additional benefit of taking antidepressants also (33). Although we are inclined to find a purely psychological explanation for these findings, it is possible that there is a biological basis to it (34). Whatever the mechanisms, the marked improvement in these patients argues strongly for a reversible component in health-related quality of life associated with a reported history of sexual abuse that should be detected and treated appropriately.
Our finding that numerous bodily symptoms emerged as the mediator of the association between reported sexual abuse and some aspects of impaired health-related quality of life is congruent with the many previous studies showing the increased number of bodily symptoms reported by such people (3,79,11). It is thought that selective attention to bodily sensations, a tendency to amplify these sensations, and a conviction that one has a serious illness may underlie this relationship (3538). Presumably, the paroxetine reduced the number of somatic symptoms as part of the improved depression. It is apparent that there was a marked reduction in SCL-90 somatization score during the active treatment period for those with an abuse history (Figure 3C) concurrent with the initial improvement in SF-36 scores. This was followed by an even greater improvement in physical component score in the rape group.
The association between reported sexual abuse and impaired health-related quality of life appears to be important even after depression is adjusted for (Table 5), indicating that these psychological mechanisms of hypervigilance, amplification, and disease conviction operate independently of depression, even though they may be amplified by anxiety or depression. This association between reported sexual abuse and impaired health-related quality of life even after psychiatric diagnoses have been controlled has been reported in one large population-based sample, although different SF-36 subscales were associated with abuse in that study (6). We have reported previously that reported sexual abuse and depression are each independently associated with a lowered tolerance to rectal distension in a subgroup of this sample of patients with severe IBS (39,40); both might influence the cognitive appraisal of bodily sensations, though in different ways (41). We did not measure all the relevant variables, but it is likely that the reduction of number of somatic symptoms observed in our active treatment groups is accompanied by reduced fear of cancer, fewer somatic attributions, and fewer catrophizing cognitions, as occurs in other satisfactory treatment of IBS (42).
There are a number of limitations to this study. Our sample of IBS patients were selected on the basis of their severe disorder and failure to respond to usual treatments, which means the results cannot be generalized to IBS patients as a whole. The second limitation lies in the fact that this report concerns secondary analyses of data, which were collected for another purpose. This means that we have not performed a naturalistic prospective study; rather we have been able to compare treated and untreated groups. This has some advantages, but it means that the numbers with abuse in each treated group are small. The study may have been underpowered to provide an accurate reflection of the effect of reported abuse on health-related quality of life as the association with pain and physical function was only just significant. Alternatively, there may be a narrow range of health-related quality of life with such marked impairment in this selected group of patients with severe IBS. Third, our response rate at follow-up was only 75%. Data have been presented in Table 4 only for those patients who completed baseline and follow-up questionnaires, but the 5 patients who dropped out of the forced touching group were significantly less impaired than the remainder (there were no differences for the no abuse and rape groups). Lastly, we had to rely on a self-report questionnaire, which may have underestimated the prevalence of previous abuse. We were unable to interview our subjects in detail about a history of sexual abuse, as this would have interfered with our trial. In two other studies, we have used a detailed interview to determine the occurrence of childhood abuse, and both showed a similar association between reported childhood sexual abuse and impairment of health-related quality of life (31,32).
On the other hand, our study has a number of strengths. We have included only patients with a confirmed diagnosis of IBS, which is not possible in large population-based studies. We used an objective interview-rated measure of depression and a combination of diary and self-report measures for IBS symptoms and a widely used measure of health-related quality of life. We have displayed the results according to three categories of abuse in order to try and assess whether a dose-response effect is found.
This may have obscured partially an association between IBS symptoms and severe abuse; like others (3), we found that respondents reporting rape had the most severe abdominal pain and worst scores on SF-36; we also found that they showed greatest improvement following treatment. Our results demonstrate these relationships more clearly than any previous studies (3) because of the prospective nature of our study, the adjustment for confounding variables, such as marital status and depression, the dose-response relationship at baseline, and the improvement with treatment
The main clinical implication of this study is that patients with severe IBS, which has not responded to usual treatment, may benefit from psychological treatment. The indication for such treatment might be elicited by gastroenterologists who may either identify a history of prior sexual abuse or, more realistically in a routine medical consultation, elicit numerous bodily symptoms. Psychological treatment needs to be available for such patients who are quite numerous in gastroenterology clinics.
The authors thank the following: the MRC for financing the study, the Health Authorities for financing the psychotherapists, the patients who consented to take part in the trial, and the doctors who prescribed the antidepressant medication.
| NOTES |
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Supported by Medical Research Council, UK North West Regional Health Authority Research & Development Directorate.
DOI:10.1097/01.psy.0000163457.32382.ac
| REFERENCES |
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