Douglas A. Drossman

Functional bowel disorders and functional abdominal pain

The Rome diagnostic criteria for the functional bowel disorders and functional abdominal pain are used widely in research and practice. A committee consensus approach, including criticism from multinational expert reviewers, was used to revise the diagnostic criteria and update diagnosis and treatment recommendations, based on research results. The terminology was clarified and the diagnostic criteria and management recommendations were revised. A functional bowel disorder (FBD) is diagnosed by characteristic symptoms for at least 12 weeks during the preceding 12 months in the absence of a structural or biochemical explanation. The irritable bowel syndrome, functional abdominal bloating, functional constipation, and functional diarrhea are distinguished by symptom-based diagnostic criteria. Unspecified FBD lacks criteria for the other FBDs. Diagnostic testing is individualized, depending on patient age, primary symptom characteristics, and other clinical and laboratory features. Functional abdominal pain (FAP) is defined as either the FAP syndrome, which requires at least six months of pain with poor relation to gut function and loss of daily activities, or unspecified FAP, which lacks criteria for the FAP syndrome. An organic cause for the pain must be excluded, but aspects of the patient’s pain behavior are of primary importance. Treatment of the FBDs relies upon confident diagnosis, explanation, and reassurance. Diet alteration, drug treatment, and psychotherapy may be beneficial, depending on the symptoms and psychological features.

U.S. householder survey of functional gastrointestinal disorders. Prevalence, sociodemography, and health impact

Our objective was to obtain national data of the estimated prevalence, sociodemographic relationships, and health impact of persons with functional gastrointestinal disorders. We surveyed a stratified probability random sample of U.S householders selected from a data base of a national market firm (National Family Opinion, Inc.). Questions were asked about bowel symptoms, sociodemographic associations, work absenteeism, and physician visits. The sampling frame was constructed to be demographically similar to the U.S. householder population based on geographic region, age of householder, population density, household income and household size. Of 8250 mailings, 5430 were returned suitable for analysis (66% response). The survey assessed the prevalence of 20 functional gastrointestinal syndromes based on fulfillment of multinational diagnostic (Rome) criteria. Additional variables studied included: demographic status, work absenteeism, health care use, employment status, family income, geographic area of residence, population density, and number of persons in household. For this sample, 69% reported having at least one of 20 functional gastrointestinal syndromes in the previous three months. The symptoms were attributed to four major anatomic regions: esophageal (42%), gastroduodenal (26%), bowel (44%), and anorectal (26%), with considerable overlap. Females reported greater frequencies of globus, functional dysphagia, irritable bowel syndrome, functional constipation, functional abdominal pain, functional biliary pain and dyschezia; males reported greater frequencies of aerophagia and functional bloating. Symptom reporting, except for incontinence, declines with age, and low income is associated with greater symptom reporting. The rate of work/school absenteeism and physician visits is increased for those having a functional gastrointestinal disorder. Furthermore, the greatest rates are associated with those having gross fecal incontinence and certain more painful functional gastrointestinal disorders such as chronic abdominal pain, biliary pain, functional dyspepsia and IBS. Preliminary information on the prevalence, socio-demographic features and health impact is provided for persons who fulfill diagnostic criteria for functional gastrointestinal disorders.

Sexual and physical abuse in women with functional or organic gastrointestinal disorders

STUDY OBJECTIVES To determine the prevalence of a history of sexual and physical abuse in women seen in a referral-based gastroenterology practice, to determine whether patients with functional gastrointestinal disorders report greater frequencies of abuse than do patients with organic gastrointestinal diseases, and to determine whether a history of abuse is associated with more symptom reporting and health care utilization. DESIGN A consecutive sample of women seen in a university-based gastroenterology practice over a 2-month period was asked to complete a brief questionnaire. MEASUREMENTS The self-administered questionnaire requested information about demographics, symptoms, health care utilization, and history of abuse. Physicians indicated the primary diagnosis for each patient and whether she had ever discussed having been sexually or physically abused. RESULTS Of 206 patients, 89 (44%) reported a history of sexual or physical abuse in childhood or later in life; all but 1 of the physically abused patients had been sexually abused. Almost one third of the abused patients had never discussed their experiences with anyone; only 17% had informed their doctors. Patients with functional disorders were more likely than those with organic disease diagnoses to report a history of forced intercourse (odds ratio, 2.08; 95% CI, 1.03 to 4.21) and frequent physical abuse (odds ratio, 11.39; CI, 2.22 to 58.48), chronic or recurrent abdominal pain (odds ratio, 2.06; CI, 1.03 to 4.12), and more lifetime surgeries (2.7 compared with 2.0 surgeries; P less than 0.03). Abused patients were more likely than nonabused patients to report pelvic pain (odds ratio, 4.05; CI, 1.41 to 11.69), multiple somatic symptoms (7.1 compared with 5.8 symptoms; P less than 0.001), and more lifetime surgeries (2.8 compared with 2.0 surgeries; P less than 0.01). CONCLUSIONS We found that a history of sexual and physical abuse is a frequent, yet hidden, experience in women seen in referral-based gastroenterology practice and is particularly common in those with functional gastrointestinal disorders. A history of abuse, regardless of diagnosis, is associated with greater risk for symptom reporting and lifetime surgeries.

Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome

Objective To investigate whether placebo effects can experimentally be separated into the response to three components—assessment and observation, a therapeutic ritual (placebo treatment), and a supportive patient-practitioner relationship—and then progressively combined to produce incremental clinical improvement in patients with irritable bowel syndrome. To assess the relative magnitude of these components. Design A six week single blind three arm randomised controlled trial. Setting Academic medical centre. Participants 262 adults (76% women), mean (SD) age 39 (14), diagnosed by Rome II criteria for and with a score of ≥150 on the symptom severity scale. Interventions For three weeks either waiting list (observation), placebo acupuncture alone (“limited”), or placebo acupuncture with a patient-practitioner relationship augmented by warmth, attention, and confidence (“augmented”). At three weeks, half of the patients were randomly assigned to continue in their originally assigned group for an additional three weeks. Main outcome measures Global improvement scale (range 1-7), adequate relief of symptoms, symptom severity score, and quality of life. Results At three weeks, scores on the global improvement scale were 3.8 (SD 1.0) v 4.3 (SD 1.4) v 5.0 (SD 1.3) for waiting list versus “limited” versus “augmented,” respectively (P<0.001 for trend). The proportion of patients reporting adequate relief showed a similar pattern: 28% on waiting list, 44% in limited group, and 62% in augmented group (P<0.001 for trend). The same trend in response existed in symptom severity score (30 (63) v 42 (67) v 82 (89), P<0.001) and quality of life (3.6 (8.1) v 4.1 (9.4) v 9.3 (14.0), P<0.001). All pairwise comparisons between augmented and limited patient-practitioner relationship were significant: global improvement scale (P<0.001), adequate relief of symptoms (P<0.001), symptom severity score (P=0.007), quality of life (P=0.01).Results were similar at six week follow-up. Conclusion Factors contributing to the placebo effect can be progressively combined in a manner resembling a graded dose escalation of component parts. Non-specific effects can produce statistically and clinically significant outcomes and the patient-practitioner relationship is the most robust component. Trial registration Clinical Trials NCT00065403.

Bowel patterns among subjects not seeking health care. Use of a questionnaire to identify a population with bowel dysfunction

To understand the disorders of bowel motility, it is important to know the range of bowel patterns in the general population. We have devised a brief self-administered questionnaire which, when used among a group of 789 students and hospital employees, disclosed that 94.2% had stool frequencies between three per day and three per week, and that 17.1% had bowel dysfunction. When compared with the remaining sample, the bowel dysfunction group was predominantly female. This group also reported more often that stress influenced their bowel function, and more often used laxatives and visited physicians for bowel complaints. Further medical evaluation to characterize this subgroup is needed. We believe that selection, for psychologic and physiologic study, of subjects with bowel dysfunction not seeking health care will provide a needed comparison group in our understanding of patients with irritable bowel syndrome.

Sexual and physical abuse history in gastroenterology practice: how types of abuse impact health status.

Objective There is an increasing amount of literature pointing to a relationship between sexual and/or physical abuse history and poor health status, although few studies provide evidence concerning which aspects of abuse may impact on health. In female patients with gastrointestinal (GI) disorders, the present study examined the effects on health status of: 1) history of sexual abuse and physical abuse, 2) invasiveness or seriousness of sexual abuse and physical abuse, and 3) age at first sexual and physical abuse. Method: The sample included 239 female patients from a referral gastroenterology clinic who were interviewed to assess sexual and physical abuse history. Results: We found the following: 1) 66.5% of patients experienced some type of sexual and/or physical abuse; 2) women with sexual abuse history had more pain, non-GI somatic symptoms, bed disability days, lifetime surgeries, psychological distress, and functional disability compared to those without sexual abuse; 3) women with physical abuse also had worse health outcome on most health status indicators; 4) rape (intercourse) and life-threatening physical abuse seem to have worse health effects than less serious physical violence, and sexual abuse involving attempts and touch; and 5) those with first abuse in childhood did not appear to differ on health from those whose first abuse was as adults. Conclusions: The authors conclude that asking about abuse should be integrated into history taking within referral-based gastroenterology practices.

Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders

BACKGROUND & AIMS Studies of antidepressants and psychological treatments in functional bowel disorders (FBD) are methodologically limited. The aim of this study was to assess the clinical efficacy and safety of cognitive-behavioral therapy (CBT) against education (EDU) and desipramine (DES) against placebo (PLA) in female patients with moderate to severe FBD (irritable bowel syndrome, functional abdominal pain, painful constipation, and unspecified FBD). We also evaluated the amenability of clinically meaningful subgroups to these treatments. METHODS This randomized, comparator-controlled, multicenter trial enrolled 431 adults from the University of North Carolina and the University of Toronto with moderate to severe symptoms of FBD. Participants received psychological (CBT vs. EDU) or antidepressant (DES vs. PLA) treatment for 12 weeks. Clinical, physiologic, and psychosocial assessments were performed before and at the end of treatment. RESULTS The intention-to-treat analysis showed CBT as significantly more effective than EDU (P = 0.0001; responder rate, 70% CBT vs. 37% EDU; number needed to treat [NNT ], 3.1). DES did not show significant benefit over PLA in the intention-to-treat analysis (P = 0.16; responder rate, 60% DES vs. 47% PLA; NNT, 8.1) but did show a statistically significant benefit in the per-protocol analysis (P = 0.01; responder rate, 73% DES vs. 49% PLA; NNT, 5.2), especially when participants with nondetectable blood levels of DES were excluded (P = 0.002). Improvement was best gauged by satisfaction with treatment. Subgroup analyses showed that DES was beneficial over PLA for moderate more than severe symptoms, abuse history, no depression, and diarrhea-predominant symptoms; CBT was beneficial over EDU for all subgroups except for depression. CONCLUSIONS For female patients with moderate to severe FBD, CBT is effective and DES may be effective when taken adequately. Certain clinical subgroups are more or less amenable to these treatments.

Quality of Life in Persons with Irritable Bowel Syndrome (Development and Validation of a New Measure)

How irritable bowel syndrome (IBS) and itstreatment affect quality of life (QOL) is important. Todevelop a quality-of-life measure specific to irritablebowel syndrome, items were generated using a conceptual model and qualitative interviews with personsdiagnosed using the Rome criteria. Symptom frequency andbothersomeness indices were created. Psychometricevaluation methods involved an initial cross-sectional survey followed by a repeat survey. Theresulting 34-item measure demonstrated high internalconsistency (Cronbachs alpha = 0.95) and highreproducibility (ICC = 0.86) with average time of sevendays (SD = 1). For discriminant validity: number of symptoms(P < 0.05), self-reported severity of symptoms (P< 0.001), and the functional bowel disorder severityindex (P < 0.001) significantly predicted IBS-QOLscores. Convergent validity and analyses confirmedpredictions that scores are more closely related topsychological well-being (0.45) than to function (0.36).We conclude this measure meets established psychometric criteria for reliability and validity; testingof its responsiveness is warranted.

Sexual and Physical Abuse and Gastrointestinal Illness: Review and Recommendations

Although the mechanisms for this association are unknown, psychological factors (somatization, response bias, reinforcement of abnormal illness behavior) and physiologic factors (psychophysiologic response, enhanced visceral sensitivity) probably contribute. On the basis of these data, recommendations are made on how to identify patients at risk, how to obtain this information, and, if needed, how to make appropriate referrals. Conclusions: The authors agree with existing data on the association between abuse history and gastrointestinal illness. Physicians should ask patients with severe or refractory illness about abuse history. Appropriate referral to a mental health professional may improve the clinical outcome. In recent years, the lay media and the scientific community have addressed the frequency of sexual and physical abuse in U.S. society. Psychologists and psychiatrists now recognize several psychiatric syndromes (for example, somatization disorder, severe depression, post-traumatic stress disorder, the dissociative disorders, borderline personality disorder, and multiple personality disorder) as consequences of abuse [1, 2]. However, only in the last few years has attention turned to the physical concomitants of sexual and physical abuse, that is, their association with certain medical disorders and their effect on health care [3-7]. Of recent interest is the growing evidence that a history of sexual and physical abuse is associated with gastrointestinal illness [8]. Is this association unique to patients with gastrointestinal disorders, or is it part of a more generalized association between abuse history and somatization and reporting of symptoms? If a relation does exist, what are the possible reasons for it? Finally, what is the clinicians role in eliciting this type of history and in responding to patient disclosure? To answer these questions, a working team sponsored by the Functional Brain-Gut Research Group of the American Gastroenterology Association was formed. Our goals were 1) to review existing data on the relation between abuse history and gastrointestinal illness, 2) to discuss possible reasons for this association, 3) to offer suggestions for identifying patients at risk and sensitively eliciting a history, and 4) to provide information on how mental health professionals and patient support groups can be accessed. Although other forms of trauma, such as emotional abuse and neglect, may also be associated with medical and psychiatric illness, the data for gastrointestinal clinical populations are limited and will not be discussed. Methods Each member of the working team was assigned a topic by the primary author. He or she then did a MEDLINE search on that topic and submitted it to the primary author, who integrated the material into a manuscript that was then resubmitted to the working team and revised. The final document was agreed on by consensus. Clinical and Epidemiologic Associations Methodologic Considerations in Evaluating Studies of Abuse Reporting The widely differing estimates of the prevalence of abuse (6% to 62%) in the United States [9] result from the varying definitions and methods used to assess abuse history. Furthermore, police records and confirmation with family or acquaintances grossly underestimate the frequency of abuse, leaving no gold standard of validation. For clinicians, merely the disclosure of this information is considered truthful unless proven otherwise. However, to evaluate epidemiologic estimates of abuse history in clinical or population-based studies, clinicians and investigators must consider several factors. Changing Societal Values about Definitions of Abuse Numerous studies have suggested that the number of reports of sexual and physical abuse is high and may be increasing. In a review comparing the frequency of sexual abuse reported in the United States from the 1940s to the late 1970s, Leventhal [10] concluded that the frequency of these reports has increased (from 24% to 48% by the broad definition of abuse and from 12% to 28% by the narrow definition). The increase relates in part to changing societal values: The disclosure of an abusive experience is now encouraged and supported, whereas it was previously considered secretive and shameful. For example, society now considers date rape to be a form of sexual abuse. Thirty or 40 years ago, however, this experience may not have been defined as such, and victims may have been more reluctant to report it to officials. Investigators therefore must consider that the frequency of abuse reports are higher in areas where there is increased public attention to these events. Interview versus Questionnaire Some evidence suggests that interview methods may yield more reports of abuse than questionnaires [9, 11]. This theory is difficult to assess because most studies that use interviews also use more questions and specific activity-based questions that are known to increase abuse reporting. A carefully administered interview in a supportive environment may be the best way to identify a history of abuse [11], but this theory has yet to be tested adequately. The Operational Definition There is evidence that more persons report abuse when definitions include questions based on behavior (for example, Has anyone ever touched the sex organs of your body when you did not want this?) rather than general or emotionally charged questions (for example, Have you ever been sexually abused or molested?) [9, 12, 13]. Furthermore, a broader definition of abuse that includes many types of forced or unwanted sexual encounters (such as noncontact abuse or fondling) results in higher estimates of abuse prevalence. Noncontact sexual abuse includes unsolicited sexual advances or encounters with exhibitionists during childhood [9]. Noncontact experiences include attempted or threatened rape or sexual touching in which force is used but sexual contact does not occur (such as when the victim escapes). Contact abuse can include both touch experiences (that is, being fondled or being made to touch the perpetrator) and penetration (that is, vaginal sex, anal sex, or oral sex [14, 15]). Similarly, physical abuse is identified by several variables: being assaulted or attacked with a weapon, beaten up, hit with a fist or object, kicked, bit, burned, slapped, or threatened with a weapon. Because the life-threat associated with these experiences can differ, investigators can use groupings of physical abuse experiences [in descending order of threat]: 1) being assaulted or attacked with a weapon [such as a gun or knife]; 2) being attacked without a weapon but with the intent to kill; 3) being beaten up, hit with a fist or object, kicked, bit, burned, or slapped by another without intent to kill; 4) being threatened with a weapon but not actually attacked; or 5) being threatened with harm but without a weapon or threat to life [16, 17]. The degree of coercion indicated in the question can affect estimates of the prevalence of abuse. Some investigators consider any unwanted sexual experiences to be abuse [18]. Others define abuse more rigorously as using force or threatening harm to engage in sexual acts [19-21]. Because abused persons are more likely to acknowledge abuse using the first definition and because questionnaires may tend to underestimate abuse [12], defining abuse as unwanted sexual experiences may be a more sensitive measure. However, with interviews, defining abuse in terms of force or threat of harm may be more valid because the nature of the abuse can be further clarified. Many researchers stipulate that there be a 5-year age difference between the perpetrator and a child [9] so that the possibility of consensual sexual activity with peers can be eliminated. However, this definition may exclude abusive encounters with peers or siblings. We believe that by stipulating unwanted or forced sexual experience in the definition, the requirement of a 5-year difference in age is unnecessary. Estimates of childhood sexual abuse have also varied because different age criteria have been used to define childhood. The definition of childhood has ranged from 13 to 18 years, with some studies not defining what is meant by child. Age 14 years has recently been used as a cut-off for child and adult sexual abuse [22, 23]. Nature of the Setting and Patient Sample The clinical setting in which the information is obtained may be as important as the type of questions asked. Studies done in referral practices (such as pain centers or academic practices) yield much higher response rates than those done in primary care or nonclinical settings. Similarly, patients seeing mental health professionals for emotional difficulties may be more likely to report abusive experiences than patients attending medical practices [24]. Furthermore, the prevalence of abuse tends to be higher in younger samples and perhaps among persons in certain regional areas (for example, urban compared with rural) [13, 25]. Investigators should also consider that the positive predictive value of a screening evaluation will probably be greater in clinical settings in which the prevalence is high than in nonclinical settings in which the prevalence is low. The Psychosocial Profile of the Patient Patients with certain psychiatric disorders (such as somatization disorder) or personality disorders (such as borderline personality disorder) may set low thresholds for reporting medical or psychological symptoms. These patients might therefore overinterpret and over-report previous experiences as abuse. In contrast, patients with dissociation disorders who may not recall these experiences, or those who harbor intense feelings of shame or guilt, are less likely to report a history of abuse. Finally, patients who are experiencing ongoing abuse, but who have limited social support or poorly developed coping skills or who fear retribution from the perpetrator, are much less likely to repo

Impact of Sexual and Physical Abuse Dimensions on Health Status: Development of an Abuse Severity Measure

Objective Despite the abundant literature showing a relationship of sexual and/or physical abuse history with poor health status, few studies provide evidence about with dimensions of abuse may have a worse impact on health. In female patients with gastrointestinal (GI) disorders, the present study aims to identify which dimensions of abuse history (eg, number of perpetrators, injury) might predict poor current health status, in order to develop an empirically based severity of abuse measure. Methods Of a sample of 239 female patients from a referral gastroenterology clinic, this paper primarily focuses on 121 women with a past history of contact sexual abuse (N = 99), and/or life threatening physical abuse (N = 68). Results Among those with a sexual abuse history, 24% of current health status was explained by serious injury during abuse (p =.0006), victimization by multiple perpetrators (p =.03), and being raped (p =.09). Among the physically abused, rape (in addition to life threat) (p =.0001), and multiple life-threatening incidents (p =.002) explained 39% of the variance in overall health. Among the women with a sexual and/or physical abuse history, the experience of rape, serious injury during sexual abuse, and multiple life-threatening incidents explained one fourth of the variance in current health status. Based on these three dimensions of abuse, we created an abuse severity measure which explained about one fourth of the variance in health status among the subgroup with abuse history, and among the entire clinic sample. Conclusions Given the high prevalence of abuse in referral practice, and the potential health impact of previous abuse, it is important that history taking include details concerning the abuse experience. The severity of abuse measure developed in this paper should prove useful for both research and clinical practice.