Control groups appropriate for behavioral interventions

AbstractThere are 4 sources of bias in clinical trials: investigator bias, patient expectation (placebo response), ascertainment bias (inadvertent selection of an unrepresentative sample), and nonspecific effects such as the normal waxing and waning of symptoms over time and the quality of the doctor-patient relationship. In drug trials, these biases are adequately controlled by comparing active to inert pills, randomly assigning subjects to treatments, blinding both the investigator and subject to group assignment, and testing subjects at multiple sites. However, there are special problems with conducting clinical trials of behavioral or psychological interventions that render these controls inadequate. It is impossible to blind the experimenter to which treatment is active, it is difficult to identify a control treatment that is inactive but just as credible to the subject, and doctor-patient relationship variables are more important than in drug trials. The inability to blind the experimenter can be circumvented by having an independent, blinded investigator assess the outcome, and doctor-patient effects can be controlled by using multiple, experienced therapists. The most difficult problem, identifying an appropriate control treatment, can be solved by adhering to 2 principles: the control treatment should be plausible, and it should not have a significant impact on the mechanism that is thought to explain the effectiveness of the investigational treatment. Investigators should confirm that these 2 goals have been achieved by monitoring expectation of benefit with a treatment credibility questionnaire, measuring changes in process variables (variables that reflect the presumed mechanism of treatment), and monitoring differential dropout rates

“Orthotopic” ossiculum terminale persistens and atlantoaxial instability in a child less than 12 years of age: a case report and review of the literature

We report ossiculum terminale persistens associated with atlantoaxial instability in a child less than 12 years of age. Static and dynamic X-rays, thin-cut computed tomography with sagittal and coronal reconstructions, and magnetic resonance imaging of the cervical spine showed atlantoaxial instability and an “orthotopic” ossiculum terminale persistens. This pathologic state was differentiated from the primary ossification center at the tip of the odontoid, which normally is not expected to fuse with the body of the odontoid until the age of 12 years. The patient was taken to the operating room for a posterior instrumented fusion of C1 and C2. The patient has done well in short- and long-term follow-up

Validation of Symptom-Based Diagnostic Criteria for Irritable Bowel Syndrome: A Critical Review

Critically review the validity of symptom-based criteria (Manning, Rome I, Rome II, and Rome III) for irritable bowel syndrome (IBS)

Psychological Treatments in Functional Gastrointestinal Disorders: A Primer for the Gastroenterologist

The functional gastrointestinal disorders (FGIDs) often show inadequate response to usual medical care. Psychological treatments can help improve FGID patient outcomes, and such treatment should be considered for patients who have moderate or severe symptoms after 3 to 6 months of medical care, and those whose symptoms are clearly exacerbated by stress or emotional symptoms. Effective psychological treatments, based on multiple randomized controlled trials, include cognitive behavioral therapy (CBT) and hypnosis for irritable bowel syndrome and pediatric functional abdominal pain; CBT for functional chest pain; and biofeedback for dyssynergic constipation in adults. Successful referral by the gastroenterologist for psychological treatment is facilitated by educating the patient about the rationale for such treatment, reassurance about the diagnosis and continuation of medical care, firm doctor-patient therapeutic alliance, and identification of, and communication with, an appropriate psychological services provider

Biofeedback Benefits Only Patients With Outlet Dysfunction, Not Patients With Isolated Slow Transit Constipation

BACKGROUND & AIMS: Biofeedback is reported to be as effective for slow transit constipation as for pelvic floor dyssynergia and no more effective than education. We aimed to test the hypothesis that biofeedback benefits only patients with pelvic floor dyssynergia, describe the physiologic mechanism of treatment, and identify predictors of success. METHODS: Fifty-two patients (49 women; average age, 35 years), all with delayed whole gut transit, included 34 with pelvic floor dyssynergia, 12 with slow transit only, and 6 who met only 1 of 2 criteria for pelvic floor dyssynergia. All received 5 weekly biofeedback sessions directed at increasing rectal pressure and relaxing pelvic floor muscles during straining plus practice defecating a balloon. Patients were retested by questionnaire; symptom diary; balloon defecation; transit study at 1, 6, 12, and 24 months; and anorectal manometry at 1 and 6 months. RESULTS: At 6 months, greater improvements were seen in pelvic floor dyssynergia compared with slow transit only; 71% versus 8% reported satisfaction ( P = .001), and 76% versus 8% reported >/=3 bowel movements per week ( P < .001). Improvements were maintained at 24 months of follow-up. Biofeedback eliminated dyssynergia in 91% and enabled 85% to defecate the balloon. Satisfaction was correlated with improved ability to defecate the balloon (rho = .73; P < .001), reductions in dyssynergia (rho = .69; P < .001), and increased rectal pressure during straining (rho = .36; P < .01). Success was predicted by pelvic floor dyssynergia, milder constipation, and less frequent abdominal pain at baseline. CONCLUSIONS: Biofeedback is an effective treatment for pelvic floor dyssynergia but not slow transit constipation

Systematic review of the comorbidity of irritable bowel syndrome with other disorders: What are the causes and implications?

AbstractBackground & Aims: Comorbid or extraintestinal symptoms occur frequently with irritable bowel syndrome and account for up to three fourths of excess health care visits. This challenges the assumption that irritable bowel is a distinct disorder. The aims of this study were to (1) assess comorbidity in 3 areas: gastrointestinal disorders, psychiatric disorders, and nongastrointestinal somatic disorders; and (2) evaluate explanatory hypotheses. Methods: The scientific literature since 1966 in all languages cited in Medline was systematically reviewed. Results: Comorbidity with other functional gastrointestinal disorders is high and may be caused by shared pathophysiological mechanisms such as visceral hypersensitivity. Psychiatric disorders, especially major depression, anxiety, and somatoform disorders, occur in up to 94%. The nongastrointestinal nonpsychiatric disorders with the best-documented association are fibromyalgia (median of 49% have IBS), chronic fatigue syndrome (51%), temporomandibular joint disorder (64%), and chronic pelvic pain (50%). Conclusions: Multivariate statistical analyses suggest that these are distinct disorders and not manifestations of a common somatization disorder, but their strong comorbidity suggests a common feature important to their expression, which is most likely psychological. Some models explain the comorbidity of irritable bowel with other disorders by suggesting that each disorder is the manifestation of varying combinations of interacting physiological and psychological factors. An alternative hypothesis is that the irritable bowel diagnosis is applied to a heterogeneous group of patients, some of whom have a predominantly psychological etiology, whereas others have a predominantly biological etiology, and that the presence of multiple comorbid disorders is a marker for psychological influences on etiology.GASTROENTEROLOGY 2002;122:1140-115

Amplification of simian retroviral sequences from human recipients of baboon liver transplants

Investigations into the use of baboons as organ donors for human transplant recipients, a procedure called xenotransplantation, have raised the specter of transmitting baboon viruses to humans and possibly establishing new human infectious diseases. Retrospective analysis of tissues from two human transplant recipients with end-stage hepatic disease who died 70 and 27 days after the transplantation of baboon livers revealed the presence of two simian retroviruses of baboon origin, simian foamy virus (SFV) and baboon endogenous virus (BaEV), in multiple tissue compartments. The presence of baboon mitochondrial DNA was also detected in these same tissues, suggesting that xenogeneic 'passenger leukocytes' harboring latent or active viral infections had migrated from the xenografts to distant sites within the human recipients. The persistence of SFV and BaEV in human recipients throughout the posttransplant period underscores the potential infectious risks associated with xenotransplantation

Validation of a Measure of Protective Parent Responses to Children??s Pain

To assess the validity of the Protect Scale of the Adult Responses to Children’s Symptoms (ARCS) Questionnaire with regard to mothers’ responses to their children’s abdominal pain