Group behavioral treatment of retentive encopresis

Investigated the efficacy of behavioral group treatment for children with retentive encopresis who had previously failed medical management. Eighteen children between the ages of 4 and 11 years and their parents were seen in small treatment groups of 3 to 5 families over 6 sessions. The sessions focused on education about retentive encopresis, and the integration of behavioral parenting procedures with medical management. Parents and children were taught to deliver an enema clean-out, increase the children's dietary fiber, and appropriate toileting techniques. The results indicated that children significantly increased their fiber consumption by 40%, increased appropriate toileting by 116%, and decreased their soiling accidents by 83% pre- to posttreatment. Further, these treatment gains maintained or improved at the 6-month follow-up. The results are discussed in terms of cost-effective interventions and the interface between psychology and medicine in pediatric psychology.     

Treatment of A Retentive Encopretic Child Using Contingency Management and Diet Modification with Stimulus Control

This clinical case study utilized a new method of systematicdiet modification in combination with stimulus control trainingand contingency management to treat a 7-year-old retentive encopreticmale. Diet modification comprised increasing the child's intakeof dietary fiber through a point system. Diet change (increasesin "fiber points") was associated with increases in appropriatebowel movements and decreases in soiling accidents. The combinationof diet modification, stimulus control, and contingency managementeliminated soiling accidents, and treatment gains were maintainedat 1-year follow-up. The findings provide preliminary supportfor diet change as a possible alternative to use of purgativesin behavioral treatment for retentive encopresis. Limitationsof the study are discussed, and recommendations for furtherresearch on diet modification are made.     

Reflex movements in patients with brain death: a prospective study in a tertiary medical center

Reflex movements have been reported to occur in up to 75% of brain-dead patients, but this issue has not been addressed in Korea. The patients admitted to our hospital who met the criteria for brain death were enrolled between March 2003 and February 2005. The frequency and type of reflex movements in these patients were evaluated prospectively using a standardized protocol. Brain death was determined according to the guideline of Korean Medical Association. Of 26 patients who were included, five (19.2%) exhibited reflex movements such as the pronation-extension reflex, abdominal reflex, flexion reflex, the Lazarus sign, and periodic leg movements. This finding suggests that the frequency of spinal reflex movements is not rare and the awareness of these movements may prevent delays in brain-dead diagnosis and misinterpretations.     

Evidence-Based Psychosocial Treatments for Pediatric Elimination Disorders

Pediatric elimination disorders are common in childhood, yet psychosocial correlates are generally unclear. Given the physiological concomitants of both enuresis and encopresis, and the fact that many children with elimination disorders are initially brought to their primary care physician for treatment, medical evaluation and management are crucial and may serve as the first-line treatment approach. Scientific investigation on psychological and behavioral interventions has progressed over the past couple of decades, resulting in the identification of effective treatments for enuresis and encopresis. However, the body of literature has inherent challenges, particularly given the multicomponent nature of many of the treatment packages. This review identified 25 intervention studies—18 for nocturnal enuresis and 7 for encopresis—over the past 15 years and classified them according to the guidelines set forth by the Task Force on the Promotion and Dissemination of Psychological Procedures. For nocturnal enuresis, the urine alarm and dry-bed training were identified as well-established treatments, Full Spectrum Home Therapy was probably efficacious, lifting was possibly efficacious, and hypnotherapy and retention control training were classified as treatments of questionable efficacy. For encopresis, only two probably efficacious treatments were identified: biofeedback and enhanced toilet training (ETT). Best practice recommendations and suggestions for future research are provided to address existing limitations, including heterogeneity and the multicomponent nature of many of the interventions for pediatric elimination disorders.     

Ovulation detection methods for urinary hormones: precision, daily and intermittent sampling and a combined hierarchical method

BACKGROUND: We evaluate the performance of ovulation detection methods and present new approaches, including evaluation of methods for precision, combining multiple markers into a hierarchical system and using ovulation markers in intermittent sampling designs. METHODS: With serum LH peak day as the 'gold standard' of ovulation, we estimated accuracy and precision of ovulation day algorithms using 30 ovulatory menstrual cycles with daily urinary and serum hormones and transvaginal ultrasound. Sensitivity and specificity for estimating the presence of ovulation were tested using visually assessed ovulatory (30) and anovulatory (22) cycles. RESULTS: Sensitivity and specificity ranged from 70 to 100% for estimating presence of ovulation with twice-per-cycle, weekly, twice weekly, every-other-day and daily specimens. A combined hierarchical method estimated ovulation day using daily specimens within +/-2 days of the gold standard in 93% of cases. Accuracy of estimating ovulation day within +/-2 days using intermittent sampling ranged from 40% (weekly sampling) to 97% (every-other-day). CONCLUSIONS: A combined hierarchical algorithm using precise and accurate markers allows maximal use of available data for efficient and objective identification of ovulation using daily specimens. In intermittent sampling designs, the presence and the timing of ovulation can be estimated with good sensitivity, specificity and accuracy.     

Efficacy and Safety of Crofelemer for Noninfectious Diarrhea in HIV-Seropositive Individuals (ADVENT Trial): A Randomized,Double-Blind,Placebo-Controlled,Two-Stage Study

Abstract

Background: HIV-associated diarrhea remains a significant concern with limited treatment options. Objective: To determine the optimal dose, efficacy, and safety of crofelemer for noninfectious diarrhea. Methods: This randomized, double-blind, phase 3 trial used a 2-stage design. Both stages included 2-week screening, 4-week placebo-controlled treatment, and 20-week placebo-free (open-label) extension phases. In stage I, 196 HIV-seropositive patients with chronic diarrhea were randomized to crofelemer 125 mg, 250 mg, or 500 mg or placebo twice daily. Using a prospective analysis, the 125-mg twice-daily dose was selected for stage II. In stage II, 180 new patients were randomized to crofelemer 125 mg twice daily or placebo for 4 weeks. Primary efficacy analysis was the percentage of patients (stages I/II combined) who achieved clinical response (defined as ≤2 watery stools/week during ≥2 of 4 weeks). During the placebo-free extension phase, response (≤2 watery stools) was assessed weekly. Results: Significantly more patients receiving crofelemer 125 mg achieved clinical response versus placebo (17.6% vs 8.0%; one-sided, P = .01). Crofelemer 125 mg resulted in a greater change from baseline in number of daily watery bowel movements (P = .04) and daily stool consistency score (P = .02) versus placebo. During the placebo-free extension phase, percentages of weekly responders ranged from 40% to 56% at weeks 11 to 24. Crofelemer was minimally absorbed, well tolerated, did not negatively impact clinical immune parameters, and had a safety profile comparable to placebo. Conclusions: In HIV-seropositive patients taking stable antiretroviral therapy, crofelemer provided significant improvement in diarrhea with a favorable safety profile.     

Chronic asthma and chiropractic spinal manipulation: a randomized clinical trial

The purpose of this randomized patient- and observer-blinded cross-over trial was to evaluate the efficacy of chiropractic treatment in the management of chronic asthma when combined with pharmaceutical maintenance therapy. The trial was conducted at the National University Hospital's Out-patient Clinic in Copenhagen, Denmark. Thirty-one patients aged 18–44 years participated, all suffering from chronic asthma controlled by bronchodilators and/or inhaled steroids. Patients, or who had received chiropractic treatment for asthma within the last 5 years, who received oral steroids and immunotherapy, were not eligible. Patients were randomized to receive either active chiropractic spinal manipulative treatment or sham chiropractic spinal manipulative treatment twice weekly for 4 weeks, and then crossed over to the alternative treatment for another 4 weeks. Both phases were preceded and followed by a 2-week period without chiropractic treatment. The main outcome measurements were forced expiratory volume in the first second (FEV₁), forced vital capacity (FVC), daily use of inhaled bronchodilators, patient-rated asthma severity and non-specific bronchial reactivity (n-BR). Using the cross-over analysis, no clinically important or statistically significant differences were found between the active and sham chiropractic interventions on any of the main or secondary outcome measures. Objective lung function did not change during the study, but over the course of the study, non-specific bronchial hyperreactivity (n-BR) improved by 36% (P= 0.01) and patient-rated asthma severity decreased by 34% (P= 0.0002) compared with the baseline values. The results do not support the hypothesis that chiropractic spinal manipulative therapy is superior to sham spinal manipulation in the management of pharmaceutically controlled chronic asthma in adults when administered twice weekly for 4 weeks.     

Combining psychotherapy and antidepressants in the treatment of depression

OBJECTIVE: To compare the efficacy of antidepressants with that of antidepressants plus psychotherapy ("combined therapy") in the treatment of depression. METHODS: 6 month randomised clinical trial of antidepressants (N=84) and combined therapy (N=83) in ambulatory patients with Major Depression and a 17-item HDRS baseline score of at least 14 points. The antidepressant protocol provides for three successive steps in case of intolerance or inefficacy: fluoxetine, amitriptyline and moclobemide. The combined therapy condition consists, in addition to pharmacotherapy, of 16 sessions of Short Psychodynamic Supportive Psychotherapy. Efficacy is assessed using the 17-item HDRS, the CGI of Severity and of Improvement, the depression subscale of the SCL-90, and the Quality of Life Depression Scale. The data analysis is conducted on three samples: the intention-to-treat sample, the per protocol sample and the observed cases sample. RESULTS: After randomisation, 32% of the patients refused the proposed pharmacotherapy while 13% refused the proposed combined therapy. In 24 weeks, 40% of the patients who started with the pharmacotherapy stopped medication; 22% of those receiving the combined therapy did so. The difference in success rates is statistically significant, favouring combined therapy, in 23%, 31% and 62% of the patients after 8, 16 and 24 weeks of treatment, respectively. At week 24, the mean success rate is 40.7% in the pharmacotherapy group and 59.2% in the combined therapy group. CONCLUSION: Patients found combined treatment significantly more acceptable, they were significantly less likely to drop out of combined therapy and, ultimately, significantly more likely to recover. Combined therapy is preferable to pharmacotherapy in the treatment of ambulatory patients with major depression.     

Oral versus intravenous empirical antimicrobial therapy for fever in patients with granulocytopenia who are receiving cancer chemotherapy. International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer.

BACKGROUND: Intravenously administered antimicrobial agents have been the standard choice for the empirical management of fever in patients with cancer and granulocytopenia. If orally administered empirical therapy is as effective as intravenous therapy, it would offer advantages such as improved quality of life and lower cost. METHODS: In a prospective, open-label, multicenter trial, we randomly assigned febrile patients with cancer who had granulocytopenia that was expected to resolve within 10 days to receive empirical therapy with either oral ciprofloxacin (750 mg twice daily) plus amoxicillin-clavulanate (625 mg three times daily) or standard daily doses of intravenous ceftriaxone plus amikacin. All patients were hospitalized until their fever resolved. The primary objective of the study was to determine whether there was equivalence between the regimens, defined as an absolute difference in the rates of success of 10 percent or less. RESULTS: Equivalence was demonstrated at the second interim analysis, and the trial was terminated after the enrollment of 353 patients. In the analysis of the 312 patients who were treated according to the protocol and who could be evaluated, treatment was successful in 86 percent of the patients in the oral-therapy group (95 percent confidence interval, 80 to 91 percent) and 84 percent of those in the intravenous-therapy group (95 percent confidence interval, 78 to 90 percent; P=0.02). The results were similar in the intention-to-treat analysis (80 percent and 77 percent, respectively; P=0.03), as were the duration of fever, the time to a change in the regimen, the reasons for such a change, the duration of therapy, and survival. The types of adverse events differed slightly between the groups but were similar in frequency. CONCLUSIONS: In low-risk patients with cancer who have fever and granulocytopenia, oral therapy with ciprofloxacin plus amoxicillin-clavulanate is as effective as intravenous therapy.     

Multicenter randomized study comparing initial daily induction with high dose lymphoblastoid interferon vs. standard interferon treatment for chronic hepatitis C

One hundred fifty-five chronic hepatitis C patients were assigned at random to receive natural lymphoblastoid interferon (IFN)alpha-n1, s.c., for 13 months in one of three treatment regimens: initial daily induction with 10 million units (MU) followed (group 1, n = 50) or not (group 2, n = 52) by 1 month of rest and then three times weekly 10 MU (2 months), 5 MU (2 months), and 3 MU (8 months); group 3 (n = 53) received tiw 5 MU (2 months) followed by 3 MU (11 months). By intention-to-treat analysis, ALT normalization at completion of treatment was greater in patients who received continuous IFNalpha-n1 therapy with initial daily induction (group 2: 24/52, 46%) compared with those given intermittent therapy with initial daily induction (group 1: 17/50, 34%) and those who received standard IFNalpha-n1 therapy (group 3, 18/53, 34%; P not significant). The sustained ALT response was 26%, 27% and 21% and the sustained virological response was 20%, 27%, and 19%, in groups 1, 2, and 3, respectively. A trend was observed towards a higher biochemical and virological end-of-treatment response in patients given induction therapy (17%) compared with standard therapy (6%, P = 0.053). Sustained biochemical and virological responses were 20%, 27%, and 17% in groups 1, 2, and 3, respectively. Platelet and leukocyte counts decreased following daily high-dose treatment and remained low until therapy cessation (P < 0.001). The data suggest that daily s.c. induction with 10 MU IFNalpha-n1 followed by intermittent or continuous maintenance therapy for 1 year does not improve the results achieved with the standard 1-year IFNalpha course in the treatment of chronic hepatitis C patients.     

Psychological differences between children with and without chronic encopresis

OBJECTIVE: To validate a theoretical model of encopresis in terms of psychological factors that differentiates children with and without chronic encopresis and to identify scales that demonstrate these differences. METHODS: Eighty-six children with encopresis were compared to 62 nonsymptomatic children on five psychometric instruments. Differences in the mean scores and the percentages of children falling beyond preselected clinical thresholds were compared across the patient-control groups. RESULTS: Children with encopresis were found to have more anxiety/depression symptoms, family environments with less expressiveness and poorer organization, more attention difficulties, greater social problems, more disruptive behavior, and poorer school performance (ps =.01 < or =.001 on 15/20 subscales). There were no differences in self-esteem. On those subscales where proportionately more encopretic children exceeded clinical thresholds, approximately 20% more of the encopretic children exceeded thresholds than control children. CONCLUSIONS: As a group, children with encopresis differ from children without encopresis on a variety of psychological parameters. However, only a minority of children with encopresis demonstrated clinically significant elevations in these parameters. Identification and treatment of such clinical issues may enhance treatment efficacy.     

Development of a national protocol to screen Dutch cancer survivors on late cancer treatment effects

PURPOSES: The development of a national protocol to formalize the screening of Dutch cancer survivors on potential late cancer treatment effects and the medical terminology used in describing the patient follow up procedures. METHODS: A combined evidence-based and qualitative approach, the Glaser's State of the Art Strategy, was used to reach consensus on how to screen Dutch cancer survivors on late cancer treatment effects. A core working group set up a first proposal of a screening protocol and a handbook of medical term definitions by incorporating available research evidence (1980-2003), clinical expertise and definitions from Dutch medical dictionaries and textbooks. External experts reviewed this proposal in a cycle of two postal and two discussion rounds. The follow-up procedures and medical term definitions described in the draft screening protocol were to be accepted if consensus among external experts was > or =50%. RESULTS: A protocol for screening cancer survivors on late cancer treatment effects was developed describing the follow-up procedures for cancer survivors according to previous therapeutic exposures. Four hundred and twenty one medical terms were used in describing these follow-up procedures. One hundred and fifteen of these terms were classified as multi-interpretable and 101 of these terms were defined. No definitions could be found for the remaining 14 medical terms. CONCLUSIONS: We succeeded in reaching consensus throughout The Netherlands on a protocol to screen cancer survivors on late cancer treatment effects. This protocol is now in use by all Dutch outpatient clinics and warrants that the screening of cancer survivors is consistent across The Netherlands. The screening protocol specifies in detail how screening of cancer survivors should take place and can therefore be used by clinicians who were not involved in the consensus study.     

Plasma exchange and concomitant therapy in TTP

Since plasma exchange was introduced in the management of thrombotic thrombocytopenic purpura (TTP) in 1977, patient survival rate has increased from 10 to 80%. However, approximately 50 subsequent case reports in the literature provide no consensus as to the optimal therapy. We review here 4 episodes of TTP in 3 patients. In all cases, treatment was started with intensive FFP plasma exchange combined with administration of antiplatelet agents and corticosteroids. Remission was achieved in 3 out of 4 episodes although all required individualization of the medication regimen. In the remaining patient, cytotoxic therapy (vincristine) and ultimately splenectomy were required to achieve stable remission. The variable clinical response to these therapeutic protocols indicates that TTP may not represent a single homogeneous disease entity but rather may involve various underlying pathologies. We conclude that the most effective present therapy for the management of TTP is daily plasma exchange with fresh frozen plasma infusions combined with antiplatelet agents and steroids. Vincristine and splenectomy should only be employed if this protocol proves ineffective.     

Relation between malpractice claims and adverse events due to negligence. Results of the Harvard Medical Practice Study III

BACKGROUND AND METHODS. By matching the medical records of a random sample of 31,429 patients hospitalized in New York State in 1984 with statewide data on medical-malpractice claims, we identified patients who had filed claims against physicians and hospitals. These results were then compared with our findings, based on a review of the same medical records, regarding the incidence of injuries to patients caused by medical management (adverse events). RESULTS. We identified 47 malpractice claims among 30,195 patients' records located on our initial visits to the hospitals, and 4 claims among 580 additional records located during follow-up visits. The overall rate of claims per discharge (weighted) was 0.13 percent (95 percent confidence interval, 0.076 to 0.18 percent). Of the 280 patients who had adverse events caused by medical negligence as defined by the study protocol, 8 filed malpractice claims (weighted rate, 1.53 percent; 95 percent confidence interval, 0 to 3.2 percent). By contrast, our estimate of the statewide ratio of adverse events caused by negligence (27,179) to malpractice claims (3570) is 7.6 to 1. This relative frequency overstates the chances that a negligent adverse event will produce a claim, however, because most of the events for which claims were made in the sample did not meet our definition of adverse events due to negligence. CONCLUSIONS. Medical-malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.     

Successful neurological outcome of a child with classical phenylketonuria and acute lymphoblastic leukemia: a 7-year follow-up

We report on the medical management and outcome of a child with classical phenylketonuria (PKU) who developed acute lymphoblastic leukemia (ALL). Chemotherapy began at 24 months of age. Initial problems associated with treatment lead to remarkable releases of phenylalanine, a neurotoxin. Causes included increased catabolism secondary to tumor lysis and chemotherapy, as well as infection, intermittent fasting and anorexia. Medical management involved daily monitoring of Phe levels and major changes in the amount of medical formula and the intake of protein containing foods in the diet. The child is currently in remission from ALL and has a normal neurodevelopmental outcome 7 years after the ALL diagnosis.     

Patients with osteoporosis prefer once weekly to once daily dosing with alendronate

OBJECTIVES: Once weekly dosing of alendronate has been shown to provide equivalent efficacy to once daily dosing for treatment of osteoporosis in postmenopausal women. Whether patients will prefer weekly dosing to daily dosing for a chronic condition such as osteoporosis has not been studied. The aim of this international study was to assess preference for the weekly or daily dosing regimen of alendronate among postmenopausal women with osteoporosis. METHODS: This randomised open-label crossover study was conducted at 45 study sites in 19 countries. Four hundred and six postmenopausal women with osteoporosis were assigned randomly to treatment with either alendronate 70 mg once weekly for 4 weeks followed by alendronate 10 mg once daily for 4 weeks or vice versa. The main outcome was the responses of the participants to the Dosing Regimen Questionnaire administered at the end of the study. RESULTS: Of the participants expressing a preference, 84% preferred the once weekly dosing regimen with alendronate to the once daily dosing regimen. In addition, the once weekly regimen was considered by 87% of the participants to be more convenient and was the regimen most of the participants (84%) would be more willing to take for a long period of time (P < 0.001 for each parameter). CONCLUSIONS: The majority of postmenopausal women with osteoporosis preferred the once weekly to the once daily dosing regimen of alendronate. Physicians should consider patient preference for dosing regimen when selecting the appropriate treatment for osteoporosis.     

Emergency department protocolised management of acute atrial fibrillation: how many patients in a tertiary hospital are eligible?

An emergency observation department unit (EDOU) treatment protocol for the management of acute atrial fibrillation (AAF) has been demonstrated to be feasible in the United States of America. The aim of this study was to quantify the number of patients presenting with AAF eligible for EDOU protocolized management in an Irish hospital. A retrospective observational study was performed by identifying a sample of patients admitted to hospital with acute atrial fibrillation between January and December 2002. Medical records of one hundred and eleven patients presenting with AAF were identified. Nine patients were eligible for EDOU management. Fourteen patients (12.6%) reverted spontaneously to sinus rhythm in the ED without medical intervention. Eight percent of patients presenting with AAF in an Irish hospital are eligible for protocolized EDOU management.     

Treatment approaches to major depressive disorder relapse. Part 1: dose increase

OBJECTIVE: Although continuing antidepressant treatment after patients have responded to medication has been shown to greatly reduce the risk of relapse, this risk is not eliminated. A number of theories have been proposed to account for this apparent loss of efficacy. A common initial approach to managing relapse is to increase the dose of antidepressant. We prospectively evaluated the likelihood of response to increasing the fluoxetine doses in patients relapsing during a long-term efficacy study of two fluoxetine dosing regimens. METHOD: Patients meeting the DSM-IV criteria for major depressive disorder with modified HAMD17 scores > or =18 and CGI-severity scores > or =4 were treated for 13 weeks with open-label 20 mg/day fluoxetine in a multicenter US study. Responders (n = 501) were randomized to 20 mg fluoxetine daily, placebo, or 90 mg enteric-coated fluoxetine weekly for 25 weeks of double-blind continuation treatment. If the patients relapsed during the continuation phase, they were offered a 25-week optional rescue treatment phase during which the study medication dose was increased as follows: (1) patients on placebo had treatment with fluoxetine 20 mg/day reinitiated, (2) patients on fluoxetine 20 mg/day had their dose increased to 40 mg/day, and (3) patients on a 90-mg weekly dose had their dose increased to 90 mg twice a week. The results of the rescue phase for the latter two groups who relapsed while on continuation treatment with fluoxetine are reported. Response was defined as a 50% reduction in the modified HAMD17 score since time of relapse and a CGI-severity score < or =2. Additional efficacy analyses included HAMD and CGI-severity changes from baseline to endpoint. Safety measures included assessment of treatment-emergent adverse events, vital signs, and laboratory measures. RESULTS: Overall, patients relapsing during the continuation treatment responded to an increased dose (57% of the 40-mg-daily group and 72% of the enteric-coated 90-mg-twice-weekly group). Mean modified HAMD17 scores decreased from a mean of approximately 20 to below 8 and were maintained for up to 6 months in the responders. Thirty-five percent of patients either did not respond or initially responded but again relapsed after augmentation of medication. CONCLUSIONS: The patients relapsing after initially responding to fluoxetine can benefit from an increase in fluoxetine dose. These results also generally support increasing dose as a first-line treatment strategy for a patient who has relapsed while taking a previously effective dose of an antidepressant. Increasing enteric-coated fluoxetine 90 mg once weekly to twice weekly appeared to be as well-tolerated and effective in restoring response as increasing a daily fluoxetine dose from 20 to 40 mg.     

Peritoneovenous shunting as compared with medical treatment in patients with alcoholic cirrhosis and massive ascites. Veterans Administration Cooperative Study on Treatment of Alcoholic Cirrhosis with Ascites

The optimal management of severe ascites in patients with alcoholic cirrhosis has not been defined. in a 5 1/2-year study, we randomly assigned 299 men with alcoholic cirrhosis, who had persistent or recurrent severe ascites despite a standard medical regimen, to receive either intensive medical treatment or peritoneovenous (LeVeen) shunting. We identified three risk groups: Group 1 had normal or mildly abnormal results on liver-function tests, Group 2 had more severe liver dysfunction or previous complications, and Group 3 had severe prerenal azotemia without kidney disease. For the patients who received the medical treatment and those who received the surgical treatment combined, the median survival times were 1093 days in Group 1, 222 days in Group 2, and 37 days in Group 3 (P less than or equal to 0.01) for all comparisons). For all the groups combined, the median time to the resolution of ascites was 5.4 weeks for medical patients and 3.0 weeks for surgical patients (P less than 0.01). Within each risk group, mortality during the initial hospitalization and median long-term survival were similar among patients receiving either treatment. However, the median time to the recurrence of ascites in Group 1 was 4 months in medical patients, as compared with 18 months in surgical patients (P = 0.01); in Group 2 it was 3 months in medical patients as compared with 12 months in surgical patients (P = 0.04). The median duration of hospitalization was longer in medical patients than in surgical patients (6.1 vs. 2.4 weeks in Group 1 [P less than 0.001] and 5.0 vs. 3.1 weeks in Group 2 [P less than 0.01]). Group 3 was too small to permit a meaningful comparison. During the initial hospitalization, the incidence of infections, gastrointestinal bleeding, and encephalopathy was similar among the medical and surgical patients. We conclude that peritoneovenous shunting alleviated disabling ascites more rapidly than medical management. However, survival was closely related to the severity of the illness at the time of randomization and was not altered by shunting.