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Results for “Randomized trial”

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At least 343 records · Page 19Linked to original sources

PubMed1994

Adjuvant preoperative radiotherapy for locally advanced rectal carcinoma. Results of a prospective, randomized trial.

PURPOSE: A prospective, randomized clinical trial was conducted by the Northwest Rectal Cancer Group to study the effects of preoperative radiotherapy given one week before surgery in locally advanced (tethered or fixed) rectal carcinoma. METHODS: A total of 284 patients were entered into the trial between 1982 and 1986; 141 were allocated to receive surgical treatment alone, and 143 were allocated to receive preoperative radiotherapy. A 10 x 10 x 10 cm volume in the posterior pelvis, centered on the tumor, was irradiated at a dose of 20 Gy, divided into four daily fractions of 5 Gy each. RESULTS: No differences were observed in any of the clinicopathologic variables in the two arms of the trial; there were no striking down-staging effects in the irradiated tumors. After a minimum follow-up period of 96 months, the overall and cancer-related mortality rates were similar in both arms of the study (P = 0.21 and P = 0.09, respectively). There was a highly significant reduction in local recurrences in the irradiated group (12.8 percent x-ray therapy vs. 36.5 percent surgery; P = 0.0001). The majority of local recurrences after preoperative radiotherapy occurred inside the radiotherapy field (10 cases; 7 percent), with only six cases (5 percent) outside the field. No significant difference was observed in the rates of distant metastasis between the two treatment groups (P = 0.73). CONCLUSIONS: Although there is no statistically significant survival benefit in the whole series, there is a survival benefit for the subset of patients considered by the surgeon to have undergone a curative operation. We recommend that this form of adjuvant therapy should be offered to all patients with locally advanced rectal cancer who are to undergo radical surgery.

Aged↗

PubMed2005

Ovarian cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial: findings from the initial screen of a randomized trial.

OBJECTIVE: Ovarian cancer screening with transvaginal ultrasound (TVU) and CA-125 was evaluated in the Prostate, Lung, Colorectal and Ovarian (PLCO) Trial. STUDY DESIGN: This was a randomized controlled trial of screening versus usual care. Baseline screening results are reported. RESULTS: Of 39,115 women randomized to receive screening, 28,816 received at least 1 test. Abnormal TVU was found in 1338 (4.7%), and abnormal CA-125 in 402 (1.4%). Twenty-nine neoplasms were identified (26 ovarian, 2 fallopian, and 1 primary peritoneal neoplasm). Nine were tumors of low malignant potential and 20 were invasive. The positive predictive value for invasive cancer was 3.7% for an abnormal CA-125, 1.0% for an abnormal TVU, and 23.5% if both tests were abnormal. CONCLUSION: The effect of screening on ovarian cancer mortality in the PLCO cohort has yet to be evaluated and will require longer follow-up. Screening identified both early- and late-stage neoplasms, and the predictive value of both tests was relatively low.

Aged↗

PubMed2006

Autologous stem cell transplantation in chronic myeloid leukaemia: a meta-analysis of six randomized trials.

RATIONALE: A number of collaborative trial groups developed prospective randomized trials to compare autologous stem cell transplantation (ASCT) with non-transplant therapy (interferon-alpha alone or in combination) for chronic myeloid leukaemia (CML) with the aim of obtaining reliable evidence on the possible benefit of ASCT. With the arrival of tyrosine kinase inhibitors, notably imatinib, these trials closed early without reaching their recruitment targets and no trial was able to address its objectives. Following discussions with the principal investigators, it was agreed that a meta-analysis be performed to attempt to determine the effect of ASCT on the main outcomes. OBJECTIVES: To establish the effect of ASCT followed by interferon-alphacompared with interferon-alpha only. FINDINGS: There was no evidence of a difference in survival; odds ratio=0.99 (95% confidence intervals=0.67-1.46). Nor were there statistically significant differences between treatment groups in best haematological or cytogenetic response achieved in the first year. It was not possible to analyse whether autografting with predominantly Philadelphia negative cells early on in the disease resulted in a better outcome. CONCLUSIONS: The results do not suggest a role for ASCT in initial treatment for CML, but it may still merit investigation in patients resistant to tyrosine kinase inhibitors.

Angiogenesis Inhibitors↗

PubMed2002

Questionnaire color and response rates to mailed surveys. A randomized trial and a meta-analysis.

The authors conducted a randomized trial in Geneva, Switzerland, to assess whether response rates to a mailed survey could be increased by printing the questionnaire on green paper. The authors also conducted a meta-analysis of 10 experimental studies that tested the effect of colored questionnaires on response rates. The randomized trial showed no effect (relative risk of responding [RR] = 1.00). The meta-analysis showed that mailing questionnaires on pink paper increased response rates by 12% (RR = 1.12, 95% confidence interval = 1.01 to 1.25, p = 0.04). Other colors had no statistically significant effect (blue: RR = 1.03, p = 0.49; green: RR = 1.02, p = 0.23; yellow: RR = 0.96, p = 0.30). Overall, using colored instead of white paper had no effect (RR = 1.02, p = 0.17). Thus, printing questionnaires on colored paper does not substantially increase response rates in surveys, except for pink paper.

Adult↗

PubMed1993

Mitomycin C in combination with orchiectomy for newly diagnosed metastatic prostate cancer: preliminary results on a randomized trial.

The preliminary results of a randomized trial comparing orchiectomy versus orchiectomy and mitomycin C in 119 newly diagnosed metastatic prostate cancer patients are presented. Of 109 evaluable patients 57 were treated with orchiectomy alone and 52 received adjuvant intravenous mitomycin C. Mean interval to progression was 13 months in the orchiectomy group versus 11 months in the mitomycin C group. Preliminary analysis did not demonstrate a favorable effect of the combination with this chemotherapeutic agent compared to orchiectomy alone (p = 0.3).

Aged↗

PubMed1999

Comparison of the toxicity of amphotericin B in 5% dextrose with that of amphotericin B in fat emulsion in a randomized trial with cancer patients.

A multicentric randomized trial was undertaken to compare the toxicity of amphotericin B in 5% dextrose with that of amphotericin B in a fat emulsion (Intralipid) in cancer patients. Group 1 (n = 33) received amphotericin B diluted in 5% dextrose with premedication consisting of promethazine plus an antipyretic. Group 2 (n = 28) received amphotericin B diluted in 20% Intralipid without premedication. Amphotericin B was infused daily at a dose of 1 mg/kg of body weight over a 1-h period to members of both groups for empirical antifungal therapy (in neutropenic patients) or for the treatment of documented fungal infections. The majority of patients (80%) received empirical amphotericin B treatment. The two groups were comparable with regard to age, gender, underlying disease, and the following baseline characteristics: use of other nephrotoxic drugs and serum levels of potassium and creatinine. The median cumulative doses of amphotericin B were 240 mg in group 1 and 245 mg in group 2 (P = 0.73). Acute adverse events occurred in 88% of patients in group 1 and in 71% of those in group 2 (P = 0.11). Forty percent of the infusions in group 1 were associated with fever, compared to 23% in group 2 (P < 0.0001). In addition, patients in group 2 required less meperidine for the control of acute adverse events (P = 0.008), and fewer members of this group presented with hypokalemia (P = 0.004) or rigors (P < 0.0001). There was no difference in the proportions of patients with nephrotoxicity (P = 0.44). The success rates of empirical antifungal treatment were similar in the two groups (P = 0.9). Amphotericin B diluted in a lipid emulsion seems to be associated with a smaller number of acute adverse events and fewer cases of hypokalemia than amphotericin B diluted in 5% dextrose.

Adolescent↗

PubMed1996

[Inguinal hernia. Pre-peritoneal laparoscopic surgery vs. the Stoppa procedure. A prospective randomized trial: 100 cases].

In a prospective randomized trial between totally pre peritoneal (TPP) laparoscopic surgery ant Stoppa procedure (open), 100 patients with groin hernia 'Nyhus IIIA, IIIB, IV) were included and followed during 3 years. Both groups were comparable. In the "laparoscopic" group, operating time was significatelly longer (p = 0.01) but hospital stay (3.2 vs 7.3 days) and delay to return to work (17 vs 35 days) were significantely reduced (p = 0.01 =. Post operative comfort (less pain) was better (p = 0.001) after laparoscopy. In this group, morbidity was also reduced (4% vs 20% p = 0.02). The mean follow up was 605 days and 93 per cent of the patients were reviewed at three years. There was 3 (6%) recurrence after TTP, specially in the beginning of the surgeon experience (learning curve) versus for the Stoppa (ns). In case of bilateral hernia, the authors suggest to use a large prosthesis than two little one to prevent recurrences. In these conditions, laparoscopics (TPP) approach of groin hernia treatment will have the same recurrence rate as open (Stoppa) procedure, but a real advantages in the early post operative period.

Adult↗

PubMed2003

Corticosteroids in the initial treatment of Kawasaki disease: report of a randomized trial.

OBJECTIVE: We conducted a prospective randomized trial to determine whether the addition of corticosteroids to intravenous immunoglobulin (IVIG) might improve outcomes in Kawasaki disease (KD). STUDY DESIGN: Subjects were randomized to receive IVIG, 2 gm/kg over 10 hours, with or without pulsed-dose intravenous methylprednisolone (IVMP), 30 mg/kg. All patients received standard doses of aspirin (ASA). Groups were similar in baseline demographic and laboratory data. RESULTS: Patients in the IVMP plus ASA/IVIG group, compared with those in the ASA/IVIG alone group, had a shorter mean duration of fever >/=38.3 degrees C after initiation of therapy (1.0 +/- 1.3 vs 2.4 +/- 1.9 days, mean +/- SD, P =.012), shorter hospital stays (1.9 +/- 0.7 vs 3.3 +/- 2.1 days, P =.010), and at six weeks, lower mean erythrocyte sedimentation rate (11.1 +/- 5.7 vs 19.4 +/- 12.4, P =.027) and median c-reactive protein (0.03 vs 0.08, P =.011, Wilcoxon). No significant differences between treatment groups were noted in coronary dimensions, but statistical power was limited. IVMP was well tolerated; transient hypertension developed in one child, but it did not require treatment. CONCLUSIONS: Treatment of acute KD with IVMP plus ASA/IVIG, compared with ASA/IVIG alone, resulted in faster resolution of fever, more rapid improvement in markers of inflammation, and shorter length of hospitalization. Adverse effects were infrequent. Steroid therapy should be further assessed in a multicenter, placebo-blind trial.

Child↗

PubMed1993

Current and ongoing randomized trials in heart failure and left ventricular dysfunction.

Several large randomized trials have been completed recently and provided valuable information on the effects of various interventions in heart failure and left ventricular dysfunction. A review of ongoing randomized trials showed that there were 19 major trials addressing the effect of treatments on exercise tolerance, morbidity or mortality. Although it is hoped that these trials will answer many questions, they will also raise additional questions. Therefore, these remaining questions will need to be answered by future clinical trials.

Adrenergic beta-Antagonists↗

PubMed2005

Flexible sigmoidoscopy in the PLCO cancer screening trial: results from the baseline screening examination of a randomized trial.

BACKGROUND: The Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial is a randomized clinical trial to test the effectiveness of cancer screening, including the effect of flexible sigmoidoscopy screening on colorectal cancer mortality. Here we report findings from the baseline screening flexible sigmoidoscopy examination. METHODS: Analyses included 77,465 men and women aged 55-74 years who were enrolled at 10 screening centers. The trial administered baseline risk factor questionnaires, offered 60-cm flexible sigmoidoscopy examinations, referred patients with screen-detected colorectal polyps or masses to personal physicians, and tracked subjects with polyps or masses to determine results from diagnostic follow-up. Cochran-Mantel-Haenszel statistics and logistic regression were used to test for differences in proportions according to sex and age. RESULTS: A total of 64 658 subjects (83.5%) underwent screening flexible sigmoidoscopy, and at least one polyp or mass was identified in 15,150 subjects (23.4%). Of these, 74.2% received follow-up lower endoscopic procedures. Follow-up lower endoscopy was more frequent in subjects with at least one larger (> or = 0.5 cm) polyp or mass (86.0% [95% confidence interval {CI} = 84.6% to 87.4%] and 81.0% [95% CI = 79.8% to 82.2%] in women and men, respectively) than in those with a smaller (< 0.5 cm) polyp or mass (69.1% [95% CI = 67.5% to 70.6%] and 65.4% [95% CI = 64.1% to 66.7%] in women and men, respectively). The yields per 1000 screened, depending on 5-year age group, were as follows: for colorectal cancer, 1.1-2.5 in women and 2.4-5.6 in men; for advanced adenoma, 18.0-30.4 in women and 36.1-49.1 in men; and for colorectal cancer or any adenoma, 50.6-79.6 in women and 101.9-128.6 in men. Approximately 77% (130/169) of the colorectal adenocarcinoma patients were stage I or II at diagnosis. CONCLUSIONS: Acceptance of screening flexible sigmoidoscopy was high. Diagnostic follow-up varied according to polyp size, yet cancer or adenoma detection rates met expectations.

Adenoma↗

PubMed2006

A randomized trial of diagnostic techniques for ventilator-associated pneumonia.

BACKGROUND: Critically ill patients who require mechanical ventilation are at risk for ventilator-associated pneumonia. Current data are conflicting as to the optimal diagnostic approach in patients who have suspected ventilator-associated pneumonia. METHODS: In a multicenter trial, we randomly assigned immunocompetent adults who were receiving mechanical ventilation and who had suspected ventilator-associated pneumonia after 4 days in the intensive care unit (ICU) to undergo either bronchoalveolar lavage with quantitative culture of the bronchoalveolar-lavage fluid or endotracheal aspiration with nonquantitative culture of the aspirate. Patients known to be colonized or infected with pseudomonas species or methicillin-resistant Staphylococcus aureus were excluded. Empirical antibiotic therapy was initiated in all patients until culture results were available, at which point a protocol of targeted therapy was used for discontinuing or reducing the dose or number of antibiotics, or for resuming antibiotic therapy to treat a preenrollment condition if the culture was negative. RESULTS: We enrolled 740 patients in 28 ICUs in Canada and the United States. There was no significant difference in the primary outcome (28-day mortality rate) between the bronchoalveolar-lavage group and the endotracheal-aspiration group (18.9% and 18.4%, respectively; P=0.94). The bronchoalveolar-lavage group and the endotracheal-aspiration group also had similar rates of targeted therapy (74.2% and 74.6%, respectively; P=0.90), days alive without antibiotics (10.4+/-7.5 and 10.6+/-7.9, P=0.86), and maximum organ-dysfunction scores (mean [+/-SD], 8.3+/-3.6 and 8.6+/-4.0; P=0.26). The two groups did not differ significantly in the length of stay in the ICU or hospital. CONCLUSIONS: Two diagnostic strategies for ventilator-associated pneumonia--bronchoalveolar lavage with quantitative culture of the bronchoalveolar-lavage fluid and endotracheal aspiration with nonquantitative culture of the aspirate--are associated with similar clinical outcomes and similar overall use of antibiotics. (Current Controlled Trials number, ISRCTN51767272 [controlled-trials.com].).

Anti-Bacterial Agents↗

PubMed2005

Is bare-metal stenting superior to balloon angioplasty for small vessel coronary artery disease? Evidence from a meta-analysis of randomized trials.

AIMS: To compare, by meta-analytical techniques, the clinical impact of bare-metal stenting vs. balloon angioplasty for the treatment of lesions in small coronary arteries. METHODS AND RESULTS: We included trials with random allocation and prospective comparison of angioplasty vs. stenting, reference vessel diameter<3 mm, and follow-up>or=6 months. Random effect odds ratios (OR) for death, myocardial infarction (MI), repeat revascularization (RR), and major adverse cardiac events (MACEs) were computed. In a pre-specified subgroup analysis, we compared stenting with optimal (post-procedural stenosis<20%) and suboptimal (>20%) angioplasty. Thirteen studies (4383 patients) were selected. No differences were found in terms of death and MI, while MACEs, mainly driven by RR, were significantly less common after stenting (17.6%) than after angioplasty (22.7%), OR 0.71 (0.57-0.90). Heterogeneity among trials was present. When considering only optimal angioplasty, MACE rates were homogeneously similar, 17.9 vs. 21.1%, OR 0.86 (0.66-1.11). If angioplasty were suboptimal, MACEs were significantly more common after angioplasty (24%) than after stenting (17.3%), OR 0.62 (0.44-0.88). CONCLUSION: Stenting is superior to balloon angioplasty for the treatment of small vessels, in particular after suboptimal angioplasty. However, MACE and RR rates remain high after stenting, and the advantage of stent over angioplasty is moderate. An optimal balloon angioplasty strategy (with provisional stenting) may achieve results not inferior to routine stenting.

Angioplasty, Balloon, Coronary↗

PubMed1988

Toxicity, physical function and everyday activity reported by patients with inoperable non-small cell lung cancer in a randomized trial (chemotherapy versus radiotherapy).

In a randomized trial, patients with inoperable non-small cell lung cancer with limited disease were randomly given either radiotherapy (42 Gy) or combination chemotherapy with cisplatin, 70 mg/m2, and etoposide, 100 mg/m2, given every third week with a maximum of 4 cycles. The patients were asked to fill in a questionnaire concerning psychosocial well-being, medical and treatment related symptoms, physical function and everyday activity. Of the chemotherapy patients 61% reported nausea 5 weeks after their last chemotherapy session and 44% had spells of vomiting. Only 14% of the radiotherapy patients had nausea and 5% vomited 14 weeks after start of treatment. Of the radiotherapy patients 64% experienced dysphagia compared to 8% of the chemotherapy patients 6 weeks after the start of treatment.

Carcinoma, Non-Small-Cell Lung↗

PubMed1995

Polyglyconate (Maxon) versus nylon suture in midline abdominal incision closure: a prospective randomized trial.

A prospective, randomized comparison of nylon versus polyglyconate (Maxon) looped suture in running mass closure of midline abdominal incisions was conducted in 225 patients. In the nylon group, 91 patients were evaluable at 2-year follow up; in the polyglyconate group, 80 patients were evaluable at follow up. Eleven patients (4 nylon and 7 polyglyconate) developed a ventral hernia. Three of the nylon and none of the polyglyconate sutured patients had a dehiscence. There was no significant difference in the overall rate of ventral hernia and dehiscence between the two suture groups. Running mass closure of midline abdominal wounds yielded satisfactory results with both of the suture materials studied.

Elective Surgical Procedures↗

PubMed1983

Intravenous nitroglycerin in the treatment of spontaneous angina pectoris: a prospective, randomized trial.

A prospective, randomized study of i.v. nitroglycerin (TNG) in the management of repetitive spontaneous angina pectoris was undertaken in 40 consecutive patients. The clinical effectiveness of i.v. TNG (group A) was compared with that of oral isosorbide dinitrate (ISDN) and topical 2% nitroglycerin ointment (NO) in combination (group B) during a 72-hour treatment period. The doses of both nitrate regimens were adjusted so that the mean arterial pressure in the two groups was reduced by 15 +/- 3% of control values to the same level (77 mm Hg). The i.v. TNG dose of 10-200 micrograms/min yielded arterial plasma TNG levels of 1.2-65.3 ng/ml and estimated plasma (arterial) clearance of 106 +/- 55 ml/min/kg of body weight (mean +/- SD). In group B, the doses were 20-60 mg (oral ISDN) and 1/2-2 inches (NO) every 6 hours. Intravenous TNG reduced the number of spontaneous ischemic episodes from 3.3 +/- 0.8 per 24 hours during the control period to 1.0 +/- 0.3 per 24 hours during the treatment period (p less than 0.01), while the ISDN/NO combination reduced the number of episodes from 3.1 +/- 0.4 to 1.4 +/- 0.3 (p less than 0.01). Overall, the magnitude of the therapeutic effect of i.v. TNG was statistically indistinguishable from that of ISDN/NO, although i.v. TNG did have somewhat greater clinical benefit on day 2 of the 3-day treatment period. Furthermore, the data suggested more consistent control of ischemic episodes with i.v. TNG during the first 24 hours of the trial. Although both regimens markedly reduced the frequency of spontaneous ischemic episodes, only 36% of patients in group A and 17% in group B experienced no ischemic episodes during the study period (NS). Forty-three percent of patients in group A and 61% in group B (NS) required early coronary artery bypass surgery to control recurrent ischemic episodes refractory to medical therapy. We conclude that i.v. TNG and ISDN/NO, when administered in doses adjusted to produce similar effects on systemic arterial pressure, have nearly equivalent clinical effects in the management of patients with frequent episodes of spontaneous angina pectoris. Intravenous TNG offers the advantage of more consistent control of ischemic episodes during the first 24 hours of treatment. Nevertheless, the recurrence rate of spontaneous ischemic episodes during medical therapy is high with both regimens, and early coronary artery bypass surgery may be required for long-term management.

Aged↗

PubMed1993

Postoperative hypofractionated radiotherapy versus conventionally fractionated radiotherapy in malignant gliomas. A preliminary report on a randomized trial.

A prospective randomized study of 108 patients with cerebral malignant gliomas was carried out at the Department of Radiation Oncology of Maria Sklodowska-Curie Memorial Center in Kraków. 44 patients with histologically proven glioblastoma multiforme and 64 patients with anaplastic astrocytoma received postoperative radiotherapy. Patients were randomized to two treatment arms: Conventionally Fractionated Radiotherapy (CFR) and Hypofractionated Radiotherapy (HF). In the CFR group, the whole brain was irradiated to the total dose of 50 Gy in 25 fractions over 5 weeks, then a 10 Gy 'boost' in 5 fractions in 5 days was delivered to the site of the primary lesion. In the HF group, there were 3 courses of irradiation separated by a one month interval. In each of the two first series the patients received 20 Gy in 5 fractions in 5 days to the whole brain, and in the third course, 10 Gy 'boost' in 5 days was delivered as in the CFR regimen. The tolerance to treatment has been found to be good in both groups. The 2-year actuarial survival rate for patients with anaplastic astrocytoma was 22% for CFR and 18% for HF. Patients with glioblastoma multiforme treated with HF had a better prognosis in comparison to the CFR group with the two-year actuarial survival rates being 23% and 10%, respectively. This difference is statistically significant at the 0.05 level.

Adult↗

PubMedDate not supplied

Subtotal parathyroidectomy versus total parathyroidectomy and autotransplantation in secondary hyperparathyroidism: a randomized trial.

In a randomized study subtotal parathyroidectomy (sPTX) was compared with total parathyroidectomy and autotransplantation of fresh tissue (PTX + AT) in 40 patients with severe secondary hyperparathyroidism (HPT). After surgery both groups were followed at 19 +/- 6 months (PTX + AT) and 19 +/- 7 months (sPTX) and at 43 +/- 9 months (PTX + AT) and 40 +/- 7 months (sPTX). There were 17 patients alive in each group at the time of the second follow-up. After sPTX, 2 patients required re-operation because of recurrent disease originating from the remaining parathyroid gland in the neck and another 2 patients were hypercalcemic at follow-up. After PTX + AT both serum calcium and alkaline phosphatase normalized significantly more often (p less than 0.03) than after sPTX. Re-operations were not required in this group. Radiological signs also improved significantly more after PTX + AT, as did clinical signs like pruritus (p less than 0.005) and muscle weakness (p less than 0.04). These results and the fact that in recurrent disease a re-operation at the autograft in the forearm is simpler than a re-operation in the neck, lead to the recommendation that PTX + AT should be considered as the method of choice in the surgical treatment of secondary HPT.

Adult↗

PubMed1992

Sodium benzoate in the treatment of acute hepatic encephalopathy: a double-blind randomized trial.

A prospective randomized double-blind study was conducted to evaluate the efficacy of sodium benzoate in the treatment of acute portal-systemic encephalopathy. Seventy-four consecutive patients with cirrhosis or surgical portasystemic anastomosis and hepatic encephalopathy of less than 7 days duration were randomized to receive lactulose (dose adjusted for 2 or 3 semiformed stools/day) or sodium benzoate (5 gm twice daily). Assessment of response included mental status, asterixis, arterial ammonia level, electroencephalogram and number-connection test. Each was given a score between 0 and 4+. A portal-systemic encephalopathy index was calculated with these scores. Visual, auditory and somatosensory evoked potentials and a battery of psychometric tests for intelligence and memory were also performed to assess improvement. Thirty-eight patients received sodium benzoate; 36 took lactulose. Thirty patients (80%) receiving sodium benzoate and 29 (81%) receiving lactulose recovered; the remaining patients died. Improvement in portal-systemic encephalopathy parameters occurred in both treatment groups and was similar (p greater than 0.1). Electroencephalogram and evoked potentials were not as helpful as mental status in assessing of recovery. Psychometric test scores remained abnormal after recovery of mental status (21 to 42 days) and were probably too sensitive for monitoring of these patients. The incidence of side effects was similar in the two treatment groups. The cost of lactulose for one course of therapy was 30 times that of sodium benzoate. We conclude that sodium benzoate is a safe and effective alternative to lactulose in the treatment of acute portasystemic encephalopathy.

Acute Disease↗