Randomised controlled trial comparing oral and intravenous rehydration therapy in children with diarrhoea.

OBJECTIVE--To determine the effectiveness of oral rehydration in children with moderate dehydration caused by gastroenteritis, and to compare the complications of oral and intravenous treatment. DESIGN--Randomised controlled trial. SETTING--Emergency department and infectious diseases ward in a large urban teaching hospital. PATIENTS--111 children aged 3-36 months who had been previously healthy, had had diarrhoea for seven days or less, had clinical signs of dehydration, and were not in shock. Six children were withdrawn because the diagnosis was incorrect (four in oral group, two in intravenous group) and one (oral group) was withdrawn at her parents'' request. INTERVENTIONS--Oral rehydration fluid was given by mouth or nasogastric tube, or both to 52 children. The remaining 52 received intravenous rehydration fluids but were allowed to drink. MAIN OUTCOME MEASURES--Success or failure of rehydration. Number of times child vomited or passed stool after starting treatment. Time taken to rehydrate. RESULTS--Oral treatment failed in two children (failure rate 3.8%, upper 95% confidence limit 11.6%) and intravenous treatment in none. Vomiting was more common in the oral group (p less than 0.01): 26 of 50 children (52%) in the oral group and 11 of 50 (22%) in the intravenous group vomited during rehydration. There was no significant difference between the two treatment groups in the number of stools passed during rehydration (p = 0.09). None of the children had serious complications of treatment. CONCLUSION--Rehydration by mouth or nasogastric tube is a safe and effective treatment for moderately dehydrated children with gastroenteritis.     

Management of acute diarrhoea in diabetic patients using oral rehydration solutions containing glucose,rice, or glycine.

OBJECTIVE--To assess the risk of hyperglycaemia with two standard oral rehydration solutions that contain carbohydrate compared with a carbohydrate free solution during rehydration of diabetic patients with acute diarrhoea. DESIGN--Prospective randomised allocation to one of three oral rehydration solutions (World Health Organisation (glucose), rice, or glycine) groups after admission to hospital with acute diarrhoea. SETTING--Dhaka hospital of the International Centre for Diarrhoeal Disease Research, Bangladesh. SUBJECTS--45 diabetic patients aged between 15 and 60 who had had diarrhoea for fewer than three days on admission. MAIN OUTCOME MEASURES--Fluctuation of blood glucose concentrations measured three times a day, daily stool output, and time taken for recovery from diarrhoea. RESULTS--There were no significant differences in blood glucose concentrations, stool output, and duration of recovery from diarrhoea among the three groups. CONCLUSIONS--Oral rehydration solutions containing glucose, rice powder, or glycine can be safely administered to diabetic patients with acute diarrhoea and some dehydration.     

Albendazole chemotherapy for treatment of diarrhoea in patients with AIDS in Zambia: a randomised double blind controlled trial.

OBJECTIVE--To determine the value of short course, high dose albendazole chemotherapy in the treatment of persistent diarrhoea related to HIV in unselected patients in urban Zambia. DESIGN--A randomised double blind placebo controlled trial of albendazole 800 mg twice daily for two weeks. Patients were monitored intensively for one month and followed for up to six months. SETTING--Home care. AIDS services in Lusaka and Ndola. PATIENTS--174 HIV seropositive patients with persistent diarrhoea (defined as loose but not bloody stools three or more times a day for three weeks or longer). No investigations were undertaken except HIV testing after counselling. MAIN OUTCOME MEASURES--Proportion of time periods during which diarrhoea was experienced after completion of treatment; proportion of patients with full remission after completion of treatment; mortality. RESULTS--The patients taking albendazole had diarrhoea on 29% fewer days than those taking placebo (P < 0.0001) in the two weeks after treatment. The benefit of albendazole was maintained over six months. In patients with a Karnofsky score of 50 to 70 (needing help with activities of daily living and unable to work, but not needing admission to hospital) diarrhoea was reduced by 50%. Remission was obtained in 26% of all patients who received albendazole (P = 0.004 against 9% receiving placebo), and this difference was maintained over six months (log rank test, P = 0.003). Albendazole had no effect on mortality. Minimal adverse effects were noted. CONCLUSIONS--For HIV infected Zambians with diarrhoea of more than three weeks'' duration albendazole offers substantial relief from symptoms and may be used empirically, without prior investigation.     

Randomised controlled trial of vancomycin for pseudomembranous colitis and postoperative diarrhoea.

The efficacy of vancomycin in pseudomembranous colitis was assessed in a prospective randomised controlled trial. Forty-four patients with postoperative diarrhoea were allocated to five days'' treatment with either 125 mg vancomycin six-hourly or a placebo. Sixteen patients had high titres of the neutralised faecal toxin characteristic of pseudomembranous colitis; nine received vancomycin and seven placebo. At the end of treatment faecal toxins were present in one patient given vancomycin compared with five of the controls. Vancomycin caused the disappearance of Clostridum difficile from the stool in all except one patient, whereas toxicogenic strains of Cl difficile persisted in all but one of the controls. Histological evidence of psuedomembranous colitis had disappeared by the end of treatment in six out of seven patients given vancomycin compared with only one out of seven patients given vancomycin compared with only one out of five patients given placebo. In patients with faecal toxins bowel habit had returned to normal in seven of the vancomycin group compared with only one of the controls, but there was no significant difference in clinical response among patients without faecaal toxins. The results suggest that vancomycin eliminates toxin-producing Cl difficile from the colon and is associated with rapid clinical and histological improvement in patients with pseudomembranous colitis.     

A randomized controlled trial of glucose versus amylase resistant starch hypo-osmolar oral rehydration solution for adult acute dehydrating diarrhea

Background

Reduction of gross diarrhea rate in excess of that seen over time with intravenous therapy and appropriate antibiotics is not usually achieved by oral glucose-electrolyte rehydration therapy for cholera and cholera-like diarrheas.

Methodology and Principal Findings

This prospective randomized clinical trial at a tertiary referral hospital in southern India was undertaken to determine whether amylase resistant starch, substituting for glucose in hypo-osmolar oral rehydration solution, would reduce diarrhea duration and weight in adults with acute severe dehydrating diarrhea. 50 adult males with severe watery diarrhea of less than three days'' duration and moderate to severe dehydration were randomized to receive hypo-osmolar ORS (HO-ORS) or HO-ORS in which amylase resistant high amylose maize starch 50g/L substituted for glucose (HAMS-ORS). All remaining therapy followed standard protocol. Duration of diarrhea (ORS commencement to first formed stool) in hours was significantly shorter with HAMS-ORS (median 19, IQR 10-28) compared to HO-ORS (median 42, IQR 24-50) (Bonferroni adjusted P, P_adj<0.001). Survival analysis (Kaplan-Meier) showed faster recovery from diarrhea in the HAMS-ORS group (P<0.001, log rank test). Total diarrhea fecal weight in grams (median, IQR) was not significantly lower in the HAMS-ORS group (2190, 1160-5635) compared to HO-ORS (5210, 2095-12190) (P_adj = 0.08). However, stool weight at 13-24 hours (280, 0-965 vs. 1360, 405-2985) and 25–48 hours (0, 0-360 vs. 1080, 55-3485) were significantly lower in HAMS-ORS compared to HO-ORS group (P_adj = 0.048 and P = 0.012, respectively). ORS intake after first 24 hours was lower in the HAMS-ORS group. Subgroup analysis of patients with culture isolates of Vibrio cholerae indicated similar significant differences between the treatment groups.

Conclusions

Compared to HO-ORS, HAMS-ORS reduced diarrhea duration by 55% and significantly reduced fecal weight after the first 12 hours of ORS therapy in adults with cholera-like diarrhea.

Trial Registration

Current Controlled Trials ISRCTN72841333     

Parent-only treatment for childhood obesity: a randomized controlled trial

Parent-only (PO) treatments for childhood obesity are feasible, more cost-effective and potentially easier to disseminate. The objective of this study was to determine whether a PO treatment is not inferior to a parent + child (PC) treatment for childhood obesity. Eighty parent-child dyads with an 8-12 year old overweight or obese child (>85th BMI-P) were recruited and randomized into PO or PC treatment for childhood obesity. Parents or parent-child dyads attended 5-month treatment groups. Child and parent body size, child caloric intake, and child physical activity were assessed at baseline, post-treatment, and 6-months follow-up. Noninferiority testing using mixed linear models was used to compare PO treatment with PC treatment. Results showed that the PO group was not inferior to the PC group in terms of child weight loss. Results also showed that the PO group was not inferior to the PC group in terms of parent weight loss and child physical activity, but not child caloric intake. This study suggests that a PO treatment could provide similar results to PC in child weight loss and other relevant outcomes, and potentially could be more cost-effective and easier to disseminate. Although further research is needed, this study suggests that PO groups are a viable method for providing childhood obesity treatment.     

Cyclosporin treatment of IgA nephropathy: a short term controlled trial.

Cyclosporin''s known regulatory effects on the immune system suggest that it may be useful in treating patients with IgA nephropathy. A randomised prospective single blind study of 19 patients with IgA nephropathy and proteinuria (greater than 1.5 g/day) was conducted to determine the therapeutic value of cyclosporin. The patients were divided into two groups: nine patients were given oral cyclosporin (5 mg/kg/day) for 12 weeks and 10 patients a placebo. The two groups were comparable in age of presentation, ratio of men to women, plasma creatinine and serum IgA concentrations, creatinine clearance, daily urinary protein excretion, severity of renal histopathological changes, and prevalence of hypertension. A significant reduction of proteinuria and an increase of plasma albumin concentration was observed with treatment with cyclosporin. Nevertheless, a significant rise of plasma creatinine concentration and a fall in creatinine clearance was found in patients after six weeks'' treatment with cyclosporin, although the plasma cyclosporin concentrations were maintained within a narrow therapeutic range. Serum IgA concentrations were reduced in seven patients. Renal function improved within eight weeks after treatment was stopped. Three months after treatment was stopped proteinuria remained less than half of the pretreatment values in three patients. No similar biochemical changes were observed in the controls. Short term cyclosporin therapy may be beneficial in reducing proteinuria in some patients with IgA nephropathy. As transient renal impairment was seen, despite cyclosporin concentrations being maintained within a narrow therapeutic range, indiscriminate use of cyclosporin in glomerulonephritis should be discouraged.     

Transurethral microwave treatment for benign prostatic hypertrophy: a randomised controlled clinical trial.

OBJECTIVES--To determine whether transurethral microwave treatment for patients with benign prostatic hypertrophy provides significant symptomatic relief, a reduction in residual urine volumes, and improvements in flow rates compared with sham treatment. DESIGN--Prospective double blind randomised study with follow up at three months. SETTING--Department of Urology in a London teaching hospital. PATIENTS--40 men completed the study: 22 received microwave treatment and 18 received sham treatment. Entry criteria were symptoms of prostatism of at least six months'' duration, a total symptom score > 14, and a peak urine flow rate < 15 ml/s or a residual urine volume > 50 ml. Exclusion criteria were prostatic cancer, a residual urine volume > 200 ml, a very large prostate, an obstructing middle lobe, acute urinary retention, impaired renal function, coexisting urinary tract disease, and previous prostatic surgery. INTERVENTIONS--A single 90 minute transurethral microwave treatment or sham treatment. OUTCOME MEASURES--Patients'' symptoms (including daytime frequency and nocturia) recorded in a self assessment symptom score questionnaire, peak urinary flow rates, and residual urine volumes. RESULTS--The mean total symptom scores of the patients who received microwave treatment fell from 30 to 11 compared with a fall from 31 to 26 for patients who received sham treatment (p < 0.001). Among patients who received microwave treatment daytime frequency fell from 9.4 to 5.5 voids a day and night time frequency from 3.5 to 1.6 voids a night; residual urine volumes fell from 104 ml to 52 ml; and peak urine flow rates increased by 2.3 ml/s. In the control group there was no improvement in any of these features. Treatment preserved sexual function and antegrade ejaculation. CONCLUSIONS--For selected patients with prostatism microwave treatment is effective and has few side effects.     

Screening for small for dates fetuses: a controlled trial.

In the hope of reducing perinatal risks associated with retardation of intrauterine growth a previously described two stage ultrasound screening schedule was evaluated by a controlled trial in 877 women with low risk single pregnancies. The two stages of ultrasound examination were an assessment of gestational age during early pregnancy followed by measurement of length from crown to rump and area of trunk at between 34 and 36 weeks'' gestation. The product of crown to rump length and trunk area was calculated. The sensitivity of this schedule in identifying in advance 94% of babies who were small for dates at birth, with 90% specificity, and the speed and simplicity of measurement confirmed the accuracy and feasibility of two stage ultrasonography as a screening procedure. The controlled trial did not, however, show any benefit from its routine application in these low risk pregnancies.     

Tramadol for the treatment of catheter-related bladder discomfort: a randomized controlled trial

Background

Intra-operative urinary catheterization frequently causes postoperative catheter related bladder discomfort (CRBD) during recovery. We conducted this study to evaluate the efficacy of tramadol, which with muscarinic receptor antagonist property, as a treatment for CRBD.

Methods

Ninety patients who underwent elective gynecological surgery and complained of CRBD in the (PACU) were randomized into three groups of 30 each. Group A received normal saline, group B 1?mg/kg tramadol, and group C 1.5?mg/kg tramadol. The medication was administered from the Murphy’s dropper with a slow drip, and the severity of CRBD (none, mild, moderate, and severe) and postoperative pain were assessed after 0, 0.5, 1, 2 and 6?h.

Results

The severity of CRBD was reduced in group C compared with that in groups A and B at 1?h, and in groups C and B compared with that in group A at 2?h. The incidence of CRBD was reduced in group C compared with that in groups A and B at 2?h, and in group C compared with that in group A at 6?h. The visual analog scale (VAS) was reduced in group C compared with that in groups A and B at all time intervals. No differences in adverse effects were observed.

Conclusions

Tramadol 1.5?mg/kg was more effective than tramadol 1?mg/kg in treating CRBD and reducing postoperative pain, without significant side effects.

Trial registration

ChiCTR1800016390. Registered on 30 May 2018.

     

Elemental diet as primary treatment of acute Crohn's disease: a controlled trial.

Acute exacerbations of Crohn''s disease are usually treated with prednisolone or potentially more toxic immunosuppressive drugs or by surgery. In pilot studies replacing the normal diet by a protein free elemental diet also induced remission. A controlled trial was therefore conducted in which 21 patients acutely ill with exacerbations of Crohn''s disease were randomised to receive either prednisolone 0.75 mg/kg/day or an elemental diet (Vivonex) for four weeks. Assessment at four and 12 weeks showed that the patients treated with the elemental diet had improved as much as and by some criteria more than the steroid treated group. Elemental diet is a safe and effective treatment for acute Crohn''s disease.     

Cost of surfactant replacement treatment for severe neonatal respiratory distress syndrome: a randomised controlled trial.

OBJECTIVE--To estimate the cost of treating babies with severe respiratory distress syndrome with natural porcine surfactant. DESIGN--Retrospective controlled survey. SETTING--Regional neonatal intensive care unit, Belfast. PATIENTS--33 Preterm babies with severe respiratory distress syndrome who were enrolled in a European multicentre trial during 1985-7. 19 Babies were treated with surfactant and 14 served as controls. INTERVENTIONS--Treatment with natural porcine surfactant. MAIN OUTCOME MEASURE--Cost associated with surfactant replacement treatment per extra survivor in the treatment group and cost per quality adjusted life year for each extra survivor. RESULTS--Fifteen (79%) of the 19 treated babies and five (36%) of the 14 control babies survived. On average, the control babies required 20 days in hospital compared with 61 days for the treated babies (or 95 [corrected] days per extra survivor in the treatment group). The cost per extra survivor in the treatment group was pounds 13,720, with the cost per quality adjusted life year estimated at pounds 710. CONCLUSION--These costs compare favourably with those of established forms of treatment in adults. Thus surfactant replacement treatment for severe respiratory distress syndrome is fairly inexpensive and cost effective.     

Cost effectiveness of day and inpatient psychiatric treatment: results of a randomised controlled trial.

OBJECTIVE: To compare direct and indirect costs of day and inpatient treatment of acute psychiatric illness. DESIGN: Randomised controlled trial with outcome and costs assessed over 12 months after the date of admission. SETTING: Teaching hospital in an inner city area. SUBJECTS: 179 patients with acute psychiatric illness referred for admission who were suitable for random allocation to day hospital or inpatient treatment. 77 (43%) patients had schizophrenia. INTERVENTIONS: Routine inpatient or day hospital treatment. MAIN OUTCOME MEASURES: Direct and indirect costs over 12 months, clinical symptoms, social functioning, and burden on relatives over the follow up period. RESULTS: Clinical and social outcomes were similar at 12 months, except that inpatients improved significantly faster than day patients and burden on relatives was significantly less in the day hospital group at one year. Median direct costs to the hospital were 1923 pounds (95% confidence interval 750 pounds to 3174 pounds) per patient less for day hospital treatment than inpatient treatment. Indirect costs were greater for day patients; when these were included, overall day hospital treatment was 2165 pounds cheaper than inpatient treatment (95% confidence interval of median difference 737 pounds to 3593 pounds). Including costs to informants when appropriate meant that day hospital treatment was 1994 pounds per patient cheaper (95% confidence interval 600 pounds to 3543 pounds). CONCLUSIONS: Day patient treatment is cheaper for the 30-40% of potential admissions that can be treated in this way. Carers of day hospital patients may bear additional costs. Carers of all patients with acute psychiatric illness are often themselves severely distressed at the time of admission, but day hospital treatment leads to less burden on carers in the long term.     

Cholestyramine in treatment of postvagotomy diarrhoea--double-blind controlled trial.

A double-blind controlled trial was performed to assess the effectiveness of cholestyramine in treating severe continuous postvagotomy diarrhoea. Each patient and a clinician assessed the results, and those treated with cholestyramine showed a considerable improvement over those given placebo. There were no significant side effects or changes in laboratory values in the cholestyramine group. Although the numbers were too small for statistical analysis, these results suggest that cholestyramine may be of value in the management of some patients with severe continuous postvagotomy diarrhoea who are unresponsive to other forms of treatment.     

Electroacupuncture in fibromyalgia: results of a controlled trial.

OBJECTIVE--To determine the efficacy of electroacupuncture in patients with fibromyalgia, a syndrome of unknown origin causing diffuse musculoskeletal pain. DESIGN--Three weeks'' randomised study with blinded patients and evaluating physician. SETTING--University divisions of physical medicine and rehabilitation and rheumatology, Geneva. PATIENTS--70 patients (54 women) referred to the division for fibromyalgia as defined by the American College of Rheumatology. INTERVENTIONS--Patients were randomised to electroacupuncture (n = 36) or a sham procedure (n = 34) by means of an electronic numbers generator. MAIN OUTCOME MEASURES--Pain threshold, number of analgesic tablets used, regional pain score, pain recorded on visual analogue scale, sleep quality, morning stiffness, and patient''s and evaluating physician''s appreciation. RESULTS--Seven of the eight outcome parameters showed a significant improvement in the active treatment group whereas none were improved in the sham treatment group. Differences between the groups were significant for five of the eight outcome measures after treatment. CONCLUSIONS--Electroacupuncture is effective in relieving symptoms of fibromyalgia. Its potential in long term management should now be studied.     

Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open,randomised controlled trial.

OBJECTIVE--To see whether there is a difference in outcome between patients treated with oral and intravenous antibiotics for lower respiratory tract infection. DESIGN--Open controlled trial in patients admitted consecutively and randomised to treatment with either oral co-amoxiclav, intravenous followed by oral co-amoxiclav, or intravenous followed by oral cephalosporins. SETTING--Large general hospital in Dublin. PATIENTS--541 patients admitted for lower respiratory tract infection during one year. Patients represented 87% of admissions with the diagnosis and excluded those who were immunocompromised and patients with severe life threatening infection. MAIN OUTCOME MEASURES--Cure, partial cure, extended antibiotic treatment, change of antibiotic, death, and cost and duration of hospital stay. RESULTS--There were no significant differences between the groups in clinical outcome or mortality (6%). However, patients randomised to oral co-amoxiclav had a significantly shorter hospital stay than the two groups given intravenous antibiotic (median 6 v 7 and 9 days respectively). In addition, oral antibiotics were cheaper, easier to administer, and if used routinely in the 800 or so patients admitted annually would lead to savings of around 176,000 pounds a year. CONCLUSIONS--Oral antibiotics in community acquired lower respiratory tract infection are at least as efficacious as intraveous therapy. Their use reduces labour and equipment costs and may lead to earlier discharge from hospital.     

Tolerance and safety evaluation in a large cohort of healthy infants fed an innovative prebiotic formula: a randomized controlled trial

Background

the addition of oligosaccharides to infant formula has been shown to mimic some of the beneficial effects of human milk. The aim of the study was to assess the tolerance and safety of a formula containing an innovative mixture of oligosaccharides in early infancy.

Methodology/Principal Findings

this study was performed as a multi-center, randomized, double-blind, placebo-controlled trial including healthy term infants. Infants were recruited before the age of 8 weeks, either having started with formula feeding or being fully breast-fed (breastfeeding group). Formula-fed infants were randomized to feeding with a regular formula containing a mixture of neutral oligosaccharides and pectin-derived acidic oligosaccharides (prebiotic formula group) or regular formula without oligosaccharides (control formula group). Growth, tolerance and adverse events were assessed at 8, 16, 24 and 52 weeks of age. The prebiotic and control groups showed similar mean weight, length and head circumference, skin fold thicknesses, arm circumference gains and stool frequency at each study point. As far as the anthropometric parameters are concerned, the prebiotic group and the control group did not attain the values shown by the breastfeeding group at any study point. The skin fold thicknesses assessed in the breastfeeding group at 8 weeks were strikingly larger than those in formula fed infants, whereas at 52 weeks were strikingly smaller. The stool consistency in the prebiotic group was softer than in the control group at 8, 16 and 24 weeks (p<0.001) and closer to that of the breastfeeding group. There was no difference in the incidence of adverse events between the two formula groups.

Conclusions

our findings demonstrate the tolerability and the long term safety of a formula containing an innovative mixture of oligosaccharides in a large cohort of healthy infants.

Trial Registration:

drks-neu.uniklinik-freiburg.de DRKS 00000201