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Results for “randomised trial”

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PubMed1992

The selection of cases for randomised trials: a registry survey of concurrent trial and non-trial patients. The British Stomach Cancer Group.

A randomised trial of adjuvant chemotherapy vs placebo in operable stomach cancer recruited 249 patients from the West Midlands Region between 1976-1980. A Cancer Registry survey identified a further 1261 suitable concurrent cases. Trial patients were compared with the 960 non-trial cases from participating Districts. Only 493 (51%) non-trial cases passed all of the prospective trial selection criteria for entry. Stage and fitness caused the majority of exclusions and were also highly prognostic. A univariate analysis comparing eligible patients with the trial showed the two groups to be balanced for the significant independent prognostic factors of the trial. However, differences in patient age and the surgery performed indicate that recruitment may have been influenced by unknown selection factors. This survey highlights the difficulty of retrospective selection and confirms the need for randomised controls. Data available from specialist Registries may be used to help develop new protocols and to verify and extend trial results.

Adolescent↗

PubMed1994

Effect of high-dose dexamethasone in carcinomatous metastatic spinal cord compression treated with radiotherapy: a randomised trial.

We performed a randomised single blind trial of high-dose dexamethasone as an adjunct to radiotherapy in patients with metastatic spinal cord compression from solid tumours. After stratification for primary tumour and gait function, 57 patients were allocated randomly to treatment with either high-dose dexamethasone or no steroidal treatment. Dexamethasone was administered as a bolus of 96 mg intravenously, followed by 96 mg orally for 3 days and then tapered in 10 days. A successful treatment result defined as gait function after treatment was obtained in 81% of the patients treated with dexamethasone compared to 63% of the patients receiving no dexamethasone therapy. Six months after treatment, 59% of the patients in the dexamethasone group were still ambulatory compared to 33% in the no dexamethasone group. Life table analysis of patients surviving with gait function showed a significantly better course in patients treated with dexamethasone (P < 0.05). Median survival was identical in the two treatment groups. Similar results were found in subgroup analysis of 34 patients with breast cancer as the primary malignancy. Significant side-effects were reported in 3 (11%) of the patients receiving glucocorticoids, 2 of whom discontinued the treatment. We conclude that high-dose glucocorticoid therapy should be given as adjunct treatment in patients with metastatic epidural spinal cord compression.

Adult↗

PubMed1998

Investigation by Parkinson's Disease Research Group of United Kingdom into excess mortality seen with combined levodopa and selegiline treatment in patients with early, mild Parkinson's disease: further results of randomised trial and confidential inquiry.

OBJECTIVE: To determine whether the excess mortality observed in patients who received both levodopa and selegiline in a randomised trial could be explained by revised diagnosis of Parkinson's disease, autonomic or cardiovascular effects, more rapid disease progression, or drug interactions. DESIGN: Open randomised trial and blind comparison and reclassification of the cause of death of patients who were recruited from 93 hospitals between 1985 and 1990 and who had died before December 1993 in arms 1 and 2. SETTING: United Kingdom. SUBJECTS: 624 patients with early Parkinson's disease who were not receiving dopaminergic treatment and a subgroup fo 120 patients who died during the trial. INTERVENTIONS: Levodopa and a dopa carboxylase inhibitor (arm 1), levodopa and a dopa decarboxylase inhibitor in combination with selegiline (arm 2), or bromocriptine alone (arm 3). MAIN OUTCOME MEASURES: All cause mortality for 520 subjects in arms 1 and 2 and for 104 subjects who were randomised into these arms from arm 3. Cause specific mortality for people who died in the original arms 1 and 2 on the basis of the opinion of a panel, revised diagnosis and disability ratings, evidence from clinical records of either autonomic or cardiovascular episodes, other clinical features before death, and drug interactions. RESULTS: After extended follow up (mean 6.8 years) until the end of September 1995, when arm 2 was terminated, the hazard ratio for arm 2 compared with arm 1 was 1.32 (95% confidence interval 0.98 to 1.79). For subjects who were randomised from arm 3 the hazard ratio for arm 2 was 1.54 (0.83 to 2.87). When all subjects were included the hazard ratio was 1.33 (1.02 to 1.74) and after adjustment for other baseline factors it was 1.30 (0.99 to 1.72). The excess mortality seemed to be greatest in the third and fourth year of follow up. Cause specific death rates showed an excess of deaths from Parkinson's disease only (hazard ratio 2.5 (1.3 to 4.7)). No significant differences were found for revised diagnosis, disability rating scores, autonomic or cardiovascular events, other clinical features, or drug interactions. Patients who died in arm 2 were more likely to have had possible dementia and a history of falls before death compared with those who died in arm 1. CONCLUSION: The results consistently show excess mortality in patients treated with combined levodopa and selegiline. Revised diagnosis, autonomic or cardiovascular events, or drug interactions could not explain this finding, but falls and possible dementia were more common in arm 2. The results do not support combined treatment in patients with newly diagnosed Parkinson's disease. In more advanced disease, combined treatment should perhaps be avoided in patients with postural hypotension, frequent falls, confusion, or dementia.

Antiparkinson Agents↗

PubMed2000

Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. PORTEC Study Group. Post Operative Radiation Therapy in Endometrial Carcinoma.

BACKGROUND: Postoperative radiotherapy for International Federation of Gynaecology and Obstetrics (FIGO) stage-1 endometrial carcinoma is a subject of controversy due to the low relapse rate and the lack of data from randomised trials. We did a multicentre prospective randomised trial to find whether postoperative pelvic radiotherapy improves locoregional control and survival for patients with stage-1 endometrial carcinoma. METHODS: Patients with stage-1 endometrial carcinoma (grade 1 with deep [> or =50%] myometrial invasion, grade 2 with any invasion, or grade 3 with superficial [<50%] invasion) were enrolled. After total abdominal hysterectomy and bilateral salpingo-oophorectomy, without lymphadenectomy, 715 patients from 19 radiation oncology centres were randomised to pelvic radiotherapy (46 Gy) or no further treatment. The primary study endpoints were locoregional recurrence and death, with treatment-related morbidity and survival after relapse as secondary endpoints. FINDINGS: Analysis was done according to the intention-to-treat principle. Of the 715 patients, 714 could be evaluated. The median duration of follow-up was 52 months. 5-year actuarial locoregional recurrence rates were 4% in the radiotherapy group and 14% in the control group (p<0.001). Actuarial 5-year overall survival rates were similar in the two groups: 81% (radiotherapy) and 85% (controls), p=0.31. Endometrial-cancer-related death rates were 9% in the radiotherapy group and 6% in the control group (p=0.37). Treatment-related complications occurred in 25% of radiotherapy patients, and in 6% of the controls (p<0.0001). Two-thirds of the complications were grade 1. Grade 3-4 complications were seen in eight patients, of which seven were in the radiotherapy group (2%). 2-year survival after vaginal recurrence was 79%, in contrast to 21% after pelvic recurrence or distant metastases. Survival after relapse was significantly (p=0.02) better for patients in the control group. Multivariate analysis showed that for locoregional recurrence, radiotherapy and age below 60 years were significant favourable prognostic factors. INTERPRETATION: Postoperative radiotherapy in stage-1 endometrial carcinoma reduces locoregional recurrence but has no impact on overall survival. Radiotherapy increases treatment-related morbidity. Postoperative radiotherapy is not indicated in patients with stage-1 endometrial carcinoma below 60 years and patients with grade-2 tumours with superficial invasion.

Adenocarcinoma↗

PubMed1996

Ovarian ablation in early breast cancer: overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group.

BACKGROUND: Among women with early breast cancer, the effects of ovarian ablation on recurrence and death have been assessed by several randomised trials that now have long follow-up. In this report, the Early Breast Cancer Trialists' Collaborative Group present their third 5-yearly systematic overview (meta-analysis), now with 15 years' follow-up. METHODS: In 1995, information was sought on each patient in any randomised trial of ovarian ablation or suppression versus control that began before 1990. Data were obtained for 12 of the 13 studies that assessed ovarian ablation by irradiation or surgery, all of which began before 1980, but not for the four studies that assessed ovarian suppression by drugs, all of which began after 1985. Menopausal status was not consistently defined across trials; therefore, the main analyses are limited to women aged under 50 (rather than "premenopausal") when randomised. Oestrogen receptors were measured only in the trials of ablation plus cytotoxic chemotherapy versus the same chemotherapy alone. FINDINGS: Among 2102 women aged under 50 when randomised, most of whom would have been premenopausal at diagnosis, 1130 deaths and an additional 153 recurrences were reported. 15-year survival was highly significantly improved among those allocated ovarian ablation (52.4 vs 46.1%, 6.3 [SD 2.3] fewer deaths per 100 women, logrank 2p = 0.001), as was recurrence-free survival (45.0 vs 39.0%, 2p = 0.0007). The numbers of events were too small for any subgroup analyses to be reliable. The benefit was, however, significant both for those with ("node positive") and for those without ("node negative") axillary spread when diagnosed. In the trials of ablation plus cytotoxic chemotherapy versus the same chemotherapy alone, the benefit appeared smaller (even for women with oestrogen receptors detected on the primary tumour) than in the trials of ablation in the absence of chemotherapy (where the observed survival improvements were about six per 100 node-negative women and 12 per 100 node-positive women). Among 1354 women aged 50 or over when randomised, most of whom would have been perimenopausal or postmenopausal, there was only a nonsignificant improvement in survival and recurrence-free survival. INTERPRETATION: In women aged under 50 with early breast cancer, ablation of functioning ovaries significantly improves long-term survival, at least in the absence of chemotherapy. Further randomised evidence is needed on the additional effects of ovarian ablation in the presence of other adjuvant treatments, and to assess the relevance of hormone-receptor measurements.

Breast Neoplasms↗

PubMed1984

Applying results of randomised trials to clinical practice: impact of losses before randomisation.

The problem of generalisability in randomised clinical trials was highlighted by studies that entered only 10-14% of screened patients. To determine the magnitude and source of prerandomisation losses in clinical trials a survey was conducted of 41 trials listed in the 1979 inventory of the National Institute of Health. Two thirds of the trials maintained screening logs, but only half maintained any records of the number of patients who met the eligibility criteria but were not entered into the trial. Among 21 trials (51%) that kept data on the number of patients who were eligible but not entered, losses of eligible subjects were attributable to refusals by patients in 25% and refusals by physicians in 29%. Other protocol requirements accounted for the remaining losses of eligible patients. Only a few trials documented the characteristics of patients who were eligible but not entered; in those trials the patients who were not entered were similar demographically but differed clinically from those enrolled. Thus minimising prerandomisation losses of eligible patients requires the use of less restrictive criteria for entering patients. Twenty four of the trials achieved 75% or more of their recruitment goals, eight between 25% and 74%, and six less than 25%. Among trials that screened less than twice their projected sample size, only three out of 13 (23%) achieved 75% or more of their recruitment goal. By contrast, 12 out of 16 trials (75%) that screened more than twice their projected sample size achieved 75% or more of their recruitment goal. Screening large numbers of patients appears to be a pragmatic requirement for success in achieving recruitment goals; therefore, trials should not be criticised as lacking generalisability on that basis alone. The number and characteristics of eligible patients who were not entered, however, were documented by only a few trials; these data are critical in the assessment of generalisability. Additionally, the number of patients with the index disease who did not meet the eligibility criteria should also be documented. Together, these two types of data characterise the population to whom the trial results may be applied.

Clinical Trials as Topic↗

PubMed1998

Can unequal be more fair? Ethics, subject allocation, and randomised clinical trials.

Randomised clinical trials provide the most valid means of establishing the efficacy of clinical therapeutics. Ethical standards dictate that patients and clinicians should not consent to randomisation unless there is uncertainty about whether any of the treatment options is superior to the others ("equipoise"). However, true equipoise is rarely present; most randomised trials, therefore, present challenging ethical dilemmas. Minimising the tension between science and ethics is an obligation of investigators and clinicians. This article briefly reviews several techniques for addressing this issue and suggests that unbalanced randomisation, a technique rarely employed in current clinical trial practice, may be useful for enhancing the ethical design of human experimentation.

Attitude to Health↗

PubMed1994

Duodenal ulcer healing by eradication of Helicobacter pylori without anti-acid treatment: randomised controlled trial.

Randomised trials have shown that duodenal ulcers treated by H2 blockers heal faster if Helicobacter pylori is eradicated concurrently. It remains unknown whether eradication of H pylori without suppression of acid-secretion, is sufficient to allow healing. 153 patients with H pylori infection and duodenal ulcer were randomised to receive either a 1-week course of bismuth subcitrate, tetracycline, and metronidazole (76), or omeprazole for 4 weeks with the same three-drug regimen for the first week (77). Endoscopy and antral biopsies were done at entry and 4 weeks after treatment. 132 patients were suitable for analysis. Duodenal ulcers healed in 60 (92%; 95% CI 86-100%) patients taking bismuth, tetracycline, and metronidazole compared with 63 (95%; 88-100%) taking omeprazole in addition to the three other drugs. H pylori was eradicated in 61 (94%; 88-100%) who received only three drugs compared with 66 (98%; 96-100%) who received omeprazole as well. Symptoms were reduced more effectively during the first week in patients who received omeprazole (p = 0.003). We conclude that a 1-week regimen of bismuth, tetracycline, and metronidazole for patients with H pylori and duodenal ulcer eradicates the organism and heals the ulcer in most patients. Concurrent administration of omeprazole reduces ulcer pain more rapidly but has no effect on ulcer healing.

Adult↗

PubMed1992

R2 compared with R1 resection for gastric cancer: morbidity and mortality in a prospective, randomised trial.

OBJECTIVE: To compare the postoperative course of patients in the Dutch nationwide randomised trial of R1 (conventional) compared with R2 resection (including extended lymph node dissection) in the treatment of gastric cancer. DESIGN: Prospective randomised controlled trial. SETTING: National multicentre trial with 72 participating hospitals in The Netherlands. SUBJECTS: 192 patients who were operated on between August 1989 and May 1990. INTERVENTIONS: 96 patients were randomised for a R1, and 96 for a R2 resection. MAIN OUTCOME MEASURES: Morbidity and mortality among 131 patients (64 R1 and 67 R2) for whom the resection was performed with curative intent. RESULTS: The groups were comparable for age, sex, type of resection, site of tumour and depth of invasion. Complications developed in 23 R1 (36%) and in 29 R2 patients (43%). Seven patients died in the postoperative period. Median hospital stay was significantly longer after R2 (18 days, range 7-122) than after R1 resection (15 days, range 2-63) (p < 0.05). Morbidity and mortality among the patients whose R2 resection was done by the Japanese instructor (n = 34) did not differ significantly from those among patients operated on by the Dutch supervisors (n = 33), but those operated on by the Japanese instructor stayed in hospital significantly longer (20 compared with 16 days, p < 0.05). CONCLUSIONS: If R2 resections are carried out by properly trained surgeons under supervision, they can be done safely. The reported high morbidity after R2 resection in Western countries seems to result from a lack of proper instruction and quality control.

Adenocarcinoma↗

PubMed2005

[The CONSORT statement for cluster randomised trials].

With the publication of the CONSORT statement there is now increased awareness of the need to adequately report the findings of randomised controlled trials. The CONSORT statement includes a checklist of items that should be addressed in the trial report. The original CONSORT statement was developed to ensure the appropriate reporting of parallel group randomised controlled trials in which individual participants are allocated to different intervention groups. In cluster randomised trials, however, groups of participants, rather than individuals, are randomly allocated to study groups. The process of allocating groups of participants raises additional reporting considerations and led to the publication of an extension to the CONSORT statement specifically for cluster randomised trials. In this paper we review the CONSORT extension to cluster randomised trials, outlining the special features of the cluster randomised trial which must be considered.

Authorship↗

PubMed1987

Colostomy or ileostomy after colorectal anastomosis?: a randomised trial.

Sixty one patients were entered in a randomised trial to compare transverse loop colostomy with loop ileostomy after a colorectal anastomosis thought to be at risk of dehiscence. Radiologically proven breakdown of the colorectal anastomosis occurred in 13% of these selected patients and most frequently in the colostomy group. Ileostomies functioned earlier than colostomies (P less than 0.001) but there was no other significant difference in outcome between the groups. In 52 patients intestinal continuity was restored by excision of the stoma within a month of construction with no difference in morbidity between the two groups. A loop ileostomy, closed as soon as the colorectal anastomosis has healed, is recommended as an alternative to transverse colostomy.

Aged↗

PubMed2001

Adjuvant radiotherapy for rectal cancer: a systematic overview of 8,507 patients from 22 randomised trials.

BACKGROUND: At least 28 randomised, controlled trials have compared outcomes of surgery for rectal cancer combined with preoperative or postoperative radiotherapy with those of surgery alone. We have done a collaborative meta-analysis of these results to give a more balanced view of the total evidence and to increase statistical precision. METHODS: We centrally checked and analysed individual patient data from 22 randomised comparisons between preoperative (6,350 patients in 14 trials) or postoperative (2157 in eight trials) radiotherapy and no radiotherapy for rectal cancer. FINDINGS: Overall survival was only marginally better in patients who were allocated to radiotherapy than in those allocated to surgery alone (62% vs 63% died; p=0.06). Rates of apparently curative resection were not improved by preoperative radiotherapy (85% radiotherapy vs 86% control). Yearly risk of local recurrence was 46% (SE 6) lower in those who had preoperative radiotherapy than in those who had surgery alone (p=0.00001), and 37% (10) lower in those who had postoperative treatment than those who had surgery alone (p=0.002). Fewer patients who had preoperative radiotherapy died from rectal cancer than did those who had surgery alone (45% vs 50%, respectively, p=0.0003), but early (</=1 year after treatment) deaths from other causes increased (8% vs 4% died, p<0.0001). INTERPRETATION: Preoperative radiotherapy (at biologically effective doses >/=30 Gy) reduces risk of local recurrence and death from rectal cancer. If safety can be improved without compromising effectiveness, then overall survival would be moderately improved by use of preoperative radiotherapy, especially for young, high risk patients. Postoperative radiotherapy also reduces local recurrence, but short preoperative radiation schedules seem to be at least as effective as longer schedules.

Aged↗

PubMed2005

[Selective reporting of positive outcomes in randomised trials--secondary publication.. A comparison of protocols with published reports].

INTRODUCTION: Selective reporting of positive outcomes is associated with bias. MATERIALS AND METHODS: We conducted a cohort study of 102 protocols of randomised trials approved by the Scientific Ethics Committees for Copenhagen and Frederiksberg in 1994-1995 and the corresponding 122 reports. RESULTS: The median proportion of incompletely reported outcomes per trial was 50%. Statistically significant outcomes were more often fully reported, odds ratio 2.4. In 62% of trials, at least one primary outcome was changed. DISCUSSION: Outcomes in randomised trials are often reported selectively.

Clinical Protocols↗

PubMed2000

The effect of hormone replacement therapy on arterial distensibility and compliance in perimenopausal women: a 2-year randomised trial.

A single centre randomised placebo-controlled trial was performed to assess the 2-year effects of hormone replacement therapy compared to placebo on mechanical arterial properties in 99 perimenopausal women recruited from the general population. The trial was double-blind with respect to a sequential combined regimen of oral 17beta-oestradiol and desogestrel (17betaE(2)-D) and the placebo group and open with respect to combination of conjugated equine oestrogens and norgestrel (CEE-N). At baseline, distensibility and compliance of the common carotid artery were measured non-invasively with B-mode ultrasound and a vessel wall movement detector system, and the distensibility coefficient (DC) and compliance coefficient (CC) were calculated. Measurements were repeated after 6 and 24 months. Change in DC and CC in treatment groups was compared to placebo. After 24 months, changes for 17betaE(2)-D compared to placebo were -1.4x10(-3)/kPa (95% CI -4.4; 1.7, P=0.39) for DC and 0. 26 mm(2)/kPa (95% CI -0.01; 0.53, P=0.07) for CC. Changes for CEE-N compared to placebo were 0.4x10(-3)/kPa (95% CI -1.0; 1.9, P=0.79) and 0.11 mm(2)/kPa (95% CI -0.14; 0.37, P=0.40). For systolic blood pressure (SBP), diastolic blood pressure (DBP) and arterial lumen diameter no changes were found. In this study no significant differences in changes in distensibility and compliance were found between perimenopausal women using 17betaE(2)-D or CEE-N and women using placebo after 6 and 24 months.

Adult↗

PubMed2004

What influences participants' treatment preference and can it influence outcome? Results from a primary care-based randomised trial for shoulder pain.

BACKGROUND: In randomised clinical trials (RCTs), outcome may be influenced by the opinions of the participants about the efficacy of treatments. AIM: To examine how initial treatment preferences of participants in a shoulder pain trial affected functional outcome and future treatment preferences. DESIGN OF STUDY: Observational cohort study nested within a multicentre, pragmatic RCT of steroid injection versus physiotherapy for unilateral shoulder pain. SETTING: Nine general practices in north Staffordshire. METHOD: Two hundred and seven adults were randomised in the trial. Disability scores and preferences of the participants for the trial treatments were elicited at two points: prior to randomisation and 6 months post-randomisation. A good functional outcome was defined as at least a halving in the disability score at the 6 months follow-up point. RESULTS: Pre-randomisation preferences were: 40% for injection and 20% for physiotherapy, and 40% gave no preference. A good outcome was achieved in a higher percentage of participants who gave a pre-randomisation treatment preference compared with those who did not (62% compared with 48% percentage difference = 14%; 95% confidence interval [CI] = -1 to 27%) with similar percentages in each preferred treatment group. However, receiving the preferred treatment did not confer any additional benefit in those who expressed a preference (receiving preferred treatment = 56%; not receiving preferred treatment = 69%). At 6 months post-randomisation, participants with a good, as opposed to poor, outcome were more likely to report as their preferred treatment the one to which they had been randomised, irrespective of pre-randomisation preference and whether the preferred treatment was received. CONCLUSION: This analysis suggests that preferences prior to treatment can affect outcome, but that treatment outcome is a stronger influence on post-treatment preferences. We present some empirical evidence to support the statement that treatment preferences can have important effects on the results of RCTs.

Adrenal Cortex Hormones↗

PubMed2000

A prospective randomised trial of tourniquet in varicose vein surgery.

A prospective randomised trial of 50 patients was carried out to assess the autoclavable Lofquist cuff (Boazal, Sweden) as a tourniquet in varicose vein surgery and determine the effect on bleeding, bruising, cosmesis and patient pain and activity. Patients undergoing unilateral long saphenous vein ligation, stripping and avulsions were randomised to tourniquet or no tourniquet. Lofquist cuffs were applied after inflation to 120 mmHg to the upper thigh for the duration of the surgery. Varicose vein grade, duration of surgery, blood loss, extent of bruising at 7 days, pain and activity scores over the first week, and wound complications and cosmetic result at 6 weeks were recorded. Patients' age, sex, and varicose vein grade were similar in the two groups. Peroperative blood loss (median, range) was significantly reduced in the tourniquet group (0 ml, 0-20 ml) compared to the no tourniquet group (125 ml, 20-300; P < 0.01). Operative time and thigh bruising (median, range) were also reduced in the tourniquet group (30 min, 11-47 min; 72 cm2, 30-429 cm2), respectively, compared to the no tourniquet group (37 min, 18-50 min; 179 cm2, 24-669 cm2) both (P < 0.01). There was no difference in pain and activity scores in the two groups and cosmetic results were also similar. The use of the Lofquist cuff tourniquet during varicose vein surgery reduces peroperative blood loss, operative time and postoperative bruising without any obvious drawbacks.

Activities of Daily Living↗

PubMed1996

The role of post-operative radiotherapy in non-small-cell lung cancer: a multicentre randomised trial in patients with pathologically staged T1-2, N1-2, M0 disease. Medical Research Council Lung Cancer Working Party.

The role of post-operative radiotherapy for patients with non-small-cell lung cancer (NSCLC) is unclear despite five previous randomised trials. One deficiency with these trials was that they did not include adequate TNM staging, and so the present randomised trial was designed to compare surgery alone (S) with surgery plus post-operative radiotherapy (SR) in patients with pathologically staged T1-2, N1-2. M0 NSCLC. Between July 1986 and October 1993, 308 patients (154 S, 154 SR) were entered from 16 centres in the UK. The median age of the patients was 62 years, 74% were male, > 85% had normal or near normal levels of general condition, activity and breathlessness, 68% had squamous carcinoma, 52% had had a pneumonectomy, 63% had N1 disease and 37% N2 disease. SR patients received 40 Gy in 15 fractions starting 4-6 weeks post-operatively. Overall there was no advantage to either group in terms of survival, although definite local recurrence and bony metastases appeared less frequently and later in the SR group. In a subgroup analysis, in the N1 group no differences between the treatment groups were seen, but in the N2 group SR patients appeared to gain a one month survival advantage, delayed time to local recurrence and time to appearance of the bone metastases. There is, therefore, no clear indication for post-operative radiotherapy in N1 disease, but the question remains unresolved in N2 disease.

Aged↗

PubMed2004

Non-absorbable disaccharides for hepatic encephalopathy: systematic review of randomised trials.

OBJECTIVE: To assess the effects of non-absorbable disaccharides (lactulose and lactitol) in patients with hepatic encephalopathy. DATA SOURCES: Cochrane Hepato-Biliary Group controlled trials register, Cochrane Library, Medline, and Embase until March 2003; reference lists of relevant articles; authors and pharmaceutical companies. REVIEW METHODS: Randomised trials that compared non-absorbable disaccharides with placebo, no intervention, or antibiotics for hepatic encephalopathy were included. The primary outcome measures were no improvement of hepatic encephalopathy and all cause mortality. RESULTS: 22 trials were included. Compared with placebo or no intervention, non-absorbable disaccharides seemed to reduce the risk of no improvement in patients with hepatic encephalopathy (relative risk 0.62, 95% confidence interval 0.46 to 0.84, six trials). However, high quality trials found no significant effect (0.92, 0.42 to 2.04, two trials). Compared with placebo or no intervention, non-absorbable disaccharides had no significant effect on mortality (0.41, 0.02 to 8.68, four trials). Non-absorbable disaccharides were inferior to antibiotics in reducing the risk of no improvement (1.24, 1.02 to 1.50, 10 trials) and lowering blood ammonia concentration (weighted mean difference 2.35 micromol/l, 0.06 micromol/l to 13.45 micromol/l, 10 trials). There was no significant difference in mortality (0.90, 0.48 to 1.67, five trials). CONCLUSIONS: There is insufficient evidence to support or refute the use of non-absorbable disaccharides for hepatic encephalopathy. Antibiotics were superior to non-absorbable disaccharides in improving hepatic encephalopathy, but it is unclear whether this difference is clinically important. Non-absorbable disaccharides should not serve as comparator in randomised trials on hepatic encephalopathy.

Anti-Infective Agents↗