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Results for “Randomised Controlled Trial”

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PubMed2004

Effectiveness of pindolol plus serotonin uptake inhibitors in depression: a meta-analysis of early and late outcomes from randomised controlled trials.

BACKGROUND: Contradictory results on the efficacy of pindolol associated with selective serotonin reuptake inhibitors (SSRIs) in depressive illness have been published and no former review has produced an overall figure of its efficacy. This study aims to review the efficacy and tolerability of pindolol plus SSRIs in depressive illness. METHODS: A meta-analysis of randomised controlled trials (RCTs) comparing pindolol plus SSRIs with placebo plus SSRIs. RESULTS: Nine RCTs met inclusion criteria. Outcome favoured pindolol at 2 weeks time (N=5; OR=2.8; 95% CI 1.4-5.7), but not at four to 6 weeks (N=7; OR=1.4; 95% CI 0.8-2.7). Results for early outcome studies were robust to sensitivity analysis. Nineteen more studies, averaging null results, would be needed to change the overall probability (P=0.0001) to a non-significant figure. CONCLUSIONS: Pindolol seems to hasten the response to SSRIs in depression with a timing window circumscribed to the first weeks of treatment.

Adolescent↗

PubMed2003

Biphasic and monophasic shocks for transthoracic defibrillation: a meta analysis of randomised controlled trials.

INTRODUCTION: Biphasic waveforms are routinely used for implantable defibrillators. These waveforms have been less readily adopted for external defibrillation. This study was performed in order to evaluate the efficacy and harms of biphasic waveforms over monophasic waveforms for the transthoracic defibrillation of patients in ventricular fibrillation (VF) or haemodynamically unstable ventricular tachycardia. METHODS: Studies included randomised controlled trials comparing monophasic and biphasic external defibrillation for participants with VF or hemodynamically unstable ventricular tachycardia. Seven trials (1129 patients) were included in the analysis. All trials were conducted during electrophysiology procedures or implantable cardioverter/defibrillator testing. RESULTS: Compared with 200 J monophasic shocks, 200 J biphasic shocks reduced the risk of post-first shock asystole or persistent VF by 81% (relative risk (RR) 0.19; 95% confidence intervals (CI) 0.06-0.60) for the first shock. Reducing the energy of the biphasic waveform to 115-130 J resulted in similar effectiveness compared with the monophasic waveform at 200 J (RR 1.07, CI 0.66-1.74). Low energy biphasic shocks produce less myocardial injury than higher energy monophasic shocks as determined by ST segment deflection after shock. CONCLUSIONS: Biphasic waveforms defibrillate with similar efficacy at lower energies than standard 200 J monophasic waveforms, and greater efficacy than monophasic shocks of the same energy. Available data suggests that lower delivered energy and voltage result in less post-shock myocardial injury.

Defibrillators, Implantable↗

PubMed2006

Does completing a dental anxiety questionnaire increase anxiety? A randomised controlled trial with adults in general dental practice.

UNLABELLED: The assessment of dental anxiety can be achieved by using brief multi-item scales. OBJECTIVE: To test the null hypothesis that completing the Modified Dental Anxiety Scale had no immediate influence on patient state anxiety. OUTCOME MEASURE: Speilberger State Anxiety Inventory-6 item Short Form. STUDY DESIGN: Randomised controlled trial. PARTICIPANTS: Patients (n = 1,028) attending 18 dental practices in Northern Ireland were invited to participate. RESULTS: Twenty-four patients refused (response rate 98%) providing 1,004 patients (mean age = 41 years, range = 16 to 90 years; 65% female) for analysis. Patients who completed the dental anxiety scale were found to have a virtually identical state anxiety score: mean (SD) = 11.36 (4.33) compared to those who completed the state anxiety assessment only: mean (SD) = 11.01 (4.35). The mean (CI95%) difference was 0.35 (0.89 to -0.18), t = 1.29, df1002, p = 0.2. CONCLUSION: The completion of a brief dental anxiety questionnaire before seeing the dentist has a non significant effect on state anxiety.

Adolescent↗

PubMed2005

Post-discharge home-based support for older cardiac patients: a randomised controlled trial.

BACKGROUND: Hospital and exercise-based cardiac rehabilitation programmes do not suit many older patients and home-based rehabilitation may be more effective. OBJECTIVE: To evaluate a home-based intervention for patients aged 65 years or over discharged home from hospital after emergency admission for suspected myocardial infarction. DESIGN: A single-blind randomised controlled trial comparing home-based intervention by a nurse with usual care. SUBJECTS: Patients aged 65 years or over discharged home after hospitalisation with suspected myocardial infarction (n= 324). INTERVENTION: Home-based intervention (n = 163) consisted of home visits at 1-2 and 6-8 weeks after hospital discharge by a nurse who encouraged compliance with and knowledge of their treatment regimen, offered support and guidance about resuming daily activities, and involved other community services as appropriate. MEASUREMENTS: Up to 100 days after admission, data were collected on deaths, hospital readmissions and use of outpatient services. Survivors were sent a postal questionnaire to assess activities of daily living and quality of life. RESULTS: At 100 day follow-up there was no difference in deaths, activities of daily living or overall quality of life, but those in the intervention group scored significantly better on the confidence and self-esteem subsections. The intervention group had fewer hospital readmissions (35 versus 51, relative risk 0.68, 95% CI 0.47-0.98, P < 0.05) and fewer days of hospitalisation after initial discharge (mean difference -1.7, 95% CI -2.09 to -1.31, P < 0.05). A total of 42/43 individuals in the intervention group had resumed driving at follow-up, compared with 32/43 in the usual care group (observed difference between proportions 23%, 95% CI 9-37%, P < 0.05). CONCLUSION: Amongst older patients discharged home after hospitalisation for suspected myocardial infarction, home-based nurse intervention may improve confidence and self-esteem, and reduce early hospital readmissions.

Age Factors↗

PubMed1999

A randomised controlled trial to assess the relative benefits of large volume spacers and nebulisers to treat acute asthma in hospital.

OBJECTIVES: To compare the clinical effectiveness, acceptability, and cost benefit of administering beta2 agonists by means of a metered dose inhaler and large volume spacer with conventional nebulisers to children admitted to hospital with acute asthma. METHODS: A randomised controlled trial was conducted over five months. Sixty one children older than 3 years admitted to a large teaching hospital and a district general hospital with acute asthma completed the study. Children received either 5 mg of salbutamol up to one hourly by jet nebuliser, or up to 10 puffs of salbutamol 100 microg by means of a metered dose inhaler and spacer up to one hourly. RESULTS: Median hospital stay was 40 hours in the nebuliser group and 36.5 hours in the spacer group. Asthma disability scores at two weeks after discharge were significantly improved in the spacer group. Drug costs were pound 14.62 less for each patient in the spacer group. CONCLUSIONS: Large volume spacers are an acceptable, cost effective alternative to nebulisers in treating children admitted with acute asthma, provided that the children can use the mouthpiece, and symptoms are not severe. Their use facilitates effective home treatment by parents, with subsequent reduction in morbidity and re-admission rates.

Acute Disease↗

PubMed1995

Randomised controlled trial comparing problem solving treatment with amitriptyline and placebo for major depression in primary care.

OBJECTIVE: To determine whether, in the treatment of major depression in primary care, a brief psychological treatment (problem solving) was (a) as effective as antidepressant drugs and more effective than placebo; (b) feasible in practice; and (c) acceptable to patients. DESIGN: Randomised controlled trial of problem solving treatment, amitriptyline plus standard clinical management, and drug placebo plus standard clinical management. Each treatment was delivered in six sessions over 12 weeks. SETTING: Primary care in Oxfordshire. SUBJECTS: 91 patients in primary care who had major depression. MAIN OUTCOME MEASURES: Observer and self reported measures of severity of depression, self reported measure of social outcome, and observer measure of psychological symptoms at six and 12 weeks; self reported measure of patient satisfaction at 12 weeks. Numbers of patients recovered at six and 12 weeks. RESULTS: At six and 12 weeks the difference in score on the Hamilton rating scale for depression between problem solving and placebo treatments was significant (5.3 (95% confidence interval 1.6 to 9.0) and 4.7 (0.4 to 9.0) respectively), but the difference between problem solving and amitriptyline was not significant (1.8 (-1.8 to 5.5) and 0.9 (-3.3 to 5.2) respectively). At 12 weeks 60% (18/30) of patients given problem solving treatment had recovered on the Hamilton scale compared with 52% (16/31) given amitriptyline and 27% (8/30) given placebo. Patients were satisfied with problem solving treatment; all patients who completed treatment (28/30) rated the treatment as helpful or very helpful. The six sessions of problem solving treatment totalled a mean therapy time of 3 1/2 hours. CONCLUSIONS: As a treatment for major depression in primary care, problem solving treatment is effective, feasible, and acceptable to patients.

Adolescent↗

PubMed2001

Improving question formulation for use in evidence appraisal in a tertiary care setting: a randomised controlled trial [ISRCTN66375463].

BACKGROUND: The specificity of clinical questions is gauged by explicit descriptions of four dimensions: subjects, interventions, comparators and outcomes of interest. This study determined whether adding simple instructions and examples on clinical question formulation would increase the specificity of the submitted question compared to using a standard form without instructions and examples. METHODS: A randomised controlled trial was conducted in an evidence-search and appraisal service. New participants were invited to reformulate clinical queries. The Control Group was given no instructions. The Intervention Group was given a brief explanation of proper formulation, written instructions, and diagrammatic examples. The primary outcome was the change in the proportion of reformulated questions that described each the dimensions of specificity. RESULTS: Fifty-two subjects agreed to participate in the trial of which 13 were lost to follow-up. The remaining 17 Intervention Group and 22 Control Group participants were analysed. Baseline characteristics were comparable. Overall, 20% of initially submitted questions from both groups were properly specified (defined as an explicit statement describing all dimensions of specificity). On follow-up, 7/14 questions previously rated as mis-specified in the Intervention Group had all dimensions described at follow-up (p = 0.008) while the Control Group did not show any changes from baseline. Participants in the Intervention Group were also more likely to explicitly describe patients (p = 0.028), comparisons (p = 0.014), and outcomes (p = 0.008). CONCLUSIONS: This trial demonstrated the positive impact of specific instructions on the proportion of properly-specified clinical queries. The evaluation of the long-term impact of such changes is an area of continued research.

Allied Health Personnel↗

PubMed2004

Giving patients an audiotape of their GP consultation: a randomised controlled trial.

BACKGROUND: Providing patients with an audiotape of their medical consultation has been a relatively common practice in oncology clinics for some years. However, broader generalisability of the technique has yet to be examined. AIMS: To investigate the efficacy of providing patients with an audiotape of their consultation in a general practice setting. DESIGN OF STUDY: Randomised controlled trial: 95 experimental participants, 85 controls. SETTING: Routine surgeries run by two general practitioners (GPs) in two different health centres. METHOD: All patients attending GP appointments were eligible for inclusion. Patients were followed up by telephone 7-10 days later. RESULTS: More than half (61%) of the patients who received a tape listened to it. Among listeners, 64% rated the tape useful or very useful; 24% noticed information not heard in the consultation. Half of listeners (46%) said that their understanding of the consultation improved after listening to the tape. Half of the listeners (48%) shared the tape with others, of whom 71% found sharing helpful or very helpful. However, 21% of those who shared the information with others found this unhelpful or very unhelpful, suggesting that patients may need to be briefed on the potential risks of sharing. At follow-up a week later, it emerged that being given a tape had no effect on adherence with GPs' advice, nor on anxiety about conditions. CONCLUSION: Providing patients with an audiotape of their GP consultation was positively rated by many patients. Although there were no detectable clinical effects at follow-up, the technique merits further evaluation in general practice.

Adult↗

PubMed2005

Randomised controlled trial to compare GP-run orthopaedic clinics based in hospital outpatient departments and general practices.

BACKGROUND: To reduce outpatient waiting times, a growing number of outpatient clinics for selected groups of patients are being provided by GPs with special interests (GPwSIs). AIM: To determine whether there are differences in patient satisfaction or clinical outcome among patients attending orthopaedic clinics provided by GPwSIs in hospital or community settings. DESIGN OF STUDY: Randomised controlled trial. SETTING: Hospital outpatient departments or general practices. METHOD: Three hundred and twenty-one patients with minor orthopaedic problems were referred by GPs to the orthopaedic surgery department of the University Hospitals of Leicester NHS Trust; 168 patients were randomised to care by GPwSIs in practices, and 153 were randomised to care by the same GPwSIs in clinics held at hospital outpatient departments. Patients completed the SF-36v2 and satisfaction questionnaires at their first appointment, and again 3 months later. RESULTS: There was no significant difference between the sites in changes in health. After the first clinic attendance, patients attending practice-based clinics were more satisfied with access to appointments and information received. CONCLUSION: For selected orthopaedic referrals seen by GPwSIs, there were no significant differences in clinical outcomes between practice-based and hospital-based clinics, but some features of practice-based clinics tend to be preferred by patients.

Adult↗

PubMed2003

Postnatal home visits in teenage mothers: a randomised controlled trial.

BACKGROUND: Teenage pregnancies are associated with negative socioeconomic effects. Our aim was to ascertain whether a postnatal home-visiting service for teenage mothers younger than age 18 years could reduce the frequency of adverse neonatal outcomes and improve knowledge of contraception, breastfeeding, and infant vaccination schedules in this parent group. METHODS: We enrolled 139 adolescents, attending a teenage pregnancy clinic, in a randomised controlled trial. After completing an antenatal questionnaire designed to assess their knowledge of contraception, infant vaccination, and breastfeeding, we assigned participants to either receive five structured postnatal home visits by nurse-midwives (n=65) or not (n=71). Assessment interviews were done 6 months postpartum. Our primary endpoint was unadjusted difference in knowledge between groups, and incidence of predefined adverse neonatal outcomes. Analysis was by intention to treat. FINDINGS: Three women withdrew before randomisation because of late fetal loss, 11 mothers withdrew because of adverse neonatal outcomes (adverse neonatal outcome was a primary endpoint, but resulted in withdrawal from the study for knowledge outcomes), and one left voluntarily. Follow-up data were, therefore, available for 124 teenagers. Postnatal home visits were associated with a reduction in adverse neonatal outcomes (intervention: 2; control: 9; relative risk 0.24, 95% CI 0.05-1.08), and a significant increase in contraception knowledge (mean difference 0.92, 95% CI 0.32-1.52). However, there was no significant increase in knowledge with respect to breastfeeding or infant vaccination schedules associated with the home visits. INTERPRETATION: Postnatal home-visiting services by nurse-midwives reduce adverse neonatal events and improve contraception outcomes, but do not affect breastfeeding or infant vaccination knowledge or compliance.

Adolescent↗

PubMed1992

Randomised controlled trial of adjuvant chemotherapy by portal-vein perfusion after curative resection for colorectal adenocarcinoma.

About half the patients treated with curative resection for colorectal cancer do not survive long-term. Adjuvant chemotherapy given during and after surgery may prevent hepatic metastases and improve patient survival. In patients with colorectal cancer, we have done a multicentre, randomised controlled trial comparing five-year survival after intraportal infusion of fluorouracil (1 g per day) plus heparin (10,000 U per day) (130 patients) or heparin alone (123) during curative resection and for 7 days thereafter, or after resection alone (145). There was no reduction in liver metastasis or increased overall survival advantage in either active-treatment arm of the study. However, patients who had stage III, Dukes' C (lymph-node-positive) tumours resected and were treated with fluorouracil plus heparin had a significant (p less than 0.03) survival advantage of about 16% compared with surgery-only controls. Further study of intraportal infusion of chemotherapeutic agent as adjuvant treatment to surgery in patients with colorectal cancer appears worthwhile.

Adenocarcinoma↗

PubMed2003

Isolated limb perfusion with melphalan in the treatment of malignant melanoma of the extremities: a systematic review of randomised controlled trials.

Isolated limb perfusion is a surgical procedure for delivering a high dose of chemotherapeutic or immunochemotherapeutic agent to a localised area, thus avoiding the severity of side-effects caused by systemic administration. This technique is generally used for treatment of patients with tumours of the limbs and extremities. We have done a systematic review of randomised controlled trials assessing the effectiveness of this treatment in patients with melanoma of the extremities. Four trials of 1038 patients met our inclusion criteria and were analysed. Although our analysis confirmed the reported increase in survival in two of the trials, neither had sufficient power to detect significant benefit for perfusion. Results from the trials showed that prophylactic perfusion has an equivocal effect on survival in patients with limb melanoma. Therefore, current evidence suggests that prophylactic isolated limb perfusion cannot be recommended as a routine adjunct to standard surgery in patients with high-risk primary limb melanoma, but only as a treatment for local disease control if other forms of locoregional therapy are not available.

Antineoplastic Agents, Alkylating↗

PubMed1993

Randomised controlled trial of oxytocin alone versus oxytocin and ergometrine in active management of third stage of labour.

OBJECTIVE: To compare intramuscular oxytocin alone and intramuscular oxytocin with ergometrine (Syntometrine) for their effect in reducing the risk of postpartum haemorrhage when both are used as part of the active management of the third stage of labour. DESIGN: Double blind, randomised controlled trial. SETTING: Two metropolitan teaching hospitals in Perth, Western Australia. SUBJECTS: All women who expected a vaginal birth during the period of the trial. Informed consent was obtained. MAIN OUTCOME MEASURES: Postpartum haemorrhage, nausea, vomiting, and increased blood pressure. RESULTS: 3497 women were randomly allocated to receive oxytocin-ergometrine (n = 1730) or oxytocin (n = 1753). Rates of postpartum haemorrhage (> or = 500 ml or > or = 1000 ml) were similar in both arms (odds ratio 0.90 (0.82); 95% confidence interval 0.75 to 1.07 (0.59 to 1.14) at 500 ml (1000 ml) threshold). The use of oxytocin-ergometrine was associated with nausea, vomiting, and increased blood pressure. CONCLUSIONS: There are few advantages but several disadvantages for the routine use of oxytoxinergometrine when prophylactic active management of the third stage of labour is practised. Further investigation of dose-response for oxytocin may be warranted.

Blood Pressure↗

PubMed1999

Randomised controlled trial of follow up care in general practice of patients with myocardial infarction and angina: final results of the Southampton heart integrated care project (SHIP). The SHIP Collaborative Group.

OBJECTIVE: To assess the effectiveness of a programme to coordinate and support follow up care in general practice after a hospital diagnosis of myocardial infarction or angina. DESIGN: Randomised controlled trial; stratified random allocation of practices to intervention and control groups. SETTING: All 67 practices in Southampton and south west Hampshire, England. SUBJECTS: 597 adult patients (422 with myocardial infarction and 175 with a new diagnosis of angina) who were recruited during hospital admission or attendance at a chest pain clinic between April 1995 and September 1996. INTERVENTION: Programme to coordinate preventive care led by specialist liaison nurses which sought to improve communication between hospital and general practice and to encourage general practice nurses to provide structured follow up. MAIN OUTCOME MEASURES: Serum total cholesterol concentration, blood pressure, distance walked in 6 minutes, confirmed smoking cessation, and body mass index measured at 1 year follow up. RESULTS: Of 559 surviving patients at 1 year, 502 (90%) were followed up. There was no significant difference between the intervention and control groups in smoking (cotinine validated quit rate 19% v 20%), lipid concentrations (serum total cholesterol 5.80 v 5.93 mmol/l), blood pressure (diastolic pressure 84 v 85 mm Hg), or fitness (distance walked in 6 minutes 443 v 433 m). Body mass index was slightly lower in the intervention group (27.4 v 28.2; P=0.08). CONCLUSIONS: Although the programme was effective in promoting follow up in general practice, it did not improve health outcome. Simply coordinating and supporting existing NHS care is insufficient. Ischaemic heart disease is a chronic condition which requires the same systematic approach to secondary prevention applied in other chronic conditions such as diabetes mellitus.

Angina Pectoris↗

PubMed2002

Radiography for low back pain: a randomised controlled trial and observational study in primary care.

BACKGROUND: Lumbar spine radiography has limited use in diagnosing the cause of acute low back pain. Consensus-based guidelines recommend that lumbar spine x-rays are not used routinely. However there have been no studies of the effect of referral for radiography at first presentation with low back pain in primary care. AIM: To compare short and long-term physical, social, and psychiatric outcomes for patients with low back pain who are referred or not referred for lumbar spine x-ray at first presentation in general practice. DESIGN OF STUDY: A randomised unblinded controlled trial with an observational arm to enable comparisons to be made with patients not recruited to the trial. SETTING: Ninety-four general practices in south London and the South Thames region. METHOD: Patients consulting their general practitioner (GP) with low back pain at first presentation were recruited to a randomised controlled trial (RCT) or to an observational group. Patients in the trial were randomly allocated to immediate referral for x-ray or to no referral. All patients were asked to complete questionnaires initially, and then at six weeks and one year after recruitment. RESULTS: Six hundred and fifty-nine patients were recruited over 26 months: 153 to the randomised trial and 506 to the observational arm. In the RCT referral for x-ray had no effect on physical functioning, pain or disability, but was associated with a small improvement in psychological wellbeing at six weeks and one year. These findings were supported by the observational study in which there were no differences between the groups in physical outcomes after adjusting for length of episode at presentation; however, those referred for x-ray had lower depression scores. CONCLUSIONS: Referral for lumbar spine radiography for first presentation of low back pain in primary care is not associated with improved physical functioning, pain or disability. The possibility of minor psychological improvement should be balanced against the high radiation dose involved.

Adult↗

PubMed2005

Randomised controlled trial and cost consequences study comparing initial physiotherapy assessment and management with routine practice for selected patients in an accident and emergency department of an acute hospital.

OBJECTIVE: The Department of Health is reviewing the effectiveness of accident and emergency (A&E) departments. This study aimed to compare health and economic effects of physiotherapy initial assessment and management with routine practice in an A&E department. METHODS: Randomised controlled trial and cost and consequences study. Patients presenting at A&E were eligible if suspected at triage to have soft tissue injury without fracture. The efficacy end point was "days to return to usual activities". Secondary end points included patient satisfaction with their care and further health outcomes and cost data. RESULTS: 766 of 844 (915) patients were randomised. The median days before return to usual activities (available for 73% of those randomised) was greater in the physiotherapist group (41 days compared with 28.5 days; hazard ratio 0.85 p = 0.071). The physiotherapy group expressed greater satisfaction with their A&E care (on a scale of 1 to 5, median was 4.2 compared with 4.0, p<0.001), were more likely to be given advice and reassurance, and more likely to be provided with aids and appliances. Costs were the same between the two arms. CONCLUSION: There is evidence that physiotherapy leads to a prolonged time before patients return to usual activities. This study shows no clear danger from physiotherapy intervention and long term outcomes may be different but given these findings, a best estimate is that introducing physiotherapist assessment will increase costs to the health service and society. Routine care should continue be provided unless there is some reason why it is not feasible to do so and an alternative must be found.

Adolescent↗

PubMed2001

Evaluation of the impact of two educational interventions on GP management of familial breast/ovarian cancer cases: a cluster randomised controlled trial.

BACKGROUND: It has been suggested that primary care should become more involved in providing genetic services, such as basic risk assessment, to enable patients with a moderate/high risk to be referred and those with a low risk to receive reassurance and advice from their general practitioner (GP). However, GPs currently lack knowledge and confidence in this area. AIM: To investigate the effect of an in-practice educational session and information pack on GP management of familial breast/ovarian cancer cases. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: GP principals in 170 practices in Oxfordshire and Northamptonshire. Of the 688 GPs, 426 (62%) participated. METHOD: Practices were randomised either to Group A (receiving an inpractice educational session plus information pack), Group B (receiving an information pack alone), or Group C (receiving neither an educational session nor a pack). The main study outcome was the proportion of GPs making the correct referral decision on at least five out of six family history vignettes. A secondary outcome was GPs' reported confidence in managing patients with a family history of breast/ovarian cancer, measured by a score that was generated by combining responses to four questions. RESULTS: There was a 40% (95% CI = 30-50%, P < 0.001) improvement in the proportion of GPs who made the correct referral decision on at least five out of the six vignettes in Group A (111/140 [79%]) compared with Group C (controls) (63/162 [39%]), and a 42% (95% CI = 31-52%, P < 0.001) improvement in Group B (100/124 [81%]) compared with the control group. There was a trend in reported confidence in the management of individuals with a family history of breast/ovarian cancer from a mean confidence score of 2.3 in Group A to 2.0 in Group B and 1.5 in Group C (P < 0.001). CONCLUSION: Providing GPs with an information pack significantly improved referral decisions regarding patients with a family history of breast/ovarian cancer. Although extremely well received, an in-house educational session produced no additional improvements. There were, however, greater levels of reported confidence in the group who received the educational session in addition to the information pack.

Breast Neoplasms↗

PubMed2002

Incidence of side effects during therapy with different types of alpha interferon: a randomised controlled trial comparing recombinant alpha 2b versus leukocyte interferon in the therapy of naive patients with chronic hepatitis C.

BACKGROUND: Alpha interferon (IFN) alone or in combination with Ribavirin (RBV) is the treatment of choice for HCV related chronic liver disease. There are many types of alpha IFN and to date only few reports are available comparing different types of alpha interferon. We run a randomised controlled trial with the aim to compare tolerability and efficacy of two different types of IFN: recombinant alpha 2b interferon (IFN-R) and leukocyte alpha n-3 interferon (IFN-L) at the same dosage of 3 MU subcutaneously thrice weekly for one year. METHODS: one hundred sixty eight consecutive anti-HCV positive naive patients, 34 mild chronic active hepatitis (MCH), 81 moderate-severe hepatitis (MSCR) and 53 active cirrhosis (CIRR) that met the inclusion criteria were enrolled into the study. The diagnosis of HCV chronic liver disease was established by liver biopsy performed on patients with abnormal serum alanine aminotransferase (ALT) value for at least one year. HCV serology: all patients were tested for confirmatory test RIBA II, HCV-RNA, and identification of viral genotype. Patients were randomised to receive either IFN-R or IFN-L. Follow-up continued for at least two years after stopping treatment. RESULTS: no significant differences were observed between the two groups of treatment as far as the incidence of side effects is concerned. Tolerability was good: only 11 in IFN-R and 8 patients IFN-L group respectively had to stop therapy due to side effects. The two types of IFN showed a comparable efficacy: an end of therapy response was observed in 34% of IFN-R and 30% of IFN-L patients; a sustained response was seen in 16% of IFN-R and in 19% of IFN-L patients. CONCLUSIONS: in the treatment of patients with chronic hepatitis C there was no statistically significant difference in tolerability and efficacy between the two IFNs tested.

Antiviral Agents↗