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Results for “randomized controlled trial (RCT)”

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PubMed2003

Calcium channel blockers for reducing cardiac morbidity after noncardiac surgery: a meta-analysis.

Cardiac complications are the leading cause of death after noncardiac surgery. Despite theoretical benefits, calcium channel blockers (CCB) are not widely used in the perioperative setting. This systematic review assessed the efficacy of CCBs during noncardiac surgery. MEDLINE, EMBASE, Science Citation Index, PubMed, and reference lists were searched without language restriction for randomized controlled trials (RCT) evaluating CCBs during noncardiac surgery. Two reviewers independently abstracted data on death, myocardial infarction (MI), ischemia, supraventricular tachyarrhythmia (SVT), and congestive heart failure (CHF). Treatment effects were calculated as relative risks (RR) with 95% confidence intervals (CI). Eleven studies (1007 patients) were included. CCBs significantly reduced ischemia (RR, 0.49; 95% CI, 0.30-0.80; P = 0.004) and SVT (RR, 0.52; 95% CI, 0.37-0.72; P < 0.0001). CCBs were associated with trends towards reduced death and MI. In post hoc analyses, CCBs significantly reduced death/MI (RR, 0.35; 95% CI, 0.15-0.86; P = 0.02) and major morbid events (MME), defined as death, MI, or CHF (RR, 0.39; 95% CI, 0.17-0.89; P = 0.02). In subgroup analyses, diltiazem significantly reduced ischemia, SVT, death/MI, and MMEs. This meta-analysis shows CCBs significantly reduced ischemia, SVT, and combined end-points in the setting of noncardiac surgery. The majority of these benefits are attributable to diltiazem, suggesting the need for further evaluation of this drug in a large RCT.

Calcium Channel Blockers↗

PubMed2000

Design issues for drug epidemiology.

Despite the difficulties involved in designing drug epidemiology studies, these studies are invaluable for investigating the unexpected adverse effects of drugs. The aim of this paper is to discuss various aspects of study design, particularly those issues that are not easily found in either textbooks or review papers. We have also compared and contrasted drug epidemiology with the randomized controlled trial (RCT) wherever possible. Drug epidemiology is especially useful in the many situations where the RCT is not suitable, or even possible. The study base has to be defined before the appropriate cohort of subjects is assembled. If all of the cases are identified, then a referent sample of controls may be assembled by random sampling of the study base. If all of the cases cannot be assembled, a hypothetical secondary base may need to be created. Preferably, only new-users of the drug should be included, and the risk-ratio will be different for acute users and chronic users. Studies will usually only be possible when researching the unintended effects of drugs. It is difficult to study efficacy because of confounding by indication. In occasional circumstances it may be possible to study efficacy (examples are given). Discussion of the dangers of designing with generalisability in mind is provided. Additionally, the similarities in study design between drug epidemiology and the RCT are discussed in detail, as well as the design-characteristics that cannot be shared between the two methods.

Cohort Studies↗

PubMed2004

Investigating patient exclusion bias in meta-analysis.

BACKGROUND: Trial investigators frequently exclude patients from trial analyses which may bias estimates of the effect of treatment. Combining these estimates in a meta-analysis could aggregate any such biases. METHODS: To investigate how excluding patients from trials can affect the results of both trials and meta-analyses, we used 14 meta-analyses of individual patient data (IPD) that addressed therapeutic questions in cancer. These included 133 randomized controlled trials (RCT) and 21 905 patients. We explored whether exclusions were related to trial characteristics and categorized the reasons for exclusions. For each RCT and meta-analysis, we compared results of an intention-to-treat analysis of all randomized patients with an analysis based on those patients included in the investigators' analysis. RESULTS: In all, 92 trials (69%) excluded between 0.3 and 38% of patients randomized. Trials excluding patients tended to be older and larger than those that did not. Most patients were excluded because of ineligibility or protocol violations. Exclusions varied substantially by meta-analysis, more patients tending to be excluded from the treatment arm. Comparing trial analyses there was no clear indication that exclusion of patients altered the results more in favour of either treatment or control. However, comparing meta-analysis results, there was a tendency for those based on 'included' patients to favour the research treatment (P = 0.03). Inconsistency of trial results was often increased as a result of the investigators' exclusions. CONCLUSIONS: Trials, systematic reviews, and meta-analyses may be prone to bias associated with post-randomization exclusion of patients. Wherever possible, the level of such exclusions should be taken into account when assessing the potential for bias in trials, systematic reviews, and meta-analyses. Ideally, trials, systematic reviews, and meta-analyses should be based on all randomized patients.

Bias↗

PubMed2003

Design, quality, and bias in randomized controlled trials of systemic lupus erythematosus.

OBJECTIVE: To appraise systematically the study design and quality of reporting of randomized controlled trials (RCT) on systemic lupus erythematosus (SLE) and to identify potential defects and biases. METHODS: RCT with at least 5 patients with SLE were retrieved from MEDLINE, EMBASE, and the Cochrane Library. We analyzed study design, quality of reporting, and trial results. RESULTS: Ninety-four trial reports (37 on lupus nephritis) were eligible with 2,257 SLE patients (n = 795 in lupus nephritis trials). Median sample size was 28 patients. Fifty-one trials (54.3%) were double blind, but only 31 (33.0%) mentioned the randomization mode, only 19 (20.2%) described allocation concealment, and only 7 (7.5%) were adequately powered. Sixty-three trials (67%) described adequately reasons for withdrawals. Nephritis trials had on average longer followup (p = 0.001) and were less likely to be double blind (p < 0.001), to describe reasons for withdrawals [both overall (p = 0.008) and per arm (p = 0.009)] and to involve a comparison against placebo or no treatment (p < 0.001). Larger trials scored higher on several quality characteristics. Significant efficacy or trend for efficacy was claimed in 72 reports (76.6%) and this was even more common in trials published in 1999-2002 (89.5%). Significant efficacy was found more frequently in trials that clearly specified withdrawals per arm (p = 0.001) and outcomes (p = 0.001) and used intention-to-treat analyses (p = 0.03). Besides outcome specification, no other quality variables seemed to improve significantly over time. CONCLUSION: Several aspects of the design and reporting of RCT on SLE can be improved. Larger, adequately powered, and accurately reported trials are needed.

Bias↗

PubMed2002

Randomized controlled trials for evaluating surgical questions.

OBJECTIVE: To discuss some of the obstacles inherent in the design of the randomized controlled trial (RCT) that the surgeon must confront and options to minimize these obstacles. DATA SOURCES: The literature was searched for articles discussing RCTs using MEDLINE from 1966 to 1998. STUDY SELECTION: Studies relevant to the general use of RCTs for evaluating surgical questions were selected. SYNTHESIS: Several problems inherent in RCTs were noted: (1) ethical considerations, (2) difficulties in patient accrual, (3) patient preferences, and (4) variability in surgical proficiency/technique. Some means of minimizing these problems are (1) the concept of clinical equipoise, (2) multicenter trials, and (3) stratified sampling of patients. Alternatives to the classic RCT are discussed, namely, the randomized consent design and the patient preference design. CONCLUSIONS: The nature of the RCTs is that they are difficult to use to evaluate surgical techniques. Some options are available to minimize these difficulties. Designing and conducting RCTs to evaluate surgical interventions require careful planning and some compromises. Unless the previously mentioned criteria are applied, the validity of the RCT can be considered no greater than that of other trials.

Ethics, Medical↗

PubMed2006

Probiotics in the prevention of antibiotic-associated diarrhea in children: a meta-analysis of randomized controlled trials.

OBJECTIVE: To systematically evaluate the effectiveness of probiotics in preventing antibiotic-associated diarrhea (AAD) in children. STUDY DESIGN: The following electronic databases up to December 2005, in any language, were searched for studies relevant to AAD and probiotics: MEDLINE, EMBASE, and The Cochrane Library. Only randomized controlled trials (RCT) were considered for study inclusion. RESULTS: Six placebo-controlled, RCTs (766 children) were included. Treatment with probiotics compared with placebo reduced the risk of AAD from 28.5% to 11.9% (relative risk, RR, 0.44, 95% CI 0.25 to 0.77, random effect model). Preplanned subgroup analysis showed that reduction of the risk of AAD was associated with the use of Lactobacillus GG (2 RCTs, 307 participants, RR 0.3, 95% CI 0.15 to 0.6), S. boulardii (1 RCT, 246 participants, RR 0.2, 95% CI 0.07-0.6), or B. lactis & Str. thermophilus (1 RCT, 157 participants, RR 0.5, 95% CI 0.3 to 0.95). CONCLUSIONS: Probiotics reduce the risk of AAD in children. For every 7 patients that would develop diarrhea while being treated with antibiotics, one fewer will develop AAD if also receiving probiotics.

Anti-Bacterial Agents↗

PubMed1999

Methodological issues of corticosteroid use in SLE clinical trials.

OBJECTIVE: To describe and analyze how investigators handled concurrent steroid intake in SLE clinical trials; to identify remaining methodological problems and to discuss potential solutions. METHODS: A review of the literature was performed in Medline to identify randomized controlled trials (RCT) in lupus published during the past decade. A set of criteria was defined a priori to analyze these trials covering different aspects of steroid use in RCTs with regard to eligibility, randomization, post-randomization steroid use, analysis and reporting. RESULTS: Seventeen trials met the inclusion criteria and were analyzed. Median sample size was 30, ranging from 10-71. In three trials corticosteroid application was the study intervention. Three reports did not address steroid use among study subjects at all. In seven trials steroid use was part of the eligibility criteria in some way. Of the trials that allowed concurrent steroid use, seven checked for equal distribution of baseline steroids. In some cases clinically relevant differences did not reach statistical significance as sample sizes were very small. In only one study was randomization stratified for steroid use. Instructions for post-randomization steroid use were specified in only 3 of 14 trials where steroids were not part of the intervention. In 11 RCTs concurrent steroid use was free or no information was provided. Steroid dosing during the intervention was reported as a secondary outcome measure in four trials. CONCLUSIONS: As sample sizes are often small, simple randomization is not reliable to avoid relevant between-group differences in baseline steroids. The power of statistical testing for group differences is limited for the same reason. Stratified randomization is rarely used. Free concurrent steroid use during the intervention is frequently allowed in lupus RCTs despite the risk of bias. Better data and accepted standards for a priori specified steroid regimens in RCTs are highly warranted.

Adrenal Cortex Hormones↗

PubMed2004

Effects of augmented exercise therapy time after stroke: a meta-analysis.

BACKGROUND AND PURPOSE: To present a systematic review of studies that addresses the effects of intensity of augmented exercise therapy time (AETT) on activities of daily living (ADL), walking, and dexterity in patients with stroke. SUMMARY OF REVIEW: A database of articles published from 1966 to November 2003 was compiled from MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, PEDro, DARE, and PiCarta using combinations of the following key words: stroke, cerebrovascular disorders, physical therapy, physiotherapy, occupational therapy, exercise therapy, rehabilitation, intensity, dose-response relationship, effectiveness, and randomized controlled trial. References presented in relevant publications were examined as well as abstracts in proceedings. Studies that satisfied the following selection criteria were included: (1) patients had a diagnosis of stroke; (2) effects of intensity of exercise training were investigated; and (3) design of the study was a randomized controlled trial (RCT). For each outcome measure, the estimated effect size (ES) and the summary effect size (SES) expressed in standard deviation units (SDU) were calculated for ADL, walking speed, and dexterity using fixed and random effect models. Correlation coefficients were calculated between observed individual effect sizes on ADL of each study, additional time spent on exercise training, and methodological quality. Cumulative meta-analyses (random effects model) adjusted for the difference in treatment intensity in each study was used for the trials evaluating the effects of AETT provided. Twenty of the 31 candidate studies, involving 2686 stroke patients, were included in the synthesis. The methodological quality ranged from 2 to 10 out of the maximum score of 14 points. The meta-analysis resulted in a small but statistically significant SES with regard to ADL measured at the end of the intervention phase. Further analysis showed a significant homogeneous SES for 17 studies that investigated effects of increased exercise intensity within the first 6 months after stroke. No significant SES was observed for the 3 studies conducted in the chronic phase. Cumulative meta-analysis strongly suggests that at least a 16-hour difference in treatment time between experimental and control groups provided in the first 6 months after stroke is needed to obtain significant differences in ADL. A significant SES supporting a higher intensity was also observed for instrumental ADL and walking speed, whereas no significant SES was found for dexterity. CONCLUSIONS: The results of the present research synthesis support the hypothesis that augmented exercise therapy has a small but favorable effect on ADL, particularly if therapy input is augmented at least 16 hours within the first 6 months after stroke. This meta-analysis also suggests that clinically relevant treatment effects may be achieved on instrumental ADL and gait speed.

Activities of Daily Living↗

PubMedDate not supplied

Economic evaluations relating to diabetes: a descriptive review and their compliance with guidance.

From a search of the Health Economics Evaluations Database (HEED), 301 studies relating to diabetes-related interventions were identified. Of these, 223 studies contained some original data, i.e., were applied studies. Over the 1990s, the number of studies undertaken in this area appears to be increasing year on year, and more of the studies are applicable to the USA than to all other countries combined. Most studies are peer reviewed, the main type of analysis is cost-consequence, and the interventions most often assessed are pharmaceutical and care services. Both the public and the private sectors sponsor many of these studies. However, only a fraction of these studies appear to accord with guidance for good economic evaluation. For example, when the search criteria were tightened to capture only those studies that consider both outcomes and costs, 173 studies were identified. Narrowing the search criteria to capture only those studies that were based on randomized controlled trial (RCT) or modeling data-the methods recommended by the US Panel and the National Institute of Clinical Excellence (NICE)-reduced the sample to 56 studies. With specific focus on those studies that evaluated pharmaceuticals, only the modeling approach appeared to show any compliance at all with another key recommendation of the existing guidance on methods; that of using outcome measures that are applicable to a long-term time horizon. Though modeling does offer certain advantages over RCTs (for example, a larger range of comparators can be more readily incorporated, long-term outcome measures can be more easily and inexpensively estimated), modeling results have less internal validity. Also, modeling in itself relies on good RCT data. Therefore, the results of economic evaluations should be interpreted with care, irrespective of whether they are principally based on RCT or model-based methods.

Diabetes Mellitus, Type 2↗

PubMed2001

Surgery for persistent otitis media with effusion: generalizability of results from the UK trial (TARGET). Trial of Alternative Regimens in Glue Ear Treatment.

TARGET (Trial of Alternative Regimens in Glue Ear Treatment) is a multicentre UK randomized controlled trial (RCT) comparing bilateral ventilation tubes with and without adjuvant adenoidectomy against non-surgical management in children with bilateral, persistent otitis media with effusion (OME). This paper compares the recruited and randomized children with those that, although eligible, were not included in the RCT for various reasons. This is necessary to identify any potential bias in the overall estimate of treatment effectiveness. At the first visit, 1315 children with OME satisfied the criteria of age (3 years 3 months-6 years 9 months), no previous ear or adenoid surgery, tympanometric evidence of fluid (bilateral B or B + C2) and a hearing loss (conductive loss in both ears of > or =20 dBHL). Of these children, 151 (11%) were not followed up because of overriding concern and 70 (5%) because of parental refusal. Of the 506 children eligible for randomization, because of persistence over 12 weeks of watchful waiting of bilateral OME with the same criteria, 20 (4%) were not randomized because of overriding concern and 75 (15%) because of parental refusal. The distribution of the potential effect modifiers was determined for each group. At the first visit, the only significant differences (P < 0.05), comparing those not recruited because of overriding concern with those recruited, were in respect of sex (61% girls compared with 52% boys) and hearing level (34.6 compared with 33.0 dBHL). At the second visit, the only significant difference involved less frequent upper respiratory tract infections (URTIs) in children whose parents refused to allow randomization (8% compared with 18% had had episodic URTI more often than once every 3 months). It is probable that the findings from the TARGET trial will translate to the entire clinic population in this age group as long as they meet the same audiometric and tympanometric criteria. The differences found can be handled by presentation of disaggregated results.

Adenoidectomy↗

PubMed2005

Plasma therapies in thrombotic syndromes.

BACKGROUND: Plasma therapies are being applied to thombotic syndromes, but there are limited controlled studies. OBJECTIVE: To review the evidence and the current practices for plasma therapies in thrombotic syndromes. METHODS: Expert-enhanced evidence-based analysis. Evidence obtained as of Dec 31, 2002 using PubMed electronic reference library and expert-obtained library for a total of > 3,000 references obtained using the terms plasma therapy or plasma exchange or plasmapheresis or plasmafiltration or sorbents each combined with the words thrombotic syndrome or sepsis or septic shock. The authors screened the abstracts, reviewed the agreed set of papers, and compiled the recommendations. RESULTS: Plasma therapies, which alter the plasma components in patients, have been applied in thrombotic syndromes worldwide. In these patients, there is a biologic plausibility for plasma therapies since they have molecules that are prothrombotic and/or antifibrinolytic which would put them at risk for microvascular thrombosis and end-organ damage. There are respectively one randomized controlled trial (RCT) in primary thrombotic syndrome, and secondary thrombotic syndrome, which showed an improvement in mortality in applying plasma therapies (plasma exchange by centrifugation). However, there are numerous non-randomized and case series. Plasma exchange is accepted as the standard therapy for primary thrombotic syndrome as in thrombotic thrombocytopenic purpura (TTP). However, no consensus has been reached for plasma exchange in secondary thrombotic syndromes such as in sepsis, hemolytic uremic syndrome (HUS), thrombocytopenia associated multiple organ failure, TTP/HUS, s/p bone marrow or solid organ transplant, HELLP syndrome, immunologic disorders, drug exposure, or pancreatitis. CONCLUSIONS: As we understand more about the pathophysiology of thrombotic syndromes, specific plasma therapies can be applied for the specific need of a particular patient population. There are sufficient preliminary data to recommend a definitive RCT to evaluate the efficacy of the different types of plasma therapies in secondary thrombotic syndromes.

Hemolytic-Uremic Syndrome↗

PubMed2006

A randomized, controlled trial of massage therapy as a treatment for migraine.

BACKGROUND: Migraine is a distressing disorder that is often triggered by stress and poor sleep. Only one randomized controlled trial (RCT) has assessed the effects of massage therapy on migraine experiences, which yielded some promising findings. PURPOSE: An RCT was designed to replicate and extend the earlier findings using a larger sample, additional stress-related indicators, and assessments past the final session to identify longer-term effects of massage therapy on stress and migraine experiences. METHODS: Migraine sufferers (N = 47) who were randomly assigned to massage or control conditions completed daily assessments of migraine experiences and sleep patterns for 13 weeks. Massage participants attended weekly massage sessions during Weeks 5 to 10. State anxiety, heart rates, and salivary cortisol were assessed before and after the sessions. Perceived stress and coping efficacy were assessed at Weeks 4, 10, and 13. RESULTS: Compared to control participants, massage participants exhibited greater improvements in migraine frequency and sleep quality during the intervention weeks and the 3 follow-up weeks. Trends for beneficial effects of massage therapy on perceived stress and coping efficacy were observed. During sessions, massage induced decreases in state anxiety, heart rate, and cortisol. CONCLUSIONS: The findings provide preliminary support for the utility of massage therapy as a nonpharmacologic treatment for individuals suffering from migraines.

Adaptation, Psychological↗

PubMed2003

The role of choice in health education intervention trials: a review and case study.

Although the randomized, controlled trial (RCT) is considered the gold standard in research for determining the efficacy of health education interventions, such trials may be vulnerable to "preference effects"; that is, differential outcomes depending on whether an individual is randomized to his or her preferred treatment. In this study, we review theoretical and empirical literature regarding designs that account for such effects in medical research, and consider the appropriateness of these designs to health education research. To illustrate the application of a preference design to health education research, we present analyses using process data from a mixed RCT/preference trial comparing two formats (Group or Self-Directed) of the "Women take PRIDE" heart disease management program. Results indicate that being able to choose one's program format did not significantly affect the decision to participate in the study. However, women who chose the Group format were over 4 times as likely to attend at least one class and were twice as likely to attend a greater number of classes than those who were randomized to the Group format. Several predictors of format preference were also identified, with important implications for targeting disease-management education to this population.

Aged↗

PubMed2000

Screening for lung cancer: do we need randomized trials?

In a scientifically ideal randomized controlled trial (RCT) on the efficacy of screening for lung cancer, screening-detected cases would be allocated to immediate intervention or to no action until symptoms lead to diagnostics. The study would provide for learning about the extent to which earlier interventions (defined by disease stage and stage-conditional tumor size) enhance curability, and also about the distributions of disease stage and stage-conditional tumor size at the time of diagnosis under the particular regimen of screening and its associated diagnostics. Because ethics call for randomization to screening or no screening, this contrast no longer provides for studying the curability function of shared concern for all regimens of screening; it addresses only the overall curability advantage specific to the regimen deployed. The same information that is provided by the scientifically ideal RCT is obtainable from a noncomparative study in which each member of the study cohort is subject to both screening and early intervention, so long as the problem of "overdiagnosis" is avoided by documenting growth before biopsy for cytologic or histologic criteria of malignancy and so long as the outcome of intervention is documented by follow-up. The ethically feasible RCT, in addition to compromising the objects of study, involves validity problems of its own and is less efficient by an order of magnitude.

Humans↗

PubMed2004

Randomization in controlled clinical trials: why the flip of a coin is so important.

The randomized controlled trial (RCT) is considered the highest level of medical evidence. In this brief overview, we discuss several key principles of the RCT. First, balance is paramount. Comparison groups must have similar proportions of participants with "important" prognostic and confounding factors. Randomization may or may not achieve this balance; if it does not, statistical adjustments should be used. Second, a statistical analysis should emphasize comparability and not mask dissimilarity. If the trial was indeed randomized, certain analysis techniques, such as an intention to treat analysis, should always be presented. Third, additional bias-reducing techniques, such as concealing treatment assignments from treating physicians and participants (i.e., masking) and using clearly defined exclusion and inclusion criteria, should be used wherever possible.

Humans↗

PubMed2005

Prospective randomized evaluation of emergency extracorporeal shock wave lithotripsy (ESWL) on the short-time outcome of symptomatic ureteral stones.

OBJECTIVE: Here, we report the results of a randomized controlled trial (RCT) assessing the efficacy of emergency ESWL (eESWL) on the short-term outcome of symptomatic ureteral stones. MATERIAL: The trial enrolled 100 patients admitted in emergency room for renal colic caused by a ureteral radioopaque [corrected] stone. Patients were randomized to medical therapy alone or combined with eESWL. eESWL was performed within 6 hours of the onset of renal colic without specific analgesia on a Lithostar lithotripter (Siemens Medical, Munich, Germany). The primary endpoints were the proportion of patients stone free rate after 48 hours (SF-48) and the cumulative proportion of patients discharged from the hospital after 48 and 72 hours. RESULTS: Ureteral stone's location was proximal and distal in respectively 46% and 54% of the patients; stone's mean size was 5.5 mm (range 2-10 mm). Median hospital stay was 3 days, ranging from 1 to 14 days. SF-48 in the control group varied from 76% for distal stones <5 mm to 28.6% for proximal stones >5 mm, averaging at 61%. On average, eESWL increased SF-48 by 13% (p: 0.126), the gain strictly depending on stone size and location. SF-48 increase ranged from 40% for proximal stones >5 mm to 1.8% for distal stone <5 mm. On average, eESWL increased the median duration of hospital stay by one day. This mean negative impact results from ESWL increasing significantly the duration of hospital stay in case of distal stone, while slightly shortened it for stones located proximally. CONCLUSION: This study demonstrated for the first time that rapidly performed ESWL is a valuable therapeutic option to improve elimination of ureteral stones and shorten duration of hospital stay, proven that the stone is located proximally to the iliac vessels.

Adult↗

PubMed2005

Single embryo transfer: a mini-review.

This paper provides a concise review of single embryo transfer (SET) in cycles using fresh embryos as well as in cycles using frozen-thawed embryos. Relevant studies were identified by a computerized search in PubMed for the period 1995-2004. The pregnancy rates, delivery rates and multiple pregnancy/birth rates were evaluated after fresh or frozen embryo transfer as well as cumulative delivery rates after fresh and frozen SET. The results of four randomized controlled trials (RCT) and seven observational studies using fresh embryo transfers are analysed. No RCT with SET in freezing-thawing cycles was identified, while one observational study was identified. The effects of a change in the rules from the National Board of Health and Welfare in Sweden in 2003 regarding the implementation of SET in Sweden are summarized.

Cryopreservation↗

PubMed1996

A randomized double-blind controlled trial of sulphasalazine combined with pulses of methylprednisolone or placebo in the treatment of rheumatoid arthritis.

Thirty-eight patients with rheumatoid arthritis meeting American College of Rheumatism (ACR) criteria were entered in a randomized controlled trial (RCT) of 6 months to assess whether monthly treatment with i.v. methylprednisolone (MP) enhances or accelerates the efficacy of sulphasalazine (SSZ). All patients had failed at least one second-line agent and were randomized to receive SSZ (2g/day) and pulses of MP (5 mg/kg), or SSZ+ (2 g/day) and pulses of saline (SA). A single infusion of 2 h was carried out in both groups for a total of three times (0, 1 and 2 months). The two groups were comparable at baseline regarding their demographic and clinical characteristics. Disease activity was evaluated every 2 months by means of: (1) joint count; (2) morning stiffness; (3) grip strength; (4) visual analogue pain score; (5) health assessment questionnaire; and (6) erythrocyte sedimentation rate. All outcome measures improved significantly in both groups (P < 0.001). Evaluation at each follow-up visit showed no significant differences between the groups in any of the adverse effects attributable to SSZ therapy (one SA vs two MP). Adverse effects attributable to SA/MP therapy were rare and mild. We concluded that repeated pulses of MP during the first 3 months of treatment did not improve the efficacy of SSZ. Therefore, there is no justification for using MP in this way during the induction phase of SSZ therapy.

Adult↗