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Results for “Randomised Controlled Trial”

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PubMed1991

Randomised controlled trial of the effectiveness of a respiratory health worker in reducing impairment, disability, and handicap due to chronic airflow limitation.

A randomised controlled trial was undertaken to determine whether a respiratory health worker was effective in reducing the respiratory impairment, disability, and handicap experienced by patients with chronic airflow limitation attending a respiratory outpatient department. The 152 adults (aged 30-75 years) who participated had a prebronchodilator forced expiratory volume in one second (FEV1) below 60% predicted and no other disease. They were randomised to receive the care of a respiratory health worker or the normal services provided by the outpatient department. The respiratory health worker provided health education and symptom and treatment monitoring in liaison with primary care services. After one year there was little difference between the two groups in spirometric values (FEV1 and forced vital capacity before and after salbutamol 200 micrograms), disability (six minute walking distance and paced step test), and handicap (sickness impact profile, hospital anxiety and depression scale). Patients not looked after by the respiratory health worker were more likely to die (relative risk 2.9 (95% confidence limits 0.8, 10.2); when age and FEV1 were controlled for this risk increased to 5.5 (95% confidence limits 1.2, 24.5). Patients looked after by the respiratory health worker attended their general practitioner more frequently and were prescribed a greater range of drugs. This is the third study to have found limited measurable benefit in terms of morbidity from the intervention of a respiratory health worker. This may be due to the ability of such workers to keep frail patients alive.

Adult↗

PubMed2002

Acupuncture treatment during labour--a randomised controlled trial.

OBJECTIVE: To investigate acupuncture treatment during labour with regard to pain intensity, degree of relaxation and outcome of the delivery. DESIGN: Randomised controlled trial. SETTING: Delivery ward at a tertiary care centre hospital in Sweden. POPULATION: Ninety parturients who delivered during the period April 12, 1999 and June 4, 2000. METHODS: Forty-six parturients were randomised to receive acupuncture treatment during labour as a compliment, or an alternative, to conventional analgesia. MAIN OUTCOME MEASURES: Assessments of pain intensity and degree of relaxation during labour, together with evaluation of delivery outcome. RESULTS: Acupuncture treatment during labour significantly reduced the need of epidural analgesia (12% vs 22%, relative risk [RR] 0.52, 95% confidence interval [CI] 0.30 to 0.92). Parturients who received acupuncture assessed a significantly better degree of relaxation compared with the control group (mean difference -0.93, 95% CI -1.66 to -0.20). No negative effects of acupuncture given during labour were found in relation to delivery outcome. CONCLUSIONS: The results suggest that acupuncture could be a good alternative or complement to those parturients who seek an alternative to pharmacological analgesia in childbirth. Further trials with a larger number of patients are required to clarify if the main effect of acupuncture during labour is analgesic or relaxing.

Acupuncture Analgesia↗

PubMed2005

Exercises to prevent lower limb injuries in youth sports: cluster randomised controlled trial.

OBJECTIVE: To investigate the effect of a structured warm-up programme designed to reduce the incidence of knee and ankle injuries in young people participating in sports. DESIGN: Cluster randomised controlled trial with clubs as the unit of randomisation. SETTING: 120 team handball clubs from central and eastern Norway (61 clubs in the intervention group, 59 in the control group) followed for one league season (eight months). PARTICIPANTS: 1837 players aged 15-17 years; 958 players (808 female and 150 male) in the intervention group; 879 players (778 female and 101 male) in the control group. INTERVENTION: A structured warm-up programme to improve running, cutting, and landing technique as well as neuromuscular control, balance, and strength. MAIN OUTCOME MEASURE: The rate of acute injuries to the knee or ankle. RESULTS: During the season, 129 acute knee or ankle injuries occurred, 81 injuries in the control group (0.9 (SE 0.09) injuries per 1000 player hours; 0.3 (SE 0.17) in training v 5.3 (SE 0.06) during matches) and 48 injuries in the intervention group (0.5 (SE 0.11) injuries per 1000 player hours; 0.2 (SE 0.18) in training v 2.5 (SE 0.06) during matches). Fewer injured players were in the intervention group than in the control group (46 (4.8%) v (76 (8.6%); relative risk intervention group v control group 0.53, 95% confidence interval 0.35 to 0.81). CONCLUSION: A structured programme of warm-up exercises can prevent knee and ankle injuries in young people playing sports. Preventive training should therefore be introduced as an integral part of youth sports programmes.

Adolescent↗

PubMed1995

Randomised controlled trial of laparoscopic versus open repair of inguinal hernia: early results.

OBJECTIVE: To establish the safety, short term outcome, and theatre costs of transabdominal laparoscopic repair of inguinal hernia performed as day surgery. DESIGN: Randomised controlled trial. The control operation was the two layer modified Maloney darn. SETTING: Teaching hospital and district general hospital. SUBJECTS: 125 men randomised to laparoscopic or open repair of inguinal hernia. OUTCOME MEASURES: Morbidity, postoperative pain and use of analgesics, quality of life, and theatre costs. Outcome was assessed by questionnaires administered to patients daily for 10 days and at six weeks postoperatively and by outpatient review at six weeks. Return to normal activity was assessed by questionnaire at three months. RESULTS: One vascular complication (2%) occurred in the group that had open repair. Seven complications (12%) including vessel injury and early recurrence arose in the group that had laparoscopic repair (difference in complication rate 10% (95% confidence interval 4% to 18%; P = 0.02). Pain scores and quality of life assessed by the short form 36 showed a significant benefit to the group that had laparoscopic repair in the early postoperative period. Return to normal activity was not significantly different between the two groups. Total theatre costs were higher in the group that had laparoscopic repair (mean cost for laparoscopic repair 850 pounds (622 pounds to 1078 pounds); mean cost for open repair 268 pounds (245 pounds to 292 pounds)). CONCLUSIONS: Because of the greater complication rate and higher theatre costs for laparoscopic repair and the patient outcome preferences expressed, the results of larger trials of clinical and cost effectiveness using recurrence as the primary outcome measure should be known before laparoscopic herniorrhaphy is widely adopted.

Adult↗

PubMed1999

Intramuscular opioids for maternal pain relief in labour: a randomised controlled trial comparing pethidine with diamorphine.

OBJECTIVE: To compare the pain relief and side effects of intramuscular pethidine with intramuscular diamorphine in labour. DESIGN: Double-blind randomised controlled trial. SETTING: The labour ward in a UK teaching hospital. PARTICIPANTS: Sixty-nine nulliparous women and 64 multiparous women in labour who requested narcotic analgesia and remained undelivered one hour after trial entry. METHODS: Nulliparous women were randomised to receive either 150 mg intramuscular pethidine or 7.5 mg intramuscular diamorphine. Multiparous women were randomised to receive either 100 mg intramuscular pethidine or 5 mg intramuscular diamorphine. All participants received the anti-emetic prochloroperazine at the same time as the trial drugs. MAIN OUTCOME MEASURES: Maternal analgesia assessed by a visual analogue score and verbal scales of pain intensity and pain relief, maternal sedation and vomiting, neonatal outcome assessed by Apgar scores and the need for resuscitation. RESULTS: More women allocated to receiving pethidine than to diamorphine reported slight or no pain relief at 60 minutes after administration of these drugs (P = 0.03). This trend was repeated in most of the other measures for maternal analgesia. There was no difference in maternal sedation, but the incidence of vomiting within 60 minutes was lower for women who received diamorphine (P = 0.02). Pethidine was associated with lower Apgar scores at 1 minute (P < 0.05). CONCLUSION: Intramuscular diamorphine in labour appears to have some benefits, compared with intramuscular pethidine, but the trial was small and further research, particularly into alternative opioids and long term effects on the infants is still needed.

Analgesics, Opioid↗

PubMed2007

Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598].

OBJECTIVES: To evaluate the effectiveness of a decision aid for women with a breech presentation compared with usual care. DESIGN: Randomised controlled trial. SETTING: Tertiary obstetric hospitals offering external cephalic version (ECV). POPULATION: Women with a singleton pregnancy were diagnosed antenatally with a breech presentation at term, and were clinically eligible for ECV. METHODS: Women were randomised to either receive a decision aid about the management options for breech presentation in addition to usual care or to receive usual care only with standard counselling from their usual pregnancy care provider. The decision aid comprised a 24-page booklet supplemented by a 30-minute audio-CD and worksheet that was designed for women to take home and review with a partner. MAIN OUTCOME MEASURES: Decisional conflict (uncertainty), knowledge, anxiety and satisfaction with decision making, and were assessed using self-administered questionnaires. RESULTS: Compared with usual care, women reviewing the decision aid experienced significantly lower decisional conflict (mean difference -8.92; 95% CI -13.18, -4.66) and increased knowledge (mean difference 8.40; 95% CI 3.10, 13.71), were more likely to feel that they had enough information to make a decision (RR 1.30; 95% CI 1.14, 1.47), had no increase in anxiety and reported greater satisfaction with decision making and overall experience of pregnancy and childbirth. In contrast, 19% of women in the usual care group reported they would have made a different decision about their care. CONCLUSIONS: A decision aid is an effective and acceptable tool for pregnant women that provides an important adjunct to standard counselling for the management of breech presentation.

Adolescent↗

PubMed1999

Labour pain treated with cutaneous injections of sterile water: a randomised controlled trial.

OBJECTIVE: To evaluate the relief of pain in labour with subcutaneous and intracutaneous injections of sterile water, compared with placebo. DESIGN: Randomised controlled trial. SETTING: Labour ward with approximately 3000 deliveries annually in a suburban area near Gothenburg, Sweden. PARTICIPANTS: Ninety-nine pregnant women at term, requiring pain relief for severe lower back pain during the first stage of labour. The women were randomised to receive four injections of 0.1 mL sterile water (without salt) intracutaneously (n = 33), four injections of 0.5 mL sterile water subcutaneously (n = 33) or placebo treatment (n = 33). MAIN OUTCOME MEASURES: Reduction of labour pain measured by visual analogue scale. RESULTS: The median visual analogue scale pain score for labour pain was significantly lower compared with initial values in the two study groups and compared with placebo at 10 and 45 minutes after treatment. The median reductions in visual analogue scores after 10 minutes were 5.0 cm and 4.5 cm in the intracutaneous and subcutaneous injection groups, respectively; women in the placebo group scored a median reduction of 1.7 cm. After 45 minutes the median reductions in the visual analogue scores were 4.9 cm and 4.0 cm in the intracutaneous and subcutaneous injection groups, respectively, compared with 1.0 cm for women in the placebo group. No significant differences in analgesic effect or pain experienced during administration were found between the two study groups. CONCLUSION: The new subcutaneous method of administering sterile water, as well as the earlier described intracutaneous injection method, were effective for the relief of pain in labour.

Adult↗

PubMed1997

Feasibility and effects of nurse run clinics for patients with epilepsy in general practice: randomised controlled trial. Epilepsy Care Evaluation Group.

OBJECTIVE: To test the feasibility and effect of nurse run epilepsy clinics in primary care. DESIGN: A randomised controlled trial of nurse run clinics versus "usual care." SETTING: Six general practices in the South Thames region. SUBJECTS: 251 patients aged over 15 years who were taking anti-epileptic drugs or had a diagnosis of epilepsy and an attack in the past two years who met specified inclusion criteria and had responded to a questionnaire. MAIN OUTCOME MEASURES: Questionnaire responses and recording of key variables extracted from the clinical records before and after the intervention. RESULTS: 127 patients were randomised to a nurse run clinic, of whom 106 (83%) attended. The nurse wrote 28 letters to the general practitioners suggesting changes in epilepsy management. For this intervention group compared with the usual care group there was a highly significant improvement in the level of advice recorded as having been given on drug compliance, adverse drug effects, driving, alcohol intake, and self help groups. CONCLUSIONS: Nurse run clinics for patients with epilepsy were feasible and well attended. Such clinics can significantly improve the level of advice and drug management recorded.

Anticonvulsants↗

PubMed1998

Treatment of myofascial trigger-points with ultrasound combined with massage and exercise--a randomised controlled trial.

The effect of treatment with ultrasound, massage and exercises on myofascial trigger-points (MTrP) in the neck and shoulder was assessed in a randomised controlled trial. The outcome measures were pain at rest and on daily function (Visual Analogue Scale, VAS), analgesic usage, global preference and index of MTrP. Long-term effect for treatment and control groups was assessed after 6 months using a questionnaire. The patients were randomised to three groups. The first group was treated with ultrasound, massage and exercise (A), the second group with sham-ultrasound, massage and exercise (B), while the third group was a control group (C). The duration of the study was 6 weeks. Treatment was given twice a week from the second to the fifth week. The number and index of MTrPs were recorded at each treatment session in groups A and B but only at entry as well as end of study in group C. VAS and analgesic usage was recorded in all three groups throughout the study period. Six months after the last treatment session a questionnaire was send to the patients. A total of 67 patients were included. Nine patients dropped-out during the study, which left 58 patients that could be included in the final analysis. Twenty patients were randomised to group A, 18 to group B and 18 to group C. A significant reduction in index were found between treatment groups (A and B) and control group (C), but no difference between group A and B. VAS scores, analgesic usage or global preference showed no difference between group A, B or C. The patients in the group C were offered treatment (ultrasound, massage, exercise) after the 6 weeks treatment period. At the questionnaire after 6 month 44 (87%) of the 52 patients from all three groups who had treatment responded. Sixty-four percent answered that they had had good or some effects, 68 percent were still doing the exercise programme and 17 percent had received other forms of therapy after they had completed the study. No difference between groups given ultrasound or sham ultrasound were found. It is concluded that US give no pain reduction, but apparently massage and exercise reduces the number and intensity of MTrP. The impact of this reduction on neck and shoulder pain is weak.

Adolescent↗

PubMed2003

Long chain polyunsaturated fatty acid supplementation in infant formula and blood pressure in later childhood: follow up of a randomised controlled trial.

OBJECTIVE: To determine whether supplementation of infant formula milk with long chain polyunsaturated fatty acids (LCPUFAs) influences blood pressure in later childhood. DESIGN: Follow up of a multicentre, randomised controlled trial. SETTING: Four study centres in Europe. PARTICIPANTS: 147 formula fed children, with a reference group of 88 breastfed children. INTERVENTION: In the original trial newborn infants were randomised to be fed with a formula supplemented with LCPUFAs (n=111) or a formula without LCPUFAs but otherwise nutritionally similar (n=126). In the present follow up study the blood pressure of the children at age 6 years was measured. MAIN OUTCOME MEASURES: Systolic, diastolic, and mean blood pressure. RESULTS: 71 children in the LCPUFA supplementation group (64% of the original group) and 76 children in the non-supplementation group (60%) were enrolled into the follow up study. The LCPUFA group had significantly lower mean blood pressure (mean difference -3.0 mm Hg (95% confidence interval -5.4 mm Hg to -0.5 mm Hg)) and diastolic blood pressure (mean difference -3.6 mm Hg (-6.5 mm Hg to -0.6 mm Hg)) than the non-supplementation group. The diastolic pressure of the breastfed children (n=88 (63%)) was significantly lower than that of the non-supplemented formula group but did not differ from the LCPUFA formula group. CONCLUSIONS: Dietary supplementation with LCPUFAs during infancy is associated with lower blood pressure in later childhood. Blood pressure tends to track from childhood into adult life, so early exposure to dietary LCPUFAs may reduce cardiovascular risk in adulthood.

Blood Pressure↗

PubMed2006

A randomised controlled trial of the effect of continuous electronic physiological monitoring on the adverse event rate in high risk medical and surgical patients.

We conducted a randomised controlled trial of mandated five-channel physiological monitoring vs standard care, in acute medical and surgical wards in a single UK teaching hospital. In all, 402 high-risk medical and surgical patients were studied. The primary outcome was the proportion of patients experiencing one or more major adverse events, including urgent staff calls, changes to higher care levels, cardiac arrests or death, in 96 h following randomisation. Secondary outcomes were the proportion of patients requiring acute treatment changes, and the 30-day and hospital mortality. In the 96 h following randomisation, 113 (56%) patients in the monitored arm and 116 (58%) in the control arm (OR 0.94, 95% CI 0.63-1.40, p = 0.76) had a major event. An acute change in treatment was necessary in 107 (53%) monitored patients and 101 (50%) control patients (OR 0.55, 95% CI 0.87-1.29). Thirty-four (17%) monitored patients and 35 (17%) control patients died within 30 days. Thirteen patients in the control group received full five-channel monitoring at the request of the ward staff. We conclude that mandated electronic vital signs monitoring in high risk medical and surgical patients has no effect on adverse events or mortality.

Adult↗

PubMed1996

Does home visiting prevent childhood injury? A systematic review of randomised controlled trials.

OBJECTIVE: To quantify the effectiveness of home visiting programmes in the prevention of child injury and child abuse. DESIGN: Systematic review of 11 randomised controlled trials of home visiting programmes. Pooled odds ratios were estimated as an inverse variance weighted average of the study specific odds ratios. SETTING: Randomised trials that were available by April 1995. SUBJECTS: The trials comprised 3433 participants. RESULTS: Eight trials examined the effectiveness of home visiting in the prevention of childhood injury. The pooled odds ratio for the eight trials was 0.74 (95% confidence interval 0.60 to 0.92). Four studies examined the effect of home visiting on injury in the first year of life. The pooled odds ratio was 0.98 (0.62 to 1.53). Nine trials examined the effect of home visiting on the occurrence of suspected abuse, reported abuse, or out of home placement for child abuse. Because of the potential for bias in outcome reporting in these studies, pooled effect estimates were not calculated. CONCLUSIONS: Home visiting programmes have the potential to reduce significantly the rates of childhood injury. The problem of differential surveillance for child abuse between intervention and control groups precludes the use of reported abuse as a valid outcome measure in controlled trials of home visiting.

Child↗

PubMed2002

Suturing versus conservative management of lacerations of the hand: randomised controlled trial.

OBJECTIVE: To assess the difference in clinical outcome between lacerations of the hand closed with sutures and those treated conservatively. DESIGN: Randomised controlled trial. SETTING: Emergency department in a tertiary hospital. PARTICIPANTS: Consecutive patients presenting between 16 February and 30 November 2000 with uncomplicated lacerations of the hand (full thickness <2 cm; without tendon, joint, fracture, or nerve complications) who would normally require sutures. 154 patients were eligible, 58 refused, and 5 were missed; 91 patients with 95 lacerations were enrolled. INTERVENTION: Participants were randomised to suturing or conservative treatment. MAIN OUTCOME MEASURES: Primary outcome was cosmetic appearance after three months, rated on a previously validated visual analogue scale. Duration of treatment, pain during treatment, patients' assessment of their outcome, and the time for patients to resume normal activities were also measured. RESULTS: Participants treated with sutures and those treated conservatively did not differ significantly in the assessment of cosmetic appearance by independent blinded doctors after three months: 83 mm v 80 mm, (mean difference 3 (95% confidence interval -1 to 8) mm) on the visual analogue scale. The mean time to resume normal activities was the same in both groups (3.4 days). Patients treated conservatively had less pain (difference 18 (12 to 24) mm) and treatment time was 14 (10 to 18) min shorter. CONCLUSION: Similar cosmetic and functional outcomes result from either conservative treatment or suturing of small uncomplicated lacerations of the hand, but conservative treatment is faster and less painful.

Esthetics↗

PubMed2000

"Hospital at home" versus hospital care in patients with exacerbations of chronic obstructive pulmonary disease: prospective randomised controlled trial.

OBJECTIVES: To compare "hospital at home" and hospital care as an inpatient in acute exacerbations of chronic obstructive pulmonary disease. DESIGN: Prospective randomised controlled trial with three months' follow up. SETTING: University teaching hospital offering secondary care service to 350 000 patients. PATIENTS: Selected patients with an exacerbation of chronic obstructive pulmonary disease where hospital admission had been recommended after medical assessment. INTERVENTIONS: Nurse administered home care was provided as an alternative to inpatient admission. MAIN OUTCOME MEASURES: Readmission rates at two weeks and three months, changes in forced expiratory volume in one second (FEV(1)) from baseline at these times and mortality. RESULTS: 583 patients with chronic obstructive pulmonary disease referred for admission were assessed. 192 met the criteria for home care, and 42 refused to enter the trial. 100 were randomised to home care and 50 to hospital care. On admission, FEV(1) after use of a bronchodilator was 36.1% (95% confidence interval 2.4% to 69.8%) predicted in home care and 35.1% (6.3% to 63. 9%) predicted in hospital care. No significant difference was found in FEV(1 )after use of a bronchodilator at two weeks (42.6%, 3.4% to 81.8% versus 42.1%, 5.1% to 79.1%) or three months (41.5%, 8.2% to 74.8% versus 41.9%, 6.2% to 77.6%) between the groups. 37% of patients receiving home care and 34% receiving hospital care were readmitted at three months. No significant difference was found in mortality between the groups at three months (9% versus 8%). CONCLUSIONS: Hospital at home care is a practical alternative to emergency admission in selected patients with exacerbations of chronic obstructive pulmonary disease.

Aged↗

PubMed1994

Pregnancy outcomes in a randomised controlled trial of periconceptional multivitamin supplementation. Final report.

The effect of periconceptional multivitamin/trace element supplementation on pregnancy outcomes was evaluated in a randomised controlled trial. The final data-base included 5,502 females with confirmed pregnancy. A multivitamin including 0.8 mg folic acid or a trace element were supplemented for at least 28 days before conception and continuing for at least until the second missed menstrual period. Number of pregnancies, terminations of pregnancies, four types of fetal deaths, livebirths including low birth weight, preterm birth and sex ratio were analysed. Periconceptional multivitamin supplementation increased fertility (higher rates of cumulative conceptions and multiple births), had no significant effect on the rate of different groups of fetal deaths, low birth weight and preterm birth in singletons. This primary preventive method can reduce the occurrence and recurrence of neural-tube defects and had no other significant effect on pregnancy outcomes except multiple births.

Adult↗

PubMed2005

Patient preferences in randomised controlled trials: conceptual framework and implications for research.

Patient preferences have recently been highlighted as a potential threat to the validity of randomised controlled trials (RCTs). Although there have been significant methodological and statistical developments in relation to these issues, comparatively little attention has been paid to the development of a conceptual model concerning preferences and their effects on decision-making. This article describes the development of such a model, which was undertaken in parallel with a systematic review of the empirical data concerning preference effects. The model describes the concept of preference in terms of theoretical concepts from the psychological and economics literature, and describes a preliminary model of the development and operation of preferences in the context of RCTs. The paper then examines the implications of the model for informed consent and recruitment procedures. Key issues for future research are also outlined.

Clinical Trials as Topic↗

PubMed2005

Effect of iron supplementation on mental and motor development in children: systematic review of randomised controlled trials.

OBJECTIVE: To evaluate the effect of iron supplementation on mental and motor development in children through a systematic review of randomised controlled trials (RCTs). DATA SOURCES: Electronic databases, personal files, hand search of reviews, bibliographies of books, abstracts and proceedings of international conferences. REVIEW METHODS: RCTs with interventions that included oral or parenteral iron supplementation, fortified formula milk or cereals were evaluated. The outcomes studied were mental and motor development scores and various individual development tests employed, including Bayley mental and psychomotor development indices and intelligence quotient. RESULTS: The pooled estimate (random effects model) of mental development score standardised mean difference (SMD) was 0.30 (95% confidence interval (CI) 0.15 to 0.46, P<0.001; P<0.001 for heterogeneity). Initial anaemia and iron-deficiency anaemia were significant explanatory variables for heterogeneity. The pooled estimate of Bayley Mental Development Index (weighted mean difference) in younger children (<27 months old) was 0.95 (95% CI -0.56 to 2.46, P=0.22; P=0.016 for heterogeneity). For intelligence quotient scores (> or =8 years age), the pooled SMD was 0.41 (95% CI 0.20 to 0.62, P<0.001; P=0.07 for heterogeneity). There was no effect of iron supplementation on motor development score (SMD 0.09, 95% CI -0.08 to 0.26, P=0.28; P=0.028 for heterogeneity). CONCLUSIONS: Iron supplementation improves mental development score modestly. This effect is particularly apparent for intelligence tests above 7 years of age and in initially anaemic or iron-deficient anaemic subjects. There is no convincing evidence that iron treatment has an effect on mental development in children below 27 months of age or on motor development.

Adolescent↗

PubMed2005

Fluconazole versus itraconazole for antifungal prophylaxis in neutropenic patients with haematological malignancies: a meta-analysis of randomised-controlled trials.

Fluconazole and itraconazole are used as antifungal prophylaxis in neutropenic patients with haematological malignancies. A meta-analysis of randomised-controlled trials (RCTs) was performed in order to compare their safety and effectiveness in this population. Data were obtained from PubMed, Current Contents, Cochrane Central Register for Controlled Trials and references from relevant articles. Five RCTs were included in the analysis. Publication bias and statistically significant heterogeneity was not observed among the analysed studies. Fewer patients were withdrawn due to the development of adverse effects associated with fluconazole when compared with itraconazole [odds ratio (OR) = 0.27, 95% confidence interval (CI): 0.18-0.41]. On the contrary, prophylactic use of fluconazole resulted in significantly more fungal infections (documented and suspected infections combined, OR = 1.62, 95% CI: 1.06-2.48). There were no statistically significant differences regarding documented fungal infections (OR = 1.51, 95% CI: 0.97-2.35), invasive fungal infections (OR = 1.44, 95% CI: 0.96-2.17), overall mortality (OR = 0.89, 95% CI: 0.63-1.24) and mortality attributed by the authors to fungal infections (OR = 1.30, 95% CI: 0.75-2.25) between the two medications. These data suggest that, even though itraconazole is more effective than fluconazole in the prevention of fungal infections in neutropenic patients with haematological malignancies, the development of more adverse effects may limit its use.

Antifungal Agents↗