Non-placebo Controlled Trial Research Articles

The efficacy of trazodone in reducing stress related behaviours in hospitalised dogs or dogs confined postsurgery

Clinical bottom line Category of research Treatment. Number and type of study designs reviewed Three papers were critically reviewed. One was a prospective, randomised, blinded observational study, another was a randomised, placebo-controlled clinical trial, and the last was a non-randomised prospective, open-label clinical trial. Strength of evidence Weak. Outcomes reported The administration of trazodone to hospitalised dogs reduced several observed stress related behaviours compared to a control group that was environmentally matched to the treatment group (Gilbert-Gregory et al., 2016). In dogs subjected to postsurgical confinement at home, trazodone administration was not more effective at reducing stress related behaviours compared with a placebo in one study (Gruen et al., 2017); however, it was effective when observed in a non-placebo controlled clinical trial (Gruen et al., 2014). Further investigation with a larger sample size would assist in strengthening the evidence of an association between trazodone administration and a reduction in the behavioural signs of stress in dogs. Conclusion The available evidence weakly supports the hypothesis that administration of trazodone is an effective treatment in reducing stress related behaviours in hospitalised dogs and dogs confined post-surgery, and further studies are required to confirm its efficacy. The quality of the evidence when hospitalised dogs was studied was moderate (Gilbert-Gregory et al., 2016), however in dogs studied that were confined postsurgery, the evidence is weaker (Gruen et al., 2014; Gruen et al., 2017). Different trazodone doses were evaluated in the studies and so further studies focusing on dose effects are required to determine appropriate dose rates. Further studies also need to be conducted to evaluate the appropriate length of time that trazodone should be given prior to a stressful event, as well as whether trazodone needs to be used in conjunction with other anxiolytic drugs to optimise efficacy. How to apply this evidence in practice The application of evidence into practice should take into account multiple factors, not limited to: individual clinical expertise, patient’s circumstances and owners’ values, country, location or clinic where you work, the individual case in front of you, the availability of therapies and resources. Knowledge Summaries are a resource to help reinforce or inform decision making. They do not override the responsibility or judgement of the practitioner to do what is best for the animal in their care.

Bortezomib in antibody-mediated autoimmune diseases (TAVAB): study protocol for a unicentric, non-randomised, non-placebo controlled trial

IntroductionThe clinical characteristics of autoantibody-mediated autoimmune diseases are diverse. Yet, medical treatment and the associated complications are similar, that is, the occurrence of long-term side effects and the problem that...

Inhaled corticosteroids for bronchiectasis.

Bronchiectasis is being increasingly diagnosed and recognised as an important contributor to chronic lung disease in both adults and children in high- and low-income countries. It is characterised by irreversible dilatation of airways and is generally associated with airway inflammation and chronic bacterial infection. Medical management largely aims to reduce morbidity by controlling the symptoms, reduce exacerbation frequency, improve quality of life and prevent the progression of bronchiectasis. This is an update of a review first published in 2000. To evaluate the efficacy and safety of inhaled corticosteroids (ICS) in children and adults with stable state bronchiectasis, specifically to assess whether the use of ICS: (1) reduces the severity and frequency of acute respiratory exacerbations; or (2) affects long-term pulmonary function decline. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Register of trials, MEDLINE and Embase databases. We ran the latest literature search in June 2017. All randomised controlled trials (RCTs) comparing ICS with a placebo or no medication. We included children and adults with clinical or radiographic evidence of bronchiectasis, but excluded people with cystic fibrosis. We reviewed search results against predetermined criteria for inclusion. In this update, two independent review authors assessed methodological quality and risk of bias in trials using established criteria and extracted data using standard pro forma. We analysed treatment as 'treatment received' and performed sensitivity analyses. The review included seven studies, involving 380 adults. Of the 380 randomised participants, 348 completed the studies.Due to differences in outcomes reported among the seven studies, we could only perform limited meta-analysis for both the short-term ICS use (6 months or less) and the longer-term ICS use (> 6 months).During stable state in the short-term group (ICS for 6 months or less), based on the two studies from which data could be included, there were no significant differences from baseline values in the forced expiratory volume in the first second (FEV1) at the end of the study (mean difference (MD) -0.09, 95% confidence interval (CI) -0.26 to 0.09) and forced vital capacity (FVC) (MD 0.01 L, 95% CI -0.16 to 0.17) in adults on ICS (compared to no ICS). Similarly, we did not find any significant difference in the average exacerbation frequency (MD 0.09, 95% CI -0.61 to 0.79) or health-related quality of life (HRQoL) total scores in adults on ICS when compared with no ICS, though data available were limited. Based on a single non-placebo controlled study from which we could not extract clinical data, there was marginal, though statistically significant improvement in sputum volume and dyspnoea scores on ICS.The single study on long-term outcomes (over 6 months) that examined lung function and other clinical outcomes, showed no significant effect of ICS on any of the outcomes. We could not draw any conclusion on adverse effects due to limited available data.Despite the authors of all seven studies stating they were double-blind, we judged one study (in the short duration ICS) as having a high risk of bias based on blinding, attrition and reporting of outcomes. The GRADE quality of evidence was low for all outcomes (due to non-placebo controlled trial, indirectness and imprecision with small numbers of participants and studies). This updated review indicates that there is insufficient evidence to support the routine use of ICS in adults with stable state bronchiectasis. Further, we cannot draw any conclusion for the use of ICS in adults during an acute exacerbation or in children (for any state), as there were no studies.

Montelukast for bronchiolitis obliterans syndrome after lung transplantation: A randomized controlled trial.

Bronchiolitis obliterans syndrome (BOS) remains the major problem which precludes long-term survival after lung transplantation. Previously, an open label pilot study from our group demonstrated a possible beneficial effect of montelukast in progressive BOS patients with low airway neutrophilia (<15%), and already on azithromycin treatment, in whom the further decline in pulmonary function was attenuated. This was, however, a non-randomized and non-placebo controlled trial. The study design is a single center, prospective, interventional, randomized, double blind, placebo-controlled trial, with a two arm parallel group design and an allocation ratio of 1:1. Randomization to additional montelukast (10 mg/day, n = 15) or placebo (n = 15) was performed from 2010 to 2014 at the University Hospitals Leuven (Leuven, Belgium) in all consecutive patients with late-onset (>2years posttransplant) BOS ≥1. Primary end-point was freedom from graft loss 1 year after randomization; secondary end-points were acute rejection, lymphocytic bronchiolitis, respiratory infection rate; and change in FEV1, airway and systemic inflammation during the study period. Graft loss at 1 y and 2y was similar in both groups (respectively p = 0. 981 and p = 0.230). Montelukast had no effect on lung function decline in the overall cohort. However, in a post-hoc subanalysis of BOS stage 1 patients, montelukast attenuated further decline of FEV1 during the study period, both in absolute (L) (p = 0.008) and % predicted value (p = 0.0180). A linear mixed model confirmed this association. Acute rejection, lymphocytic bronchiolitis, respiratory infections, systemic and airway inflammation were comparable between groups over the study period. This randomized controlled trial showed no additional survival benefit with montelukast compared to placebo, although the study was underpowered. The administration of montelukast was associated with an attenuation of the rate of FEV1 decline, however, only in recipients with late-onset BOS stage 1.

Treatment of restless legs syndrome/Willis-Ekbom disease with the non-selective ENT1/ENT2 inhibitor dipyridamole: testing the adenosine hypothesis

ObjectivesRecent animal models of restless legs syndrome (RLS) suggest that brain iron deficiency is associated with a hypoadenosinergic state, with downregulation of adenosine A1 receptors (A1R) in the striatum and cortex. We hypothesized that an increase in extracellular adenosine induced by inhibitors of adenosine transporters, such as the non-selective ENT1/ENT2 inhibitor dipyridamole, would result in an improvement in RLS symptoms. MethodsIn a prospective two-month open-label, non-placebo controlled clinical trial, 15 untreated idiopathic RLS patients began treatment with 100 mg dipyridamole (with uptitration to 400 mg if necessary). Multiple Suggested Immobilization Tests and polysomnography were performed at baseline and at eight weeks. Severity was assessed at four and eight weeks using the IRLS, and the CGI scales. The primary endpoint was therapeutic response (50% improvement in IRLS total score). ResultsThirteen patients completed the study. IRLS score improved from a mean (±S.D.) of 23.4 ± 4.6 at baseline to 10.7 ± 4.5 at eight weeks. Six out of 13 patients were full responders and four were partial responders. The mean (±S.D.) effective dose of dipyridamole at eight weeks was 281.8 ± 57.5 mg/day. Sleep variables also improved, and the mean (±S.D.) periodic leg movement index decreased from 26.7 ± 7.2 to 4.3 ± 1.9. Dipyridamole was generally well tolerated. Main side effects were abdominal cramps, diarrhea, dizziness, and flushing. ConclusionsThese preliminary results suggest that dipyridamole has significant therapeutic effects on both sensory and motor symptoms, as well as sleep. In addition, it provides evidence that hypoadenosinergic mechanisms play a central role in RLS. Classification of evidenceThe study provides class III evidence supporting the therapeutic effects of dipyridamole in RLS.

The Effects of Rhodiola rosea L. Extract on Anxiety, Stress, Cognition and Other Mood Symptoms.

This trial evaluated the impact of a Rhodiola rosea L. extract on self-reported anxiety, stress, cognition, and other mood symptoms. Eighty mildly anxious participants were randomized into two different groups of either Rhodiola rosea L (2 × 200 mg dose Vitano®, 1 tablet taken before breakfast and 1tablet before lunch) or a control condition (no treatment). Self-report measures and cognitive tests were completed at four testing sessions over a period of 14 days. Relative to the controls, the experimental group demonstrated a significant reduction in self-reported, anxiety, stress, anger, confusion and depression at 14 days and a significant improvements in total mood. No relevant differences in cognitive performance between the groups were observed. Rhodiola rosea L (Vitano®) presented a favourable safety tolerability profile. Although this was a non-placebo controlled trial, it is unlikely that the findings were the result of placebo effects as changes appeared gradual and were specific to certain psychological measures. However, we cannot determine a causal relationship; further investigations are recommended to support the effects of Rhodiola rosea L. extract on stress related symptoms.

A systematic review of post first-line treatments for advanced gastrointestinal stromal tumor (GIST): Direct pairwise meta-analyses and indirect comparisons.

195 Background: Treatment for metatastatic or unresectable GIST is with imatinib. The majority of patients eventually acquire imatinib resistance, prompting the development of a growing number of agents as post-first-line treatment. Currently no studies directly compare these treatments. Methods: A systematic review was performed through MEDLINE, EMBASE, CENTRAL, and ASCO meeting abstracts up to July 2014 to identify randomized controlled trials that included GIST patients who were previously treated with a first-line chemotherapy for advanced disease. Progression-free survival (PFS) and overall survival (OS) with 95% credible regions were extracted using the Parmar method. Direct pairwise meta-analyses and indirect comparisons using the Bucher method were performed. Results: Four studies were identified for the systematic review. 1 study (n=312) showed that sunitinib in the second-line setting (vs. placebo) improved PFS but not OS. 3 studies (n=528) examined the third-line setting (imatinib resumption vs. placebo; regorafenib vs. placebo; nilotinib vs. best supportive care with or without imatinib or sunitinib). Of the 3 third-line studies, there was significant heterogeneity between placebo-controlled trials and the non-placebo controlled trial (I2= 98%). Direct pairwise meta-analysis using random-effects of the 2 placebo-controlled studies showed that the PFS hazard ratio (HR) was 0.63 (0.22-0.61, p=0.0001), whereas the PFS HR for the non-placebo controlled study was 0.90 (0.65-1.26, p=0.56). These 2 HRs are different statistically (interaction: p=0.002). Indirect comparisons of imatinib resumption vs. regorafenib suggested that the PFS HR was 0.59 (0.31-1.11, p=0.10), trending in favor of regorafenib. OS HRs were not significant for direct or indirect comparison in the third-line setting. Conclusions: The number and size of completed phase III studies and the lack of a standard comparator arm limit the use of direct and indirect comparison methods to determine the best therapeutic option for patients who have progressed on imatinib. At this time, clinicians should interpret the available evidence at an individual level.

Allopurinol on Hypertension: Insufficient Evidence to Recommend

To the Editor: In the review “Effect of Allopurinol on Blood Pressure: A Systematic Review and Meta-Analysis,” the authors conclude that allopurinol and other xanthine oxidase inhibitors may be used as adjunctive antihypertensive agent. This meta-analysis was performed that included heterogeneous studies as well as trials with poor methodological quality, eg, Siu and colleagues (2006) (an open, nonplacebo-controlled trial including individuals with and without hypertension in which allopurinol decreased only systolic blood BP); Kanbay and colleagues (2007) (open, nonrandomized, nonplacebo-controlled study enrolling normotensive and hypertensive individuals); and Kanbay and colleagues (2011) (an open, nonplacebo-controlled trial including adults with normal blood pressure. Positive results of allopurinol were seen in decreasing systolic but not diastolic BP). Inclusion of these studies may have strengthened the BP-lowering effect of allopurinol. Furthermore, one can reasonably assume that several studies enrolling normotensive individuals are inadequate to support the conclusion that allopurinol may be used to treat hypertension. In the systematic review “Pharmacotherapy for Hyperuricemia in Hypertensive Patients” (Cochrane Database of Systematic Reviews), which has more rigorous entry criteria, the authors found that, to date, there is only one study designed to answer whether allopurinol treatment has a positive effect in reducing BP in hypertensive individuals. Feig and colleagues conducted a double-blind, placebo-controlled, crossover trial that randomized 30 adolescents (11–17 years), newly diagnosed with stage I primary hypertension and with serum uric acid >6 mg/dL, to receive allopurinol 200 mg twice daily for 4 weeks and placebo for 4 weeks with a 2-week washout period between treatments. Although it was a well-conducted study, it had a few limitations, as follows: small sample size; exclusion of more severe hypertensive individuals; short duration of treatment, not sufficient to detect adverse events associated with allopurinol or to evaluate whether the effect on BP is sustained after long-term therapy; and the reserved external validity, extending only to adolescents with mild new diagnosis of hypertension. Another concern is how clinicians might interpret the conclusion of this review. Treatment with allopurinol is not free of risks and interactions. Although rare, serious side effects can be associated with allopurinol therapy, such as fatal Stevens-Johnson syndrome and chronic interstitial nephritis. Therefore, increased incidence of side effects can be observed with the increased prescription of allopurinol. Thus, in light of current evidence, recommendation (or encouraging use) of allopurinol or other hypouricemic agent as initial or adjuvant treatment of hypertension is premature and more “RCTs” are needed.

Abstract withdrawn

Methods Changes from baseline to endpoint (last evaluable visit) in Asthma Control Questionnaire (ACQ) scores were assessed in subjects from 3 Phase III trials (low[n=746], medium[n=781], and high-dose [n=728] previous ICS use). The ACQ categorizes asthma symptoms and use of rescue-medication using a 7-point scale (0=totally controlled, 6=severely uncontrolled). In two placebo controlled trials, subjects were randomized to receive MF/F (100/10μg or 200/10μg), MF (100μg or 200μg), F (10μg), or placebo (26 weeks; all twice-daily [BID] via metereddose inhaler [MDI]); In a non-placebo controlled trial, subjects were randomized to receive MF/F 200/10μg, MF/F 400/10μg, or MF 400μg (12 weeks; all BID via MDI).

Pharmacotherapy of urolithiasis: evidence from clinical trials

Urolithiasis is a worldwide problem with significant health and economic burdens. Medical therapy that alters the course of stone disease has enormous medical and financial impact. Urolithiasis is a final manifestation of a broad range of etiologies and pathogenesis. The modest progress in understanding the pathophysiology has hampered successful development of targeted therapy. Current regimens are based mostly on rational alteration of urinary biochemistry and physical chemistry to lower the risk of precipitation. In terms of pharmacotherapy, there are drugs to successfully improve hypercalciuria, hypocitraturia, aciduria, hyperuricosuria, and hypercystinuria. These agents have been proven to be effective in randomized controlled trials in improving urinary biochemical and physicochemical risk factors, as well as clinical outcomes. Although our current regimens have clearly improved the management and lives of stone formers, there are still clearly identifiable immense voids in the knowledge of pathophysiology of stone disease that can be filled with combined basic science and clinical studies.

A Randomized, Single‐Blind Study of Lansoprazole for the Prevention of Exacerbations of Chronic Obstructive Pulmonary Disease in Older Patients

To investigate whether proton pump inhibitor (PPI) therapy reduces the frequency of common colds and exacerbations in patients with chronic obstructive pulmonary disease (COPD). Twelve-month, randomized, observer-blind, controlled trial. A university hospital and three city hospitals in Miyagi prefecture in Japan. One hundred patients with COPD (mean age +/- SD 74.9 +/- 8.2) participated. They were all ex-smokers and had received conventional therapies for COPD, including smoking cessation and bronchodilators. Patients with gastroesophageal reflux disease or gastroduodenal ulcer were excluded. Patients were randomly assigned to conventional therapies (control group) or conventional therapies plus PPI (lansoprazole 15 mg/d; PPI group) and observed for 12 months. Frequency of common colds and COPD exacerbations. The number of exacerbations per person in a year in the PPI group was significantly lower than that in the control group (0.34 +/- 0.72 vs 1.18 +/- 1.40; P<.001). The adjusted odds ratio with logistic regression for having exacerbation (> or =once/year) in the PPI group compared with the control group was 0.23 (P=.004). In contrast, there was no significant difference in the numbers of common colds per person per year between the PPI group and the control group (1.22 +/- 2.09 vs 2.04 +/- 3.07; P=.12). PPI therapy significantly reduced the risk of catching frequent common colds (> or =3 times/year), the adjusted odds ratio of which was 0.28 (P=.048). In this single-blind, nonplacebo-controlled trial, lansoprazole was associated with a significant decrease in COPD exacerbations. More definitive clinical trials are warranted.

Effect of white wine consumption on oxidative stress markers and homocysteine levels

The aim of this study was to assess the influence of regular daily consumption of white wine on oxidative stress and cardiovascular risk markers. Forty-two healthy male volunteers consumed 375 ml of white wine daily. Each participant provided three venous blood samples (before wine consumption, following the wine consumption period and again a month later). Levels of superoxide dismutase, glutathione peroxidase, reduced glutathione, total antioxidant capacity, total cholesterol, HDL-cholesterol, apolipoprotein A I, apolipoprotein B, triglycerides, paraoxonase 1, C-reactive protein, homocysteine, thiobarbituric acid reactive substances (TBARS) and advanced oxidation protein products (AOPP) were measured. Immediately following the month of white wine consumption there was a significant increase in HDL-cholesterol (p<0.0001), paraoxonase 1 (p<0.001), glutathione peroxidase (p<0.001) and reduced glutathione (p<0.01) levels, a decrease in superoxide dismutase activities (p<0.0001), and a decrease in oxidation protein products (p<0.001) and TBARS (p<0.05) concentrations. However, there was also a clear increase in homocysteine (p<0.0001) after a month of white wine consumption. The results of our non-placebo controlled trial suggest that regular daily white wine consumption is associated not only with both antioxidative and antiatherogenic effects but also with a potentially proatherogenic increase of homocysteine concentrations.

Impact of zinc supplementation in children with acute diarrhoea in Turkey

Objective: Zinc deficiency is prevalent in children in developing countries. Supplemental zinc provides therapeutic benefits in diarrhoea. Our aim was to evaluate the effect of daily zinc supplementation for 14...

Controlled withdrawal of selective serotonin reuptake inhibitors in elderly patients in nursing homes with no indication of depression—a commentary

Recent investigations performed by the Swedish National Board of Health and Welfare have indicated that as many as 40% of the elderly in nursing homes are on anti-depressive drugs, mainly modern selective serotonin reuptake inhibitors (SSRIs) such as citalopram and sertraline. These studies have also shown that in many cases SSRI treatment is administered without a correct indication, and therefore one quality indicator of medicine use in the elderly [1, 2] is the percentage of patients on SSRI treatment without a correct indication. Increasing the quality of medication in nursing homes is a humane, social, and medical priority and any study aimed at this goal should be encouraged. We have read with great interest an article published by Ulfvarson et al. [3]. The study—directed by Christer von Bahr—was an open, randomized, non-placebo controlled clinical trial aimed at investigating the effects of withdrawal of SSRIs in elderly nursing home patients with no documented diagnosis or symptoms of depression. Of a total of 350 patients on SSRI treatment from 11 nursing homes in the county of Stockholm, Sweden, 70 patients aged 75 years or older with no current depressive symptoms and no history of depression or anxiety and who were taking citalopram or sertraline for at least 6 months met the inclusion criteria and consented to participate. Patients were randomized to either intervention (withdrawal of SSRI) or the control group (no change in treatment). According to the authors, the main outcomes were standardized measures of depression, global functioning, and health. After 6 months of follow-up, the authors found no significant difference between the intervention and control groups in any outcome measure. The authors concluded that treatment with SSRIs in patients without major clinical depression or anxiety disorder is often unjustified and should be discontinued. The conclusion of this investigation seems to confirm the established indications for withdrawing SSRI treatment in elderly patients [1]. Unfortunately, the study contains so many flaws in both design and analysis, which make it an unacceptable source of evidence. The authors seem to be unaware on any guidelines for good clinical trial practice or recommendation for publication of clinical trials as the CONSORT statement, which is a relevant research tool to improve the quality of reports of randomized trials [http:// www.consort-statement.org/]. In general many aspects of the trial [2] lack transparency, which makes it difficult to understand how the trial was designed, conducted, and analyzed.

SRL172 (killed Mycobacterium vaccae) in addition to standard chemotherapy improves quality of life without affecting survival, in patients with advanced non-small-cell lung cancer: phase III results

BackgroundThis open-label, randomised phase III study was designed to further investigate the clinical activity and safety of SRL172 (killed Mycobacterium vaccae suspension) with chemotherapy in the treatment of non-small-cell lung cancer (NSCLC). Patients and methodsPatients were randomised to receive platinum-based chemotherapy, consisting ofup to six cycles of MVP (mitomycin, vinblastine and cisplatin or carboplatin) with (210 patients) or without (209 patients) monthly SRL172. ResultsThere was no statistical difference between the two groups in overall survival (primary efficacy end point) over the course of the study (median overall survival of 223 days versus 225 days; P = 0.65). However, a higher proportion of patients were alive at the end of the 15-week treatment phase in the chemotherapy plus SRL172 group (90%), than in the chemotherapy alone group (83%) (P = 0.061). At the end of the treatment phase, the response rate was 37% in the combined group and 33% in the chemotherapy alone group. Patients in the chemotherapy alone group had greater deterioration in their Global Health Status score (–14.3) than patients in the chemotherapy plus SRL172 group (–6.6) (P = 0.02). ConclusionIn this non-placebo controlled trial, SRL172 when added to standard cancer chemotherapy significantly improved patient quality of life without affecting overall survival times.

Use of Erythropoietin in Stable Preterm Infants (1000-1500 grams) to Reduce Erythrocyte Transfusions † 1374

Objective: Earlier studies have shown that erythropoietin (Epo) is beneficial in reducing erythrocyte transfusions given for symptomatic anemia among very low birth weight infants. The objective of this study was to determine if blood transfusions could be reduced using erythropoietin among stable preterm infants who are still at risk of donor blood exposure.Methods: A randomized, non-placebo controlled clinical trial was conducted on 28 preterm infants with birth weights ranging from 1000 to 1500 grams. Inclusion criteria also included being appropriately sized for gestational age and having an hematocrit ≥30% at study entry. Study infants were randomly assigned to receive Epo, 300 units/kg/day 3 times a week subcutaneously (n=13) or no treatment (n=15) starting at less than 2 weeks of age for 6 weeks. Criteria for transfusion was set by a standard protocol for both the treatment group and controls. Infants in both groups were supplemented with iron (Fer-In-Sol 0.3ml/day) beginning at 2 weeks of age. The dose of Fer-In-Sol was increased weekly by 0.3ml/day if serum ferritin level was noted to be less than 65.0ng/ml. The primary outcome variable was the total number and volume of transfusions given per group during the entire hospitalization. Results: Two infants required transfusions among the 13 Epo treated infants compared to 9 infants among the 15 control infants(p=0.02). The total number of transfusions given was 2 in the Epo group versus 18 in the controls (89% reduction, p=0.01). The total volume of transfusions given to the Epo group was 39 ml compared to 487 ml in the control group (92% reduction, p=0.007). We found no differences in the total white blood count, neutrophil count, platelet count, incidence of sepsis, necrotizing enterocolitis, seizures and hypertension between the groups. The mean hematocrit for the Epo group at 2 weeks into the study was 34.5±2.8 compared to 29.2±4.7 among controls (p=0.003). The mean hematocrit values at other study periods could not be meaningfully analysed because of transfusions given to control infants. Conclusions: These data suggest that use of Epo in stable preterm infants with birth weights of 1000 to 1500 grams is an effective means of reducing the need for transfusions.