scholarly journals Ivermectin in combination with doxycycline for treating COVID-19 symptoms: a randomized trial

2021 ◽  
Vol 49 (5) ◽  
pp. 030006052110135
Author(s):  
Reaz Mahmud ◽  
Md. Mujibur Rahman ◽  
Iftikher Alam ◽  
Kazi Gias Uddin Ahmed ◽  
A.K.M. Humayon Kabir ◽  
...  
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Confidence Interval ◽  
Recovery Time ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Data Repository ◽  
Rt Pcr ◽  
Clinical Recovery ◽  
Number Of Patients

Objective We evaluated whether ivermectin combined with doxycycline reduced the clinical recovery time in adults with COVID-19 infection. Methods This was a randomized, blinded, placebo-controlled trial in patients with mild-to-moderate COVID-19 symptoms randomly assigned to treatment (n = 200) and placebo (n = 200) groups. The primary outcome was duration from treatment to clinical recovery. Secondary outcomes were disease progression and persistent COVID-19 positivity by RT-PCR. Results Among 556 screened patients, 400 were enrolled and 363 completed follow-up. The mean patient age was 40 years, and 59% were men. The median recovery time was 7 (4–10, treatment group) and 9 (5–12, placebo group) days (hazard ratio, 0.73; 95% confidence interval, 0.60–0.90). The number of patients with a ≤7-day recovery was 61% (treatment group) and 44% (placebo groups) (hazard ratio, 0.06; 95% confidence interval, 0.04–0.09). The proportion of patients who remained RT-PCR positive on day 14 and whose disease did not progress was significantly lower in the treatment group than in the placebo group. Conclusions Patients with mild-to-moderate COVID-19 infection treated with ivermectin plus doxycycline recovered earlier, were less likely to progress to more serious disease, and were more likely to be COVID-19 negative by RT-PCR on day 14. Trial Registration ClinicalTrials.gov Identifier: NCT04523831. Data Repository ID Dryad. doi:10.5061/dryad.qjq2bvqf6

Attenuation of the Preoperative Stress Response with Midazolam

2000 ◽  
Vol 93 (1) ◽  
pp. 141-147 ◽  
Author(s):  
Zeev N. Kain ◽  
Ferne Sevarino ◽  
Sharon Pincus ◽  
Gerianne M. Alexander ◽  
Shu Ming Wang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Global Health ◽  
Outpatient Surgery ◽  
Controlled Trial ◽  
Self Report ◽  
Anesthetic Technique ◽  
Double Blind ◽  
Clinical Recovery ◽  
Sf 36

Background Previously, effects of preoperative sedatives were assessed mainly with respect to preoperative outcomes such as anxiety and compliance. The purpose of this investigation was to evaluate the effects of preoperative sedatives on postoperative psychological and clinical recovery. Methods Patients undergoing general anesthesia and outpatient surgery were enrolled in a double-blind, randomized, placebo-controlled trial. Subjects (n = 55) were randomly assigned to receive either 5 mg intramuscular midazolam (n = 26) or a placebo injection (n = 29) at least 30 min before surgery. The anesthetic technique was controlled. Postoperative anxiety, pain, analgesic consumption, clinical recovery parameters, and global health (SF-36) were evaluated up to 1 month after surgery. Results Surgery length did not differ significantly between the treatment and placebo groups (118 +/- 45 min vs 129 +/- 53 min; P = NS). Throughout the first postoperative week, subjects in the treatment group reported a greater reduction in postoperative pain compared with subjects in the placebo group (F1,50= 3.5; P = 0.035). Moreover, at 1 week, ibuprofen use was reported by less subjects in the treatment group than in the placebo group (0% vs 17.2%; P = 0.026). Subjects in the treatment group also reported a greater reduction in postoperative anxiety throughout the follow-up period (F1,53 = 9.2; P = 0.04). However, global health indexes (SF-36) did not detect any significant differences between the two experimental groups (multivariate F1,45 = 0.44; P = 0.51). Conclusion Subjects treated with midazolam preoperatively self-report improved postoperative psychological and pain recovery. However, the clinical significance of these findings is unclear at the present time.

scholarly journals Zinc as Adjunct Therapy in Neonatal Sepsis

2020 ◽  
Vol 32 (2) ◽  
pp. 112-116
Author(s):  
Syed Mortaza Ali ◽  
Mujibul Hoque ◽  
Md Manajjir Ali ◽  
Md Noor Uddin Talukder ◽  
Tanjina Chowdhury
Keyword(s):  
Placebo Group ◽  
Neonatal Sepsis ◽  
Recovery Time ◽  
Controlled Trial ◽  
Feeding Tube ◽  
Zinc Homeostasis ◽  
Double Blind ◽  
Adjunct Therapy ◽  
Clinical Recovery ◽  
Pediatric Sepsis

Introduction:Altered zinc homeostasis is an important feature of pediatric sepsis, thus raising the possibility of zinc supplementation as a therapeutic strategy in neonatal sepsis, a major source of morbidity and mortality with few therapeutic options beyond antibiotics. Its objective was to find the role of zinc as adjunct therapy in neonatal sepsis. Materials and Methods: This prospective, randomized double blind placebo controlled trial was conducted in the Department of Paediatrics, Sylhet M A G Osmani Medical College, Sylhet, Bangladesh during January 2013 to December 2014. A total 288 neonates with neonatal sepsis were enrolled. Group allocation to either zinc or placebo group was done by lottery method. Each packet contained 5 mg dispersible zinc sulphate or placebo. One packet dissolved in 2.5 ml expressed breast milk was given orally or through feeding tube. Results: The age of the patients in zinc group and placebo group was 14.40 ± 6.49 days and 15.09 ± 7.18 days respectively. There were 49 (75.6%) male neonates and 16 (24.6%) female neonates in zinc group; while 50 (78.1%) neonates were male and 14 (21.9%) were female in placebo group. Clinical recovery was 61 (93.8%) and failure in 4 (6.2%) patients in zinc group; while clinical recovery was 59 (92.2%) and failure in 5 (7.8%) patients in placebo group. The mean clinical recovery time in zinc group was 104.20 ± 16.61 hours and that of control groups was 111.46 ± 19.43 hours. Conclusion: Oral zinc as adjunct therapy shortens the clinical recovery time. Medicine Today 2020 Vol.32(2): 112-116

Lithium vs valproate in the maintenance treatment of bipolar I disorder: A post- hoc analysis of a randomized double-blind placebo-controlled trial

2019 ◽  
Vol 54 (3) ◽  
pp. 298-307
Author(s):  
Mehar G Kang ◽  
Hong Qian ◽  
Kamyar Keramatian ◽  
Trisha Chakrabarty ◽  
Gayatri Saraf ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Atypical Antipsychotic ◽  
Maintenance Treatment ◽  
Atypical Antipsychotics ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Post Hoc

Objective: Lithium and valproate are commonly used either in monotherapy or in combination with atypical antipsychotics in maintenance treatment of bipolar I disorder; however, their comparative efficacy is not well understood. This study aimed to compare the efficacy of valproate and lithium on mood stability either in monotherapy or in combination with atypical antipsychotics. Methods: We performed a post hoc analysis using data from a 52-week randomized double-blind, placebo-controlled trial, that recruited 159 patients with recently remitted mania during treatment with lithium or valproate and adjunctive atypical antipsychotic therapy. Patients were randomized to discontinue adjunctive atypical antipsychotic at 0, 24 or 52 weeks. Results: No significant differences in efficacy were observed between valproate and lithium (hazard ratio: 0.99; 95% confidence interval: [0.66, 1.48]) in time to any mood event. Valproate with 24 weeks of atypical antipsychotic was significantly superior to valproate monotherapy in preventing any mood relapse (hazard ratio: 0.46; 95% confidence interval: [0.22, 0.97]) while lithium with 24 weeks of atypical antipsychotic was superior to lithium monotherapy in preventing mania (hazard ratio: 0.27; 95% confidence interval: [0.09, 0.85]) but not depression. Conclusion: Overall, this study did not find significant differences in efficacy between the two mood-stabilizing agents when used as monotherapy or in combination with atypical antipsychotics. However, study design and small sample size might have precluded from detecting an effect if true difference in efficacy existed. Further head-to-head investigations with stratified designs are needed to evaluate maintenance therapies.

Body Mass and Weekly Training Distance Influence the Pain and Injuries Experienced by Runners Using Minimalist Shoes: A Randomized Controlled Trial

2017 ◽  
Vol 45 (5) ◽  
pp. 1162-1170 ◽  
Author(s):  
Joel T. Fuller ◽  
Dominic Thewlis ◽  
Jonathan D. Buckley ◽  
Nicholas A.T. Brown ◽  
Joseph Hamill ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Body Mass ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Level Of Evidence ◽  
Safe Alternative ◽  
Visual Analog Scales ◽  
Weekly Training ◽  
Running Shoes ◽  
Clinical Trials Registry

Background: Minimalist shoes have been popularized as a safe alternative to conventional running shoes. However, a paucity of research is available investigating the longer-term safety of minimalist shoes. Purpose: To compare running-related pain and injury between minimalist and conventional shoes in trained runners and to investigate interactions between shoe type, body mass, and weekly training distance. Study Design: Randomized clinical trial; Level of evidence, 2. Methods: Sixty-one trained, habitual rearfoot footfall runners (mean ± SD: body mass, 74.6 ± 9.3 kg; weekly training distance, 25 ± 14 km) were randomly allocated to either minimalist or conventional shoes. Runners gradually increased the time spent running in their allocated shoes over 26 weeks. Running-related pain intensity was measured weekly by use of 100-mm visual analog scales. Time to first running-related injury was also assessed. Results: Interactions were found between shoe type and weekly training distance for weekly running-related pain; greater pain was experienced with minimalist shoes ( P < .05), and clinically meaningful increases (>10 mm) were noted when the weekly training distance was more than 35 km/wk. Eleven of 30 runners sustained an injury in conventional shoes compared with 16 of 31 runners in minimalist shoes (hazard ratio, 1.64; 95% confidence interval, 0.63-4.27; P = .31). A shoe × body mass interaction was found for time to first running-related injury ( P = .01). For runners using minimalist shoes, relative to runners using conventional shoes, the risk of sustaining an injury became more likely with increasing body mass above 71.4 kg, and the risk was moderately increased (hazard ratio, 2.00; 95% confidence interval, 1.10-3.66; P = .02) for runners using minimalist shoes who had a body mass of 85.7 kg. Conclusions: Runners should limit weekly training distance in minimalist shoes to avoid running-related pain. Heavier runners are at greater risk of injury when running in minimalist shoes. Registration: Australian New Zealand Clinical Trials Registry (ACTRN12613000642785).

Cinnarizine and sodium valproate as the preventive agents of pediatric migraine: A randomized double-blind placebo-controlled trial

Cephalalgia ◽  
2019 ◽  
Vol 40 (7) ◽  
pp. 665-674
Author(s):  
Man Amanat ◽  
Mansoureh Togha ◽  
Elmira Agah ◽  
Mahtab Ramezani ◽  
Ali Reza Tavasoli ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Effects ◽  
Confidence Interval ◽  
Children And Adolescents ◽  
Sodium Valproate ◽  
Medical Center ◽  
Controlled Trial ◽  
Migraine Prophylaxis ◽  
Double Blind ◽  
Double Blind Placebo

Background Few migraine preventive agents have been assessed in a pediatric population. We evaluated the safety and efficacy of cinnarizine and sodium valproate for migraine prophylaxis in children and adolescents. Methods We carried out a randomized double-blind placebo-controlled trial in the Children’s Medical Center and Sina hospital, Tehran, Iran. Eligible participants were randomly assigned in 1:1:1 ratio via interactive web response system to receive either cinnarizine, sodium valproate, or placebo. The primary endpoints were the mean change in frequency and intensity of migraine attacks from baseline to the last 4 weeks of trial. The secondary endpoint was the efficacy of each drug in the prevention of migraine. The drug was considered effective if it decreased migraine frequency by more than 50% in the double-blind phase compared with the baseline. Safety endpoint was adverse effects that were reported by children or their parents. Results A total of 158 children participated. The frequency of migraine attacks significantly reduced compared to baseline in cinnarizine (difference: −8.0; 95% confidence interval (CI): −9.3 to −6.6), sodium valproate (difference: −8.3; 95% confidence interval: −9.3 to −7.2), and placebo (difference: −4.4; 95% confidence interval: −5.4 to −3.4) arms. The decrease was statistically greater in cinnarizine (difference: −3.6; 95% confidence interval: −5.5 to −1.6) and sodium valproate (difference: −3.9; 95% confidence interval: −5.8 to −1.9) arms, compared to placebo group. Children in all groups had significant reduction in intensity of episodes compared to baseline (cinnarizine: −4.6; 95% confidence interval: −5.2 to −4.0; sodium valproate: −4.0; 95% confidence interval: −4.8 to −3.3; placebo: −2.6; 95% confidence interval: −3.4 to −1.8). The decrease was statistically greater in cinnarizine (difference: −2.0; 95% confidence interval: −3.2 to −0.8) and sodium valproate (difference: −1.5; 95% confidence interval: −2.7 to −0.3) arms, compared to the placebo group. Seventy-one percent of individuals in the cinnarizine group, 66% of cases in the sodium valproate group, and 42% of people in the placebo arm reported more than 50% reduction in episodes at the end of the trial. The odds ratio for >50% responder rate was 3.5 (98.3% confidence interval: 1.3 to 9.3) for cinnarizine versus placebo and 2.7 (98.3% confidence interval: 1.0 to 6.9) for sodium valproate versus placebo. Nine individuals reported adverse effects (three in cinnarizine, five in sodium valproate, and one in the placebo group) and one case in the sodium valproate group discontinued the therapy due to severe sedation. Conclusion Cinnarizine and sodium valproate could be useful in migraine prophylaxis in children and adolescents. Trial registration: IRCT201206306907N4.

scholarly journals Propofol and Midazolam versus Propofol Alone for Sedation following Coronary Artery Bypass Grafting: A Randomized, Placebo-controlled Trial

2002 ◽  
Vol 30 (2) ◽  
pp. 171-178 ◽  
Author(s):  
B. Walder ◽  
A. Borgeat ◽  
P. M. Suter ◽  
J. A. Romand
Keyword(s):  
Mechanical Ventilation ◽  
Placebo Group ◽  
Low Dose ◽  
Controlled Trial ◽  
Artery Bypass ◽  
Bypass Grafting ◽  
Cumulative Number ◽  
Intention To Treat ◽  
Midazolam Group ◽  
Number Of Patients

The aim was to compare the efficacy and side-effects of propofol combined with a constant, low dose of midazolam versus propofol alone for sedation. In a prospective, randomized and double-blinded study, 60 male patients scheduled for elective coronary bypass grafting were enrolled. Postoperatively, patients were stratified to receive either a continuous intravenous infusion of midazolam 1 mg/h or placebo. Target Ramsay sedation score was 3 to 5 corresponding to conscious sedation. An intention-to-treat design for propofol was performed to reach target sedation. Efficacy of sedation was statistically significantly higher in the group midazolam+intention-to-treat with propofol compared with the group placebo+intention-to-treat with propofol (91% vs 79%; P=0.0005). Nine of 27 patients in the midazolam group (33.4%) and nine of 26 patients in the placebo group (34.6%) needed no supplementary propofol. Weaning time from mechanical ventilation was longer in the midazolam group whether or not they required supplemental propofol when compared with placebo group (all: 432±218 min vs 319±223 min; P=0.04; supplementary propofol: 424±234 min vs 265±175 min; P=0.03). The cumulative number of patients remaining intubated was significantly higher in the group midazolam+propofol compared with the group placebo+propofol (P=0.03). In conclusion, target sedation is reached slightly more often by the co-administration of propofol and a low dose of midazolam, but weaning time from mechanical ventilation is prolonged by the co-administration of propofol and a low dose of midazolam.

Severe Acute Kidney Injury and Mortality in Extremely Low Gestational Age Neonates

2021 ◽  
Vol 16 (6) ◽  
pp. 862-869
Author(s):  
Sangeeta Hingorani ◽  
Robert H. Schmicker ◽  
Patrick D. Brophy ◽  
Patrick J. Heagerty ◽  
Sandra E. Juul ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Gestational Age ◽  
Regression Models ◽  
Cox Regression ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Time Dependent ◽  
Recombinant Erythropoietin ◽  
The Relationship ◽  
Extremely Low Gestational Age

Background and objectivesAKI is associated with poor short- and long-term outcomes. Questions remain about the frequency and timing of AKI, and whether AKI is a cause of death in extremely low gestational age neonates.Design, setting, participants, & measurementsThe Recombinant Erythropoietin for Protection of Infant Kidney Disease Study examines the kidney outcomes of extremely low gestational age neonates enrolled in the Preterm Epo Neuroprotection study, a randomized, placebo-controlled trial of recombinant human erythropoietin. We included 900 of 941 patients enrolled in Preterm Epo Neuroprotection. Baseline characteristics were compared by primary exposure (severe AKI versus none/stage 1 AKI) using unadjusted logistic regression models. Cox regression models estimated the relationship between severe AKI and death after adjustment for potential confounders. Time-dependent AKI was modeled as a binary outcome and a categorical variable by stage of AKI. We fit Cox models using time-dependent AKI status lagged by <7 days before death. Landmark analyses examined the relationship of death with development of severe AKI.ResultsSevere AKI occurred in 168 of 900 (19%, 95% confidence interval, 17% to 20%) neonates, and stage 3 AKI occurred in 60 (7%, 95% confidence interval, 5% to 8%). Stage 3 AKI occurring 7 days before death (hazard ratio, 3.88; 95% confidence interval, 1.26 to 11.96), intraventricular hemorrhage (hazard ratio, 2.01; 95% confidence interval, 1.01 to 3.99) and sepsis (hazard ratio, 2.85; 95% confidence interval, 1.12 to 7.22) were all independently associated with death. Severe AKI occurring 7 days before death (hazard ratio, 2.21; 95% confidence interval, 0.92 to 5.26) was associated with death but not statistically significant. In a landmark analysis, after adjusting for potential confounders, late (after day 14 and before day 28) severe AKI was strongly associated with higher hazard of death (hazard ratio, 4.57; 95% confidence interval, 1.82 to 11.5).ConclusionsSevere AKI occurs frequently in extremely low gestational age neonates. Stage 3 AKI is associated with mortality, and this association is present 7 days before death.

scholarly journals AYUSH-64 as an adjunct to Standard Care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India

2021 ◽  
Author(s):  
Harbans Singh ◽  
Sumit Shrivastva ◽  
Babita Yadav ◽  
Amit Kumar Rai ◽  
Sophia Jameela ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Inflammatory Markers ◽  
Standard Care ◽  
Controlled Trial ◽  
Control Group ◽  
Rt Pcr ◽  
Open Label ◽  
Clinical Recovery ◽  
Randomized Controlled ◽  
Significant Difference

Background: There is limited evidence on the safety and efficacy of administering Ayurveda interventions as add-on to the standard care for COVID-19. Objective: To explore the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in the management of mild to moderate stage COVID-19.Design, setting, participants and interventions: This was an open-label randomized controlled trial with 80 patients of mild to moderate stage COVID-19. Participants in the AYUSH-64 add-on group received two tablets (500 mg each) three times daily for 30 days along with conventional standard care (Paracetamol, Cetirizine, Vitamin C, and Azithromycin). The control group received standard care alone. Main outcome measures: The primary outcome assessed was the proportion of participants with clinical recovery and negative RT-PCR assay for COVID-19 on day 7, 15, 23, and 30. Additionally, change in pro-inflammatory markers, metabolic functions, HRCT chest and incidence of Adverse Drug Reaction (ADR) / Serious Adverse Event (SAE) were assessed.Results: Statistically significant difference was observed in the proportion of participants with clinical recovery in the AYUSH-64 add-on group (p&lt;0.001) at each of the scheduled follow-up visits. All the participants in the AYUSH-64 add-on group clinically recovered by day 23 compared to 32.4 per cent in the control group. The mean duration for clinical recovery in AYUSH-64 add-on group (5.8 ± 2.67 days) was less as compared to control group (10.0 ± 4.06 days). The proportion of participants who turned RT-PCR negative for COVID-19 on day 7, 15, and 23 were 81.8, 94.5, and 100 per cent in AYUSH-64 add-on group, and 79.4, 94.5, and 97.2 per cent in control group, however, the difference observed was statistically not significant (p=0.314). The proportion of participants with improvement in HRCT chest was statistically significant in AYUSH-64 add-on group (p=0.031) unlike in control group (p=0.210). Similar reductions in most inflammatory markers measured (IL-6, CRP, Serum ferritin, and LDH) on day 30 (p&lt;0.05) were observed in both groups. Conclusion: AYUSH-64 as adjunct to standard conventional care is safe and hastens clinical recovery in adult patients with mild to moderate COVID-19.

scholarly journals Botulinum Toxin Therapy for Managing Sleep Bruxism: A Randomized and Placebo—Controlled Trial

Toxins ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 168
Author(s):  
Young Joo Shim ◽  
Hee Jin Lee ◽  
Keun Jeong Park ◽  
Hyung Tack Kim ◽  
Il Hee Hong ◽  
...  
Keyword(s):  
Placebo Group ◽  
Botulinum Toxin ◽  
Treatment Group ◽  
Masseter Muscle ◽  
Controlled Trial ◽  
Group Interaction ◽  
Sleep Bruxism ◽  
Peak Amplitude ◽  
Significant Time ◽  
Botulinum Toxin Therapy

The purpose of this study is to evaluate the effects of botulinum toxin type A (BoNT-A) for managing sleep bruxism (SB) in a randomized, placebo-controlled trial. Thirty SB subjects were randomly assigned into two groups evenly. The placebo group received saline injections into each masseter muscle, and the treatment group received BoNT-A injections into each masseter muscle. Audio–video–polysomnographic recordings in the sleep laboratory were made before, at four weeks after, and at 12 weeks after injection. Sleep and SB parameters were scored according to the diagnostic and coding manual of American Academy of Sleep Medicine. The change of sleep and SB parameters were investigated using repeated measures analysis of variance (RM-ANOVA). Twenty-three subjects completed the study (placebo group 10, treatment group 13). None of the SB episode variables showed a significant time and group interaction (p > 0.05) except for electromyography (EMG) variables. The peak amplitude of EMG bursts during SB showed a significant time and group interaction (p = 0.001). The injection decreased the peak amplitude of EMG bursts during SB only in the treatment group for 12 weeks (p < 0.0001). A single BoNT-A injection cannot reduce the genesis of SB. However, it can be an effective management option for SB by reducing the intensity of the masseter muscle.

Long-term cure after complete resection and adjuvant immunotherapy for distant melanoma metastases.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8534-8534
Author(s):  
Donald L. Morton ◽  
Nicola Mozzillo ◽  
Mohammed Kashani-Sabet ◽  
John F Thompson ◽  
Mark C. Kelley ◽  
...  
Keyword(s):  
Placebo Group ◽  
Confidence Interval ◽  
Skin Test ◽  
Group Versus ◽  
Stage Iv ◽  
Complete Resection ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Stage Iv Melanoma

8534 Background: In phase II trials, postoperative therapy with Canvaxin allogeneic melanoma cell vaccine plus Bacillus Calmette-Guerin (BCG) improved the survival of patients with stage IV melanoma. A multicenter, phase III placebo-controlled study was undertaken to investigate the vaccine’s efficacy. Methods: After complete resection of melanoma involving up to 5 distant sites, patients were randomized to treatment with BCG plus Canvaxin (BCG-Canvaxin) or BCG plus placebo (BCG-placebo). The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS) and skin test responsiveness to the study agent. Results: Between May 1998 and April 2005, 496 patients were randomized. In April 2005, entry to the study was terminated due to low probability of demonstrating treatment differences. However, 256 patients from sites enrolled in a follow-up study were monitored until March 2010. Median OS and 5-year and 10-year rates of OS were 39.1 months, 43.3% and 33.3%, respectively, in the BCG-placebo group, versus 34.9 months, 42.5% and 36.4%, respectively, in the BCG-Canvaxin group (hazard ratio, 1.053; 95% confidence interval, 0.81 to 1.36; p=0.6964). Median DFS, 5-year DFS, and 10-year DFS were 7.6 months, 23.8% and 21.7%, respectively, for the BCG-placebo group, versus 8.5 months, 30.0%, and 30.0%, respectively, for the BCG-Canvaxin group (hazard ratio, 0.882; 95% confidence interval, 0.708 to 1.097; p=0.2595). Positive skin test results correlated with improved survival. Conclusions: BCG-Canvaxin was not superior to BCG-placebo, but the highly favorable long-term survival for combined groups indicates that complete metastasectomy should be considered as initial therapy for patients with resectable stage IV melanoma (ClinicalTrials.gov identifier: NCT00052156).

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