Standard versus sequential anti-tubercular treatment in patients with tuberculous meningitis: a randomized controlled trial

2020 ◽  
Author(s):  
Usha Kant Misra ◽  
Mritunjai Kumar ◽  
Jayantee Kalita
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Mortality ◽  
Tuberculous Meningitis ◽  
Controlled Trial ◽  
Hospital Death ◽  
Inclusion Criteria ◽  
Open Label ◽  
Drug Induced ◽  
Standard Regimen ◽  
Randomized Controlled

Abstract Background To compare the safety and efficacy of sequential anti-tubercular treatment (ATT) regimen with the standard regimen in tuberculous meningitis (TBM). Methods This single-centre, open-label, parallel group randomized controlled trial was conducted from May 2017 to June 2019 in India. Treatment-naïve patients with TBM fulfilling the inclusion criteria were randomized to four drug ATT regimens (rifampicin, isoniazid, ethambutol and pyrazinamide) administered either simultaneously (standard arm) or one after another (sequential arm) in a 1 : 1 ratio. The primary endpoint was drug-induced hepatitis (DIH) and the secondary endpoints were in-hospital death and disability at 3 and 6 months using a modified Rankin Scale. Results A total of 97 patients with TBM were recruited; 15 did not meet the inclusion criteria and 2 refused to participate. The median age of the patients was 26 y (range 15–75) and 37 (46.2%) were males. The patients in the sequential arm had fewer cases of DIH (20% vs 42.5%; p=0.03). The patients in the sequential arm had lower in-hospital mortality (2.5% vs 17.5%; p=0.025) and better 6-month outcomes (25.0% vs 50.0%; p=0.02) compared with the standard arm. Conclusions Sequential ATT was associated with a lower frequency of DIH, lower in-hospital mortality and better 6-month outcome. Trial registration Clinical Trials Registry of India (ctri.nic.in) identifier: REF/2016/09/012214/CTRI/2017/10/010072.

scholarly journals Safety and efficacy of antiviral therapy alone or in combination in COVID-19 - a randomized controlled trial (SEV COVID Trial)

2021 ◽  
Author(s):  
◽  
Prasan Kumar Panda
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Treatment ◽  
Therapeutic Potential ◽  
Controlled Trial ◽  
Antiviral Treatment ◽  
Severe Disease ◽  
Open Label ◽  
Drug Induced ◽  
Randomized Controlled ◽  
Severe Group

Background Definitive antiviral treatment is not available for COVID-19 infection except remdesivir that even with many doubts. Various combination antivirals have been tried. Methods A single-center, open-label, parallel-arm, stratified randomized controlled trial evaluated the therapeutic potential of hydroxychloroquine and lopinavir-ritonavir in combination with ribavirin in COVID-19. Enrolled patients in severe category were randomized into three groups: A: standard treatment, B: hydroxychloroquine+ribavirin+standard treatment, or C: lopinavir+ritonavir+ribavirin+standard treatment; while non-severe category into two groups: A: standard treatment or B: hydroxychloroquine+ribavirin. Combination antivirals was given for 10 days and followed for 28 days. The primary endpoints were safety, symptomatic and laboratory recovery of organ dysfunctions, and time to SARS-CoV-2 RT-PCR negative report. Results Total 111 patients randomized: 24, 23, and 24 in severe category A, B, and C respectively, and 20 in each non-severe group. Two patients receiving ribavirin experienced drug induced liver injury and another developed QT prolongation after hydroxychloroquine. In the severe category, 47.6%, 55%, and 30.09% in A, B, and C groups respectively showed symptomatic recovery compared to 93.3% and 86.7% in A and B groups respectively in the non-severe category at 72hrs (P>0.05). Conclusions The results failed to show statistical superiority of the antiviral combination therapies to that of the standard therapy in both the severe and non-severe categories in symptomatic adult patients of COVID-19. However, results do indicate the benefit of non-standard interventional combination therapy in severe disease. Furthermore, the dose of ribavirin needs to be reconsidered in the Indian population.

scholarly journals The Effectiveness of Mometasone Spray and Triamcinolone Acetonide Gel in Preventing Sore Throat, Cough, and Hoarse after Intubation

2021 ◽  
Vol 2 (1) ◽  
pp. 135-147
Author(s):  
Zentika. I. Fajri ◽  
Fredi Heru Irwanto ◽  
A Miarta ◽  
Theodorus
Keyword(s):  
Randomized Controlled Trial ◽  
General Anesthesia ◽  
Sore Throat ◽  
Triamcinolone Acetonide ◽  
Endotracheal Intubation ◽  
Controlled Trial ◽  
Inclusion Criteria ◽  
Open Label ◽  
Randomized Controlled ◽  
Significant Difference

Background: Endotracheal intubation is a procedure performed by inserting an endotracheal tube into the airway. With endotracheal intubation, there can be several complications ranging from mild to severe. Sore throat, coughing, and hoarseness were several endotracheal intbation complications. From several studies, it was found that the incidence of POST was 21-65%. This study aimed to determine the efficacy between 0.1% triamcinolone acetonide gel and 100 mcg mometasone spray in reducing sore throat, cough, and hoarseness due to endotracheal intubation. Method: A Randomized Controlled Trial, Open-Label was carried out on patients undergoing endotracheal intubation with general anesthesia in RSMH operating room from September 2020 - November 2020. Seventy-two study subjects met the inclusion criteria and were divided into two groups, namely the triamcinolone acetonide gel group, and the mometasone spray group. Analyzing data was SPSS version 23. Result: There were no difference between age, sex, ASA PS classification, and length of operation between the two groups (p> 0.05). Mometasone spray 100 mcg and triamcinolone acetonide gel 0.1% had the same effectiveness to reduce endotracheal intubation such as sore throat, cough, and hoarseness within 24 hours of endotracheal intubation (p> 0.05). There was a significant difference in the incidence of sore throat between two groups in the first hour (p = 0.039). Conclusion: There was no statistically significant difference between the efficiency of mometasone spray 100 mcg and triamcinolone acetonide gel 0.1% on a sore throat, cough, and hoarseness within 24 hours of endotracheal intubation (p > 0.05).

scholarly journals The The Effectiveness of Early Mobilization Time on Balance and Functional Ability after Ischemic Stroke

2019 ◽  
Vol 7 (7) ◽  
pp. 1088-1092
Author(s):  
Umi Budi Rahayu ◽  
Samekto Wibowo ◽  
Ismail Setyopranoto
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Functional Ability ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Berg Balance Scale ◽  
Early Mobilisation ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
Significant Difference

BACKGROUND: Early mobilisation (EM) after-ischemic stroke is a motor learning intervention aimed to restore nerve cells and to improve balance and functional ability. Unfortunately, the study of when this intervention began has not been widely studied. AIM: On this study was compared the effect of EM started at 24 hours and 48 hours after an ischemic stroke on balance and functional ability. MATERIAL AND METHODS: Randomized controlled trial involving 40 patients on 2 groups meeting predefined inclusion criteria. The levels of balance were measured using the Berg Balance Scale, and the functional ability was measured using the Barthel Index, at 5th and 7th day. RESULTS: A significant difference was observed in both balance (p = 0.038) and functional ability (p = 0.021) obtained on the 7th day of assessment between both groups. A significant difference on the 5th day was observed only in the functional ability (p = 0.002) and not in the balance (p = 0.147), between the groups. CONCLUSION: EM started at 24 hours after the ischemic stroke has been found to have a better impact on balance and functional ability compared to that at 48 hours.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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