Efficacy of a step-down regimen of oral prednisolone in axial spondyloarthritis: result of a double-blind randomized controlled trial (COBRA-AS Study)

Rheumatology ◽  
2020 ◽  
Author(s):  
Debashish Mishra ◽  
Varun Dhir ◽  
G S R S N K Naidu ◽  
Aastha Khullar ◽  
Vishal Kumar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Oral Prednisolone ◽  
Functional Improvement ◽  
Inadequate Response ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Step Down

Abstract Objectives To evaluate the efficacy and safety of a step-down regimen of oral prednisolone over 24 weeks in patients of axial SpA (axSpA). Methods This proof-of-concept double-blind randomized controlled trial enrolled patients with active axSpA (BASDAI ≥4) having predominantly axial disease (≤1 active joint currently) and inadequate response to NSAIDs. They were randomized to receive either oral prednisolone (n = 32) or placebo (n = 33) at a dose of 60, 40, 30, 20, 15 and 10 mg daily for 1 week each, following which they received 5 mg prednisolone (or placebo) daily for 18 weeks. The primary endpoint was a 50% improvement in the BASDAI (BASDAI50) at week 24. Analysis was intention to treat. Results A BASDAI50 was achieved by 12 of 32 patients (37.5%) in the prednisolone arm and 3 of 33 patients (9.1%) in the placebo arm at 24 weeks [difference 28.4% (95% CI 7.9, 46.7)]. However, there was no difference in achieving a 20 or 40% improvement in the Assessment of SpondyloArthritis international Society response between the groups. Although there was a significant intergroup difference in adjusted ΔBASDAI and ΔAnkylosing Spondylitis Disease Activity Score with CRP at 24 weeks, there was no difference at 12 weeks. There was also no significant difference in ΔBASFI, ΔBAS-G or ΔBASMI at 12 or 24 weeks. No serious adverse events were noted. There was significant weight gain in the first 12 weeks in the prednisolone group vs placebo [0.9 (s.d. 0.4) kg], but not at 24 weeks. Conclusions In this small study, oral prednisolone was efficacious in axSpA in achieving the primary outcome, but many crucial secondary outcomes such as functional improvement were not met. Its impact on bone loss was not studied. Trial registration: CTRI/2018/01/011342.

scholarly journals Randomized controlled trial of erdosteine for acute cough in children with colds

2011 ◽  
Vol 51 (2) ◽  
pp. 111
Author(s):  
Yenny Yenny ◽  
Roni Naning ◽  
Amalia Setyati
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Improvement ◽  
Common Cold ◽  
Controlled Trial ◽  
Research Subjects ◽  
Acute Cough ◽  
Chi Square ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference

Background T h e prevalence of the common cold in children is high, v.ith 30% of cases exhibiting an acute cough, the most common complaint by parents. Erdosteine, a recently developed cough medicine, is available for children. Erdosteine has been reported to increase mucodliary clearance, act as an antioxidant and prevent bacterial adhesion.Objective To assess the clinical improvement in acute cough in children \\lith a common cold taking erdosteine vs. a placebo.Methods We conducted a double􀀾blind, randomized, controlled trial at the Public Health Center of Gedongtengen, Yogyakarta with 140 children selected by a consecutive sampling method. Research subjects were randomized by computer program into two treatment groups, those receiving erdosteine therapy and those receiving a placebo. Both groups were monitored for 6 days. A scoring system was used to assess the improvement of acute cough symptoms and analyzed by Chi-square test.Results No significant differences in basic characteristics, cough severity, or environment were found among the 140 children with common cold in the two groups. After 6 days of treatment, no significant difference in clinical improvement of acute cough was found between the erdosteine (65 subjects improved out of 70) and placebo groups (62/70),92.5% and 88.6%, respectively (P=0.382).Conclusion Erdosteine was not more effective than the placebo for treatment of acute cough in children with common cold.

scholarly journals Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

2016 ◽  
Vol 9 (5) ◽  
pp. 67
Author(s):  
Mansoureh Mirzadeh ◽  
Najmeh Shahini ◽  
Masoud Kashani Lotf Abadi ◽  
Maryam Tavakoli ◽  
Arash Javanbakht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Schizophrenic Patients

<p>Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients.<strong> </strong>This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14<sup>th</sup> and 28<sup>th</sup> days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2<sup>nd</sup>, 7<sup>th</sup>, 14<sup>th</sup>, 28<sup>th</sup>. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28<sup>th</sup> compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor<strong> </strong><strong>p </strong>value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05.<strong> </strong>Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.</p>

A prospective double-blind randomized controlled trial of the effect of topical bupivacaine on post-operative pain in bilateral nasal surgery with bilateral nasal packs inserted

2005 ◽  
Vol 119 (4) ◽  
pp. 284-288 ◽  
Author(s):  
Malcolm A Buchanan ◽  
Graham R Dunn ◽  
Gillian M MacDougall
Keyword(s):  
Randomized Controlled Trial ◽  
Local Anaesthetic ◽  
Controlled Trial ◽  
Nasal Surgery ◽  
Double Blind ◽  
Control Power ◽  
Randomized Controlled ◽  
Post Operative Pain ◽  
Number Of Patients ◽  
Significant Difference

To ascertain whether local anaesthetic use is of clinical benefit in nasal surgery, a prospective double-blind randomized controlled trial of topical bupivacaine on post-operative pain in patients packed after bilateral nasal surgery was carried out. Each patient received a bupivacaine-soaked and a saline-soaked Merocel pack, thereby acting as their own control. Power analysis ascertained the number of patients required to enter the trial to detect a statistically significant difference in pain. Fifty-seven patients completed the trial. Visual analogue scales determined the level of post-operative pain at different time points in each nostril. Less pain was demonstrated in nostrils containing bupivacaine-soaked packs compared with saline-soaked packs at two hours (p < 0.0001), four hours (p = 0.0183) and six hours (p = 0.0476) post-operatively. Although not statistically significant, less pain was noted on pack removal on the local anaesthetic sides. These results provide clinical-based evidence for the use of bupivacaine as a local anaesthetic in reducing pain following nasal surgery with packing.

Early analgesic effects of intravenous parecoxib and rectal diclofenac following laparoscopic sterilization: A double-blind, double-dummy randomized controlled trial

2018 ◽  
Vol 4 (1) ◽  
pp. 49
Author(s):  
Alexander Ng, MD, FRCA ◽  
Ajay Swami, FFARCSI ◽  
Graham Smith, MD, FRCA ◽  
Joe Emembolu, FRCOG
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Double Blind ◽  
Rescue Analgesia ◽  
Analgesic Effects ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Laparoscopic Sterilization ◽  
Rescue Antiemetic

The aim of this double-blind double-dummy randomized controlled trial was to investigate if there was any difference in analgesia between the maximum recommended doses of rectal diclofenac and iv parecoxib after laparoscopic sterilization. The authors studied 55 ASA I-II patients undergoing gynecological laparoscopy; each patient received either preoperative rectal diclofenac 100 mg and 2 mL of normal saline at induction of anesthesia, or preoperative placebo suppository and 2 mL of parecoxib 40 mg at induction. Pain intensity, sedation, and nausea were measured using a 100-mm visual analogue scale on awakening and at 1, 2, and 3 hour postoperatively. Median (interquartile range) pain intensity at rest on awakening and at 1, 2, and 3 hour postoperatively were 15 (0-40), 37 (10-56), 16 (6-29), and 13 (2-32) mm, respectively, in the parecoxib group, and 3 (0-34), 22 (5-45), 24 (6-37), and 10 (4-21) mm, respectively, in the diclofenac group. There was no significant difference in these scores. Furthermore, there was no significant difference between the two groups in sedation, nausea, rescue analgesia, or rescue antiemetic consumption. Preoperative rectal diclofenac 100 mg and parecoxib 40 mg iv at induction of anesthesia were found to have equianalgesic effects after laparoscopic sterilization. Both drugs appear to be useful after short anaesthetics.

ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis

2017 ◽  
Vol 77 (7) ◽  
pp. 1003-1011 ◽  
Author(s):  
Pierre Quartier ◽  
Amandine Baptiste ◽  
Véronique Despert ◽  
Emma Allain-Launay ◽  
Isabelle Koné-Paut ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Anterior Uveitis ◽  
Early Onset ◽  
Controlled Trial ◽  
Topical Therapy ◽  
Topical Steroids ◽  
Inadequate Response ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Significant Difference

ObjectivesTo assess the efficacy and safety of adalimumab on uveitis in patients with early onset, chronic, juvenile idiopathic arthritis (JIA)-associated or idiopathic anterior uveitis and an inadequate response to topical steroids and methotrexate (MTX).MethodsPatients aged 4 years or more with ocular inflammation quantified by laser flare photometry (LFP) ≥30 photon units/ms were double-blindly randomised (1:1) to 2 groups, one treated with placebo and one with adalimumab subcutaneously at a dose of 24 mg/m2 in patients aged <13 years, 40 mg in the others, every other week. The primary outcome was response at month 2 (M2) defined as a 30% reduction of inflammation on LFP in the assessable eye with more severe baseline inflammation and no worsening on slit lamp examination. From M2 to M12, all patients received adalimumab.ResultsAt M2, among 31 patients included in intention-to-treat analysis, there were 9/16 responders on adalimumab and 3/15 on placebo (P=0.038, Χ2 test; relative risk=2.81, 95% CI 0.94 to 8.45; risk difference: 36.3%, 95% CI 2.1 to 60.6); there was no significant difference using the Standardised Uveitis Nomenclature classification criteria of improvement. Thirty patients continued the trial after M2 and received adalimumab (open-label phase), 29 reached M12. There were seven serious adverse events none related to study treatment.ConclusionsThis trial is in favour of using adalimumab in patients with early onset, chronic anterior uveitis, which is in most cases associated with JIA, in case of inadequate response to topical therapy and MTX. LFP could be a valuable tool to assess early treatment efficacy.Trial registration numberNCT01385826.

scholarly journals Levothyroxine versus Levothyroxine with Iodine in Reduction of Thyroid Nodule Volume: A Double-Blind Randomized Controlled Trial

2019 ◽  
Vol 34 (1) ◽  
pp. 14-19
Author(s):  
Donnie Jan D. Segocio ◽  
Joseph E. Cachuela
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Thyroid Nodule ◽  
Controlled Trial ◽  
Therapeutic Use ◽  
Volume Reduction ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Nodule Volume

Objective: To compare levothyroxine alone and in combination with iodine on thyroid nodule volume reduction. Methods:           Design:           Double-Blind Randomized Controlled Trial           Setting:           Tertiary Government Hospital           Participants: Nineteen (19) euthyroid patients age 19­-54 with at least 1 cytologically benign thyroid nodule were randomized to receive either levothyroxine + iodine or levothyroxine + placebo, taken once a day for 6 months with ultrasound and thyroid stimulating hormone monitoring on the 3rd and 6th month of intervention. Results: Main outcome measures included thyroid nodule volume reduction after six months of intervention. The mean change in volume from baseline to six months of levothyroxine + iodine group showed no statistically significant difference in nodule volume across time between  levothyroxine + placebo group, -0.010 ± 1.250 (CI -0.521 - 0.501) versus 0.507 ± 1.128 (CI 0.025 - 0.990), p=.158.  There were also new nodules (4 nodules) in the placebo group and none in the iodine group. No major adverse events were noted during the study. Conclusion: The two groups did not significantly differ in terms of nodule volume reduction. Keywords: thyroid nodule, prevention and control; drug therapy; iodine compounds, therapeutic use; levothyroxine, therapeutic use

scholarly journals Effects of Neuromuscular Electrical Stimulation Combined with Exercises versus an Exercise Program on the Pain and the Function in Patients with Knee Osteoarthritis: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Aline Mizusaki Imoto ◽  
Stella Peccin ◽  
Kelson Nonato Gomes da Silva ◽  
Lucas Emmanuel Pedro de Paiva Teixeira ◽  
Marcelo Ismael Abrahão ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Electrical Stimulation ◽  
Knee Osteoarthritis ◽  
Rating Scale ◽  
Controlled Trial ◽  
Neuromuscular Electrical Stimulation ◽  
Functional Improvement ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Significant Difference

Objectives. To investigate the effect of 8 weeks of NMES + Ex (neuromuscular electrical stimulation combined with exercises) on pain and functional improvement in patients with knee osteoarthritis (OA) compared to exercise (Ex) alone.Design. Randomized controlled trial.Setting. A specialty outpatient clinic.Participants. Patients (N=100; women = 86, men = 14; age range, 50–75 years) with knee OA.Interventions. Participants were randomly assigned to NMES + Ex or Ex group.Outcome Measures. Numerical Rating Scale 0 to 10 (NRS) and the Timed Up and Go (TUG) test were the primary outcomes. The secondary outcomes used were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).Results. Following the interventions, a statistically significant improvement in both groups was observed in all outcomes assessed. For the comparison between the groups, no statistically significant difference was found between the NMES + Ex and the Ex groups in NRS (P=0.52), TUG test (P=0.12), and aspects of WOMAC: pain (P=0.26), function (P=0.23), and stiffness (P=0.63).Conclusion. The addition of NMES to exercise did not improve the outcomes assessed in knee OA patients. This study was registered at the Australian Clinical Trials Registry (ACTRN012607000357459).

scholarly journals Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257238
Author(s):  
Carmen Hernandez-Cardenas ◽  
Ireri Thirion-Romero ◽  
Sebastián Rodríguez-Llamazares ◽  
Norma E. Rivera-Martinez ◽  
Patricia Meza-Meneses ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Severe Disease ◽  
Public Health Problem ◽  
Major Public Health Problem ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Secondary Outcomes

Introduction The novel coronavirus pandemic (COVID–19) represents a major public health problem and it is key to find a treatment that reduces mortality. Our objective was to estimate whether treatment with 400 mg/day of Hydroxychloroquine for 10 days reduces in-hospital mortality in subjects with severe respiratory disease due to COVID-19 compared with placebo. Material and methods A double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of Hydroxychloroquine for the treatment of severe disease by COVID-19 through an intention-to-treat analysis. Eligible for the study were adults aged more than 18 years with COVID-19 confirmed by RT-PCR and lung injury requiring hospitalization with or without mechanical ventilation. Primary outcome was 30-day mortality. Secondary outcomes: days of mechanical ventilation, days of hospitalization and cumulative incidence of serious adverse events. Results A total of 214 patients with COVID-19 were recruited, randomized and analyzed. They were hypoxemic with a mean SpO2 of 65% ± 20, tachycardic (pulse rate 108±17 min-1) and tachypneic (32 ±10 min-1); 162 were under mechanical ventilation at randomization. Thirty-day mortality was similar in both groups (38% in Hydroxychloroquine vs. 41% in placebo, hazard ratio [HR] 0.88, 95% Confidence Interval [95%CI] 0.51–1.53). In the surviving participants, no significant difference was found in secondary outcomes. Conclusion No beneficial effect or significant harm could be demonstrated in our randomized controlled trial including 214 patients, using relatively low doses of Hydroxychloroquine compared with placebo in hospitalized patients with severe COVID-19.

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