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Prednisolone 20 mg vs 40 mg in complex regional pain syndrome type I: A randomized controlled trial.Journal of Clinical Neuroscience :... Jul 2023High dose of corticosteroid has been found beneficial in complex regional pain syndrome type I (CRPS-I). We report the efficacy and safety of prednisolone 20 mg versus... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
High dose of corticosteroid has been found beneficial in complex regional pain syndrome type I (CRPS-I). We report the efficacy and safety of prednisolone 20 mg versus 40 mg in CRPS-I in an open label randomized controlled trial.
METHODS
The patients with CRPS-I of the shoulder joint with a CRPS score of ≥8 were included. Their demographic details, comorbidities, and underlying etiology were noted. The severity of CRPS was assessed using a 0-14 CRPS scale, the pain using a 0-10 Visual Analogue Scale (VAS), and sleep quality using a 0-10. Daily Sleep Interference Scale (DSIS). Patients were randomized to prednisolone 40 mg/day (group I) or 20 mg/day (group II) for 14 days, then tapered to 10 mg in group I and to 5 mg in group II by 1 month. Thereafter both groups received prednisolone 5 mg/day for 2 months. The primary outcome was a >50% reduction in VAS score, and secondary outcomes were a reduction in CRPS score, DSIS score, and adverse events.
RESULTS
Fifty patients were included, and their baseline characteristics were comparable. At one month, all the patients had >50% reduction in the VAS score. The effect size was 0.38 (95% CI 0.93-0.20; p = 0.20). On the Kaplan-Mayer analysis, the improvement in the VAS score (Hazard ratio-1.43, 95 % CI-0.80-2.56, p = 0.22) and the CRPS score (HR-0.79,95 % CI-0.45-1.39; p = 0.41) was insignificant between the two groups. The DSIS score improved in group II (HR-1.85,95 % Cl-1.04-3.31,p = 0.04). Group I patients needed frequent adjustment of antidiabetic drugs (14 vs 6; p = 0.04).
CONCLUSION
The efficacy of prednisolone 20 mg is not inferior to 40 mg in CRPS-I, and is safe in diabetic patients.
LIMITATIONS
This is an open label randomized controlled trial with small sample size without a placebo arm.
Topics: Humans; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Prednisolone; Pain Measurement
PubMed: 37257216
DOI: 10.1016/j.jocn.2023.05.017 -
Cancer Epidemiology Jun 2024A recent epidemiological study systematically screened 250 prescription medications for associations with oesophageal cancer risk, using Scottish data, and identified an...
BACKGROUND
A recent epidemiological study systematically screened 250 prescription medications for associations with oesophageal cancer risk, using Scottish data, and identified an increased risk with use of prednisolone and warfarin. We investigated whether oral prednisolone or warfarin use was associated with increased oesophageal cancer risk.
METHODS
A case-control study was conducted within the Clinical Practice Research Datalink. In the primary analysis oesophageal cancer cases were identified from linked cancer registry records. Up to 5 cancer-free controls were matched to each case (based upon sex, birth year, GP practice and year of GP registration). Prednisolone and warfarin medications were identified from prescribing records. Odds ratios (OR) and 95% confidence intervals (CI) were calculated using conditional logistic regression after adjusting for covariates including demographics, comorbidities and medication use.
RESULTS
There were 4552 oesophageal cancer cases and 22,601 matched control participants. Overall, there was no evidence of an increased risk of oesophageal cancer with oral prednisolone use (unadjusted OR=1.16 95% CI 1.06, 1.27 and adjusted OR=0.99 95% CI 0.89, 1.11) or warfarin use (unadjusted OR=1.12 95% CI 0.99, 1.28 and adjusted OR=1.08 95% CI 0.92, 1.27).
CONCLUSIONS
In this large population-based study, oral prednisolone and warfarin were not associated with oesophageal cancer risk.
Topics: Humans; Warfarin; Case-Control Studies; Esophageal Neoplasms; Prednisolone; Male; Female; Middle Aged; Aged; Administration, Oral; Anticoagulants; Risk Factors; Adult; Aged, 80 and over
PubMed: 38447250
DOI: 10.1016/j.canep.2024.102552 -
International Immunopharmacology Dec 2023Bullous pemphigoid (BP) is a common subepidermal bullous disease. Dupilumab is a novel treatment for BP. However, its long-term efficacy and safety have not been...
BACKGROUND
Bullous pemphigoid (BP) is a common subepidermal bullous disease. Dupilumab is a novel treatment for BP. However, its long-term efficacy and safety have not been demonstrated in prospective studies.
OBJECTIVE
Evaluate the long-term efficacy and safety of dupilumab in treating severe BP.
METHODS
Patients were divided into two groups: the methylprednisolone monotherapy group (M), and the methylprednisolone and dupilumab combination therapy group (D + M). This study consisted of two stages. The first stage focused on the initial treatment phase, where the early efficacy and safety was evaluated. The study then entered the 12-month maintenance treatment stage, where we assessed recurrence in both groups. Additionally, we evaluated the rate of healing of skin lesions, glucocorticoids burden and length of hospital stay and various laboratory test indicators.
RESULTS
After four weeks of treatment, the Bullous Pemphigoid Disease Area Index (BPDAI) and pruritus Numerical Rating Scale scores of the D + M group decreased significantly more than those of the M group. The median BPDAI at week 4 was 0 (range: 0.0-3.0) in the D + M group and 10.0 (5.0-12.0) in the M group (P < 0.001). Patients treated with dupilumab experienced a faster cessation of new blisters, quicker glucocorticoid reduction, shorter healing times, and shorter hospital stays (P < 0.001). Additionally, after two weeks of treatment, the levels of eosinophils and immunoglobulin E also decreased (P < 0.001). Follow-up studies further demonstrated that dupilumab monotherapy was associated with a lower recurrence rate. Notably, no serious adverse effects were observed in the study.
CONCLUSIONS
Our study provides evidence for the efficacy of dupilumab in the treatment of BP based on prospective studies. Additionally, our findings suggest that dupilumab can be considered a reliable single-agent maintenance treatment due to its good safety profile and lower relapse.
Topics: Humans; Pemphigoid, Bullous; Prospective Studies; Antibodies, Monoclonal, Humanized; Methylprednisolone
PubMed: 37925949
DOI: 10.1016/j.intimp.2023.111157 -
Pediatric Nephrology (Berlin, Germany) Oct 2023IgA nephropathy (IgAN), the most common form of primary glomerulonephritis, is mainly observed in young adults and children. Clinical and basic studies indicate the role... (Review)
Review
IgA nephropathy (IgAN), the most common form of primary glomerulonephritis, is mainly observed in young adults and children. Clinical and basic studies indicate the role of immunity in IgAN pathogenesis; however, corticosteroid therapy has been controversial in past decades. The TESTING study, initiated in 2012, is an international, multicenter, double-blinded, randomized, placebo-controlled trial that aimed to evaluate oral methylprednisolone's safety and long-term efficacy under conditions of optimized supportive treatment in patients with IgAN whose risk of progression is high. After a decade of effort, the successful completion of the TESTING study showed that a 6- to 9-month course of oral methylprednisolone is an effective regimen to protect kidney function in high-risk patients with IgAN, but also demonstrated safety concerns. Compared with the full-dose regimen, the reduced-dose regimen was reported to be beneficial, with successfully increased safety. Overall, the TESTING trial provided more data regarding the treatment dosage and safety of corticosteroids, a cost-effective therapy, in IgAN, which have important implications for pediatric patients with IgAN. With a deeper understanding of the disease pathogenesis of IgAN, ongoing studies of novel therapeutic regimens would help further optimize the benefit-risk ratio.
Topics: Young Adult; Humans; Child; Glomerulonephritis, IGA; Adrenal Cortex Hormones; Methylprednisolone; Clinical Protocols; Multicenter Studies as Topic
PubMed: 36881171
DOI: 10.1007/s00467-023-05919-9 -
Journal of Crohn's & Colitis Feb 2024Oral corticosteroids are first-line agents to induce remission in moderately active ulcerative colitis [UC], but are associated with adverse effects. We compared the... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Oral corticosteroids are first-line agents to induce remission in moderately active ulcerative colitis [UC], but are associated with adverse effects. We compared the efficacy and safety of tofacitinib and prednisolone for induction of remission in moderately active UC.
METHODS
This was a single-centre, prospective, open-label, randomized, active-controlled pilot study. Eligible patients [aged ≥18 years] had moderately active UC. Participants were randomly assigned to receive either prednisolone [40 mg daily, tapered by 5 mg every week] or tofacitinib [10 mg twice daily] for 8 weeks. The primary endpoint was composite remission [defined as total Mayo clinic score ≤2, with endoscopic sub-score of 0 and faecal calprotectin <100 µg/g] at 8 weeks.
RESULTS
Seventy-eight patients were randomly assigned to either of the treatment groups. At week 8, the proportion of patients achieving composite remission in the tofacitinib [7/43, 16.28%] and prednisolone groups [3/35, 8.57%] were not significantly different (odds ratio [OR] 2.07, 95% confidence interval [CI] 0.49-8.70; p = 0.31). The time to achieve symptomatic remission [normal stool frequency with absence of rectal bleeding] was similar (10 days, interquartile range [IQR 7-18.75] and 10 days [IQR 5-12.5] for tofacitinib and prednisolone, respectively; p = 0.25) in the two groups. One patient each in the tofacitinib and prednisolone group discontinued treatment due to development of pulmonary tuberculosis and pustular acne, respectively. One patient receiving tofacitinib developed herpes zoster, but did not require cessation of therapy. No serious adverse events or major adverse cardiovascular events were observed.
CONCLUSION
In patients with moderately active UC, there was no difference in the efficacy and safety of tofacitinib and oral prednisolone for induction of remission at 8 weeks.
TRAIL REGISTRATION
Clinical Trials Registry of India [CTRI/2021/10/037641].
Topics: Humans; Adolescent; Adult; Colitis, Ulcerative; Pilot Projects; Prospective Studies; Prednisolone; Remission Induction; Treatment Outcome; Piperidines; Pyrimidines
PubMed: 37656880
DOI: 10.1093/ecco-jcc/jjad153 -
Journal of Oncology Pharmacy Practice :... Dec 2023Vincristine is a vesicant chemotherapeutic agent which may leak from the vessel at the infusion site to the perivascular tissue and cause extravasation. Extravasation, a...
INTRODUCTION
Vincristine is a vesicant chemotherapeutic agent which may leak from the vessel at the infusion site to the perivascular tissue and cause extravasation. Extravasation, a severe complication of chemotherapeutic drugs, can result in tissue necrosis that is considered an oncological emergency.
CASE REPORT
We aimed to report a case of a 29-year-old woman with ALL-B cell (Acute lymphoblastic leukemia) on maintenance chemotherapy regimen including vincristine, methotrexate, prednisolone, and 6-mercaptopurine (POMP). 48 h after administering intravenous vincristine, the patient experienced burning, pain and tenderness at the injection site (left hand - cubital cavity).
MANAGEMENT & OUTCOME
7 days after the onset of symptoms, the patient was hospitalized with a large brown lesion at the site. She was prescribed betamethasone cream, DSMO (Dimethyl sulfoxide) solution, and oral levofloxacin on his second day after admission. The lesion was completely improved 10 days after initiation of therapy and there were no serious problems.
DISCUSSION
Due to the ineffectiveness of antidote therapy for the management of delayed extravasation of vincristine and beneficial effect of our clinical approach, it could consider for the management of similar cases with delayed extravasation following vincristine administration.
Topics: Female; Humans; Adult; Vincristine; Antineoplastic Combined Chemotherapy Protocols; Methotrexate; Mercaptopurine; Prednisolone
PubMed: 37475540
DOI: 10.1177/10781552231187591 -
Trials Oct 2023Gout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute inflammatory reactions. There are...
Prednisolone Versus Colchicine for Acute Gout in Primary Care (COPAGO): protocol for a two-arm multicentre, pragmatic, prospective, randomized, double-blind, controlled clinical trial of prednisolone and colchicine for non-inferiority with a parallel group design.
BACKGROUND
Gout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute inflammatory reactions. There are various approved drugs that can be prescribed for pain relief during an acute gout attack. However, to date, no direct comparison of efficacy of colchicine and prednisolone for the treatment of acute gout attacks has been investigated. Furthermore, the majority of previous research studies were not only conducted in tertiary centres but also excluded patients with common comorbidities due to contraindications to naproxen.
METHODS
This pragmatic, prospective, double-blind, double-dummy, parallel-group, randomized, non-inferiority trial investigates whether prednisolone (intervention) is non-inferior to treatment with colchicine (active control) in patients with acute gout. Adult patients presenting with acute gout to their general practitioners in 60 practices across 3 university sites (Greifswald, Göttingen, and Würzburg) are eligible to participate in the study. Participants in the intervention group receive 30 mg prednisolone for 5 days. Those in the control group receive low-dose colchicine (day 1: 1.5 mg; days 2-5: 1 mg). The primary outcome is the absolute level of the most severe pain on day 3 (in the last 24 h) measured with an 11-item numerical rating scale. Day 0 is the day patients take their study medication for the first time. They are then asked to fill out a study diary the same time each day for pain quantification. Pain scores are used for comparison between the two medications. Secondary outcomes are average response to treatment, swelling, tenderness and physical function of the joint, patients' global assessment of treatment success, use of additional pain medication and non-pharmacological pain therapies. For safety reasons, potential side effects and course of systolic blood pressure are assessed.
DISCUSSION
This trial will provide evidence on the effectiveness of pain reduction and side effects of colchicine and prednisolone in acute gout in primary care.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT05698680 first posted on January 26, 2023 (retrospectively registered). URL of trial registry record: https://clinicaltrials.gov/study/NCT05698680.
Topics: Adult; Humans; Colchicine; Prednisolone; Prospective Studies; Arthritis, Gouty; Gout; Pain; Treatment Outcome; Primary Health Care; Double-Blind Method; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 37798801
DOI: 10.1186/s13063-023-07666-6 -
Journal of Neuroimmunology Dec 2023This study included 51 patients with muscle-specific kinase antibody-positive myasthenia gravis (MuSK-MG) from a Japanese multicenter survey to examine clinical features...
This study included 51 patients with muscle-specific kinase antibody-positive myasthenia gravis (MuSK-MG) from a Japanese multicenter survey to examine clinical features and outcomes. Median onset age was 37 years and female predominance was observed. All patients developed generalized symptoms and almost all (50/51) patients had bulbar symptoms. About half of the patients met the criteria for refractory MG. The refractory group had a lower age of onset, higher severity scores, and higher maximum daily doses of oral prednisolone compared to the nonrefractory group. The outcomes for MuSK-MG patients in Japan are not favorable, indicating the need for more aggressive treatment.
Topics: Humans; Female; Adult; Male; Japan; Myasthenia Gravis; Prednisolone; Muscles; Autoantibodies
PubMed: 37952282
DOI: 10.1016/j.jneuroim.2023.578241 -
Best Practice & Research. Clinical... Dec 2023Glucocorticoids (GCs) continue to be essential agents for the management of systemic lupus erythematosus, since there are no other drugs able to active remission of... (Review)
Review
Glucocorticoids (GCs) continue to be essential agents for the management of systemic lupus erythematosus, since there are no other drugs able to active remission of active disease so rapidly. However, their potential for causing irreversible damage greatly limit their use. Fortunately, some strategies may help take advantage of their huge anti-inflammatory power while limiting GC-induced side effects. This article reviews the pharmacological basis of GC action and their translation into the clinical ground. We also offer the practical approach for the use of GC in induction and maintenance therapy as well as the strategies for GC withdrawal of the respective practice of the authors. The three main basic principles are a) using methyl-prednisolone pulses to induce remission not only in severe disease; b) limiting initial doses of prednisone to ≤30 mg/d, with rapid tapering to ≤5 mg/d, which should be the dose for maintenance therapy; and c) individualizing the decision and the strategy to withdraw GCs. Long-term therapy with HCQ and the early introduction of immunosuppressive treatment would help achieve these objectives.
Topics: Humans; Lupus Erythematosus, Systemic; Glucocorticoids; Immunosuppressive Agents; Remission Induction; Methylprednisolone; Prednisone
PubMed: 37957076
DOI: 10.1016/j.berh.2023.101873 -
The Laryngoscope Nov 2023The diversity of glucocorticoid (GC) properties may underlie variability of clinical efficacy for vocal fold (VF) disease. Optimized therapeutic approaches must account...
OBJECTIVE
The diversity of glucocorticoid (GC) properties may underlie variability of clinical efficacy for vocal fold (VF) disease. Optimized therapeutic approaches must account for tissue complexity as well as interactions between cell types. We previously reported that reduced GC concentrations inhibited inflammation without eliciting fibrosis in mono-cultured VF fibroblasts and macrophages. These data suggested that a refined approach to GC concentration may improve outcomes. In the current study, co-culture of VF fibroblasts and macrophages was employed to investigate the effects of different concentrations of methylprednisolone on fibrotic and inflammatory response genes in VF fibroblasts to optimize management paradigms.
STUDY DESIGN
In vitro.
METHODS
THP-1 monocyte-derived macrophages were stimulated with interferon-γ (IFN-γ), lipopolysaccharide (LPS), or transforming growth factor-β (TGF-β) to induce inflammatory (M(IFN/LPS)) and fibrotic (M(TGF)) phenotypes. Macrophages were then co-cultured with a human VF fibroblast cell line using a 0.4 μm pore membrane with or without 0.1-3000 nM methylprednisolone. Inflammatory (CXCL10, TNF, and PTGS2) and fibrotic (ACTA2, CCN2, and COL1A1) gene expression was quantified in fibroblasts.
RESULTS
Incubating VF fibroblasts with M(IFN/LPS) macrophages increased expression of TNF and PTGS2, and this effect was inhibited by methylprednisolone. Incubation of VF fibroblasts with M(TGF) macrophages increased expression of ACTA2, CCN2, and COL1A1, and this effect was enhanced by methylprednisolone. The concentration of methylprednisolone required to downregulate inflammatory genes (TNF and PTGS2) was lower than that to upregulate fibrotic genes (ACTA2, CCN2, and COL1A1).
CONCLUSION
Reduced concentration of methylprednisolone effectively suppressed inflammatory genes without enhancing fibrotic genes, suggesting that a refined approach to GC concentration may improve clinical outcomes.
LEVEL OF EVIDENCE
N/A Laryngoscope, 133:3116-3122, 2023.
Topics: Humans; Methylprednisolone; Coculture Techniques; Vocal Cords; Lipopolysaccharides; Cyclooxygenase 2; Glucocorticoids; Macrophages; Fibrosis; Fibroblasts; Cells, Cultured
PubMed: 37246727
DOI: 10.1002/lary.30763