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Comparison of oral Nano-Curcumin with oral prednisolone on oral lichen planus: a randomized double-blinded clinical trial.
Kia, SJ, Basirat, M, Mortezaie, T, Moosavi, MS
BMC complementary medicine and therapies. 2020;(1):328
Abstract
BACKGROUND Oral lichen planus (OLP) is a mucocutaneous autoimmune disease with T-cell mediation. Corticosteroids are considered as a first choice in OLP and should be used for a long period with a subsequent increase in dose since the disease has a chronic and recalcitrant nature. There have been efforts to use alternative therapies due to the Corticosteroid's side effects. Curcumin is a non-toxic natural product with different effects on various oral diseases. It demonstrates antioxidant, anti-inflammatory, antimicrobial, and anticarcinogenic activities. It seems that Curcumin can be used as a proper alternative for Corticosteroid treatments. To overcome limitations in the bioavailability of Curcumin, the therapeutic effect of oral Nano-Curcumin was evaluated for the first time. METHODS Sixty OLP patients were included in this double-blinded randomized clinical trial. The patients were randomly divided into two groups and received either 'Nano-Curcumin 80 mg' or 'Prednisolone 10 mg' treatments for 1 month. The patients should take one capsule after having their breakfast. The VAS scale was used to analyze pain severity and burning sensation. To assess lesion size the Thongprasom scale was employed. Repeated measures and independent t-tests, as well as LSD paired-test, were used to analyze the data. RESULTS Data from 57 patients were analyzed. The level of pain, burning sensation, and OLP lesions decreased in both groups of Curcumin and Prednisolone and no statistically significant difference was observed between the two groups. CONCLUSION Despite many studies conducted to find an effective approach for managing OLP, the results have often been unsatisfactory. In comparison with previous studies, current results clarify the importance of Nano-Curcumin bioavailability in therapeutic effects. Pain VAS and lesion size were decreased with oral Curcumin. The results have shown that oral Curcumin can be used as an alternative therapy for OLP in patients with the contraindicated Corticosteroids or should be used with caution. Oral Curcumin can be used in preventing the recurrence of OLP lesions after the treatment and initial control. Moreover, the amount of Curcumin dose is more important than its use duration in improving OLP. TRIAL REGISTRATION IRCT, IRCT20100101002950N5. Registered 9 February 2019, https://www.irct.ir/trial/36704 .
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Incidence of cystoid macular edema following routine cataract surgery using NSAIDs alone or with corticosteroids.
Walter, KA, Lee, RY, Chen, K, Komanski, C
Arquivos brasileiros de oftalmologia. 2020;(1):55-61
Abstract
PURPOSE To evaluate the rate of cystoid macular edema development among cataract surgery patients on four different therapeutic regimens. METHODS The present study is a retrospective analysis of 5,380 eyes following uncomplicated phacoemulsification at Wake Forest University. The study period went from July 2007 to December 2012. Patients received one of four regimens, as follows: postoperative generic ketorolac 0.4% and prednisolone 1%, postoperative name-brand ketorolac 0.45% and prednisolone 1%, postoperative bromfenac 0.09% and prednisolone 1%, preoperative and postoperative bromfenac 0.09% alone. A statistical analysis was performed to assess the differences in rate of cystoid macular edema development among the four different therapeutic regimens. The diagnosis of cystoid macular edema required worsening of vision and evidence of increased macular thickness on optical coherence tomography. RESULTS The overall rate of cystoid macular edema was 0.82%. Treatment by postoperative generic ketorolac 0.45% and prednisolone 1% demonstrated the highest rate of cystoid macular edema development (2.20% of the cases). Postoperative name-brand ketorolac 0.45% and prednisolone 1% exhibited intermediate rates of cystoid macular edema development (0.90% of the cases). Postoperative administration of bromfenac 0.09% and prednisolone 1% exhibited intermediate rates of cystoid macular edema development (0.44% of the cases). Preoperative and postoperative bromfenac 0.09% alone resulted in the lowest rate of cystoid macular edema development (0.09% of the cases). The rate of cystoid macular edema was significantly lower when bromfenac was used alone vs. either regimen where ketorolac and prednisolone were used (OR 0.043, 95% CI 0.002 to 0.312; p<0.001). CONCLUSIONS Post-cataract surgery cystoid macular edema developed less frequently following topical non-steroidal anti-inflammatory drugs regimen compared to the other therapies evaluated. Bromfenac, without corticosteroids, achieved lower rates of cystoid macular edema vs. various combinations of non-ste-roidal anti-inflammatory drugs with corticosteroids.
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Steroids versus No Steroids in Nonarteritic Anterior Ischemic Optic Neuropathy: A Randomized Controlled Trial.
Saxena, R, Singh, D, Sharma, M, James, M, Sharma, P, Menon, V
Ophthalmology. 2018;(10):1623-1627
Abstract
PURPOSE To examine the role of oral steroid therapy in the treatment of nondiabetic cases of acute nonarteritic anterior ischemic optic neuropathy (NAAION). DESIGN Randomized double-blind clinical trial. PARTICIPANTS Thirty-eight patients with acute nondiabetic NAAION divided into 2 arms of 19 patients each. One arm constituted the cases and the other constituted the controls. METHODS Cases received oral steroid therapy and were designated the steroid group, whereas controls received placebo and were designated the nonsteroid group. Best-corrected visual acuity (BCVA), visual evoked response (VER), and OCT were performed at baseline, 1 month, 3 months, and 6 months after recruitment into the trial. MAIN OUTCOME MEASURES Best-corrected visual acuity, VER, and retinal nerve fiber layer changes on OCT. RESULTS Both groups showed significant improvement in BCVA, VER latency, and resolution of disc edema on OCT parameters over 6 months. Final outcome showed no statistically significant difference with regard to visual acuity, although VER was better in the steroid group (P = 0.011). Best-corrected visual acuity, VER amplitude, and VER latency (P = 0.02, P = 0.02, and P = 0.04, respectively) showed a greater percentage improvement in the steroid group, which also saw a faster resolution of disc edema on OCT (1-month follow-up). CONCLUSIONS Oral steroids in acute NAAION did not improve the visual acuity significantly at 6 months. However, they improved resolution of disc edema significantly and enabled a greater improvement in VER parameters. This subtle benefit of oral steroids in NAAION is clinically unimportant and does not provide support for its use.
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Phenotyping patients with chronic cough: Evaluating the ability to predict the response to anti-inflammatory therapy.
Sadeghi, MH, Wright, CE, Hart, S, Crooks, M, Morice, A
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology. 2018;(3):285-291
Abstract
BACKGROUND Whether the fraction of exhaled nitric oxide (FeNO) measurement can predict the response to anti-inflammatory treatment in chronic cough is unknown. OBJECTIVE To explore whether the effectiveness of treatment with 10 mg of montelukast or 20 mg of prednisolone in patients with chronic cough is predicted by FeNO level. METHODS In this randomized, open-label, controlled pilot study conducted in the Clinical Trial Unit in Castle Hospital in the United Kingdom, 50 nonsmoking patients with a cough that lasted more than 8 weeks were sequentially enrolled in the study. Thirty patients with high FeNO levels (≥30 ppb) were randomized in a 1:1 ratio to receive 10 mg of montelukast or 20 mg of prednisolone for 2 weeks followed by 10 mg of montelukast for 2 weeks. Twenty patients with a low FeNO level (≤20 ppb) received 10 mg of montelukast. The primary objective was to determine the effectiveness of treatment on 24-hour cough counts. RESULTS The 24-hour cough counts decreased in both groups by approximately 50% (P < .005), indicating that FeNO did not predict treatment response. However, it was a good marker for eosinophilic inflammation with a high degree of correlation with blood and sputum eosinophilia (P < .001). CONCLUSION These results suggest that prior investigation may not predict response to anti-inflammatory treatment, which may be consequent on localized leukotriene-mediated inflammation. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02479074.
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Influence of prednisolone on parameters of de novo lipogenesis and indices for stearoyl-CoA- and Δ6- desaturase activity in healthy males: A Post-hoc analysis of a randomized, placebo-controlled, double-blind trial.
Pranger, IG, van Raalte, DH, Brands, M, Muskiet, MHA, Kema, IP, Serlie, MJ, Diamant, M, Bakker, SJL, Muskiet, FAJ
Prostaglandins, leukotrienes, and essential fatty acids. 2018;:8-15
Abstract
Glucocorticoid treatment decreases liver insulin sensitivity and may modify fatty acid metabolism. We investigated the influence of oral prednisolone on indices for de novo lipogenesis (DNLi), stearoyl-CoA desaturase (SCDi) and Δ6-desaturase (D6Di) activity in healthy males. In addition, we explored whether the changes may be associated with prednisolone-induced changes in glucose and lipid metabolism and insulin sensitivity. Thirty-two healthy young males (mean ± SD age 22 ± 3 years, BMI 22.4 ± 1.7 kg/m2) were allocated to receive prednisolone 7.5 mg/day (PRED7.5; n = 12), prednisolone 30 mg/day (PRED30; n = 12), or placebo (n = 8) in a randomized double-blind fashion for 2 weeks. Fatty acid compositions of plasma cholesteryl esters (CE), phospholipids (PL) and triglycerides (TG) were measured at baseline and on day 14. DNLi, SCDi and D6Di were estimated from product/precursor ratios in CE, with DNLi primary deriving from 16:1ω7/18:2ω6, SCDi from 16:1ω7/16:0 and D6Di from 22:6ω3/20:5ω3. Ratios were also assessed in PL and TG. In CE, PRED30 increased DNLi by 51.2 [95%CI 14.8; 87.6]%, increased SCDi by 48.6 [18.7; 78.5]%, and decreased D6Di by 57.7 [-91.8; -23.5]% (p ≤ 0.01 for all, compared to placebo). The prednisolone-induced increases in DNLi and SCDi were positively correlated with insulin sensitivity (r = 0.35 and 0.50, respectively). Similar results were found in PL and TG. Prednisolone dose-dependently increases DNLi and SCDi and decreases D6Di in plasma CE, PL and TG in healthy males after 2 weeks. The observed unfavorable effects on fatty acid metabolism were related to the induction of glucocorticoid-induced insulin resistance.
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Addition of pyridoxine to prednisolone in the treatment of infantile spasms: A pilot, randomized controlled trial.
Kunnanayaka, V, Jain, P, Sharma, S, Seth, A, Aneja, S
Neurology India. 2018;(2):385-390
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Abstract
BACKGROUND West syndrome is a catastrophic epilepsy syndrome characterized by infantile spasms, hypsarrhythmia, and developmental arrest or regression. AIM: The aim of this study was to explore the role of pyridoxine in the management of infantile spasms. SETTING AND DESIGN This was a pilot, randomized, open-label trial conducted at a tertiary level hospital from November 2012 to March 2014. MATERIALS AND METHODS Children aged 3 months to 3 years presenting with infantile spasms in clusters (at least 1 cluster/day) with hypsarrhythmia or its variants on electroencephalogram (EEG) were enrolled. The study participants were randomized to receive either oral prednisolone (4 mg/kg/day) alone or 30 mg/kg/day of pyridoxine with oral prednisolone. The primary outcome measure was the proportion of children who achieved spasm freedom for 48 h on day-14 after treatment initiation, as per parental reports, in both the groups. The adverse effects were also monitored. The study was registered with clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT01828437). RESULTS Sixty-two children were randomized into the two groups with comparable baseline characteristics. The proportion of children with spasm cessation on day-14 was similar in the two groups (39 vs. 37%, P = 0.98). The adverse effects were comparable in both the groups. CONCLUSIONS The combination of pyridoxine with oral prednisolone was not found to be a beneficial therapy as compared to prednisolone alone in the treatment of infantile spasms in this pilot study. However, high dose pyridoxine may be safe in children with infantile spasms.
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Comparative Evaluation of Premedication with Ketorolac and Prednisolone on Postendodontic Pain: A Double-blind Randomized Controlled Trial.
Praveen, R, Thakur, S, Kirthiga, M
Journal of endodontics. 2017;(5):667-673
Abstract
INTRODUCTION The present clinical trial aimed to evaluate and compare the effect of a single pretreatment dose of ketorolac (20 mg), prednisolone (30 mg), and placebo on postendodontic pain in patients undergoing endodontic therapy for irreversible pulpitis or pulpal necrosis using a visual analog scale. METHODS Ninety-two subjects were included in the present trial; 46 subjects had a pulpal diagnosis of irreversible pulpitis, and the other 46 had pulpal necrosis. These subjects were randomly allocated into 1 of the 3 pretreatment medication groups: ketorolac (20 mg), prednisolone (30 mg), or a placebo. The drugs were administered 30 minutes before the procedure followed by a routine single-visit root canal treatment. Preoperative and postoperative pain was evaluated using a visual analog scale at 6 time intervals. A comparison between the different groups was performed using one-way analysis of variance followed by the Tukey post hoc test. A comparison of pain within each group at various time intervals was performed using repeated measures analysis of variance followed by the paired t test and Bonferroni correction. RESULTS At the end of 6 hours, in irreversible pulpitis cases, the ketorolac group showed an effective reduction in pain scores compared with the other drugs. At the end of 12 hours, the prednisolone group significantly reduced the pain scores compared with the other drugs. CONCLUSIONS From this study, it could be concluded that a single pretreatment dose of prednisolone has a more sustained effect in reducing postendodontic pain compared with placebo or ketorolac.
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Treatment of prednisolone-induced hyperglycaemia in hospitalized patients: Insights from a randomized, controlled study.
Radhakutty, A, Stranks, JL, Mangelsdorf, BL, Drake, SM, Roberts, GW, Zimmermann, AT, Stranks, SN, Thompson, CH, Burt, MG
Diabetes, obesity & metabolism. 2017;(4):571-578
Abstract
AIM: Prednisolone causes hyperglycaemia predominantly between midday and midnight. Consequently, glargine-based basal-bolus insulin regimens may under treat daytime hyperglycaemia and cause nocturnal hypoglycaemia. We investigated whether an isophane-based insulin regimen is safer and more effective than a glargine-based regimen in hospitalized patients. MATERIALS AND METHODS Fifty inpatients prescribed ≥20 mg/day prednisolone acutely with (1) finger prick blood glucose level (BGL) ≥15 mmol/L or (2) BGLs ≥10 mmol/L within the previous 24 hours were randomized to either insulin isophane or glargine before breakfast and insulin aspart before meals. The initial daily insulin dose was 0.5 U/kg bodyweight or 130% of the current daily insulin dose. Glycaemic control was assessed using a continuous glucose monitoring system. RESULTS On Day 1, there were no significant differences in percentage of time outside a target glucose range of 4 to 10 mmol/L (41.3% ± 5.5% vs 50.0% ± 5.7%, P = .28), mean daily glucose (10.2 ± 0.7 vs 10.8 ± 0.8 mmol/L, P = .57) or glucose <4 mmol/L (2.2% ± 1.1% vs 2.0% ± 1.3%, P = .92) in patients randomized to isophane and glargine. In patients treated for 3 days, the prednisolone dose was reduced ( P = .02) and the insulin dose was increased over time ( P = .02), but the percentage of time outside the 4 to 10 mmol/L glucose range did not differ over time ( P = .45) or between groups ( P = .24). CONCLUSIONS There were no differences in the efficacy or safety of the isophane and glargine-based insulin regimens. We recommend an initial daily insulin dose of 0.5 units/kg bodyweight if not on insulin, a greater than 30% increase in pre-prednisolone insulin dose and larger insulin dose adjustments in patients with prednisolone-induced hyperglycaemia.
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A sputum gene expression signature predicts oral corticosteroid response in asthma.
Berthon, BS, Gibson, PG, Wood, LG, MacDonald-Wicks, LK, Baines, KJ
The European respiratory journal. 2017;(6)
Abstract
Biomarkers that predict responses to oral corticosteroids (OCS) facilitate patient selection for asthma treatment. We hypothesised that asthma patients would respond differently to OCS therapy, with biomarkers and inflammometry predicting response.Adults with stable asthma underwent a randomised controlled cross-over trial of 50 mg prednisolone daily for 10 days (n=55). A six-gene expression biomarker signature (CLC, CPA3, DNASE1L3, IL1B, ALPL and CXCR2) in induced sputum, and eosinophils in blood and sputum were assessed and predictors of response were investigated (changes in forced expiratory volume in 1 s (ΔFEV1), six-item Asthma Control Questionnaire score (ΔACQ6) or exhaled nitric oxide fraction (ΔFeNO)).At baseline, responders to OCS (n=25) had upregulated mast cell CPA3 gene expression, poorer lung function, and higher sputum and blood eosinophils. Following treatment, CLC and CPA3 gene expression was reduced, whereas DNASE1L3, IL1B, ALPL and CXCR2 expression remained unchanged. Receiver operating characteristic (ROC) analysis showed the six-gene expression biomarker signature as a better predictor of clinically significant responses to OCS than blood and sputum eosinophils.The six-gene expression signature including eosinophil and Th2 related mast cell biomarkers showed greater precision in predicting OCS response in stable asthma. Thus, a novel sputum gene expression signature highlights an additional role of mast cells in asthma, and could be a useful measurement to guide OCS therapy in asthma.
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Effects of early intratympanic steroid injection in patients with acoustic trauma caused by gunshot noise.
Chang, YS, Bang, KH, Jeong, B, Lee, GG
Acta oto-laryngologica. 2017;(7):716-719
Abstract
CONCLUSION This study evaluated the efficacy of concurrent administration of ITSI and systemic steroids in delayed treatment of NIHL after gunshot noise exposure. The results showed additional hearing benefits with administration of ITSI. Further evaluation is warranted to confirm this efficacy. OBJECTIVE This investigation evaluated the effects of early administration of an intratympanic steroid injection (ITSI) in combination with systemic steroids treatment in patients with acoustic trauma caused by gunshot noise. METHODS Nineteen patients eligible under the criteria established concerning delayed treatment for noise-induced hearing loss (NIHL) were enrolled in this study. Patients were divided into two groups: those who received prednisolone (PD) only (n = 8), and those who received PD with ITSI (n = 11). ITSI treatment was initiated simultaneously alongside systemic PD administration. These patients received ITSI every other day for a total of four treatments. Pure-tone air conduction threshold audiometry, to record the pure-tone average (PTA) at 2, 4, and 8 kHz, was conducted upon each patient's initial visit, and 1 month after starting treatment, to evaluate the degree of hearing gain (hearing gain (dB) = (initial PTA) - (final PTA)). RESULTS The initial PTA in PD-only and PD with ITSI groups were 52.75 ± 15.50 dB and 50.27 ± 12.01 dB, respectively. There were no significant differences in the baseline characteristics of the two groups, which include age and the number of days that treatment was delayed. In the multivariable linear regression analysis, both the initial PTA and the treatment method showed a significant association (R2 = 0.41). The unstandardized regression coefficient of the initial PTA was 0.47 (p = 0.02). Patients with additional ITSI showed significant improvement in the degree of hearing gain compared with the PD-only group (unstandardized regression coefficient =11.48, p = 0.03).