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Recovery After Adenotonsillectomy-Do Steroids Help? Outcomes From a Randomized Controlled Trial.
Greenwell, AG, Isaiah, A, Pereira, KD
Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery. 2021;(1):83-88
Abstract
OBJECTIVES The primary objective was to compare pain control following adenotonsillectomy (AT) in children with and without a single postoperative dose of oral dexamethasone in addition to standard analgesic medication. The secondary objective was to compare changes in caregiver-reported snoring, return to normal diet and baseline function, and the number of phone calls and emergency department (ED) visits. STUDY DESIGN Prospective randomized controlled trial. SETTING Tertiary care university hospital. METHODS Children aged 3 to 10 years with sleep-disordered breathing who were scheduled to undergo AT were randomized to receive standard analgesia with or without dexamethasone (0.6 mg/kg) administered on the third postoperative day. Standard analgesia was defined as alternating weight-based doses of ibuprofen and acetaminophen. A nurse practitioner blinded to the study condition performed telephone surveys postoperatively, and the electronic medical record was reviewed. RESULTS Enrollment comprised 149 children, of whom 119 were included. When compared with the control group (n = 61, 51%), children who received dexamethasone (n = 58, 49%) had a greater decrease in reported pain score on day 4 (mean ± SD, 2.5 ± 3.1 vs 1.1 ± 3.5, P < .001). Additionally, steroid use was associated with fewer caregiver phone calls (18 [29.5%] vs 6 [10%]) and ED visits (6 [10%] vs 1 [2%]). CONCLUSION A single dose of dexamethasone administered on day 3 after adenotonsillectomy significantly improved pain control. There were fewer phone calls and ED visits in the steroid arm. These results support the use of oral steroids as an adjunct for postoperative pain control in children undergoing AT.
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Prophylactic metformin after antenatal corticosteroids (PROMAC): a double blind randomized controlled trial.
Hong, JGS, Tan, PC, Kamarudin, M, Omar, SZ
BMC pregnancy and childbirth. 2021;(1):138
Abstract
BACKGROUND Antenatal corticosteroids (ACS) are increasingly used to improve prematurity-related neonatal outcome. A recognized and common adverse effect from administration of antenatal corticosteroid is maternal hyperglycemia. Even normal pregnancy is characterized by relative insulin resistance and glucose intolerance. Treatment of maternal hyperglycemia after ACS might be indicated due to the higher risk of neonatal acidosis which may coincide with premature birth. Metformin is increasingly used to manage diabetes mellitus during pregnancy as it is effective and more patient friendly. There is no data on prophylactic metformin to maintain euglycemia following antenatal corticosteroids administration. METHODS A double blind randomized trial. 103 women scheduled to receive two doses of 12-mg intramuscular dexamethasone 12-hour apart were separately randomized to take prophylactic metformin or placebo after stratification according to their gestational diabetes (GDM) status. First oral dose of allocated study drug was taken at enrolment and continued 500 mg twice daily for 72 hours if not delivered. Six-point blood sugar profiles were obtained each day (pre- and two-hour post breakfast, lunch and dinner) for up to three consecutive days. A hyperglycemic episode is defined as capillary glucose fasting/pre-meal ≥ 5.3 mmol/L or two-hour post prandial/meal ≥ 6.7 mmol/L. Primary outcome was hyperglycemic episodes on Day-1 (first six blood sugar profile points) following antenatal corticosteroids. RESULTS Number of hyperglycemic episodes on the first day were not significantly different (mean ± standard deviation) 3.9 ± 1.4 (metformin) vs. 4.1 ± 1.6 (placebo) p = 0.64. Hyperglycemic episodes markedly reduced on second day in both arms to 0.9 ± 1.0 (metformin) vs. 1.2 ± 1.0 (placebo) p = 0.15 and further reduced to 0.6 ± 1.0 (metformin) vs. 0.7 ± 1.0 (placebo) p = 0.67 on third day. Hypoglycemic episodes during the 3-day study period were few and all other secondary outcomes were not significantly different. CONCLUSIONS In euglycemic and diet controllable gestational diabetes mellitus women, antenatal corticosteroids cause sustained maternal hyperglycemia only on Day-1. The magnitude of Day-1 hyperglycemia is generally low. Prophylactic metformin does not reduce antenatal corticosteroids' hyperglycemic effect. TRIAL REGISTRATION The trial is registered in the ISRCTN registry on May 4 2017 with trial identifier https://doi.org/10.1186/ISRCTN10156101 .
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Comparison of Therapeutic Results with/without Additional Hyperbaric Oxygen Therapy in Idiopathic Sudden Sensorineural Hearing Loss: A Randomized Prospective Study.
Tong, B, Niu, K, Ku, W, Xie, W, Dai, Q, Hellström, S, Duan, M
Audiology & neuro-otology. 2021;(1):11-16
Abstract
OBJECTIVE To assess the efficacy of the combination of hyperbaric oxygen (HBO) and pharmacological treatment in patients with idiopathic sudden sensorineural hearing loss (ISSNHL) and define patients amenable for HBO therapy. METHODS Prospective, randomized, trial involving 136 cases with unilateral ISSNHL that were randomly divided into 2 groups: the pharmacological treatment (P) group and HBO + pharmacological treatment (HBO+P) group, which received additional HBO for 14 days besides the pharmacological treatments. Pure tone audiometry gain larger than 15 dBHL was defined as success, and the success rate of each group was calculated. RESULTS The overall success rate of the HBO+P group and the P group is 60.6% (40/66) and 42.9% (30/70), respectively (p < 0.05). Furthermore, patients with mild-moderate baseline hearing loss, aged ≤50 years, receiving treatment in ≤14 days, or without accompanied dizziness/vertigo in the HBO+P group had higher success rate than the P group (p < 0.05). CONCLUSIONS HBO combined with pharmacological treatments leads to better hearing recovery than pharmacological treatments alone.
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A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.
Ta, CN, Raizman, MB, Gross, RD, Joshi, S, Mallick, S, Wang, Y, Segal, B
American journal of ophthalmology. 2020;:56-65
Abstract
PURPOSE To evaluate the efficacy and safety of a topical ophthalmic suspension combination of povidone-iodine 0.6% (PVP-I) and dexamethasone 0.1% (DEX) for infectious and inflammatory components of bacterial conjunctivitis. DESIGN Randomized, double-masked, multicenter, phase 3 clinical trial. METHODS Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I alone, or placebo. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at the day 5 visit. Adverse events (AEs) were documented at all visits. RESULTS Overall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; placebo [n = 321]); mean and standard deviation (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity). CONCLUSION In this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.
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Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections.
Besirli, CG, Smith, SJ, Zacks, DN, Gardner, TW, Pipe, KP, Musch, DC, Shah, AR
Ophthalmology. Retina. 2020;(10):979-986
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Abstract
PURPOSE To test the safety and preliminary efficacy of rapid, nonpharmacologic anesthesia via cooling for intravitreal injections. DESIGN Single-center, randomized phase 1 dose-ranging safety study (ClinicalTrials.gov identifier, NCT02872012). PARTICIPANTS Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included. METHODS A handheld device was developed to provide anesthesia via cooling to a focal area on the surface of the eye before intravitreal treatment (IVT). In 22 patients undergoing bilateral IVT, 1 eye was randomized to receive standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia at 1 of 5 different temperatures and cooling times. Subjective pain was assessed via the visual analog scale (VAS; range, 1-10) at 2 time points: (1) immediately after IVT and (2) 4 hours after IVT. Treated eyes were assessed for ocular safety 24 hours after IVT. MAIN OUTCOME MEASURES We determined the occurrence of adverse events in eyes treated with cooling anesthesia. Mean VAS pain scores immediately after IVT and 4 hours after IVT in eyes receiving cooling anesthesia were compared with eyes receiving SOC. RESULTS A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC. No dose-related toxicity was found with cooling anesthesia. Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC. The mean±standard error of the mean (SEM) VAS pain scores immediately after intravitreal injection were 2.3 ± 0.4 for patients receiving SOC and 2.2 ± 0.6 in patients receiving -10° C cooling anesthesia (P = 0.8). Mean±SEM pain scores 4 hours after injection were 1.6 ± 0.4 for SOC and 1.2 ± 0.5 in the combined -10° C arms (P = 0.56). Total mean±SEM procedure time was 124 ± 5 seconds for patients treated with cooling anesthesia versus 395 ± 40 seconds for SOC (P < 0.0001). CONCLUSIONS Ultra-rapid cooling of the eye for anesthesia was well tolerated, with -10° C treatment resulting in comparable levels of anesthesia to SOC with a reduction in procedure time.
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Glucocorticoids affect metabolic but not muscle microvascular insulin sensitivity following high versus low salt intake.
Schütten, MT, Kusters, YH, Houben, AJ, Niessen, HE, Op 't Roodt, J, Scheijen, JL, van de Waardenburg, MP, Schalkwijk, CG, de Leeuw, PW, Stehouwer, CD
JCI insight. 2020;(6)
Abstract
BACKGROUNDSalt-sensitive hypertension is often accompanied by insulin resistance in obese individuals, but the underlying mechanisms are obscure. Microvascular function is known to affect both salt sensitivity of blood pressure and metabolic insulin sensitivity. We hypothesized that excessive salt intake increases blood pressure and decreases insulin-mediated glucose disposal, at least in part by impairing insulin-mediated muscle microvascular recruitment (IMMR).METHODSIn 20 lean and 20 abdominally obese individuals, we assessed mean arterial pressure (MAP; 24-hour ambulatory blood pressure measurements), insulin-mediated whole-body glucose disposal (M/I value; hyperinsulinemic-euglycemic clamp technique), IMMR (contrast-enhanced ultrasound), osmolyte and water balance, and excretion of mineralocorticoids, glucocorticoids, and amino and organic acids after a low- and high-salt diet during 7 days in a randomized, double-blind, crossover design.RESULTSOn a low-, as compared with a high-salt, intake, MAP was lower, M/I value was lower, and IMMR was greater in both lean and abdominally obese individuals. In addition, natural logarithm IMMR was inversely associated with MAP in lean participants on a low-salt diet only. On a high-salt diet, free water clearance decreased, and excretion of glucocorticoids and of amino acids involved in the urea cycle increased.CONCLUSIONOur findings imply that hemodynamic and metabolic changes resulting from alterations in salt intake are not necessarily associated. Moreover, they are consistent with the concept that a high-salt intake increases muscle glucose uptake as a response to high salt-induced, glucocorticoid-driven muscle catabolism to stimulate urea production and thereby renal water conservation.TRIAL REGISTRATIONClinicalTrials.gov, NCT02068781.
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Study protocol for efficacy and safety of steroid-containing mouthwash to prevent chemotherapy-induced stomatitis in women with breast cancer: a multicentre, open-label, randomised phase 2 study.
Kuba, S, Yamanouchi, K, Matsumoto, M, Maeda, S, Hatachi, T, Sakiko, S, Kawashita, Y, Morita, M, Sakimura, C, Inamasu, E, et al
BMJ open. 2020;(2):e033446
Abstract
INTRODUCTION Stomatitis is a frequent adverse event in patients undergoing chemotherapy for breast cancer. Stomatitis can hamper oral nutrition resulting in malnutrition, reduce quality of life and introduce the need for dose reductions and interruption of chemotherapy; however, there is currently no standard approach for preventing chemotherapy-induced stomatitis. We aimed to assess the safety and efficacy of a dexamethasone-based elixir mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer. METHODS AND ANALYSIS In this multicenter, randomised, controlled phase 2 trial, we will randomly assign 120 women with early breast cancer undergoing chemotherapy to use of a dexamethasone-based elixir or standard oral care, to compare their preventive effects on chemotherapy-induced stomatitis. Patients will be assigned in a 1:1 ratio. Patients in the intervention group will receive chemotherapy, oral care and a dexamethasone-based elixir (10 mL 0.1 mg/mL; swish for 2 min and spit, four times daily for 9 weeks), and patients in the control group will receive chemotherapy and oral care. The primary endpoint is the difference in incidence of stomatitis between the two groups. The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups. Secondary endpoints are severity of stomatitis, duration of stomatitis, completion rate of chemotherapy and adverse events. ETHICS AND DISSEMINATION All participants signed a written consent form, and the study protocol has been reviewed and approved by the Clinical Research Review Board of Nagasaki University (CRB7180001). TRIAL REGISTRATION NUMBER UMIN Clinical Trials Registry (UMIN000030489).
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Conservative Treatment Versus Ultrasound-Guided Injection in the Management of Meralgia Paresthetica: A Randomized Controlled Trial.
Kiliç, S, Özkan, FÜ, Külcü, DG, Öztürk, G, Akpinar, P, Aktas, I
Pain physician. 2020;(3):253-262
Abstract
BACKGROUND Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), in which conservative treatment options are not always sufficient. OBJECTIVES The aim of this study was to evaluate the efficacy of ultrasound (US)-guided LFCN injection in the management of MP by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham TENS therapy. STUDY DESIGN A prospective, randomized, sham-controlled study. SETTING Health Sciences University Training and Research Hospital in Turkey. METHODS Patients diagnosed with LFCN compression with clinical and electrophysiological findings were included in this study. Patients were randomly assigned to 3 groups: (1) US-guided injection group, (2) TENS group, and (3) sham TENS group. The blockage of the LFCN was performed for therapeutic MP management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days per week for 2 weeks, for 20 minutes per daily session in group 2, and sham TENS was applied to group 3 with the same protocol. Visual Analog Scale (VAS), painDETECT questionnaire, Semmes-Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life (36-Item Short Form Health Survey [SF-36]) at onset (T1), 15 days after treatment (T2), and 1 month after treatment (T3) were used for evaluation. Patients and the investigator who evaluated the results were blinded to the treatment protocol during the study period. RESULTS A total of 54 of the 62 patients (group 1 n = 17, group 2 n = 16, group 3 n = 21) completed the study, 3 patients from group 1, 4 patients from group 2, and 1 patient from group 3 dropped out during the follow-up period. The mean changes in painDETECT and SWMt scores showed a statistically significant difference between groups in favor of group 1 at T2 and T3 compared with T1 (P < 0.05). There was no statistically significant difference between groups in terms of VAS, SF-36, and PSQI scores (P > 0.05). In-group analysis of VAS scores showed a statistically significant decrease in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of the VAS scores statistically significant decrease was shown in T2 compared with T1 in group 2 (P < 0.05). In-group analysis of painDETECT scores statistically significant decrease was shown in T2 and T3 compared with T1 in all groups (P < 0.05). In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of SF-36 and PSQI scores, there was no statistically significant decrease in all groups (P > 0.05). LIMITATIONS The limitation of the study was a short follow-up period. CONCLUSIONS US-guided LFCN injection and TENS may be therapeutic options for MP treatment, however, for patients with neuropathic pain symptoms, US-guided LFCN injection may be a safe and alternative method to conservative treatment. KEY WORDS Meralgia paresthetica, ultrasound-guided injection, transcutaneous electrical nerve stimulation.
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Effectiveness of Phonophoresis Treatment in Carpal Tunnel Syndrome: A Randomized Double-blind, Controlled Trial.
Boonhong, J, Thienkul, W
PM & R : the journal of injury, function, and rehabilitation. 2020;(1):8-15
Abstract
OBJECTIVE To determine the effects of phonophoresis of piroxicam (PH-P) and phonophoresis of dexamethasone sodium phosphate (PH-Dex) on mild to moderate carpal tunnel syndrome (CTS), and to compare each of them with the control group of nondrug ultrasound (US) therapy. DESIGN A randomized, double-blind controlled trial. SETTING Department of rehabilitation medicine, university hospital. PARTICIPANTS Patients with clinical signs and symptoms of CTS underwent an electrophysiological study to confirm the diagnosis of CTS and severity grading. Thirty-three patients, 50 hands (52% of the patients had bilateral CTS, n = 17) with mild to moderate CTS were randomly allocated into three study groups: PH-P, PH-Dex, or US. INTERVENTION All three groups received 10 sessions of 1-MHz frequency, 1.0 w/cm2 intensity ultrasound wave with stroking technique, continuous mode, at the palm side of the hand over the carpal tunnel area-10 minutes per session, two to three times per week for 4 weeks, for a total of 10 sessions. During each session, the patients received 15 cm3 of study gel according to the study groups. The PH-P group received 0.5% piroxicam gel mixture (equivalence of 20 mg of piroxicam). The PH-Dex group received 0.4% dexamethasone sodium phosphate gel mixture (equivalence 60 mg of dexamethasone). The US group received nondrug gel. MAIN OUTCOME MEASUREMENTS Boston Carpal Tunnel Questionnaire for symptom severity (BCTQ SYMPT), Boston Carpal Tunnel Questionnaire for functional status (BCTQ FUNCT) and electrophysiological parameters of the median nerve including distal sensory latency (DSL) and distal motor latency (DML) were evaluated before the first treatment and after the last treatment. RESULTS After treatment, all treatment groups (PH-P, PH-Dex, and US) showed significant improvements of the BCTQ SYMPT (P < .001, -0.74 ± 0.73 [-1.12, -0.37], -0.91 ± 0.96 [-1.41, -0.42], and - 0.68 ± 0.71 [-1.05, -0.30], respectively) and the BCTQ FUNCT (P < .001, -0.68 ± 0.89 [-1.14, -0.22], -0.74 ± 0.84 [-1.17, -0.30], and - 0.80 ± 0.80 [-1.22, -0.37], respectively). For the BCTQ SYMPT, only the PH-Dex showed an improvement score above MCID at 0.8 level [-0.91 ± 0.96]. The improvement of BCTQ FUNCT score of all groups was above Minimal Clincally Important Difference (MCID) at 0.5 level (-0.68 ± 0.89, -0.74 ± 0.84 and - 0.80 ± 0.80, respectively).The DSL was decreased in all groups but the changes were not statistically significant (P = .70, -0.11 ± 0.34 [-0.28, 0.06], -0.09 ± 0.32 [-0.26, 0.07], and - 0.14 ± 0.29 [-0.29, 0.02], respectively). The DML showed decrease only in PH-DEX and the US group but it was not statistically significant (P = .68, 0.05 ± 0.44 [-0.17, 0.27], -0.09 ± 0.51[-0.34, 0.17], and - 0.27 ± 0.49 [-0.53, 0.01], respectively). All measured outcomes were not statistically different in between-group-comparison of BCTQ SYMPT, BCTQ FUNCT, DSL, and DML (P = .58, P = .79, P = .20 and P = .39, respectively). However, there was a clinically significant difference of the improvement of BCTQ SYMPT in between-group comparison; only the PH-DEX was above the MCID level, while the PH-P and US were not. CONCLUSIONS Neither nondrug US nor phonophoresis treatments (PH-P and PH-Dex) were effective to improve the DSL and DML in mild to moderate CTS. All three groups showed significant improvements in clinical symptoms (BCTQ SYMPT) and functional status (BCTQ FUNCT). At 1 MHz frequency and 1.0 w/cm2 intensity of ultrasound wave, there is no statistically significant difference between phonophoresis and the nondrug US. LEVEL OF EVIDENCE I.
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Eldecalcitol is superior to alfacalcidol in maintaining bone mineral density in glucocorticoid-induced osteoporosis patients (e-GLORIA).
Matsumoto, T, Yamamoto, K, Takeuchi, T, Tanaka, Y, Tanaka, S, Nakano, T, Ito, M, Tomomitsu, T, Hirakawa, A, Soen, S
Journal of bone and mineral metabolism. 2020;(4):522-532
Abstract
INTRODUCTION Eldecalcitol increases bone mineral density (BMD) and reduces vertebral fracture in patients with primary osteoporosis. However, the effect of eldecalcitol on BMD and fracture in glucocorticoid-induced osteoporosis (GIO) patients is unknown. This study was undertaken to compare the effect of eldecalcitol on BMD and fracture with that of alfacalcidol in GIO patients. MATERIALS AND METHODS A randomized, open-label, parallel group study was conducted to identify the effectiveness and safety of monotherapy with 0.75 μg eldecalcitol compared with 1.0 μg alfacalcidol in GIO patients. RESULTS Lumbar spine BMD increased with eldecalcitol, but decreased with alfacalcidol at 12 and 24 months (between group difference 1.29%, p < 0.01, and 1.10%, p < 0.05, respectively). Total hip and femoral neck BMD were maintained until 24 months by eldecalcitol, but decreased by alfacalcidol (between group difference 0.97%, p < 0.05 and 1.22%, p < 0.05, respectively). Both bone formation and resorption markers were more strongly suppressed by eldecalcitol than by alfacalcidol. Eldecalcitol showed better effect on BMD than alfacalcidol in patients with no prevalent fracture and BMD > 70% of the young adult mean, and with ≤ 3 months of previous glucocorticoid treatment. No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups. CONCLUSIONS Eldecalcitol was more effective than alfacalcidol in maintaining BMD in GIO patients. Because eldecalcitol was effective in patients with no or short-term previous glucocorticoid treatment, as well as those without prevalent fracture or low BMD, eldecalcitol can be a good candidate for primary prevention of GIO. CLINICAL TRIAL REGISTRATION NUMBER UMIN000011700.