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Use of Prophylactic Steroids to Prevent Hypocalcemia and Voice Dysfunction in Patients Undergoing Thyroidectomy: A Randomized Clinical Trial.
Dhahri, AA, Ahmad, R, Rao, A, Bhatti, D, Ahmad, SH, Ghufran, S, Kirmani, N
JAMA otolaryngology-- head & neck surgery. 2021;(10):866-870
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Abstract
IMPORTANCE Total thyroidectomy is associated with risks related to temporary hypocalcemia and vocal quality dysfunction. Dexamethasone has been proposed to have a physiological effect on hypocalcemia and voice quality. OBJECTIVE To assess the effect of preoperative dexamethasone used to improve hypocalcemia and postthyroidectomy voice dysfunction. DESIGN, SETTING, AND PARTICIPANTS This double-blind, parallel-group, placebo-controlled randomized clinical trial was conducted from January 15, 2014, to December 31, 2019, at the Department of Surgery, Holy Family Hospital in Rawalpindi, Pakistan. All patients with a benign thyroid condition and no preoperative corrected hypocalcemia and voice or vocal quality dysfunction were included. Patients were excluded if they had previous thyroid or neck surgery, known vocal cord dysfunction on laryngoscopy, hearing or voice problems, a history of gastroesophageal reflux, stomach ulcer disease, or contraindications to steroid use. INTERVENTIONS Corrected serum calcium levels and Voice Analog Score defined and measured preoperatively. The dexamethasone group received a 2-mL intravenous dose of 8 mg of dexamethasone 60 minutes before the induction of anesthesia. In contrast, the placebo group received 2 mL of intravenous normal saline (0.9%) 60 minutes before the induction of anesthesia. MAIN OUTCOMES AND MEASURES Evidence of hypocalcemia and voice dysfunction. Voice dysfunction was defined as a subjective score of less than 50 on a Voice Analog Score scale of 0 to 100 points. RESULTS A total of 192 patients (mean [SD] age, 38.9 [12.4] years; 156 women [81.2%]) were included in the study, with 96 patients randomized to each study group (dexamethasone group, mean [SD] age, 39.2 [12.1] years; 75 women [78.1%]; placebo group, mean [SD] age, 38.5 [12.9] years; 81 women [84.5%]). In the first 24 hours after undergoing thyroidectomy, 47 patients (24.4%) developed hypocalcemia and 18 (9.4%) were symptomatic. At 3 days postthyroidectomy, 4 of 96 patients (4.2%) in the placebo group had hypocalcemia compared with no patients in the dexamethasone group. At 24 hours postthyroidectomy, 8 of 96 patients (8.3%) in the dexamethasone group had voice dysfunction compared with 32 of 96 patients (33.3%) in the placebo group. A total of 40 patients (20.8%) reported voice dysfunction. The absolute reduction in the rate of hypocalcemia at 24 hours was 24% (95% CI, 11.9%-35.2%) and at 3 days was 4.2% (-0.44% to 10.0%). The rate of symptomatic hypocalcemia was 19% lower in the dexamethasone group than in the placebo group (95% CI, 11.1%-27.7%). The rate of voice dysfunction was 25% lower in the dexamethasone group than in the placebo group (95% CI, 13.7%-35.7%). CONCLUSIONS AND RELEVANCE In this randomized clinical trial, a single preoperative dose of dexamethasone was safe and effective in reducing postoperative hypocalcemia and voice dysfunction rates in patients undergoing thyroidectomy. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT04752852.
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Effects of lisdexamfetamine on plasma steroid concentrations compared with d-amphetamine in healthy subjects: A randomized, double-blind, placebo-controlled study.
Strajhar, P, Vizeli, P, Patt, M, Dolder, PC, Kratschmar, DV, Liechti, ME, Odermatt, A
The Journal of steroid biochemistry and molecular biology. 2019;:212-225
Abstract
The novel d-amphetamine prodrug lisdexamfetamine is applied to treat attention-deficit/hyperactivity disorder (ADHD). d-Amphetamine releases dopamine and norepinephrine and stimulates the hypothalamic-pituitary-adrenal (HPA) axis, which may contribute to its reinforcing effects and risk of abuse. However, no data is currently available on the effects of lisdexamfetamine on circulating steroids. This randomized, double-blind, placebo-controlled, cross-over study evaluated the effects of equimolar doses of d-amphetamine (40 mg) and lisdexamfetamine (100 mg) and placebo on circulating steroids in 24 healthy subjects. Plasma steroid and d-amphetamine levels were determined up to 24 h. Delayed increase and peak levels of plasma d-amphetamine concentrations were observed following lisdexamfetamine treatment compared with d-amphetamine administration, however the maximal concentrations and total exposure (area under the curve [AUC]) were similar. Lisdexamfetamine and d-amphetamine significantly enhanced plasma levels of adrenocorticotropic hormone, glucocorticoids (cortisol, cortisone, corticosterone, 11-dehydrocorticosterone, and 11-deoxycortisol), androgens (dehydroepiandrosterone, dehydroepiandrosterone sulfate, and Δ4-androstene-3,17-dione [androstenedione]), and progesterone (only in men) compared with placebo. Steroid concentration-time curves were shifted to later time points due to a non-significantly later onset following lisdexamfetamine administration than after d-amphetamine, however maximal plasma steroid concentrations and AUCs did not differ between the active treatments. None of the active treatments altered plasma levels of the mineralocorticoids aldosterone and 11-deoxycorticosterone or the androgen testosterone compared with placebo. The effects of the amphetamines on glucocorticoid production were similar to those that were previously reported for methylphenidate (60 mg) but weaker than those for the serotonin releaser 3,4-methylenedioxymethamphetamine (MDMA; 125 mg) or direct serotonin receptor agonist lysergic acid diethylamide (LSD; 0.2 mg). Lisdexamfetamine produced comparable HPA axis activation and had similar pharmacokinetics than d-amphetamine, except for a delayed time of onset. Thus, serotonin (MDMA, LSD) may more effectively stimulate the HPA axis than dopamine and norepinephrine (D-amphetamine).
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Prevention of Orbitopathy by Oral or Intravenous Steroid Prophylaxis in Short Duration Graves' Disease Patients Undergoing Radioiodine Ablation: A Prospective Randomized Control Trial Study.
Vannucchi, G, Covelli, D, Campi, I, Currò, N, Dazzi, D, Rodari, M, Pepe, G, Chiti, A, Guastella, C, Lazzaroni, E, et al
Thyroid : official journal of the American Thyroid Association. 2019;(12):1828-1833
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Abstract
Background: Radioiodine (RAI) is a known risk factor for activation or de novo occurrence of Graves' orbitopathy (GO). Several studies demonstrated that GO can be prevented by glucocorticoids (GCs) in patients with pre-existing GO. We have previously shown that Graves' disease duration (GDd) <5 years is a risk factor for RAI-induced GO. We studied the effect of prophylaxis with either oral GCs (OGCs) or intravenous GCs (IVGCs) on GO activation in patients with GDd. Methods: In total, 99 hyperthyroid patients without GO or with pre-existing inactive GO with GDd <5 years were randomized to receive IVGCs (N = 49) or OGCs (N = 50) before RAI; 22 patients with GDd >5 did not receive steroids and were studied as controls. All patients underwent ophthalmological assessment before and 45, 90, 180 days and for a 5-year follow-up after RAI. Serum thyrotropin (TSH) receptor antibodies (TRAbs), thyroid hormones, and thyroid volume (TV) were also measured in response to RAI therapy and steroid prophylaxis. Results: No patient on prophylaxis developed GO after RAI. One woman of the control group, without steroid prophylaxis, and who had a marked elevation of her TSH, showed transient reactivation of GO, which spontaneously improved after restoring euthyroidism. On follow-up at 12 and 20 months after RAI, two patients developed overt optic neuropathy. A smaller TV was associated with a higher prevalence of RAI-induced hypothyroidism. Serum TRAbs increased significantly after RAI (p < 0.0001) but less in patients receiving steroids than in those without prophylaxis at 45 days (p < 0.01). Conclusions: The risk of RAI-induced GO can be prevented in all patients with GDd <5 years by steroids. Such treatment may not be necessary in patients with GDd >5 years. The blunting of TRAb elevation after RAI may be related to the prophylactic effect of steroids.
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Effect of Oral Administration of a Mixture of Probiotic Strains on SCORAD Index and Use of Topical Steroids in Young Patients With Moderate Atopic Dermatitis: A Randomized Clinical Trial.
Navarro-López, V, Ramírez-Boscá, A, Ramón-Vidal, D, Ruzafa-Costas, B, Genovés-Martínez, S, Chenoll-Cuadros, E, Carrión-Gutiérrez, M, Horga de la Parte, J, Prieto-Merino, D, Codoñer-Cortés, FM
JAMA dermatology. 2018;(1):37-43
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IMPORTANCE Oral intake of new probiotic formulations may improve the course of atopic dermatitis (AD) in a young population. OBJECTIVE To determine whether a mixture of oral probiotics is safe and effective in the treatment of AD symptoms and to evaluate its influence on the use of topical steroids in a young population. DESIGN, SETTING, AND PARTICIPANTS A 12-week randomized, double-blind, placebo-controlled intervention trial, from March to June 2016, at the outpatient hospital Centro Dermatológico Estético de Alicante, Alicante, Spain. Observers were blinded to patient groupings. Participants were children aged 4 to 17 years with moderate atopic dermatitis. The groups were stratified and block randomized according to sex, age, and age of onset. Patients were ineligible if they had used systemic immunosuppressive drugs in the previous 3 months or antibiotics in the previous 2 weeks or had a concomitant diagnosis of intestinal bowel disease or signs of bacterial infection. INTERVENTIONS Twelve weeks with a daily capsule containing freeze-dried powder with 109 total colony-forming units of the probiotic strains Bifidobacterium lactis CECT 8145, B longum CECT 7347, and Lactobacillus casei CECT 9104 and maltodextrin as a carrier, or placebo (maltodextrin-only capsules). MAIN OUTCOMES AND MEASURES SCORAD index score and days of topical steroid use were analyzed. RESULTS Fifty children (26 [50%] female; mean [SD] age, 9.2 [3.7] years) participated. After 12 weeks of follow-up, the mean reduction in the SCORAD index in the probiotic group was 19.2 points greater than in the control group (mean difference, -19.2; 95% CI, -15.0 to -23.4). In relative terms, we observed a change of -83% (95% CI, -95% to -70%) in the probiotic group and -24% (95% CI, -36% to -11%) in the placebo group (P < .001). We found a significant reduction in the use of topical steroids to treat flares in the probiotic arm (161 of 2084 patient-days [7.7%]) compared with the control arm (220 of 2032 patient-days [10.8%]; odds ratio, 0.63; 95% CI, 0.51 to 0.78). CONCLUSIONS AND RELEVANCE The mixture of probiotics was effective in reducing SCORAD index and reducing the use of topical steroids in patients with moderate AD. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02585986.
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A randomized nutrition counseling intervention in pediatric leukemia patients receiving steroids results in reduced caloric intake.
Li, R, Donnella, H, Knouse, P, Raber, M, Crawford, K, Swartz, MC, Wu, J, Liu, D, Chandra, J
Pediatric blood & cancer. 2017;(2):374-380
Abstract
BACKGROUND Quality of life in survivors of pediatric acute lymphocytic leukemia (ALL) can be compromised by chronic diseases including increased risk of second cancers, cardiovascular disease, and diabetes. Overweight or obesity further increases these risks. Steroids are a component of chemotherapy for ALL, and weight gain is a common side effect. To impact behaviors associated with weight gain, we conducted a randomized nutrition counseling intervention in ALL patients on treatment. PROCEDURE ALL patients on a steroid-based treatment regimen at the MD Anderson Children's Cancer Hospital were recruited and randomized into control or intervention groups. The control group received standard care and nutrition education materials. The intervention group received monthly one-on-one nutrition counseling sessions, consisting of a baseline and 12 follow-up visits. Anthropometrics, dietary intake (3-day 24-hr dietary recalls) and oxidative stress measures were collected at baseline, 6 months, and postintervention. Dietary recall data were analyzed using the Nutrition Data System for Research. RESULTS Twenty-two patients (median age 11.5 years), all in the maintenance phase of treatment, were recruited. The intervention group (n = 12) reported significantly lower calorie intake from baseline to 12-month follow-up and significant changes in glutamic acid and selenium intake (P < 0.05). Waist circumference was significantly associated with calorie, vitamin E, glutamic acid, and selenium intake. CONCLUSIONS A year-long dietary intervention was effective at reducing caloric intake in pediatric ALL patients receiving steroid-based chemotherapy, indicating that this is a modality that can be built upon for obesity prevention and management.
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Steroid vs. Platelet-Rich Plasma in Ultrasound-Guided Sacroiliac Joint Injection for Chronic Low Back Pain.
Singla, V, Batra, YK, Bharti, N, Goni, VG, Marwaha, N
Pain practice : the official journal of World Institute of Pain. 2017;(6):782-791
Abstract
BACKGROUND Despite widespread use of steroids to treat sacroiliac joint (SIJ) pain, their duration of pain reduction is short. Platelet-rich plasma (PRP) can potentially enhance tissue healing and may have a longer-lasting effect on pain. OBJECTIVES To assess the efficacy and safety of PRP compared with methylprednisolone in ultrasound-guided SIJ injection for low back pain. STUDY DESIGN Prospective randomized open blinded end point (PROBE) study. METHODS Forty patients with chronic low back pain diagnosed with SIJ pathology were randomly allocated into 2 groups. Group S received 1.5 mL of methylprednisolone (40 mg/mL) and 1.5 mL of 2% lidocaine with 0.5 mL of saline, while Group P received 3 mL of leukocyte-free PRP with 0.5 mL of calcium chloride into ultrasound-guided SIJ injection. Visual analog scale (VAS) scores, Modified Oswestry Disability Questionnaire (MODQ) scores, Short Form (SF-12) Health Survey scores, and complications (if any) were evaluated at 2 weeks, 4 weeks, 6 weeks, and 3 months. RESULTS Intensity of pain was significantly lower in Group P at 6 weeks (median [interquartile range (IQR)] = 1 [1 to 1] vs. 3.5 [2 to 5]; P = 0.0004) and 3 months (Median [IQR] = 1 [1 to 3] vs. 5 [3 to 5]; P = 0.0002) as compared to Group S. The efficacy of steroid injection was reduced to only 25% at 3 months in Group S, while it was 90% in Group P. A strong association was observed in patients receiving PRP and showing a reduction of VAS ≥ 50% from baseline when other factors were controlled. The MODQ and SF-12 scores were improved initially for up to 4 weeks but deteriorated further at 3 months in Group S, while both the scores improved gradually for up to 3 months in Group P. CONCLUSION The intra-articular PRP injection is an effective treatment modality in low back pain involving SIJ.
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"Coffee plus honey" versus "topical steroid" in the treatment of chemotherapy-induced oral mucositis: a randomised controlled trial.
Raeessi, MA, Raeessi, N, Panahi, Y, Gharaie, H, Davoudi, SM, Saadat, A, Karimi Zarchi, AA, Raeessi, F, Ahmadi, SM, Jalalian, H
BMC complementary and alternative medicine. 2014;:293
Abstract
BACKGROUND Oral mucositis is one of the common complications of cancer chemotherapy and about 40% of the patients who take chemotherapy protocols, experience this irritating problem. The purpose of this study was to draw comparison between the therapeutic effects of our treatment modalities (topical steroid, honey, honey plus coffee) in patients suffering from oral mucositis. METHODS This was a double blinded randomised clinical trial of a total of 75 eligible adult participants which they randomly fell into three treatment groups. For all the participants a syrup-like solution was prepared. Each 600 grams of the product consisted of "20 eight-mg Betamethasone solution ampoules" in the Steroid (S) group, "300 grams of honey plus 20 grams of instant coffee" in the Honey plus Coffee (HC) group, and "300 grams of honey" for the Honey (H) group. The participants were told to sip 10 ml of the prescribed product, and then swallow it every three hours for one week. Severity of lesions was clinically evaluated before the treatment and also one week after the initiation of the intervention. This study adhered to the principles of the Declaration of Helsinki and guidelines of Good Clinical Practice. RESULTS This study showed that all three treatment regimens reduce the severity of lesions. The best reduction in severity was achieved in HC group. H group and S group took the second and third places. In other words, honey plus coffee regimen was the most effective modality for the treatment of oral mucositis. CONCLUSION Oral mucositis can be successfully treated by a combination of honey and coffee as an alternative medicine in a short time. Further investigations are warranted in this field. TRIAL REGISTRATION Iranian Registry of Clinical Trials IRCT 201104074737N3, (9 May 2011).
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Complete steroid avoidance is effective and safe in children with renal transplants: a multicenter randomized trial with three-year follow-up.
Sarwal, MM, Ettenger, RB, Dharnidharka, V, Benfield, M, Mathias, R, Portale, A, McDonald, R, Harmon, W, Kershaw, D, Vehaskari, VM, et al
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 2012;(10):2719-29
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To determine whether steroid avoidance in pediatric kidney transplantation is safe and efficacious, a randomized, multicenter trial was performed in 12 pediatric kidney transplant centers. One hundred thirty children receiving primary kidney transplants were randomized to steroid-free (SF) or steroid-based (SB) immunosuppression, with concomitant tacrolimus, mycophenolate and standard dose daclizumab (SB group) or extended dose daclizumab (SF group). Follow-up was 3 years posttransplant. Standardized height Z-score change after 3 years follow-up was -0.99 ± 2.20 in SF versus -0.93 ± 1.11 in SB; p = 0.825. In subgroup analysis, recipients under 5 years of age showed improved linear growth with SF compared to SB treatment (change in standardized height Z-score at 3 years -0.43 ± 1.15 vs. -1.07 ± 1.14; p = 0.019). There were no differences in the rates of biopsy-proven acute rejection at 3 years after transplantation (16.7% in SF vs. 17.1% in SB; p = 0.94). Patient survival was 100% in both arms; graft survival was 95% in the SF and 90% in the SB arms (p = 0.30) at 3 years follow-up. Over the 3 year follow-up period, the SF group showed lower systolic BP (p = 0.017) and lower cholesterol levels (p = 0.034). In conclusion, complete steroid avoidance is safe and effective in unsensitized children receiving primary kidney transplants.
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A randomized trial to assess the impact of early steroid withdrawal on growth in pediatric renal transplantation: the TWIST study.
Grenda, R, Watson, A, Trompeter, R, Tönshoff, B, Jaray, J, Fitzpatrick, M, Murer, L, Vondrak, K, Maxwell, H, Van Damme-Lombaerts, R, et al
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 2010;(4):828-836
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Minimizing steroid exposure in pediatric renal transplant recipients can improve linear growth and reduce metabolic disorders. This randomized multicenter study investigated the impact of early steroid withdrawal on mean change in height standard deviation score (SDS) and the safety and efficacy of two immunosuppressive regimens during the first 6 months after transplantation. Children received tacrolimus, MMF, two doses of daclizumab and steroids until day 4 (TAC/MMF/DAC, n=98) or tacrolimus, MMF and standard-dose steroids (TAC/MMF/STR, n=98). Mean change in height SDS was 0.16 +/- 0.32 with TAC/MMF/DAC and 0.03 +/- 0.32 with TAC/MMF/STR. The mean treatment group difference was 0.13 (p < 0.005 [95% CI 0.04-0.22]), 0.21 in prepubertal (p = 0.009 [95% CI 0.05-0.36]) and 0.05 in pubertal children (p = ns). Frequency of biopsy-proven acute rejection was 10.2%, TAC/MMF/DAC, and 7.1%, TAC/MMF/STR. Patient and graft survival and renal function were similar. Significantly greater reductions in total cholesterol and triglycerides but significantly higher incidences of infection and anemia were found with TAC/MMF/DAC (p < 0.05 all comparisons). Early steroid withdrawal significantly aided growth at 6 months more so in prepubertal than pubertal children. This was accompanied by significantly better lipid and glucose metabolism profiles without increases in graft rejection or loss.
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Protocol for evaluation of the comparative effectiveness of percutaneous adhesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis.
Manchikanti, L, Pampati, V, Cash, KA
Pain physician. 2010;(2):E91-E110
Abstract
BACKGROUND Treatment of chronic low back pain with or without lower extremity pain continues to be a challenge. Epidural steroids are commonly utilized in patients after the failure of conservative treatment. The results of epidural steroid injections have been variable based on the pathophysiology, the route of administration, injected drugs, and utilization of fluoroscopy. In patients resistant to fluoroscopically directed epidural injections, percutaneous epidural adhesiolysis and percutaneous targeted delivery of injections with or without adhesiolysis has been recommended. Percutaneous adhesiolysis has been studied in chronic pain syndromes related to post laminectomy syndrome and spinal stenosis with encouraging results. There is a paucity of literature regarding the effectiveness of the targeted delivery of medications with or without epidural adhesiolysis in patients recalcitrant to epidural steroid injections without a history of surgery and spinal stenosis. STUDY DESIGN A randomized, equivalence trial of percutaneous lumbar adhesiolysis and caudal epidural steroid injections in patients with low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. SETTING An interventional pain management practice setting in the United States. OBJECTIVE The study is designed to evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare it with fluoroscopically directed caudal epidural steroid injections METHODS The study design includes 120 patients randomly assigned into 2 groups. Group I (60 patients), the control group, will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution; Group II (60 patients), the intervention group, will receive percutaneous adhesiolysis with target delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-participate betamethasone. Randomization will be performed by computer-generated random allocation sequence by simple randomization. OUTCOME MEASURES Multiple outcome measures will be utilized including numeric rating scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, 12, 18 and 24 months post treatment. Significant pain relief is considered as 50% or more, whereas significant improvement in the disability score is defined as a reduction of 40% or more. RESULTS The results will be analyzed to show significant relief as well as improvement in functional status. LIMITATIONS This study is limited by potentially inadequate double blinding and the lack of a placebo group.