Alfacalcidol versus calcitriol in the management of patient with hypoparathyroidism: a randomized control trial

Author(s):  
Soma Saha ◽  
Sreenivas Vishnubhatla ◽  
Ravinder Goswami

Abstract Context Alfacalcidol and calcitriol are commonly used for managing hypoparathyroidism. Their relative merits have not been systematically assessed. Objective We compared the effect of alfacalcidol and calcitriol on phosphatemic control, hypercalciuria and associated factors in idiopathic-hypoparathyroidism (IH). Design and Setting Open label randomized-controlled-trial, tertiary-care-center. Subjects and Methods IH patients with optimal calcemic control on alfacalcidol were continued on the same (n=20) or switched to calcitriol (n=25) at half of the ongoing alfacalcidol dose. The dose was adjusted during follow-up to maintain serum total calcium between 8.0-9.5 mg/dL. Serum calcium, phosphorus, 25-hydroxyvitamin-D, 1,25-dihydroxyvitamin-D, 24-hr urine calcium-to-creatinine ratio, fractional-excretion-of-phosphorus (FEPh) were measured at baseline and six-months. Plasma intact-FGF23 was measured at final follow-up. Result Patients receiving alfacalcidol and calcitriol had comparable serum calcium at six-months (8.7 ± 0.4 vs. 8.9 ± 0.4 mg/dL, P = 0.13). Their median (IQR) dose at six-months was 2.0 (1.0-2.5) and 0.75 (0.5-1.0) µg/d, respectively. Serum 1,25(OH)2D levels were physiological in both (35.3 ± 11.6 and 32.3 ± 16.9 pg/ml). Serum phosphate and calcium-excretion were comparable in two arms. Majority had hyperphosphatemia (75% vs. 76%), hypercalciuria (75% vs. 72%) and elevated FGF23 (116 ± 68 and 113 ± 57 pg/mL). Age showed significant independent association with plasma FGF23 (β = 1.9, P = 0.001). Average FEPh was low despite high FGF23. Conclusion At optimal calcium control both alfacalcidol and calcitriol lead to comparable but high serum phosphate levels, hypercalciuria, physiological circulating 1,25(OH)2D and elevated FGF23. Further studies are required to systematically investigate other treatment options.

2008 ◽  
Vol 139 (2_suppl) ◽  
pp. P36-P36 ◽  
Author(s):  
Yalon Dolev ◽  
Martin J Black ◽  
Michael P Hier ◽  
Michael Tamilia ◽  
Richard J Payne

Objective To clearly define what constitutes successful parathyroidectomy in patients with primary hyperparathyroidism and to review our institution's results. Methods A retrospective chart review was conducted for consecutive patients who underwent parathyroidectomy at a university-affiliated tertiary care center between January 1998 and February 2006. Intraoperative pre- and post-excision PTH levels were recorded. PTH and calcium levels were recorded at 3 – 6 month intervals in the first 2 years and then yearly. Results 84 patients were analyzed. 50 (60%) had normal calcium and normal PTH levels following surgery, 28 (33%) had normal calcium and elevated PTH following surgery, and 6 (7%) had both elevated calcium and PTH. The mean follow-up time was 2.23 years, with a range of 0.25 to 5 years. Conclusions Surgery was successful, as indicated by normocalcemia, in 78 patients (93%). Of these 78 patients, 28 (33%) developed persistent PTH elevation without developing hypercalcemia. Other studies have studied this subgroup of patients with normalized post-operative calcium and consistently elevated PTH levels and noted that these new set points persist. Consequently, successful parathyroidectomy should be defined by serum calcium and not PTH levels.


2020 ◽  
Vol 14 (2) ◽  
pp. 87-90
Author(s):  
Sadaf Amin Chaudhry ◽  
Nadia Ali Zafar ◽  
Rabia Hayat ◽  
Ayesha Noreen ◽  
Gulnaz Ali ◽  
...  

Background: Acne is the eighth most prevalent disease affecting 9.4% of the population worldwide and its prevalence in our country is estimated to be around 5%. Severe inflammatory acne is most likely to leave scars and in order to prevent facial disfigurement due to acne scarring, early treatment is desirable. Various treatment options have been formulated for acne, and are tailored according to the severity of the disease. Numerous clinical trials have been conducted till now, to determine the usefulness and side effect profile of such therapies, making acne treatment a highly studied area in dermatology. Objective of this study is to highlight the fact that oral Dapsone could be used as a cheaper alternate to isotretinoin in recalcitrant severe acne, especially in females where retinoids are sometimes contraindicated. Patients and methods: 51 patients, suffering from severe nodulocystic acne, fulfilling the criteria, were enrolled from the Department of Dermatology, Sir Ganga Ram Hospital, Lahore. All the study patients were given oral Dapsone 50mg for initial two weeks and then 100mg daily for the next 10 weeks along with oral cimetidine and topical clindamycin application twice daily. Investigator Global Assessment Scale (IGAS) was employed to measure effectiveness. The treatment was considered ʽeffectiveʹ if the patient achieves 2 or more than 2-grade improvement or almost clear or clear skin at the end of 12 weeks according to IGAS scale. The lesion counts were also done before the start of therapy (day 1) and at every two weeks follow up for 12 weeks. The change in lesion count observed between the baseline number and that seen at follow up visits was also used to evaluate the effectiveness of oral Dapsone. Safety was analyzed by fortnightly visits of the patients to look for any undesirable side effects and monitoring of the hematologic profile of the patients. Final follow up was done at the end of 16 weeks. Results: The study was conducted on 51 patients, with a ratio of 1:3 for males and females and a mean age of 25.2 years (SD ±5.81). At 12th week, patients had significant reduction in their acne lesions; with 7 patients (13.7%) showing completely clear skin, 17 patients (33.3%) had almost clear skin, 5 patients (9.8%) had 3-grade improvement. Twelve patients (23.5%) had 2-grade improvement from baseline score and only 2 patients (3.9%) had 1-grade improvement from baseline. Based on percentage reduction of lesions, excellent response was seen in 32 patients (62.7%), good response in 9 patients (17.6%), moderate response in 2 patients (3.9%), while no patient showed poor response. Dapsone was discontinued in 8 patients due to derangement of hematologic profile. Conclusion: Oral Dapsone, when given carefully, is a very effective therapeutic option in severe recalcitrant acne, with limited side effects.


Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001253
Author(s):  
Ovidio De Filippo ◽  
Matteo Bianco ◽  
Matteo Tebaldi ◽  
Mario Iannaccone ◽  
Luca Gaido ◽  
...  

BackgroundThe role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.Methods and analysisPULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.Trial registration numberNCT04144881


OTO Open ◽  
2021 ◽  
Vol 5 (1) ◽  
pp. 2473974X2097502
Author(s):  
Joseph Chang ◽  
Sen Ninan ◽  
Katherine Liu ◽  
Alfred Marc Iloreta ◽  
Diana Kirke ◽  
...  

Objectives Virtual reality (VR) has been used as nonpharmacologic anxiolysis benefiting patients undergoing office-based procedures. There is little research on VR use in laryngology. This study aims to determine the efficacy of VR as anxiolysis for patients undergoing in-office laryngotracheal procedures. Study Design Randomized controlled trial. Setting Tertiary care center. Methods Adult patients undergoing office-based larynx and trachea injections, biopsy, or laser ablation were recruited and randomized to receive standard care with local anesthesia only or local anesthesia with adjunctive VR. Primary end point was procedural anxiety measured by the Subjective Units of Distress Scale (SUDS). Subjective pain, measured using a visual analog scale, satisfaction scores, and procedure time, and baseline anxiety, measured using the Hospital Anxiety and Depression Scale (HADS), were also collected. Results Eight patients were randomized to the control group and 8 to the VR group. SUDS scores were lower in the VR group than in the control group with mean values of 26.25 and 53.13, respectively ( P = .037). Baseline HADS scores did not differ between groups. There were no statistically significant differences in pain, satisfaction, or procedure time. Average satisfaction scores in VR and control groups were 6.44 and 6.25, respectively ( P = .770). Average pain scores were 3.53 and 2.64, respectively ( P = .434). Conclusion This pilot study suggests that VR distraction may be used as an adjunctive measure to decrease patient anxiety during office-based laryngology procedures. Procedures performed using standard local anesthesia resulted in low pain scores and high satisfaction scores even without adjunctive VR analgesia. Level of Evidence 1


2021 ◽  
pp. 1-8
Author(s):  
Halil Celik ◽  
Sadettin Burak Acikel ◽  
Fatih Mehmet Akif Ozdemir ◽  
Erhan Aksoy ◽  
Ulkuhan Oztoprak ◽  
...  

<b><i>Background and Aim:</i></b> Although anyone can be affected by the COVID-19 pandemic, it may cause additional concern for people with chronic conditions. Epilepsy is the most common neurological disease in childhood and adolescence. The aim of this study was to determine anxiety levels among the mothers of children under follow-up for epilepsy in our clinic during the COVID-19 pandemic. <b><i>Methods:</i></b> The study group consisted of the mothers of epilepsy patients who were under follow-up in the pediatric neurology outpatient clinic of the tertiary care center and were scheduled for a routine examination during the COVID-19 pandemic. The mothers’ anxiety levels according to the Beck Anxiety Inventory and their opinions about COVID-19 in relation to their child were assessed and compared based on whether the mother/patient attended their appointments in person and whether the child had frequent or infrequent seizures. <b><i>Results:</i></b> There was no statistically significant difference in anxiety level between the mothers of 64 children with epilepsy who attended their appointment during the pandemic and those of the mothers of 52 who did not attend their appointment. However, the mothers of children with frequent seizures had significantly higher anxiety levels. <b><i>Conclusion:</i></b> Anxiety level of mothers whose children have frequent seizures was significantly higher compared to mothers whose children have infrequent seizures. It is important to be aware about this point and using telemedicine approach in suitable population and postpone routine outpatient follow-up appointments as much as possible.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mona Dietrichkeit ◽  
Marion Hagemann-Goebel ◽  
Yvonne Nestoriuc ◽  
Steffen Moritz ◽  
Lena Jelinek

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.


2020 ◽  
Vol 105 (4) ◽  
pp. e1215-e1224 ◽  
Author(s):  
Soma Saha ◽  
Devasenathipathy Kandasamy ◽  
Raju Sharma ◽  
Chandrasekhar Bal ◽  
Vishnubhatla Sreenivas ◽  
...  

Abstract Context There are concerns about the long-term safety of conventional therapy on renal health in patients with hypoparathyroidism. Careful audit of these would help comparisons with upcoming parathyroid hormone therapy. Objective We investigated nephrocalcinosis, renal dysfunction, and calculi, their predictors and progression over long-term follow-up in patients with primary hypoparathyroidism (PH). Design and Setting An observational study at a tertiary care center was conducted. Participants and Methods A total of 165 PH patients receiving conventional therapy were evaluated by radiographs, ultrasonography, and computed tomography. Their glomerular filtration rate (GFR) was measured by Tc-99m-diethylenetriamine penta-acetic acid clearance. Clinical characteristics, serum total calcium, phosphorus, creatinine, hypercalciuria, and fractional excretion of phosphorus (FEPh) at presentation and during follow-up were analyzed as possible predictors of renal complications. Controls were 165 apparently healthy individuals. Results Nephrocalcinosis was present in 6.7% of PH patients but not in controls. Patients younger than 15 years at presentation and with higher serum calcium-phosphorus product were at higher risk. Nephrocalcinosis showed no significant association with cataract and intracranial calcification. Prevalence of renal calculi was comparable between hypoparathyroid patients and controls (5% vs 3.6%, P = .58). Fourteen percent of patients had a GFR less than 60 mL/min/1.73 m2. Increased FEPh during follow-up was the significant predictor of low GFR. Nephrocalcinosis developed in 9% of patients over 10 years of conventional therapy. Conclusion A total of 6.7% of PH patients had nephrocalcinosis, and 14% showed renal dysfunction. Prevalence of renal calculi was similar in patients and controls. Nine percent of patients developed nephrocalcinosis over 10 years of conventional therapy.


2018 ◽  
Vol 10 (1) ◽  
Author(s):  
C. A. Cabizuca ◽  
P. S. Rocha ◽  
J. V. Marques ◽  
T. F. L. R. Costa ◽  
A. S. N. Santos ◽  
...  

2017 ◽  
Vol 01 (03) ◽  
pp. 150-155
Author(s):  
Arun Gupta ◽  
Ajay Mehta ◽  
Nitin Mishra ◽  
Rajendra Bansal ◽  
Ajit Yadav

AbstractVariceal bleeding is one of the most feared complications of cirrhosis and portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective minimally invasive option to achieve adequate decompression of the portal system. The aim of the study was to assess the efficacy and complications of TIPS in patients presenting with variceal bleed. It was a retrospective study done in a tertiary care center in North India in cirrhotic patients with acute or recurrent variceal bleed who underwent TIPS from April 2010 to October 2013. All the patients were followed up till April 2014. We could successfully implant TIPS in 100% of our patients with 100% success rate in controlling variceal bleeding immediately and during the follow-up period. Our primary patency rate was 94.5% and overall patency rate was 100%. Major TIPS-related complication was hepatic encephalopathy in 20% of patients; 7 of 22 patients died during the follow-up period. TIPS is a safe and effective procedure for control of acute or recurrent variceal bleed. Emerging evidence in favor of early TIPS is further going to expand its indication in variceal bleed. Hepatic encephalopathy was the major procedure-related complication in our study consistent with previous literature reports.


Author(s):  
Michele Spinicci ◽  
Iacopo Vellere ◽  
Lucia Graziani ◽  
Marta Tilli ◽  
Beatrice Borchi ◽  
...  

Abstract We evaluated 100 post-acute COVID-19 patients, a median of 60 days (IQR 48-67) after discharge from the Careggi University Hospital, Italy. Eighty-four (84%) had at least one persistent symptom, irrespective of COVID-19 severity. A considerable number of hospital re-admission (10%) and/or infectious diseases (14%) during the post-discharge period was reported.


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