PS-084-Pregabalin for muscle cramps in patients with liver cirrhosis: A randomized, double-blind, placebo-controlled trial

2019 ◽  
Vol 70 (1) ◽  
pp. e53-e54
Author(s):  
Won Kim ◽  
Jimin Han ◽  
Yoon-Ho Hong
2013 ◽  
Vol 44 (1) ◽  
pp. 83-91 ◽  
Author(s):  
Kiwamu Okita ◽  
Seiji Kawazoe ◽  
Chitomi Hasebe ◽  
Kozo Kajimura ◽  
Akira Kaneko ◽  
...  

2020 ◽  
Vol 7 (1) ◽  
pp. e000531
Author(s):  
K de Wit ◽  
J J Schaapman ◽  
F Nevens ◽  
J Verbeek ◽  
S Coenen ◽  
...  

IntroductionCirrhotic patients with portal hypertension can suffer from variceal bleeding or refractory ascites and can benefit from a transjugular intrahepatic portosystemic shunt (TIPS). Post-TIPS hepatic encephalopathy (HE) is a common (20%–54%) and often severe complication. A prophylactic strategy is lacking.Methods and analysisThe Prevention of hepatic Encephalopathy by Administration of Rifaximin and Lactulose in patients with liver cirrhosis undergoing placement of a TIPS (PEARL) trial, is a multicentre randomised, double blind, placebo controlled trial. Patients undergoing covered TIPS placement are prescribed either rifaximin 550 mg two times per day and lactulose 25 mL two times per day (starting dose) or placebo 550 mg two times per day and lactulose 25 mL two times per day from 72 hours before and until 3 months after TIPS placement. Primary endpoint is the development of overt HE (OHE) within 3 months (according to West Haven criteria). Secondary endpoints include 90-day mortality; development of a second episode of OHE; time to development of episode(s) of OHE; development of minimal HE; molecular changes in peripheral and portal blood samples; quality of life and cost-effectiveness. The total sample size is 238 patients and recruitment period is 3 years in six hospitals in the Netherlands and one in Belgium.Ethics and disseminationThis study protocol was approved in the Netherlands by the Medical Research Ethics Committee of the Academic Medical Centre, Amsterdam (2018-332), in Belgium by the Ethics Committee Research UZ/KU Leuven (S62577) and competent authorities. This study will be conducted in accordance with Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. Study results will be submitted for publication in a peer-reviewed journal.Trial registration numbersClinicalTrials.gov (NCT04073290) and EudraCT database (2018-004323-37).


1997 ◽  
Vol 27 (8) ◽  
pp. 860-867 ◽  
Author(s):  
V.A. VARNEY ◽  
J. EDWARDS ◽  
K. TABBAH ◽  
H. BREWSTER ◽  
G. MAVROLEON ◽  
...  

2001 ◽  
Vol 120 (5) ◽  
pp. A384-A384
Author(s):  
L MOLLISON ◽  
L TOTTEN ◽  
C HOVELL ◽  
K THAYNE ◽  
C CONNELLY ◽  
...  

2007 ◽  
Vol 177 (4S) ◽  
pp. 14-15
Author(s):  
Brian J. DeCastro ◽  
Jack R. Walter ◽  
Leah P. McMann ◽  
Andrew C. Peterson

2012 ◽  
Vol 82 (4) ◽  
pp. 260-266 ◽  
Author(s):  
Salah E. Gariballa ◽  
Sarah J. Forster ◽  
Hilary J. Powers

Background: Although a number of studies have reported raised total plasma homocysteine (tHcy) concentrations in free-living older people, there are no data on homocysteine response to a mixed nutrient supplement in older patients. A raised plasma homocysteine concentration in older patients is partly a reflection of their co-morbidity, including impaired renal function, and there is uncertainty about the extent to which dietary interventions can improve plasma tHcy. Aim: To determine the plasma tHcy response to dietary supplements during acute illness. Methods: Two-hundred and thirty-six hospitalized, acutely ill older patients, who were part of a randomized double-blind placebo-controlled trial, were assigned to receive a daily oral nutritional supplement drink containing 1.3 mg of vitamin B2, 1.4 mg of vitamin B6, 1.5 μg of B12, 200 μg of folic acid, or a placebo, for 6 weeks. Outcome measures were plasma tHcy concentration at baseline, 6 weeks, and 6 months. Results: The mean plasma tHcy concentration fell among patients given the supplements (mean difference 4.1 µmol/L [95 % C.I, 0.14 to 8.03), p = 0.043], but tHcy concentration increased between 6 weeks and 6 months, after patients stopped taking the supplements [mean difference -2.0 µmol/L (95 % C.I, -03.9 to -0.18), p = 0.033]. About 46 % of patients in the placebo group and 55 % of patients in the supplement group had hyperhomocysteinemia (>14 µmol/L) at baseline compared with 45 % and 29 % at the end of the treatment period. Conclusions: A mixed nutrient supplement containing physiological amounts of B vitamins significantly reduced plasma tHcy concentrations in older patients recovering from acute illness.


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