A Randomized Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone in Treatment of Overt Hepatic Encephalopathy.

Background and Aims: Hepatic encephalopathy (HE) is a reversible spectrum of neuropsychiatric abnormalities associated with liver dysfunction. Lactulose is a nonabsorbable disaccharide presently used to treat HE. Nitazoxanide (NTZ) has a broad-spectrum activity against urease-producing bacteria, so...

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Publicado en:Journal of Clinical Gastroenterology Vol. 53; no. 3; pp. 226 - 231
Autores principales: Abd-Elsalam, Sherief, El-Kalla, Ferial, Elwan, Nadia, Badawi, Rehab, Hawash, Nehad, Soliman, Shaimaa, Soliman, Samah, Elkhalawany, Walaa, ElSawaf, Mennat-Allah, Elfert, Asem
Formato: research randomized controlled trial Journal Article
Publicado: Lippincott Williams & Wilkins Mar2019
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Mar2019
      vid: 53
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      pub: Lippincott Williams & Wilkins
      place: Baltimore, Maryland
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        10.1097/MCG.0000000000001040
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        atl: A Randomized Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone in Treatment of Overt Hepatic Encephalopathy.
      aug:
        au:
          Abd-Elsalam, Sherief
          El-Kalla, Ferial
          Elwan, Nadia
          Badawi, Rehab
          Hawash, Nehad
          Soliman, Shaimaa
          Soliman, Samah
          Elkhalawany, Walaa
          ElSawaf, Mennat-Allah
          Elfert, Asem
        affil: Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta
      sug:
        subj:
          Gastrointestinal Agents Therapeutic Use
          Thiazoles Therapeutic Use
          Liver Cirrhosis
          Disaccharides Therapeutic Use
          Human
          Middle Age
          Gastrointestinal Agents Administration and Dosage
          Disaccharides Administration and Dosage
          Male
          Treatment Outcomes
          Thiazoles Administration and Dosage
          Drug Administration Schedule
          Drug Therapy, Combination
          Female
          Hepatic Encephalopathy
          Validation Studies
          Comparative Studies
          Evaluation Research
          Multicenter Studies
          Randomized Controlled Trials
          Arthritis Impact Measurement Scales
          Scales
          Middle Aged: 45-64 years
          Male
          Female
      ab: Background and Aims: Hepatic encephalopathy (HE) is a reversible spectrum of neuropsychiatric abnormalities associated with liver dysfunction. Lactulose is a nonabsorbable disaccharide presently used to treat HE. Nitazoxanide (NTZ) has a broad-spectrum activity against urease-producing bacteria, so it decreases ammonia production and is therefore expected to reverse the symptoms of HE. A previous pilot study on HE patients given NTZ and lactulose had encouraging results with regard to amelioration of the clinical picture. Patients showed improvement in mental status and the drug was well-tolerated. Results such as these are encouraging larger studies. The aim of this study was to compare the safety and adequacy of NTZ plus lactulose versus lactulose and placebo in management of overt HE.Methods: In total, 120 cirrhotic patients suffering from overt HE were randomly designated to take either NTZ plus lactulose (n=60) or lactulose and placebo (n=60). The Clinical Hepatic Encephalopathy Staging Scale (CHESS) score was assessed for all patients on inclusion to the study and 1 week from the start of treatment.Results: Both groups evinced an improvement in CHESS score at 1 week, yet the improvement was significantly better in the NTZ group as the score decreased from 4.15±2.09 to 0.00±0.00 compared with 4.96±2.29 to 1.28±0.91 in patients receiving lactulose and placebo (P-value <0.001).Conclusions: NTZ significantly decreases the CHESS score and improves mental status in the form of patient alertness, orientation, response to stimulation, and ability to talk. NTZ is safe and well-tolerated apart from infrequent epigastric pain.
      pubtype: Academic Journal
      doctype:
        research
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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