The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study
Asmaa Abdel Aziz Mohammed Elrakaybi;
Abstract
Hepatic encephalopathy is defined asa brain dysfunction caused by liver insufficiency and/or portosystemic shunting; The clinical manifestations of HE can be extremely heterogeneous in nature, with symptoms presenting anywhere on a continuum ranging from apparently normal cognitive performance, right the way through to states of confusion, stupor and coma.
Overt HE occurs in approximately 30–45% of patients with cirrhosis and 10–50% of patients with transjugular intrahepatic portosystemic shunt. It is associated with poor survival and high risk of recurrence along with reduced quality of life of patients and their caregivers. There is general consensus that ammonia plays a pivotal role in HE. Thus, treatment for HE is based on strategies aimed at reducing the concentration of circulating blood ammonia through decreasing its production or absorption or improving its elimination from systemic circulation.
Antibiotics (eg. metronidazole and rifaximin) have been used with nonabsorbable disaccharides for management of patients with HE, but they are associated with GI disturbances and sometimes even more severe adverse events such as neurotoxicity and bacterial resistance.
Nitazoxanide is an antiparasitic agent that has excellent activity against anaerobes, protozoa and helminthes. It was administered to a group of cirrhotic patients suffering HEand showed improvement in their mental status and quality of life beside its good tolerability.
The current study was designed to evaluate the efficacy and safety of NTZ compared to metronidazole and rifaximin in patients with grade II-III HE and to evaluate its effect on patients’ quality of life. This was accomplished by assessing its effect on serum ammonia level, CHESS and CLDQ scores at baseline and at end of treatment. The study wasa prospective, randomized, controlled, open-label, pilot study conducted on 34 adult patients with HE. These patients were randomized to one of the three groups:
• Nitazoxanide Group: 12 patients received 500 mg nitazoxanide tablets twice daily
• Metronidazole group: 11 patients received 250 mg metronidazole tablets every 8 hours
• Rifaximin group:11 patients received two 200 mg rifaximin tablets every 8 hours
The patients received one of the three antibiotics (nitazoxanide, metronidazole or rifaximin) in addition to standard treatmentfor seven days.
All patients were subjected to a thorough history taking and the following parameters were evaluated at the end of the 7 days for the three groups:
a- Serum ammonia level, b- CHESS score, c- CLDQ score, d- Adverse events/effects profile
The current study showed that:
• There was no significant difference between baseline and after 1 week ammonia level among the 3 groups.
• The 3 groups showed significant difference between baseline and after 1 week CHESS score.
• Nitazoxanide significantly improved CLDQ total and fatigue score after 1 week of treatment while other domains did not significantly change. The other two groups did not show significant changes in all CLDQ domains.
• Comparison of the percent change in CHESS, fatigue and total CLDQ scores among the 3 groups did not show significant differences.
Conclusion:
• Administration of 500 mg of NTZ twice daily over 7 days had non-significant effect on serum ammonia level
• Administration of 500 mg of NTZ twice daily over 7 days showed significant improvement in CHESS score similar to metronidazole and rifaximin
• Administration of 500 mg of NTZ twice daily over 7 days showed significant improvement in fatigue and total CLDQ score compared to metronidazole and rifaximin.
Recommendations:
Further studies with larger sample sizes are needed to evaluate the potential effect of NTZ on HE patients.
Overt HE occurs in approximately 30–45% of patients with cirrhosis and 10–50% of patients with transjugular intrahepatic portosystemic shunt. It is associated with poor survival and high risk of recurrence along with reduced quality of life of patients and their caregivers. There is general consensus that ammonia plays a pivotal role in HE. Thus, treatment for HE is based on strategies aimed at reducing the concentration of circulating blood ammonia through decreasing its production or absorption or improving its elimination from systemic circulation.
Antibiotics (eg. metronidazole and rifaximin) have been used with nonabsorbable disaccharides for management of patients with HE, but they are associated with GI disturbances and sometimes even more severe adverse events such as neurotoxicity and bacterial resistance.
Nitazoxanide is an antiparasitic agent that has excellent activity against anaerobes, protozoa and helminthes. It was administered to a group of cirrhotic patients suffering HEand showed improvement in their mental status and quality of life beside its good tolerability.
The current study was designed to evaluate the efficacy and safety of NTZ compared to metronidazole and rifaximin in patients with grade II-III HE and to evaluate its effect on patients’ quality of life. This was accomplished by assessing its effect on serum ammonia level, CHESS and CLDQ scores at baseline and at end of treatment. The study wasa prospective, randomized, controlled, open-label, pilot study conducted on 34 adult patients with HE. These patients were randomized to one of the three groups:
• Nitazoxanide Group: 12 patients received 500 mg nitazoxanide tablets twice daily
• Metronidazole group: 11 patients received 250 mg metronidazole tablets every 8 hours
• Rifaximin group:11 patients received two 200 mg rifaximin tablets every 8 hours
The patients received one of the three antibiotics (nitazoxanide, metronidazole or rifaximin) in addition to standard treatmentfor seven days.
All patients were subjected to a thorough history taking and the following parameters were evaluated at the end of the 7 days for the three groups:
a- Serum ammonia level, b- CHESS score, c- CLDQ score, d- Adverse events/effects profile
The current study showed that:
• There was no significant difference between baseline and after 1 week ammonia level among the 3 groups.
• The 3 groups showed significant difference between baseline and after 1 week CHESS score.
• Nitazoxanide significantly improved CLDQ total and fatigue score after 1 week of treatment while other domains did not significantly change. The other two groups did not show significant changes in all CLDQ domains.
• Comparison of the percent change in CHESS, fatigue and total CLDQ scores among the 3 groups did not show significant differences.
Conclusion:
• Administration of 500 mg of NTZ twice daily over 7 days had non-significant effect on serum ammonia level
• Administration of 500 mg of NTZ twice daily over 7 days showed significant improvement in CHESS score similar to metronidazole and rifaximin
• Administration of 500 mg of NTZ twice daily over 7 days showed significant improvement in fatigue and total CLDQ score compared to metronidazole and rifaximin.
Recommendations:
Further studies with larger sample sizes are needed to evaluate the potential effect of NTZ on HE patients.
Other data
| Title | The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study | Other Titles | التأثيرات الإكلينيكية لعقار النيتازوكسانايد فى مرضى الاعتلال الدماغى الكبدى: دراسة تجريبية | Authors | Asmaa Abdel Aziz Mohammed Elrakaybi | Issue Date | 2015 |
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