Sudhakar Pandey1, Gaurav Kumar Gupta1, Shashank J Wanjari1, Sandeep Nijhawan2. 1. Department of Gastroenterology, Sawai Man Singh, Medical College, J L N Marg, Jaipur, 302 004, India. 2. Department of Gastroenterology, Sawai Man Singh, Medical College, J L N Marg, Jaipur, 302 004, India. dr_nijhawan@yahoo.com.
Abstract
BACKGROUND:Metronidazole is a drug of choice for amebic liver abscess (ALA), but has long course and significant side effects. Thus, drugs like tinidazole with a better tolerability record need evaluation. METHODS: We conducted a randomized controlled trial at the Department of Gastroenterology, SMS Hospital, Jaipur, India. One hundred and fifty admitted patients were randomized into two treatment groups, metronidazole (group M, n = 75) and tinidazole (group T, n = 75). Patients were observed for clinical response, laboratory parameters, imaging, and side effects. Early clinical response (ECR) was defined as the absence of fever and abdominal pain within 72 h of treatment. Symptomatic clinical response (SCR) was defined as the absence of fever and abdominal pain irrespective of duration of treatment required. Follow up was done at 1, 3, and 6 months. RESULTS:ECR was 62.3% in group T vs. 37.7% in group M (p = 0.02). SCR was shorter in group T than group M (3.29 ± 1.61 days vs. 5.67 ± 2.93, p ≤ 0.001). Mean residual volume at the end of 1 month was lower in group T (130.7 ± 108.1 vs. 184.7 ± 143.3 mL, p = 0.01) and no significant difference was seen at 3 and 6 months. Tinidazole was better tolerated with fewer side effects. Low socioeconomic status, baseline abscess volume > 500 mL, hypoalbuminemia, pleural effusion, and history of ethanol use were associated with a late clinical response on univariate analysis of which low socioeconomic status was the only associated factor. CONCLUSION:Tinidazole, as compared to metronidazole, has early clinical response, shorter treatment course, favorable rate of recovery, and high tolerability; thus, tinidazole can be preferred over metronidazole in ALA.
RCT Entities:
BACKGROUND:Metronidazole is a drug of choice for amebic liver abscess (ALA), but has long course and significant side effects. Thus, drugs like tinidazole with a better tolerability record need evaluation. METHODS: We conducted a randomized controlled trial at the Department of Gastroenterology, SMS Hospital, Jaipur, India. One hundred and fifty admitted patients were randomized into two treatment groups, metronidazole (group M, n = 75) and tinidazole (group T, n = 75). Patients were observed for clinical response, laboratory parameters, imaging, and side effects. Early clinical response (ECR) was defined as the absence of fever and abdominal pain within 72 h of treatment. Symptomatic clinical response (SCR) was defined as the absence of fever and abdominal pain irrespective of duration of treatment required. Follow up was done at 1, 3, and 6 months. RESULTS: ECR was 62.3% in group T vs. 37.7% in group M (p = 0.02). SCR was shorter in group T than group M (3.29 ± 1.61 days vs. 5.67 ± 2.93, p ≤ 0.001). Mean residual volume at the end of 1 month was lower in group T (130.7 ± 108.1 vs. 184.7 ± 143.3 mL, p = 0.01) and no significant difference was seen at 3 and 6 months. Tinidazole was better tolerated with fewer side effects. Low socioeconomic status, baseline abscess volume > 500 mL, hypoalbuminemia, pleural effusion, and history of ethanol use were associated with a late clinical response on univariate analysis of which low socioeconomic status was the only associated factor. CONCLUSION:Tinidazole, as compared to metronidazole, has early clinical response, shorter treatment course, favorable rate of recovery, and high tolerability; thus, tinidazole can be preferred over metronidazole in ALA.
Entities:
Keywords:
Amebic liver abscess; Clinical response; Metronidazole; Side effects; Tinidazole