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Antiamoebic drugs for treating amoebic colitis - The Cochrane Library

Antiamoebic drugs for treating amoebic colitis - The Cochrane Library

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Batra 1972 (Continued)<br />

Not included in this review: number of hours from start of treatment to reduction in diarrhoea, tenesmus, and bloody<br />

stools; disappearance of colonic ulcers on sigmoidoscopic examination on day 5 and day 11 of treatment<br />

Notes Location: hospital in New Delhi, India<br />

Date: 1972 (date of publication only; actual study period not reported)<br />

Source of funding: Merck, Sharp and Dohme<br />

Botero 1974<br />

Methods Generation of allocation sequence: unclear<br />

Allocation concealment: unclear<br />

Blinding: unclear; reported as “double-blind”, but blinding of participants, care provider, and outcome assessors not<br />

described<br />

Inclusion of all randomized participants: 95.8% (115/120)<br />

Participants Number: 120 enrolled; 115 analysed; 5 lost to follow up; 1 participant in the Ro 7-0207 terminated treatment after<br />

day 6 because of adverse effects<br />

Inclusion criteria: adult males with clinical symptoms of intestinal amoebiasis and confirmed by the presence of E.<br />

histolytica in the stools examined by direct and Ritchie <strong>for</strong>malin-ether concentration methods<br />

Exclusion criteria: not stated<br />

Interventions 1. Ro 7-0207 (ornidazole): 2 x 250 mg capsules twice daily <strong>for</strong> 10 days<br />

2. Metronidazole: 2 x 250 mg capsules twice daily <strong>for</strong> 10 days<br />

Outcomes 1. Parasitological response: clearance of E. histolytica from stools at the end of treatment and on at weekly<br />

intervals on follow up <strong>for</strong> at least 1 month<br />

2. Relapse: reappearance of E. histolytica in the stools within 1 month after becoming negative at the end of<br />

treatment<br />

3. Clinical response: disappearance or improvement of clinical signs and symptoms on day 5, at the end of<br />

treatment, and at weekly intervals during follow up <strong>for</strong> at least 1 month<br />

4. Adverse events: clinical adverse events monitored <strong>for</strong> all participants but cardiovascular, neurological, and<br />

laboratory monitoring only <strong>for</strong> the first 20 participants (laboratory tests not specified)<br />

Notes Location: hospital in Medellin, Colombia<br />

Date: 1974 (date of publication only; actual study period not reported)<br />

Source of funding: not stated<br />

Botero 1977<br />

Methods Generation of allocation sequence: unclear<br />

Allocation concealment: unclear<br />

Blinding: unclear; reported as “double-blind”, but blinding of participants, care provider, and outcome assessors not<br />

described<br />

Inclusion of all randomized participants: 100%<br />

Participants Number: 100 enrolled and 100 analysed<br />

Inclusion criteria: adult males with clinical symptoms of intestinal amoebiasis and stools positive <strong>for</strong> E. histolytica<br />

examined by direct and Ritchie <strong>for</strong>malin-ether concentration methods<br />

<strong>Anti<strong>amoebic</strong></strong> <strong>drugs</strong> <strong>for</strong> <strong>treating</strong> <strong>amoebic</strong> <strong>colitis</strong> (Review)<br />

Copyright © 2009 <strong>The</strong> <strong>Cochrane</strong> Collaboration. Published by John Wiley & Sons, Ltd.<br />

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