Antiamoebic drugs for treating amoebic colitis - The Cochrane Library

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Figure 2. Alternative drug vs metronidazole: parasitological failure 15 to 60 days after end of treatment. No data on relapse were reported. Adverse events were incompletely reported. There were no serious adverse events or adverse events that necessitated drug withdrawal in the three trials that reported on this (Joshi 1975; Mathur 1976; Awal 1979). For the other adverse events, they were more common in those given metronidazole compared to those given tinidazole (RR 0.65, 95% CI 0.46 to 0.92; 477 participants, 8 trials, Analysis 1.6). The most common adverse events reported were nausea, vomiting, decreased appetite, altered taste or metallic taste, and abdominal discomfort (see Appendix 11 for other details). 1.2. Other drugs versus metronidazole Other alternative drugs tested were ornidazole (128 participants, 3 trials), panidazole (44 participants, 1 trial), and satranidazole (40 participants, 1 trial). The number of trials was too small to detect any difference in clinical failure or parasitological failure compared Antiamoebic drugs for treating amoebic colitis (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. with metronidazole (Analysis 1.1, Analysis 1.2, Analysis 1.3, and Analysis 1.4). For relapse, data were reported for two trials, and both compared ornidazole with metronidazole. There were more relapses in those given ornidazole compared with metronidazole (RR 4.74, 95% CI 1.07 to 20.99; 135 participants, 2 trials, Analysis 1.5), but there were insufficient data to draw definite conclusions. There were no serious adverse events or withdrawals resulting from adverse events in two trials that reported on this (Pehrson 1984; Tripathi 1986). One participant given ornidazole developed a temporary numbness of the hands and tongue with difficulty of speaking that disappeared after stopping treatment (Botero 1974). In another trial (Naoemar 1973), the daily dosage of ornidazole had to be reduced from 1500 mg to 1000 mg in two participants each in the ornidazole group and metronidazole group because of dizzi- 13
ness or nausea. No abnormalities in laboratory tests were seen in trials in which these tests were done (see Appendix 11 for other details). 2. Any antiamoebic drug versus placebo Any antiamoebic drug was compared with placebo in four trials: versus two different luminal agents, nitazoxanide (167 participants, 2 trials) and quinfamide (96 participants, 1 trial); and versus 10 different drugs belonging to six drug classes (367 participants, 1 trial - Donckaster 1964). Compared with placebo, the other antiamoebic drugs reduced clinical failure one to 14 days after the end of treatment by 73% (RR 0.27, 95% CI 0.13 to 0.57; 193 participants, 3 trials, Analysis 2.1) and reduced parasitological failure by 67% (RR 0.33, 95% CI 0.23 to 0.50; 630 participants, 4 trials, Analysis 2.2). There was significant heterogeneity among the trials so only subtotals are presented. Subgroup analysis using clinical categories did not explain heterogeneity (Analysis 7.1), but heterogeneity was reduced in trials that included adults only (Analysis 7.2 and Analysis 7.3). Excluding the single trial that used stool antigen-based ELISA test for confirming E. histolytica (Rossignol 2007) also reduced heterogeneity in the remaining trials (RR 0.36, 95% CI 0.23 to 0.56; 93 participants, 3 trials, analysis not shown). Sensitivity analysis was not possible using concealment and blinding because only one trial was concealed (Rossignol 2007) and only two trials were blinded (Donckaster 1964; Rossignol 2007). No data on relapse were reported. There were no serious adverse events or withdrawals due to adverse events in the two trials that reported on this (Rossignol 2001; Rossignol 2007). For the other adverse events, there was no evidence of a difference in adverse events in those given antiamoebic drugs compared with placebo (530 participants, 3 trials, Analysis 2.3), although the results could be biased because of a great imbalance in the number of those given placebo compared to the active drugs. The most common adverse events were mild gas- Antiamoebic drugs for treating amoebic colitis (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. trointestinal symptoms such as nausea, vomiting, abdominal pain, and headache. One individual given diiodohydroxyquinoline presented with severe intestinal colic (see Appendix 12 for details). 3. Combination regimen versus monotherapy Three trials compared various combination regimens with metronidazole alone while four trials compared other combination regimens with alternative single drugs. 3.1. Combination regimen versus metronidazole alone Three trials that compared combination therapy with metronidazole alone showed that combination therapy reduced clinical failure one to 14 days after the end of treatment by 67% (RR 0.33, 95% CI 0.11 to 0.98; 1025 participants, 3 trials, Analysis 8.1). The heterogeneity seen in the trials could be due to the various combination regimens used: a combination of dehydroemetine, tetracycline, and diloxanide furoate (Rubidge 1970); a fixed-drug combination suspension of metronidazole and furazolidone (Prasad 1985); and a fixed-drug combination tablet of metronidazole and diiodohydroxyquinoline (Asrani 1995). Excluding one trial that was funded by a pharmaceutical company (Rubidge 1970) reduced heterogeneity, and the analysis showed that combination therapy significantly reduced clinical failure compared with metronidazole alone (RR 0.17, 95% CI 0.12 to 0.25; 986 participants, 2 trials, analysis not shown). For parasitological failure, results showed a 64% reduction in parasitological failures one to 14 days after the end of treatment in those given the combination compared to metronidazole alone (RR 0.36, 95% CI 0.15 to 0.86; 720 participants, 3 trials, Analysis 8.2). There was no significant heterogeneity among the trials (see Figure 3). Excluding the trial funded by a pharmaceutical company (Rubidge 1970) did not significantly change the results (RR 0.25, 95% CI 0.13 to 0.46; 681 participants, 2 trials, analysis not shown). 14
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Page 3 and 4: Analysis 6.4. Comparison 6 Subgroup
Page 5 and 6: Authors’ conclusions Tinidazole i
Page 7 and 8: parasite RNA and DNA (Haque 1995; H
Page 9 and 10: histopathology. We included individ
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Page 21 and 22: with some activity against cysts in
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Page 25 and 26: suspension (two days dosage) in the
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Sensitivity analyses We intended to
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Antiamoebic drugs for treating amoebic colitis - The Cochrane Library

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