Metronidazole controlled studies

Metronidazole has been the mostly investigated agent. In 1978, Blichfeldt et al. [34] performed the first controlled study of metronidazole in CD. They did not find a difference between metronidazole and placebo-treated patients but a positive trend in favor of metronidazole was observed when the colon was involved. In the National Cooperative Swedish study, metronidazole was compared to sulfasalazine no significant difference was found between the two groups however, in the crossover section of the study, metronidazole was effective in patients not responding to sulfasalazine [35],... 

An antibiotic association was used in an Italian randomized controlled study in which metronidazole 250 mg... 

A case control study was conducted in an attempt to identify risk factors associated with an outbreak of Stevens-Johnson syndrome/toxie epidermal neeroly sis that occurred amongst Filipino workers in Taiwan. The risk of developing this serious condition was significantly higher in workers who had taken both metronidazole and mebendazole sometime in the preceding 6 weeks (odds ratio of 9.5). In addition, there was an increase in risk with higher doses of metronidazole. ... 

Isolated cases of combined oral contraceptive failure have been reported with metronidazole. The interaction (if such it is) appears to be very rare indeed. In a controlled study, metronidazole did not affect contraceptive steroid levels. 

Y. Ren, W. Li, Y. Guo, R. Ren, L. Zhang, D. Jin and C. Hui, Study on quality control of metronidazole powder pharmaceuticals using near infrared reflectance first-derivative spectroscopy and multivariate statistical classification technique, Jisuanji Yu Ymgyong Huaxue, 14, 105-109 (1997). 

Potentially, although controlled evidence for their use is sparse and more study is needed. Patients with pouchitis (which may occur following some surgical procedures for ulcerative colitis) may have significant clinical improvement following the use of metronidazole. Ciprofloxacin is also useful for pouchitis, and concurrent use with metronidazole appears to be superior to either antibacterial alone. Ciprofloxacin alone may also be of potential use for disease control in ulcerative colitis, but data in the absence of other standard treatments are lacking. Antibacterials tend to be of more use in Crohn s disease. 

Diav-Citrin O, Shechtman S, Gotteiner T, Arnon J, Ornoy A. Pregnancy outcome after gestational exposure to metronidazole a prospective controlled cohort study. Teratology 2001 63(5) 186-92. 

There is no effective treatment for hexamitosis. Penicillin (52), oxytetracycline (3), chlorotetracydine (20), Enheptin (53, 2-amino-5-nitrothiazole [121 -66-4]), and streptomycin (54) sulfate [3810-74-0] were found to have limited value. Hexamitosis in carrier pigeons caused by YLexamita columbae was treated successfully with ronidazole (55, Dugro) (Table 6). An experimental infection of nude mice with YLexamita muris was treated with dimetridazole (56, 1,2-dimethyl-5-nitro- 1H-imidazole [557-92-8]), metronidazole (1), tinidazole (11), and acranil (51). All compounds lowered or suppressed the fecal discharge of cysts, but the latter reappeared when the 1—3 week treatment terminated. In a related study, dimetridazole (56) controlled the clinical disease in mice but did not eliminate the infection. 

The most commonly reported nitroimidazoles in the literature include dimetridazole (DMZ), metronidazole (MNZ), ronidazole (RNZ), and ipronidazole (IPZ) (Fig. 7.7). More recently, additional members of this class such as carnidazole (CNZ), ornidazole (ONZ), tinidazole (TNZ), and ternidazole (TRZ) have also been incorporated into analytical methods. Extensive studies on the metabolism of nitroimidazoles in poultry, beef, swine, and fish have shown that the hydroxy metabolites of the parent compounds, formed by oxidation of the side-chain in the C2 position of the imidazole ring, are of additional concern. These compounds have been shown to have toxicity equal to that of their parent forms and are often rapidly formed by metabolism within the animal. Studies in both poultry and rainbow trout have shown that the distribution of parents to metabolites is analyte- and species-specific. As a result, it has been suggested that it is imperative that a residue control program considers both the parent and the metabolites. The metabolites indicated in the literature include MNZ-OH, IPZ-OH, and HMMNI (2-hydroxymethyl-l-methyl-5-nitroimidazole) as the hydroxy metabolites of MNZ, IPZ, and DMZ, respectively. HMMNI has also been identified as a metabolite of RNZ, but through a different pathway. HMMNI is not a major metabolite of RNZ, however, and is therefore not suitable on its own for use as a marker of RNZ use. 

Studies in animals, designed to show whether or not metronidazole is a carcinogen, have proved inconclusive. Defects in the design, the very high incidence of tumours in some of the control animals and the known effects of factors other than the presence of a carcinogen, make interpretation difficult. 

Jayawickrema, U. S. and Lionel, N. D. W. (1975) Comparison of metronidazole with emetine and chloroquine in the treatment of hepatic amoebiasis - a controlled double blind study. Ceylon med. J., 20, 99. 

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