Active Ingredient: Norfloxacin
However, these five observational studies were not included in the assessment due to serious limitations with the selection of the comparison group: those who were not vaccinated had either refused vaccination or were not referred for vaccination because they were judged to be engaging in types of travel at lower risk for cholera and thus by extrapolation also potentially at lower risk for TD.
In both cases, this presents important differences in risk profile between the vaccinated and non-vaccinated groups which quite probably biased the results.
This indication is largely based on a field study conducted in an endemic population with a primary outcome of ETEC diarrhea Reference 103.
This study was considered in the review of the evidence but was excluded from the analysis given that it was not conducted in a traveller population that is potentially exposed to a broad spectrum of TD-causing bacteria.
Harms We were unable to assess with GRADE the safety of the inactivated oral cholera vaccines due to insufficient detail provided on adverse events.
No serious adverse reactions were recorded and no differences were observed between vaccine and placebo groups in each of the three RCTs, except for a slightly higher number of "gastrointestinal symptoms" in the placebo group of one study Reference 94.
A GRADE assessment of these interventions was not conducted since they are still in varying stages of clinical development and are not currently licenced in Canada.
The LT patch Reference 105, Reference 106 and the live oral cholera vaccine Reference 107 were also evaluated in traveller populations: neither vaccine was found to increase benefit for prevention of TD as compared to placebo.
A vaccine to target another pathogen responsible for TD, Shigella, is in early-stage human clinical trials, but cannot be evaluated at this time Reference 108. Viral agents such as rotavirus can also cause TD in children. However, the results for low dosage only, as well as those for comparing high to low dosage, are of lower quality since they rely more heavily on the results of one study where there were low levels of compliance to therapy, and are limited in their ability to detect a true effect due to a lower number of subjects imprecision.
Although we were unable to assess with GRADE any differences in efficacy between liquid and tablet forms of BSS, the results do not appear to differ between the two delivery mechanisms. The evidence does not appear to indicate any serious harm associated with BSS use.
There is a probable increased risk for experiencing black tongue and black stool, although these side effects are not harmful Reference 112.
There are also reports of increases in constipation in those taking BSS Reference 111, although this is not reported consistently across studies Reference 110. There did not appear to be a difference in risk of side effects between high and low dosages.
Bismuth subsalicylate should be avoided by those allergic to aspirin and during pregnancy.
Those taking other concurrent medications should check for possible interactions with BSS. Prophylactic BSS at these doses has not been studied for periods longer than four weeks.
Prolonged use of BSS in children carries a risk of salicylate intoxication and bismuth encephalopathy, as well as a theoretical risk of Reye's syndrome Reference 113.
Use of BSS is permitted in the case of certain children aged two years and older, based on an individual assessment of risks and benefits. BSS use is not recommended in children younger than two years old. These risks are often not well documented in studies, but theoretically would include an increased risk for carriage and infection with antibiotic resistant pathogens, antibiotic associated diarrhea and infection with Clostridium difficile, and other adverse reactions including hypersensitivity reactions, photosensitivity reactions, tendinopathy and cardiac arrhythmia.
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