Probiotics and Diarrhoea - Case Study Example

Introduction Antibiotics are commonly used in hospitals to treat various infections. Even though many of these antibiotics prove fairly effective, accounting for their popularity among clinical staff, they can also cause diarrhea among patients who use them. This raises the question of what to do either to eliminate the antibiotic-associated diarrhea or reduce its incidence among such a population of antibiotic users. There are indications that the use of probiotics, which are mono or mixed cultures of non-pathogenic microorganisms ingested by patients can have some benefits in reducing the incidence of antibiotic-associated diarrhea. Clinical Question Is there a relationship between probiotic use and reduced incidence of antibiotic-associated diarrhea? Search for the Evidence A basic Google search was done as a starting point to get a general overview of discussions surrounding this issue. When "probiotics," and "prevention of diarrhea" were run through the search engine, hundreds of web sites came up, most of which were from health and nutrition advocacy groups and probiotic manufacturing companies. A few journal articles displaying only the abstract, popped up as well, prompting a more defined search in scholarly databases. EBSCOHOST and ProQuest yielded dozens of articles that purported to show some kind of evidence of some association. Two such articles were chosen for closer analysis. The Evidence Study #1 The objective of the study by Hickson et al (2007, p 1) was to find out how efficacious a probiotic drink containing Lactobacillus could be in preventing any diarrhea resulting from the use of an antibiotic and in particular caused by Clostridium difficile. The study was randomised; it was also double blind and placebo controlled and involved a probiotic that was commercially available. Subjects were older patients in a hospital who were undergoing treatment with antibiotics. Three hospitals in London were selected from whic to draw the subjects for the study. All participants were aged 50 or more and had been prescribed either single or multiple use of antibiotics. Also, the antibiotics were either oral or intravenous. A total of 164 subjects were enrolled either through personal consent or through permission of the the hospital's ethics approval regime for those who could not grant consent for one reason or another. The participants were grouped in 2, with 82 on each side. One group received a probiotics yoghurt drink under the tradename of Activel, Danone, or France and containing one of several bacteria such as Lactobacillus casei DN-114001 or (L casei immunitas). The other group received a placebo and both groups started using their assigned drinks with 48 hours of starting their antibiotic treatment regimen. The drinks were given to the patients by the hospital pharmacy and stool was collected from participants in order to determine a baseline screen for the asymptomatic carriage of C. difficile. Stool charts were used to monitor bowel movements. Following the antibiotic regime a week's worth of drinks were given out and a follow-up date was set for four weeks later. Labels were removed from the drinks and both patients and researchers were blind to the study administered. Between November 20 and January 2005, 135 patients entered the study. Exclusions were granted to some individuals for safety reasons or when it was determined that their diarrhea was not caused by their intake of antibiotics. Others were excluded because they were unable to give their consent or in the case of one patient, because of a dairy allergy. No adverse events connected to the study drinks were reported. The final result was that there was significant reduction in diarrhea caused by antibiotics in general (p=0.0007) and those caused by C. difficile (p=0.001) in the case of those in the probiotic group. The absolute risk reduction "for occurrence of antibiotic associated diarrhea was 22% (95% confidence interval 7% to 37%), and number needed to treat was 5 (3 to 15). For C difficile-asociated diarrhea the figures were 17% (7% to 27%) and 6 (4 to 14)" (Hickson 2007, p 1). Hickson et al. (2007, p 1) concluded that taking probiotic drink with L casei, L bulgaricus, and S thermopoly twice a day for one week beyond the duration of an antibiotic treatment can prevent diarrhea associated with the one of antibiotics in general and C. difficile in particular. The researchers recognized that it was possible that some participants or researchers may have become aware of what they were taking, that is, some may have become unblinded, but precautions were taken to avoid such unblinding possibilities. Recruitment was also difficult and there was a high refusal rate possibly caused by such research requirements as the collection of stools from patients. Study #2 Beausoleil et al (2007, p 732) made use of a double-blind, placebo-controlled study that was also randomised and set in Maisonneuve-Rosemont Hospital in Montreal, Quebec between September 2003 and May 2004. The study protocol was approved by the institution and each participant gave personal consent. Patients were randomly assigned to either the placebo or the lactobacilli-fermented milk or a placebo. In both cases, patients received their drink once a day. The preparations were put in identically labelled containers and taste and texture were also identical. If patients developed diarrhea, prophylaxis was stopped; also, patients were asked not to take in any other kind of probiotic or yogurt during the period of the study as this might create a confounding effect for the research. . Participants selected in this 700-bed hospital were those slated to spend at least 3 days in the hospital and that were on any kind of of antibiotic. Within 48 hours of starting the antibiotic regime; the "study preparation" was administered. Those who had active diarrhea at enrollment were excluded and those who had been diagnosed with C. difficile-associated diarrhea (CDAD) within the last 3 months were excluded. Others excluded were those being treated with vancomycin or an aminoglucoside or those who were lactose intolerant or had a range of other conditions. Those who were judged to have AAD had their stool tested to rule out other possibilities. Medical records were used to ascertain frequency of stools. Data relating to demographics, previous history of AAD or CDAD, or the use of antibiotics in the previous month were collected to ensure that there were no such confounding factors. Eighty nine subjects participated in the study, with 44 in the lactobacilli group and 45 in the placebo group. Of the 44 that took the lactobacilli fermented milk, 7 got AAD while participating in the study (15.9%) and of the 45 participants that were under placebo, 16 got AAD (35.6%). "The difference in the rate of occurrence of AAD between the two study groups was statistically significant" (Beausoleil et al 2007, p 734). The researchers came to the conclusion that the lactobacilli preparation resulted in the reduction of the incidence of AAD in comparison with the use of the placebo. Critique of Evidence An important strength of the two studies was that they were random in nature and involved sizes that were not huge but then not too small either. The sample population from London were all White Europeans but the study in Montreal did not indicate whether participants were of homogeneous ethnicity or mixed. Such information can be useful in determining the extent to which findings can be generalized. Each of the studies presented details about how the research was conducted, including exclusions, and details about the frequency of administration of the product. Though assignment to one of the two groups was random, the groups as a whole might be considered to some extent convenient since the researchers had what seems to be ready access to patients in particular hospitals. The use of professional statistics assistance by Beausoleil et al (2007, p 735) gives an indication of the care that the researchers took to ensure that their results were properly analyzed and that their figures were right. However, the provision of financial support and the placebo by BioK + Int'l, a company with potential interest in the findings, cast a bit of shadow over the results. Even so, the authors claim no specific conflict of interest. An excellent idea on the part of the Hickson et al. (2007, p5) was to calculate roughly how much it would cost to include the bacteria agreement regime is highly useful and information. Implications for Practice When patients enter a hospital to seek relief from a health program it is disconcerting for them to pick up another ailment from the hospital setting whether due to poor hygiene or from the medicine that is supposed to make them get better. In the case of the use of antibiotics to treat infectious, the possible incidence of diarrhea is one that many clinicians would seek to control for the well being of the patients. Knowing that it is possible to use a probiotic to cut down on the incidence of such diarrhea ought to be a welcome opportunity for health practitioners and patients alike. While the use of possibility medically prescribed preparations may be costly the knowledge that commonly available probiotics such as yoghurt may be helpful is comforting. The research studies considered here, both seem to have focused on uniform populations though in one case, it was not very clear if this was so. It would be instructive to have other studies that take ethnicity into consideration to reveal if the use of lactobacilli has truly universal benefits. Bibliography Beausoleil, M. et al. 2007. Effect of a fermented milk combining Lactobacillus acidophilus CL1285 and Lactobacillus casei in the prevention of antibiotic- associated diarrhea: A randomized, double-blind, placebo-controlled trial. Canadian Journal of Gastroenterology, 21(11), pp732-736. Hickson, et al. 2007. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics randomised double blind placebo controlled trial. www.bmj.com (Retrieved March 25, 2009) Read More