Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Microbial cause might interfere with the result?
- Jeanne A Pawitan (10 August 2007)
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Lactobacillus reuteri
- Janine Zimardo, Roberto Berni Canani (11 August 2007)
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All nutritional supplements should be classified as drugs
- Paula J Whittaker (12 August 2007)
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Critical appraisal
- ABRAHAM P. GEORGE (13 August 2007)
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Re: All nutritional supplements should be classified as drugs
- Raymond G Holder (14 August 2007)
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Re: All nutritional supplements should be classified as drugs
- George de Jager (21 August 2007)
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Good practical advice is needed not professional protectionism
- Rupert Gude (21 August 2007)
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Probiotic and diarrhoea: make the good choice
- Silvia Salvatore, Serena Arrigo, Mara Salmaso, Chiara Citro, Lucia Morando, Luigi Nespoli, Yvan Vandenplas (28 August 2007)
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Probiotics for treatment of acute diarrhoea in children
- María G. Joyanes (6 October 2007)
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Jeanne A Pawitan, Professor Department of Histology, Faculty of Medicine, University of Indonesia, Jakarta10430, Indonesia
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Dear editor, I would like to comment the article about probiotics by Canani et al. In the study, the subjects enrolled were children with acute diarrhea, but the cause of the diarrhea was not mentioned. I supposed that the cause is infection or food poisoning, as other causes such as food allergy, cystic fibrosis etc. were excluded. However microbiological examination was only performed when there were specific clinical reasons, so that no complete information was available.(1) Though Cochrane Database systematic review showed therapeutic benefit regardless of organism,(2) microbiological examination might reveal additional value. The 2 successful and/or the 3 other preparations that showed no significant effect might be due to the specific microbial cause. In other word, microbial cause might interfere with the result. Moreover, the use of probiotic in children should be used cautiously, as a case report has reported sepsis due to Lactobacillus GG in two hospitalized children having post antibiotic diarrhea during treatment for other diseases.(3) References: 1. Canani RB, Cirillo P, TerrinG, Cesarano L, Spagnuolo MI, de Vincenzo A, et al. Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations. BMJ, doi:10.1136/bmj.39272.581736.55 (published 9 August 2007). 2. Allen SJ, Okoko B, Martinez E, Gregorio G, Dans LF. Probiotics for treating infectious diarrhoea. Cochrane Database Syst Rev 2004;(2):CD003048. 3. land MH, Rouster-Stevens K, Woods CR, Cannon ML, Cnota J, Shetty AK. Lactobacillus sepsis associated with probiotic therapy. Pediatrics 2005;115 (1):178-81. Competing interests: None declared |
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Janine Zimardo, healthcare patrol 08879, Roberto Berni Canani
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This response is for: Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations. If I was going to conduct a study to show that commercial otc probiotics are not the best first choice for treatment then this study is ok for that purpose. However, if I was treating my own child and looked to this published study to help make me make an informed decision I would ask myself how could they miss the Lactobacillus reuteri? and why suffer the children? L. reuteri is exclusive to Stonyfield Farm Organic Yogurt (in the US). I think that it's also available in capsule form in health food stores. Lactobacillus reuteri improved colic in babies, says study Source: Pediatrics January 2007, Volume 119, Number 1, Pages. e124-e130; doi:10.1542/peds.2006-1222 “Lactobacillus reuteri (American Type Culture Collection Strain 55730) Versus Simethicone in the Treatment of Infantile Colic: A Prospective Randomized Study” Authors: F. Savino, E. Pelle, E. Palumeri, R. Oggero, and R. Miniero Lactobacillus reuteri May Attenuate Asthma Response Respir Crit Care Med, 2007; DOI:10.1164/rccm200606-821OC). Competing interests: None declared |
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Paula J Whittaker, SpR Public Health Greater Manchester Health Protection Unit M30 0NJ
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The study by Canani et al. concluded that probiotics should be classified as drugs, and physicians should select preparations for which evidence of efficacy, in a given clinical condition, is supported by solid data(1). All nutritional supplements that are sold on the basis of their health-promoting properties should be classified as drugs, and should have to undergo the same rigorous process as pharmaceutical drugs to establish their efficacy and safety BEFORE they are placed on the market. The global market for probiotics and supplements continues to grow, and there are a growing number of “nutritionists” and nutritional supplements wanting to cash in. Consumers deserve to have accurate information about their efficacy, and potential side effects in same way as other over-the-counter drugs. If these substances were classified as drugs, doctors could then prescribe them on the NHS for their specific indication supported by good evidence. At the moment there are a few RCTs showing effectiveness of specific probiotics for certain diagnoses, but for most so-called probiotics there is only weak or no evidence of their effectiveness. Classifying such substances as drugs would also make the label “probiotic” meaningful as a substance with proven health benefit, preventing ineffective preparations cashing in by association. References: 1. Canani R et al. Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations. BMJ, doi:10.1136/bmj.39272.581736.55 (published 9 August 2007) Competing interests: None declared |
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ABRAHAM P. GEORGE, SpR Public Health Greater Manchester Health Protection Unit M30 0NJ
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The authors are to be congratulated for their sincere attempt to investigate the efficacy of a food additive (in the treatment of acute diarrhoeal diseases), which is largely under researched, but widely consumed in developed countries. I would just like to point out a few methodological issues: the study mentions the age group of the study participants was between 3 – 36 months. Since dietary factors vary considerably with increasing age and ethnic group (for example consumption of fruit or natural yoghurt) generalisability of study results to other population sub groups is questionable. Secondly, the authors did not state that breast feeding (Table 2 shows at least 10 % of children in each study group were breast fed) could also be a confounding factor because its immunological properties protect the infant from acute diarrhoeal diseases. Finally, it would have been useful for the authors to acknowledge that outcome ascertainment was limited by subjective reporting of diarrhoeal episodes and probiotic compliance rate by parents and whether there were any objective attempts to verify them. Competing interests: None declared |
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Raymond G Holder, Retired engineer BH9 3NF
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May heaven preserve us all from the efforts of the regulators, there are enough restrictions already on harmless and effective non drug remedies. Legislation in this sphere can only harm those who are not catered for by licensed drugs, which are mainly subject to such strong controls and expensive testing, that they become unaffordable, and thus unavailable to all. It is no exaggeration to say that I would have died 5 years ago if Coenzyme Q10 had been unavailable, as no drug manufacturer would have wanted the expense of getting an unpatentable substance approved, for other makers to benefit. Carnitine is another such substance, without which I have serious muscle wastage and high CK, available in licensed form at an unaffordable price, but used as an ingredient of food products and by sportsmen at a much more reasonable figure, and just as effective. Official medicine has not got all the answers, and many factors get in the way of giving approval to truly scientific products, not the least of which are prejudice and the desire not to upset financial backers. Blanket bans are not the answer, rogue products are easily dealt with. Soon the nanny state will take over and we shall be banned from buying figs or rhubarb, because they may cause GI problems. The other alternative is for medicine to take the value of so many supplements on board and make the beneficial ones freely available. Competing interests: Statin damaged patient |
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George de Jager, Registrar University of Pretoria
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I couldn't agree more, It is very sad to see desperate people with chronic debilitating diseases being ripped off by "fly-by-night" companies. Some alternative therapies may even benefit if they withstood the rigorous testing process successfuly. The only problem could be multibillion dollar drug companies and their effective monopoly on clinical research. Competing interests: None declared |
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Rupert Gude, Retired General Practitioner Tavistock, Devon, PL19 9EL
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In the last 5 weeks the BMJ has published 2 research articles on Probiotics. This week we read that 2 probiotic preparations have a significent difference (<0.001) in reducing the duration of diarrhoea in young children - a result that a lot of drug companies could only dream of. Yet the paper concludes in an obfuscating way,not giving prominence to the 2 probiotics that work and which should be recommended to parents. In the previous paper from Charing Cross Hospital(1)a Lactobacillus preparation given to elderly patients on antibiotic courses had significent (p=0.007) effect on the patients reducing diarrhoea and above all giving protection from C difficile. The type of probiotic is given prominence and there is a strong suggestion that it should be used routinely in patients over 50. How do two papers come to such different conclusions? The Charing Cross one is headed by a dietician who appears to be trying to break into the rigid thinking of hospital staff that only 'drugs' do good and has shown a certain probiotic is a good adjunct to antibiotic prescribing. This one from Naples in Italy almost seems disappointed that two of probiotics worked so well. They do not give high publicity to the names of these probiotics and then suggest that they should be classified as drugs. Is this an attempt at the medical profession trying to keep power to themselves? My conclusion is that doctors can now advise patients with a little bit more evidence to buy certain probiotics rather than others and that these products should be well known and the manufacturers allowed to advertise the benefits. However I do note the warning from Professor Pawitan about the possibility of septicaemia and always the availability of any substance needs to measured on a benefit/deficit balance. 1.Use of probiotic Lactobacillus preparation to prevent diarrheoa associated with antibiotics. M Hickson et al. BMJ2007:335;80-83 Competing interests: None declared |
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Silvia Salvatore, Senior Lecturer in Paediatrics Paediatric Dpt, Università dell'Insubria, Osp. F. Del Ponte, Piazza Biroldi, 21100 Varese, Italy, Serena Arrigo, Mara Salmaso, Chiara Citro, Lucia Morando, Luigi Nespoli, Yvan Vandenplas
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Interest in probiotics has recently dramatically increased and created not only an intriguing scientific research field but also a great economic business. In Italy hundreds of products claiming some probiotic content and properties are now on the market with poor quality control and efficacy demonstrations. Testing all the commercial available preparations is practically impossible and comparative randomized controlled clinical studies are difficult to realize with a number large enough to obtain significant results. Berni Canani et al(1) made a great effort in analyzing the effects of five probiotics products frequently recommended in Italy for add-on treatment of acute diarrhoea in children. Their results confirmed a significant shortening of diarrhoea (not requiring hospitalization) for preparations containing Lactobacillus rhamnosus strain GG or a probiotic mix of L. delbrueckii var bulgaricus, Streptococcus thermophilus, L. acidophilus and Bifidobacterium bifidum, when used at high concentration (10(9) CFU/dose) and in the early phase of infection. Strains specificity and different efficacy on different pathogens has already been highlighted(2). The likely low rate of bacterial pathogens (limited microbiological investigations were performed and their results were not reported by the authors) could explain the not significant effect of Saccharomyces boulardii in this study (1). L. reuteri was also not present in the products tested and new studies comparing other probiotic preparations should be encouraged to better orientate clinician choice. Cost-benefit ratio of probiotic administration in acute enteritis is debatable both in developing and developed countries. However Berni Canani et al1 demonstrated that an appropriate probiotic supplementation, commercially available (in Italy) for 10 euros, could save about 36 hours of diarrhoea and child caring, reducing morbidity, hospitalization and social costs. 1. Berni Canani R, Cirillo P, Terrin G, Cesarano L, Spagnuolo MI, De Vincenzo A, Albano F, Passariello A, De Marco G, Manguso F, Guarino A. Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different peparations. BMJ 2007; 335:340-3. 2. Szajewska H, Setty M, Mrukowicz J, Guandalini S. Probiotics in gastrointestinal disease in children: hard and not-so-hard evidence of efficacy. J Pediatr Gastroenterol Nutr 2006;42:454-75 Competing interests: None declared |
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María G. Joyanes, Researcher CNA-AESAN Health Ministry of Spain
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Canani et al. in their excellent work of Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations concluded that the efficacy of probiotic preparations for treating of children with acute diarrhoea is related to bacterial strain (1). I agree with this conclusion that the modulation of gastrointestinal microbiota is basically strain dependent. Other factors also need consideration. Children are aged 3-36 months in each group (n=45). The sample size was chosen in order to improve statistical test power. However, probiotic action depends also on microbiota found in the gastrointestinal tract is related to the age of children, environment and food. The broadly aged groups (involves babies and infants 2-3 y) beyond homogeneity, distribution overlap with the groups. Because of this it could be suggested another closer analysis to the specific age in order to obtain a more precise interpretation. Canani RB, Cirillo P, Terrin G, Cesarano L, Spagnuolo MI, De Vincenzo A, Albano F, Passariello A, De Marco G, Manguso F, Guarino A Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations. BMJ 2007;335:340 (18 August), doi:10.1136/bmj.39272.581736.55 (published 9 August 2007) Competing interests: None declared |
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