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What are the main claims of the paper and how important are they?
The authors are planning on giving women probiotics to prevent premature birth, however with a sample of 50, they will not be able to show anything. The authors presume that probiotic pills have LIVE Lactobacillus, when research shows that the pills can only be plated out with good recovery for about a month after production, and only if they are stored in ideal conditions- refrigerated all the time, and not in a hot truck being shippped somewhere. (1) "Under refrigeration at 4 -15 degrees C, spray dried Lactobacillus have good recovery rates, when stored in the absence of outside moisture and oxygen. However at 37 degrees C, there was no recovery of Lactobacillus after 8 weeks. " (1)
1.Corcoran BM, Ross RP, Fitzgerald GF, Stanton C. Comparative survival of probiotic lactobacilli spray-dried in the presence of prebiotic substances.Journal of Applied Microbiology. 2004;96(5):1024-39.
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Are these claims novel? If not, please specify papers that weaken the claims to the originality of this one.
Originality is irrelevant in this case.
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Are the claims properly placed in the context of the previous literature?
No
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Do the results support the claims? If not, what other evidence is required?
No
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If a protocol is provided, for example for a randomized controlled trial, are there any important deviations from it? If so, have the authors explained adequately why the deviations occurred?
Yes, no.
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Is the methodology valid? Does the paper offer enough details of its methodology that its experiments or its analyses could be reproduced?
Not at all.
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Would any other experiments or additional information improve the paper? How much better would the paper be if this extra work was done, and how difficult would such work be to do, or to provide?
See summary
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Is this paper outstanding in its discipline? (For example, would you like to see this work presented in a seminar at your hospital or university? Do you feel these results need to be incorporated in your next general lecture on the subject?) If yes, what makes it outstanding? If not, why not?
This experiment is a waste of time.
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Other Comments:
I suggest a group of 4000- 2000 controls and 2000 women who have delivered a baby that died from infection before birth or at birth- between 24-34 weeks. Both groups have to eat the same diet except add to one groups diet- live lactobacillus yogurts- in food, not pills. It is very uncommon for women to have repeat dead premature babies from infection- happens perhaps once in 1000 or less. Even this group might not be big enough to show significance.
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Competing interests:
None
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Invited by the author to review this article? :
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Have you previously published on this or a similar topic?:
No
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References:
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Experience and credentials in the specific area of science:
I have written a paper on it, reviewing research that says the pills are alive. All the research claiming positive influence and health attributes of probiotic pills suffer from conflict of interest, as it is subsidized by companies who make probiotics. Ultimately, if probiotics had live lactobacillus, you would only need one pill: When you make yogurt, you dont add lactobacillus every day, but only once. When you get food poisoning, you dont eat bad bacteria every day, But once is enough. Bacteria multiply well in the warm intestines. Protocols that call for daily probiotics appear to have profit motivating them.
- How to cite: Cohain J S.A Sample of 50 Will not be Enough to Support Anything[Review of the article 'ProB Trial: Probiotics and the Prevention of Preterm Labour; A Randomised Controlled Trial Protocol ' by Othman M].WebmedCentral 2012;3(6):WMCRW002003
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Probiotics given to patients in early second trimester(12-16wk) who had a history of preterm labor without any anatomical cause can be useful to prevent preterm labour by varous immunological mechanisms of action.
No not novel. Recent advances by john bonnar .
Yes.
More patient need to be included in study
Standard protocol used.
Valid. not enough details.
Yes, the number of patients recruited for the study need to be increased.not much difficult to do this and the information thus gained would increase statistical significance.
Not outstanding. But i would like to include it in my general lecture on the subject.
It is a good study and wold gain further importance if it can include thousands of patients. The importance of the study lies in its effect of preventing preterm labour, a very important clinical problem in the society. Given a chance this should be carried out as a world wide multicentric trial. Though the rationale of use needs to be studied in further details, the apparently harmless nature of the therapy should not withhold the ethical committes to go ahead with the trials. Commercial attitude needs to be restricted and in the due course of time and research, there can be household therapy also.
No
No
No
None
20 percent of the cases in our institute (yearly 7000 to 8000 deliveries) are preterm labors