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Comments concerning the evaluation of PROBIOTIC products     

 “An evaluation of nine probiotic products available in South Africa, August 2003” SAMJ, 94, (2), FEB. 2004, PP 121-124.

Dr Ela Johannsen submitted to the editor of the SAMJ her detailed critical assessment of the paper by Drs Elliot and Teversham, entitled: “An evaluation of nine probiotic products available in South Africa, August 2003”, which appeared in the SAMJ, Vol. 94, No. 2, Feb. 2004, pp 121-124.  She pointed out that the paper by Drs Elliot and Teversham contains a number of scientific flaws and shortcomings.

The main points of criticism or concern are:

1.      An insufficient description of the conditions under which the evaluation of the nine probiotic products was carried out.  If the sampling, preparation of dilutions and plating of samples were carried out outside of the anaerobic equipment, this could have had an adverse effect on the Bifidobacterium counts since this bacterium is killed by the presence of even traces of oxygen.  However, the same conditions would not affect the counts of Lactobacilli, which are able to grow in the presence of a low oxygen concentration.  The medium on which the Bifidobacterium strains were grown is also questioned.

2.  Complete lack of statistical data:

a.       The authors do not state how many samples were analysed per product or how many capsules or sachets were analysed per container.  Such data constitute the sine qua non of any evaluation, and their lack is unacceptable in the evaluation, the results of which in fact discredit the products of competitors.

b No batch numbers of each respective product under evaluation were given.The counts in which “0” bacteria were recovered are questioned, as no information indicating the lowest dilution from which they were not recovered is given.  It seems likely that if undiluted samples were plated, a number of bacteria would inevitably be recovered.

c.   The viable counts prepared in triplicate are reported without specifying standard error or standard deviation, without which the accuracy and precision with which such counts were carried out cannot be assessed.

3.      Complete lack of controls:  The use of controls is a standard requirement in any test to verify the validity of the results.  No controls were reported for the crucial stages of the testing procedure, e.g. for the extraction of DNA from lyophilised cultures, or as a proof of the DNA electrophoretic patterns of the type cultures used for the identification of the bacteria and a yeast strain.  Controls constitute the basis of any scientific research, let alone an evaluation of this type.

4. The recovery of “the contaminating” microorganisms: Without specifying the numbers of such microorganisms recovered or without indicating their concentration, such a statement is meaningless.  A contamination growing on a medium agar plate could have been purely accidental.  Such problems are encountered by any microbiological laboratory.  This aspect should have been very carefully scrutinised, confirmed and evaluated before an accusation of this nature was made.

5.      The authors used only a single criterion to identify a range of microorganisms, including yeasts, i.e. the electrophoretic patterns of bacterial and yeast DNA.  According to the reference published in 2003 and cited in the letter to the editor of the SAMJ, for the reliable identification of probiotic bacteria a number of criteria, namely physiological, morphological and genetic, should be used.

6.      The authors’ unfamiliarity with the currently accepted classification of the genus Bifidobacterium, which led to an unjustified accusation of mislabelling of Combiforte. (According to Dr Johannsen, Bifidobacterium infantis and B. longum would be impossible to distinguish using only the genetic criterion for identification, as was done by the authors.)

7.      The removal of dual coating from Culturelle samples is not discussed.  If a correct, usually complex procedure was not followed, it could have easily led to significant loses in the number of recovered bacteria or to their depletion or even disappearance.

8.      The results reported for Lacteol Forte are misleading.  The Lacteol label clearly indicates that the product is based on the use of killed bacteria, so the viable count should not have even been conducted.  Therefore, the reported viable count of ‘0’ in Table II makes a wrong impression.  In addition, it is currently recognized that killed probiotic bacteria do posses immunoregulatory properties.

These are just some of the points of concern raised.  In Dr Johannsen’s opinion, an article with so many elementary omissions should not have been accepted for publication in a scientific journal.  An evaluation that in fact borders on comparative advertising – which is not permitted in South Africa – should have been prepared and appraised with far greater circumspection and objectivity.

Dr Johannsen requested that the SAMJ should invite specialists in the field of probiotic and anaerobic bacteria to evaluate her comments.  She suggested that if the validity of her comments is confirmed, the SAMJ should officially revoke the findings reported in the above-mentioned publication and offer a public apology to the parties about whose products defamatory remarks have been published, and whose professional and commercial integrity has been called into question by this dubious publication.

Additional points of criticism relating to the SAMJ article:

i)    The stated objective of the paper was to evaluate nine probiotic products currently available in South Africa in terms of correlation between label claims and the actual contents.  If this was the only objective of the paper, there was no need to publish the names of the products, as the overall conclusions would not have changed had the products been referred to by numbers or symbols.  In any case, it is questionable whether this type of paper is suitable for a scientific journal 

ii)   The authors’ statement in the introduction to the article, relating to “the lack of independent technical expertise available in South Africa” is not only incorrect but also prejudicial.  The authors apparently did not make any effort to try to identify such laboratories.  They include: The Department of Microbiology at the University of Cape Town (UCT), The Department of Microbiology at the University of Stellenbosch, Microbiology Laboratory at Cape Technikon, (Cape Town), to mention just a few.

iii)  Equally detrimental and unsubstantiated is the authors’ statement that probiotic

“products are currently not subjected to stringent scrutiny”.  It is not clear on what grounds this statement is based.  As the authors do not provide any proof for this sweeping statement, it must be considered irresponsible and defamatory. 

As the producer of one of the probiotic product ranges available in South Africa for the last nine years,  I strongly object to such statements.   Each batch of each product that has been produced over this period of time was checked not only for the number of viable bacteria present per capsule but also for the presence of any potential faecal infection.

It can be easily ascertained that each delivery of Bioflora’s products to the Scientific  Pharmaceuticals (Pty) Ltd  (Tel No: 011 652 400) over the period of the last three years, was accompanied by a Quality Control Certificate, issued for each batch of products delivered.       

   General comments

A)  It should be stressed that Dr Johannsen fully supports the need for registration of nutritional supplements available in  South Africa.  The registration procedure should ensure satisfactory standards of safety, quality and efficacy of the products.  These aspects should also be periodically checked by an appropriate authority.  Labelling of nutritional supplements should also be regulated to ensure that:

(i)    the composition of the product agrees with that stated on the label, and

(ii)   that any claims concerning efficacy and safety are based on reliable evidence. 

    This would protect the South African public from products that may be of inferior quality, harmful or ineffective.

B)  The evaluation of any product should not be based on the results obtained from a single sample, and should preferably be based on tests carried out by more than one laboratory.

Another key requirement is that the selection and handling of test samples should be carried out by an independent party.

Any conclusions based on a single set of samples, collected and dispatched by a party with a vested interest in one of the products, and evaluated by a single laboratory, cannot be accepted as valid and final. 

            Dr Ela Johannsen: qualifications and experience 

MSc (Microbiology) Poland, PhD (Microbiology) Rhodes University, Grahamstown, SA, (promoter: Professor Dave Woods).  Over 30 years of practical experience (26 years at the CSIR). 

The author or co-author of over 75 scientific publications, presentations or seminars, as well as of 3 international patents.

During the last 10 years she has been involved in the research and manufacturing of probiotic products and published 7 scientific and 8 popular articles relating to the field of probiotic bacteria.

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Revised: March 31, 2004 .