Una aclaración conceptual....

Hace unos días un lector me comentó que mis consejos no se ajustaban a la dieta paleolítica ya que recomendaba productos industriales (que, lógicamente no tienen nada que ver con lo que comían nuestros antepasados). La reflexión de este lector me parece muy lógica y voy a aprovechar su escrito para comentar mi posición al respecto.

En primer lugar, aunque el título del blog y muchos de mis comentarios se ajusten a la llamada dieta paleolítica o dieta ancestral, quiero dejar claro que no soy un portavoz de la corriente comercial que ha surgido en USA a raíz de los libros y escritos de profesores como Loren Cordain. Tan solo utilizo la fuente de conocimientos que supone el descubrimiento (muy reciente) de los alimentos utilizados en nuestra evolución, para entender algunos problemas de nuestra dieta actual con el fin de evitar desequilibrios y déficits de nutrientes (como ocurre con el hierro, calcio, vitamina D  y otros nutrientes).

Este blog está dedicado, básicamente, a personas que realizan una actividad física intensa, primera cuestión que se tiene que asumir si queremos acercarnos a nuestros orígenes. Nuestro metabolismo lo hemos adaptado a una intensísima actividad física y, por tanto, de nada sirve ir a un restaurante de dieta paleolítica y pensar que se están siguiendo los pasos ancestrales, si al tiempo, no se entrena nuestro cuerpo de una forma similar.

Teniendo en cuenta esta primera cuestión, la siguiente pregunta que uno se hace es como suplementar y qué cambios hay que hacer en nuestra dieta para ingerir los nutrientes necesarios teniendo en cuenta los déficits, que hoy sabemos, que plantea nuestra dieta con respecto a la de toda nuestra evolución

¿Cuáles son los desequilibrios más importantes en la dieta actual?

1)      Alta ingesta de grasas saturadas (derivado de la introducción de rumiantes y animales sedentarios como fuente proteica)

2)      Desequilibrio entre ácidos grasos n6 y n3 (derivado de la introducción en nuestra cocina de aceites poliinsaturados de origen vegetal), unido a la disminución de pescado salvaje en nuestra dieta habitual

3)      Ingesta de carbohidratos simples (azúcares, bollería etc)

4)      Ácidos grasos trans de origen exclusivamente industrial (desconocidos por nuestro organismo)

5)      Menor consumo de antioxidantes naturales (polifenoles) que tomábamos al consumir uvas con sus pedúnculos (rabillo) y semillas que es donde estaban estos nutrientes (ahora tomamos la parte carnosa del fruto, que es básicamente agua y fructosa).

6)      Eliminación de costumbres importantísimas como roer huesos, comer espinas pequeñas etc (fuentes de calcio), tomar sangre (fuente de hierro), así como la vida al aire libre (fuente de vitamina D)

7)      Excesivo cocinado en los alimentos, con el consiguiente peligro de disminución de ingesta de vitaminas termolábiles

8)      Etc etc etc

¿Cómo podemos en nuestra situación actual corregir este problema?

Utilizando la tecnología, claro que sí. ¿Cómo podemos razonar de forma sensata que lo adecuado es retornar al pelistoceno? Nuestra especie es, en la actualidad, fruto del esfuerzo y de los cambios planetarios efectuados por miles de millones de antepasados, algunos de los cuales nos han dejado un acerbo tecnológico y cultural que ahora todos compartimos. ¿Cómo se puede volver atrás?

La tecnología nos permite, ahora, tomar proteínas exentas de grasa (para equilibrar un desayuno absolutamente desequilibrado como supone un zumo de naranja, croissant y café con leche, que es el llamado desayuno español). El aislado de suero de leche, es una maravilla tecnológica que no podemos desaprovechar. Del mismo modo, podemos tomar el ácido graso n3 (DHA) cuyo déficit es un gravísimo problema (sin necesidad de tomar pescados contaminados), o tomar fuentes de calcio o vitaminas deficitarias en pastillas proporcionadas por la industria.

Otra cosa son los suplementos cuya ingesta supone un aumento del rendimiento debido a forzar rutas metabólicas o generar almacenamiento de sustratos, como en el caso de la creatina o de la carnosita. En este sentido, todo mi afán es tratar de explicar lo que se sabe, con rigor, de estos suplementos y cuales son las falacias de las industrias que se dedican a ganar dinero a costa de medias verdades (cuando no de mentiras completas).

Un ejemplo de lo que suelo hacer cuando aparece una supuesta ayuda ergogénica es lo que he realizado a raíz de la consulta de una lectora sobre el NADH y su acción como suplemento ergogénico. Voy a PubMed (http://www.ncbi.nlm.nih.gov/pubmed/ )(en donde aparecen las publicaciones científicas del área médica) y hago una búsqueda bibliográfica. Inmediatamente observo que los únicos estudios se hicieron en pacientes con síndrome de fatiga crónica y aún así, los resultados no indican ninguna mejoría, salvo en uno cuya crítica la dejo a continuación, como ejemplo de la utilización de ciertos artículos por parte de la industria y del marketing.

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The curious case of NADH and chronic fatigue syndrome

During research for a talk on quack medicines. I came across several web sites that were selling the common co-enzyme, NADH, for a whole variety of ailments. One of these sites, Wizards Gate, no longer sells NADH ("because the profit is too small"). but continues to carry the following advertisement for it.

A recent Georgetown University Medical Center clinical pilot study among CFS patients reports that participants taking ENADA® were four times more likely than those taking a placebo to experience a reduction in symptoms. Please click on the links below for more information.

What this does NOT mention is that the huge column on the left represents eight people out of 26, and the tiny one on the right represents two people (out of 26)!

The reader is then referred to ImmuneSupport.com, who describe NADH as follows (with my comments in italics).

• Improves cellular energy [This, as it stands, is meaningless]
• Elevates mental clarity [There is no evidence that this is true]
• Promotes mental alertness and concentration [Again, there is no evidence that this is true]

The ImmuneSupport site goes on to say
"NADH is proven to trigger energy production through ATP generation [true].
A naturally occurring coenzyme found in all living cells, NADH helps supply cells with energy.[true].
Thus, as NADH levels rise in the body, the cells become more energized, helping the body feel stronger and more vitalized. [This sentence confuses energy in the technical sense that is used in physics, with the everyday use of the term to describe a mental and physical state, In fact there is no reason to think that NADH "helps the body feel stronger" to any greater extent than a placebo].

Other sites that promote NADH heavily are Enada.com, and the Menuco Corporation, of which more below
The clinical trial referred to in all of these advertisements is Forsyth, L. M., Preuss, H. G., MacDowell, A. L., Chiazze, L., Jr., Birkmayer, G. D., & Bellanti, J. A. (1999). Therapeutic effects of oral NADH on the symptoms of patients with chronic fatigue syndrome. Ann.Allergy Asthma Immunol. 82, 185-191.
It is very clear from the letter below that this trial is flawed, but it is impossible to see exactly how flawed it is because the authors, in breach of all guidelines on such matters, have refused, for over a year, to make available the raw data that would allow a correct analysis to be done.

Annals of Allergy, Asthma, & Immunology ©2000;84:639-640

To the Editor: We should like to comment on the paper by Forsyth et al. 1 This paper claims, on the basis of a randomized double-blind clinical trial, that NADH is effective in the treatment of chronic fatigue syndrome. It seems that there are several problems with the work described in this paper. On page 187, the 'raw symptom score' is defined as a score from a questionnaire normalized to lie between 0 and 1 (the questionnaire had 50 questions, each scored 1, 2, 3 or 4, so raw scores are in the range 50 to 200). This was normalized to lie between 0 and 1 by first subtracting 50 and then dividing by 150. However, patients with chronic fatigue syndrome are said to have scores ranging from 10.9 to 55.8, so the normalized score has presumably been expressed as a percentage, whereas in the case of normal patients the values of 0.01 to 0.13 suggest that proportions have been used. Furthermore, even using percentages rather than proportions, we cannot reproduce the ranges given for patients. For example, a raw score of 66 yields a normalized score of 10.7 whereas the next possible value 67 translates to 11.3.  How in that case could Forsyth et al get 10.9? Similarly 133 yields a score of 55.3 but 134 yields 56.  So what raw score can have produced 55.8? It is stated that, "an individual was considered improved if s/he demonstrated at least a 10% improvement," but then it is also stated that, "the degree of improvement for the results to show a positive effect was an improvement by one point in 10 questions or by 2 points in 5 questions" (p 187). This corresponds to a decrease in the raw score of 10 points, not a "10% improvement." Table 5 gives the scores (presumably normalized score x 100) for each of the 26 patients on each of the tests. It is stated that 8/26 improve on NADH and 2/26 improve on placebo. This appears to be a change in normalized score (x 100) by 10, not to a change in raw score of 10. The method of analysis given on page 187 is a test of difference between two independent estimates of a binomial proportion. This is entirely inappropriate for the analysis of a crossover trial. 2 Most importantly, nothing whatsoever is said about which of the 26 patients in Table 5 received which treatment. Without knowing which treatment was given in which period it is impossible for the reader to repeat the analysis using methods more appropriate for crossover trials. The simple addition of one column here, giving the sequence to which the patient was allocated, would have permitted others to have performed the necessary calculations. Drs Forsythe and Bellanti were asked in June 1999 to provide the raw data, in particular the crucial information on sequences that would allow re-analysis of their results. Despite several further requests we have not had any response. This is made all the more disturbing in view of fact that their paper is being used to justify vigorous marketing 3 of NADH as a treatment that "Enhances energy naturally, elevates mental clarity, improves alertness, and concentration," which treatment is also being claimed by some to be useful for everything from improving athletic performance to Alzheimer's disease. In view of this it seems that the least that it is owed the readers of your journal is for the authors to produce the original data so that their claims can be verified. David Colquhoun Stephen Senn Professor of Pharmacology, University College London, Hon, Director Wellcome Laboratory for Molecular Pharmacology, Dept of Pharmacology, University College London, London, United Kingdom and , Professor of Pharmaceutical and Health Statistics, Department of Epidemiology & Public Health, and Department of Statistics, University College London, London, United Kingdom   REFERENCES 1. Forsythe LM, Preuss HG, MacDowell AL, et al. Ann Allergy Asthma Immunol 1999;82:185-191. 2. Senn SJ. Cross-over trials in clinical research. Wiley, Chichester, 1993. 3. See, for example, http://www.enada.com/,http://www.wizardsgate.com/ and many others. Professor Bellanti's response: We have reviewed the two "Letters to the Editor" from Professors Colquhoun and Senn and from Professor Lorden and wish to respond to both. Recognizing that there are various methods and points of view concerning statistical analyses, since this was a preliminary study and not a definitive one, we chose to analyze the data in the manner described. This was done to determine whether there was a basis for the therapeutic efficacy of NADH in chronic fatigue syndrome and, if so, then to proceed to a larger, more definitive study. We feel that we have accomplished this goal in obtaining sufficient evidence to proceed further. We are grateful for the constructive elements of the readers' comments and we shall take these into consideration as we plan the definitive studies. Joseph A Bellanti, MD Professor of Pediatrics and Microbiology-Immunology Georgetown University School of Medicine Washington, DC

This reply from Professor Bellanti stands in contrast to his own statement in a recent report presented to Annual Meeting of American College of Allergy, Asthma and Immunology in which he says "We have recently demonstrated the clinical effectiveness of reduced nicotinamide adenine dinucleotide (NADH) in a group of 26 patients with CFS in a double-blinded, placebo-controlled, crossover study". There is no mention here (or in any of the advertisements) of the study being "preliminary" or "not definitive". (The measurement of 5-HIAA urinary concentration as a possible predictive marker of disease activity and therapeutic efficay of NADH in the chronic fatigue syndrome. Joseph A Bellanti MD; Linda M Forsyth MD; Ana Luiza MacDowell-Carneiro MD; Dawn B. Wallerstedt, MSN, FNP; Harry G Preuss MD and Georg D Birkmayer MD. PhD ).
This reply gives no reason at all for refusing to disclose the raw data, to allow others to check the conclusions. It does say that "there are various methods and points of view concerning statistical analyses", but does not (unsurprisingly) refer to anyone who thinks that a test of difference between two independent estimates of a binomial proportion is an appropriate way to analyse a cross over trial.

Financial interests

The editor of Annals of Allergy, Asthma, & Immunology, Dr Edward O'Connell, tells me that the journal requires authors to disclose any financial interest in the work, and that no such interests were declared in the case of Forsyth et al. This seems very odd, since the address of one of the authors, Dr G.D Birkmayer is given as Birkmayer Pharmaceuticals (Vienna), who market the ENADA brand of NADH, on which Dr Birkmayer holds patents. Birkmayer Pharmacuticals supported the work by a grant, and analysed the data.

Latest news The case of the Bellanti paper was referred to the Georgetown University's Research Integrity Committee for review, in February 2001. That committee has reported that "no violation within the purview of the Code has been committed". In the light of the facts concerning (a) improperly analysed data, (b) non-disclosure of financial interest and (c) the refusal to allow independent analysis of the data, it seems the the University has a novel view of what constitutes research integrity!