2016 Discoveries Made by Spanking FIT

leonardo

It was out of growing concern about false claims and exaggerations that abound in media that in 2014 I, Dr. Garrett, launched my web site Spanking FIT! (http://www.spankingfit.com/). I introduced it as a “spanking new” approach to health, medicine, fitness, and sexual topics based on REAL Science. As explained in the web site’s ABOUT US section, a common source of false claims in health-related fields are peer-reviewed papers published in well-regarded scientific journals. Their authors, while well trained in medicine, often have little or no education in the Science of Statistical Inference, also. Understandably, the media journalists who report on them do not possess the skills to critically evaluate them. My stated objective was a thorough investigation into all popular claims using my special personal statistical expertise. It is my belief that with reader input, I have been able so far to take a modest step forward toward achieving my goal.

What major topics did Spanking FIT cover in 2016? They are best summarized as (1) natural health restoration and performance enhancement using human bodily acid supplementation (H.B.A.S) (2) natural illness prevention (3) natural pain alleviation, and (4) healthful recreation and nudity. Here’s a summary of major findings relevant to each topic:

Natural health restoration and performance enhancement using human bodily acid supplementation (H.B.A.S)

In 2016, Spanking FIT rigorously evaluated published efficacy research pertaining to four important natural bodily acid supplements: alpha lipoic acid, L-carnitine, L-citrulline, and taurine. Natural supplementation therapy, if effective, obviously may provide a much safer alternative to conventional pharmaceutical therapy. We present below a summary of findings in tabular form. Column 1 of each table names the natural acid supplement. Column 2 summarizes the most common health/ medical claims made about it by so-called medical “authorities”. Column 3 presents a summary of published research “findings” based on clinical trial outcomes. Note my use of quotation marks around the word findings. This is due to the fact that much published medical research suffers from common weaknesses and flaws, especially in the field of statistical data analysis. These flaws, in most cases, do not completely undermine published claims, in my opinion. Rather they call attention to the need for additional experimental work and improved statistical design and analysis in order to validate them. Let’s get started:

Natural Bodily Acid Commonly claimed supplementation benefits Claims made in published clinical trial outcomes Uncovered weaknesses & flaws in published works
Alpha lipoic (A.L.)/ thioctic acid 1)    AL is an anti-oxidant which limits damage to body cells caused by free radicals. (a)  Supplementation with AL lowers creatine kinase (C.K.) content of muscles following aerobic/ anaerobic exercise (C.K. is a marker for muscle damage.) (a) Small sample sizes, inappropriate parametric stat tests.
(b)    Supplementation with A.L. reduces oxidative stress to the muscles of athletes. (b) Small sample sizes, inappropriate parametric stat tests.
(2)    A.L plays important role in energy metabolism (a)    Supplementation with A.L. enhances exercise work performance

(athletes performed isometric/ isokinetic exercise of their quadricep muscles)

(a) Small sample sizes, inappropriate parametric stat tests.
(b)    Increases PGC-1 alpha protein activation in mice (said protein induces cells to synthesize mitochondria) (b) Small sample sizes, inappropriate parametric stat tests, extremely high doses used (human equiv. of 40 gms. per day)
(c)     Yields higher relative percentage of lean mass to total mass in mice. (c) Small sample sizes, inappropriate parametric stat tests, extremely high doses used (human equiv. of 40 gms. per day)
(d)    Elevates E.P.O. levels in young athletes. (d) Small sample sizes, inappropriate parametric stat tests.
(e)    Yields weight reduction

 

(e) Potential conflict of interest on the part of researchers

(work sponsored by Dalim BioTech, manufacturer of A.L.)

(f)  lowers food consumption in mice (Nature Medicine publication)

 

(f) Small sample sizes, inappropriate parametric stat tests

For the detailed results please read: “Can Alpha Lipoic Transform Your Body?“; Spanking FIT,  Jan. 2016

alpha-lipoic

 

Natural Bodily Acid

 

Commonly claimed supplementation benefits

 

Claims made in published clinical trial outcomes Uncovered weaknesses & flaws in published work
L-carnitine: amino acid derivative of Lysine (1)    Memory improvement

 

 

(a) Improvement in both total no. of intact mitochondria and ultra-structures of neurons in hippocampus of rat brain.

 

(a)    Small sample sizes, inappropriate parametric stat tests.

 

(2) Transports cellular fuel in form of fatty acids across mitochondria membranes to oxidation sites (a) Improves symptoms of chronic fatigue syndrome (C.F.S.) including declines in “attention concentration”. (a)    Lack of a control or a placebo group.

Appearance of a conflict of interest on part of study authors.

 

 

(b)    Decreases mental & physical fatigue, & increases cognitive function in elderly patients (b)    Research study involved centenarians only.

 

 

(c)     Enhances athletic performance

 

(c) Small sample sizes, inappropriate parametric stat tests, appropriate stat tests yielded non-significant results.

 

(d)    Improved male sexual performance which is safer than t-supplementation (e.g. prostate volume (P.V.) does not increase.) (d) Less than ideal stat tests were employed, an appearance of a conflict of interest on part of researchers.

For detailed results please read: “Does l-carnitine Enhance Sexual performance & more?“; Spanking FIT, Aug. 2016.

l-carnitine-2

 

Natural Bodily Acid Commonly claimed benefits of supplementation Claims made in published clinical trial outcomes Uncovered weaknesses & flaws in published work
L-arginine/ citrulline (1) Increases production of the enzyme NOS, which in turn increases NO production in endothelial tissue of arteries & veins yielding improved blood circulation. (a)    Supplementation improves erectile response

(b)  Improves sexual satisfaction

 

 

 

 

(c)     Enhances aerobic athletic performance

 

 

(d)    Enhances anaerobic athletic performance & aids in muscle repair

(a) & (b) The majority of studies used small sample sizes; some study results were erroneously reported as statistically significant; only a single study supports claimed hypotheses.

 

(c) Small sample sizes; inappropriate stat tests; conflict of interest appearances

For detailed results read: “Penis Improvement Ideas”; Spanking FIT, Sept. 2016.

penis-improvement-2

 

Natural Bodily Acid Commonly claimed benefits of supplementation Claims made in published clinical trial outcomes Observed weaknesses & flaws in published work
taurine Enhanced athletic performance

 

Improvements in concentric strength of athletes

 

Researchers employed inappropriate stat tests

 

 

Improved isometric strength of athletes

 

Small sample sizes; inappropriate stat tests

 

 

Decreased oxidative damage to muscles

 

Small sample sizes; inappropriate stat tests

 

 

Improvements in treadmill performance of heart patients Small sample sizes; inappropriate stat tests

For detailed results read: “Are Taurine Energy Drink Claims Bull?”; Spanking FIT, Oct. 2016.

bull-the-fed

Based on the above observed weaknesses and flaws in published medical research, Spanking FIT recommends that researchers slow down and focus on fewer human physiological parameters, while paying greater attention to critical statistical data requirements. Also, it is essential that they improve the quality of statistical analysis that they use.

Natural Illness Prevention

The skin cancer paradox

nude-beach-best

Spanking FIT advocates regular moderate sunshine exposure (preferably nude) for health reasons. Consequently, it was necessary for me to investigate  common overexposure warnings and sunscreen use recommendations from the medical community. In “Can Sunscreen Cause Skin Cancer?Spanking FIT, March 2016, I evaluated published research pertaining to the current medical controversy regarding causality between sunshine exposure and both melanomic and non-melanomic skin cancer. (Melanoma is the more deadly form of that disease). Recently, some researchers have taken a dissenting position by suggesting that a lack of adequate sunshine, and not over-exposure, may be causal for melanoma. Spanking FIT got started by reviewing key references cited by the World Health Organization (W.H.O) which, in their opinion, support the sunshine/ overexposure skin cancer hypothesis. We were surprised to discover that principal W.H.O. references contain results that are not statistically significant and; hence, do not validate their claims. We also uncovered non-W.H.O. research which suggested that a negative correlation actually exists between sunshine exposure and incidence of melanomic skin cancer. This is to say that inadequate sunshine exposure may, in some cases, be causal for melanoma. These apparent contradictions led Spanking FIT to question the standard methodology used by W.H.O. researchers and others which consists of comparing incidence rates among populations located in different latitudes and therefore receiving different U.V. exposure levels. We noted that studied populations had probably adapted to their environments following the laws of environmental selection, and that such adaptive behavior would tend to invalidate their method of studying sunshine exposure/ skin cancer correlation by using latitude comparisons. Subsequently, Spanking FIT performed an independent comparison of melanoma rates in Oslo, Norway versus Helsinki, Finland. (Both cities are at the same latitude and have similar populations with respect to skin type and sunshine exposure patterns.) We discovered that Oslo has a much higher adjusted incidence rate than Helsinki. Our findings suggest that there are other unknown contributing factors to melanoma development aside from sunshine exposure patterns. On the other hand, our discovery that the adjusted melanoma rate of Australians compared to Brits is substantially higher, led us to conjecture that high melanoma incidence may result when a population that is not environmentally selected for prolonged exposure to high intensity U.V. radiation is transplanted to such a high U.V. environment.

The nasty debate on circumcision within the medical community

safe-sex

In “To Cut or Not to Cut-the Circumcision Question“,  May 2016, Spanking FIT addressed another well-publicized medical controversy regarding the age-old practice of male circumcision. (This one has become especially nasty among medical “professionals”, even resulting in malicious online name-calling.) We began with an examination of U.S. Centers for Disease Control (C.D.C.) claims that “circumcision reduces risk that a man will acquire H.I.V. from a female partner, and also lowers risk of other S.T.D.s”. C.D.C. further makes the claim that there exists a reduced risk of cervical cancer and H.P.V. for female sex partners of circumcised males. Upon review of published research that C.D.C. cited to back up their claims, Spanking FIT discovered significant defects in both their methodology and in their analysis. In the majority of studies, researchers failed to record the safe sex practices of participants. Whether or not an individual practices safe sex obviously influences their chances of acquiring an S.T.D., regardless of their circumcision status. In one major clinical trial conducted in Africa by the Male Circumcision Partnership and which was funded by the Bill and Melinda Gates Foundation, research “findings” were confounded by the fact that a large percentage of trial participants did not use condoms during sex. This would, of course, tend to exaggerate the importance of circumcision as a S.T.D. preventative measure. Spanking FIT also conducted an independent comparative risk assessment and found that for those individuals who consistently use condoms during intercourse, circumcision affords only miniscule reduction in probability of acquiring H.I.V. infection. Spanking FIT also presented analysis which suggests that high quality latex condoms, when used correctly, are very effective in preventing a wide range of S.T.D.s. Finally, we reviewed research asserting that an uncircumcised  penis provides enhanced sexual pleasure for a man.

Exercising for “Healthy Body Art” in lieu of  tattoos

legs 2

Legitimate concerns on the part of Spanking FIT regarding tattooing health risks, especially among the very young, led us to embark on our “Healthy Body Art for the ‘Boys’ & the ‘Girls‘” series.  The series contains exercise sets designed to safely enhance sexual attractiveness of the female and the male body, but without the health hazards of commercial “body art” such as tattoos and piercings. So far, our series includes exercises for acquiring Venus Dimples, for enhancing the Butt, for developing Broad Shoulders, for enhancing the Chest, Biceps & Triceps, and the Legs. In the Legs segment, Spanking FIT also evaluated health claims that cycling is beneficial for rehabilitation of the knees following injury and even following knee surgery. Cycling may in certain cases also be prescribed for such chronic knee conditions as osteoarthritis (O.A.). The unproven theory behind this claim is that cycling “nourishes” joint cartilage. Spanking FIT discovered that presently only anecdotal evidence exists to back up these common medical practices, and that there is a lack of experimental work refuting or affirming them. The good news, however, is that clinical trials are presently underway in Oslo, Norway to investigate this issue. We also examined the current sports controversy pertaining to “deep squatting”, and whether or not this exercise type leads to serious degeneration of the knees over the long term, as some believe. Our evaluation of published research indicated that, although professional weight lifters are at increased risk for O.A., there is no evidence that those who incorporate moderate squatting into their regular exercise routines are at any risk. Finally, for those concerned about the risk of long term joint injury from conventional squatting, Hindu Squatting may provide a safer alternative with added aerobic benefits.

A vitamin D connection to muscle health & repair?

shoulder-pain

Reliable sources indicate that over 100 million Americans each year suffer from some form of chronic pain. Conventional chronic pain treatments including steroids carry with them serious side effects such as osteoporosis and aseptic necrosis (bone death). Over-prescription of opioid pain killers has contributed to the current U.S. addiction crisis. For this reason, Spanking FIT decided to embark on its Scientific Advancements in Pain series where we evaluate research pertaining to more natural pain alleviation remedies. The series begins with the topic of “shoulder pain”. First, we evaluated the efficacy of Myofascial Trigger Point Therapy (M.T.P.T.) in treating chronic pain. M.T.P.T. is based on the theory that chronic pain may be the result of small knots which develop in muscle fascia following injury or strain. M.T.P.T. practitioners believe that it is possible to eliminate pain by massaging out these fascia knots. Spanking FIT’s research evaluation uncovered clinical trial evidence that supports the theory. I also uncovered solid scientific evidence that Vitamin D not only plays a well-recognized important role in bone health, but also in maintaining the health of skeletal muscles. Hence, vitamin D therapy also shows promise in alleviating chronic muscle pain following injury or strain.

Healthy Recreation & Nudity      

ufo beach

The scientific evidence is convincing that moderate all over sun light exposure benefits human health. There is even unconfirmed evidence that exposing male genitalia to sun light may be healthier yet! For this reason, Spanking FIT embarked on a quasi-scientific international nude beach evaluation. The evaluation begins in North America. Part I-A covers the U.S. state of California. Part I-B covers the Pacific Northwest including Oregon, U.S.A., and Vancouver, British Columbia. Also there is , Part I-C: “Dangerously Naked-Nude Beaches of Mexico”, Part I-D: “Skinny Dipping in the Southern U.S.A.”, and Part I-E: “Fellow Travelers-Hit the Nude Beaches of Communist Cuba”. Stay tuned for more to come in 2017.

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The Science of Seasonal Allergy Relief- Pt. 2

In “Science of Seasonal Allergy Relief- Part 1”,  Spanking FIT reviewed safety concerns regarding popular prescription and over-the-counter remedies for seasonal allergies including grass pollen, tree pollen, and ragweed allergies. I noted the main side effects acknowledged by their makers including drowsiness, prostate enlargement in men, fatigue, mental confusion, memory loss, and rapid or irregular heartbeat. Acknowledged side effects of corticosteroid nasal sprays include sore throat, coughing, and even glaucoma. Spanking FIT raised the additional concern that anti-histamines, which work by binding to H(1) histamine receptors on sensitive nasal tissue, may compromise ability of the immune system to fight off other pathogens such as bacteria (see “Role and relevance of mast cells in fungal infections” by R. Saluja published in Frontiers In Immunology, 2012; 3: 146). The latter reference reviews the important broader immunity role that histamine-producing mast cells play. Spanking FIT took note of the dearth of experimental work relevant to this concern. This is especially worrisome given that anti-histamine products have been used by the public in enormous quantities for decades.

Previously in Part 1, Spanking FIT presented a list of the most popular “natural” remedies for allergy treatment  often recommended by online health resources as alternatives to the above products. I jokingly referred to the list as the “Granny list”, because many of the included items  sound like ones that Granny from the popular U.S. T.V. show “The Beverly Hillbillies” would have recommended.  Out of the dozen listed, I uncovered serious clinical trial validation experiments pertaining to four of them only: butterbur, phelum pratense (timothy grass), procyanidin, and pycnogenol. Part 1 presented the scientific evidence supporting butterbur efficacy. Here in part 2, I disclose my findings regarding the others, beginning with phelum pratense:

Phelum pratense (Timothy Grass)

allergy 3

Although native to Northern Europe, Timothy Grass was introduced to North America by early 18th century European settlers. It is used primarily as hay for feeding horses and cattle. Unfortunately, its pollen is also a bane for many allergy or “hay fever” sufferers. Some medical researchers claim it is possible to immunize patients against a variety of grass pollens using phelum pratense extract alone. Here are the results of Spanking FIT’s evaluation of their claim:

“Immunotherapy with a phelum pretense allergen extract induces an immune response to a grass-mix extract” by C. Martinez-Cocera and published in “Journal of Investigational Allergology and Clinical Immunology” 2010; 20 (1): 13-9.

In this clinical trial, 46 patients with allergic rhinitis history and confirmed sensitivity to a grass pollen mix were randomly assigned to either a specific immunotherapy treatment (S.I.T.) group or to a placebo group. The S.I.T., lasting two to three months, utilized Phlp5, a major allergen extract of timothy grass. At baseline and 3-4 months after beginning the treatment, patients were tested for cutaneous reactivity to both grass pollen mix and to phelum pratense. Blood samples were further collected so that immunoglobin analysis could be performed. In the treatment group, researchers reported a statistically significant decline in delayed cutaneous response following intradermal testing, not only for phelum pratense as expected, but for the grass mixture as well. That was not the case in the placebo/ control group. Researchers also reported statistically significant differences between control versus treatment group in delayed response changes from baseline for both allergens that favored their hypothesis. The previous findings constitute evidence that it may be possible to immunize against a variety of grass pollens using phelum pratense extract alone. Researchers also reported a significant difference in measured increase over baseline in Immunoglobulin G4 (IgG4) levels between treatment and control favoring their hypothesis. Such was the case for both phelum pratense-specific IgG4 and grass mixture-IgG4. (IgG4 is a non-inflammatory isotype which captures the allergen before it reaches effector cell-bound IgE  and in doing so  prevents the allergic chain reaction.) Researchers further strengthened their case for phelum pratense immunizing against  general grass pollen allergy by conducting correlation analyses between measured rye grass allergen- IgG4 levels versus measured phelum pratense (Phlp5)- IgG4 levels. In the process of doing so, they reported a rather high degree of correlation between the two.

From a statistical perspective, the study suffers from flaws common to much modern medical research. While I realize that most readers are not statisticians,  I will state them anyway for completeness: the usage of so-called parametric stat tests, in this case student t-test, given that rather small sample sizes were collected (25 treated subjects, versus 13 receiving placebo). Researchers admittedly log transformed the data prior to conducting analysis attesting to the fact that the basic requirement for use of the parametric statistical test – that of a  normally distributed population, wasn’t met.

Finally, it should be noted that this study was funded by ALK-Abello Company, the present maker of AVANZ.  The latter is the trademarked name of the companies’ phelum pratense allergy immunotherapy product. However, in fairness to the study researchers, product trademarking occurred several years after their clinical trial was conducted.

Procyanidin

CINNAMON

Procyanidins are actually an entire class of plant bioflavonoid believed to provide plants with protective defenses against herbivores. They also display antioxidant properties in vitro in mammalian cells.  Dietary sources include apples, cinnamon, cocoa beans, and grapes (both skin and seeds). Evidence that procyanidins protect against human allergic responses is primarily anecdotal in nature. However, Spanking FIT did turn up an efficacy study that was actually based on a clinical trial outcome:

Anti-allergic effect of intranasal administration of type-A procyanidin polyphenols __” by U. Aswar, et al. published in Phytotherapy Research; March 2015, 29 (3).

In this experiment, 60 mice were randomly assigned to one of six groups: (1) a “normal” group in which mice remained unsensitized to ovalbumin (OVA) and consequently not susceptible to OVA-induced allergic rhinitis (A.R.). (2) a control group in which mice were previously made susceptible  to A.R. through OVA sensitization.  During a one week “treatment” period these mice received placebo only.  (3) a bona fide treatment group previously made susceptible to A.R. through OVA sensitization. During the treatment period these mice received an anti-histamine. (4) same set-up as in #3 above except treatment consisted of a low dosage of the procyanidin product TAPP-CZ. (5) same set-up as in #3,4 above except treatment with medium TAPP-CZ dosage.(6) same set-up as #3,4,5 except treatment with a high TAPP-CZ dosage.

TAPP-CZ is a trademarked extract of cinnamon bark made by Indus Biotech Private Ltd. of India. It consists precisely of 76% pentameric type-A procyanidin flavonoids, 10% tetrameric, and 2% turmeric. As previously explained, flavonoids probably function to protect plants from herbivores.

After the one week treatment period, mice in all six groups were “OVA-challenged” and several allergic response variables quantified per subject. Among the quantified variables was (1) number of nasal rubbings within a ten minute observation period, and (2) number of sneezes within same period. Researchers reported that the median (middle) value of both variables was significantly lower in the medium and the high dose TAPP-CZ treated groups by comparison to AR- control. Furthermore, they claimed an exceptionally high degree of statistical significance. Researchers also reported significant lowering in levels of certain serum biochemical markers including histamine and IgE in the #5 and #6 treatment groups. Both histamine and IgE production play an important role in the allergic response with its associated symptoms.

Now from a statistical perspective: Given the small sample sizes involved (10 subjects per group), researchers are to be commended for using the appropriate non-parametric tests (Kruskal-Wallis followed by Dunn’s) in analyzing symptom variables. However, for some unexplained reason, they switched to less appropriate parametric A.N.O.V.A. followed by also parametric Dunnett’s test in analyzing biochemical marker data. Consequently, their stated claims in the latter regard are not as firm, in my opinion.

Pycnogenol

PYCNOGENOL

Pycnogenol is a procyanidin-containing product, also. Nevertheless, Spanking FIT chose to list it separately for two reasons: (1) it possesses the unique characteristic of being an extract from the bark of a specific species of pine (pinus pinaster); (2) its exact ingredients are unknown. (Spanking FIT contacted Horphag Research, Ltd. in Geneva, Switzerland which holds the product trademark . The company would not reveal  information regarding exact ingredients.) Spanking FIT uncovered the following clinical trial which was conducted to validate pycnogenol efficacy for allergic rhinitis treatment:

“A randomized, double blind, placebo-controlled exploratory study to  evaluate the potential of pyconogel for improving allergic rhinitis symptoms” by D. Wilson, et al. published in Phytotherapy Research, Aug. 2010; 24 (8).

In this experiment, 39 confirmed birch allergy patients were assigned randomly to either a treatment or a placebo group. The treatment entailed taking the product Pycnogenol at least five weeks prior to birch allergy season. Researchers reported improvements in allergic rhinitis symptoms including nasal and eye symptoms. They also reported decreased production of birch specific IgE, an important allergy symptom mediator.

One obvious problem with this study:  birch pollen season partially coincided with oak pollen season, and the recorded percentage of subjects who were allergic to oak pollen was greater in the placebo group than in the treatment group. Consequently, the reported symptomatic relief findings pertaining to birch pollen are confounded by the oak pollen factor. Just as importantly, upon careful examination of the results, Spanking FIT determined that none were statistically significant. In other words, the observed differences may have occurred  purely by chance.

Conclusion

allergy

Legitimate concerns regarding safety and adverse side effects of both prescription and over-the-counter allergy remedies, including anti-histamines, have caused consumers to consider using other more “natural” products  for seasonal allergy relief. However, Spanking FIT identified four products only for which serious clinical trial experimentation has been conducted. They are: butterbur, phelum pratense, procyanidins, and pycnogenol. I next evaluated relevant experimentation from the viewpoint of statistical validity and reached the following conclusion: empirical evidence exists to support the hypotheses that butterbur ingestion and procyadinin ingestion lessen symptoms of allergic rhinitis and inhibit adverse reactions to allergens.  The case for immunotherapy prior to allergy season with a phelum pratense preparation is a bit weaker due to flaws in statistical methodology used by researchers.  (Once again, I implore medical journal editors to make it mandatory that all published research provide links to collected raw data  so that independent statistical analyses may be conducted.)

Please don’t forget to read “The Science of Seasonal Allergy Relief- Pt. 1” in the event that you missed it. In it I explain the physiological mechanisms behind common allergic responses and present the scientific case for butterbur treatment efficacy.  I look forward to your valuable feedback, as usual. Sincerely,  Dr. Garrett

 

 

A spanking new approach to fitness, health, etc. based on REAL science