Vigro – Dr Nye’s substantiation

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Below is the substantiation of Dr David Nye in support of the claims for Vigro. As mentioned before, Dr Nye has “substantiated” a number of dubious products previously. Readers are welcome to read Dr Nye’s substantiation and compare with ours. Dr Nye’s substantiation, in our opinion, is typical of a number of “experts” who substantiate products – cherry pick evidence and hide that which does not fit.

Dr Nye makes the point: “It is important to point out that the majority of evidence (articles and monographs) are subscription based, and that is why Dr Steinman is unable to find the supporting evidence on his “two major sources of accurate scientific information”, namely Pubmed and the Natural Medicines Database.

How does Dr Nye measure up? Dr Nye supports his substantiation with over 40 accompanying documents which we have not included here, but are simply the articles used in support of his substantiation and listed as references. It is common to “throw” an overload of documents in support of claims when in fact, none add up – as previously demonstrated for Patrick Holford’s claims for one of his products.

As it will be time-consuming to deconstruct Dr Nye’s full submission, only one or two examples will be used to argue that if an “expert” is at fault at one key aspect, can one trust the rest of the submission?

In this instance, we will focus on Para aminobenzoic acid (PABA) – item 22 in his document.

Para aminobenzoic acid (PABA)

Dr Nye supports the evidence for this ingredient by stating: “PABA is found naturally in several foods, and is part of the folic acid molecule. Orally PABA is used to darken grey hair, for vitiligo, to rejuvenate the skin and to prevent hair loss. 31 It has been historically investigated as an agent to restore colour to grey hair, and several small trials have shown this. 32

Reference 31 and 32 are:
Natural Medicines Comprehensive Database. Accessed 05-03-2013.
32 Cline DJ. Changes in Hair Color. Dermatol Clin 1988;6(2):295-303.

What Dr Nye does not indicate is that the reference by Cline DJ is published in 1988. A subsequent review in 1992 makes the following point: “Drug-induced hair colour changes are not a common adverse effect from medications. A wide variety of drugs have been implicated in causing hair colour changes but very few have data to support a true relationship. Of the drugs reported, chloroquine and cancer chemotherapeutic agents have the best evidence to support an association. Other drugs, such as p-aminobenzoic acid, calcium pantothenate, anthralin, chinoform, mephenesin, minoxidil, propofol, valproic acid, and verapamil await confirmatory data.

Not a single study since 1992 has demonstrated that PABA darkens hair in the average user.

Dr Nye’s second reference in support of the claims for PABA is Natural Medicines Comprehensive Database (NMCD).

NMCD states for PABA: “

People Use This For:
Orally, PABA is used for vitiligo, pemphigus, dermatomyositis, morphea, scleroderma, and Peyronie’s disease. PABA is also used orally to treat female infertility, arthritis, anemia, rheumatic fever, constipation, disseminated systemic lupus erythematosus, lymphoblastoma cutis, and headaches. It is also used orally to darken gray hair, prevent hair loss, rejuvenate the skin, and prevent phototoxic reactions. Topically, PABA is used as a sunscreen.

However, under the heading, EFFECTIVENESS (i.e., whether there is any evidence to support the claims or what “people use this for”, there is NONE, ZERO, ZIP for ” . . is also used orally to darken gray hair, prevent hair loss, rejuvenate the skin . . . “. In other words, people claim this without any evidence. Seems like Dr Nye is following suit.

Inositol (item 10 in the substantiation)

For this ingredient, Dr Nye writes: “Also known as anti-alopecia factor, inositol is used for promoting hair growth (refer monograph on the Natural Medicines Comprehensive Database 5).”

What does NMCD state for Inositol?

People Use This For: Orally, inositol is used for diabetic neuropathy, conditions associated with disorders of fat transport and metabolism, panic disorder, high cholesterol, insomnia, cancer, depression, schizophrenia, Alzheimer’s disease, attention deficit-hyperactivity disorder (ADHD), autism, treating lithium-induced side effects, psoriasis, and promoting hair growth. Inositol is also used orally for treating conditions associated with polycystic ovary syndrome, including anovulation, hypertension, hypertriglyceridemia, and elevated serum concentrations of testosterone.”

However, under the heading, EFFECTIVENESS (i.e., whether there is any evidence to support the claims or what “people use this for”, there is NONE, ZERO, ZIP for ” . . Orally, inositol is used for . .and promoting hair growth .  . “. In other words, people claim this without any evidence. Seems like Dr Nye is following suit.

We do not suggest or argue that every aspect of Dr Nye’s arguments are without merit, but that if many are simply without evidence, does this justify arguing that the whole product has efficacy when in fact, there is no evidence for some of the ingredients, and most importantly, when there is simply not ONE item of proof that mixing these ingredients together results in a product that works!

In fact, one of the most interesting aspects of Dr Nye’s substantiation is that he argues that the individual ingredients in FOLLICUSAN has efficacy, in contrast to my argument where I show that the company’s own evidence for the product itself, i.e., not the individual ingredients, has NO efficacy! Dr Nye is completely silent on this!

VIGRO/H A STEINMAN/21666

EVALUATION OF EVIDENCE TO SUPPORT THE EFFECTIVENESS OF FOLLICUSAN AND VIGRO PLUS BIO-CAPSULES AS COMPONENTS OF THE VIGRO 3-STEP

PROGRAMME

  1. I, Dr David Michel Nye, have been commissioned by Nativa (Pty) Ltd, the manufacturers
    and marketers of the Vigro range of products, to evaluate the evidence it holds in support of the efficacy of Follicusan, the active ingredient of the Vigro range, and Vigro (Plus) Bio capsules. In particular, the complaints lodged before the Advertising Standards Authority of SA by Dr H Steinman have been brought to my attention, and in my evaluation of the evidence I will be mindful of his concerns raised.
  2. I hereby declare that I have no financial or other interests in Nativa, and practise as an
    independent, integrative medical practitioner. In my practice I do prescribe and dispense herbal and other CAMS products to my patients.
  3. Summary of my Curriculum Vitae:

[CV removed simply to focus on pertinent substantiation]

  1. In this evaluation, I evaluate the efficacy of ingredients of Follicusan and the Vigro Bio­capsules, as the complainant stated that there was no “ingredient-specific substantiation”. An “ingredient-specific” evaluation is also acceptable within the paradigm of Complementary and Alternative Medicines (CAMS). I have been advised that Nativa furthermore requested an independent evaluation of the evidence for Follicusan as a compound, by Mr John Knowlton in a separate submission.
  2. Follicusan is a trademarked active compound produced by the German company Chemisches Laboratorium Dr. Kurt Richter GmbH (CLR).
  3. It comprises:
    1. Milk based bioactive signalling molecules (milk protein and lactose)
    2. DL-Ethylpanthenol (panthenyl ethyl ether)
    3. Inositol
    4. Sulphur-rich amino acids: N-acetyl cysteine (NAC) and N-acetyl methionine
    5. Water-alcohol medium
    6. Preservatives: sodium citrate and citric acid.
    7. It is important to point out that the majority of evidence (articles and monographs) are subscription based, and that is why Dr Steinman is unable to find the supporting evidence on his “two major sources of accurate scientific information”, namely Pubmed and the Natural Medicines Database.

 

EVALUATION OF THE EFFICACY OF INGREDIENTS OF FOLLICUSAN AND THE VIGRO BIO­CAPSULES

FOLLICUSAN

The individual ingredients in Follicusan discussed below have evidence to show their effect on the growth of hair.

8. Milk based bioactive signalling molecules

It is important to understand what exactly signalling molecules are. 1. A signalling molecule is a chemical involved in transmitting information between cells. Such molecules are released from the cell sending the signal, cross over the gap between cells by diffusion, and interact with specific receptors in another cell, triggering a response in that cell by activating a series of enzyme controlled reactions, which lead to changes inside the cell.

As signalling molecules, the bioactive peptides play important roles in physiological functions and pathogenesis. Bioactive peptides have been defined as specific protein fragments that have a positive impact on body functions and conditions and may ultimately influence health. 2

The major role of milk proteins is to supply amino acids and nitrogen to the young mammals and constitute an important part of dietary proteins for the adult. Intact milk proteins have also specific functions such as micelle formation. Furthermore, milk proteins have physiological importance, they facilitate uptake of several important nutrients such as trace elements and vitamins and contain a group of proteins which perform a protective function. This means that milk proteins are highly functional substances. Once bioactive peptides are liberated, they may act as regulatory compounds with hormone-like activity. Milk proteins are the most important source of bioactive peptides, though other animal as well as plant proteins also contain potential bioactive sequences.. 3

1 . Gilbert, Scott F. (2000). “Juxtacrine Signaling”. In NCBI bookshelf. Developmental biology (6. ed. Ed.). Sunderland, Mass.: Sinauer Assoc. ISBN 0878932437
2 Kitts, D. D. and. Weiler, K. A. (2003). Bioactive proteins and peptides from food sources applications of bioprocesses used in isolation and recovery. Current Pharmaceutical Design, 9, 1309-1323.
3 Sharma S, Singh R, Rana S. Bioactive Peptides: A Review. Int.J.Bioautomation, 2011, 15(4), 223-250.
9. DL ethyl panthenol

This is the ether form of dextrorotatory isomer of pantothenic acid, belonging to the group of water-soluble vitamins, member of B-complex vitamins, specially designed for topical application. When it is applied to the skin directly or in cosmetic formulations, it is rapidly absorbed and changed into pantothenic acid (a precursor of coenzyme A) by hydrolysis and oxidation. It improves the comb-ability of wet hair, penetrates well into the hair shaft, causes long lasting moisturizing effects, promotes gloss and elasticity, improves the structure of hair and has a repair effect. 4

See also paragraph 15 below.

10. Inositol

Also known as anti-alopecia factor, inositol is used for promoting hair growth (refer monograph on the Natural Medicines Comprehensive Database 5).

11. N acetyl cysteine

N-acetyl cysteine is a precursor of glutathione, which is a potent antioxidant. Glutathione cannot cross the cell membrane, but N-acetyl cysteine easily crosses the cell membrane where it is converted to cysteine and, subsequently, glutathione. Reactive oxygen species (ROS) such as hydrogen peroxide and hydroxyl-free radicals reduce intracellular and extracellular concentrations of glutathione. N-acetyl cysteine is a very efficient way to replenish glutathione and reduce damage caused by ROS. 6 On the face of it effective against seborrhoea of the scalp, it prevents formation of dandruff and accelerated greasing of the hair. It has also been shown to significantly reduce hair-pulling compulsion (trichotillamania). 7 The protein of the cuticle of hair has been analysed and demonstrated to be high in cysteine. 8 Upon hair damage, this protein is released from hair fibres and possibly destabilizes the hair tissue architecture. 9

4 http://www.kyowa.eu/files/pdfs/broschures/d-pantothenyl ethyl ether.pdf. Site accessed 03-03-2013. [no longer available] 5 http://naturaldatabase.therapeuticresearch.com.
6 Kelly GS. Clinical applications of N-acetylcysteine. Altern Med Rev 1998;3:114-27.
7 Grant JE, Odlaug BL, Kim SW. N-acetylcysteine, a glutamate modulator, in the treatment of trichotillomania: a double-blind, placebo-controlled study. Arch Gen Psychiatry 2009;66:756-63.
8 Roger M A et al. Human Hair Keratin‐Associated Proteins (KAPs). International Review of Cytology, Vol. 251 pp 209-263.
9 Kizawa K et al. Characterization of the cysteine-rich calcium-binding S100A3 protein from human hair cuticles. Biochemical and Biophysical Research Communications 299 (2002) 857–862.

 

12. Acetyl methionine

It is, on the face of it, effective against seborrhoea of the scalp, preventing formation of dandruff and accelerated greasing of the hair.

13. According to the author of a review of Nutrition and Hair: “Although many nutritional supplements have been used traditionally to treat hair disorders, there is limited evidence of their use in non-deficient patients. Further studies are needed to increase the evidence on nutritional supplements on hair.” 10

THE VIGRO BIO-CAPSULES

All the individual, active ingredients of the Bio-capsules discussed below have evidence to show their effect on the growth of hair. These ingredients assist the body to correct any possible nutritional deficiencies that could be causes of hair loss.

14. Lycopene

Lycopene is a red pigment found mainly in tomatoes and other fruits. It belongs to a group of compounds called carotenoids, and is found in high concentration in several organs including the skin. 11 Lycopene is well known as a powerful antioxidant, which prevents oxidative damage to DNA. 12 Hair is exposed every day to a range of harmful effects such as sunlight (degradation by UV rays), pollution, cosmetic treatments, grooming practices and cleansing. Antioxidants have been shown to improve mechanical properties, such as fibre integrity, preserve colour and shine of fibres, and also coating and protecting them against UV rays. 13

It has been shown in both men and women that the association of antioxidants with polyunsaturated fatty acids, zinc, taurine and plant polyphenols was able to restore a more balanced hair cycle leading to decreased hair loss and increased hair density together with an improvement of hair quality. 14 15

Incorporation of antioxidants, at low concentrations, in cosmetics can better protect and possibly correct the damage by neutralising free radicals and retard lipid oxidation. 16

10 Finner AM. Nutrition and Hair: Deficiencies and supplements. www.derm.theclinics.com. Volume 31, issue 1. Jan 2013.
11 Natural Standard professional monograph. Feb 2013.
12 Di Mascio P, Kaiser S, Sies H. Lycopene as the most efficient biological carotenoid singlet oxygen quencher. Arch Biochem Biophys. 1989 Nov 1;274(2):532-8.
13 Fernández E et al. Efficacy of antioxidants in human hair. Journal of Photochemistry and Photobiology B: Biology 117 (2012) 146–156.
14 Piccardi N et al. Nutrition and nutritional supplementation: Impact on skin health and beauty.
Dermatoendocrinol. 2009 Sep-Oct; 1(5): 271–274.
15 Bouilly-Gauthier D, et al. A new nutritional supplementation is effective against hair loss and improves hair quality. EADV 2008; 1003.
16 Fernández E et al. Efficacy of antioxidants in human hair. Journal of Photochemistry and Photobiology B: Biology 117 (2012) 146–156.

 

There is no standard dosage for Lycopene, as it varies widely in the literature. Two capsules (recommended daily dose of the product) contain 2mg, which is a low concentration, as recommended above.

Lycopene is Generally Regarded As Safe (GRAS).

15. Selenium

Selenium is required for activation of glutathione peroxidase, which is an important antioxidant enzyme (to reduce oxidative stress). Deficiency may also result in hypo-pigmentation of skin and hair 17 and hair loss. 18

Selenium appears to be safe when taken short-term in amounts less than 400ug daily. 19 Reference daily intake (RDA) for adults is 55ug. Two capsules contain 100ug.

16. Calcium pantothenate

Also known as Vitamin B5, it is used for treating alopecia, dandruff and grey hair. 20

Pantothenic acid also appears to be essential to normal epithelial function. 21 Vitamin B5 has been used for many years in hair care products, because it functions as a humectant, increasing the water content and improving the elasticity of hair. 22 It is essential in all mammals to preserve hair colour and prevent hair loss. 23

The minimum daily requirement is 4-7mg/kg. Two capsules contain 200mg. See also paragraph 9 above.

17. Choline bitartrate

Choline has traditionally been considered a B vitamin. However, this is controversial because choline can be synthesized by the human body. Choline is produced in the liver via the methylation of phosphatidylethanolamine. Choline is also readily available in the typical diet

17 Finner AM. Nutrition and Hair: Deficiencies and supplements. www.derm.theclinics.com. Volume 31, issue 1. Jan 2013.
18 Goldberg LJ, Lenzy Y. Nutrition and hair. Clinics in Dermatology (2010) 28, 412–419.
19 Natural Medicines Comprehensive Database. Accessed 05-03-2013.
20 Natural Medicines Comprehensive Database. Accessed 05-03-2013.
21 McKevoy GK, ed. AHFS Drug Information. Bethesda, MD: American Society of Health-System Pharmacists, 1998.
22 Mary P. Lupo, Antioxidants and Vitamins in cosmetics, Clin. Dermatol. 19 (2001) 467–473.
23 Smith CM et al. Comparative nutrition of pantothenic acid. The Journal of Nutritional Biochemistry Volume 7, Issue 6, June 1996, Pages 312–321.

 

in liver, muscle meats, fish, etc. 24 The purpose of its inclusion in the product appears to be other than hair loss.

18. Inositol

See paragraph 10 above.

19. Folic acid

Folic acid (also known as Vitamin B9) plays an important role in hair loss prevention. Together with Vitamins B6 and B12 and biotin, folic acid helps maintain haemoglobin levels in the blood. The main function of haemoglobin is to transport oxygen between the lungs and the body’s tissues, so both hair and skin suffer if these vitamins are deficient. Folic acid is required for normal hair growth. 25

The RDA for folic acid is 400ug per day with an upper limit of 1000ug. Two capsules contain 800ug.

20. Nicotinamide

It is an amide of Nicotinic acid or Niacin, also known as Vitamin B3. One of the early signs of deficiency is diffuse hair loss. 26 Nicotinamide is quickly converted to NAD (Nicotine adenine dinucleotide), which is required for DNA repair in damaged hair.

The recommended daily allowance of Nicotinamide is 14-16mg/day. It is safe up to doses of 6gm/day. 27 Two capsules contain 50mg.

21. Vitamin B12

A deficiency of Vitamin B12 can cause grey hair. 28 Vitamin B12 is used for seborrhoeic dermatitis, and is essential for the effective utilisation of folic acid. 29

24 Natural Medicines Comprehensive Database. Accessed 05-03-2013.
25 Marly E. Novel Agents for the Treatment of Alopecia. Seminars in Cutaneous Medicine and Surgery. Vol 17, No 4 (December), 1998: pp 276-283.
26 Finner AM. Nutrition and Hair: Deficiencies and supplements. www.derm.theclinics.com. Volume 31, issue 1. Jan 2013.
27 Natural Standard Professional Monograph. Copyright 2013. www.naturalstandard.com.
28 Finner AM. Nutrition and Hair: Deficiencies and supplements. www.derm.theclinics.com. Volume 31, issue 1. Jan 2013.
29 Natural Medicines Comprehensive Database. Accessed 05-03-2013.

 

Treatment with other alopecia medicines such as cyproterone acetate and ethinyl estradiol produce a decrease of vitamin B12, therefore women treated for female pattern hair loss with these agents must be treated with supplemental vitamin B12. 30

The RDA for Vitamin B12 is 2.4ug/day. Two capsules contain 10ug.

22. Para aminobenzoic acid (PABA)

PABA is found naturally in several foods, and is part of the folic acid molecule. Orally PABA is used to darken grey hair, for vitiligo, to rejuvenate the skin and to prevent hair loss. 31 It has been historically investigated as an agent to restore colour to grey hair, and several small trials have shown this. 32

There is no standard recommended daily dose. Two capsules contain 60mg.

23. Ferrous gluconate

Iron deficiency is ranked by the WHO as the world’s most common deficiency. Iron is functional in haemoglobin, stored in ferritin and transported in transferrin. Deficiency can cause hair loss and other skin symptoms. The impaired keratin production can lead to thinner anagen hairs. 33 Studies have shown that decreased ferritin is associated with alopecia in women. 34 35 Decreased levels of both iron and zinc have been associated with hair loss. It is commonly associated with telogen effluvium but has also been identified in patients with alopecia areata. Repleting zinc and iron through supplementation may help the hair growth environment in both the conditions. 36

The recommended daily allowance is 8 (males) to 18 (females) mg/day. Two capsules contain 36mg.

30 Camacho-Martínez FM. Hair Loss in Women. Seminars in Cutaneous Medicine and Surgery, Volume 28, Issue 1, March 2009, Pages 19-32.
31 Natural Medicines Comprehensive Database. Accessed 05-03-2013.
32 Cline DJ. Changes in Hair Color. Dermatol Clin 1988;6(2):295-303.
33 Finner AM. Nutrition and Hair: Deficiencies and supplements. www.derm.theclinics.com. Volume 31, issue 1. Jan 2013.
34 Kantor J, Kessler LJ, Brooks DG, et al. Decreased serum ferritin is associated with alopecia in women. J Invest Dermatol.2003;121(5):985–988.
35 Goldberg LJ, Lenzy Y. Nutrition and hair. Clinics in Dermatology (2010) 28, 412–419.
36 Trost LB, Bergfeld WF, Calogeras E. The diagnosis and treatment of iron deficiency and its potential relationship to hair loss. J Am Acad Dermatol 2006;54:824-44.

24. Copper sulphate

Copper is essential for oxidation of thiol groups needed in the formation and strength of keratin fibre, which is a component of hair and nails. 37

There is no established RDA for copper. Two capsules contain 400ug.

25. Manganese glycerophosphate

Trace Minerals International of Boulder, Colorado examined the mineral metabolism of 19 patients with alopecia. The spectrophotometric analysis showed manganese deficiency in all 19. Eighteen patients showed considerable problems with calcium absorption, and twelve patients had problems with their zinc metabolism. Specific nutritional and mineral therapy resulted in improved hair growth after 2-3 months of treatment. 38

Although no RDA has been established for manganese, adequate intake level for manganese is estimated at 1.8-2.3 mg/day. 39 Two capsules contain 10mg.

26. Zinc gluconate

Zinc deficiency is still common in developing countries, in the elderly, in alcoholics, in anorexics and those on ACE inhibitor drugs. 40 Zinc deficiency can lead to telogen effluvium, thin white and brittle hair and other skin and nail problems. 41 Alopecia is often a presenting sign of zinc deficiency. 42 In 130 patients after gastroplasty for morbid obesity, hair loss developed in 47 even though they were taking a vitamin supplement. All responded to oral zinc supplementation. 43

The recommended dietary allowance is 8-11mg/day. Two capsules contain 30mg zinc.

27. Most of the ingredients in the Follicusan and the Bio-active capsules discussed above have been shown to have evidence to justify their inclusion in these products as part of the Vigro 3 step programme.

37 Finner AM. Nutrition and Hair: Deficiencies and supplements. www.derm.theclinics.com. Volume 31, issue 1. Jan 2013.
38 Blaurock-Busch, E. Wichtige Nahrstoffe fur Gesunde Haut und Haare, Kosmetik Internat. 3/87.
39 Natural Standard Professional Monograph. Copyright 2013. www.naturalstandard.com.
40 Prasad AS. Discovery of human zinc deficiency: 50 years later. J Trace Elem Med Biol. 2012;26(2–3):66–69.
41 Finner AM. Nutrition and Hair: Deficiencies and Deficiencies and supplements. www.derm.theclinics.com . Volume 31, issue 1. Jan 2013.
42 Goldberg LJ, Lenzy Y. Nutrition and hair. Clinics in Dermatology (2010) 28, 412–419.
43 Neve HJ, Bhatti W, Soulsby C, et al. Reversal of hair loss following vertical gastroplasty when treated with zinc sulphate. Obes Surg1996;6:63-5.

 

28. Although most references state difficulties with prescription of standard daily dosage recommendations, it appears that the dosages of most ingredients in the product are aligned within recommended ranges.

29. The ingredients are all safe, if used within recommended dosages.

30. The complainant requests substantiation for the following claims:

  1. “An effective long lasting solution to thinning hair
  2. Supports your scalp to re-activate hair growth and thereby helping to maintain the natural balance of hair loss and growth
  3. “With the active ingredient Follicusan – shown to reactivate hair cells to promote new hair growth, as well as helping to strengthen weakened hair follicles
  4. “Bio-capsules are a nutritional supplement containing a combination of vitamins and minerals essential for healthy hair growth to help effectively promote healthy hair growth from the inside
  5. “With added Lycopene, an anti-oxidant that can assist to prevent oxidative damage to the hair follicles.”

31. I have evaluated the evidence above, which supports these claims. I therefore am of the conclusion that these claims are fully substantiated. 

D M Nye

12-03-2013

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