Studio su nutraceutico ed una lozione fitoterapica in donne con AGA in post-menopausa

Tricoblog

STUDIO SU UN NUTRACEUTICO ED UNA LOZIONE FITOTERAPICA IN DONNE CON ALOPECIA FEMMINILE POST-MENOPAUSA

Lucia Villa, Giovanni Profeta, Francesca D’Anna, Massimiliano Cametti, Bartalini Luisa, Cuffaro Loredana, Andrea Marliani

1. Introduzione

Nelle pazienti di sesso femminile, carenze di estrogeni nel follicolo pilifero, possono portare alla manifestazione di un’Alopecia femminile di tipo Ludwig. Infatti, come noto, il ciclo del capello è controllato dagli ormoni sessuali, sia estrogeni che androgeni, presenti e prodotti a livello follicolare. Una neonata branca della scienza medica è infatti l’”intracrinologia” la quale si occupa di studiare le interazioni intracellulari “intracrine”, degli ormoni e di come essi influenzino profondamente vari processi biologici. Nello specifico a livello intrafollicolare, due ormoni sessuali ricoprono un ruolo molto importante per la regolazione fisiologica del ciclo del capello: il Diidrotestosterone e l’Estrone.

Estrone maintains the mitotic activity of the hair matrix, lengthens the duration of the anagen phase, and activates hair stem cells; DHT, on the other hand, exerts an opposite action, terminating the anagen phase by bringing the hair into telogen and the follicle into catagen.

La presenza di DHT, prodotto a livello pilifero dalla 5-alfareduttasi tipo I è causa principale dell’Alopecia androgenetica maschile. Tuttavia, nelle donne, la presenza ematica di testosterone, e di conseguenza di DHT a livello follicolare è normalmente molto bassa, salvo casi molto rari di anomala produzione ormonale, spesso dovuta a tumori. È possibile partire dal presupposto per cui, escluse altre cause di natura autoimmune o da carenze nutrizionali, l’AGA femminile è causata da una carenza di estrone a livello del follicolo pilifero.

Intake of phytoestrogens may help to make up for this deficiency at the peripheral level. However, it is interesting how phytoestrogens have a peculiar biochemical behavior within the human body. In fact, from medical meta-analysis studies conducted on Asian populations in which the diet is high in phytoestrogen-rich vegetables, particular cytoprotective characteristics of phytoestrogen have been found to protect the breasts, female genitalia, and uterine mucosa from the onset of cancer. It is likely that this is due to the greater affinity of phytoestrogen for estrogen-binding cell receptors than for endogenous female hormones, thus preventing their binding, and preventing the aggravation of estrogen-sensitive tumor situations with an anti-estrogenic action. In contrast, at the skin and hair level, phytoestrogens have a true estrogenic action. The biochemical reason behind this peculiarity of action remains unclear.

However, as a result of what has just been discussed, it is apparent that, improving estrogen concentration at the level of the hair bulb is a viable therapeutic approach for Alopecia Femminile estrone deficiency.

2. Obiettivo dello studio

The objective of the study is to evaluate the efficacy and tolerability of a treatment consisting of a nutraceutical (Restax Donna Plus 30cps) and a topical lotion (Restax Donna Lotion 100ml) containing phytotherapeutic active ingredients in postmenopausal female patients and has as its primary end-point, the evaluation of hair status before and after treatment. This assessment will be carried out by means of an evaluation form, completed by the physician at the beginning of treatment and after 8 months, on which the intensity of clinical symptoms associated with Alopecia is noted.

3. Materiali e metodi

A total of 106 postmenopausal patients participated in the study; each patient was asked to take 1 capsule of Restax Donna Plus supplement daily, during dinner, and to apply Restax Women’s Lot ion every other day a minimum of 3 times per week, applying 15 sprays to the affected areas, to damp or dry hair that was not necessarily washed before each application.

Il ricercatore dopo visita ed anamnesi del paziente ha quindi compilato il questionario a T0 e T8, valutando sintomi clinici quali il risultato del pull test, la presenza di tricodinia e di prurito, usando una scala da 0 a 5, dove 5 indicava una presenza molto forte del sintomo in questione, 0 ne indicava l’assenza. Il ricercatore ha anche valutato il diametro medio dei capelli, con un valore di 5 per un valore osservato di diametro del capello molto buono e 0 per un valore osservato indicante capelli estremamente sottili. Il medico ha quindi espresso il proprio parere sulla situazione clinica del paziente in questione, con un valore di 0 indicante una situazione clinica negativa ed un valore di 5 indicante una situazione clinica molto positiva. Come ulteriore dato clinico è stato annotato il livello di Alopecia secondo la scala di Ludwig, usando numeri da 0 a 7, con 0 indicante assenza totale di capelli in zona apicale del capo e 7 indicante una capigliatura perfettamente normale. Inoltre sono stati espressi valori di soddisfazione per l’efficacia e la tollerabilità da parte del medico e del paziente alla fine dello studio.

3.1 Criteria for inclusion and exclusion

Sono incluse nello studio donne in menopausa con alopecia femminile, di qualsiasi età.

Sono escluse dallo studio: donne non in menopausa, donne con storia clinica di tumori, donne in trattamento con psicofarmaci, donne già in trattamento tricologico con prodotti per os o lozioni ad uso topico.

3.2 Caratteristiche dei prodotti testati

Nutraceutical Restax Woman Plus 30 cps:

Chasteberry dry extract, 200 mg, 0.5% agnuside: A natural progestin that acts on adenylyl cyclase activity, it reduces the duration of catagen and telogen phases as it hampers the 5-alpha-reductase metabolic pathway by reducing follicular DHT synthesis; it also helps activate aromatase, which converts excess testosterone to estrone.

Luppolo estratto secco, 200mg, 0,4% rutina: Contenente fitoestrogeni che attivano la fase di anagen del capello, tra i fitoestrogeni presenti nel Luppolo, di particolare importanza è l’hopeina, il più potente fitoestrogeno ad oggi conosciuto. Tale molecola è caratterizzata da una attività estrogenica pari a quella di concentrazioni di genisteina o daidzeina notevolmente superiori, anche di 50-100 volte, questo a causa della maggior biodisponibilità dell’hopeina rispetto agli altri fitoestrogeni. Svolge un’azione di promozione fisiologica della fase anagen.

Kudzu estratto secco, 150 mg, 40% in isoflavoni: Il Kudzu è una pianta originaria dell’Asia orientale, ricca di isoflavoni quali genisteina, daidzeina e puerarina. Viene impiegato come fonte di fitoestrogeni, grazie ai quali riduce le vampate di calore, stimola la rimineralizzazione ossea, calma la fame nervosa e aiuta il corretto funzionamento cardiovascolare. L’estratto di Kudzu, tra l’altro svolge anche una funzione adattogena, stimolando la produzione di serotonina e dopamina e riequilibrando il tono dell’umore e il ciclo sonno veglia, particolarmente utile in pazienti donne soggette ad Alopecia, poiché per loro la perdita di capelli è anche associata ad un forte impatto negativo a livello psicologico.

Resveratrol from Polygonum cuspidatum root , 50 mg: Powerful antioxidant, and anti-inflammatory, slows cellular aging by protecting biological molecules from oxidizing agents.

Niacin 25 mg: Also known as Vitamin B3 or PP, it is involved in the production of NADH, a coenzyme of fundamental importance in all cellular metabolic processes; its deficiency leads to progressive hair loss and weakening.

Biotina 450 ug: Nota anche come vitamina B8 o Vitamina H, è un nutriente essenziale in quanto l’organismo umano è incapace di sintetizzarla autonomamente. Aiuta l’assorbimento di nutrienti a livello cellulare ed esplica una importante funzione nel metabolismo di grassi e carboidrati. La sua mancanza porta ad assottigliamento e perdita di colore nei capelli.

Piper nigrum estratto secco di radice, 7 mg, 95% in piperina: Possibile anti-androgeno in quanto ha dimostrato un’attività inibitoria della 5-alfareduttasi in vitro, l’estratto di pepe nero migliora l’assorbimento degli altri principi attivi, aumentandone la BIODISPONIBILITΆ

Figura 1 Riassunto dell’attività degli estratti di Agnocasto, Kudzu e Luppolo.

Whereas as for Restax Women’s Lotion 100mL :

Main solvent: 80% v/v water ethyl alcohol mixture, to best solubilize all product components

Dimethyl Sulfone 0.5%

It enhances the solubilization and release of all active ingredients, promoting their passage through the superficial keratin layer of the dermis.

Sphinganine 0.3%

It is a natural skin sphingolipid of fundamental importance for its biological functions. It acts physiologically on hair loss by rebalancing the hair cycle, nourishing the hair follicle and improving scalp health.Sphinganine balances the natural hair cycle and promotes the Anagen phase by slowing down the telogen phase through physiological 5-alpha reductase inhibition action.

Chasteberry 0.7%

Agnuside, contained in Agnocaste extract, is a natural progestin that acts by going to stimulate the skin-level activity of P450 aromatase, and also has a moderate anti-androgenic action by inhibiting DHT synthesis.

This stimulates adenylate cyclase activity by lengthening the ANAGEN phase. Agnocaste also regulates progesterone levels, influencing the Progesterone/Estrone ratio in favor of the former.

Hops 0.35%

Hops extract contains phytoestrogens which go on to physiologically increase follicular estrone levels, contributing to the activation and elongation of the ANAGEN phase. Specifically, Hops contains Hopein, the most potent phytoestrogen currently known, which exhibits abilities to bind to estrogen receptors comparable to those of significantly higher concentrations (50-100 times) of soy phytoestrogens; this is due to the higher bioavailability of hopein compared to these substances.

Ribes nigrum 0.7%

Currant extract is a natural anti-inflammatory and has the ability to block the synthesis of anti-inflammatory cytokines locally, which are often involved in the ultimate loss of the hair follicle.

4. Risultati

A total of 106 postmenopausal patients, ranging in age from 44 to 95 years, participated in the study; the average age of the patients was 61.77 years. Following the 8 months of therapy, patients were asked about their degree of satisfaction with the therapy by asking questions regarding the taste of the product, its efficacy (rated by both the doctor and the patient), ease of digestion, and ease of intake. The evaluation was possible through a form with values from 0 to 5, where 0 indicated a negative liking value and 5 a strongly positive value. No patients reported negative judgments regarding the therapy they underwent, except for two patients who judged the taste of the nutraceutical taken as not pleasant. The ratings for the other categories were mainly on the value of very positive (3) or strongly positive (5).

Figura 2 Grafico rappresentante il gradimento del trattamento dopo 8 mesi

As for clinical data, on the other hand, the rating was expressed in values from 0 to 7 for Ludwig’s scale and again from 0 to 5 for each other category. The initial value of alopecia level according to the Ludwig scale stood at a value of 3.49, indicating a situation of already visible apical thinning and a medium alopecia, while at the end of the study the value went to a value of 5.06 indicating a condition of very moderate alopecia with slight thinning, demonstrating an improvement of 30.97% over the initial value. For clinical assessment, pull test, trichodynia and itching lower values indicated less presence of the problem or better clinical assessment, for hair diameter on the other hand, higher values identified larger diameters. Specifically, at the beginning of the study, out of 107 patients, 82.08% reported positive pull test results, 53.77% reported suffering from trichodynia and 42.28% reported scalp itching. At the end of the study, the same symptoms were reported by a very small number of patients, specifically positive pull test was in 35.85% of patients, trichodynia in 12.26 and scalp itching in 5.66, with a substantial reduction in the number of patients suffering from these symptoms. In addition, the average intensity of these symptoms has also been decreasing, in fact The initial values stood at 1.81; 1.27 1.08 for pull test, trichodynia and itching respectively, indicating a sitation of positive pull test, trichodynia and mild itching. At the end of the study these values were reduced to 0.53; 0.16 and 0.08 with an average decrease in symptoms of 70.83% for pull test, 87.40% for trichodynia and 92.98% for itching. Average hair diameter also went up, with a reported initial mean value of 2.63 out of 5 and a final value of 3.91 out of 5, a 48.42% improvement. In addition to this, out of 106 women participants, 2 reported reporting side effects, but these were minor and did not prevent discontinuation of the treatment. Specifically, one patient, 82 years old, reported developing hemorrhoids as a side effect as a result of taking the product, however, the problem was not particularly severe and resolved quickly by taking an antihemorrhoid medication. A second patient, age 51 complained of constipation problems that arose a few weeks after starting treatment: again, the problem resolved quickly and without particular discomfort for the patient.

5.Conclusioni

The study indicates a positive correlation between treatment with taking the nutraceutical “Restax Woman Plus” and the application of the lotion “Restax Woman Lotion“, and the decrease of female Alopecia symptoms. Moreover, the products in question proved to be substantially safe and with high tolerability: any side effects, where present, were limited in time and did not affect the ability to complete the therapy or significantly diminish the quality of life of the patients who suffered from them. Given these results, it is reasonable to conclude that a combination of the nutraceutical and the lotion under study can be used as a viable answer to the problem of Female Alopecia in old age.

References

Manfredi G.: “Considerations on the antiandrogenic activity of progesterone,” Med Est 1981; 4: 160.

Marliani A.: “The medical therapy of common baldness,” Etruria Medica, Florence, 1992.

Mauvais-Jarvis P., Kuttenn F., Baudod N.: “Inhibition of testosterone conversion to dihydrotestosterone in man treated percutaneously by progesterone” J Clin Endocrinol Metabol 1974; 38: 142.

Prince V.H.: “Testosterone metabolism in the skin,” Arch. Derm 1975; 11: 1496.