Effect Of Tocotrienol Supplementation On Hair Growth
Study Design
A randomized, double blind, placebo-controlled two groups parallel study was conducted to compare the effect of a mixture of tocotrienols, comprising #945;-, #947;-, and #948;-tocotrienols and alpha-tocopherol, with placebo on hair growth. All volunteers were randomized to receive one capsule comprising either (i) a mixture of tocotrienols and alpha-tocopheral, or (ii) a placebo, twice daily after food over a period of at least 5 months. They were seen for an efficacy evaluation every month throughout the study. The control was a placebo capsule containing 600 mg of soya bean oil, and the tocotrienol formulation consisted of capsules containing a mixture of about 50 mg of tocotrienols and about 23 i.u. alpha-tocopherol. The entire study took 15 months for completion.
Although the preferred embodiment of the formulation is in the form of soft gelatin capsule, other oral pharmaceutical dosage forms are not excluded. The preferred dosage range of tocotrienols for oral consumption is from about 20 mg to about 1500 mg/day. The formulation may also be applied topically and may be in the form of a cream, a lotion, an ointment, a gel, a liquid, or any other topical form. The concentration of tocotrienols used in the topical formulation is about 1.0%, and the minimum concentration of tocotrienols in any formulation is about 0.1%.
Inclusion Criteria
Volunteers of 15 years of age or older and in good general health were recruited into the study. Alopecia must have present for least 2 months and the areas alopecia must not have any visual evidence of new hair growth. Volunteers previously exposed to minoxidil were ineligible to participate in the study, as were patients who have used hair-restorers or systemic drugs like steroids, antihypertensives, cytotoxic compounds, vasodilators, anticonvulsant drugs, #946;-blockers, spironolactone, cimetidine, ketoconazole, estrogens or progesterons within the previous three months. Patients experiencing hair loss due to thyroid disease, adverse drug reactions, scalp or hair trauma, structural hair shaft abnormalities and lichen planus were excluded from the study.
Efficacy Evaluation
Two parameters were chosen to evaluate the efficacy of tocotrienols and alpha-tocopherol supplementation: i) Hair count--hair count served as the primary efficacy measure. An area of 2¡Á2 cm was selected in the area of hair thinning for each patient, and the two opposing corners of the square were permanently marked (using a 4 cm2 wire template) to ensure that the hair in the same area was counted at each visit. ii) Weight of hair--a small tuft of hair (at least 20 strands) within the demarcated area was clipped horizontally. Twenty strands were randomly chosen and cut into 1 cm in length. The total weight was obtained using a microbalance and the mean weight was recorded.
All of the two parameters were obtained at baseline and every month thereafter during the study. Only the terminal hair growth was recorded and analyzed.
Results of Hair Growth Studies
Nineteen patients (14 men and 5 women) entered the study and completed at least the first 5 months of therapy. Their ages ranged from 23 to 59 years. The mean duration of current alopecia episode was approximately 5 years. The extent of alopecia was as follows: less than 25%, 6 patients; 25 49%, 8 patients; 50 74%, 4 patients; 75 99%, 1 patient.
Eleven volunteers were randomized to receive the tocotrienol formulation supplementation while 8 volunteers were in the placebo group. Comparability of the treatment groups with respect to initial hair counts as well as the weight of hair was assessed. No statistically significant difference between treatment groups was detected for any of the above characteristics.
At the end of the supplementation period, all volunteers in the tocotrienol formulation group had positive results, recording an increase in the number of hairs in the evaluation area. Seven volunteers (64%) showed regrowth of between 10 35% while 3 volunteers (27%) had 50% or greater regrowth. One volunteer had regrowth of more than 100%. The mean percentage of increase in the number of hairs is 42.4¡À40.9% (mean¡ÀSD). (Table 1 and FIG. 1). The increase is statistically significant (p<0.05) when analyzed using paired sample t-test. On the other hand, of the total eight volunteers in the placebo group, two showed hair regrowth, two had hair loss while the other four did not show any significant changes in the number of hairs. The mean percentage of increase was 1.4¡À13.8%. No statistically significant difference (p>0.05) in the number of hairs was detected between baseline and post-supplementation, thus indicating that the placebo effect did not occur during this study.
However, in terms of the weight of the hair, no statistically significant difference (p>0.05) between pre- and post-supplementation was detected for both groups of volunteers (tocotrienol and placebo). The mean percentage of weight increment was 16.4¡À42.5% in the tocotrienol formulation group while that of the placebo group had an increase of 5.7¡À40.1%. (Table 2).
The above-mentioned studies therefore indicate that supplementation with a formulation comprising a mixture of tocotrienol, alpha-tocopherol and pharmaceutically acceptable excipient appears to promote hair growth and increase the number of hair in persons experiencing hair loss. The choice of pharmaceutically acceptable excipients will be obvious to those skilled in the relevant art. Acceptable excipients include any inert, compatible substances added to make the final dosage forms, for the formulations, such as tablets, capsules, or soft gelatin capsules. For example, vegetable oil can be added as an excipient to make up the volume for the encapsulation of soft gelatin capsules. As such, a pharmaceutically acceptable excipient includes any excipients that are approved for use by the relevant authorities and are compatible with tocotrienols.
TRaduzione approssimativa:
Effetto della supplementazione Tocotrienol sulla crescita dei capelli
Design Studio
Un randomizzato, in doppio cieco, controllati con placebo, due gruppi di studio ¨¨ stato condotto in parallelo, per confrontare l'effetto di una miscela di tocotrienols, comprendente-¦Á, ¦Ã, ¦Ä e tocotrienols e-alfa-tocoferolo, Con placebo sulla crescita dei capelli. Tutti i volontari sono stati randomizzati a ricevere una capsula composta da (i) una miscela di tocotrienols e alfa-tocopheral, o (ii) un placebo, due volte al giorno dopo i pasti per un periodo di almeno 5 mesi. Essi sono stati osservati per una valutazione di efficacia ogni mese durante lo studio. Il controllo ¨¨ stato un placebo capsula contenente 600 mg di olio di semi di soia, e la formulazione tocotrienol consisteva in capsule contenenti una miscela di circa 50 mg di tocotrienols e circa 23 UI Alfa-tocoferolo. L'intero studio ha preso 15 mesi per il completamento.
Sebbene l'incarnazione di preferito la formulazione ¨¨ in forma di capsule di gelatina molle, le altre forme farmaceutiche orali di dosaggio non sono escluse. Il dosaggio preferito gamma di tocotrienols consumo per via orale ¨¨ di circa 20 mg di circa 1500 mg / die. La formulazione pu¨° anche essere applicata topicamente e pu¨° essere in forma di crema, lozione, un unguento, un gel, un liquido, o qualsiasi altra forma di attualit¨¤. La concentrazione di tocotrienols utilizzati per la formulazione attuale ¨¨ di circa 1,0%, e la concentrazione minima di tocotrienols in ogni formulazione ¨¨ di circa 0,1%.
Criteri per l'inclusione
Volontari di 15 anni di et¨¤ o pi¨´ anziani e in buone condizioni generali di salute sono stati reclutati in studio. Alopecia deve avere presenti per almeno 2 mesi e le aree alopecia non deve avere alcuna prova visiva di nuovo la crescita dei capelli. Precedentemente volontari sono stati esposti a mino
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