ReinhardtKosmetische Cosmetic Medicine
MEDIZIN ORGANSCHAFTEN:Vereinigung für ästhetische Dermatologie und Lasermedizin e.V.
Deutsche Gesellschaft für Ästhetische Dermatologie Österreichische Gesellschaft für Ärztliche Kosmetologie und Altersforschung der Haut Bockshornsamen + Mikronährstoffe:
Wirksamkeit eines Nahrungsergänzungsmittels gegen Haarausfall
Fenugreek + micronutrients: Efficacy
of a food supplement against hair loss
Christiane Schulz, Stephan Bielfeldt, Dr. Jürgen Reimann
Haarausfall, Haarwachstum, Bockshornklee, Bockshorn+Mikro- hair loss, hair growth, fenugreek, Bockshorn+Mikronährstoff nährstoff Haarkapseln Arcon-Tisane® plus, Phototrichogramm, kli- Haarkapseln Arcon-Tisane® plus, phototrichogram, clinical study, nische Studie, Nagelgesundheit Haarverlust, dünner werdendes Haar, schlecht wachsende Haare Hair loss, hair thinning, poorly growing hair and powerless or dull und kraftlose oder stumpfe Haare sind bekannte Beschwerden in hair are common complaints in clinical dermatology. There is a der klinischen Dermatologie. Daher gibt es einen Bedarf an Produk- need for products, which support the hair growing process and con- ten zur Unterstützung des Haarwachstums oder die regulierend in trol some of the disturbances in the hair cycle dynamics. In context den Haarzyklus eingreifen. Im Rahmen einer randomisierten, Pla- of a randomised, placebo-controlled clinical trial efficacy of a fenu- cebo-kontrollierten klinischen Studie wurde die Wirksamkeit eines, greek seeds containing food supplement against hair loss is evalu- auf Bockshornkleesamen basierenden Nahrungsergänzungsmittels ated. The results indicate a successful treatment of low to moder- gegen Haarausfall überprüft. Die Ergebnisse zeigen eine erfolgrei- ate hair loss in women and men. Additionally, positive effects on che Behandlung bei leichtem bis mäßigem Haarausfall bei Frauen hair growth were demonstrated.
und Männern. Weiterhin zeigt das Präparat positive Effekte auf dasHaarwachstum.
new hair shaft emerges at the skin surface. In normal states it is esti-mated that 85–90 % of scalp hairs are in anagen, with the majority Hair growth depends on a com- of the remainder in telogen state [4, 6, 11]. If this balance in hair plex and precisely controlled growth cycle is impaired effluvium occurs . This can be caused process, which is not fully under- due to complex interactions which may involve molecular mecha- stood. It is a cyclical process, nisms, angiogenesis, micro-inflammation, neuroendocrine influences involving synthesis, elongation as well as environmental impact, microorganisms and nutritional and finally shedding of the hair supply .
shaft. Three phases are recog-nized in this cycle, namely the Hair loss, hair thinning, poorly growing hair and powerless or dull anagen (growth), catagen (regres- hair are common complaints in clinical dermatology. Therefore it is sion) and telogen (rest) phases.
desirable to have products, which support the hair growing process Shedding of the hair shaft occurs and control some of the disturbances in the hair cycle dynamics. The at a time called telogenesis.
aim of the study was to investigate the efficacy of a fenugreek seeds Fig. 1: Fenugreek After telogenesis, a latency extract containing food supplement* against hair loss. The efficacy (Trigonella foenum-graceum L.). period may be present before a was evaluated over time and in comparison to placebo.
The verum preparation used in this study is a fenugreek seedsextract containing food supplement, which additionally containsmicronutrients like hair active B-vitamins, antioxidants and traceelements. Fenugreek (Trigonella foenum-graceum L.) (fig. 1) is anannual herb of leguminosea. Fenugreek is native to SouthernEurope, the Mediterranean region and Western Asia. Seeds of fenu-greek contain a wide range of active ingredients like saponins, espe-cially derivatives of diosgenin, yamogenin and gitogenin, alkaloids(trigonelline), flavonoids, vitamins and fiber galactomannan etc Fig. 2: Picture analysis prior (left) and post treatment (right) with Bockshorn . Its seeds have a strong aroma and somewhat bitter in taste. It + Mikronährstoff Haarkapseln Arcon-Tisane® plus over a period of 6 months. has a long history as both a culinary and medicinal herb in theancient world. Beneficial properties of fenugreek seeds haveattracted wide attention in the recent past due to their therapeutic 11,0 years and 54,4 ± 11,0 years, respectively. However, the sub- potential, including its use as hypoglycemic, antiulcerogenic, hypo- groups regarding gender and preparation showed no significant dif- cholesterolemic and antihypertensive agent [1, 3, 13]. Beyond, it is ference in age (p = 0,1304). BMI was distributed quite homoge- used in Ayurvedic medicine . Up to now, all active ingredients neously between study groups. Noticeable is the high fraction (31,5 responsible for the possible observed effects are not identified yet.
%) of subjects with BMI > 30 kg/m2, termed as overweight. However, In monography of fenugreek a dosage of 6 g / day is quoted for oral looking at outcome parameters, these volunteers did not show out- use and 50 g powdered drug in 1/4 l water for external use.
standing differences to other volunteers. In total, volunteers build arepresentative group for examination of intended objectives.
Positive effects of fenugreek on hair growth are known, however, themechanism is not characterized. It is discussed that fenugreek inter- Compliance and compatibility
acts in a physiologic way by stimulating blood circulation to hair fol-licles and steroid saponins are expected to interact with DHT (dihy- Compliance visits took place every month. Compliance of intake of drotestosterone) metabolism. One reason for male and female test preparations was very good. Tolerance was very high. Only a few pattern hair loss is thought to be due to the effects of DHT on geneti- volunteers disliked the strong smell of fenugreek which reminds to cally predisposed hair follicles. Binding of DHT to the hair follicle lovage. To mimic the smell in placebo capsules a fenugreek aroma results in gradual miniaturization of the hair and eventual hair loss.
was added. In both groups only a very few volunteers reported an A fenugreek containing product is already successfully on the market unpleasant smell / belch / feeling after intake of study preparations.
since 1987. Now the formulation shall be further improved with addi- This especially occurred, if preparations were taken after over night tional micronutrients: vitamins and trace element compounds. In the fast without breakfast. Volunteers in the trial were asked to take the following clinical study its efficacy against hair loss shall be scientif- preparations in the morning together with breakfast. No other side ically proven.
effects were reported in relation to the intake of study preparations. Study design
Satisfaction of preparations was quite high, 72 % and 86 % of volun-teers in placebo and verum group, respectively, would recommend The study was conducted as a mono-centric, randomised, double- product to others and most of them (85 % and 90 %, respectively) blind, placebo controlled clinical study. Prior study start, the study would take the product further on. design was approved by an independent ethics committee. Volun-teers were screened for there eligibility to take part in the clinical Hair loss / hair growth parameters
trial according to in- and exclusion criteria and enrolled afterinformed consent. 60 volunteers (30 men and 30 women) with mild Volunteers with slight to moderate hair loss were enclosed to the to moderate hair loss ingested the test preparations (2 capsules trial. Hair loss was assessed according to a scale of 0–4 (0: none, daily) over a period of 6 months. Additionally 6 volunteers were 1: very slight, 2: slight, 3: moderate, 4: strong); placebo: 2,06; enrolled two months after start of clinical trial because of drop outs verum: 2,31 (baseline values). After 6 months of intake of test prepa- due to private reasons. In total, 53 volunteers successfully finished rations, hair loss was significantly improved p < 0,0001 in both the clinical trial. Every two months there was a dermatological groups; placebo: 0,39; verum: 0,37 (dermatologist assessment).
assessment of hair loss, a questionnaire and the assessment of hair Data are confirmed by volunteer assessment. With both study prepa- parameters via phototrichogram picture analysis (fig. 2). Addition- rations improvement in hair loss was observed over treatment phase.
ally after 6 months of treatment a retrospective questionnaire was The trial was performed as double-blind study design to control for performed. Methods used enclose both subjective and objective psychological influence. However, the placebo effect is high and parameters, reliable methods to assess hair loss and hair growth intensively developed for some parameters. Anyhow, clear conclu- parameters to monitor response of therapy [4, 8, 11, 16].
sions can be stated from the clinical trial. The placebo effect isreflected in other placebo controlled trials . To mimic the intense Study group
smell of fenugreek in placebo capsules, a fenugreek aroma wasadded. However, it was not possible to get an aroma completely free Volunteers were randomly assigned to placebo (1/3 of volunteers of of saponins. Therefore it cannot ruled out, whether small amounts of each sex) or verum* group (2/3 of volunteers of each sex). Demo- saponins could have contributed to the positive effects.
graphic data were assessed with a questionnaire. Regarding age,volunteers between 30 and 67 years participated in the trial. Women Sex specific differences in baseline values were obvious especially were significantly younger compared to men (p=0,0389) with 48,5 ± for the ratio counts anagen/telogen counts. Men: 1,63 (placebo equivalent to 62 % anagen hairs) and 2,03 (verum equivalent to 67 % anagen hairs); women 4,69 (placebo equivalent to 82 % anagenhairs) and 5,43 (verum equivalent to 84 % anagen hairs). However,changes over time depending on treatment were comparable between gender groups. For evaluation of statistical significance, parameters of picture analysis and dermatologist/volunteer assess- ment were evaluated for preparations but not in gender subgroup, because of small falling number. Hair density parameter from image analysis (fig. 2) was significantly improved (p < 0,045; baseline ver- sus all treated assessment times) over time in comparison to base- line data after intake of verum preparation. Maximum hair density was observed after intake of capsules for four months. Both, hairdensity and thickness anagen hair showed diminishing values after 6months compared to 4 months. Here the seasonal shedding of hairs could have interfered with the study design. Fig. 3: Retrospective assessment of changes in hair dressing of women on a The parameter hair density was also evaluated via subjective volun- scale of –4 to +4; depicted are relative frequencies. p < 0,017. teer assessment which confirmed the results of picture analysis. Theresults clearly show superiority of the verum preparation over the Hair density at parting region
placebo preparation for the parameter hair density. With the placebopreparation no significant improvement could be documented overtotal treatment phase. Verum preparation showed significant influ- ence (p < 0,001) on the growth rate of anagen hairs with lowest lev- els prior treatment. The ratio of anagen/telogen hair counts resulted in improvement for the benefit of anagen hairs after intake of verum preparation. However, differences over time were not statistically After intake of study preparations over a period of 6 months, volun-teers were asked to evaluate retrospective subjective changes of parameters according to a scale of –4 up to +4 (1: slight, 2: moder-ate, 3: medium, 4: strong). Negative numbers referred to worsening, Fig. 4: Retrospective assessment of hair density at parting region of men on a positive numbers to improvement of parameters. Besides hair scale of –4 to +4; depicted are relative frequencies. p < 0,047. growth parameters, nail parameters were evaluated with this retro-spective subjective questionnaire. Statistical evaluation was per- Robustness of nails
formed gender specifically as the subjective assessment of parame-ters showed that between genders different problem areas aredefined and evaluated differently between gender groups.
After intake of verum preparation, 82,9 % of volunteers reported an improvement for the parameter hair volume and hair thickness. 74,3 % reported an improvement of resistance of hairs. Significant prepara- tion differences (placebo versus verum) were found for hair dressing in women (fig. 3) and hair thickness, hair density at parting region(fig. 4) and hair growth at receding brow in men for the benefit ofverum preparation. Evaluating all observed hair parameters with clustering in worsening and no change (scale: –4 to 0) versusimprovement (scale: 1 to 4) resulted in significant (p < 0,05) differ- Fig. 5: Retrospective assessment of robustness of nails in women on a scale of ences between placebo and verum preparation. –4 to +4; depicted are relative frequencies. p < 0,022. Nail health
Context of literature
In respect of nail health, volunteers mentioned changes especially innail growth and robustness of nails (fig. 5). The parameter robust- Commercially different therapeutics on the field of medical and sup- ness was significantly improved after intake of verum preparation plemental area are available. These preparations are used as topical compared to placebo (p < 0,003 for total group). The results indi- or oral applications. In the field of pharmaceutical products, Finas- cate, that intake of a supplement containing fenugreek and micronu- terid and Minoxidil are the best known preparations [7, 9, 15, 17].
trients could come along with positive changes with related tissues Finasterid, a competitive inhibitor of type 2 5-alpha reductase like nails and skin.
inhibits the transformation of testosterone to dihydrotestosterone (DHT). Androgen-dependent process in hair loss are predominantly due to the binding of DHT tothe androgen receptor. The hormone-receptor complex activates the genes responsible for the Kosmetische Medizin –
gradual change of large terminal follicles to miniaturized follicles [12, 14]. Minoxidil an adeno- sine triphosphate sensitive potassium channel opener has been reported to stimulate the pro- Organ der Vereinigung für Ästhetische duction of vascular endothelial growth factor in cultured dermal papilla cells. Dermatologie und Lasermedizin e.V.
Since the clinical success rate of treatment of hair loss with modulators of androgen metabolism Organ der Deutschen Gesellschaft fürÄsthetische Dermatologie or hair growth promoters is limited, further possible cofactors are discussed. One approach is asustained microscopic follicular inflammation considered as a possible cofactor in the complex Organ der Österreichischen Gesellschaft für Ärztliche Kosmetologie und aetiology of androgenetic alopecia . The approach of dietary supplements with focus to sup- Altersforschung der Haut port hair growth with different plant extracts, vitamins, trace elements, have shown comparablepositive effects compared to drugs with the advantage of no side effects. This outlines goodalternatives for persons with slight to moderate hair loss.
27. Jahrgang, Heft 4, 2006ISSN 1430-4031 The data support, that treatment with fenugreek containing food supplement* results in favourable effects on hair loss that contribute to improvements in hair growth observed in Brandenburgische Straße 1810707 Berlin treated volunteers. Fenugreek is used in a physiologic dosage of 300 mg extract, equivalent to1200 mg fenugreek seeds. Therewith, efficacy of Bocks-horn+Mikronährstoff Haarkapseln Arcon- Tisane® plus, a fenugreek seeds extract containing food supplement, could be documented in women and men with low to moderate hair loss.
Vorsitzender des Verlagsbeirats
Dr. Eduard Grosse
Address of Correspondence
Prof. Dr. med. Uwe WollinaHautklinik des Krankenhauses Christiane Schulz Friedrichstraße 41 Schelztorstr. 54-56 D-73728 Esslingen Telefon: 03 51/4 80 12 10 * Bockshorn + Mikronährstoff Haarkapseln Arcon-Tisane® plus Telefon: 0 30 / 88 67 49-30Fax: 0 30 / 88 67 [email protected] Ahmadiani A, Javan M, Semnanian S, Barat E, Kamalinejad M (2001) Antiinflammatory and antipyretic effects of Nach Tarif Nr. 25 vom 1. 11. 2003 Trigonella foenum-graecum leaves extract in the rat. J Ethnopharmacol 75: 283-286.
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