Article

Efficacy and safety of a dietary supplement containing a lipid co-extract from Serenoa repens and Pygeum africanum for the treatment of androgenetic alopecia (AGA) in women. Results of a randomized, double-blind, placebo-controlled clinical trial

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  • Reig Jofre Group
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... Regarding to plant extract uses, a mixture of other extracts can benefit the treatment, for example in the study carried out by [11] that used Serenoa repens extracts, as well as Pygeum africanum, in the treatment of AGA in women. A randomized, double-blind, placebo-controlled clinical trial were developed in a group of 40 post-menopausal Caucasian women, taking two capsules of a dietary supplement containing lipid co-extract "Complex Alphablok S" as main active ingredient per day during 16-week. ...
... Authors have found a statistically significant reverse in the signs of AGA with a decrease in the mean percentage of telogen hair from baseline, as well as an increase in the hair's resistance to traction. As for sideeffects, capsules were considered safe and well-tolerated, with mild digestive discomfort in a small number of subjects [11]. Likewise, [12] conducted a comparative study with placebo in a group of 20 postmenopausal women aged 50 to 75 years. ...
... Finally, Pygeum africanum, an extract from the bark of the African plum tree, has been used in Europe since 1969 for the treatment of benign prostatic hyperplasia and more recently for androgenetic alopecia. Its constituents include phytosterols and beta-sitosterol, both possessing inhibitory properties on the 5-alpha-reductase enzyme [30]. An important consideration in the use of phytotherapeutics, whether for androgenetic alopecia or other purposes, is their quality. ...
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Introduction: Androgenetic alopecia is the most common form of hair loss worldwide, occurring due to an excessive response to androgens. Its etiology is chronic and influenced by genetic and environmental factors, making it particularly challenging to treat. The primary treatment method currently involves the use of finasteride or dutasteride, which inhibit the 5-alpha-reductase enzyme. This enzyme is responsible for converting testosterone into DHT (dihydrotestosterone), thereby hindering the progression of androgenetic alopecia. Alongside the widespread use of these treatments, concerns have emerged regarding potential side effects associated with this class of drugs. Notably, these include impairments in sexual function and possible psychological disorders, observed in some users. In this context, there has been growing interest in exploring alternative approaches to hair loss treatment using plant-based preparations and/or their active ingredients. Material and Methods: The method employed for the preparation of this article was an integrative literature review to enable understandings of the use of phytotherapeutic herbs in people with hair loss. Results and Discussions: Several phytotherapeutic products are known to act against the 5-alpha-reductase enzyme, inhibiting it and reducing hair loss without significant side effects. Plants like Saw palmetto (Serenoa repens), Ginseng (Panax ginseng), Green tea (Camellia sinensis), and Pumpkin seed oil (Cucurbita pepo) are notable for their antiandrogenic effects and have shown beneficial impacts in the treatment of androgenetic alopecia. These could be considered viable options for treating androgenetic alopecia, serving as alternatives to finasteride and dutasteride.
... Podemos encontrar concentraciones de 1-4 mg/kg de MSM en vegetales y frutas, y concentraciones de 2-5 mg/l en la leche de las vacas que se alimentan de hierba fresca 10 . Así pues, el MSM es una fuente de azufre elemental, que forma parte de nuestra dieta habitual, y que tiene la ventaja de ser muy fácilmente absorbible por su pequeño tamaño, por lo que no causa trastornos gástricos y, a igualdad de dosis, aporta mayor cantidad de azufre que los aminoácidos azufrados, tales como la cistina 8 . Tal es así que 500 mg de MSM aportan la misma cantidad de azufre que 640 mg de L-cistina. ...
Article
Introduction: Androgenetic alopecia (AGA) is the most prevalent cause of male hair loss, often requiring medical and/or surgical intervention. The US FDA has approved topical minoxidil and oral finasteride for male AGA treatment. However, some AGA patients fail to respond satisfactorily to these FDA-approved treatments and/or may experience side effects, based on their individual profiles. To mitigate the shortcomings of these treatments, researchers are now exploring alternative treatments such as newer 5-α reductase inhibitors (5-ARIs) and androgen receptor antagonists (ARAs). Areas covered: This article reviews the safety and effectiveness of well-known 5-α reductase inhibitors (5-ARIs) like finasteride and dutasteride, as well as the newer 5-ARIs, emerging androgen receptor antagonists (ARAs), and natural products such as saw palmetto and pumpkin seed oil in the treatment of male AGA. Expert opinion: Although several newer 5-ARIs, ARAs, and natural products have exhibited promise in clinical trials, additional research is essential to confirm their safety and efficacy in treating male AGA. Until additional evidence is available for these agents, the preferred treatment choices for male AGA are the FDA-approved treatments, topical minoxidil, and oral finasteride.
Article
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The use of medicinal plants in the prevention and therapeutics of diseases has been carried out for a long time. Phytotherapeutic treatment is also applied in androgenetic alopecia, which is a condition characterized by hair loss and affects individuals of both sexes, with a higher prevalence in men. The objective of the article is to present the results of a bibliographical research related to the effectiveness of phytotherapy in the treatment of androgenetic alopecia. It is a literature review of the integrative type, for the construction of the research, was used of articles available in the following databases: PUBMED and ScienceDirect. After selection and analysis of the data obtained through reading, it was observed the use of several types of phytotherapics in the treatment of androgenic alopecia. The researches showed results with a positive effect of the use of this treatment on the hair growth of the individuals studied, with better resistance and increase of hair of the anagen phase.
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Female pattern hair loss (FPHL) also known as female androgenetic alopecia is a common condition afflicting millions of women that can be cosmetically disrupting. Prompt diagnosis and treatment are essential for obtaining optimal outcome. This review addresses the clinical presentation of female pattern hair loss, its differential diagnosis and treatment modalities. A) Diffuse thinning of the crown region with preservation of the frontal hairline (Ludwig's type) B) The "Christmas tree pattern" where the thinning is wider in the frontal scalp giving the alopecic area a triangular shaped figure resembling a christmas tree. C) Thinning associated with bitemporal recession (Hamilton type). Generally, FPHL is not associated with elevated androgens. Less commonly females with FPHL may have other skin or general signs of hyperandrogenism such as hirsutism, acne, irregular menses, infertility, galactorrhea and insulin resistance. The most common endocrinological abnormality associated with FPHL is polycystic ovarian syndrome (PCOS). The most important diseases to consider in the differential diagnosis of FPHL include Chronic Telogen Effluvium (CTE), Permanent Alopecia after Chemotherapy (PAC), Alopecia Areata Incognito (AAI) and Frontal Fibrosing Alopecia (FFA). This review describes criteria for distinguishing these conditions from FPHL. The only approved treatment for FPHL, which is 2% topical Minoxidil, should be applied at the dosage of 1ml twice day for a minimum period of 12 months. This review will discuss off-label alternative modalities of treatment including 5-alfa reductase inhibitors, antiandrogens, estrogens, prostaglandin analogs, lasers, light treatments and hair transplantation.
Article
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Hair loss is a commonly encountered problem in clinical practice, with men presenting with a distinctive pattern involving hairline recession and vertex balding (Norwood-Hamilton classification) and women exhibiting diffuse hair thinning over the crown (increased part width) and sparing of the frontal hairline (Ludwig classification). Female pattern hair loss has a strikingly overwhelming psychological effect; thus, successful treatments are necessary. Difficulty lies in successful treatment interventions, as only two medications - minoxidil and finasteride - are approved for the treatment of androgenetic alopecia, and these medications offer mediocre results, lack of a permanent cure, and potential complications. Hair transplantation is the only current successful permanent option, and it requires surgical procedures. Several other medical options, such as antiandrogens (eg, spironolactone, oral contraceptives, cyproterone, flutamide, dutasteride), prostaglandin analogs (eg, bimatoprost, latanoprost), and ketoconazole are reported to be beneficial. Laser and light therapies have also become popular despite the lack of a profound benefit. Management of expectations is crucial, and the aim of therapy, given the current therapeutic options, is to slow or stop disease progression with contentment despite patient expectations of permanent hair regrowth. This article reviews current perspectives on therapeutic options for female pattern hair loss.
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Androgenetic alopecia (AGA) is characterized by the structural miniaturization of androgen-sensitive hair follicles in susceptible individuals and is anatomically defined within a given pattern of the scalp. Biochemically, one contributing factor of this disorder is the conversion of testosterone (T) to dihydrotestosterone (DHT) via the enzyme 5-alpha reductase (5AR). This metabolism is also key to the onset and progression of benign prostatic hyperplasia (BPH). Furthermore, AGA has also been shown to be responsive to drugs and agents used to treat BPH. Of note, certain botanical compounds have previously demonstrated efficacy against BPH. Here, we report the first example of a placebo-controlled, double-blind study undertaken in order to examine the benefit of these botanical substances in the treatment of AGA. The goal of this study was to test botanically derived 5AR inhibitors, specifically the liposterolic extract of Serenoa repens (LSESr) and beta-sitosterol, in the treatment of AGA. Subjects: Included in this study were males between the ages of 23 and 64 years of age, in good health, with mild to moderate AGA. The results of this pilot study showed a highly positive response to treatment. The blinded investigative staff assessment report showed that 60% of (6/10) study subjects dosed with the active study formulation were rated as improved at the final visit. This study establishes the effectiveness of naturally occurring 5AR inhibitors against AGA for the first time, and justifies the expansion to larger trials.
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Extracts from Pygeum africanum, Serenoa repens and Cucurbita pepo are used in the treatment of benign prostatic hyperplasia (BPH) and prostate cancer (PCa). The activity of the androgen receptor (AR) is known to control growth of the prostate. Here, we examined extracts of these plants for their antiandrogenic activity using an AR responsive reporter gene assay for drug discovery. A selective dichloromethane extract from the stem barks of Pygeum africanum revealed the highest antiandrogenic effect. Bioactivity-directed fractionation of this extract led to the isolation of N-butylbenzenesulfonamide (NBBS) indicating that extracts of the stem bark of P. africanum harbour androgen antagonistic activity. This compound may provide a novel approach for the prevention and treatment of BPH and human PCa. Abbreviations AR:human androgen receptor BPH:benign prostate hyperplasia C. pep:Cucurbita pepo IPSS:international prostate symptom score NBBS:N-butylbenzenesulfonamide P. africanum:Pygeum africanum PCa:prostate cancer QoL:quality of life R1881:methyltrienolone RLU:relative light units S. repens:Serenoa repens
Article
Importance Androgenetic alopecia is a highly prevalent condition that can profoundly impair the quality of life in both men and women. Objective To provide the up-to-date medical and surgical treatment options for patients with androgenetic alopecia. Evidence Review A Medline search of scientific literature was conducted from 1997 to 2013. Search terms included androgenetic alopecia, hair restoration, follicular unit transplantation, and follicular unit extraction. Findings Oral finasteride and topical minoxidil are the 2 mainstream medical treatments for androgenetic alopecia. These medications have different mechanisms of action and should be combined to have an additive effect in men. Follicular unit transplantation is the gold standard for surgical management. There are 2 types of graft harvest technique: donor strip and follicular unit extraction. Each technique has its own advantages and disadvantages and should be tailored to the individual patient. Understanding of the anterior hairline design is essential to achieving a natural-appearing result. Conclusions and Relevance Medical treatment should be used in conjunction with surgery to achieve a synergistic effect. For the right candidate, follicular unit hair transplantation can lead to a long-lasting, natural result with appearance of dense scalp hair.
Article
Introduction: Androgenic alopecia (AGA) is the major type of scalp hair loss affecting 60 - 70% of the population worldwide. It is caused by two potent androgens, namely testosterone (T) and 5α-dihydrotestosterone (5α-DHT). Till date, only two FDA-approved synthetic drugs, minoxidil and finasteride, are used to cure AGA with only 35 and 48% success, respectively; therefore, a search for new drug based on the mechanism of androgens action is still needed. Areas covered: Relevant literature was reviewed to identify current therapeutic targets and treatments for AGA. The potential targets are classified into three categories: i) 5α-reductase; ii) androgen receptor and iii) growth-factor-producing genes related to hair growth. Expert opinion: Relevant assay systems using the right targets are required in order to obtain specific and effective drugs for AGA treatment. It is unlikely that single targeted agents will be sufficient for treating AGA, and therefore, it would be a challenge to obtain compounds with multiple activities.
Article
Background: Androgenetic alopecia (AGA) is one of the most common chronic problems seen by dermatologists worldwide. It is characterized by progressive hair loss, especially of scalp hair, and has distinctive patterns of loss in women versus men, but in both genders the central scalp is most severely affected. It often begins around puberty and is known to effect self-esteem and the individual's quality of life. In contrast to the high prevalence of AGA, approved therapeutic options are limited. In addition to the scarce pharmacologic treatments, there are numerous nonprescription products claimed to be effective in restoring hair in androgenetic alopecia. Objectives: The purpose of this paper is to review published medical and non-medical treatments for male and female AGA using the American College of Physicians evidence assessment methods. MEDLINE, EMBASE and Cochrane Library were searched for systematic reviews, randomized controlled trials, open studies, case reports and relevant studies of the treatment of male and female AGA. The relevant articles were classified according to grade and level of evidence. Results: The medical treatments with the best level of evidence classification for efficacy and safety for male AGA are oral finasteride and topical minoxidil solution. For female AGA, topical minoxidil solution appears to be the most effective and safe treatment. The medical treatments corresponding to the next level of evidence quality are some commonly used therapeutic non-FDA-approved options including oral and topical anti-hormonal treatments. Surgical treatment of follicular unit hair transplantation is an option in cases that have failed medical treatment although there is high variation in outcomes. Limitations: Some articles, especially those concerning traditional herbs claimed to promote hair regrowth, were published in non-English, local journals. Conclusions: An assessment of the evidence quality of current publications indicates that oral finasteride (for men only) and topical minoxidil (for men and women) are the best treatments of AGA.
Article
Androgenetic alopecia affects both men and women. In men it produces male pattern hair loss with bitemporal recession and vertex baldness. In women it produces female pattern hair loss (FPHL) with diffuse alopecia over the mid-frontal scalp. FPHL occurs as a result of nonuniform hair follicle miniaturization within follicular units. Diffuse alopecia is produced by a reduction in the number of terminal fibres per follicular unit. Baldness occurs only when all hairs within the follicular units are miniaturized and is a relatively late event in women. The concepts of follicular units and primary and secondary hair follicles within follicular units are well established in comparative mammalian studies, particularly in sheep. However, discovery of these structures in the human scalp hair and investigation of the changes in follicular unit anatomy during the development of androgenetic alopecia have provided a clearer understanding of the early stages of androgenetic alopecia and how the male and female patterns of hair loss are related. FPHL is the most common cause of alopecia in women and approximately one-third of adult caucasian women experience hair loss. The impact of FPHL is predominantly psychological. While men anticipate age-related hair loss, hair loss in women is usually unexpected and unwelcome at any age. Treatment options to arrest hair loss progression and stimulate partial hair regrowth for FPHL include the androgen receptor antagonists spironolactone and cyproterone acetate, the 5α-reductase inhibitor finasteride and the androgen-independent hair growth stimulator minoxidil. These treatments appear to work best when initiated early. Hair transplantation should be considered in advanced FPHL that is resistant to medical treatments. Hair transplantation requires well-preserved hair growth over the occipital donor area. The psychological impact of FPHL may also be reduced by cosmetic products that improve the appearance of the hair. These agents work to minimize hair fibre breakage, improve hair volume or conceal visible bald scalp.
Article
Androgenetic alopecia in the female occurs much more frequently than is generally believed. The condition is still considered infrequent, for it differs, in its clinical picture and in the sequence of events leading to it, from common baldness in men. To facilitate an early diagnosis (desirable in view of the therapeutic possibilities by means of antiandrogens) a classification of the stages of the common form (female type) of androgenetic alopecia in women is presented. The exceptionally observed male type of androgenetic alopecia can be classified according to Hamilton or to the modification of this classification proposed by Ebling & Rook.
Article
To conduct a systematic review and, where possible, quantitative meta-analysis of the existing evidence regarding the therapeutic efficacy and safety of the saw palmetto plant extract, Serenoa repens, in men with symptomatic benign prostatic hyperplasia (BPH). Studies were identified through the search of MEDLINE (1966-1997), EMBASE, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies. Randomized trials were included if participants had symptomatic BPH, the intervention was a preparation of S repens alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacological therapies for BPH, and the treatment duration was at least 30 days. Two investigators for each article (T.J.W., A.I., G.S., and R.M.) independently extracted key data on design features, subject characteristics, therapy allocation, and outcomes of the studies. A total of 18 randomized controlled trials involving 2939 men met inclusion criteria and were analyzed. Many studies did not report results in a method that permitted meta-analysis. Treatment allocation concealment was adequate in 9 studies; 16 were double-blinded. The mean study duration was 9 weeks (range, 4-48 weeks). As compared with men receiving placebo, men treated with S repens had decreased urinary tract symptom scores (weighted mean difference [WMD], -1.41 points [scale range, 0-19] [95% confidence interval (CI), -2.52 to -0.30] [n = 1 study]), nocturia (WMD, -0.76 times per evening [95% CI, -1.22 to -0.32] [n = 10 studies]), and improvement in self-rating of urinary tract symptoms; risk ratio for improvement (1.72 [95% CI, 1.21-2.44] [n = 6 studies]), and peak urine flow (WMD, 1.93 mL/s [95% CI, 0.72-3.14] [n = 8 studies]). Compared with men receiving finasteride, men treated with S repens had similar improvements in urinary tract symptom scores (WMD, 0.37 International Prostate Symptom Score points [scale range, 0-35] [95% CI, -0.45 to 1.19] [n = 2 studies]) and peak urine flow (WMD, -0.74 mL/s [95% CI, -1.66 to 0.18] [n = 2 studies]). Adverse effects due to S repens were mild and infrequent; erectile dysfunction was more frequent with finasteride (4.9%) than with S repens (1.1%; P<.001). Withdrawal rates in men assigned to placebo, S repens, or finasteride were 7%, 9%, and 11%, respectively. The existing literature on S repens for treatment of BPH is limited in terms of the short duration of studies and variability in study design, use of phytotherapeutic preparations, and reports of outcomes. However, the evidence suggests that S repens improves urologic symptoms and flow measures. Compared with finasteride, S repens produces similar improvement in urinary tract symptoms and urinary flow and was associated with fewer adverse treatment events. Further research is needed using standardized preparations of S repens to determine its long-term effectiveness and ability to prevent BPH complications.
Article
To determine the effects of a saw palmetto herbal blend (SPHB) compared with finasteride on prostatic tissue androgen levels and to evaluate needle biopsies as a source of tissue for such determinations. Prostate levels of testosterone and dihydrotestosterone (DHT) were measured on 5 to 10-mg biopsy specimens (18-gauge needle cores) in three groups of men with symptomatic benign prostatic hyperplasia: 15 men receiving chronic finasteride therapy versus 7 untreated controls; 4 men undergoing prostate adenomectomy to determine sampling variability (10 specimens each); and 40 men participating in a 6-month randomized trial of SPHB versus placebo, before and after treatment. Prostatic tissue DHT levels were found to be several times higher than the levels of testosterone (5.01 versus 1.51 ng/g), that ratio becoming reversed (1.05 versus 3.63 ng/g) with chronic finasteride therapy. The finasteride effect was statistically significant for both androgens (P <0.01), and little overlap of individual values between finasteride-treated and control patients was seen. In the randomized trial, tissue DHT levels were reduced by 32% from 6.49 to 4.40 ng/g in the SPHB group (P <0.005), with no significant change in the placebo group. For control versus finasteride-treated men, the tissue androgen values obtained with needle biopsy specimens were similar-both for absolute values and the percentage of change-to those previously reported using surgically excised volumes of prostatic tissue. The quantification of prostatic androgens by assay of needle biopsies is thus feasible and offers the possibility of serial studies in individual patients. The SPHB-induced suppression of prostatic DHT levels, modest but significant in a randomized trial, lends an element of support to the hypothesis that inhibition of the enzyme 5-alpha reductase is a mechanism of action of this substance.
Inhibidores de la 5(alfa) reductasa en la alopecia androgénica presente y futuro. Opciones terapéuticas
  • Guerra Tapia
Guerra Tapia A. Inhibidores de la 5(alfa) reductasa en la alopecia androgénica presente y futuro. Opciones terapéuticas. Act Dermatolog. 2007;46(8/9):539-47.
Androgenetic alopecia
  • B M Piraccini
  • A Alessandrini
Piraccini BM, Alessandrini A. Androgenetic alopecia. G Ital Dermatol Venereol. 2014;149(1):15-24.
Company report 0146. 5-alpha reductase expression in cultured human fibroblasts: effects of plant extracts. Research and development
  • Reig Jofre
Reig Jofre, S.A. Company report 0146. 5-alpha reductase expression in cultured human fibroblasts: effects of plant extracts. Research and development. Reig Jofre, S.A. January 2012.
Company report 0146. 5-alpha reductase expression in cultured human fibroblasts: effects of plant extracts
  • S A Reig Jofre
Reig Jofre, S.A. Company report 0146. 5-alpha reductase expression in cultured human fibroblasts: effects of plant extracts. Research and development. Reig Jofre, S.A. January 2012.