Galphimine-B Standardized Extract versus Alprazolam in Patients with Generalized Anxiety Disorder: A Ten-Week, Double-Blind, Randomized Clinical Trial.

Galphimine-B (G-B), a compound isolated from Galphimia glauca, has been shown to possess important anxiolytic activity. In this study, we evaluated the effectiveness and tolerability of a G-B standardized extract (experimental treatment) that was administered daily for 10 weeks in patients with moderate or severe Generalized Anxiety Disorder (GAD). Alprazolam was used as control treatment and administered under the same conditions. A total of 167 patients were included. At the start of the study, the severe anxiety condition prevailed, with an average on the Hamilton Anxiety Scale of 35.1 ± 8.8 and 35.8 ± 8.1 points in the control and experimental groups, respectively. After the 10 weeks of administration, the average was reduced in the control group to 4.6 ± 6.5 points and in the experimental group to 3.5 ± 5.5 points. Therapeutic success in the control group was 85.7% and in the experimental group, 92.0%. A high proportion of patients (22.2%) treated with Alprazolam manifested daytime sleepiness, while in the group treated with the G-B standardized extract, daytime sleepiness was found in 4.7%. In conclusion, a G-B standardized extract demonstrated therapeutic effectiveness in patients with GAD, without exhibiting significant difference with Alprazolam, but showing fewer cases of daytime sleepiness. The trial was registered at http://clinicaltrials.gov by identifier: NCT03702803.

Identification of Digestive Enzyme Inhibitors from Ludwigia octovalvis (Jacq.) P.H.Raven.

Current antiobesity and antidiabetic tools have been insufficient to curb these diseases and frequently cause side effects; therefore, new pancreatic lipase and α-glucosidase inhibitors could be excellent aids for the prevention and treatment of these diseases. The aim of this study was to identify, quantify, and characterize the chemical compounds with the highest degree of inhibitory activity of these enzymes, contained in a Ludwigia octovalvis hydroalcoholic extract. Chemical purification was performed by liquid-liquid separation and column chromatography. Inhibitory activities were measured in vitro, employing acarbose, orlistat, and a Camellia sinensis hydroalcoholic extract as references. For structural elucidation, Nuclear Magnetic Resonance was carried out, and High Performance Liquid Chromatography was used to quantify the compounds. For α-glucosidases, L. octovalvis hydroalcoholic extract and its ethyl acetate fraction showed half-maximal Inhibitory Concentration (IC50) values of 700 and 250 µg/mL, for lipase, 480 and 718 µg/mL, while C. sinensis showed 260 and 587 µg/mL. The most active compounds were identified as ethyl gallate (1, IC50 832 µM) and gallic acid (2, IC50 969 µM); both displayed competitive inhibition of α-glucosidases and isoorientin (3, IC50 201 µM), which displayed uncompetitive inhibition of lipase. These data could be useful in the development of a novel phytopharmaceutical drug.

Use of antifungal saponin SC-2 of Solanum chrysotrichum for the treatment of vulvovaginal candidiasis: in vitro studies and clinical experiences.

Saponin SC-2 from Solanum chrysotrichum showed antifungal activity, demonstrated in vitro, which inhibited the growth of dermatophytes, and in vivo, to be effective in the treatment against tinea pedis and pityriasis capitis. Fungistatic and fungicidal activity of saponin SC-2 on Candida albicans and other Candida species, fluconazole and ketoconazole resistaent strains was demostrated. SC-2-associated ultrastructural alterations in several Candida species were observed. An exploratory clinical, randomized, double-blind, and controlled ketoconazole study of ketoconazole was conducted with the aim of assessing the effectiveness and tolerability of an herbal medicinal product containing SC-2, on women with Vulvovaginal candidiasis (VVC). The results exhibited a percentage of therapeutic clinical effectiveness similar to that of ketoconazole (X(2), p ≥0.30), but obtained a smaller percentage of mycological effectiveness, and 100% tolerability. In conclusion, saponin SC-2 possesses fungicidale and fungistatic activity on Candida albicans and other multi resistant Candida species, causes morphological changes and fungal death, and it is an alternative therapy for the treatment of VVC.

Toxicology, genotoxicity, and cytotoxicity of three extracts of Solanum chrysotrichum.

ETHNOPHARMACOLOGICAL RELEVANCE: Infusions of Solanum chrysotrichum (Schldl.) or "sosa" are employed in Traditional Mexican Medicine for the local and systemic treatment of skin and mucosal infections. Different studies have verified its antifungal effectiveness and therapeutic safety in superficial mycosis caused by dermatophytes or yeasts, and have identified a group of spirostanic saponins, denominated SC-2-SC-6, as responsible for the antifungal activity. Of these, SC-2 is the most active molecule. Electron microscopy studies showed that SC-2 disintegrates cell wall and internal membranes of the fungi studied. In order to continue the systematic study of Solanum chrysotrichum, the goal of the present study was to evaluate the toxicity, genotoxicity, and cytotoxicity of the three different extracts of Solanum chrysotrichum. MATERIALS AND METHODS: From the dried leaves of Solanum chrysotrichum, we obtained the aqueous, hydroalcoholic, and ethanolic extracts. Saponins (SC-2-SC-6) were quantified by High-performance liquid chromatography (HPLC). For the toxicology study, we formed four groups: three experimental groups, treated with each of the extracts at 1-g/kg doses per os (po) during 4 weeks, and a negative control group treated with the vehicle. For the genotoxicity study, we added another group, which was treated with cyclophosphamide for 1 week. The cytotoxicity study was carried out with international methods and employing the nasopharyngeal cancer (KB) and breast cancer (MDA) cell lines. RESULTS: The three evaluated extracts did not modify either of the behavioral parameters, and on the hepatic-function biochemical tests (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), did not showed significant increase on comparing to placebo. The genotoxicity parameters did not exhibit differences between the experimental groups and the placebo (control) group. Histologic analysis showed that the three extracts caused amyloidosis and moderate necrosis in liver, and focal tumefaction in kidney, as well as significant, but clinically irrelevant, elevations of creatinine with the aqueous and hydroalcoholic, but not with the ethanolic, extracts. In addition, the aqueous and ethanolic extracts exhibited interesting cytotoxic activity against the KB cell line. CONCLUSIONS: At the doses administered, the ethanolic extract of Solanum chrysotrichum showed a slightly toxic effect on liver and kidney, without biochemical or genotoxic repercussions and with cytotoxic activity against the KB cell line.

Therapeutic effectiveness of Galphimia glauca vs. lorazepam in generalized anxiety disorder. A controlled 15-week clinical trial.

UNLABELLED: Galphimia glauca Cav. has demonstrated anxiolytic activity attributable to nor-seco-triterpenes denominated galphimines, the most active of which is galphimine-B. Galphimine-B inhibits ventral tegmental area dopaminergic neurons and interacts with the serotoninergic system of the dorsal hippocampus. A previous clinical study that administered a G. glauca herbal medicinal product for 4 weeks evidenced high percentages of therapeutic effectiveness and safety in patients with generalized anxiety disorder. Based on the previous findings, the goal of the present study was to evaluate the effectiveness, safety, and tolerability of G. glauca herbal medicinal product administered during 15 weeks in patients with generalized anxiety disorder. STUDY DESIGN: double-blind, randomized, lorazepam-controlled clinical trial. STUDY SUBJECTS: adult males and females, ambulatory, diagnosed with generalized anxiety disorder, with 20 or more points on the Hamilton anxiety scale, without data of depression, and without anxiolytic treatment in the previous month. Interventions were as follows. Experimental treatment: G. glauca herbal medicinal product in capsules containing the dry extract of G. glauca standardized in 0.175 mg of galphimine-B, one or two capsules twice a day, during 12 weeks plus 3 withdrawal weeks, and control treatment: lorazepam 0.5 mg with the same presentation and posology. PRIMARY OUTCOME: anxiolytic effectiveness (≥ 50 % reduction of initial Hamilton anxiety scale score). SECONDARY OUTCOMES: tolerability and safety. One hundred ninety-one patients initiated the study with 94 in the experimental group. One hundred four patients concluded the study, 51 of these in the experimental group. Anxiolytic effectiveness, measured as 0 in a negative case and as 1 in a positive case, was assessed 593 times in the experimental group and 631 in the control; the mean effectiveness observed was 0.686 ± 0.019 vs. 0.588 ± 0.019 (repeated-measures ANOVA; p = 0.0003). In the same way, G. glauca-herbal medicinal product diminished the score in the Hamilton anxiety scale to 11.51 ± 8.27 points and lorazepam to 12.40 ± 8.07 points (repeated-measures ANOVA; p = 0.05). The tolerability analysis, which comprised patients who concluded the treatment plus 11 patients who withdrew due to adverse reactions did not show differences between treatments (p = 0.35), nor did therapeutic safety demonstrate differences between groups (p = 0.21). There were no cases of tolerance, intoxication, dependence, or suppression syndrome. We concluded that G. glauca herbal medicinal product, standardized in 0.175 mg of galphimine-B and administered for 15 weeks to patients with generalized anxiety disorder, showed greater anxiolytic effectiveness than that obtained with lorazepam, with high percentages of therapeutic tolerability and safety.

A randomised comparative trial on the use of a hydrogel with tepescohuite extract (Mimosa tenuiflora cortex extract-2G) in the treatment of venous leg ulcers.

Tepescohuite is an extract obtained from the bark of the Mimosa tenuiflora tree and is used as an empirical treatment in wounds for its healing and antiseptic properties. Venous leg ulcers (VLUs) are a common health care problem in most countries with a high rate of morbidity. The standard of care is moist interactive healing and compression; however, the ideal topical treatment is yet to be established. This study is designed to evaluate the effectiveness and safety of M. tenuiflora cortex extract (MTC-2G) in the treatment of VLUs in an Interdisciplinary Wound and Ostomy Care Center (IWOCC). A randomised, placebo-controlled, double blind clinical trial was conducted to compare the use of a hydrogel containing MTC-2G with the hydrogel alone in VLUs. The study included all patients with venous ulcers referred to the IWOCC. Laboratory tests and tissue biopsies were performed at the beginning and at the end of the study. The patients were instructed to daily cleansing followed by topical application of the hydrogel and compression. Forty-one patients were included, 22 patients received the MTC-2G and 19 patients received the hydrogel only. Of the 41 patients, 32 completed the study, 18 in the experimental arm and 14 in the control group, 19 were women and 13 men. The mean age of the subjects was 60 years. The mean time from presentation was 38 months. The mean surface reduction was 6·29 cm(2) [confidence interval (IC) 95%: 3·28-9·29] (P = 0·0001) in the MTC-2G group and 5·85 cm(2) (95% CI: 3·58-8·12) (P = 0·001) in the hydrogel group. There was no significant difference between the groups (P = 0·815). No changes in the laboratory parameters were noted. In the histology, there were not any differences between groups either. A hydrogel containing MTC-2G was not superior to a hydrogel alone in the treatment of VLUs.

[Therapeutic use Hibiscus sabadariffa extract in the treatment of hypercholesterolemia. A randomized clinical trial]. / Tratamiento de la hipercolesterolemia con Hibiscus sabadariffa. Ensayo clínico aleatorizado controlado.

OBJECTIVE: to compare the effectiveness, safety and tolerability of Hibiscus sabadariffa extract (SHE) versus pravastatin in hypercholesterolemia. METHODS: double blind and controlled clinical trial. Men and women with hypercholesterolemia ≥ 220 mg/dL, and over 30 years without previous treatment were included. TREATMENTS: Experimental I, SHE standardized 10 mg of anthocyanins, control, 20 mg of pravastatin; Experimental II, extract of H. sabdariffa, standardized to 20 mg of anthocyanins for 12 weeks. SHE Data analysis with Anova and χ(2) tests were used. RESULTS: we included 104 patients, at baseline there were no significant differences in age, weight, BMI, total cholesterol, HDL, LDL, VLDL or triglycerides. At the end of the study, the experimental I group reduced triglycerides (p ≤0.0001), the control treatment reduced triglycerides, total cholesterol and its fractions (p = 0.02), and finally, the experimental treatment II reduced triglycerides (p = 0.0001). The three treatments showed high percentages (> 96) of safety and tolerability, without showing significant differences (p ≥ 0.57). CONCLUSIONS: the treatments, with 10 and 20 mg of anthocyanins reduce triglycerides. The control treatment showed the greatest effect on lowering total cholesterol and fractions compared to experimental treatments.

Interaction of the natural anxiolytic Galphimine-B with serotonergic drugs on dorsal hippocampus in rats.

AIM OF THE STUDY: Galphimine-B (G-B) is a nor-seco triterpene with an anxiolytic-like effect obtained from the plant species Galphimia glauca Cav. By means of a double blind clinical trial, it has been demonstrated that the extract from this plant, standardized in G-B content, possesses therapeutic effectiveness in patients with generalized anxiety. The mechanism of action of this compound remains unknown to date, but it has already demonstrated a non interaction with the γ-aminobutyric acid (GABA)ergic system. For this reason, the objective of this work was to evaluate the pharmacological interaction between G-B with the 5-hydroxytryptamine 1A (5HT(1A)) and 5-hydroxytryptamine 2A (5HT(2A)) serotonergic receptors on CA1 neurons of hippocampus. MATERIALS AND METHODS: Electrophysiological records were performed as the frequency of discharge of in vivo CA1 cells from dorsal hippocampus in rats. RESULTS: G-B was able to increase the frequency of discharge of neurons of the CA1 cells with some characteristics that support an interaction with the serotonergic system in this zone. It was demonstrated that this triterpene modulates the induced response of 5HT(1A) receptors, in an allosteric manner. CONCLUSION: This effect demonstrated an interaction between G-B and the serotonergic system in dorsal hippocampus and evidenced that the mechanism of action of this compound could involve a complex series of actions on different neurotransmitter systems related with the anxiety disorder.

Inhibition of angiotensin convertin enzyme (ACE) activity by the anthocyanins delphinidin- and cyanidin-3-O-sambubiosides from Hibiscus sabdariffa.

ETHNOPHARMACOLOGICAL RELEVANCE: The beverages of Hibiscus sabdariffa calyces are widely used in Mexico as diuretic, for treating gastrointestinal disorders, liver diseases, fever, hypercholesterolemia and hypertension. Different works have demonstrated that Hibiscus sabdariffa extracts reduce blood pressure in humans, and recently, we demonstrated that this effect is due to angiotensin converting enzyme (ACE) inhibitor activity. AIM OF THE STUDY: The aim of the current study was to isolate and characterizer the constituents responsible of the ACE activity of the aqueous extract of Hibiscus sabdariffa. MATERIALS AND METHODS: Bioassay-guided fractionation of the aqueous extract of dried calyces of Hibiscus sabdariffa using preparative reversed-phase HPLC, and the in vitro ACE Inhibition assay, as biological monitor model, were used for the isolation. The isolated compounds were characterized by spectroscopic methods. RESULTS: The anthocyanins delphinidin-3-O-sambubioside (1) and cyanidin-3-O-sambubioside (2) were isolated by bioassay-guided purification. These compounds showed IC(50) values (84.5 and 68.4 microg/mL, respectively), which are similar to those obtained by related flavonoid glycosides. Kinetic determinations suggested that these compounds inhibit the enzyme activity by competing with the substrate for the active site. CONCLUSIONS: The competitive ACE inhibitor activity of the anthocyanins 1 and 2 is reported for the first time. This activity is in good agreement with the folk medicinal use of Hibiscus sabdariffa calyces as antihypertensive.

Ultrastructural changes on clinical isolates of Trichophyton rubrum, Trichophyton mentagrophytes, and Microsporum gypseum caused by Solanum chrysotrichum saponin SC-2.

Worldwide, dermatophytoses represent a high percentage of all superficial mycoses. The most frequently isolated dermatophyte is Trichophyton rubrum. Solanum chrysotrichum is a vegetal species widely used in Mexican traditional medicine to treat skin infections; its extract has been used to formulate an herbal medicinal product that is used successfully to treat Tinea pedis. Spirostanic saponin SC-2 from S. Chrysotrichum possesses high activity against dermatophytes. The present study reports the ultrastructural changes observed by means of transmission electron microscopy (TEM) in clinical isolates of T. rubrum, T. mentagrophytes, and Microsporum gypseum induced by saponin SC-2. Strains were grown in RPMI 1640 containing SC-2 (1600 microg/mL). Fungi were harvested at 6, 12, 24, and 48 h; controls without SC-2 were included. T. mentagrophytes was the most susceptible to the SC-2 saponin, followed by M. gypseum, while T. rubrum was the most resistant. The main alterations caused by the SC-2 saponin were as follows: i) loss of cytoplasmic membrane continuity; ii) organelle degradation; iii) to a lesser extent, irreversible damage to the fungal wall; and iv) cellular death.

Exploratory study on the clinical and mycological effectiveness of a herbal medicinal product from Solanum chrysotrichum in patients with Candida yeast-associated vaginal infection.

Mexican traditional medicine uses Solanum chrysotrichum to treat fungi-associated dermal and mucosal illness; its methanolic extract is active against dermatophytes and yeasts. Different spirostanic saponins (SC-2-SC-6) were identified as the active molecules; SC-2 was the most active in demonstrating a fungicidal effect against Candida albicans and non-albicans strains. The aim of the present study was to compare the clinical (elimination of signs and symptoms) and mycological effectiveness (negative mycological studies) of an S. chrysotrichum herbal medicinal product (Sc-hmp), standardized in 1.89 mg of SC-2, against ketoconazole (400 mg) in the topical treatment of cervical and/or vaginal infection by Candida. Both treatments (vaginal suppositories) were administered daily during 7 continuous nights. The study included 101 women (49 in the experimental group) with a confirmed clinical condition and positive mycological studies (direct examination and/or culture) of Candida infection. Basal conditions did not show differences between the groups; a moderate clinical picture was present in 62% of the cases, direct examination was positive in 69%, and the culture was positive with C. albicans predominating (65%). At the end of the administration period, both treatments demonstrated 100% tolerability, and clinical cure in 57.14% of S. chrysotrichum-treated cases and in 72.5% of ketoconazole-treated cases (p = 0.16), as well as 62.8% and 97.5% of mycological effectiveness, respectively (p = 0.0 001). We conclude that, at the doses used, Sc-hmp exhibits the same clinical effectiveness as ketoconazole, but with lower percentages of mycological eradication. Additional clinical studies with Sc-hmp are necessary, with increasing doses of SC-2, for improving the clinical and mycological effectiveness.

[The alternative medicine used as complementary in patients positive for HIV]. / Uso de terapia alternativa/complementaria en pacientes seropositivos a VIH.

OBJECTIVE: To evaluate the use of complementary alternative medicine (CAM) in patients infected with the human immunodeficiency virus (HIV), and to identify the type and factors associated to its use. METHODS: Cross-sectional study made in HIV clinics of three majors institutions from Morelos State, Mexico; the sample was 293 subjects; a specific questionnaire looking for demographic information and CAM use was applied. RESULTS: The use of CAM was 73.4%; 71% informed to the physician of their use. 51% of the patients reported using nutritional complements, 29.7% herbal products and 19% used physical agents like exercise, Chinese medicine, and therapy by contact. A total of 96.6 % of the users reported some perception of benefit with its use. The patients with low income, IMSS beneficiaries and on antirretroviral treatment were the greatest CAM users. CONCLUSIONS: CAM use is a common practice among HIV (+) patients. The multivitamins and herbal products were the most used. The majority was prescribed by health personnel and the users showed some benefit. Other longitudinal studies are required to establish the CAM impact on the disease evolution and the quality of life of HIV (+) patients.

Interés de la flor de hibisco en problemas cardiovasculares / Interest of Hibiscus sabdariffa on cardiovascular diseases

El hibisco (Hibiscus sabdariffa) es una especie vegetal usada desdehace siglos por diversas culturas con fines culinarios. Popularmentese le han atribuido propiedades diuréticas, antihipertensivas, antiparasitariasy laxantes, pero en los últimos veinte años una serie detrabajos han demostrado la actividad antihipertensiva, hipolipemiantey antioxidante de sus cálices y calículos (flor de hibisco). Los extractosricos en flavonoides y antocianósidos ejercen una notable actividadantihipertensiva al inhibir la enzima convertidora de la angiotensina(ECA). También se sugiere que los efectos relajantes sobre el músculoliso de los vasos sanguíneos están relacionados con la activación de laNO-sintasa. Por otro lado, una serie de compuestos antioxidantes deesta especie, entre los que figura el ácido protocatéquico, inhiben deforma dosis-dependiente la oxidación de las LDL, lo que otorga a estaespecie una actividad hipolipemiante. Estudios in vivo y clínicos handemostrado una disminución de colesterol y triglicéridos séricos(AU)

Roselle (Hibiscus sabdariffa) is a plant species used forcenturies by several cultures for cooking. Diuretic, antihypertensive,antiparasitic and laxative properties have beenattributed in folk medicine. In the last twenty years, severalresearch works have demonstrated antihypertensive,hypolipidemic and antioxidant effects of their calyces andepicalycles. Extracts rich in flavonoids and anthocyanosidesexert a remarcable important antihypertensive activityby inhibiting the angiotensin converting enzyme (ACE). It isalso suggested that the relaxant effects on smooth muscleof blood vessels are associated with the activation ofthe NO-synthase. Furthermore, a number of antioxidantscompounds of this species, such as protocatechuic acid,inhibited LDL oxidation in a dose-dependent manner, whichgives this species a hypolipidemic activity. In vivo and clinicalstudies have shown a decrease in serum cholesteroland triglycerides(AU)

Mycological and electron microscopic study of Solanum chrysotrichum saponin SC-2 antifungal activity on Candida species of medical significance.

Solanum chrysotrichum is utilized in traditional Mexican medicine for the treatment of mycotic skin infections. Several microbiological studies have provided evidence of its antifungal activity against dermatophytes and yeasts. S. chrysotrichum saponins have been identified as a group of compounds with antifungal activity and saponin SC-2 has demonstrated to be the most active. Previous clinical studies have shown the therapeutic effectiveness of S. chrysotrichum-derived saponin-standardized herbal products in the treatment of Tinea pedis and Pityriasis capitis. There is no previous evidence of the activity of these saponins against Candida non-albicans species, or fluconazole- and ketoconazole-resistant Candida strains. The present study reports the biological activity of the SC-2 saponin (inhibitory concentration [IC (50)] and minimum fungicide concentration [MFC]), against 12 Candida strains of clinical significance ( C. albicans, five strains; C. glabrata and C. parapsilosis, two; C. krusei, C. lusitaniae and C. tropicalis, one), including some fluconazole (Fluco)- and ketoconazole (Keto)-resistant clinical isolates. In addition, SC-2-associated microstructural alterations were reported in four of the above-mentioned Candida species. Seven strains had IC (50) of 200 microg/mL for SC-2, 400 microg/mL was found in four strains, and 800 microg/mL for a sole C. glabrata strain. Susceptibility to SC-2 saponin was as follows: C. albicans = C. lusitaniae > C. krusei > C. glabrata. The MFC was 800 microg/mL for the majority of strains (nine), 400 microg/mL for C. albicans (two strains) and C. lusitaniae. The ultrastructural Candida changes originated by SC-2 included the following: 1) damage on cytoplasmic membrane and organelles; 2) changes in cell wall morphology and density, with separation of cytoplasmatic membrane from cell wall and disintegration of the latter; and 3) total degradation of cellular components and death. Changes were manifested from 6 h of incubation, reaching their maximum effect at 48 h. In conclusion, the saponin SC-2 possesses fungicide and fungistatic activity on different Candida albicans and non- albicans species (including some azole-resistant strains) with IC (50) values of 200 microg/mL (in Fluco-susceptible strains) and of 400 - 800 mug/mL (in Fluco-resistant strains). Additionally, we observed by transmission electron microscopy (TEM) that saponin SC-2 causes severe changes in all fungal cell membranes, and to a lesser degree on the cell wall.

Efficacy and tolerability of a standardized herbal product from Galphimia glauca on generalized anxiety disorder. A randomized, double-blind clinical trial controlled with lorazepam.

Galphimia glauca Cav. is a plant used in Mexican traditional medicine as a "nerve tranquilizer". Previous studies have demonstrated that the methanolic extract from this plant species possess an anxiolytic effect. Galphimine B (GB, a nor-seco-triterpene), is the active principle, with an innovative action mechanism. Against this background, a standardized herbal medicinal product was developed from the aqueous extract of G. glauca (GgHP). The present work compared the therapeutic effectiveness, safety, and tolerability of the new GgHP with lorazepam on patients with generalized anxiety disorder (GAD). By means of a controlled, randomized, double-blind clinical trial, outpatients of either sex who matched the DSM-IV diagnostic criteria with a score of > or = 19 points on the Hamilton Anxiety Scale (HAM-A) were included. The experimental group was treated orally with GgHP in capsules twice a day for 4 weeks. The control group received lorazepam (1 mg) under the same conditions and presentation. A total of 152 patients were included in the trial (72 in the experimental group). From the first week of treatment, GgHP showed important anxiolytic effectiveness, very similar to that produced with lorazepam. Both treatments showed therapeutic safety (no alterations on biochemical analysis of hepatic and renal function). Nevertheless, concerning side effects, GgHP evidenced a considerably higher tolerability than lorazepam.

Clinical effects produced by a standardized herbal medicinal product of Hibiscus sabdariffa on patients with hypertension. A randomized, double-blind, lisinopril-controlled clinical trial.

Hibiscus sabdariffa L. (Malvaceae) has been used in different countries as an antihypertensive. Pharmacological work has demonstrated that this effect is probably produced by a diuretic activity and inhibition of the angiotensin-converting enzyme (ACE). Two clinical trials have confirmed the antihypertensive effect using watery infusions, in which a natriuretic effect was also detected. To compare therapeutic effectiveness, tolerability, and safety, as well as the effect on serum electrolytes and the ACE inhibitory effect of a herbal medicinal product prepared from the dried extract of H. sabdariffa calyxes (HsHMP) with those of lisinopril on patients with hypertension (HT), a randomized, controlled, and double-blind clinical trial was conducted. Patients of either sex, 25 - 61 years of age, with hypertension stage I or II, were daily treated for 4 weeks with the HsHMP, 250 mg of total anthocyanins per dose (experimental group), or 10 mg of lisinopril (control group). Outcome variables included effectiveness (diastolic blood pressure [DBP] reduction, >or= 10 mmHg), safety (absence of pathological modifications in the biochemical tests of hepatic and renal function), tolerability (absence of intense side effects), effect on serum electrolytes, and effect on ACE activity. Basal analysis included 193 subjects (100 in the experimental group), while outcome variable analysis integrated 171. Results showed that the experimental treatment decreased blood pressure (BP) from 146.48/97.77 to 129.89/85.96 mmHg, reaching an absolute reduction of 17.14/11.97 mmHg (11.58/12.21%, p < 0.05). The experimental treatment showed therapeutic effectiveness of 65.12 % as well as tolerability and safety of 100 %. BP reductions and therapeutic effectiveness were lower than those obtained with lisinopril (p < 0.05). Under the experimental treatment, the serum chlorine level increased from 91.71 to 95.13 mmol/L (p = 0.0001), the sodium level showed a tendency to decrease (from 139.09 to 137.35, p = 0.07), while potassium level was not modified. ACE plasmatic activity was inhibited by HsHMP from 44.049 to 30.1 Units (Us; p = 0.0001). In conclusion, the HsHMP exerted important antihypertensive effectiveness with a wide margin of tolerability and safety, while it also significantly reduced plasma ACE activity and demonstrated a tendency to reduce serum sodium (Na) concentrations without modifying potassium (K) levels. Further studies are necessary for evaluating the dose-dependency of HsHMP and for detecting lower effective doses.

Toxicological and cytotoxic evaluation of standardized extracts of Galphimia glauca.

Galphimia glauca Cav (Malpighiaceae) has been widely used in Mexican traditional medicine as a remedy for the treatment of mental disorders, principally as a sedative and tranquilizer. The sedative activity of extracts obtained from this plant has been demonstrated with different neuropharmacological models. Different triterpenes, known as galphimines, have been identified from the active extract. Galphimine-B (G-B) possesses anxiolytic activity and is able to selectively inhibit discharges of dopaminergic neurons in the ventral tegmental area in rats. Nevertheless, there have been no toxicological investigations carried out with products obtained from this plant. In this work three different extracts (aqueous, ethanolic, and methanolic) of Galphimia glauca, standardized in the content of three galphimines, were evaluated for their behavioral and pharmaco-toxicological effects. After administering the extracts to mice for 28 days (2.5g/kg, p.o.), no deaths were found and the histopathological analysis of different organs did not show alterations; only the behavioral parameters analyzed showed a diminution of spontaneous activity. The administration of these extracts for 56 days (same doses and route) in mice did not cause any changes in the biochemical parameters that evaluate liver function. On the other hand, no cytotoxic effects were found on KB, UISO, and OVCAR-5 transformed cell lines, but all extracts specifically inhibited colon cancer cell line growth with an ED(50) lower than 2microg/ml. The extracts were also evaluated in genotoxicity tests in vitro (250, 100 and 50microg/ml), which demonstrate that none of the three extracts from Galphimia glauca showed a genotoxic effect.

Therapeutic effectiveness of a Mimosa tenuiflora cortex extract in venous leg ulceration treatment.

The cortex of Mimosa tenuiflora is a popular remedy utilized in Mexico for the treatment of skin lesions. Modern studies support the existence in this cortex of compounds with cicatrizing properties. In the present study the therapeutic effectiveness of an extract elaborated with this bark in the treatment of venous leg ulceration disease was explored. A randomized, double-blind, placebo-controlled clinical trial was conducted with ambulatory patients distributed into two groups, one receiving a hydrogel containing 5% of a crude extract standardized in its tannin concentration (1.8%), while the control group, was administered the same hydrogel but without addition of the extract. In both aseptic washings were performed initially followed by topical application of the corresponding hydrogel and dressing. Follow-up lasted 13 weeks and ulcer healing was determined through measurement of the lesion area by digital-photographic parameters. Therapeutic effectiveness occurred in all patients of the extract group; after the 8th treatment week, ulcer size was reduced by 92% as mean value in this group, whereas therapeutic effectiveness was observed only in one patient of the control group (chi(2), p=0.0001). No side effects were observed in any patient in either group.

Effectiveness and tolerability of a standardized extract from Ageratina pichinchensis on patients with tinea pedis: an explorative pilot study controlled with ketoconazole.

Ageratina pichinchensis has been used for many years in Mexican traditional medicine for the treatment of superficial mycosis. Previous studies have demonstrated the antifungal effectiveness of a hexane extract from aerial parts of this plant on in vitro cultures of Candida albicans, Aspergillium niger, Trichophyton mentagrophytes, and Trichophyton rubrum. To compare the effectiveness and tolerability of A. pichinchensis with ketoconazole in patients with the clinical and mycological diagnosis of tinea pedis, we carried out a double-blind pilot study. The experimental group was treated topically with a cream containing A. pichinchensis standardized extract (10 %), while the control group was administered a similarly colored cream containing 2 % ketoconazole. All patients were clinically followed weekly for 4 weeks. By means of a mycological examination (direct microscopic detection), the mycological diagnosis of tinea pedis was performed. This technique was also used for evaluating the mycological effectiveness at the end of treatment. A total of 120 patients were included, 60 in each treatment group. Of these, 97 patients were included in the statistical analysis, 51 from the experimental group and 46 controls. The remainder of the patients withdrew from the study due to non-medical causes. Clinical effectiveness was reached in 80.3 and 76 %, while therapeutic success was achieved in 80.3 and 71.7 % of the experimental and control groups, respectively. There were no statistical differences between groups (P = 0.31). Our results suggest the effectiveness and tolerability of a standardized extract from A. pichinchensis in treatment of patients with tinea pedis.

[Knowledge of phytopharmaceuticals among physicians from Morelos, Mexico]. / Conocimiento sobre fitofámacos en médicos de atención primaria del estado de Morelos.

OBJECTIVES: To analyze the proportion of primary care physicians from the Health System in the State of Morelos with knowledge about phytopharmaceuticals, and to explore some factors related to this knowledge. MATERIAL AND METHODS: Through a descriptive, transversal and prospective study, physicians who work in the Instituto Mexicano del Seguro Social, in the Secretaría de Salud in the State of Morelos, and in private practice, an "adequate knowledge" was conveyed when 70% or more answers were correct and "deficient knowledge," when this proportion was lower than 70%. A bivariated analysis was used in order to determine association and statistical differences. RESULTS: A total of 264 physicians were included. The majority (90.2%) fell in the group of "deficient knowledge," and only 9.8% fell into the "adequate knowledge" group. An association was found between the possession of adequate knowledge and private physicians (PR = 4.66, CI = 95%), as well as deficient knowledge and working in a morning shift (PR = 2.92, CI = 95%). CONCLUSIONS: As the results demonstrate, knowledge about phytopharmaceuticals among primary care physicians is deficient, regardless of the institution where they work.