Assessment of the Effects of Tribulus Terrestris on Sexual Function of Menopausal Women / Avaliação dos efeitos do Tribulus Terrestris na sexualidade de mulheres no climatério

Objective The aim of this study was to study the effects of Tribulus terrestris on sexual function in menopausal women. Methods This was a prospective, randomized, double-blind, placebo-controlled clinical trial that included 60 postmenopausal women with sexual dysfunction. The women were divided into two groups, placebo group and Tribulus group, and evaluated by using the Sexual Quotient-female version (SQ-F) and Female Intervention Efficacy Index (FIEI) questionnaires. Results There was no significant difference between the groups in age, age at menopause, civil status, race, and religion. In the evaluation with the SQ-F questionnaire, there were significant differences between the placebo (7.6±3.2) and Tribulus (10.2±3.2) groups in the domains of desire and sexual interest (p d" 0.001), foreplay (3.3±1.5 versus 4.2±1.0) (p d" 0.01), arousal and harmonious interaction with the partner (5.7±2.1 versus 7.2±2.6) (p d" 0.01), and comfort in sexual intercourse (6.5±2.4 versus 8.0±1.9) (p d" 0.01). There was no significant difference between the placebo and Tribulus groups in the domains of orgasm and sexual satisfaction (p = 0.28). In the FIEI questionnaire, there was a significant improvement (p < 0.001) in the domains of vaginal lubrication during coitus and/or foreplay (20 versus 83.3%), sensation in the genitalia during sexual intercourse or other stimuli (16.7 versus 76.7%), sensation in the genital region (20 versus 70%), sexual intercourse and/or other sexual stimulations (13.3 versus 43.3%), and the ability to reach orgasm (20% versus 73.3%). There was no significant difference in adverse effects between the two groups. Conclusions After 90 days of treatment, at the doses used, we found Tribulus terrestris to be effective in treating sexual problems among menopausal women.

Objetivo Estudar os efeitos doTribulus terrestris na função sexual demulheres após a menopausa. Métodos Ensaio clínico, prospectivo, randomizado, duplo-cego, placebo controlado, com 60 mulheres após a menopausa com disfunção sexual, divididas em dois grupos: Grupo Placebo e Grupo Tribulus, avaliadas através dos questionários Quociente Sexualversão Feminina (QS-F) e Female Intervention Efficacy Index (FIEI). Resultados Não houve diferença significante entre os grupos quanto à idade, idade de menopausa, estado civil, raça e religião. Na avaliação do questionário QS-F houve diferença significante entre os grupos Placebo (7,6±3,2) e Tribulus (10,2±3,2) nos aspectos desejo e interesse sexual (p d" 0,001), preliminares (3,3±1,5 versus 4,2±1,0) (p d" 0,01), excitação da mulher e sintonia com o parceiro (5,7±2,1 versus 7,2±2,6) (p d" 0,01) e no aspecto conforto na relação sexual (6,5±2,4 versus 8,0±1,9) (p d" 0,01). O aspecto orgasmo e satisfação sexual não houve diferença significante entre o Grupo Placebo e Tribulus (p = 0,28). No questionário FIEI houve melhora significante (p < 0,001) na lubrificação vaginal durante o coito e/ou preliminares (20 versus 83,3%), na sensação nas genitálias durante a relação sexual ou outros estímulos (16,7 versus 76,7%), na sensação na área genital (20 versus 70%), nas relações sexuais e/ou outras estimulações sexuais (13,3 versus 43,3%) e na capacidade de ter orgasmo (20% versus 73,3%). Quanto aos efeitos colaterais não houve diferença significante entre os dois Grupos. Conclusões Após noventa dias, podemos concluir que o Tribulus terrestris nas doses utilizadas demonstrou ser efetivo no tratamento das queixas sexuais dasmulheres após a menopausa.

Assessment of the Effects of Tribulus Terrestris on Sexual Function of Menopausal Women.

OBJECTIVE: The aim of this study was to study the effects of Tribulus terrestris on sexual function in menopausal women. METHODS: This was a prospective, randomized, double-blind, placebo-controlled clinical trial that included 60 postmenopausal women with sexual dysfunction. The women were divided into two groups, placebo group and Tribulus group, and evaluated by using the Sexual Quotient-female version (SQ-F) and Female Intervention Efficacy Index (FIEI) questionnaires. RESULTS: There was no significant difference between the groups in age, age at menopause, civil status, race, and religion. In the evaluation with the SQ-F questionnaire, there were significant differences between the placebo (7.6 ± 3.2) and Tribulus (10.2 ± 3.2) groups in the domains of desire and sexual interest (p ≤ 0.001), foreplay (3.3 ± 1.5 versus 4.2 ± 1.0) (p ≤ 0.01), arousal and harmonious interaction with the partner (5.7 ± 2.1 versus 7.2 ± 2.6) (p ≤ 0.01), and comfort in sexual intercourse (6.5 ± 2.4 versus 8.0 ± 1.9) (p ≤ 0.01). There was no significant difference between the placebo and Tribulus groups in the domains of orgasm and sexual satisfaction (p = 0.28). In the FIEI questionnaire, there was a significant improvement (p < 0.001) in the domains of vaginal lubrication during coitus and/or foreplay (20 versus 83.3%), sensation in the genitalia during sexual intercourse or other stimuli (16.7 versus 76.7%), sensation in the genital region (20 versus 70%), sexual intercourse and/or other sexual stimulations (13.3 versus 43.3%), and the ability to reach orgasm (20% versus 73.3%). There was no significant difference in adverse effects between the two groups. CONCLUSIONS: After 90 days of treatment, at the doses used, we found Tribulus terrestris to be effective in treating sexual problems among menopausal women.

Effects of Glycine max (L.) Merr. soy isoflavone vaginal gel on epithelium morphology and estrogen receptor expression in postmenopausal women: a 12-week, randomized, double-blind, placebo-controlled trial.

OBJECTIVE: Evaluate the effects of vaginal administration of isoflavones derived from Glycine max (L.) Merr. as a treatment option for vaginal atrophy, on the morphology and expression of estrogen receptors in vaginal epithelium of postmenopausal women. METHODS: The double-blind, randomized, placebo-controlled, clinical trial. Sixty women were treated for 12 weeks with isoflavone vaginal gel 4% (1g/day) and a placebo gel. After 4 and 12 weeks, the vaginal atrophy symptoms were classified at none, mild, moderate and severe and the vaginal cytology were taken to determine the maturation value. Vaginal pH was measured at the beginning and end of therapy. Microbiopsies in vaginal fornix were performed before the treatment and after 12 weeks of treatment. RESULTS: Isoflavone vaginal gel was effective for relief of vaginal dryness and dyspareunia symptons and an increase in the intermediate and superficial cells was noted. The vaginal pH in the isoflavone group was 7.1 at baseline and 5.4 after 12 weeks, whereas in the placebo group there was no significant change. A significant increase in thickness after treatment was detected in the Isoflavone Group. The percentage of estrogen receptor positive cells in vaginal epithelium for the Isoflavone Group ranged from 58.5% at the beginning of treatment to 82.6% after 12 weeks. These results were superior to placebo gel. CONCLUSION: Glycine max (L.) Merr. at 4% vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms, maturation values, vaginal pH, morphology and expression of estrogen receptors in vaginal epithelium. Isoflavones proved good treatment options for relief of vulvovaginal atrophy.

Effective treatment of vaginal atrophy with isoflavone vaginal gel.

OBJECTIVE: To assess efficacy and tolerability of a isoflavone (Glycine max L. Merr.) vaginal gel to the treatment of vaginal atrophy in postmenopausal women. METHODS: The double-blind, randomized, placebo-controlled, clinical trial. Ninety women were treated for 12 weeks with isoflavone vaginal gel 4% (1g/day) and a placebo gel and conjugated equine estrogen cream (0.3mg/day). After 4 and 12 weeks, the vaginal atrophy symptoms were classified at none, mild, moderate and severe and the vaginal cytology were taken to determine the maturation value. The endometrial safety (by transvaginal ultrasonography) was evaluated through at screening and the end of the trial. RESULTS: Isoflavone vaginal gel appears to be effective for relief of vaginal dryness and dyspareunia symptoms and an increase in the intermediate and superficial cells was noted. These results were similar to the effects with use of conjugated equine estrogens and superior to placebo gel. No changes in endometrial thickness, sera FSH and estradiol levels were observed at study endpoint. CONCLUSION: Glycine max (L.) Merr. at 4% vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms and a significant increase in cell maturation values. Isoflavones proved good treatment options for relief of vulvovaginal symptoms especially in women who do not wish to use hormonal therapy or have contra-indications for this treatment.