Tribulus terrestris para disfunção sexual feminina: Uma Revisão Sistemática

Martimbianco, Ana Luiza Cabrera; Pacheco, Rafael Leite; Vilarino, Fábia Lima; Latorraca, Carolina de Oliveira Cruz; Torloni, Maria Regina; Riera, Rachel

doi:10.1055/s-0040-1712123

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Revista Brasileira de Ginecologia e Obstetrícia

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Sumário

Review Article • Rev. Bras. Ginecol. Obstet. 42 (07) • Jul 2020 • https://doi.org/10.1055/s-0040-1712123 copiar

Tribulus terrestris para disfunção sexual feminina: Uma Revisão Sistemática

Autoria SCIMAGO INSTITUTIONS RANKINGS

Resumo

Objetivo

Nós realizamos uma revisão sistemática para avaliar a efetividade e a segurança do Tribulus terrestris no tratamento da disfunção sexual feminina (DSF).

Fontes de dados

Nós realizados uma busca eletrônica irrestrita nas seguintes bases de dados: MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov, e OpenGrey. Seleção dos estudos Nós incluímos todos os ensaios clínico randomizados (ECR) que comparou T. terrestris com controles ativos/inativos. Após o processo de seleção, conduzido por 2 revisores, 5 ECRs (n = 279 participantes) foram incluídos.

Extração de dados

O processo de extração de dados foi realizado por dois revisores, utilizando-se um formulário de extração de dados pré-estabelecido. Síntese de dados Devido à falta de dados disponíveis e à heterogeneidade clínica entre os estudos incluídos, nós não realizamos meta-análises. O risco de viés foi avaliado pela tabela de risco de viés da Cochrane e, a certeza do corpo da evidência foi avaliada pelo Grading of Recommendations, Assessment, Development and Evaluations (GRADE).

Resultados

Após 1 a três 3 meses de tratamento, mulheres na pré e pós-menopausa randomizadas ao T. terrestris tiveram um aumento significante nos escores de função sexual. O grupo com 3 meses de tratamento com T. terrestris exibiu um aumento significante dos níveis séricos de testosterona emmulheres pré-menopausa. Não houve relato de eventos adversos graves, e nenhum estudo avaliou qualidade de vida das participantes. A certeza da evidência foi considerada muito baixa, o que significa que existe pouca certeza na estimativa dos efeitos e que é provável que futuros estudos mudem estas estimativas.

Conclusão

Mais ECRs são importantes para apoiar ou refutar o uso do T. terrestris. A decisão de usar essa intervenção deve ser compartilhada com pacientes, e as incertezas sobre seus efeitos devem ser discutidas durante o processo de decisão clínica.

Palavras-chave:
tribulus; disfunção sexual; revisão; medicina baseada em evidências

Study (year)	Participants	Interventions and comparators	Outcomes	Follow-up	Funding
Vale et al (2018)¹⁰10 Vale FBC, Zanolla Dias de Souza K, Rezende CR, Geber S. Efficacy of Tribulus Terrestris for the treatment of premenopausal women with hypoactive sexual desire disorder: a randomized doubleblinded, placebo-controlled trial. Gynecol Endocrinol. 2018;34 (05):442-445. Doi: 10.1080/09513590.2017.1409711 https://doi.org/10.1080/09513590.2017.14...	N = 40 premenopausal women with HSDDAge 18 to 44 years	G1: T. terrestris (N = 20)^* * Number of patients included in the analysis. 250 mg orally 3 times/day, 120 daysG2: Placebo (N = 20)^* * Number of patients included in the analysis.	Sexual Function (FSFI and SQ-F)Serum testosterone level	Immediately after treatment (4 months)	No financial support
Souza et al (2016)¹¹11 de Souza KZ, Vale FBC, Geber S. Efficacy of Tribulus terrestris for the treatment of hypoactive sexual desire disorder in postmenopausal women: a randomized, double-blinded, placebo-controlled trial. Menopause. 2016;23(11):1252-1256. Doi: 10.1097 /GME.0000000000000766 https://doi.org/10.1097...	N = 46 postmenopausal women with HSDDAge 43 to 65 years	G1: T. terrestris (N = 20)^* * Number of patients included in the analysis. 250 mg orally 3 times/day, 120 daysG2: Placebo (N = 16)^* * Number of patients included in the analysis.	Sexual Function (FSFI)Serum testosterone level	Immediately after treatment (4 months)	A pharmacy provided T. terrestris used in the study
Postigo et al (2016)¹²12 Postigo S, Lima SMRR, Yamada SS, dos Reis BF, da Silva GM, Aoki T. Assessment of the effects of tribulus terrestris on sexual function of menopausal women. Rev Bras Ginecol Obstet. 2016;38(03): 140-146. Doi: 10.1055/s-0036-1571472 https://doi.org/10.1055/s-0036-1571472...	N = 60 postmenopausal women with HSDDAge:G1 54 ± 5.1 yearsG2 56 ± 5.8 years	G1: T. terrestris (N = 30)^* * Number of patients included in the analysis. 250 mg orally 3 times/day, 90 daysG2: Placebo (N = 30)^* * Number of patients included in the analysis.	Sexual Function (SQ-F)	Immediately after treatment (3 months)	The study received funding from a governmental fund and the main investigator had a research fellowship.
Guazzelli et al (2014)¹³13 Guazzelli RM, Lima SMRR, Postigo S, Martins CPB, Yamada SS. Estudo dos efeitos do Tribulus terrestris e da tibolona em mulheres com disfunção do desejo sexual após a menopausa. Arq Med Hosp Fac Cienc Med Santa Casa São Paulo.. 2014;59 (01):20-26	N = 66 postmenopausal women with HSDDAgeG1 56 ± 5.8 yearsG2 53 ± 3.9 yearsG3 54 ± 5.1 years	G1: T. terrestris (N = 22)^* * Number of patients included in the analysis. 250 mg orally 3 times/day, 90 daysG2: Tibolone (N = 24)^* * Number of patients included in the analysis. 1.25 mg/oral administration/day, 90 daysG3: Placebo (N = 20)	Sexual Function (SQ-F)	Immediately after treatment (3 months)	The study received funding from a governmental fund
Akhtari et al (2014)¹⁴14 Akhtari E, Raisi F, Keshavarz M, Hosseini H, Sohrabvand F, Bioos S, et al. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study. Daru. 2014;22(01):40. Doi: 10.1186/2008-2231-22-40 https://doi.org/10.1186/2008-2231-22-40...	N = 67 premenopausal women with HSDDAgeG1 36 ± 6.2 yearsG2 36.1 ± 5.8 years	G1: T. terrestris (N = 30)^* * Number of patients included in the analysis. 7.5 ml syrup, 2 times / day, 30 days(3.5 g of ethanolic extract per 5 ml of syrup)G2: Placebo (N = 30)^* * Number of patients included in the analysis.	Sexual Function (FSFI)Adverse events	Immediately after treatment (1 month)	The study was supported by Tehran University of Medical Sciences; it is not clear if this was financial support

Outcome		Akhtari et al (2014)¹⁴14 Akhtari E, Raisi F, Keshavarz M, Hosseini H, Sohrabvand F, Bioos S, et al. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study. Daru. 2014;22(01):40. Doi: 10.1186/2008-2231-22-40 https://doi.org/10.1186/2008-2231-22-40...		Souza et al (2016)¹¹11 de Souza KZ, Vale FBC, Geber S. Efficacy of Tribulus terrestris for the treatment of hypoactive sexual desire disorder in postmenopausal women: a randomized, double-blinded, placebo-controlled trial. Menopause. 2016;23(11):1252-1256. Doi: 10.1097 /GME.0000000000000766 https://doi.org/10.1097...		Guazzelli et al (2014)¹³13 Guazzelli RM, Lima SMRR, Postigo S, Martins CPB, Yamada SS. Estudo dos efeitos do Tribulus terrestris e da tibolona em mulheres com disfunção do desejo sexual após a menopausa. Arq Med Hosp Fac Cienc Med Santa Casa São Paulo.. 2014;59 (01):20-26			Postigo et al (2016)¹²12 Postigo S, Lima SMRR, Yamada SS, dos Reis BF, da Silva GM, Aoki T. Assessment of the effects of tribulus terrestris on sexual function of menopausal women. Rev Bras Ginecol Obstet. 2016;38(03): 140-146. Doi: 10.1055/s-0036-1571472 https://doi.org/10.1055/s-0036-1571472...		Vale et al (2018)¹⁰10 Vale FBC, Zanolla Dias de Souza K, Rezende CR, Geber S. Efficacy of Tribulus Terrestris for the treatment of premenopausal women with hypoactive sexual desire disorder: a randomized doubleblinded, placebo-controlled trial. Gynecol Endocrinol. 2018;34 (05):442-445. Doi: 10.1080/09513590.2017.1409711 https://doi.org/10.1080/09513590.2017.14...
Primary outcomes (Final mean (SD))
		Tribulus	Placebo	Tribulus	Placebo	Tribulus	Placebo	Tibolone	Tribulus	Placebo	Tribulus	Placebo
Health-related quality of life		NA		NA		NA			NA		NA
Sexual function assessed by FSFI (total score)		26.80 (3.03)^* * Statistically significant difference.	22.41 (2.87)	25.8^† † Standard deviations were not reported.	22.93^† † Standard deviations were not reported.	NA			NA		25.27^† † Standard deviations were not reported.	20.29^† † Standard deviations were not reported.
Sexual function assessed by: FSFI (sub scores)	Desire	3.09 (0.71)	2.86 (0.79)	3.66^† † Standard deviations were not reported.	3.15^† † Standard deviations were not reported.						3.24^† † Standard deviations were not reported.	2.88^† † Standard deviations were not reported.
	Arousal	4.21 (0.67)^* * Statistically significant difference.	3.17 (0.75)	3.74^† † Standard deviations were not reported.	3.04^† † Standard deviations were not reported.						3.27^† † Standard deviations were not reported.	3.08^† † Standard deviations were not reported.
	Lubrication	4.66 (0.87)^* * Statistically significant difference.	4.18 (0.79)	4.62^† † Standard deviations were not reported.	4.39^† † Standard deviations were not reported.						3.98^† † Standard deviations were not reported.	3.38^† † Standard deviations were not reported.
	Orgasm	4.20 (0.72)^* * Statistically significant difference.	3.59 (0.85)	4.12^† † Standard deviations were not reported.	3.83^† † Standard deviations were not reported.						3.84^† † Standard deviations were not reported.	3.24^† † Standard deviations were not reported.
	Satisfaction	4.61 (0.93)^* * Statistically significant difference.	3.75 (1.12)	4.66^† † Standard deviations were not reported.	4.03^† † Standard deviations were not reported.						4.36^† † Standard deviations were not reported.	3.34^† † Standard deviations were not reported.
	Pain	5.07 (1.01)	4.87 (1.42)	5.0^† † Standard deviations were not reported.	4.5^† † Standard deviations were not reported.						4.58^† † Standard deviations were not reported.	4.38^† † Standard deviations were not reported.
Sexual function assessed by SQ-F (total score)		NA		NA		69†	56†	84†	70.9 (17.6)	56.6 (17.9)	Results were reported based on the presence of sexual dysfunction (%)
Serious adverse events		No cases		NA		NA					NA
Secondary outcomes (Final mean (SD)
Serum testosterone levels assessed by: serum total testosterone level		NA		14.2 (6.9)	11.7 (6.2)	NA					20.5 (9.7)^* * Statistically significant difference.	13.9 (10.7)
Minor adverse events		One patient reported abdominal cramps (not reported in which group)		NA		NA					NA

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[1] Address for correspondence Rafael Leite Pacheco, MD, Msc, Centro Universitário São Camilo, São Camilo, SP, Brazil (e-mail: rleitepacheco@hotmail.com).