Tribulus Terrestris for Female Sexual Dysfunction: A Systematic Review

We performed unrestricted electronic searches in the MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO,WHO-ICTR, Clinicaltrials.gov and OpenGrey databases. Selection of studies We included any randomized controlled trials (RCTs) that compared T. terrestris versus inactive/active interventions. After the selection process, conducted by two reviewers, 5 RCTs (n = 279 participants) were included.

Data collection

Data extraction was performed by two reviewers with a preestablished data collection formulary.

Data synthesis

Due to lack of data and clinical heterogeneity, we could not perform meta-analyses. The risk of bias was assessed by the Cochrane Risk of Bias (RoB) tool, and the certainty of evidence was assessed with Grading of Recommendations, Assessment, Development and Evaluations (GRADE).

Results

After 1 to 3 months of treatment, premenopausal and postmenopausal women randomized to T. terrestris had a significant increase in sexual function scores. Three months of treatment with T. terrestris showed a significant increase in the serum testosterone levels of premenopausal women. There was no report of serious adverse events, and none of the studies assessed health-related quality of life. The certainty of the evidence was very low, whichmeans that we have very little confidence in the effect estimates, and future studies are likely to change these estimates.

Conclusion

MoreRCTs are needed to supportor refute the use of T. terrestris. The decision to use this intervention should be shared with the patients, and the uncertainties around its effects should be discussed in the clinical decision-making process. Number of Protocol registration in PROSPERO database: CRD42019121130

Keywords:
tribulus; sexual dysfunction; review; evidence-based medicine

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).