Effect of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids on body weight and metabolic parameters in a menopausal murine model induced by bilateral ovariectomy

Valdivia, Martha; Soto-Becerra, Percy; Laguna‐Barraza, Ricardo; Rojas, Percy; Reyes-Mandujano, Ivonne Fanny; Gonzáles-Reyes, Paola; Temoche, Haydee; Timoteo, Olga S.; Lugo-Martínez, Gabriela; Calzada‐Mendoza, Claudia C.; Mezones‐Holguín, Edward

doi:10.1080/09513590.2020.1821639

Cited by 5 publications

(5 citation statements)

References 27 publications

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“…The results were favorable because this compound had better effects on menopausal symptoms and seems to be more innocuous than EPT. The present results confirm the findings from previous trials on safety and tolerability among murine models and healthy women 26,27 . The participants receiving the herbal mix had a lower average score on global and physical symptoms since the second month of treatment, compared with those receiving EPT.…”

Section: Discussionsupporting

confidence: 90%

“…The present results confirm the findings from previous trials on safety and tolerability among murine models and healthy women. 26,27 The participants receiving the herbal mix had a lower average score on global and physical symptoms since the second month of treatment, compared with those receiving EPT. Equally, they had significantly lower psychosocial symptom scores since the third month of follow-up.…”

Section: Main Findingsmentioning

confidence: 97%

“…It is aligned with drug regulatory agencies, as it has been previously tested in animals and healthy women. 26,27 This is the first phase II clinical trial assessing the effects of the herbal mix based on native products (at two different doses) against menopausal symptoms and lipid, hormonal, and safety profiles, compared with EPT. The compound was well tolerated among participants.…”

Section: Limitations and Strengthsmentioning

confidence: 99%

“…It was based on some Peruvian native plant species, which are well-known for their therapeutic properties in alleviating menopausal symptoms 24,25 . A preclinical study on menopausal mouse models showed that this herbal mix reduces weight gain and total cholesterol levels 26 . Moreover, following regulatory agencies, a phase I clinical trial was conducted that showed that this oral herbal supplement was safe and tolerable in healthy adult women 27 .…”

mentioning

confidence: 99%

“…24,25 A preclinical study on menopausal mouse models showed that this herbal mix reduces weight gain and total cholesterol levels. 26 Moreover, following regulatory agencies, a phase I clinical trial was conducted that showed that this oral herbal supplement was safe and tolerable in healthy adult women. 27 However, besides being safe, tolerable, and having promising positive effects, no study has yet assessed the compound's efficacy in menopausal women.…”

mentioning

confidence: 99%

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Short-term effects and safety of a natural oral supplement containing glucosinolates, phytosterols, and citrus flavonoids compared with hormone treatment for the management of postmenopausal symptomatic women: a pilot single-center randomized phase 2 clinical trial

Villar-López,

Soto-Becerra,

Chedraui

et al. 2023

Menopause

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Objective This study aimed to evaluate the short-term efficacy and safety of an oral herbal supplement containing glucosinolates, phytosterols, and citrus flavonoids for menopausal symptoms in comparison with estrogen plus progestogen therapy (EPT) among postmenopausal women. Methods This was a pilot single-blinded, three-armed phase II randomized clinical trial, controlled with EPT. Sixty participants were randomly assigned to receive treatment for 3 months: (1) an oral herbal supplement of 1,500 mg/d (G1, n = 20), (2) an oral herbal supplement of 3,000 mg/d (G2, n = 20), or (3) conjugated equine estrogens 0.625 mg/d plus medroxyprogesterone acetate of 5 mg/d (EPT group, n = 20). The primary endpoint was the intensity of menopausal symptoms as measured using the Menopause-Specific Quality of Life Questionnaire (global and domain scores). The Menopause-Specific Quality of Life Questionnaire uses a 7-point scale to rate the symptom intensity, with higher scores indicating severity. The secondary endpoints were hormonal, lipid, and safety profiles. Results Fifty-four participants (n = 54) completed the study. The mean, model-estimated, and global menopausal symptom scores at 3 months were 85.8 in the EPT group, 61.3 in G1, and 62.5 in G2. Participants treated with the herbal compound had lower global (13.7 [6.9-20.4], P < 0.001) and physical symptom scores (6.6 [1.6-11.5], P = 0.002) on the second month and lower psychosocial symptom scores (3.8 [1.3 to 6.3], P < 0.001) on the third month of follow-up, compared with EPT. Conversely, participants receiving EPT showed better outcomes on vasomotor symptoms since the first month of treatment (−6.1 [−8.3 to −4.0], P < 0.001). The EPT group exhibited higher values of estradiol and lower follicle-stimulating hormone and luteinizing hormone since the first month of follow-up. Also, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were significantly higher in this group than in G2. Conclusions In this small single-blind exploratory trial, the oral herbal supplement was more efficacious in reducing global, physical, and psychosocial menopausal symptoms in the short term than EPT. However, further studies are needed to adequately assess the efficacy and safety of this herbal supplement in the treatment of menopausal symptoms.

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Section: Discussionsupporting

confidence: 90%

Section: Main Findingsmentioning

confidence: 97%

Section: Limitations and Strengthsmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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