Effects of a combination of Nigella sativa and Vitex agnus-castus with citalopram on healthy menopausal women with hot flashes: results from a subpopulation analysis.

2018-08-21
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology 35(1)
- Maryam Molaie
- Behrad Darvishi
- Zahra Jafari Azar
- Mahboobeh Shirazi
- Gholamreza Amin
- Shima Afshar

PubMed: 30129806
DOI: 10.1080/09513590.2018.1499086

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 46
Population: 46 women aged between 40 and 60 years experiencing an average of more than four hot flashes per day
Methods: 8 week, double-blind, randomized, placebo-controlled study; herbal medication or placebo capsules administered once daily in morning
Blinding: Double-blind
Duration: 8 weeks

The goal of the current study was to evaluate the efficiency of a phytotherapeutic intervention consisting of a combination of Nigella sativa and Vitex agnus-castus with citalopram in the control of hot flashes in healthy menopausal women. An 8 week, double-blind, randomized, placebo-controlled study was performed among 46 women aged between 40 and 60 years experiencing an average of more than four hot flashes per day recruited during July 2016 to June 2017. Data on severity of vasomotor symptoms were collected at the end of the eighth week. Herbal medication or placebo capsules were administered once daily in morning. At the end of the 8-week treatment period, analyses of covariance demonstrated the superiority of herbal combination with citalopram over placebo and citalopram for three MENQOL domain scores including vasomotor (p < .001), physical (p = .036), psychosocial (p = .001) but no significant differences were observed in terms of sexual function (p = .231). Based on the results, the addition of a combination of N. sativa and V. agnus-castus to the citalopram may be a potential clinical application for improving therapeutic outcomes. Larger randomized, controlled trials are also warranted for further investigations of these symptoms.

Research Insights

Black Cumin→Improved Physical Domain Score
analyses of covariance demonstrated the superiority of herbal combination with citalopram over placebo and citalopram for three MENQOL domain scores including … physical (p = .036)
Effect
Beneficial
Effect size
Small
Dose
once daily in morning (dose not specified)
Black Cumin→Improved Psychosocial Domain Score
analyses of covariance demonstrated the superiority of herbal combination with citalopram over placebo and citalopram for three MENQOL domain scores including … psychosocial (p = .001)
Effect
Beneficial
Effect size
Small
Dose
once daily in morning (dose not specified)
Black Cumin→Improved Sexual Function Domain Score
no significant differences were observed in terms of sexual function (p = .231)
Effect
Neutral
Effect size
Small
Dose
once daily in morning (dose not specified)
Black Cumin→Improved Vasomotor Domain Score
analyses of covariance demonstrated the superiority of herbal combination with citalopram over placebo and citalopram for three MENQOL domain scores including vasomotor (p < .001)
Effect
Beneficial
Effect size
Small
Dose
once daily in morning (dose not specified)
Chasteberry→Improved Physical Domain Score
analyses of covariance demonstrated the superiority of herbal combination with citalopram over placebo and citalopram for three MENQOL domain scores including … physical (p = .036)
Effect
Beneficial
Effect size
Small
Dose
once daily in morning (dose not specified)
Chasteberry→Improved Psychosocial Domain Score
analyses of covariance demonstrated the superiority of herbal combination with citalopram over placebo and citalopram for three MENQOL domain scores including … psychosocial (p = .001)
Effect
Beneficial
Effect size
Small
Dose
once daily in morning (dose not specified)
Chasteberry→Improved Sexual Function Domain Score
no significant differences were observed in terms of sexual function (p = .231)
Effect
Neutral
Effect size
Small
Dose
once daily in morning (dose not specified)
Chasteberry→Improved Vasomotor Domain Score
analyses of covariance demonstrated the superiority of herbal combination with citalopram over placebo and citalopram for three MENQOL domain scores including vasomotor (p < .001)
Effect
Beneficial
Effect size
Small
Dose
once daily in morning (dose not specified)