The possible short-term of Nigella sativa - L in the management of adolescent polycystic ovarian syndrome: results of a randomized controlled trial.
- 2024-07-12
- Journal of ovarian research 17(1)
- Azamsadat Mahmoudian
- Akram Ashouri
- Roghaieh Rahmani Bilandi
- Fatemeh Mohammadzadeh
- Sareh Dashti
- Narjes Bahri
- PubMed: 38997723
- DOI: 10.1186/s13048-024-01460-x
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 103
- Population
- 114 adolescents with PCOS who were referred to gynecologist offices and clinics in Gonabad, Iran from March 2022 to March 2023
- Methods
- randomized clinical trial, participants randomly allocated to intervention (Nigella sativa 1000 mg/day) and control (10 mg/day medroxyprogesterone from the 14th day of the cycle for 10 nights) groups
- Duration
- 16 weeks
- Large Human Trial
Background
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age and the most common cause of infertility due to anovulation. PCOS in adolescents is concerning. Nigella sativa is effective in improving gonadotropins and sex hormones. The current study was designed to investigate the effect of Nigella sativa supplementation on PCOS symptoms and their severity in adolescents.Methods
The current randomized clinical trial was conducted on 114 adolescents with PCOS who were referred to gynecologist offices and clinics in Gonabad, Iran from March 2022 to March 2023. Participants were randomly allocated to the intervention (Nigella sativa 1000 mg/day) and control (10 mg/day medroxyprogesterone from the 14th day of the cycle for 10 nights) groups. The study duration was 16 weeks. Ovarian volume (measured by ultrasound), anthropometric and blood pressure; serum testosterone, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), luteinizing hormone (LH), hirsutism severity (Ferriman-Gallwey score) levels were evaluated before and after the study.Results
Data from 103 participants (control group = 53, intervention group = 50) were analyzed. The mean age of participants was 17.0 (Interquartile range [IQR]:2.0). The mean difference in hirsutism score changes (p < 0.001), right (p = 0.002), and left (p = 0.010) ovarian volume, serum LH (p < 0.001) and testosterone (p = 0.001) were significantly higher in the intervention group compared to the control group. The frequency of oligomenorrhea, menometrorrhagia, and amenorrhea, were significantly reduced after the study in the intervention group compared to the control group (ps < 0.001).Conclusions
Short-term Nigella sativa supplementation may be effective in reducing ovarian volume and improving hormonal balance, and menstrual irregularities in adolescents with PCOS. Further research and long-term studies are warranted to validate the potential therapeutic effects of Nigella sativa in adolescents with PCOS.Irct registration number
IRCT20221017056209N1 Registration date: 2022-11-22.Research Insights
The frequency of oligomenorrhea, menometrorrhagia, and amenorrhea, were significantly reduced after the study in the intervention group compared to the control group (ps < 0.001)
- Effect
- Beneficial
- Effect size
- Large
- Dose
- 1000 mg/day
Anthropometric and blood pressure were evaluated but no significant changes are reported in the abstract; thus assumed not significant.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 1000 mg/day
Anthropometric ... were evaluated but no significant changes are reported in the abstract; thus assumed not significant.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 1000 mg/day
Anthropometric ... were evaluated but no significant changes are reported in the abstract; thus assumed not significant.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 1000 mg/day
The abstract does not report a statistically significant difference for DHEA or DHEA-S; only testosterone and LH are explicitly reported as significant. DHEA and DHEA-S were measured but no significant changes are noted, so they are assumed non-significant.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 1000 mg/day
The abstract does not report a statistically significant difference for DHEA or DHEA-S; only testosterone and LH are explicitly reported as significant. DHEA and DHEA-S were measured but no significant changes are noted, so they are assumed non-significant.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 1000 mg/day
The mean difference in hirsutism score changes (p < 0.001) ... were significantly higher in the intervention group compared to the control group
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 1000 mg/day
serum LH (p < 0.001) ... were significantly higher in the intervention group compared to the control group
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 1000 mg/day
right (p = 0.002), and left (p = 0.010) ovarian volume ... were significantly higher in the intervention group compared to the control group
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 1000 mg/day
serum ... testosterone (p = 0.001) were significantly higher in the intervention group compared to the control group
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 1000 mg/day
Anthropometric ... were evaluated but no significant changes are reported in the abstract; thus assumed not significant.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 1000 mg/day