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Efficacy Of Combined Nutritional And Pharmacological Interventions In PCOS: A Six Month Randomized Controlled Trial.

  • 2025-09-30
  • Naunyn-Schmiedeberg's archives of pharmacology 399(3)
    • Musarrat Zahra
    • Mohsin Shah
    • Fiza Iqbal
    • Tariq Zubair
    • Rozina Habib
    • Fatima Zulfiqar

Study Design

Type
Randomized Controlled Trial (RCT)
Population
63 females diagnosed with PCOS
Methods
Participants treated with either Carnitine + Arginine + CoQ10 alone (nutraceutical group) or in combination with metformin (combination group) for six months
Duration
six months
Polycystic ovary syndrome is a complex heterogenous reproductive endocrine disorder affecting mainly reproductive age women worldwide. The syndrome primarily is associated with hyperandrogenism, hyperinsulinemia, menstrual irregularity, infertility, hormonal dysregulation and obesity. Here, we examined the effects of Acetyl-L-Carnitine, L-Arginine, CoQ10, (Carnitine + Arginine + CoQ10) and Metformin, alone and in combination, on PCOS management. The trial included 63 females diagnosed with PCOS. The participants were treated with either Carnitine + Arginine + CoQ10 alone (nutraceutical group) or in combination with metformin (combination group) for six months. The outcome measures included demographic, anthropometric, clinical, endocrine, metabolic, quality of Life and stress response of the participants. Over 24 weeks, both treatment regimens improved metabolic, hormonal, and psychological outcomes in women with PCOS. Repeated-measures ANCOVA showed significant group × time interactions for BMI (p < .001, η2 = .220), waist circumference (p < .001, η2 = .314), and hip circumference (p < .001, η2 = .428), favoring the combination group. Hormonal responses varied: DHEAS (p = .045, η2 = .082), FAI (p < .001, η2 = .223), testosterone (p = .004, η2 = .113), and prolactin (p = .032, η2 = .072) declined more in the combination group, whereas LH decreased more in the nutraceutical group (p < .001, η2 = .231). Quality of life improved significantly in both arms, with greater gains in the combination group (p = .037, η2 = .071). Oxidative stress (MDA) also declined significantly in both groups (p = .003), with larger numerical reductions in the combination arm (- 22% vs - 6%), though between-group differences were not significant (p = .329). Both nutraceutical and combination therapies led to significant improvements in metabolic, hormonal, and psychological outcomes in women with PCOS over 24 weeks. Repeated-measures ANCOVA confirmed greater reductions in BMI, waist and hip circumference, DHEAS, FAI, testosterone, and prolactin, as well as superior quality-of-life gains with combination therapy. Nutraceutical therapy exerted stronger effects on LH suppression, while oxidative stress (MDA) decreased significantly in both groups without between-group differences. These findings highlight the potential of nutraceuticals as a non-pharmacological option and underscore the added benefits of metformin co-administration for patients with pronounced hyperandrogenism and central adiposity. Trial Registration: clinicalTrial.gov NCT05653895. Registered March 1, 2022.

Research Insights

  • Acetyl-Carnitine→Improved Quality of Life

    Quality of life improved significantly in both arms, with greater gains in the combination group (p = .037, η2 = .071).

    Effect
    Beneficial
    Effect size
    Small
  • Acetyl-Carnitine→Reduced Hip Circumference

    Repeated-measures ANCOVA showed significant group × time interactions for BMI (p < .001, η2 = .220), waist circumference (p < .001, η2 = .314), and hip circumference (p < .001, η2 = .428), favoring the combination group.

    Effect
    Beneficial
    Effect size
    Large
  • Acetyl-Carnitine→Reduced Waist Circumference

    Repeated-measures ANCOVA showed significant group × time interactions for BMI (p < .001, η2 = .220), waist circumference (p < .001, η2 = .314), and hip circumference (p < .001, η2 = .428), favoring the combination group.

    Effect
    Beneficial
    Effect size
    Large
  • L-Arginine→Improved Quality of Life

    Quality of life improved significantly in both arms, with greater gains in the combination group (p = .037, η2 = .071).

    Effect
    Beneficial
    Effect size
    Small
  • L-Arginine→Reduced Hip Circumference

    Repeated-measures ANCOVA showed significant group × time interactions for BMI (p < .001, η2 = .220), waist circumference (p < .001, η2 = .314), and hip circumference (p < .001, η2 = .428), favoring the combination group.

    Effect
    Beneficial
    Effect size
    Large
  • L-Arginine→Reduced Waist Circumference

    Repeated-measures ANCOVA showed significant group × time interactions for BMI (p < .001, η2 = .220), waist circumference (p < .001, η2 = .314), and hip circumference (p < .001, η2 = .428), favoring the combination group.

    Effect
    Beneficial
    Effect size
    Large
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