Efficacy of Pimpinella anisum L. in Menopausal Women with Psychological Symptoms: A Randomized Controlled Study
Arfa Begum1, Arshiya Sultana1, Md Belal Bin Heyat2,3
1Department of Ilmul Qabalat wa Amraze Niswan, National Institute of Unani Medicine, Bengaluru, India.
Introduction:
Menopausal women commonly experience psychological symptoms. These symptoms reduce their quality of life. Pimpinella anisum (anise) is an Unani remedy traditionally used for such problems. This study aimed to test the effects of anise on psychological and menopausal symptoms, along with appraising machine learning models in classifying treatment response between the anise and control groups.
Methods:
A total of 60 menopausal women received either 4 g of anise per day or a matched placebo, administered in two divided doses over an eight-week period. Primary outcomes included the Depression, Anxiety, and Stress Scale 21 (DASS-21) in menopausal women. Secondary outcomes included overall Modified Kuppermen Index (MKI), Vaginal Health Index (VHI), and treatment satisfaction (MS-TSQ). Machine learning classifiers, including Gradient Boosting (GB), AdaBoost (AB), K-Nearest Neighbours (KNN), Naive Bayes (NB), and Random Forest (RF), were utilised. Safety was monitored weekly through interviews. Hepatic and renal function were evaluated at baseline and after 12 weeks.
Results:
Baseline variables were similar between the two groups. Anise significantly reduced the DASS-21 scores compared to placebo at 8 weeks (p < 0.0001). At 8 weeks, participants receiving anise demonstrated significant improvements across multiple measures. DASS‑21 scores declined markedly compared with placebo (p < 0.0001), with more than 80% reporting no symptoms of depression, anxiety, or stress. MKI and VHI scores also improved significantly in the anise group (p < 0.0001), while the control group showed no notable change. Satisfaction ratings on the MS‑TSQ were high among anise recipients but low in the placebo arm. No adverse effects were observed. In addition, the KNN model achieved outstanding performance, correctly classifying group membership with 99.20% accuracy.
Discussion:
Anise demonstrated significant benefits in reducing psychological and menopausal symptoms, with no adverse effects reported, supporting its potential as a safe non‑hormonal therapy. The strong performance of the KNN model additionally exemplifies how machine learning can improve menopausal research by precisely distinguishing treatment responses. Upcoming studies with larger and more varied populations will be important to endorse these findings and to discover long‑term outcomes.
Conclusion:
This research indicates that anise is a safe and effective alternative for relieving psychological symptoms in menopausal women. The KNN model reliably classified treatment outcomes, signifying that the integration of anise treatment with AI‑based assessment methods could enrich research on menopause care.