MedicinemedRxiv
Ranked by formulaVerdict: NotableEffects of a standardized saffron extract (Safr'Inside™) on menopause-related symptoms: a randomised, double-blind, placebo-controlled trial in perimenopausal women
Menopausal symptoms, which may emerge during perimenopause and include psychological, somatic, vasomotor, and sleep-related disturbances, can substantially impair women's well-being and quality of life.
Key numbers
- 68% and 17%
Caveats
- Preprint; not yet peer reviewed.
VerdictWorth a reader's time today.
Abstract
Menopausal symptoms, which may emerge during perimenopause and include psychological, somatic, vasomotor, and sleep-related disturbances, can substantially impair women's well-being and quality of life. Saffron (Crocus sativus L.) has emerged as a promising non-hormonal nutritional approach, with potential benefits for emotional wellbeing and stress-related symptoms. This study evaluated the efficacy and safety of Safr'Inside, a standardized saffron extract, in perimenopausal women. This multicentre, randomized, double-blind, placebo-controlled trial enrolled 104 healthy perimenopausal women (mean age: 45.7 {+/-} 3.7 years) receiving Safr'Inside (30 mg/day) or matched placebo for 12 weeks. Assessments were performed at baseline, 6 week, and 12 weeks. The primary outcome was change in menopausal symptom severity assessed using the Greene Climacteric Scale (GCS). Secondary outcomes included mood assessed using the Profile of Mood States (POMS), sleep quality using the Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life using the Short Form-36(SF-36). Metabolic, endocrine, and safety parameters were also assessed. At week 12, total GCS scores decreased significantly more with Safr'Inside than with placebo, with mean reductions of 68% and 17%, respectively (p<0.0001). Improvements were already evident at week 6 and were most pronounced for psychological and somatic symptoms, including anxiety and depression. Night sweats significantly improved, while the overall vasomotor score showed a favourable trend (p=0.06). Saffron also improved negative mood, selected sleep-related outcomes and several dimensions of quality of life. Safr'Inside significantly reduced overall perimenopausal symptom burden, with benefits across psychological, somatic, mood, sleep-related, and selected vasomotor outcomes. These findings support further investigation of standardized saffron extract as a non-hormonal nutritional approach for perimenopausal symptom management.
The editor's rubric
- Leverage2 / 5
- Reusable within one subfield (a technique, dataset, or protocol a few groups will adopt).
- Magnitude3 / 5
- Large gain: roughly 2x, or a clear new state of the art on a hard, unsaturated problem.
- Evidence4 / 5
- Strong: large scale, preregistered, independently replicated, or a well-powered randomized trial.
- Novelty2 / 5
- A new combination of known ideas.
- Trajectory3 / 5
- A clear path to scale.
- Stakes2 / 5
- Benefits a professional community (practitioners, clinicians, engineers).
Editor’s rationale
Heuristic triage from title and abstract text only, not a reading of the paper. Cues found: gains (relative gain); novelty (open problem); design (randomized, blinded, placebo-controlled); verification (p-value, error bars); scale (scalable, improves with scale).
How the score was computed
Desks place stronger verdicts first, then use this score to order work within the same verdict.
- Merit
- 5.8 / 10
- Adjusted merit
- 4.9 / 10
- Attention
- 0%
- Freshness
- 92%
- Citations0 (reference 20, via semantic-scholar, Oct 23, 2026, 06:17 UTC)