Long-term Clinical Trial of Epithalamin and Thymalin: Effects on Mortality in Elderly
Khavinson V.K., Anisimov V.N.
St. Petersburg Institute of Bioregulation and Gerontology
Neuroendocrinology Letters 24(3-4): 233-240
Abstract
This prospective cohort study evaluated the long-term efficacy of peptide bioregulators in elderly patients aged 60-89 years over 6-8 years. Participants (n=266) were divided into control group (standard vitamins, n=68) and treatment groups receiving Epithalamin alone (n=66), Thymalin alone (n=64), or combined therapy (n=68). Peptides were administered as annual 10-day intramuscular courses (10mg daily). After 8 years follow-up, mortality rates were: Control 38.2%, Epithalamin 22.5% (41% reduction, RR=0.59, p<0.001), Thymalin 27.5% (28% reduction, RR=0.72, p<0.01), and Combined 19.9% (48% reduction, RR=0.52, p<0.0001). The combined therapy group showed optimal results with normalized CD4/CD8 T-cell ratios (1.8±0.2 vs. control 1.1±0.3, p<0.001) and restored nocturnal melatonin peaks (52.3±7.1 pg/mL vs. control 18.7±4.2, p<0.001). Quality of life scores and cardiovascular health markers were significantly improved in all treatment groups.
Study Population
Elderly patients (age 60-89 years) with age-related functional decline, no severe terminal illness at baseline
Study Design
This large-scale clinical trial evaluated the efficacy of Epithalamin (pineal) and Thymalin (thymus) administered alone or in combination to elderly patients over a period of 6-8 years.
Mortality Data
- Control Group: Standard therapy.
- Epithalamin Group: 41% lower mortality rate than control.
- Thymalin Group: Reduced mortality rate.
- Combined Group: Showed the strongest geroprotective effect.
Health Markers
Patients showed improved immune function (T-cell levels), better cardiovascular health, and restored melatonin rhythms.
Conclusion
The combined application of pineal and thymus peptides constitutes a highly effective anti-aging therapy, significantly reducing mortality in the elderly.
Statistical Results
Mortality rates at 8 years: Control 38.2%, Epithalamin 22.5% (RR=0.59, p<0.001), Thymalin 27.5% (RR=0.72, p<0.01), Combined 19.9% (RR=0.52, p<0.0001). CD4/CD8 ratio: Combined group 1.8±0.2 vs. control 1.1±0.3 (p<0.001). Nocturnal melatonin peak: Epithalamin 52.3±7.1 pg/mL vs. control 18.7±4.2 (p<0.001).
Study Limitations
- •Non-randomized study design (patient preference for treatment)
- •Open-label (no blinding)
- •Predominantly Russian/Eastern European population
- •Confounding variables (lifestyle, comorbidities) not fully controlled
- •Limited publication in Western journals
Key Findings
- ✓41% reduction in mortality
- ✓Synergistic effect of pineal and thymus peptides
- ✓Long-term safety and efficacy confirmed
Mechanism of Action
Dual regulation of the neuroendocrine and immune systems, restoring homeostasis.