Open Trial of Vitamin B12 Nasal Drops in Adults With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Comparison of Responders and Non-Responders. — CFSMEATLAS
Open Trial of Vitamin B12 Nasal Drops in Adults With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Comparison of Responders and Non-Responders.
van Campen, C Linda Mc, Riepma, Klaas, Visser, Frans C · Frontiers in pharmacology · 2019 · DOI
Quick Summary
This study tested whether vitamin B12 nasal drops could help people with ME/CFS. Fifty-one patients used the nasal drops for 3 months, and about two-thirds reported feeling better. Those who improved showed increases in their activity levels, better fatigue scores, and significantly higher vitamin B12 levels in their blood. The nasal drops appear to be a practical alternative to vitamin B12 injections for some patients.
Why It Matters
ME/CFS patients often struggle with treatment access and tolerability, making alternative delivery methods for potentially beneficial interventions valuable. This study provides preliminary evidence that nasal B12 administration may be an accessible, non-invasive option compared to injections. Understanding which patients respond to B12 supplementation could help clinicians personalize treatment approaches.
Observed Findings
Median serum vitamin B12 levels increased significantly from 328 pmol/l to 973 pmol/l after 3 months of nasal drops
Two-thirds of patients (34 of 51) reported favorable clinical responses to treatment
Responders showed significant increases in daily step count and RAND-36 physical activity scale scores
Responders demonstrated significant improvements on the CIS20r fatigue scale, while concentration scores remained unchanged
Non-responders showed only small, statistically significant increases in B12 levels compared to responders
Inferred Conclusions
Nasal B12 drops effectively increase serum B12 levels and may serve as a practical alternative to injections for ME/CFS patients
Approximately two-thirds of ME/CFS patients may experience clinically meaningful improvements in physical activity and fatigue with nasal B12 supplementation
Response to nasal B12 drops may be associated with baseline B12 status or individual metabolic factors, as non-responders showed attenuated B12 absorption
Remaining Questions
What baseline characteristics or biomarkers predict which patients will respond to B12 nasal drops versus not responding?
How do the effects of nasal B12 drops compare to traditional B12 injections in a head-to-head controlled trial?
What This Study Does Not Prove
This open-label study cannot prove that nasal B12 drops caused the improvements observed, as there was no placebo control group and patients knew they were receiving treatment. The 67% response rate may reflect placebo effect, natural variation, or regression to the mean rather than true drug efficacy. Findings cannot be generalized beyond this specific population or extended to patients with different B12 baseline levels.
Tags
Symptom:Cognitive DysfunctionFatigue
Biomarker:Blood Biomarker
Method Flag:PEM Not DefinedNo ControlsSmall SampleExploratory Only