A Randomised Placebo Controlled Trial to Assess the Immunomodulatory effects of Arsenicum Album in Fifty Millesimal potency on Pro-inflammatory Cytokines in Paediatric Asthmatic Wheeze
DOI:
https://doi.org/10.48165/ahr.2026.11.3.5Keywords:
Arsenicum album, LM potency, TNF-α, IL-1α, paediatric asthma, immunomodulation, cytokines, homoeopathy, randomised controlled trialAbstract
Background: Childhood asthma is a leading chronic condition globally characterised by airway inflammation driven by pro-inflammatory cytokines including Tumour Necrosis Factor-alpha (TNF-α) and Interleukin-1 alpha (IL-1α). Homoeopathic Arsenicum album has been proposed to possess immunomodulatory properties, yet objective cytokine-level evidence in children is lacking.
Objectives: To evaluate the effect of Arsenicum album in successive Fifty Millesimal (LM) potency on serum TNF-α and IL-1α levels in children aged 2–5 years with asthmatic wheeze.
Methods: A randomised, single-blind, two-parallel arm, placebo-controlled trial was conducted at Sarada Krishna Homoeopathic Medical College Hospital, Tamil Nadu, India (January 2022–June 2023). One hundred and two participants were randomised 1:1 to receive Arsenicum album LM potency (10 drops twice daily) or identical placebo for 12 months. Serum TNF-α and IL-1α were quantified by sandwich ELISA (Diaclone, France) at baseline and at three months. Statistical analysis employed Wilcoxon signed-rank test and unpaired t-test (SPSS v22.0); significance was set at p < 0.05.
Results: Serum TNF-α declined significantly in the intervention group from 108.63 ± 156.77 pg/ml to 30.58 ± 56.15 pg/ml (mean reduction 78.06 pg/ ml; t = 4.345, p = 0.0001), while the control group exhibited a significant rise from 36.89 ± 29.80 to 54.88 ± 45.15 pg/ml (p = 0.0022). The between group difference was highly significant (t = 4.127, p < 0.0001). IL-1α similarly declined in the intervention group from 63.96 ± 65.56 to 21.55 ± 20.70 pg/ml (mean reduction 42.41 pg/ml; t = 2.968, p = 0.0046), whereas the control group showed an increase from 73.58 ± 63.73 to 93.95 ± 98.83 pg/ml (t = 3.791, p = 0.0004). Between-group comparison confirmed a highly significant difference (t = 4.876, p < 0.0001).
Conclusion: Arsenicum album in LM potency produced a statistically significant and clinically meaningful reduction in serum TNF-α and IL-1α in children with asthmatic wheeze, providing objective evidence of its immunomodulatory potential. The findings support its consideration as an adjunctive anti-inflammatory intervention in paediatric asthma management.
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