Homeopathy : the journal of the Faculty of Homeopathy · 2026
Homeopathy for Chronic Non-specific Low Back Pain: Randomised, Double-Blind, Crossover, Placebo-Controlled Clinical Trial Investigating the Efficacy of the Biotherapic Lumbar Vertebra (BIOVERT Trial).
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Adler Ubiratan Cardinalli, Adler Maristela Schiabel, Dias Deise Lilian Costa, Diniz José Nelson Martins, Grossi Manoela Gomes, Sugimoto Neli Aparecida Martins, Martinez Edson Zangiacomi
Аннотация
BACKGROUND: Chronic non-specific low back pain (CNSLBP) is a major cause of disability worldwide. Conventional pharmacological treatments offer limited benefits and carry potential risks, prompting interest in alternative approaches, including homeopathy.
OBJECTIVE: The objective of this study was to evaluate the short-term efficacy and safety of a standardised homeopathic biotherapic (Lumbar Vertebra, LM2 potency) for CNSLBP.
METHODS: A randomised, double-blind, crossover, placebo-controlled clinical trial was conducted with 120 participants diagnosed with CNSLBP. Participants received both the biotherapic and placebo in two treatment phases separated by a washout period. The primary outcome was pain intensity (numeric rating scale); secondary outcomes included functional disability (Oswestry Disability Index), adverse events and use of pain medications. Data were analysed using random effects generalised linear models.
RESULTS: Both the biotherapic and placebo interventions led to significant within-group reductions in pain and disability (p = 0.001 and p < 0.001 respectively). However, no statistically significant differences were observed between the two interventions for either outcome (pain: p = 0.435; disability: p = 0.840). The magnitude of change in pain intensity did not reach the pre-defined minimal clinically important difference (MCID), and mean pain scores at the study endpoint remained above the inclusion threshold. Adverse events were mild and comparable across groups.
CONCLUSION: No specific effect of the Lumbar Vertebra LM2 biotherapic was demonstrated. Improvements are likely due to non-specific effects such as the therapeutic environment, patient expectations and placebo response. Clinicians should consider the substantial role of non-specific responses in CNSLBP and avoid medications with unfavourable risk-benefit profiles.
OBJECTIVE: The objective of this study was to evaluate the short-term efficacy and safety of a standardised homeopathic biotherapic (Lumbar Vertebra, LM2 potency) for CNSLBP.
METHODS: A randomised, double-blind, crossover, placebo-controlled clinical trial was conducted with 120 participants diagnosed with CNSLBP. Participants received both the biotherapic and placebo in two treatment phases separated by a washout period. The primary outcome was pain intensity (numeric rating scale); secondary outcomes included functional disability (Oswestry Disability Index), adverse events and use of pain medications. Data were analysed using random effects generalised linear models.
RESULTS: Both the biotherapic and placebo interventions led to significant within-group reductions in pain and disability (p = 0.001 and p < 0.001 respectively). However, no statistically significant differences were observed between the two interventions for either outcome (pain: p = 0.435; disability: p = 0.840). The magnitude of change in pain intensity did not reach the pre-defined minimal clinically important difference (MCID), and mean pain scores at the study endpoint remained above the inclusion threshold. Adverse events were mild and comparable across groups.
CONCLUSION: No specific effect of the Lumbar Vertebra LM2 biotherapic was demonstrated. Improvements are likely due to non-specific effects such as the therapeutic environment, patient expectations and placebo response. Clinicians should consider the substantial role of non-specific responses in CNSLBP and avoid medications with unfavourable risk-benefit profiles.