By: DSM Pharma Solutions Editors
As one of the world’s most common ailments, low back pain is the leading cause of activity limitation and work absence, imposing a high economic burden on individuals, families, communities, industry, and governments. Recent research has highlighted the potential role of B-vitamins in addressing low back pain and improving global clinical outcomes.
As the second most frequent symptom-related reason for outpatient visits after the common cold, low back pain represents one of the most common ailments encountered in clinical practice, with a lifetime prevalence of up to 84%.1 Low back pain is also associated with absenteeism/presenteeism in the workplace, altered functional status, and lower health-related quality-of-life. Collectively, these symptoms profoundly impact mobility and the ability to perform activities of daily living (ADL), ultimately resulting in considerable economic and societal consequences.2,3,4
Currently established global clinical practice guidelines consistently recommend the use of acetaminophen as first-line and NSAIDs (e.g. ibuprofen, diclofenac and naproxen) as second-line treatments for low back pain.5 While both acetaminophen and NSAIDs have well-established efficacy and safety profiles, there exists a significant unmet need for patients who remain uncontrolled despite maximal therapy. Recent research has highlighted the potential role of vitamin B complex – defined in the literature as 1 mg of vitamin B12, 50-100 mg of vitamin B1 and 50-100 mg of vitamin B6 – as an adjunct to NSAID therapy in patients otherwise uncontrolled on their current therapeutic regimens and who may require intensification.[Ibid]
The DOLOR study, a randomized, double-blind study, assessed the efficacy and safety of twice-daily oral administration of either vitamin B complex combination therapy (group DB; 50 mg diclofenac + 50 mg vitamin B1, 50 mg vitamin B6 and 1 mg vitamin B12) or diclofenac monotherapy, (group D; 50mg diclofenac). After 3 days of treatment, a statistically significantly higher proportion of subjects in group DB (n = 87; 46.5%) than in group D (n = 55; 29%) terminated the study due to treatment success (χ2: 12.06; p = 0.0005). According to the study authors, combination therapy yielded superior results in pain reduction, improvement of mobility and functionality as assessed by the Visual Analog Pain Scale (VAS).6
A number of study post-hoc analyses further reinforce the utility of this adjunctive approach. For example, Geller et al. recently demonstrated a statistically significant correlation between VAS scores and FFD (finger-to-floor distance) scores in DOLOR, demonstrating the beneficial effect of adjunctive vitamin B complex on both mobility and pain intensity among patients presenting with low back pain. Geller et al. similarly demonstrated, using the Patient Functionality Questionnaire (PFQ), that patients receiving adjunctive vitamin B complex showed greater improvement than NSAIDs alone in areas related to sleep quality, mobility, ability to wash and dry, ability to walk distances, and posture comfort.7 A recent systematic meta-analysis by Marquez et al. largely confirms the aforementioned findings.5
While the exact mechanisms for vitamin B complex efficacy in the treatment of low back pain are still largely unknown, the prevailing hypothesis involves increasing afferent inhibitory control of nociceptive neurons at the spinal cord, improving sensory nerve conduction velocity and reducing neuronal hyperexcitability by altering sodium currents in injured dorsal root ganglia.8,9,10 In combination with NSAID therapy, this has the potential to produce profound synergistic effects.5
Recent research looks promising; yet, there is much to discover in the application of vitamin B complex for lower back pain management. Primarily, the subjective nature of pain, as well as the vast disparity in treatment responses to NSAIDs across various patient subgroups necessitate an individualized approach to both future research programs as well as clinical guidelines attempting to address this widespread clinical concern.
Working in pain management? Interested in enhancing your NSAID brand with B-vitamins in one combined line extension? Contact DSM’s Pharma Solutions team to learn more.
27 April 2018
10 min read
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 N. Manek et al. Epidemiology of Low Back Disorders. Curr Opin Rheumatol 2005;17:134-40.
 H. Breivik et al. Survey of Chronic Pain in Europe: Prevalence, Impact on Daily Life, and Treatment. Eur J Pain 2006;10:287-333.
 R. Froud et al. A Systematic Review and Meta-Synthesis of the Impact of Low Back Pain on People’s Lives. BMC Musculoskelet Disord 2014;15:50.
 N. Patrick et al. Acute and Chronic Low Back Pain. Med Clin North Am 2014;9:777-89.
 M. Marquez et al. Systemic Review on the Use of Diclofenac/B Complex as Anti-Inflammatory Treatment with Pain Relief Effect for Patients with Acute Lower Back Pain. J Pain Relief 2015;4(6):2-5.
 M. Mibielli et al. Diclofenac Plus B Vitamins Versus Diclofenac Monotherapy in Lumbago: the DOLOR Study. Curr Med Res Opin 2009;25(11):2589-2599.
 M. Geller et al. Impact of Low Back Pain on Quality of Life: Assessment by Patient Functionality Questionnaire and Treatment Results Using a Combination of Diclofenac plus B Vitamins or Diclofenac Monotherapy. Int J Clin Med 2016;7:113-119.
 Q. Fu et al. B Vitamins Suppress Spinal Dorsal Horn Nociceptive Neurons in the Cat. Neurosci Lett 1988;95:192-197.
 C. Jolivalt et al. B Vitamins Alleviate Indices of Neuropathic Pain in Diabetic Rats. Eur J Pharmacol 2009;612:41-47.
 X. Song et al. Thiamine Suppresses Thermal Hyperalgesia Inhibits Hyperexcitability, and Lessens Alterations of Sodium Currents in Injured Dorsal Root Ganglion Neurons in Rats. Anesthesiology 2009;110:387-400.