Evaluation of the efficacy of complex analgesic therapy, including a combination of B vitamins, in patients with combination of osteoarthritis and chronic non-specific low back pain (results of an open-label pilot clinical trial)

The vitamin B₁, B₆ and B₁₂ complex (VBC) is frequently used to treat acute and chronic low back pain.

Objective: to investigate the effect of a combination of a non-steroidal anti-inflammatory drug (NSAID) and a VBC on the main manifestations of nociceptive system dysfunction in patients with combination of osteoarthritis (OA) and chronic non-specific low back pain (NSLBP).

Material and methods. The study group consisted of 99 patients (82% women, mean age 63.6±17.2 years) with OA of various localization and

NSLBP who had moderate to severe pain (≥4 on a numerical rating scale, NRS 0–10). All patients received etoricoxib 60 mg/day (up to 14 days) and a course of intramuscular (IM) injections of VBC (a drug for parenteral administration containing solutions of thiamine 100 mg, pyridoxine 100 mg, cyanocobalamin 1.0 mg and lidocaine 20 mg) 2.0 ml №10. Treatment outcome was assessed after 14 days.

Results and discussion. During treatment, the vast majority of patients showed a significant improvement: the median severity of pain on movement (NRS) decreased from 6.3 [5.0; 8.0] to 3.7 [3.0; 5.0], p=0.0001; functional impairment  –  from 3.8 [2.0; 6.0] to 2.2 [1.0; 3.0], p=0.001; fatigue – from 5.6 [4.0; 8.0] to 3.5 [0.0; 2.0], p=0.0001. 71.6% of patients rated the treatment results as good or excellent. Six patients had adverse reactions: 2 – local pain at the site of the intramuscular injections, 1 – arterial hypertension, 3 – epigastric pain. No serious adverse events were recorded.

Conclusion. The combined use of NSAIDs and VBC can provide significant improvement in patients with a combination of OA and NSLBP.

1. Nasonov EL, Yakhno NN, Karateev AE, et al. General principles of treatment for musculoskeletal pain: Interdisciplinary consensus. Nauchno-Prakticheskaya Revmatologiya. 2016; 54(3):247-265 (In Russ.)].

2. Veronese N, Cooper C, Bruyere O, et al. Multimodal Multidisciplinary Management of Patients with Moderate to Severe Pain in Knee Osteoarthritis: A Need to Meet Patient Expectations. Drugs. 2022 Sep;82(13): 1347-1355. doi: 10.1007/s40265-022-01773-5. Epub 2022 Sep 16.

3. Trouvin AP, Perrot S. Pain in osteoarthritis.Implications for optimal management. Joint Bone Spine. 2018 Jul;85(4):429-434. doi: 10.1016/j.jbspin.2017.08.002. Epub 2017 Sep 6.

4. Moore RA, Moore OA, Derry S, et al. Responder analysis for pain relief and numbers needed to treat in a meta-analysis of etoricoxib osteoarthritis trials: bridging a gap between clinical trials and clinical practice. Ann Rheum Dis. 2010 Feb;69(2):374-9. doi: 10.1136/ard.2009.107805. Epub 2009 Apr 12.

5. Moore AR, Smugar SS, Wang H, et al. Numbers-needed-to-treat analyses-do timing, dropouts, and outcome matter? Pooled analysis of two randomized, placebo-controlled chronic low back pain trials. Pain. 2010 Dec; 151(3):592-597. doi: 10.1016/j.pain.2010.07.013.

6. Paez-Hurtado AM, Calderon-Ospina CA,Nava-Mesa MO. Mechanisms of action of vitamin B1 (thiamine), B6 (pyridoxine), and B12 (cobalamin) in pain: a narrative review. Nutr Neurosci. 2023 Mar;26(3):235-253. doi: 10.1080/1028415X.2022.2034242.

7. Karaganis S, Song XJ. B vitamins as a treatment for diabetic pain and neuropathy. J Clin Pharm Ther. 2021 Oct;46(5):1199-1212. doi: 10.1111/jcpt.13375. Epub 2021 Feb 9.

8. Sambon M, Wins P, Bettendorff L. Neuroprotective Effects of Thiamine and Precursors with Higher Bioavailability: Focus on Benfotiamine and Dibenzoylthiamine. Int J Mol Sci. 2021 May 21;22(11):5418. doi: 10.3390/ijms22115418.

9. Calderуn-Ospina CA, Nava-Mesa MO. B Vitamins in the nervous system: Current knowledge of the biochemical modes of action and synergies of thiamine, pyridoxine, and cobalamin. CNS Neurosci Ther. 2020 Jan; 26(1):5-13. doi: 10.1111/cns.13207. Epub 2019 Sep 6.

10. Barinov AN, Makhinov KA, Komarova OA. Preliminary results of the open multicenter all-Russian observation "MINERVA" (MILGAMMA in diseases of the nervous system and Algic syndromes). Russkii meditsinskii zhurnal. 2016;(24):1650-1656. (In Russ.)].

11. Parfenov VA. Treatment of acute non-specific back pain, the use of group B vitamins. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, neuropsychiatry, psychosomatics. 2022;14(6):98-102. (In Russ.)]. doi: 10.14412/2074-2711-2022-6-98-102.

12. Yu CZ, Liu YP, Liu S, et al. Systematicadministration of B vitamins attenuates neuropathic hyperalgesia and reduces spinal neuron injury following temporary spinal cord ischaemia in rats. Eur J Pain. 2014 Jan;18(1): 76-85. doi: 10.1002/j.1532-2149.2013.00390.x. Epub 2013 Sep 5.

13. Kopruszinski CM, Reis RC, Bressan E, et al. Vitamin B complex attenuated heat hyperalgesia following infraorbital nerve constriction in rats and reduced capsaicin in vivo and in vitro effects. Eur J Pharmacol. 2015 Sep 5;762:326-32. doi: 10.1016/j.ejphar.2015.05.063. Epub 2015 Jun 3.

14. Zolio L, Lim KY, McKenzie JE, et al. Systematic review and meta-analysis of the prevalence of neuropathic-like pain and/or pain sensitization in people with knee and hip osteoarthritis. Osteoarthritis Cartilage. 2021 Aug;29(8):1096-1116. doi: 10.1016/j.joca.2021.03.021. Epub 2021 May 8.

15. Schuttert I, Timmerman H, Petersen KK,et al. The Definition, Assessment, and Prevalence of (Human Assumed) Central Sensitisation in Patients with Chronic Low Back Pain: A Systematic Review. J Clin Med. 2021 Dec 17; 10(24):5931. doi: 10.3390/jcm10245931.

16. Ponce-Monter HA, Ortiz MI, Garza-Hernandez AF, et al. Effect of diclofenac with B vitamins on the treatment of acute pain originated by lower-limb fracture and surgery. Pain Res Treat. 2012;2012:104782. doi: 10.1155/2012/104782. Epub 2011 Oct 31.

17. Garza AF, Monroy-Maya R, Soto-Rios M,et al. A pilot study of the effect of diclofenac with B vitamins for the treatment of acute pain following lower-limb fracture and surgery. Proc West Pharmacol Soc. 2008;51:70-2.

18. Kim S. Overview of Clinical study design.Clin Exp Emerg Med. 2023 Jun 2. doi: 10.15441/ceem.23.036.

19. You S. Perspective and future of evidencebased medicine. Stroke Vasc Neurol. 2016 Dec 19;1(4):161-164. doi: 10.1136/svn-2016000032.

20. Bosdriesz JR, Stel VS, van Diepen M, et al. Evidence-based medicine-When observational studies are better than randomized controlled trials. Nephrology (Carlton). 2020 Oct;25(10):737-743. doi: 10.1111/nep.13742. Epub 2020 Jul 2.

21. Mahendraratnam N, Mercon K, Gill M,et al. Understanding Use of Real-World Data and Real-World Evidence to Support Regulatory Decisions on Medical Product Effectiveness. Clin Pharmacol Ther. 2022 Jan;111(1): 150-154. doi: 10.1002/cpt.2272. Epub 2021 Jul 2.

22. Suri P, Morgenroth DC, Kwoh CK, et al.Low back pain and other musculoskeletal pain comorbidities in individuals with symptomatic osteoarthritis of the knee: data from the osteoarthritis initiative. Arthritis Care Res (Hoboken). 2010 Dec;62(12):1715-23. doi: 10.1002/acr.20324.

23. Coates G, Clewes P, Lohan C, et al. Chronic Low Back Pain with and without Concomitant Osteoarthritis: A Retrospective, Longitudinal Cohort Study of Patients in England. Int J Clin Pract. 2023 Nov 9;2023:5105810. doi: 10.1155/2023/5105810.

24. Calderon-Ospina CA, Nava-Mesa MO,Arbelaez Ariza CE. Effect of Combined Diclofenac and B Vitamins (Thiamine, Pyridoxine, and Cyanocobalamin) for Low Back Pain Management: Systematic Review and Metaanalysis. Pain Med. 2020 Apr 1;21(4):766-781. doi: 10.1093/pm/pnz216.

25. Mibielli MA, Geller M, Cohen JC, et al.Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study. Curr Med Res Opin. 2009 Nov;25(11):2589-99. doi: 10.3111/13696990903246911.

26. Magaсa-Villa MC, Rocha-Gonzalez HI,Fernandez del Valle-Laisequilla C, et al. B-vitamin mixture improves the analgesic effect of diclofenac in patients with osteoarthritis: a double blind study. Drug Res (Stuttg). 2013 Jun;63(6):289-92. doi: 10.1055/s-00331334963.

27. Dehghan M. Comparative effectiveness ofB and e vitamins with diclofenac in reducing pain due to osteoarthritis of the knee. Med Arch. 2015 Apr;69(2):103-6. doi: 10.5455/medarh.2015.69.103-106