A Pragmatic Randomized Controlled Trial on the Effectiveness and Safety of Pharmacopuncture for Chronic Lower Back Pain

References

• Vos T, Abajobir AA, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390(10100):1211–1259.
   PubMed Web of Science ®Google Scholar
• Costa L, Maher CG, Hancock MJ, McAuley JH, Herbert RD, Costa LO. The prognosis of acute and persistent low-back pain: a meta-analysis. CMAJ. 2012;184(11):E613–E624. doi:10.1503/cmaj.111271
   PubMed Web of Science ®Google Scholar
• Costa L, Maher CG, McAuley JH, et al. Prognosis for patients with chronic low back pain: inception cohort study. BMJ. 2009;339:b3829.
   PubMedGoogle Scholar
• Krismer M, Van Tulder M. Low back pain (non-specific). Best Pract Res. 2007;21(1):77–91. doi:10.1016/j.berh.2006.08.004
   Web of Science ®Google Scholar
• Qaseem A, Wilt TJ, McLean RM, Forciea MA. Physicians* CGCotACo. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017;166(7):514–530. doi:10.7326/M16-2367
   PubMed Web of Science ®Google Scholar
• Ekman M, Jönhagen S, Hunsche E, Jönsson L. Burden of illness of chronic low back pain in Sweden: a Cross-Sectional, Retrospective Study in primary care setting. Spine. 2005;30(15):1777–1785. doi:10.1097/01.brs.0000171911.99348.90
   PubMed Web of Science ®Google Scholar
• Sherman KJ, Cherkin DC, Connelly MT, et al. Complementary and alternative medical therapies for chronic low back pain: what treatments are patients willing to try? BMC Complement Altern Med. 2004;4:9. doi:10.1186/1472-6882-4-9
   PubMedGoogle Scholar
• Kim M-R, Lee SM, Lee YJ, Ha I-H. Clinical research on pharmacopuncture in Korea: a scoping review. Perspect Integr Med. 2023;2(1):8–23. doi:10.56986/pim.2023.02.003
   Google Scholar
• Li J, Zhang JH, Yi T, Tang WJ, Wang SW, Dong JC. Acupuncture treatment of chronic low back pain reverses an abnormal brain default mode network in correlation with clinical pain relief. Acupunct Med. 2014;32(2):102–108. doi:10.1136/acupmed-2013-010423
   PubMed Web of Science ®Google Scholar
• Xu Z-F, Hong S-H, Wang S-J, et al. Neuroendocrine-immune regulating mechanisms for the anti-inflammatory and analgesic actions of acupuncture. World J Trad Chin Med. 2020;6(4):384–392. doi:10.4103/wjtcm.wjtcm_41_20
   Google Scholar
• Lee YJ, Shin J-S, Lee J, et al. Usage report of pharmacopuncture in musculoskeletal patients visiting Korean medicine hospitals and clinics in Korea. BMC Complement Altern Med. 2016;16(1):292. doi:10.1186/s12906-016-1288-5
   PubMed Web of Science ®Google Scholar
• Shin Y-S, Shin J-S, Lee J, et al. A survey among Korea Medicine doctors (KMDs) in Korea on patterns of integrative Korean Medicine practice for lumbar intervertebral disc displacement: preliminary research for clinical practice guidelines. BMC Complement Altern Med. 2015;15(1):432. doi:10.1186/s12906-015-0956-1
   PubMed Web of Science ®Google Scholar
• Shin B-C, Kong JC, Park T-Y, Yang C-Y, Kang K-W, Choi S-M. Bee venom acupuncture for chronic low back pain: a randomised, sham-controlled, triple-blind clinical trial. Eur J Integr Med. 2012;4(3):e271–e280. doi:10.1016/j.eujim.2012.02.005
   Web of Science ®Google Scholar
• Seo B-K, Han K, Kwon O, Jo D-J, Lee J-H. Efficacy of bee venom acupuncture for chronic low back pain: a randomized, double-blinded, sham-controlled trial. J Toxins. 2017;9(11):361. doi:10.3390/toxins9110361
   PubMed Web of Science ®Google Scholar
• Ahn Y-J, Shin J-S, Lee J, et al. Evaluation of use and cost of medical care of common lumbar disorders in Korea: cross-sectional study of Korean health insurance review and assessment service national patient sample data. BMJ Open. 2016;6(9):e012432. doi:10.1136/bmjopen-2016-012432
   PubMed Web of Science ®Google Scholar
• Kim D-Y, Lee S-H, Lee H-Y, et al. Validation of the Korean version of the Oswestry disability index. Spine. 2005;30(5):E123–E127. doi:10.1097/01.brs.0000157172.00635.3a
   PubMed Web of Science ®Google Scholar
• Lee JS, Lee DH, Suh KT, Kim JI, Lim JM, Goh TS. Validation of the Korean version of the Roland–Morris disability questionnaire. Eur Spine J. 2011;20(12):2115–2119. doi:10.1007/s00586-011-1788-4
   PubMed Web of Science ®Google Scholar
• Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–158. doi:10.1016/S0304-3959(01)00349-9
   PubMed Web of Science ®Google Scholar
• Kim S-H, Jo M-W, Ahn J, Ock M, Shin S, Park J. Assessment of psychometric properties of the Korean SF-12 v2 in the general population. BMC Public Health. 2014;14(1):1086. doi:10.1186/1471-2458-14-1086
   PubMed Web of Science ®Google Scholar
• Kim S-H, Ahn J, Ock M, et al. The EQ-5D-5L valuation study in Korea. Qual Life Res. 2016;25(7):1845–1852. doi:10.1007/s11136-015-1205-2
   PubMed Web of Science ®Google Scholar
• Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007;60(12):1234–1238. doi:10.1016/j.jclinepi.2007.02.006
   PubMed Web of Science ®Google Scholar
• Jeong S-Y, Park Z-W, Shin J-M, Kim J-Y, Youn I-Y. The comparative study of effectiveness between acupuncture and its cotreatment with Calculus Bovis. Fel Ursi. Moschus pharmacopuncture on the treatment of acute low back pain. J Acupunct Res. 2011;28(4):105–110.
   Google Scholar
• Sung-hwan L, Min-wan K, Hyun L, So-yol L. Effectiveness of Bee-venom acupuncture and ouhyul herbal acupuncture in herniation of nucleus pulposus-comparison with acupuncture therapy only. J Korean Acupunct Moxibust Soc. 2007;24:197–205.
   Google Scholar
• Song H-G, Choe J-Y, Kang J-H, Lee H. The effect of the acupuncture therapy in combination with soyeom pharmacopuncture therapy on the improvement of the symptoms of the patients with herniated intervertebral disk of L-spine in his initial stage of hospitalization. J Pharmacopunct. 2009;12(4):111–118. doi:10.3831/KPI.2009.12.4.111
   Google Scholar
• Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine. 2008;33(1):90–94. doi:10.1097/BRS.0b013e31815e3a10
   PubMed Web of Science ®Google Scholar
• Maughan EF, Lewis JS. Outcome measures in chronic low back pain. Eur Spine J. 2010;19:1484–1494. doi:10.1007/s00586-010-1353-6
   PubMed Web of Science ®Google Scholar
• Lee YJ, Shin J-S, Lee J, et al. Survey of integrative lumbar spinal stenosis treatment in Korean medicine doctors: preliminary data for clinical practice guidelines. BMC Complement Altern Med. 2017;17:1–12. doi:10.1186/s12906-017-1942-6
   PubMed Web of Science ®Google Scholar
• Choi HS, Lee YJ, Kim M-R, et al. A survey of integrative treatment practices of Korean medicine doctors for cervical disc herniation: preliminary data for clinical practice guidelines. Evid Based Complement Altern Med. 2019;2019:1–14. doi:10.1155/2019/2345640
   Web of Science ®Google Scholar
• Park SH, Hong J-Y, Kim WK, et al. Effects of SHINBARO2 on rat models of lumbar spinal stenosis. Mediators Inflamm. 2019;2019:1–11. doi:10.1155/2019/7651470
   Web of Science ®Google Scholar
• Kim WK, Chung H-J, Pyee Y, et al. Effects of intra-articular SHINBARO treatment on monosodium iodoacetate-induced osteoarthritis in rats. Chin Med. 2016;11:1–10. doi:10.1186/s13020-016-0089-6
   PubMed Web of Science ®Google Scholar
• Brien S, Lewith GT, McGregor G. Devil’s Claw (Harpagophytum procumbens) as a treatment for osteoarthritis: a review of efficacy and safety. J Altern Complement Med. 2006;12(10):981–993. doi:10.1089/acm.2006.12.981
   PubMed Web of Science ®Google Scholar
• Chrubasik S, Zimpfer C, Schütt U, Ziegler R. Effectiveness of Harpagophytum procumbens in treatment of acute low back pain. Phytomedicine. 1996;3(1):1–10. doi:10.1016/S0944-7113(96)80003-1
   PubMed Web of Science ®Google Scholar
• Mahomed IM, Ojewole JA. Analgesic, antiinflammatory and antidiabetic properties of Harpagophytum procumbens DC (Pedaliaceae) secondary root aqueous extract. Phytother Res. 2004;18(12):982–989. doi:10.1002/ptr.1593
   PubMed Web of Science ®Google Scholar
• Andersen ML, Santos EH, Maria de Lourdes VS, da Silva AA, Tufik S. Evaluation of acute and chronic treatments with Harpagophytum procumbens on Freund’s adjuvant-induced arthritis in rats. J Ethnopharmacol. 2004;91(2–3):325–330. doi:10.1016/j.jep.2004.01.003
   PubMed Web of Science ®Google Scholar
• McGregor G, Fiebich B, Wartenberg A, Brien S, Lewith G, Wegener T. Devil’s claw (Harpagophytum procumbens): an anti-inflammatory herb with therapeutic potential. Phytochem Rev. 2005;4(1):47–53. doi:10.1007/s11101-004-2374-8
   Google Scholar
• Hong JY, Kim H, Lee J, Jeon W-J, Lee YJ, Ha I-H. Harpagophytum procumbens inhibits iron overload-induced oxidative stress through activation of Nrf2 signaling in a rat model of lumbar spinal stenosis. Oxid Med Cell Longev. 2022;2022:1–18. doi:10.1155/2022/3472443
   Web of Science ®Google Scholar
• Kim M-R, Shin J-S, Lee J, et al. Safety of acupuncture and pharmacopuncture in 80,523 musculoskeletal disorder patients: a retrospective review of internal safety inspection and electronic medical records. Medicine. 2016;95(18). doi:10.1097/MD.0000000000003635
   Web of Science ®Google Scholar