Clinical Efficacy and Safety of a Modified Moxibustion Therapy for Low Back Pain in Lumbar Disc Herniation: A Two-Center, Randomized, Controlled, Non-Inferiority Trial

Abstract

Objective: Our pilot study shows that a modified moxibustion therapy called Ma’s bamboo-based medicinal moxibustion can alleviate the symptoms of low back pain in lumbar disc herniation (LDH), and has the potential to treat LDH. The aim of this study is to evaluate the efficacy and safety of Ma’s bamboo-based medicinal moxibustion for low back pain in LDH. Methods: A total of 312 LDH patients with low back pain were randomized to receive Ma’s bamboo-based medicinal moxibustion (MBMM) or acupuncture (AT). The primary efficacy measure was the change of Visual Analogue Scale (VAS) on the 14th day compared with that at baseline. The secondary efficacy measures included VAS score, Oswestry disability index (ODI), modified Japanese Orthopaedic Association (M-JOA) score, and the content of β-endorphin (β-EP) and substance-P (SP). The safety measures included the occurrence of adverse events and the changes in laboratory indicators. Results: In total, 304 patients were incorporated for the analysis of efficacy, including 96 males and 208 females, aged 21–65 years. There was no statistically significant difference in the change of VAS score between the two groups on the 14th day [mean difference (95% CI) = −2.31 (−2.48, −2.13) and −2.28 (−2.45, −2.11), respectively; p = 0.819]. The VAS, ODI, and M-JOA scores changed after the intervention in both groups (p <0.001), with increased β-EP content (p = 0.014, p = 0.032) and decreased SP content (p <0.001, p = 0.048). The ODI score (p = 0.039) and M-JOA score (p = 0.032) of the MBMM group on the 28th day were lower than those of the AT group. Conclusion: The efficacy of Ma’s bamboo-based medicinal moxibustion therapy in relieving low back pain of LDH patients is comparable to that of acupuncture, and it has post-effect advantages in improving lumbar dysfunction and daily living ability, which can be used as a safe and effective alternative method for LDH treatment.