Abstract
BACKGROUND: Lumbar disc herniation (LDH) is mainly caused by annular fiber disruption with a discrete leakage of nucleus pulposus pressing on a nerve, resulting in back pain and radiating pain. Most patients with LDH can be treated conservatively, but there are many different conservative treatments. Furthermore, most previous studies did not evaluate the long-term efficacy of these treatments and the prognosis. Therefore, an effective and safe therapeutic strategy is lacking for patients with LDH. In this study, we evaluated Xiao Sui Hua He decoction (XSHHD) in the treatment of LDH. METHODS: This was a rigorous prospective observational 3-year follow-up study. We recruited 69 participants with ruptured lumbar disc herniation (RLDH) between February 2014 and February 2016. Patients took XSHHD orally twice a day for 6 months. The primary outcome measurements were visual analogue scale (VAS) pain score, Oswestry disability index (ODI) and straight leg raising test (SLRT). The secondary outcome measurements was nucleus pulposus protrusion volume on magnetic resonance imaging (MRI). Clinical outcomes were measured at baseline (Visit 1), and at 3, 6, 12, and 36 months (Visit 2, 3, 4, and 5, respectively).. RESULTS: Sixty-three patients were followed-up for 3 years after treatment. SLRT and ODI after non-surgical treatment improved significantly compared with baseline (P < .001). There were no statistically significant differences at 6 months vs 36 months for SLRT and ODI. VAS scores (leg, back) after 3 years of treatment were statistically significantly different compared with baseline (P < .001; Z = - 6.93, - 6.637). The baseline protrusion volume was 2018.61 ± 601.16 mm(3), and the volume decreased significantly to 996.51 ± 387.42 mm3 at 36 months (t = 12.863; P < .001). The volume of protrusion resorption rate (VPRR) at 36 months was 47.24 ± 23.99%, with significant resorption in 23 cases, partial resorption in 23 cases, no resorption in 15 cases, and increased volume in 2 cases. CONCLUSIONS: This study showed that non-surgical treatment with XSHHD was effective, and the study clarified the natural outcomes in LDH.