SUMMARY: 78 patients with ankylosing spondylitis (AS) were randomly divided into the treatment group (39 subjects) and the control group (39 subjects). All subjects met the diagnostic criteria of the “1984 Modified New York Criteria for AS” according to the American College of Rheumatology, as well as the diagnostic criteria of cold-damp obstruction type of AS according to the “Guiding Principle of Clinical Research on New Drugs of Traditional Chinese Medicine (Trial)”. The main symptoms of cold-damp obstruction type of AS include: Lumbar and sacral pain, spinal pain, restricted lumbar range of motion, morning stiffness aggravated by cold and alleviated by heat; associated symptoms include: cold and painful joints in the extremities with heavy sensation, pale tongue with white coating, pulse slippery and wiry. There was no statistically significant difference between the two groups in terms of gender, age, and course of disease (P>0.05), and the two groups were therefore comparable. In the control group, subjects received 7.5mg meloxicam tablets once a day. In the treatment group, subjects received Modified Du Huo Ji Sheng Decoction 150ml twice a day after meal; the ingredients included: Du Huo 10g (獨活 Radix Angelicae Pubescentis), Sang Ji Sheng 10g (桑寄生 Ramulus Taxilli), Niu Xi 10g (牛膝Radix Achyranthis Bidentatae), Du Zhong 10g (杜仲 Cortex Eucommiae), Qin Jiao 10g (秦艽 Radix Gentianae Macrophyllae), Fu Ling 10g (茯苓 Poria), Fang Feng 10g (防風 Radix Ledebouriellae), Chuan Xiong 6g (川芎 Rhizoma Ligustici Chuanxiong), Dang Gui 10g (當歸 Radix Angelicae Sinensis), Sheng Di Huang 10g (生地黃 Radix Rehmanniae), Dan Shen 10g (丹參 Radix Salviae Miltiorrhizae), Chi Shao 10g (赤芍 Radix Paeoniae Rubra), Rou Gui 3g (肉桂 Cortex Cinnamomi), Xi Xin 3g (細辛 Herba Asari), and Gan Cao 3g (甘草 Radix Glycyrrhizae). Course of treatment was 8 weeks for both groups. To assess the efficacy of treatment, the visual analog scale (VAS), Traditional Chinese Medicine Syndrome Score (TCMSS), duration of morning stiffness, finger-to-floor distance, ESR (Erythrocyte sedimentation rate) and CRP (C-reactive protein) were monitored. A subject was considered as: 1). Cured: pain resolved or basically resolved, TCMSS reduced by ≥ 95%; 2). Markedly effective: significant improvement in pain, TCMSS reduced by ≥ 70% but < 95%; 3). Effective: pain improved and TCMSS reduced by ≥ 30% but <70%; Ineffective: no improvement or exacerbation in pain, TCMSS reduced by <30%. Total effective rate = cured rate + markedly effective rate + effective rate.
Table 1. Comparison of Treatment Efficacy between
Treatment and Control Group (n, %)
| Group | n | Cured | Markedly Effective | Effective | Ineffective | Total Effective Rate |
| Treatment | 39 | 15 (38.4) | 18 (46.2) | 4 (10.3) | 2 (5.1) | 37 (94.9) 1) |
| Control | 39 | 9 (23.1) | 15 (38.4) | 6 (15.4) | 9 (23.1) | 30 (76.9) |
After 8 weeks of treatment, the treatment group showed a more significant improvement in VAS, TCMSS, duration of morning stiffness, finger-to-floor distance, ESR, and CRP (P<0.05). The total effective rate for treatment group was 94.9%, which was significantly higher compare to the control group (76.9%). Modified Du Huo Ji Sheng Decoction may be beneficial due to its anti-inflammatory, analgesic and vasodilation effect, and can therefore reduce pain and improve quality of life and prognosis for patient with cold-damp obstruction type of AS.
Pan Cainin, et al. Fujian Journal of TCM. 2020. 51 (6): 76-77