Clinical study of Tongdu Shujin decoction in the treatment of ankylosing spondylitis with cold-dampness obstruction type: Study protocol for a randomized controlled trial.

BACKGROUND: Ankylosing spondylitis (AS) has a high incidence, and severe cases can lead to spinal deformity and even joint fusion, which causes a huge burden on patients life, work and psychology. Tongdu Shujin decoction (TDSJ) has a definite effect in the treatment of ankylosing spondylitis, so we designed a randomized controlled trial to observe the efficacy of TDSJ in the treatment of AS, and to evaluate its safety. METHODS: In this randomized controlled trial, 80 eligible patients were randomly assigned in a 1:1 ratio to a treatment group TDSJ and a control group (celecoxib capsules in combination with thalidomide tablets) for 8 weeks. Visual analogue scale, bath ankylosing spondylitis disease activity index, bath ankylosing spondylitis functional index, and traditional Chinese medicine syndrome scores will be used as primary indicators. Erythrocyte sedimentation rate, C-reactive protein, spinal mobility (figure-ground distance, occipital tubercle-wall distance, Schober test) will be used as secondary indicators. Vital signs (respiration, heart rate, body temperature, blood pressure, electrocardiogram), blood routine, urine routine, stool routine, liver function, and renal function will be used as safety indicators. The primary and secondary indicators will be detected at 0th and 8th week, while safety indicators at 0th, 4th, and 8th week. DISCUSSION: This study will provide high-quality clinical evidence for the efficacy and safety of TDSJ in the treatment of AS.

Effects of 16-Form Wheelchair Tai Chi on the Autonomic Nervous System among Patients with Spinal Cord Injury.

OBJECTIVE: This study aims to investigate the effects of 16-form Wheelchair Tai Chi (WCTC16) on the autonomic nervous system among patients with spinal cord injury (SCI). METHODS: Twenty patients with chronic complete thoracic SCI were recruited. Equivital life monitoring system was used to record and analyze heart rate variability (HRV) of patients for five minutes before and after five consecutive sets of WCTC16, respectively. The analysis of HRV in the time domain included RR intervals, the standard deviation of all normal RR intervals (SDNN), and the root mean square of the differences between adjacent NN intervals (RMSSD). The analysis of HRV in the frequency domain included total power (TP), which could be divided into very-low-frequency area (VLFP), low-frequency area (LFP), and high-frequency area (HFP). The LF/HF ratio as well as the normalized units of LFP (LFPnu) and HFP (HFPnu) reflected the sympathovagal balance. RESULTS: There was no significant difference in RR interval, SDNN, RMSSD, TP, HEP, VLFP, and LFP of SCI patients before and after WCTC16 exercise (P > 0.05). LFPnu and HF peak decreased, while HFPnu and LF/HF increased in SCI patients after WCTC16 exercise. The differences were statistically significant (P < 0.001). CONCLUSION: WCTC16 can enhance vagal activity and decrease sympathetic activity so that patients with chronic complete thoracic SCI can achieve the balanced sympathovagal tone.