Chronic low back pain: A randomised controlled multicenter trial comparing the local injection of Disci/Rhus toxicodendron comp.^® and placebo, and waiting list group

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• 作者：D. Pach ; B. Brinkhaus ; S. Roll ; K. Wegscheider ; K. Wruck ; C.M. Witt
• 刊名：European Journal of Integrative Medicine
• 出版年：2009
• 出版时间：December 2009
• 年：2009
• 卷：1
• 期：4
• 页码：213
• 全文大小：52 K

文摘

Background

The aim of the study was to investigate efficacy and safety of Disci/Rhus toxicodendron comp.^® in patients with chronic low back pain.

Methods

Patients with chronic low back pain were randomly assigned to Disci/Rhus toxicodendron comp.^® (n=51), placebo (saline solution, n=48), or a waiting list control (n=51). Physicians with different specialisation, in 9 outpatient centres, administered intervention in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks and 26 weeks. The primary outcome was the Visual Analogue Scale (VAS, 0–100) for the average pain of the last 7 days after 8 weeks. An ITT analysis using multilevel models adjusted for baseline values was performed.

Results

At total of 150 patients were enrolled from August 2007 to June 2008; eight patients were lost to follow-up at week 8, but were included in the final analysis. The mean baseline-adjusted VAS at week 8 was 37.02±4.38 (mean±se), 97.5 % CI [25.27; 48.77] in the verum group, 52.97±4.30 [41.75; 64.19] in the waiting list group, and 41.83±4.59 [30.09; 53.58] in the placebo group. Differences were significant between verum and waiting list group (p=0.001), but not between verum and placebo group (p=0.350). After 26 weeks differences between all groups were not significant. No significant side effects were observed.

Conclusion

Disci/Rhus toxicodendron comp.^® is a safe treatment. After 8 weeks Disci/Rhus toxicodendron comp.^® was superior to no treatment; however, no significant difference was observed between Disci/Rhus toxicodendron comp.^® and placebo.