Bee venom acupuncture for chronic low back pain: A randomised, sham-controlled, triple-blind clinical trial

Aim: The aim of this trial was to determine whether bee venom acupuncture (BVA) is more effective than a sham control in reducing pain and disability in subjects suffering from chronic low back pain. Participants and methods: The trial design was a randomised, sham-controlled, triple-blind, two-group parallel clinical trial. After screening, 60 participants were randomly divided into the BVA group or sham control group (normal saline injection: NSI). Both groups were treated twice a week for 4 weeks; 6 acupoints (BL23, BL24 and BL25 on bilateral sides) were injected with 0.1 ml BVA or normal saline, respectively. The primary outcome measurement was the change in pain intensity (as measured with the visual analogue scale: VAS), and the secondary outcomes were assessed using the Oswestry Disability Questionnaire (ODQ) for disability and the SF-36 questionnaire for quality of life. Results: Both groups had significant improvements in pain intensity, ODQ, and SF-36 from baseline levels. Measurements of pain intensity showed a statistically significant difference in the VAS score in favour of BVA over control at the 8th treatment (p = 0.0087). However, there was no significant difference between the two groups in either the ODQ and SF-36 measurements. All adverse reactions disappeared spontaneously without medical interventions. Conclusions: These results suggest that BVA is effective for treating chronic low back pain and appears to be a safe therapy. Future trials need to consider more effective controls and blinding. (C) 2012 Elsevier GmbH. All rights reserved.