No effect of a homoeopathic combination of Arnica montana and Bryonia alba on bleeding, inflammation, and ischaemia after aortic valve surgery
Article first published online: 5 NOV 2009
Journal compilation © 2010 The British Pharmacological Society. No claim to original French government works
British Journal of Clinical Pharmacology
Volume 69, Issue 2, pages 136–142, February 2010
How to Cite
Cornu, C., Joseph, P., Gaillard, S., Bauer, C., Vedrinne, C., Bissery, A., Melot, G., Bossard, N., Belon, P. and Lehot, J.-J. (2010), No effect of a homoeopathic combination of Arnica montana and Bryonia alba on bleeding, inflammation, and ischaemia after aortic valve surgery. British Journal of Clinical Pharmacology, 69: 136–142. doi: 10.1111/j.1365-2125.2009.03574.x
- Issue published online: 21 JAN 2010
- Article first published online: 5 NOV 2009
- Received 15 June 2009Accepted12 October 2009
- cardiac surgery;
- cardiopulmonary bypass;
- homoeopathic treatment;
- myocardial ischaemia
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• Arnica and other homoeopathic extracts have been used in various obstetrical, surgical and postsurgical conditions in attempts to control inflammation, swelling and haemorrhage with controversial results.
• However, no homoeopathic combination with haemostatic and anti-inflammatory properties has been used in cardiac surgery that is often followed by haemorrhage and involves substantial systemic inflammation.
• In this setting, exudation and blood loss are precisely quantified.
WHAT THIS STUDY ADDS
• A homoeopathic combination of Arnica montana and Bryonia alba was used in aortic valve surgery in a prospective double-blind, randomized, placebo-controlled clinical trial to evaluate its effectiveness.
• This combination did not show any benefit in avoiding bleeding, pain, inflammation, and myocardial ischaemia.
Arnica montana is a popular homoeopathic treatment with potential haemostatic and anti-inflammatory properties. A homoeopathic combination of A. montana and Bryonia alba was used in aortic valve surgery to evaluate its effectiveness in reducing bleeding, inflammation, pain and myocardial ischaemia.
One day before surgery, 92 adult patients were randomly assigned to a double-blind parallel trial with either homoeopathic granules or a matching placebo until 4 days after surgery. The primary outcome was the volume of blood/liquid in the drains at their removal. The secondary outcomes included postoperative blood/liquid losses at 12 and 24 h as well as C-reactive protein (CRP), pain, temperature and plasma troponin Ic.
At 12 h and 24 h after surgery, then at drain removal, blood losses in homoeopathy and placebo groups were not statistically significant (362 ± 218, 520 ± 269 and 640 ± 297 ml vs. 456 ± 440, 620 ± 477 and 796 ± 717 ml; P= 0.19, 0.23 and 0.35, respectively). The statistical modelling did not show significantly different patterns of CRP, troponin and body temperature changes or of pain perception. The number of transfused packed red cells was not significantly different either (P= 0.58). Two patients from each group died during the study period and the number of serious adverse events was not statistically different (six in homoeopathy vs. 10 in placebo groups; Fisher's exact test P= 0.41).
In the study setting, there was no evidence of effects of A. montana and B. alba combination on bleeding, inflammation, pain or myocardial ischaemia.