No effect of a homoeopathic combination of Arnica montana and Bryonia alba on bleeding, inflammation, and ischaemia after aortic valve surgery.
OBJECTIVE
" 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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
In the study setting, there was no evidence of effects of A. montana and B. alba combination on bleeding, inflammation, pain or myocardial ischaemia.
Cornu
Catherine
C
INSERM, CIC 201, Lyon, Hospices Civils de Lyon, Service de Pharmacologie Clinique, Lyon, Université de Lyon, Lyon and CNRS, UMR 5558, Lyon, France. catherine.cornu@chu-lyon.fr
Joseph
Pierre
P
Gaillard
Ségolène
S
Bauer
Christian
C
Vedrinne
Catherine
C
Bissery
Alvine
A
Melot
Ghislaine
G
Bossard
Nadine
N
Belon
Philippe
P
Lehot
Jean-Jacques
JJ
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D018650:Arnica; D029772:Bryonia; D006348:Cardiac Surgical Procedures / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy*; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D007249:Inflammation / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000188:drug therapy*; D010149:Postoperative Pain / Q000188:drug therapy; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000188:drug therapy*; D019106:Postoperative Hemorrhage / Q000188:drug therapy; D012044:Regression Analysis; D016896:Treatment Outcome
D010936:Plant Extracts