No effect of a homoeopathic combination of Arnica montana and Bryonia alba on bleeding, inflammation, and ischaemia after aortic valve surgery.
- 2010-01-21
- British journal of clinical pharmacology 69(2)
- Catherine Cornu
- Pierre Joseph
- Ségolène Gaillard
- Christian Bauer
- Catherine Vedrinne
- Alvine Bissery
- Ghislaine Melot
- Nadine Bossard
- Philippe Belon
- Jean-Jacques Lehot
- PubMed: 20233176
- DOI: 10.1111/j.1365-2125.2009.03574.x
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- 92 adult patients
- Methods
- randomly assigned to a double-blind parallel trial with either homoeopathic granules or a matching placebo until 4 days after surgery
- Blinding
- Double-blind
- Duration
- until 4 days after surgery
Aims
" 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.Research Insights
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).
- Effect
- Neutral
- Effect size
- Small
The statistical modelling did not show significantly different patterns of CRP, troponin and body temperature changes or of pain perception.
- Effect
- Neutral
- Effect size
- Small
The statistical modelling did not show significantly different patterns of CRP, troponin and body temperature changes or of pain perception.
- Effect
- Neutral
- Effect size
- Small
The statistical modelling did not show significantly different patterns of CRP, troponin and body temperature changes or of pain perception.
- Effect
- Neutral
- Effect size
- Small
The number of transfused packed red cells was not significantly different either (P= 0.58).
- Effect
- Neutral
- Effect size
- Small
The statistical modelling did not show significantly different patterns of CRP, troponin and body temperature changes or of pain perception.
- Effect
- Neutral
- Effect size
- Small
Adverse Events Reported
Two patients from each group died during the study period
- Finding
- No significant difference
- Severity
- Serious adverse event
- Significant
- No
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)
- Finding
- No significant difference
- Severity
- Serious adverse event
- Significant
- No