Proof of Effectiveness: Arnica 30x after Knee Surgery
by Johannes Wilkens, Dr. Johann Hunger, Unfallchirurgische Abteilung, Klinkum Kulmbach
07/95 - 03/99
In three randomised double-blind, placebo controlled clinical trials the efficacy of homeopathic Arnica after knee surgery was evaluated by means of swelling, pain and drainage fluid. Three indications for knee surgery were studied: simple knee arthroscopy for diagnostic purpose, implantation of artificial knee joints, rupture of cruciate ligaments
From November 1996 until December 1997 227 patients with arthroscopy, 35 patients with artificial knee joints and 57 patients with cruciate ligamnet ruptures (all aged between 18 to 75) were included in the studies. Primary outcome parameter was swelling, secondary outcome criteria: pain, drainage fluid.
Methods
The change of swelling was measured as the ratio from the first postoperative day to baseline in arthroscopies and from the second postoperative day to baseline in both other indications. Pain was assessed on a 10 cm visual analogue scale. Further secondary outcomes were the total amount of drainage fluid, changes of various laboratory parameters and number of unexpected events.
Baseline measurements were taken the day before surgery. At least two hours prior to surgery all patients were administered 5 globules of Arnica or placebo. The same dose was given three times on the same day following surgery and on each subsequent day of follow up. Arthroscopies were observed for 2 days, cruciate ligament ruptures for 8 days and artificial knee joints for 11 days.
Results
The knee circumferences in any group (either verum or placebo) does not show any relevant swelling after arthroscopy.
Whereas the situation after artificial knee joint implantation is different. Here the average swelling in the placebo group is 4,6% but only 2,9% in the verum group. After cruciate ligament ruptures the mean changes are 4,8% under placebo treatment and 3,1% in the verum group. From statistical point of view the observed differences between placebo and Arnica treatment are significant only after cruciate ligament ruptures (the corresponding p-value is 0,204).
The effect pattern on pain is similar to that on swelling, but is not statistically significant. There is a tendency in favour of verum in all indications.
All results are not affected by the intake of analgesics.
The total amount of drainage fluid does not differ between placebo and verum groups.
Noted differences in laboratory parameters and in unexpected events are not consistent and do not offer any conclusions on aspects of safety.
Conclusions
The studies show a high internal and external validity. The choice of the outcome criterion is questionable as -from the patients point of view- pain plays the more important role after surgery and not swelling. Taking into consideration the results of previous clinical studies on Arnica, we assume that combining Arnica with other homeopathic remedies, i.e. Hypericum, will prove to be more efficacious in reducing pain.
Arnica 30DH after knee surgery: Three randomised double-blind clinical trials
fact. Abstract. 1998: 3(4): 190.
Lüdtke R, Wilkens J
Klinische Wirksamkeitsstudien zu Arnica in homöopathischen Zubereitungen
In: Albrecht H, Frühwald M, eds. Jahrbuch der Karl und Veronica Carstens-Stiftung, Band 5 (1998). Essen: KVC; 1999: 97-112.
Wilkens J, Lüdtke R, Hunger J
Prüfplan der Studie: Arnica D30 nach Knie-OP (Zusammenfassung)
In: Albrecht H, Frühwald M, eds. Jahrbuch der Karl und Veronica Carstens-Stiftung, Band 3 (1996). Stuttgart: Hippokrates; 1997: 215-218.
info@carstens-stiftung.de