Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial.
BACKGROUND
In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain.


METHODS
We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery.


RESULTS
Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04).


CONCLUSIONS
Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance.


BACKGROUND
This study was registered at ClinicalTrials.gov. # NCT00279513.
Singer
Shepherd R
SR
The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
Amit-Kohn
Michal
M
Department of Orthopedics, Shaare Zedek Medical Center, Jerusalem, Israel.
Weiss
Samuel
S
Department of Orthopedics, Shaare Zedek Medical Center, Jerusalem, Israel.
Rosenblum
Jonathan
J
Department of Orthopedics, Shaare Zedek Medical Center, Jerusalem, Israel.
Maoz
Guy
G
Department of Orthopedics, Meir Medical Center, Kfar Saba, Israel.
Samuels
Noah
N
Biostatistics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel Hashomer, Israel.
Lukasiewicz
Esther
E
Biostatistics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel Hashomer, Israel.|Faculty of Life Sciences, Bar-Ilan University, Ramat-Gan, Israel.
Freedman
Laurence
L
Biostatistics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel Hashomer, Israel.
Paltiel
Ora
O
Department of Hematology, Hadassah University Hospital, and Hebrew University Hadassah School of Public Health, Jerusalem, Israel.
Itzchaki
Menachem
M
Department of Orthopedics, Shaare Zedek Medical Center, Jerusalem, Israel.
Niska
Meir
M
The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
Oberbaum
Menachem
M
The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006215:Hallux Valgus / Q000188:drug therapy* / Q000601:surgery*; D006705:Homeopathy; D006801:Humans; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000627:therapeutic use*; D010149:Postoperative Pain / Q000209:etiology / Q000517:prevention & control*; D010936:Plant Extracts / Q000627:therapeutic use*
D008903:Minerals; D010936:Plant Extracts; C433370:Traumeel S