TY - JOUR
T1 - Traumeel S®for pain relief following hallux valgus surgery
T2 - A randomized controlled trial
AU - Singer, Shepherd R.
AU - Amit-Kohn, Michal
AU - Weiss, Samuel
AU - Rosenblum, Jonathan
AU - Maoz, Guy
AU - Samuels, Noah
AU - Lukasiewicz, Esther
AU - Freedman, Laurence
AU - Paltiel, Ora
AU - Itzchaki, Menachem
AU - Niska, Meir
AU - Oberbaum, Menachem
PY - 2010/4/12
Y1 - 2010/4/12
N2 - 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.Method: 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.Trial Registration: This study was registered at ClinicalTrials.gov. # NCT00279513.
AB - 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.Method: 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.Trial Registration: This study was registered at ClinicalTrials.gov. # NCT00279513.
UR - http://www.scopus.com/inward/record.url?scp=77950635253&partnerID=8YFLogxK
U2 - 10.1186/1472-6904-10-9
DO - 10.1186/1472-6904-10-9
M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???
C2 - 20380750
AN - SCOPUS:77950635253
SN - 1472-6904
VL - 10
JO - BMC Clinical Pharmacology
JF - BMC Clinical Pharmacology
M1 - 9
ER -