Skip to main content
Top
Published in: BMC Clinical Pharmacology 1/2010

Open Access 01-12-2010 | Research article

Traumeel S® for pain relief following hallux valgus surgery: a randomized controlled trial

Authors: Shepherd R Singer, Michal Amit-Kohn, Samuel Weiss, Jonathan Rosenblum, Guy Maoz, Noah Samuels, Esther Lukasiewicz, Laurence Freedman, Ora Paltiel, Menachem Itzchaki, Meir Niska, Menachem Oberbaum

Published in: BMC Clinical Pharmacology | Issue 1/2010

Login to get access

Abstract

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
Appendix
Available only for authorised users
Literature
1.
go back to reference Rawal N, Hylander J, Nydahl PA, Olofsson I, Gupta A: Survey of postoperative analgesia following ambulatory surgery. Acta Anaesthesiol Scand. 1997, 41: 1017-22. 10.1111/j.1399-6576.1997.tb04829.x.CrossRefPubMed Rawal N, Hylander J, Nydahl PA, Olofsson I, Gupta A: Survey of postoperative analgesia following ambulatory surgery. Acta Anaesthesiol Scand. 1997, 41: 1017-22. 10.1111/j.1399-6576.1997.tb04829.x.CrossRefPubMed
2.
go back to reference Beauregard L, Pomp A, Choiniere M: Severity and impact of pain after day surgery. Can J Anaesth. 1998, 45: 304-11. 10.1007/BF03012019.CrossRefPubMed Beauregard L, Pomp A, Choiniere M: Severity and impact of pain after day surgery. Can J Anaesth. 1998, 45: 304-11. 10.1007/BF03012019.CrossRefPubMed
3.
go back to reference Chung F, Ritchie E, Su J: Postoperative pain in ambulatory surgery. Anesth Analg. 1997, 85: 808-16. 10.1097/00000539-199710000-00017.CrossRefPubMed Chung F, Ritchie E, Su J: Postoperative pain in ambulatory surgery. Anesth Analg. 1997, 85: 808-16. 10.1097/00000539-199710000-00017.CrossRefPubMed
4.
go back to reference McHugh GA, Thomas GMM: The management of pain following day-case surgery. Anaesthesia. 2002, 57: 266-83. 10.1046/j.1365-2044.2002.2366_2.x.CrossRef McHugh GA, Thomas GMM: The management of pain following day-case surgery. Anaesthesia. 2002, 57: 266-83. 10.1046/j.1365-2044.2002.2366_2.x.CrossRef
5.
go back to reference Rocchi A, Chung F, Forte L: Canadian survey of postsurgical pain and pain medication experiences. Can J Anaesth. 2002, 49: 1053-6. 10.1007/BF03017901.CrossRefPubMed Rocchi A, Chung F, Forte L: Canadian survey of postsurgical pain and pain medication experiences. Can J Anaesth. 2002, 49: 1053-6. 10.1007/BF03017901.CrossRefPubMed
6.
go back to reference Huang N, Cunningham F, Laurito CE, Chen C: Can we do better with postoperative pain management?. Am J Surg. 2001, 182 (5): 440-8. 10.1016/S0002-9610(01)00766-8.CrossRefPubMed Huang N, Cunningham F, Laurito CE, Chen C: Can we do better with postoperative pain management?. Am J Surg. 2001, 182 (5): 440-8. 10.1016/S0002-9610(01)00766-8.CrossRefPubMed
7.
go back to reference Chung F: Home-readiness after ambulatory surgery. Anesth Analg. 2002, 80: 896-902. 10.1097/00000539-199505000-00008. Chung F: Home-readiness after ambulatory surgery. Anesth Analg. 2002, 80: 896-902. 10.1097/00000539-199505000-00008.
8.
go back to reference Coley KC, Williams BA, DaPos SV, Chen C, Smith RB: Retrospective evaluation of unanticipated admissions and readmissions after same day surgery and associated costs. J Clin Anesth. 2002, 14: 349-53. 10.1016/S0952-8180(02)00371-9.CrossRefPubMed Coley KC, Williams BA, DaPos SV, Chen C, Smith RB: Retrospective evaluation of unanticipated admissions and readmissions after same day surgery and associated costs. J Clin Anesth. 2002, 14: 349-53. 10.1016/S0952-8180(02)00371-9.CrossRefPubMed
9.
go back to reference Ghosh S, Sallam S: Patient satisfaction and postoperative demands on hospital and community services. Br J Surg. 1994, 81: 1635-8. 10.1002/bjs.1800811124.CrossRefPubMed Ghosh S, Sallam S: Patient satisfaction and postoperative demands on hospital and community services. Br J Surg. 1994, 81: 1635-8. 10.1002/bjs.1800811124.CrossRefPubMed
10.
go back to reference McGrath B, Elgendy H, Chung F, Kamming D, Curti B, King S: Thirty percent of patients have moderate to severe pain 24 h after ambulatory surgery: a survey of 5,703 patients. Can J Anaesth. 2004, 51: 886-91. 10.1007/BF03018885.CrossRefPubMed McGrath B, Elgendy H, Chung F, Kamming D, Curti B, King S: Thirty percent of patients have moderate to severe pain 24 h after ambulatory surgery: a survey of 5,703 patients. Can J Anaesth. 2004, 51: 886-91. 10.1007/BF03018885.CrossRefPubMed
11.
go back to reference Dolin SJ, Cashman JN, Bland JM: Effectiveness of acute postoperative pain management. I. Evidence from published data. Br J Anaesth. 2002, 89: 409-23. 10.1093/bja/aef207.CrossRefPubMed Dolin SJ, Cashman JN, Bland JM: Effectiveness of acute postoperative pain management. I. Evidence from published data. Br J Anaesth. 2002, 89: 409-23. 10.1093/bja/aef207.CrossRefPubMed
12.
go back to reference Thiel W, Borho B: Die Therapie von frischen, traumatischen Blutergüssen der Kniegelenke (Hämarthros) mit Traumeel N Injektionslösung. Biol Med. 1991, 20: 506-15. [German] Thiel W, Borho B: Die Therapie von frischen, traumatischen Blutergüssen der Kniegelenke (Hämarthros) mit Traumeel N Injektionslösung. Biol Med. 1991, 20: 506-15. [German]
13.
go back to reference Bohmer D, Ambrus P: Behandlung von Sportverletzungen mit Traumeel-Salbe-Kontrollierte Doppelblindstudie. Biol Med. 1992, 21: 260-8. [German] Bohmer D, Ambrus P: Behandlung von Sportverletzungen mit Traumeel-Salbe-Kontrollierte Doppelblindstudie. Biol Med. 1992, 21: 260-8. [German]
14.
go back to reference Mergen H: Behandlung einer post mit Traumeel. Ein Beitrag zur "Dosisefekt" eines Kombinationspraeparates. Munch Med Wochenschr. 1969, 111: 298-300. [German]PubMed Mergen H: Behandlung einer post mit Traumeel. Ein Beitrag zur "Dosisefekt" eines Kombinationspraeparates. Munch Med Wochenschr. 1969, 111: 298-300. [German]PubMed
15.
go back to reference Zell J, Connert WD, Mau J, Feuerstake G: Behandlung von akuten Sprunggelenksdistorsionen. Fortschr Med. 1988, 106: 96-100. [German]PubMed Zell J, Connert WD, Mau J, Feuerstake G: Behandlung von akuten Sprunggelenksdistorsionen. Fortschr Med. 1988, 106: 96-100. [German]PubMed
16.
go back to reference Schneider C, Klein P, Stolt P, Oberbaum M: A homeopathic ointment preparation compared with 1% diclofenac gel for acute symptomatic treatment of tendinopathy. Explore. 2005, 1 (6): 446-52. 10.1016/j.explore.2005.08.010.CrossRefPubMed Schneider C, Klein P, Stolt P, Oberbaum M: A homeopathic ointment preparation compared with 1% diclofenac gel for acute symptomatic treatment of tendinopathy. Explore. 2005, 1 (6): 446-52. 10.1016/j.explore.2005.08.010.CrossRefPubMed
17.
go back to reference Vorstoffel E: Behandlung eines Spinalsyndromes mit paravertebrale Traumeelinfiltrationen. Munch Med Wochenschr. 1971, 113: 440-3. [German]PubMed Vorstoffel E: Behandlung eines Spinalsyndromes mit paravertebrale Traumeelinfiltrationen. Munch Med Wochenschr. 1971, 113: 440-3. [German]PubMed
18.
go back to reference Oberbaum M, Yaniv I, Ben-Gal Y, Stein J, Ben-Zvi N, Freedman LS, Branski D: A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S® in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation. Cancer. 2001, 92: 684-90. 10.1002/1097-0142(20010801)92:3<684::AID-CNCR1371>3.0.CO;2-#.CrossRefPubMed Oberbaum M, Yaniv I, Ben-Gal Y, Stein J, Ben-Zvi N, Freedman LS, Branski D: A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S® in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation. Cancer. 2001, 92: 684-90. 10.1002/1097-0142(20010801)92:3<684::AID-CNCR1371>3.0.CO;2-#.CrossRefPubMed
19.
go back to reference Porozov S, Cahalon L, Weiser M, Branski D, Lider O, Oberbaum M: Inhibition of IL-1beta and TNF-alpha secretion from resting and activated human immunocytes by the homeopathic medication Traumeel S®. Clin Dev Immunol. 2004, 11: 143-9. 10.1080/10446670410001722203.CrossRefPubMedPubMedCentral Porozov S, Cahalon L, Weiser M, Branski D, Lider O, Oberbaum M: Inhibition of IL-1beta and TNF-alpha secretion from resting and activated human immunocytes by the homeopathic medication Traumeel S®. Clin Dev Immunol. 2004, 11: 143-9. 10.1080/10446670410001722203.CrossRefPubMedPubMedCentral
20.
go back to reference Singer SR, Amit-Kohn M, Weiss S, Rosenblum J, Lukasiewiczc E, Itzchaki M, Oberbaum M: Efficacy of a homeopathic preparation in control of post-operative pain-A pilot clinical trial. Acute Pain. 2007, 9: 7-12. 10.1016/j.acpain.2006.11.005.CrossRef Singer SR, Amit-Kohn M, Weiss S, Rosenblum J, Lukasiewiczc E, Itzchaki M, Oberbaum M: Efficacy of a homeopathic preparation in control of post-operative pain-A pilot clinical trial. Acute Pain. 2007, 9: 7-12. 10.1016/j.acpain.2006.11.005.CrossRef
21.
go back to reference Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001, 357: 1191-4. 10.1016/S0140-6736(00)04337-3.CrossRefPubMed Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001, 357: 1191-4. 10.1016/S0140-6736(00)04337-3.CrossRefPubMed
22.
go back to reference Pollak R, Raymond GA, Jay RM, Hillstrom HJ, Mahan KT, Riff D, Jacobs EL, Brown MT, Verburg KM: Analgesic efficacy of valdecoxib for acute postoperative pain after bunionectomy. J Am Podiatr Med Assoc. 2006, 96 (5): 393-407.CrossRefPubMed Pollak R, Raymond GA, Jay RM, Hillstrom HJ, Mahan KT, Riff D, Jacobs EL, Brown MT, Verburg KM: Analgesic efficacy of valdecoxib for acute postoperative pain after bunionectomy. J Am Podiatr Med Assoc. 2006, 96 (5): 393-407.CrossRefPubMed
23.
go back to reference Desjardins PJ, Black PM, Daniels S, Bird SR, Fitzgerald BJ, Petruschke RA, Tershakovec A, Chang DJ: A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Curr Med Res Opin. 2004, 20 (10): 1523-37. 10.1185/030079904X3069.CrossRefPubMed Desjardins PJ, Black PM, Daniels S, Bird SR, Fitzgerald BJ, Petruschke RA, Tershakovec A, Chang DJ: A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Curr Med Res Opin. 2004, 20 (10): 1523-37. 10.1185/030079904X3069.CrossRefPubMed
24.
go back to reference Aasboe V, Raeder JC, Groegaard B: Betamethasone reduces postoperative pain and nausea after ambulatory surgery. Anesth Analg. 1998, 87 (2): 319-23. 10.1097/00000539-199808000-00015.PubMed Aasboe V, Raeder JC, Groegaard B: Betamethasone reduces postoperative pain and nausea after ambulatory surgery. Anesth Analg. 1998, 87 (2): 319-23. 10.1097/00000539-199808000-00015.PubMed
25.
go back to reference Gaston MS, Simpson AHRW: Inhibition of fracture healing. J Bone Joint Surg Br. 2007, 89-B: 1553-1560. 10.1302/0301-620X.89B12.19671.CrossRef Gaston MS, Simpson AHRW: Inhibition of fracture healing. J Bone Joint Surg Br. 2007, 89-B: 1553-1560. 10.1302/0301-620X.89B12.19671.CrossRef
26.
go back to reference Thipphawong JB, Babul N, Morishige RJ, Findlay HK, Reber KR, Millward GJ, Otulana BA: Analgesic efficacy of inhaled morphine in patients after bunionectomy surgery. Anesthesiology. 2003, 99 (3): 693-700. 10.1097/00000542-200309000-00026.CrossRefPubMed Thipphawong JB, Babul N, Morishige RJ, Findlay HK, Reber KR, Millward GJ, Otulana BA: Analgesic efficacy of inhaled morphine in patients after bunionectomy surgery. Anesthesiology. 2003, 99 (3): 693-700. 10.1097/00000542-200309000-00026.CrossRefPubMed
Metadata
Title
Traumeel S® for pain relief following hallux valgus surgery: a randomized controlled trial
Authors
Shepherd R Singer
Michal Amit-Kohn
Samuel Weiss
Jonathan Rosenblum
Guy Maoz
Noah Samuels
Esther Lukasiewicz
Laurence Freedman
Ora Paltiel
Menachem Itzchaki
Meir Niska
Menachem Oberbaum
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Clinical Pharmacology / Issue 1/2010
Electronic ISSN: 1472-6904
DOI
https://doi.org/10.1186/1472-6904-10-9

Other articles of this Issue 1/2010

BMC Clinical Pharmacology 1/2010 Go to the issue