Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Pediatric Transplants

Traumeel S in preventing and treating mucositis in young patients undergoing SCT: a report of the Children's Oncology Group

Abstract

Mucositis can be a serious complication of hematopoietic SCT (HSCT). A previous phase II trial in 32 children undergoing HSCT reported a beneficial effect of the homeopathic remedy Traumeel S. The Children's Oncology Group sought to replicate the results in a multi-institutional trial. The study was an international multi-center, double-blind, randomized trial comparing Traumeel with placebo in patients aged 3–25 years undergoing myeloablative HSCT. Traumeel/placebo was started on Day −1 as a five-time daily mouth rinse. Efficacy of the treatment was assessed using the modified Walsh scale for mucositis, scored daily from Day −1 to 20 days after HCST. The main outcome was the sum of Walsh scale scores (area-under-the-curve (AUC)) over this period. Other outcomes included narcotic use, days of total parenteral feeding, days of nasogastric feeding and adverse events. In 181 evaluable patients, there was no statistical difference in mucositis (AUC) in the Traumeel group (76.7) compared with placebo (67.3) (P=0.13). There was a trend towards less narcotic usage in the Traumeel patients. No statistically beneficial effect from Traumeel was demonstrated for mucositis. We could not confirm that Traumeel is an effective treatment for mucositis in children undergoing HSCT.

This is a preview of subscription content

Access options

Buy article

Get time limited or full article access on ReadCube.

$32.00

All prices are NET prices.

Figure 1

References

  1. Wilkes RW . Prevention and treatment of oral mucositis following cancer chemotherapy. Semin Oncol 1998; 25: 538–551.

    CAS  PubMed  Google Scholar 

  2. Elting LS, Cooksley C, Chambers M, Cantor SB, Manzullo E, Rubenstein EB et al. The burdens of cancer therapy: clinical and economic outcomes of chemotherapy-induced mucositis. Cancer 2003; 98: 1531–1539.

    Article  Google Scholar 

  3. Bonnaure-Mallet M, Bunetel L, Tricot-Doleux S, Guérin J, Bergeron C, LeGall E . Oral complications during treatment of malignant diseases in childhood: effects of tooth brushing. Eur J Cancer 1998; 34: 1588–1591.

    CAS  Article  Google Scholar 

  4. Childers NK, Stinnett AE, Wheeler P, Wright JT, Castleberry RP, Dasanayake AP . Oral complications in children with cancer. Oral Surg Oral Med Oral Pathol 1993; 75: 41–47.

    CAS  Article  Google Scholar 

  5. Sonis ST . Mucositis as a biological process: a new hypothesis for the development of chemotherapy-induced stomatotoxicity. Oral Oncol 1998; 34: 39–43.

    CAS  Article  Google Scholar 

  6. Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M et al. Perspectives on cancer therapy-induced mucosal injury. Pathogenesis, measurement, epidemiology, and consequences for patients. Cancer 2004; 100(Suppl 9): 1995–2025.

    Article  Google Scholar 

  7. Treister N, Sonis S . Mucositis: biology and management. Curr Opin Otolaryngol Head Neck Surg 2007; 15: 123–129.

    Article  Google Scholar 

  8. Sonis ST, Oster G, Fuchs H . Oral mucositis and the clinical economic outcomes of hematopoietic stem-cell transplantation. J Clin Oncol 2001; 19: 2201–2205.

    CAS  Article  Google Scholar 

  9. Ruescher TJ, Sodeifi A, Scrivani SJ, Kaban LB, Sonis ST . The impact of mucositis on alpha-hemolytic streptococcal infection in patients undergoing autologous bone marrow transplantation for hematologic malignancies. Cancer 1998; 82: 2275–2281.

    CAS  Article  Google Scholar 

  10. Rapoport AP, Miller Watelet LF, Linder T, Eberly S, Raubertas RF, Lipp J et al. Analysis of factors that correlate with mucositis in recipients of autologous and allogeneic stem-cell transplants. J Clin Oncol 1999; 17: 2446–2453.

    CAS  Article  Google Scholar 

  11. Rubenstein EB, Peterson DE, Schubert M, Keefe D, McGuire D, Epstein J et al. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer 2004; 100 (Suppl 9): 2026–2046.

    Article  Google Scholar 

  12. Barnes PM, Bloom B, Nahin R . CDC National Health Statistics Report no. 12, Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007. December 10, 2008..

  13. Harris P, Rees R . The prevalence of complementary and alternative medicine use among the general population: a systematic review of the literature. Complement Ther Med 2000; 8: 88–96.

    CAS  Article  Google Scholar 

  14. Thomas KJ, Nicholl JP, Coleman P . Use and expenditure on complementary medicine in England: a population based survey. Complement Ther Med 2001; 9: 2–11.

    CAS  Article  Google Scholar 

  15. Cheung CK, Wyman JF, Halcon LL . Use of complementary and alternative therapies in community-dwelling older adults. J Altern Complement Med 2007; 13: 997–1006.

    Article  Google Scholar 

  16. Molassiotis A, Browall M, Milovics L, Panteli V, Patiraki E, Fernandez-Ortega P . Complementary and alternative medicine use in patients with gynecological cancers in Europe. Int J Gynecol Cancer 2006; 16 (Suppl 1): 219–224.

    Article  Google Scholar 

  17. Hyodo I, Amano N, Eguchi K, Narabayashi M, Imanishi J, Hirai M et al. Nationwide survey on complementary and alternative medicine in cancer patients in Japan. J Clin Oncol 2005; 23: 2645–2654.

    Article  Google Scholar 

  18. Chrystal K, Allan S, Forgeson G, Isaacs R . The use of complementary/alternative medicine by cancer patients in a New Zealand regional cancer treatment centre. NZ Med J 2003; 116: U296.

    Google Scholar 

  19. Yates J, Mustian M, Morrow GR, Gillies LJ, Padmanaban D, Atkins JN et al. Prevalence of complementary and alternative medicine user in cancer patients during treatment. Support Care Cancer 2005; 13: 806–811.

    Article  Google Scholar 

  20. Kelly KM, Jacobson JS, Kennedy DD, Braudt SM, Mallick M, Weiner MA . Use of unconventional therapies by children with cancer at an urban medical center. J Pediatr Hematol Oncol 2000; 22: 412–416.

    CAS  Article  Google Scholar 

  21. Bold J, Leis A . Unconventional therapy use among children with cancer in Saskatchewan. J Pediatr Oncol Nurs 2001; 18: 16–25.

    CAS  Article  Google Scholar 

  22. Bishop F, Prescott P, Chan YK, Saville J, von Elm E, Lewith GT . Prevalence of complementary medicine use in pediatric cancer: a systematic review. Pediatrics 2010; 125: 768–776.

    Article  Google Scholar 

  23. Martel D, Bussières JF, Théorêt Y, Lebel D, Kish S, Moghrabi A et al. Use of alternative and complementary therapies in children with cancer. Pediatric Blood & Cancer 2005; 44: 660–668.

    Article  Google Scholar 

  24. Neuhouser ML, Patterson RE, Schwartz SM, Hedderson MM, Bowen DJ, Standish LJ . Use of alternative medicine by children with cancer in Washington State. Prev Med 2001; 33: 347–354.

    CAS  Article  Google Scholar 

  25. Gagnon EM, Recklitis CJ . Parents’ decision-making preferences in pediatric oncology: the relationship to health care involvement and complementary therapy use. Psycho-oncology 2003; 12: 442–452.

    Article  Google Scholar 

  26. Sencer SF, Kelly KM . Complementary and alternative therapies in pediatric oncology. Pediatr Clin North Am 2007; 54: 1043–1060.

    Article  Google Scholar 

  27. Phipps S, Barrera M, Vannatta K, Xiong X, Doyle JJ, Alderfer MA . Complementary therapies for children undergoing stem cell transplantation: report of a multisite trial. Cancer 2010; 116: 3924–3933.

    Article  Google Scholar 

  28. Phipps S . Reduction of distress associated with paediatric bone marrow transplant: complementary health promotion interventions. Pediatr Rehabil 2002; 5: 223–234.

    Article  Google Scholar 

  29. Sahler OHJ, Hunter BC, Liesveld JL . The effect of using music therapy with relaxation imagery in the management of patients undergoing bone marrow transplantation: a pilot feasibility study. Altern Ther Health Med 2003; 9: 70–74.

    PubMed  Google Scholar 

  30. http://www.merriam-webster.com/dictionary/homeopathy (accessed in November 2008).

  31. Oberbaum M, Yaniv I, Ben-Gal Y, Stein J, Ben-Zvi N, Freedman LS et al. A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced mucositis in children undergoing stem cell transplantation. Cancer 2001; 92: 684–690.

    CAS  Article  Google Scholar 

  32. Institute of Medicine. Complementary and Alternative Medicine in the United States. National Academy Press: Washington, DC, ISBN 0-309-09270-1 2005.

  33. Foley KM . The treatment of cancer pain. N Engl J Med 1985; 313: 84–95.

    CAS  Article  Google Scholar 

  34. Walsh LJ, Hill G, Seymour G, Roberts A . A scoring system for the quantitative evaluation of oral mucositis during bone marrow transplantation. Spec Care Dentist 1990; 10: 190–195.

    CAS  Article  Google Scholar 

  35. World Health Organization Handbook for reporting results of cancer treatment (offset publication 48) World Health Organization: Geneva, 1979: 15–22.

  36. http://ctep.cancer.gov/forms/CTCAEv3.pdf (accessed on 3 December 2008).

  37. Wilcoxon F . Individual comparisons by ranking methods. Biometrics 1945; 1: 80–83.

    Article  Google Scholar 

  38. Little RJA, Rubin DB . Statistical Analysis with Missing Data, 2nd edn. Wiley: Hoboken NJ, 2002.

    Book  Google Scholar 

  39. Ives JA, Moffett JR, Arun P, Lam D, Todorov TI, Brothers AB, et al. Enzyme Stabilization by Glass-Derived Silicates in Glass-Exposed Aqueous Solutions. Homeopathy 2010; 99: 15–24.

    Article  Google Scholar 

  40. Shao J, Zhong B . Last observation carry-forward and last observation analysis. Stat Med 2003; 22: 2429–2441.

    Article  Google Scholar 

  41. Leon AC, Mallinckrodt CH, Chuang-Stein C, Archibald DG, Archer GE, Chartier K . Attrition in randomized clinical trials: methodological issues in psychopharmacology. Biol Psychiatry 2006; 59: 1001–1005.

    Article  Google Scholar 

  42. 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: 143–149.

    CAS  Article  Google Scholar 

  43. Lussignoli S, Bertani S, Metelmann H, Bellavite P, Conforti A . Effect of Traumeel S, a homeopathic formulation, on blood-induced inflammation in rats. Complement Ther Med 1999; 7: 225–230.

    CAS  Article  Google Scholar 

  44. Biologische Heilmittel Heel GmbH. Traumeel Product Monograph, 2nd ed. Baden-Baden: Germany, 2009.

Download references

Acknowledgements

This research is supported by the CCOP Grant U10 CA95861, Chair's Grant U10 CA98543 and the Statistics and Data Center Grant U10 CA98413 of the Children's Oncology Group from the National Cancer Institute, National Institutes of Health, Bethesda, MD, USA. The authors would also like to thank the CRA's and nurses of the participating COG institutions; they are the backbone of clinical research.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to S F Sencer.

Ethics declarations

Competing interests

Drs. Ives and Oberbaum previously had consulting relationships with Heel Incorporated, but currently none of the authors have any financial relationships with HEEL or any other conflicts.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Sencer, S., Zhou, T., Freedman, L. et al. Traumeel S in preventing and treating mucositis in young patients undergoing SCT: a report of the Children's Oncology Group. Bone Marrow Transplant 47, 1409–1414 (2012). https://doi.org/10.1038/bmt.2012.30

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/bmt.2012.30

Keywords

  • Traumeel S
  • mucositis
  • SCT

Further reading

Search

Quick links