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

S. F. Sencer; T. Zhou; L. S. Freedman; J. A. Ives; Z. Chen; D. Wall; M. L. Nieder; S. A. Grupp; L. C. Yu; I. Sahdev; W. B. Jonas; J. D. Wallace; M. Oberbaum

doi:10.1038/bmt.2012.30

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

S. F. Sencer, T. Zhou, L. S. Freedman, J. A. Ives, Z. Chen, D. Wall, M. L. Nieder, S. A. Grupp, L. C. Yu, I. Sahdev, W. B. Jonas, J. D. Wallace, M. Oberbaum

Research output: Contribution to journal › Article › peer-review

37 Scopus citations

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 325 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) (P0.13). 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.

Original language	English
Pages (from-to)	1409-1414
Number of pages	6
Journal	Bone Marrow Transplantation
Volume	47
Issue number	11
DOIs	https://doi.org/10.1038/bmt.2012.30
State	Published - Nov 2012
Externally published	Yes

Bibliographical note

Funding Information:
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.

Funding

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.

Funders	Funder number
CCOP	U10 CA98543, U10 CA95861, U10 CA98413
National Institutes of Health
National Cancer Institute	U10CA098543

Keywords

SCT
Traumeel S
mucositis

Access to Document

10.1038/bmt.2012.30

Cite this

Sencer, S. F., Zhou, T., Freedman, L. S., Ives, J. A., Chen, Z., Wall, D., Nieder, M. L., Grupp, S. A., Yu, L. C., Sahdev, I., Jonas, W. B., Wallace, J. D., & Oberbaum, M. (2012). Traumeel S in preventing and treating mucositis in young patients undergoing SCT: A report of the Children's Oncology Group. Bone Marrow Transplantation, 47(11), 1409-1414. https://doi.org/10.1038/bmt.2012.30

@article{4084b88d996645c9bfb37da392ab2c7c,

title = "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 325 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) (P0.13). 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.",

keywords = "SCT, Traumeel S, mucositis",

author = "Sencer, {S. F.} and T. Zhou and Freedman, {L. S.} and Ives, {J. A.} and Z. Chen and D. Wall and Nieder, {M. L.} and Grupp, {S. A.} and Yu, {L. C.} and I. Sahdev and Jonas, {W. B.} and Wallace, {J. D.} and M. Oberbaum",

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

year = "2012",

month = nov,

doi = "10.1038/bmt.2012.30",

language = "אנגלית",

volume = "47",

pages = "1409--1414",

journal = "Bone Marrow Transplantation",

issn = "0268-3369",

publisher = "Nature Publishing Group",

number = "11",

}

Sencer, SF, Zhou, T, Freedman, LS, Ives, JA, Chen, Z, Wall, D, Nieder, ML, Grupp, SA, Yu, LC, Sahdev, I, Jonas, WB, Wallace, JD & Oberbaum, M 2012, 'Traumeel S in preventing and treating mucositis in young patients undergoing SCT: A report of the Children's Oncology Group', Bone Marrow Transplantation, vol. 47, no. 11, pp. 1409-1414. https://doi.org/10.1038/bmt.2012.30

TY - JOUR

T1 - Traumeel S in preventing and treating mucositis in young patients undergoing SCT

T2 - A report of the Children's Oncology Group

AU - Sencer, S. F.

AU - Zhou, T.

AU - Freedman, L. S.

AU - Ives, J. A.

AU - Chen, Z.

AU - Wall, D.

AU - Nieder, M. L.

AU - Grupp, S. A.

AU - Yu, L. C.

AU - Sahdev, I.

AU - Jonas, W. B.

AU - Wallace, J. D.

AU - Oberbaum, M.

N1 - Funding Information: 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.

PY - 2012/11

Y1 - 2012/11

N2 - 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 325 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) (P0.13). 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.

AB - 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 325 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) (P0.13). 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.

KW - SCT

KW - Traumeel S

KW - mucositis

UR - http://www.scopus.com/inward/record.url?scp=84869097692&partnerID=8YFLogxK

U2 - 10.1038/bmt.2012.30

DO - 10.1038/bmt.2012.30

M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???

C2 - 22504933

AN - SCOPUS:84869097692

SN - 0268-3369

VL - 47

SP - 1409

EP - 1414

JO - Bone Marrow Transplantation

JF - Bone Marrow Transplantation

IS - 11

ER -

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

Abstract

Bibliographical note

Funding

Keywords

Access to Document

Other files and links

Fingerprint

Cite this