Evidence map›Paper›PMID 22504933›Full record

Trial reportBone marrow transplantation2012

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 and 3 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Bone marrow transplantation, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00080873 (A Randomized Double Blind Placebo Controlled Clinical Trial to Assess the Efficacy of Traumeel® S), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00080873 nacompletednot on this map

A Randomized Double Blind Placebo Controlled Clinical Trial to Assess the Efficacy of Traumeel® S (IND#66649) for the Prevention and Treatment of Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation

TypeinterventionalSponsorChildren's Oncology GroupRan2004 to 2011Enrolled195ConditionsKidney Cancer, Leukemia, Lymphoma, NeuroblastomaArmsTraumeel S, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Oral Mucositis: Melatonin Gel an Effective New Treatment.International journal of molecular sciences · 2017
    Review
  9. Herbs in Oral Mucositis.Journal of clinical and diagnostic research : JCDR · 2017
    Review
  10. Article
  11. Review
  12. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

S F SencerDepartment of Hematology/Oncology, Children's Hospitals and Clinics of Minnesota, Minneapolis, MN 55404, USA. Susan.Sencer@childrensmn.org
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

Funding

COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI DEVIDAS, MEENAKSHI · 2003 to 2013
$67.5M
Community Clinical Oncology Program Research BaseU10CA095861 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI POLLOCK, BRAD H · 2002 to 2013
$19.5M
NCI NIH HHS U10 CA095861NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA95861NCI NIH HHS U10 CA98413NCI NIH HHS U10 CA98543
6 · The paper itself

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.

Indexed as

AdolescentAdultChildChild, PreschoolDouble-Blind MethodFemaleHematopoietic Stem Cell TransplantationHomeopathyHumansMaleMineralsMucositisPlant ExtractsTreatment OutcomeYoung AdultMineralsPlant ExtractsTraumeel S

Identifiers

PMID22504933
PMCPMC4008329

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.