Evidence map›Paper›PMID 22114899›Full record

Trial reportBMC complementary and alternative medicine2011

Safety and effects of two mistletoe preparations on production of Interleukin-6 and other immune parameters - a placebo controlled clinical trial in healthy subjects.

Roman Huber, Holger Lüdtke, Johannes Wieber, Christiane Beckmann

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary and alternative medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01378702 (Safety and Immunological Effects of Iscucin Populi and Viscum Mali e Planta Tota in Healthy Volunteers), which is not on this map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
0.7field-weighted citation impact, top 31% of its field
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.

NCT01378702 phase1completednot on this map

Safety and Immunological Effects of Iscucin Populi and Viscum Mali e Planta Tota in Healthy Volunteers

TypeinterventionalSponsorUniversity Hospital FreiburgRan2008 to 2008Enrolled71ConditionsHealthy VolunteersArmsmistletoe preparations
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Systematic analysis of mistletoe prescriptions in clinical studies.Journal of cancer research and clinical oncology · 2023
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Mistletoe and Immunomodulation: Insights and Implications for Anticancer Therapies.Evidence-based complementary and alternative medicine : eCAM · 2019
    Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. New Therapy for Chronic Sarcoidosis withJournal of evidence-based integrative medicine
    Article
  16. Article
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

4 authors at 2 institutions in 1 country.

Roman HuberUni-Zentrum Naturheilkunde, University Medical Center Freiburg, Germany. roman.huber@uniklinik-freiburg.de
Holger Lüdtke
Johannes Wieber
Christiane Beckmann
University Medical Center Freiburg · DEWala Heilmittel (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Germany, Iscucin® Populi (IP), a preparation from mistletoe growing on the poplar tree, is used in cancer therapy while Viscum Mali e planta tota (VM), a preparation from mistletoe growing on the apple tree, is used in patients with osteoarthritis. Since mistletoe preparations are suspected to induce production of potentially tumor promoting cytokines like interleukin (IL)-6, further studies on the immunological effects are of interest.

methodsIn this 3-armed randomized, double blind clinical trial healthy volunteers received increasing doses of either IP (strength F, 0.0125%, G, 0.25% and H, 5%, each for 4 weeks), or VM (1:1000 [D3], 1:100 [D2] and 2% each for 4 weeks) or placebo (isotonic solution) subcutaneously twice per week over a period of 12 weeks. Physical examination was performed weekly. Routine laboratory parameters and immunological parameters (C-reactive protein (CRP), differential blood count, lymphocyte subsets, immunoglobulins, IL-6 and tumor necrosis factor (TNF)-α) were analysed every 4 weeks.

results71 subjects were included in the study (IP = 30, VM = 21, placebo = 20) of whom 69 concluded it according to protocol. Application of IP strengths G and H caused strong local reactions at the site of injection. In parallel, a distinct eosinophilia (p < 0.001 compared to placebo) occurred. Furthermore, application of all IP concentrations resulted in an increase of CD4 cell counts (p < 0.05) compared to placebo. Stimulation of IL-6 production, CRP or relevant deviations in other laboratory parameters were not observed. Because of local reactions, IP strengths G and H were considered less tolerable than placebo. VM 2% was slightly less tolerable than placebo, caused only mild local reactions and an only small increase in eosinophile counts.

conclusionTreatment with IP results in eosinophilia and an increase of CD4 cells but not in an increase of IL-6 or CRP. No safety concerns regarding the two mistletoe preparations have been raised by this study. EudraCT-Number 2007-002166-35.

trial registrationClinicalTrials.gov: NCT01378702.

Indexed as

AdolescentAdultFemaleHumansImmunityInterleukin-6MaleMiddle AgedMistletoePlant ExtractsYoung AdultInterleukin-6Plant Extracts

Identifiers

PMID22114899
PMCPMC3257204
OpenAlexW1982042130

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.