Evidence map›Paper›PMID 22087222›Full record

Trial reportPloS one2011

Efficacy of injections with Disci/Rhus toxicodendron compositum for chronic low back pain--a randomized placebo-controlled trial.

Daniel Pach, Benno Brinkhaus, Stephanie Roll, Karl Wegscheider, Katja Icke, Stefan N Willich, Claudia M Witt

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

Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00567736 (Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group), which is not on this map. Cited by 12 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 5 pooled it
4.7field-weighted citation impact, top 6% 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.

NCT00567736 phase3completednot on this map

Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2007 to 2009Enrolled150ConditionsChronic Low Back PainArmsDisci/Rhus toxicodendron comp.®, placebo solution
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 5 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Placebo effects in low back pain: A systematic review and meta-analysis of the literature.European journal of pain (London, England) · 2021 · on this map
    Pooled it
  2. Pooled it
  3. Herbal medicine for low-back pain.The Cochrane database of systematic reviews · 2014
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Disc cell therapies: critical issues.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2014
    Review
  12. 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

7 authors at 2 institutions in 2 countries.

Daniel PachInstitute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center Berlin, Berlin, Germany.
Benno Brinkhaus
Stephanie Roll
Karl Wegscheider
Katja Icke
Stefan N Willich
Claudia M Witt
Charité - Universitätsmedizin Berlin · DEUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effectiveness of injection therapy for low-back pain is still debatable. We compared the efficacy of local injections of the homeopathic preparation Disci/Rhus toxicodendron compositum (verum) with placebo injections and with no treatment in patients with chronic low back pain. METHODOLOGY/PRINCIPAL

findingsIn a randomized controlled partly double blind multicenter trial patients with chronic low back pain from 9 German outpatient clinics were enrolled and randomly allocated in a 1∶1∶1 ratio to receive subcutaneous injections (verum or placebo) into painful sites on the lower back over 12 treatment sessions within eight weeks, or no treatment (rescue pain medication with paracetamol or NSAIDs). All trial personnel and participants were masked to treatment allocation. The primary outcome measure was the average pain intensity over the last seven days on a visual analogue scale (0-100 mm, 0 = no pain, 100 = worst imaginable pain) after eight weeks. Follow-up was 26 weeks. Primary analysis was by intention to treat. Between August 2007 and June 2008, 150 patients were randomly allocated to three groups (51 verum, 48 placebo and 51 no treatment). The mean baseline-adjusted low back pain intensity at week eight was: verum group 37.0 mm (97.5% CI 25.3;48.8), no treatment group 53.0 (41.8;64.2), and placebo group 41.8 (30.1;53.6). The verum was significantly superior to no treatment (P = 0.001), but not to placebo (P = 0.350). No significant side effects were reported. CONCLUSIONS/SIGNIFICANCE: The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief.

trial registrationClinicalTrials.gov NCT00567736.

Indexed as

ToxicodendronAcetaminophenAdultAgedAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-SteroidalChronic DiseaseDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleGermanyHumansInjectionsLow Back PainMaleMiddle AgedAcetaminophenAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-SteroidalPlant Extracts

Identifiers

PMID22087222
PMCPMC3210748
OpenAlexW2019785637

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.