Evidence map›Paper›PMID 21039759›Full record

Trial reportBritish journal of clinical pharmacology2010

Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting.

Marta Duran, Eulàlia Pérez, Sergio Abanades, Xavier Vidal, Cristina Saura, Margarita Majem, Edurne Arriola, Manel Rabanal, Antoni Pastor, Magí Farré and 3 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 11 pooled it
3.0field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 11 syntheses or guidelines pooled it, 154 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Efficacy of cannabinoids for the prophylaxis of chemotherapy-induced nausea and vomiting-a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  4. Pooled it
  5. MASCC guideline: cannabis for cancer-related pain and risk of harms and adverse events.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Guideline
  6. Pooled it
  7. Pooled it
  8. Pharmacological evidence of medicinal cannabis in oncology: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Pooled it
  9. Pooled it
  10. Marijuana use and motor vehicle crashes.Epidemiologic reviews · 2012
    Pooled it
  11. A Systematic Review on Cannabis Hyperemesis Syndrome and Its Management Options.Medical principles and practice : international journal of the Kuwait University, Health Science Centre
    Pooled it
  12. Trial
  13. Review
  14. Review
  15. Review
  16. Review
  17. Adverse events associated with the use of cannabis-based products in people living with cancer: a systematic scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  18. Hemp Extract (Pharmaceuticals (Basel, Switzerland) · 2024
    Article
  19. Review
  20. 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

13 authors at 8 institutions in 1 country.

Marta DuranFundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.
Eulàlia Pérez
Sergio Abanades
Xavier Vidal
Cristina Saura
Margarita Majem
Edurne Arriola
Manel Rabanal
Antoni Pastor
Magí Farré
Neus Rams
Joan-Ramon Laporte
Dolors Capellà
Universitat Autònoma de Barcelona · ESHospital Del Mar · ESDepartament de Salut · ESGovernment of Catalonia · ESHospital de Sant Pau · ESMunicipal Institute for Medical Research · ESSociedad Española de Farmacología Clínica · ESVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsDespite progress in anti-emetic treatment, many patients still suffer from chemotherapy-induced nausea and vomiting (CINV). This is a pilot, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the tolerability, preliminary efficacy, and pharmacokinetics of an acute dose titration of a whole-plant cannabis-based medicine (CBM) containing delta-9-tetrahydrocannabinol and cannabidiol, taken in conjunction with standard therapies in the control of CINV.

methodsPatients suffering from CINV despite prophylaxis with standard anti-emetic treatment were randomized to CBM or placebo, during the 120 h post-chemotherapy period, added to standard anti-emetic treatment. Tolerability was measured as the number of withdrawals from the study during the titration period because of adverse events (AEs). The endpoint for the preliminary efficacy analysis was the proportion of patients showing complete or partial response.

resultsSeven patients were randomized to CBM and nine to placebo. Only one patient in the CBM arm was withdrawn due to AEs. A higher proportion of patients in the CBM group experienced a complete response during the overall observation period [5/7 (71.4%) with CMB vs. 2/9 (22.2%) with placebo, the difference being 49.2% (95% CI 1%, 75%)], due to the delayed period. The incidence of AEs was higher in the CBM group (86% vs. 67%). No serious AEs were reported. The mean daily dose was 4.8 sprays in both groups.

conclusionCompared with placebo, CBM added to standard antiemetic therapy was well tolerated and provided better protection against delayed CINV. These results should be confirmed in a phase III clinical trial.

Indexed as

Administration, OralAdultAgedAntiemeticsAntineoplastic AgentsCannabidiolDose-Response Relationship, DrugDouble-Blind MethodDronabinolFemaleHumansMaleMiddle AgedNauseaPilot ProjectsVomitingAntiemeticsAntineoplastic AgentsCannabidiolDronabinol

Identifiers

PMID21039759
PMCPMC2997305
OpenAlexW1589779648

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.