Over 100 controlled clinical trials supported therapeutic potential of cannabinoids
More than 100 controlled clinical trials since 1975 led to the approval of dronabinol, nabilone, and a cannabis extract in several countries, with the most common side effects being tiredness and dizziness.
Quick Facts
What This Study Found
This review cataloged the therapeutic evidence for cannabinoids, noting that over 100 controlled clinical trials had been conducted since 1975. These trials led to three approved cannabis-based medicines: dronabinol, nabilone, and a 1:1 THC:CBD extract (Sativex).
In Germany, the cannabis extract was approved in 2011 for moderate-to-severe MS spasticity. It was commonly used off-label for anorexia, nausea, and neuropathic pain. Patients could also apply for government permission to buy medicinal cannabis flowers for supervised self-treatment.
The most common side effects (tiredness and dizziness) affected more than 10% of patients, but tolerance to these effects nearly always developed within a short time. Withdrawal symptoms were "hardly ever a problem in the therapeutic setting."
Key Numbers
Over 100 controlled clinical trials since 1975. Three approved medicines: dronabinol, nabilone, THC:CBD extract. Side effects >10%: tiredness, dizziness. Tolerance to side effects developed quickly. Withdrawal rarely problematic in clinical use.
How They Did This
Selective literature review of controlled clinical trials and regulatory approvals for cannabis-based medicines. Published in a German medical journal with a European regulatory perspective.
Why This Research Matters
By counting over 100 controlled trials, this review countered the claim that cannabis lacked scientific evidence. The regulatory framework in Germany, including patient access to medicinal flowers, represented one of the most developed systems at the time.
The Bigger Picture
The European regulatory approach to medical cannabis, particularly Germany's, differed from the US. This review reflected a system where cannabis-based medicines moved through traditional pharmaceutical approval while also allowing supervised flower access.
What This Study Doesn't Tell Us
Selective rather than systematic review. German/European focus. "Over 100 trials" includes trials of varying quality and for different conditions. Some conditions had much more evidence than others.
Questions This Raises
- ?Is the German model of combined pharmaceutical approval and flower access optimal?
- ?Which of the 100+ trials are most clinically relevant?
- ?Should more conditions be approved for cannabinoid treatment?
Trust & Context
- Key Stat:
- Over 100 controlled clinical trials since 1975
- Evidence Grade:
- Selective review summarizing a large body of controlled trial evidence. Strong evidence base overall, though the review itself is selective rather than systematic.
- Study Age:
- Published in 2012. Germany has since become one of Europe's largest medical cannabis markets with expanded indications.
- Original Title:
- The therapeutic potential of cannabis and cannabinoids.
- Published In:
- Deutsches Arzteblatt international, 109(29-30), 495-501 (2012)
- Authors:
- Grotenhermen, Franjo(4), Müller-Vahl, Kirsten(2)
- Database ID:
- RTHC-00565
Evidence Hierarchy
Summarizes existing research on a topic.
What do these levels mean? →Frequently Asked Questions
How much scientific evidence supports medical cannabis?
As of this review, over 100 controlled clinical trials had been conducted since 1975, leading to three approved cannabis-based medicines. The strongest evidence was for MS spasticity, nausea, and neuropathic pain.
Do the side effects go away?
The most common side effects (tiredness and dizziness) affected more than 10% of patients initially, but tolerance to these effects nearly always developed within a short time. Withdrawal symptoms were rarely a problem when used as prescribed.
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Cite This Study
https://rethinkthc.com/research/RTHC-00565APA
Grotenhermen, Franjo; Müller-Vahl, Kirsten. (2012). The therapeutic potential of cannabis and cannabinoids.. Deutsches Arzteblatt international, 109(29-30), 495-501.
MLA
Grotenhermen, Franjo, et al. "The therapeutic potential of cannabis and cannabinoids.." Deutsches Arzteblatt international, 2012.
RethinkTHC
RethinkTHC Research Database. "The therapeutic potential of cannabis and cannabinoids." RTHC-00565. Retrieved from https://rethinkthc.com/research/grotenhermen-2012-the-therapeutic-potential-of
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.