New Data on Sativex for MS Spasticity: No Cognitive Decline and No Driving Impairment
Additional studies involving over 1,000 MS patients found Sativex did not cause cognitive decline after 12 months and did not impair standard driving ability.
Quick Facts
What This Study Found
A randomized, placebo-controlled long-term trial demonstrated that THC:CBD spray (Sativex) was not associated with cognitive decline, depression, or significant mood changes after 12 months of treatment. This addressed a key concern about long-term cannabinoid therapy.
A prospective observational pilot study of 33 patients (ages 33-68) found that Sativex did not adversely influence standard driving ability in patients with moderate to severe MS spasticity.
Patient registry data from the UK, Germany, and Spain reinforced the efficacy and safety observed in Phase III trials. Notably, patients in real-world practice used lower average doses than those in clinical studies (5-6.4 vs. >8 sprays/day), and effectiveness was maintained. In the German/UK registry, 45% of patients had been treated for over 2 years with no additional safety concerns identified.
Key Numbers
Over 1,000 additional patients studied. No cognitive decline at 12 months. Driving not impaired in 33-patient pilot. Real-world dosing: 5-6.4 sprays/day (vs. >8 in trials). 45% of registry patients treated for >2 years.
How They Did This
This is a review of multiple new data sources available in 2013: a randomized placebo-controlled long-term follow-up trial, a prospective observational driving study, and patient registries from the UK, Germany, and Spain. Together, these sources covered approximately 1,000 additional patients beyond the original Phase III trials.
Why This Research Matters
Long-term safety data is essential for medicines used to treat chronic conditions like MS spasticity. The absence of cognitive decline after 12 months and the lack of driving impairment are reassuring findings for patients and prescribers concerned about chronic cannabinoid use.
The Bigger Picture
These post-marketing data strengthen the safety profile of Sativex for long-term use in MS spasticity. The finding that real-world doses are lower than trial doses while maintaining effectiveness suggests the drug may be more efficient in practice than clinical trials indicated.
What This Study Doesn't Tell Us
The driving study was a small pilot (n=33). Registry data is observational and subject to selection bias (patients who continue medication may be those who tolerate it well). The cognitive study assessed specific standardized measures and may not capture all aspects of cognitive function. The review was published in a supplement likely supported by the manufacturer.
Questions This Raises
- ?Does the lower real-world dosing pattern reflect patients finding their optimal dose or under-dosing due to side effects?
- ?Would even longer follow-up (5+ years) reveal delayed effects?
- ?How do these cognitive findings compare to other MS treatments?
Trust & Context
- Key Stat:
- No cognitive decline after 12 months; real-world doses (5-6 sprays/day) lower than trials (8+)
- Evidence Grade:
- This review combines data from an RCT, observational study, and patient registries, providing moderate overall evidence for long-term safety.
- Study Age:
- Published in 2014. Long-term registry data on Sativex has continued to accumulate since.
- Original Title:
- THC:CBD spray and MS spasticity symptoms: data from latest studies.
- Published In:
- European neurology, 71 Suppl 1, 4-9 (2014)
- Authors:
- Rekand, Tiina
- Database ID:
- RTHC-00854
Evidence Hierarchy
Summarizes existing research on a topic.
What do these levels mean? →Frequently Asked Questions
Does Sativex impair driving?
A pilot study of 33 patients found no adverse effect on standard driving ability. However, individual responses vary, and patients should exercise caution, especially when starting treatment or adjusting doses.
Why do patients use lower doses in practice than in clinical trials?
Clinical trials often titrate to maximum tolerated doses. In practice, patients tend to find a lower dose that provides adequate symptom relief with fewer side effects. This pattern is common across many medications.
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Cite This Study
https://rethinkthc.com/research/RTHC-00854APA
Rekand, Tiina. (2014). THC:CBD spray and MS spasticity symptoms: data from latest studies.. European neurology, 71 Suppl 1, 4-9. https://doi.org/10.1159/000357742
MLA
Rekand, Tiina. "THC:CBD spray and MS spasticity symptoms: data from latest studies.." European neurology, 2014. https://doi.org/10.1159/000357742
RethinkTHC
RethinkTHC Research Database. "THC:CBD spray and MS spasticity symptoms: data from latest s..." RTHC-00854. Retrieved from https://rethinkthc.com/research/rekand-2014-thccbd-spray-and-ms
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.