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Home/Cannabis Science/Nabiximols vs. Cannabis Decoction for MS Spasticity: What a New Formulation Comparison Study Found
Nabiximols vs Cannabis Decoction MS Spasticity | nabiximols cannabis decoction MS spasticity study
Cannabis Science

Nabiximols vs. Cannabis Decoction for MS Spasticity: What a New Formulation Comparison Study Found

By Benjamin Caplan, MD
16 Min Read
Comments Off on Nabiximols vs. Cannabis Decoction for MS Spasticity: What a New Formulation Comparison Study Found
CED Clinical Relevance #70 Safety Signal Nabiximols is an approved cannabinoid spray for MS spasticity in several countries, yet real-world discontinuation is common and rarely quantified. This retrospective single-center study is one of the few to track what actually happens over years of practice: most patients who start nabiximols eventually stop it, and among those who switch to a compounded cannabis decoction, symptoms improve further with fewer reported adverse effects. That practical, formulation-specific safety and tolerability signal clears the bar for careful coverage even though the retrospective, non-randomized design keeps it well short of a treatment-comparison verdict.
Clinical Insight | CED Clinic
Researchers at a single center in Trieste, Italy retrospectively reviewed 63 adults with multiple sclerosis-related spasticity who initiated nabiximols, an oromucosal THC:CBD spray, between 2013 and 2024. They tracked spasticity using the Modified Ashworth Scale, pain and spasticity intensity using Numerical Rating Scales, and spasm frequency using the Penn Spasm Frequency Scale, at baseline and at follow-up. Over the study period, 39 of the 63 patients, 61.9%, discontinued nabiximols, and 14 of those switched to a compounded cannabis decoction. Both nabiximols and cannabis decoction were associated with statistically significant improvements in spasticity, spasms, and pain from baseline. Among the patients who switched formulations, cannabis decoction produced significant improvement across all measured outcomes. Adverse effects were reported in 27.0% of nabiximols users compared with 14.3% of cannabis decoction users, and nabiximols showed a higher, though not statistically significant, discontinuation rate. Longer disease duration predicted discontinuation due to inefficacy, while tetraspasticity predicted switching to cannabis decoction.
Multiple SclerosisNabiximolsCannabis DecoctionSpasticityFormulation Comparison
AudiencePatients with MS-related spasticity using or considering nabiximols, clinicians managing cannabinoid therapy for multiple sclerosis, and researchers studying how cannabinoid formulation affects real-world outcomes
Primary TopicA retrospective single-center cohort study comparing nabiximols and compounded cannabis decoction for multiple sclerosis-related spasticity, spasms, and pain in 63 patients, published in Multiple Sclerosis and Related Disorders, August 2026
SourceRead the study on PubMed

Table of Contents

  • Nabiximols vs. Cannabis Decoction for MS Spasticity: What a New Formulation Comparison Study Found
    • How to Read a Formulation-Switch Study Without Overclaiming
      • A Four-Step Reading Frame
    • The Same Study Can Mean Different Things Depending on the Question Being Asked
        • A Real Pattern, Not a Reason to Switch on Your Own
        • Attrition Deserves as Much Attention as Efficacy
        • Fixed Ratio Spray Versus Variable Decoction
        • Confounding by Indication Is the Central Problem
        • Different Formulations Face Different Regulatory Paths
        • Standardization Is the Variable Most Likely to Matter
        • Framing This Accurately Protects Patient Trust
        • A Prompt for a Prospective Trial, Not an Answer
    • Frequently Asked Questions
  • Newsletter Signup Form
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Nabiximols vs. Cannabis Decoction for MS Spasticity: What a New Formulation Comparison Study Found

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In a retrospective single-center study of 63 multiple sclerosis patients, both nabiximols and compounded cannabis decoction improved spasticity, spasms, and pain, but nearly two-thirds of patients eventually discontinued nabiximols, and those who switched to decoction saw further improvement with fewer reported adverse effects.

What This Study Teaches Us
This study puts a number on something clinicians often see anecdotally: a majority of patients who start nabiximols for MS spasticity do not stay on it long term. It also offers an early, formulation-specific look at what happens to the subset who switch to a compounded cannabis decoction, finding continued improvement and a lower reported rate of adverse effects. It does not establish that cannabis decoction is a superior treatment; it describes what happened in a small, self-selected group of patients who had already found nabiximols inadequate or poorly tolerated.
Why This Matters
Nabiximols is authorized as a prescription spasticity treatment in the United Kingdom, Canada, and a number of other countries, but it is not FDA-approved in the United States, so this data is most directly actionable for clinicians and patients in jurisdictions where it is prescribed. Cannabis decoction, as studied here, is a compounded preparation dispensed through Italian pharmacies under a medical prescription, not a standardized commercial product. For US cannabis clinicians, the value of this study is less about the specific decoction and more about the underlying question it raises: when a standardized cannabinoid product is not well tolerated or effective, does a different formulation of the same plant compounds change the picture, and how should that possibility be discussed with patients honestly.
Study Snapshot
Study TypeRetrospective, single-center cohort study
Population63 adults with multiple sclerosis-related spasticity who initiated nabiximols between 2013 and 2024
ComparisonContinued nabiximols versus switching to compounded cannabis decoction after nabiximols discontinuation
Outcome MeasuresModified Ashworth Scale (spasticity), Numerical Rating Scale (spasticity and pain), Penn Spasm Frequency Scale (spasm frequency)
Analysis MethodsWithin-group and mixed-effects model efficacy analyses; Cox regression for discontinuation risk
Discontinuation Result39 of 63 patients (61.9%) discontinued nabiximols during the study period; 14 switched to cannabis decoction
Efficacy ResultBoth nabiximols and cannabis decoction were associated with significant improvement in spasticity, spasms, and pain from baseline; among switchers, cannabis decoction produced significant improvement across all outcomes
Tolerability ResultAdverse effects reported in 27.0% of nabiximols users versus 14.3% of cannabis decoction users; nabiximols showed a higher, though not statistically significant, discontinuation rate
Predictors IdentifiedLonger disease duration was associated with discontinuation due to inefficacy; tetraspasticity predicted switching to cannabis decoction
JournalMultiple Sclerosis and Related Disorders
PublishedAugust 4, 2026
DOI10.1016/j.msard.2026.107428
PMID42594706
Clinical Bottom Line
In this retrospective single-center study, most patients who started nabiximols for MS spasticity eventually discontinued it, and those who switched to compounded cannabis decoction saw further symptom improvement with fewer reported adverse effects, but the retrospective design, small switcher subgroup, and non-standardized decoction preparation mean this should prompt a clinical conversation, not a formulation switch, on its own.
What the Study Looked At

Researchers retrospectively reviewed the records of 63 adults with multiple sclerosis-related spasticity who started nabiximols, an oromucosal spray with a fixed 1:1 ratio of THC to CBD, at a single Italian center between 2013 and 2024.

Spasticity, spasm frequency, and pain were tracked using three validated instruments, the Modified Ashworth Scale, Numerical Rating Scales, and the Penn Spasm Frequency Scale, at baseline and follow-up. Discontinuation risk was analyzed with Cox regression.

Both Formulations Improved Symptoms

Patients who remained on nabiximols showed statistically significant improvement in spasticity, spasms, and pain compared with baseline.

Among the 14 patients who switched to a compounded cannabis decoction after stopping nabiximols, cannabis decoction was associated with significant improvement across all three outcome measures.

Most Patients Eventually Stopped Nabiximols

Nearly two-thirds of the cohort, 39 of 63 patients (61.9%), discontinued nabiximols at some point during the study period, and 14 of those patients switched to cannabis decoction rather than stopping cannabinoid therapy altogether.

Adverse effects were reported in 27.0% of nabiximols users compared with 14.3% of cannabis decoction users, and nabiximols showed a higher, though not statistically significant, discontinuation rate than decoction.

Formulation and Patient Factors May Explain the Pattern

The study authors note that differences in cannabinoid composition and pharmacokinetics between the standardized oromucosal spray and the compounded decoction may explain some of the variation in outcomes and tolerability between the two preparations.

Two clinical predictors emerged: longer disease duration was associated with discontinuing nabiximols due to inefficacy, while having spasticity in all four limbs, tetraspasticity, predicted switching to cannabis decoction rather than stopping cannabinoid therapy entirely.

What This Study Cannot Tell Us

This was a retrospective, unblinded, non-randomized, single-center study with no placebo comparator. The 14-patient switcher subgroup is small, and these patients were not randomly assigned to decoction, they chose or were guided to it after nabiximols had already proven inadequate or poorly tolerated for them.

The cannabis decoction used in this study was a compounded preparation dispensed under Italian pharmacy regulations, not a standardized commercial product with a fixed cannabinoid ratio, so its dose and composition are not directly comparable to products available elsewhere, including the United States.

How Strong Is This Evidence?
This study used validated, clinically meaningful outcome measures, the Modified Ashworth Scale, Numerical Rating Scales, and the Penn Spasm Frequency Scale, tracked consistently over an 11-year enrollment window, and applied appropriate statistical methods, mixed-effects models for repeated outcomes and Cox regression for discontinuation risk. A single-center chart review spanning more than a decade also captures real-world attrition patterns that shorter randomized trials typically do not observe. Those are genuine strengths for the specific question of what happens to patients over years of actual practice.
Where This Paper Deserves Skepticism
The central comparison, nabiximols continuers versus decoction switchers, is confounded by indication: the 14 patients who switched to decoction did so precisely because nabiximols had already failed them on efficacy or tolerability grounds, so improvement after switching could reflect a fresh-formulation effect, regression toward the mean, or the specific tetraspasticity phenotype that predicted switching, rather than proof that decoction is a better cannabinoid preparation. The design was retrospective and unblinded, with no placebo arm, and outcome scales with subjective components were not assessed by blinded raters. The compounded decoction also lacked a standardized cannabinoid dose or ratio, which limits how reproducible or generalizable its reported benefit is.
What This Paper Does Not Show
This study does not show that cannabis decoction is superior to nabiximols in a randomized, head-to-head comparison. It does not establish a standardized decoction dose, THC:CBD ratio, or preparation method that produced the reported benefit, and the 14-patient switcher subgroup is too small to generalize from. It also does not evaluate cannabis decoction preparations outside the Italian compounding-pharmacy context in which this study was conducted, so it does not directly tell US clinicians or patients how a dispensary or home-prepared cannabis decoction would perform, and it does not change the fact that nabiximols is not FDA-approved in the United States.
How This Fits With the Broader Clinical Conversation

CED Clinic has previously covered systematic reviews and meta-analyses of cannabinoids for MS spasticity that focus on randomized-trial efficacy, generally finding modest, patient-reported benefit with THC:CBD extracts and low overall certainty of evidence. This new study asks a different, complementary question: not whether nabiximols works in a trial setting, but how many real-world patients actually stay on it, and what happens to the ones who do not.

Because nabiximols is authorized in the United Kingdom, Canada, and parts of Europe but not FDA-approved in the United States, this specific formulation comparison is most directly relevant to clinicians and patients in those markets. For US cannabis clinicians, the more transferable lesson is the reminder that formulation, dose consistency, and route of administration can meaningfully affect both tolerability and a patient’s willingness to continue any cannabinoid therapy.

Dr. Caplan’s Take

What stands out to me most in this study is not the decoction comparison, it is the 61.9% discontinuation rate for nabiximols. That number deserves attention on its own, because it reflects a real-world attrition pattern that shorter randomized trials rarely capture, and it matches what many of us see clinically: patients start a standardized cannabinoid product, and a majority do not stay on it long term for reasons that go beyond simple lack of efficacy.

I would be cautious about reading the decoction findings as proof that a compounded, non-standardized preparation outperforms an approved product. Fourteen patients who had already failed or not tolerated nabiximols is a selected group, not a fair comparison group. What I take from this study is a prompt to have an honest conversation with patients about why a cannabinoid therapy is not working, whether that is efficacy, tolerability, or something about the formulation itself, rather than a signal to switch formulations as a first move.

What a Careful Reader Should Take Away
A retrospective single-center study found that most multiple sclerosis patients who started nabiximols eventually discontinued it, and that a small subgroup who switched to compounded cannabis decoction saw further symptom improvement with fewer reported adverse effects, a real-world attrition signal worth discussing with patients, but not evidence that decoction is a superior treatment.
Evidence Interpretation Guide

How to Read a Formulation-Switch Study Without Overclaiming

A retrospective study comparing two cannabinoid formulations can highlight a genuinely important real-world pattern while still being vulnerable to confounding that a randomized trial would control for.

Four checks keep this study’s real contribution, an attrition and tolerability signal, from being mistaken for proof that one formulation beats the other.

A Four-Step Reading Frame

Confirm what was compared
Continued nabiximols versus a self-selected group who had already stopped nabiximols and switched to decoction, not a randomized head-to-head trial.

Note who ended up in each group
Switchers chose or were guided to decoction after nabiximols had already failed them, which biases the comparison.

Separate attrition from efficacy
The 61.9% discontinuation rate for nabiximols is a real, useful finding on its own, independent of what decoction did afterward.

Watch for standardization
The decoction had no fixed dose or ratio, so its reported benefit cannot yet be tied to a reproducible product.

The Research Question
Among patients who started nabiximols for MS spasticity, how often is it discontinued, and how do outcomes and tolerability compare for those who switch to a compounded cannabis decoction?
The Patient Question
If nabiximols is not working well for me, does switching to a cannabis decoction mean I will do better?
The Bottom Line
The study shows many patients stop nabiximols and that a small group who switched to decoction improved with fewer reported side effects, but it does not prove decoction is a better treatment, since the switchers were a selected group who had already found nabiximols inadequate.
CED Perspective Lens

The Same Study Can Mean Different Things Depending on the Question Being Asked

Scientific papers rarely answer a single question. Patients, clinicians, researchers, policymakers, and critics often read the same data differently. The perspectives below explore how this study looks through several evidence-based lenses.

Lens Overview
Eight perspectives keep a genuinely useful real-world attrition finding from being read as either proof that cannabis decoction outperforms nabiximols, or dismissed as irrelevant to everyday cannabinoid practice.

A Real Pattern, Not a Reason to Switch on Your Own

If you are on nabiximols for MS spasticity and it is not working well or is hard to tolerate, this study confirms you are far from alone: most patients in this cohort eventually stopped it.

It does not mean switching to a cannabis decoction will work better for you specifically. The patients who improved after switching were a small, selected group, and any change to your cannabinoid regimen should be made with your treating clinician.

Lens takeaway
High discontinuation is common; use that as a conversation starter with your clinician, not a self-directed formulation switch.

Attrition Deserves as Much Attention as Efficacy

A 61.9% discontinuation rate over an 11-year window is a clinically important finding independent of what came next, and it argues for proactively asking patients about tolerability and adherence rather than assuming a prescribed cannabinoid is being used as intended.

The decoction data can inform a conversation about alternatives when nabiximols fails, but it should not be presented to patients as an evidence-based second-line protocol given the retrospective, confounded comparison.

Lens takeaway
Track and address nabiximols discontinuation proactively; treat the decoction findings as hypothesis-generating, not protocol-ready.

Fixed Ratio Spray Versus Variable Decoction

Nabiximols delivers a standardized, fixed 1:1 THC:CBD ratio through an oromucosal spray, while a decoction is an aqueous extraction whose cannabinoid content depends on starting plant material, preparation method, and steeping conditions.

The study authors explicitly point to differences in cannabinoid composition and pharmacokinetics between the two preparations as a plausible explanation for the different tolerability and outcome patterns observed.

Lens takeaway
Route of administration and formulation consistency are not incidental details; they may drive both efficacy and tolerability differences.

Confounding by Indication Is the Central Problem

The 14 patients who switched to decoction were not randomly assigned; they switched because nabiximols had already failed them, which makes any improvement after switching difficult to separate from regression to the mean or a fresh-start effect.

A retrospective, unblinded chart review of a 14-person subgroup cannot support a claim that one cannabinoid formulation is more effective than another.

Lens takeaway
Treat the switcher-subgroup findings as hypothesis-generating at best, given the small, self-selected sample and lack of randomization.

Different Formulations Face Different Regulatory Paths

Nabiximols is authorized as a prescription medicine in the United Kingdom, Canada, and several other countries, while compounded cannabis decoctions are dispensed through Italian pharmacies under national rules that do not have a direct US equivalent.

This regulatory patchwork means the findings translate unevenly across countries, and US clinicians should not assume a decoction obtained through a domestic dispensary matches the compounded preparation studied here.

Lens takeaway
Regulatory context shapes what this study can and cannot tell patients and clinicians outside Italy and similar markets.

Standardization Is the Variable Most Likely to Matter

Nabiximols has a fixed, quality-controlled THC:CBD ratio and dose per spray, while the compounded decoction in this study had no reported standardized dose or cannabinoid concentration.

Without knowing the decoction’s actual THC and CBD content, clinicians cannot translate its reported tolerability advantage into a specific, reproducible recommendation for patients.

Lens takeaway
A product’s tolerability profile is only as reproducible as its manufacturing or compounding standardization.

Framing This Accurately Protects Patient Trust

Describing this study as proof that cannabis decoction beats an approved pharmaceutical spray would overstate a confounded, 14-person retrospective comparison.

Accurately reporting both the meaningful attrition signal and its real limitations helps preserve trust in cannabinoid research as real-world formulation questions get more attention.

Lens takeaway
Report the attrition finding clearly, and label the formulation comparison as preliminary.

A Prompt for a Prospective Trial, Not an Answer

The study’s own authors call for prospective studies to confirm these findings and optimize treatment strategies, which is the clearest signal that this retrospective analysis is a starting point rather than a conclusion.

A properly designed prospective comparison, with standardized decoction dosing and a fair, non-confounded comparator, is the necessary next step this single-center chart review does not provide.

Lens takeaway
The authors themselves frame this as groundwork for future prospective research, not a practice-changing result.

Join the Conversation

Have a question about how this applies to your situation? Ask Dr. Caplan

Want to discuss this topic with other patients and caregivers? Join the forum discussion

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Source: Sartori A, Favero A, Rossi L, et al. A matter of formulation: Efficacy and tolerability of nabiximols and cannabis decoction for the treatment of multiple sclerosis-related spasticity. Mult Scler Relat Disord. 2026 Aug 4. DOI: 10.1016/j.msard.2026.107428. PMID: 42594706.
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A meta-analysis on nabiximols effects beyond spasticity, offering earlier CED coverage of the same medication examined in this new formulation study.

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Earlier coverage on closely related evidence

When a new paper overlaps with earlier CED Clinic coverage, we preserve the chain instead of hiding the overlap. These links point to older related posts so readers can compare what is new, what is repeated, and how the evidence has moved.

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A systematic review of 27 randomized trials found modest patient-reported improvement in MS spasticity with THC:CBD extracts, with low overall certainty of evidence and frequent, mostly mild to moderate adverse events.

Covers the same condition and drug class from a randomized-trial angle; this new study instead examines real-world discontinuation and a formulation switch.
Compare the randomized-trial evidence
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Nabiximols for MS: What a New Meta-Analysis Shows Beyond Spasticity

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Frequently Asked Questions

What did this study look at?

A retrospective, single-center review of 63 adults with multiple sclerosis-related spasticity who started nabiximols between 2013 and 2024, tracking spasticity, spasm frequency, and pain, along with how many patients discontinued nabiximols and what happened to those who switched to a compounded cannabis decoction.

What is nabiximols?

Nabiximols is an oromucosal spray with a fixed 1:1 ratio of THC to CBD, approved as a prescription treatment for MS-related spasticity in the United Kingdom, Canada, and several other countries. It is not FDA-approved in the United States.

What is cannabis decoction?

In this study, cannabis decoction was a compounded cannabis preparation dispensed through Italian pharmacies under a medical prescription. It does not have a standardized cannabinoid dose or ratio the way nabiximols does, and it is not equivalent to any specific product sold elsewhere, including the United States.

How many patients discontinued nabiximols?

Thirty-nine of 63 patients, 61.9%, discontinued nabiximols at some point during the study period, and 14 of those patients switched to cannabis decoction rather than stopping cannabinoid therapy altogether.

Did cannabis decoction work better than nabiximols?

Among the 14 patients who switched, cannabis decoction was associated with significant improvement across all measured outcomes, and adverse effects were reported less often, 14.3% versus 27.0% for nabiximols. However, this was a small, self-selected group who had already found nabiximols inadequate, so this does not establish decoction as a superior treatment in a fair, head-to-head comparison.

Were adverse effects more common with one formulation?

Adverse effects were reported in 27.0% of nabiximols users compared with 14.3% of cannabis decoction users, and nabiximols showed a higher, though not statistically significant, discontinuation rate than decoction.

What predicted whether a patient discontinued nabiximols or switched to decoction?

Longer disease duration was associated with discontinuing nabiximols due to inefficacy, while having spasticity in all four limbs, tetraspasticity, predicted switching to cannabis decoction rather than stopping cannabinoid therapy entirely.

Why might cannabis decoction and nabiximols produce different results?

The study authors point to differences in cannabinoid composition and pharmacokinetics between the standardized oromucosal spray and the compounded decoction as a plausible explanation, though the study was not designed to isolate that mechanism directly.

What are the main limitations of this study?

The study was retrospective, unblinded, non-randomized, and conducted at a single center with no placebo comparator. The 14-patient decoction switcher group was not randomly assigned and had already found nabiximols inadequate, which confounds any comparison between the two formulations. The decoction also lacked a standardized dose or cannabinoid ratio.

Does this mean I should switch from nabiximols to a cannabis decoction?

No. This study does not support switching formulations on your own. It shows that many patients eventually stop nabiximols and that a small subgroup who switched to decoction improved with fewer reported side effects, but any change to cannabinoid therapy for MS spasticity should be discussed with your treating clinician, and nabiximols and the decoction studied here are not available or regulated the same way in every country.

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Cannabis Decoctioncannabis decoction multiple sclerosisMultiple SclerosisNabiximolsnabiximols discontinuation rateSativex vs cannabis decoction
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