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  4. Cannabis-Based Medicine for Neuropathic Pain and Spasticity—A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial

Cannabis-Based Medicine for Neuropathic Pain and Spasticity—A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial

Pharmaceuticals, 2023 · DOI: 10.3390/ph16081079 · Published: July 28, 2023

NeurologyPain Management

Simple Explanation

This study investigated whether cannabis-based medicine (CBM) could help reduce neuropathic pain (NP) and spasticity in patients with multiple sclerosis (MS) or spinal cord injury (SCI). Patients were given either THC, CBD, a combination of both, or a placebo. The primary goal was to see if these treatments could decrease the intensity of NP and/or spasticity reported by the patients. They also looked at other effects, such as changes in quality of life and any adverse events. The study found no significant difference between the active treatments (THC, CBD, or THC&CBD) and the placebo in reducing NP or spasticity. However, patients in the THC-containing groups reported more adverse events.

Study Duration
6 weeks
Participants
134 patients (MS n = 119, SCI n = 15)
Evidence Level
Level 1: Randomized, double-blinded, placebo-controlled trial

Key Findings

  • 1
    No significant difference was found between the THC, CBD, or THC&CBD groups and the placebo group in reducing mean pain intensity.
  • 2
    Similarly, no significant difference was found between the active treatment groups and the placebo group in reducing mean spasticity intensity.
  • 3
    Patients in the THC and THC&CBD groups reported significantly more adverse events compared to the placebo group.

Research Summary

This study evaluated the effectiveness of THC, CBD, and a combination of THC&CBD in capsule form for treating neuropathic pain and spasticity in patients with multiple sclerosis or spinal cord injury. The results indicated that there was no significant difference between the active treatments and the placebo in reducing pain or spasticity intensity. However, the study found that patients receiving THC alone or in combination with CBD experienced more adverse events.

Practical Implications

Limited Efficacy of CBM

The study suggests that CBM, specifically THC and CBD, may not be effective for treating neuropathic pain and spasticity in MS and SCI patients at the dosages used.

Increased Risk of Adverse Events

The use of THC, particularly in combination with CBD, is associated with a higher incidence of adverse events, which should be considered when prescribing CBM.

Need for Alternative Treatments

Given the lack of efficacy demonstrated in this trial, alternative or adjunctive treatments should be explored for managing neuropathic pain and spasticity in these patient populations.

Study Limitations

  • 1
    The study did not reach the planned number of patients due to the COVID-19 pandemic and other recruitment challenges.
  • 2
    The study cannot exclude a small effect of the treatments due to confidence intervals.
  • 3
    The potential for unblinding due to the effects/side effects of the active treatments.

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