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Cannabis sativa (Sativex) for the treatment of spasticity due to multiple sclerosis: Overview

Created: ; Last Update: August 23, 2018; Next update: 2021.

Introduction

A cannabis sativa extract (trade name: Sativex) has been approved in Germany since May 2011 for the treatment of moderate to severe spastic paralysis and muscle spasms due to multiple sclerosis in adults.

Multiple sclerosis (MS) is a chronic and incurable inflammatory disease of the central nervous system in which the body’s immune system damages nerve pathways in the brain and the spinal cord. This condition can cause abnormal sensations, arm and leg pain, spasms, paralysis, dizziness and trembling. The disease often comes in episodes with symptom-free intervals between acute phases. Some patients have chronic spasms or paralysis in certain muscles or entire parts of their body. This is known as spasticity. The muscle spasms originate in the brain or spinal cord.

Cannabis sativa is the Latin name for hemp plants. The cannabis extract is considered in combination with other drugs if other treatments alone have not reduced spasticity enough.

Application

The cannabis extract is used as a mouth spray. The dose is increased every day until optimal relief of symptoms is noticeable. The maximum dose is 12 sprays per day. If the symptoms don't improve within the first four weeks, the treatment should be stopped.

Other treatments

The other treatment options for patients with spastic paralysis and cramps include optimized treatment with antispasmodic (anticonvulsant) medications such as baclofen, tizanidine, or dantrolene. The choice of treatment depends on various factors, such as whether it is the initial treatment or which treatments have been tried before. It is individually adjusted by the doctor.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of the cannabis extract in people who have moderate to severe spastic paralysis and cramps due to multiple sclerosis.

Data from two studies involving a total of 163 participants was available for this analysis. In the study, one half of the patients had treatment with the cannabis extract, while the other half received a placebo. In addition, all participants had optimized treatment with baclofen, tizanidine, or dantrolene. The following results were found after three months:

What are the advantages of the cannabis extract?

  • Improvement of spasticity: The studies suggest that the cannabis extract can relieve muscle spasms. The spasticity improved in 85 to 93 out of 100 people who used the cannabis extract, compared to about 41 to 66 out of 100 people who didn't use the cannabis extract.
  • Spasticity-related pain: In women, the results suggest that the cannabis extract has an advantage here. Those women who used it had less spasticity-related pain than women who didn't use it. There was no difference here for men.

What are the disadvantages of the cannabis extract?

  • The cannabis extract was not found to have any disadvantages.

No difference

  • Life expectancy: There was no difference between the groups here. A total of two people passed away.
  • Activities of everyday life: There was also no difference in terms of daily activities related to things like personal hygiene, meals, dressing and undressing, or mobility.
  • Serious side effects: There was no difference here either: In the studies, 2 to 11 out of 100 people in each group had serious side effects.
  • There was also no difference in terms of the following:
    • Sleep disruptions due to spasticity
    • Walking speed
    • General health
    • Health-related quality of life
    • Treatment stopped due to side effects
    • Psychiatric disorders

What remains unanswered?

  • Dizziness: The manufacturer didn't provide any suitable data about this side effect.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of cannabis sativa (Sativex).

Sources

  • Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Extract from Cannabis sativa L. – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission A12-01. March 29, 2012. (IQWiG reports; Volume124).
  • Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Extract from Cannabis sativa (spasticity due to multiple sclerosis – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission A18-27. August 01, 2018. (IQWiG reports; Volume 651).
  • IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

    Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. We do not offer individual consultations.

    Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

© IQWiG (Institute for Quality and Efficiency in Health Care)
Bookshelf ID: NBK525777

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