The first study to use a cannabis-based medicine (CBM) for treating rheumatoid arthritis has found that it has a significant effect on easing pain and on suppressing the disease.
Writing in the medical journal Rheumatology, the researchers say that although the differences were small and variable in the group of 56 patients they studied, the results are statistically significant and a larger trial is needed to investigate in more detail the effects of CBM on the disease which affects approximately 600,000 people in the UK (1 in 100 of the population).
There is anecdotal evidence that cannabis can provide pain relief for people with rheumatoid arthritis (RA), and in a recent survey 155 (16%) of 947 people who obtained cannabis on the black market for medicinal reasons said they did so to obtain relief from symptoms of RA. However, this study in Rheumatology journal, led by David Blake, Professor of Bone and Joint Medicine at the Royal National Hospital for Rheumatic Diseases (RNHRD), Bath, and the University of Bath, UK, is the first randomised controlled trial to investigate the effect of a CBM on RA.
In the double-blind trial, the researchers randomised 31 patients to receive the CBM and 27 the placebo. The CBM (brand name: Sativex) was in the form of an easy-to-use mouth spray that patients could administer themselves up to a maximum of six doses a day. The CBM consisted of a blend of whole plant extracts, standardised for content, that delivered approximately equal amounts of two key therapeutic constituents from the cannabis plant: ?-9-Tetrahydrocannabinol (THC) and cannabidiol (CBD). Mouse studies have shown that THC and CBD have anti-inflammatory effects, and that CBD blocked progression of RA and produced improvements in symptoms.
Dr Ronald Jubb, Consultant Rheumatologist, at the University Hospital Birmingham NHS Foundation Trust, UK, said: “Patients had a baseline assessment at the beginning of the trial and then were randomised to receive either the CBM or placebo. Patients only took the doses in the evening in order to minimise possible intoxication-type reactions. The starting dose was one actuation within half an hour of retiring, and this was increased by one actuation every two days to a maximum of six doses according to individual response over a period of two weeks. Stable dosing was then maintained for a further three weeks.”
The researchers found that in comparison with the placebo, patients who had taken the CBM had statistically significant improvements in pain on movement, pain at rest, quality of sleep, inflammation (measured by a Disease Activity Score involving 28 joints – DAS 28) and intensity of pain (measured by the Short-Form McGill Pain Questionnaire SF-MPQ).
For instance, on a score of 0-10 where 0 is no pain, CBM patients on average moved from 7 to 4.8 for pain on movement (placebo patients moved from 6.7 to 5.3), 5.3 to 3.1 (placebo 5.3 to 4.1) for pain at rest, and 5.7 to 3.4 (placebo 5.8 to 4.6) for quality of sleep. On the DAS 28 score of 0-10, the CBM patients moved from 5.9 to 5 (placebo 6 to 5.9), and on the SF-MPQ score of 0-100 for intensity of pain at present, the CBM patients moved from 48 to 33, while the placebo patients remained unchanged at 50.
Adverse side effects were mostly mild or moderate (e.g. dizziness, light-headedness, dry mouth, nausea). Of the eight patients who experienced mild dizziness, in four patients this occurred during the initial two-week period when they were gradually increasing the doses, and two occurred two days after this initial period, so these were probably due to patients getting used to the correct dose. No patients taking the CBM had to withdraw from the trial due to adverse side effects, but three did from the placebo group.
Dr Philip Robson, Senior Research Fellow and Consultant Psychiatrist at the Oxford University Department of Psychiatry and Director of the Cannabinoid Research Institute within GW Pharmaceuticals (the manufacturer of Sativex), explained: “Withdrawals from the placebo group were probably due to a psychological effect, a spontaneous occurrence, or a reaction with another medicine.”