Page 6 - Cannabis for the Management of Pain: Assessment of Safety Study

1238 The Journal of Pain Cannabis for the Management of Pain
Table 2. SAEs Categorized by System Organ Class

SERIOUS AEs CANNABIS GROUP CONTROL GROUP
SYSTEM ORGAN CLASS (MEDDRA) NUMBER OF EVENTS RATE* NUMBER OF EVENTS RATE*
Surgical and medical procedures 10 5.65 11 5.39
Gastrointestinal disorders 10 5.65 7y 3.43
Musculoskeletal and connective tissue disorders 5 2.82 6 2.94
Injury, poisoning, and procedural complications 4 2.26 1 .49
Renal and urinary disorders 3 1.69 1 .49
Nervous system disorders 2 1.13 4 1.96
Respiratory, thoracic, and mediastinal disorders 1 .56 7 3.43
Infections and infestations 1 .56 5 2.45
Vascular disorders 1 .56 3 1.47
Metabolism and nutrition disorders 1 .56 2 .98
Psychiatric disorders 1 .56 2z .98
Investigations 1 .56 0 .00
General disorders and administration site conditions 0 .00 3 1.47
Blood and lymphatic system disorders 0 .00 1 .49
Eye disorders 0 .00 1 .49
Hepatobiliary disorders 0 .00 1 .49
Immune system disorders 0 .00 1 .49
Total 40 22.60x 56 27.45x
Total number of patients 28 13.02%k 42 19.44%k
*Unit: n/100 person-years.
yOne patient died in the operating room.
zOne patient committed suicide.
xThe rates of serious AEs did not differ significantly between these 2 groups (Unadjusted incidence rate ratio = .82, 95% CI = .46–1.46).
The risk of having reported at least 1 SAE was not significantly different between 2 groups (Unadjusted odds ratio = .62, 95% CI = .37–1.04).
k
assessed as certainly/very likely related to cannabis were Pulmonary Function Tests
somnolence (n = 5, .6%), amnesia (n = 4, .5%), cough
After adjusting for tobacco smoking and other covari-
(n = 4, .5%), nausea (n = 4, .5%), dizziness (n = 3, .4%), ates, we did not find a significant change in slow vital ca-
euphoric mood (n = 3, .4%), hyperhidrosis (n = 2, .2%),
pacity, functional residual capacity, and total lung
and paranoia (n = 2, .2%) (Supplementary Table 7). capacity over 1 year among the cannabis users. Residual
In the control group, gastrointestinal disorders volume was reduced (mean reduction 142 mL), and a
(n = 101, 17.4%) and nervous system disorders (n = 93, mean decline of 54 mL in FEV 1 and a mean decrease of
16.0%) were the most frequently reported (Table 3).
.78% in the FEV 1 /FVC ratio were noted. The FEF 25–75%
The majority of AEs among controls were mild (57.3%)
was lower with a mean decrease of .2; no change was
or moderate (42.0%); 4 (.7%) were categorized as ‘‘se- observed in FVC (Supplementary Tables 13 and 14).
vere’’ (abdominal pain, breast cancer, pulmonary embo-
lism, and upper respiratory tract infection) Blood Tests
(Supplementary Tables 6–8).
Seventy-eight patients in the cannabis group had
Multiple Regression Analyses blood tests conducted at baseline and at 1 year. No
changes in liver, renal, and endocrine function were
The association between cannabis use and the rate of
observed (Supplementary Tables 15 and 16).
AEs is summarized in Table 4. Medical cannabis users
had an increased risk of non-serious AEs (adjusted
IRR = 1.74, 95% CI = 1.42–2.14) but not SAEs (adjusted Efficacy Measures
IRR = 1.08, 95% CI = .57–2.04). Increasing the daily dose Pain Intensity
of cannabis did not lead to higher risks of SAEs or AEs
Compared with baseline, a significant reduction in
(Supplementary Table 10).
average pain intensity over 1 year was observed in the
cannabis group (change = .92; 95% CI = .62–1.23) but
Neurocognitive Tests not in the control group (change = .18; 95% CI = .13
Significant improvements were observed in all neuro- to .49). After adjusting for confounders, a greater reduc-
cognitive subtests after 6 and 12 months in cannabis tion in pain was observed among cannabis users than
users and controls (Table 5). After adjusting for age, among controls (difference = 1.10, 95% CI = .72–1.56)
gender, education, alcohol history, disability status, con- (Fig 3; Supplementary Tables 17 and 18).
current average pain intensity, quality of life, and clinic
sites, no difference in neurocognitive function after 1 Quality of Life
year was found between cannabis users and controls With regard to the change in Physical Component
(Supplementary Table 12). Summary (PCS) score, a significant improvement from