CANNABIS. ⢠Physicians grasp medical cannabis as a palliative treatment and as part of a multi-model pain treatment. ⢠Medical cannabis does not exist as part ...
A MULTI-CENTER REGISTRY OF MEDICAL CANNABIS (MC) FOR CHRONIC PAIN: INITIAL RESULTS SHORT-TERM EFFICACY
J, Aviram, RN, PhC, D, Pud, PhD, B, Schiff-Keren, MD, M, Oginitz, RN, BA, T, Yashar, MD, H.M, Adahan, MD, S, Brill, MD, I, Gur-Arie, MD, H, Amital, E, Eisenberg, MD. 1
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CHRONIC PAIN • Chronic pain treatment is based on combination of pharmacotherapy and complementary nonpharmacotherapy treatment.
• The approach for pharmacology treatment of chronic pain relief is based primarily on pain intensity: 1. Mild pain- "simple" analgesics: Paracetamol\Dypirone. 2. Moderate to severe pain- NSAIDs\opioids.
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CANNABIS • Physicians grasp medical cannabis as a palliative treatment and as part of a multi-model pain treatment. • Medical cannabis does not exist as part of the training of physicians due to the minority of quality RCTs in this field. • Clinical research on medical cannabis is limited in quality and quantity because: 1. Lack of financial motivation.
2. Studying the positive effects of cannabis is in contrast to the global anti-smoking and anti-drugs strategies.
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CANNABIS & PAIN • Cannabis has an analgesic effect in various chronic pain conditions.
• Evidence regarding the appropriate indication as well as for preferred administration route of cannabis remain unclear. 5
AIM OF INVESTIGATION • To set up a registry on the use of MC for the relief of chronic pain in a large patient population in Israel. • It is structured to collect data prospectively on the effectiveness and safety of MC and to identify predictors for success\failure of MC treatment. • The study has recently begun. This is a preliminary report on the characteristics of the first group of patients with chronic pain for whom a MC license use application has been submitted with short-term effects results. 6
PROGRESS • Thus far, 427 patients (256M/ 171F) were recruited. Their mean (±SD) age is 49(±16) years old.
• Mean pain duration is 9.6±9.9 years (ranging from 1-69 years).
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MC licenses status 300
281
Time for treatment initiation: 65.2±69.7 days (4-938 range)
Number of patients
250 200
150 100
84
50
24
0
38
8
Approved
Declined
In process of submitting
Waiting for response
PROGRESS • 160 patients (86M/ 74F) reached and reported on their onemonth treatment effects.
• Most patients received 20gr of MC by inhalation (79.4%) or as oil extracts (20.6%).
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Gender
40.05% 59.95%
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Male
Female
Co-morbidities
38.20% 61.80%
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Yes
No
Co-morbidities diagnosis distribution 40 35
Percent
30 25 20
15 10
37 31
30
27
26
24
24 17
17
16
15
14
13
12
12
11 7
5 0
12
Employment Status 5.40%
30%
19.10%
22.20% 18.20%
5.20% Working full-time Retired
Working part-time Unemployed
Household maintnance Student
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Pain diagnosis etiology 80% 70%
Percent
60% 50%
70%
51%
40% 30% 20% 10% 0%
15%
13%
12% 1%
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Past cannabis experience
42.70% 57.20%
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Yes
No
Past cannabis experience- indication
13.90%
86.10%
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Pain treatment
Recreational
MC SHORT-TERM EFFECTS One month treatment
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Pain frequency 70 60
66 54
Baseline 1.3±0.6
Percent
50 40
35
30
One month 1.6±0.8
26
20 10
3
4
5
6 0
0
Constant
Few times a Up to twice a Few times a day day week Baseline
1
Up to 4 times a month
One month
0
0
0
0
Up to twice a Less than a month month 18
Current pain intensity (0-10 NPS scale) 25
Baseline 7.7±2.0
22
23
22 19
Percent
20 17
One month 6.2±2.3
15
13 10
10 6
5
5
3 1
0
0 No pain
0 0
1
2
13
9
9
6
6
2
1
0
13
3
4
Baseline
5
6
One month
7
8
9
10 Worst 19 pain
Administration route effect on one month mean pain intensity 7
6.9
6.8
Mean
6.6
Total one month pain intensity 6.2±2.3
6.4 6.2
6.1
6
5.8 20
5.6 Cannabis oil extracts
Inhalation (smoking)
Baseline 7.6±1.72
9
8
8 7
Mean
6
7
7 6
One month 6.4±2.1
Positional pain (0-10) scale
7 6
8 7
8 7
8 7
7
6
5 4
3 2 1 0
Bed rest
Turning around in bed
Sitting
Sitting standing transfer
Baseline
Standing
One month
Walking
Overall weekly pain
21
3
Baseline 25.5±9.0
2.5
Mean
2 1.5
2.1 1.8 1.5
1.6
SF-MPQ Sensory & Affective pain (0-45) scale 2.7 2.6 2.4
2.3 2 1.5
1.8 1.7 1.6 1.4 1.4 1.4 1.2
2
One month 20.7±10.1 2.5
1.8 1.4
1.8
2.1
2
1.5
1.3
1.2 0.9 0.7
1
0.8
0.5 0
22
Baseline
One month
80%
Baseline 1.8±0.4
Analgesic medications amount
One month 1.5±0.5
74%
70% 60%
55%
Percent
50%
44%
40% 30%
20%
20%
10%
5%
2%
0% 1
2-5
Baseline
One month
5>
23
Analgesic pain medications change- one month 50 45
43
40
Percent
35
30
30
26
25 20 15 10
3
5
3
0
1 24
No change
Stopped Reduced dose taking some
Stopped all
Added analgesics
Increased dose
30 25
Analgesic medications pain relief (0-100%)
Baseline 30.6±24.5 24
20
Percent
20
17
15
15 10
One month 45.5±25.8
12 7
5
13
12
10
8
10
9 6
5
5
10
6
3
2
4
0
0% None
10%
20%
30%
40%
Baseline
50%
60%
One month
70%
80%
90%
3 0
100% Full 25 relief
Administration route effect on one month analgesics pain relief 48% 47%
47%
Total one month pain relief 45.5±25.8
46%
Percent
45% 44%
43% 42%
42%
41%
40% 26
39% Cannabis oil extracts
Inhalation (smoking)
OUTCOME MEASURES Baseline Mean±SD
One month Mean±SD
Scale range
Disability (PDI)
6.5±1.9
5.4±2.2
0-10
Catastrophizing (PCS) Sleep quality (PSQI) Anxiety (GAD-7)
37.5±11.2
33.4±12.7
0-52
12.6±3.8
5.0±5.9
0-21
10.5±6.6
6.7±5.8
0-21
Depression (BDI) Quality of life (EQ5)
21.6±1.8
14.9±10.3
0-63
4.9±1.8
4.0±1.8
27
0-10
MC Adverse Effects (AEs)
44.30% 66.70%
Yes
No
Administration route AEs differences Percent
80% 60%
40%
62.50%
60.50%
39.50%
37.50%
20% 0% Yes
Inhalation AEs
No
Oil extracts AEs
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MC CNS Adverse Effects (AEs) 90% 80%
80%
70%
64.70%
Percent
60% 50% 40%
35.30%
30% 20%
20% 10% 0% Yes
Inhalation AEs
No
Oil extracts AEs
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CONCLUSIONS • Candidates for MC treatment have significant pain and disabilities. Preliminary findings of this ongoing study suggest a short-term improvement of pain and associated symptoms by MC.
• MC inhalation Is showing preliminary signs of providing more pain reduction and less AEs reports than MC oil extracts. • Further long-term data collection may shed light on the safety and effectiveness of MC in reducing pain and associated symptoms.
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