Extraction form for project: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain

Design Details

1. Trial Name


	None

2. What kind of study is this?

3. Month/Year Study Included

Add the month and year the study was included in the review


	November 2020

4. Setting

List country or continent


	Canada

5. Study Design


	RCT

6. Crossover Design

Is this a crossover trial?


	Yes No

7. Pain Population


	NPP

8. Pain Condition

Add specific condition here if specified


	Diabetic neuropathy

9. Prior Cannabis Exposure


	Excluded patients previously exposed to nabilone

10. Age Measure (Mean, Median)

11. Age, Years

Input the mean or median age for the entire sample


	Mean

12. Female %

Input the whole number here for the entire study sample - no need to add %


	62

13. Race, White %

Add % White for entire sample and round to nearest whole number - no need to add %


	94

14. Race, Black %

Add % Black for entire sample and round to nearest whole number - no need to add %


	2

15. Race, Hispanic/Latino %

Add % Hispanic/Latino for entire sample and round to nearest whole number - no need to add %


	0

16. Race, Asian %


	4

17. Race, Other %

Add % Other Race for entire sample and round to nearest whole number - no need to add %


	0

18. Pain Duration Measure (Mean, Median)


	Mean

19. Pain Duration, Months


	85

20. Psychiatric Comorbidity %

Add % psychiatric comorbidity for entire sample and round to nearest whole number - no need to add %. If excluded from inclusion criteria, say "Excluded"


	Excluded

21. Opioid Use at Baseline

Add information for opioid use at baseline.


	NR

22. N Randomized


	26

23. N Analyzed


	26

24. Treatment Duration, weeks

25. Assessment Time Category

26. Funding Source

27. Companion Paper


	None

Arms

Arm Name	Arm Description
High THC/CBD ratio	Nabilone 0.5 mg/day titrated up to a max dose of 2 mg twice daily
Placebo	Placebo

Arm Details

1. Dose Received, mean

High THC/CBD ratio


	max dose 4mg/day

Placebo


	NR

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Categorical	Pain Response ≥30%	NRS	All Participants	Followup
Continuous	Pain Severity (change)	NRS and VAS	All Participants	Baseline Followup
Continuous	Pain Interference (change)	MBPI	All Participants	Baseline Followup
Continuous	Depression (change)	HADS-D	All Participants	Baseline Followup
Continuous	Anxiety (change)	HADS-A	All Participants	Baseline Followup
Continuous	Quality of Life (change)	EQ-5D Index score	All Participants	Baseline Followup
Continuous	Sleep Quality/Interference (change)	MOSS	All Participants	Baseline Followup
Categorical	Any Adverse Event		All Participants	Followup

Outcome Details

1. Other Outcomes Reported (primary)

What other primary outcomes, besides: "Pain Response >= 30%", "Pain Severity (Change)", "Pain Interference (Change)", "Function/Disability (Change)".


	NA

2. Other AE Outcomes of Importance reported


	Dizziness; dry mouth, drowsiness; confusion or impaired memory; lethargy; euphoria; headache; and increased appetite were reported

3. Notes


	AEs were described briefly as mild or moderate in intensity.

Results

Categorical

Pain Response ≥30% (NRS)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo
Followup
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		High THC/CBD ratio	Placebo

Any Adverse Event

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo
Followup
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		High THC/CBD ratio	Placebo

Continuous

Pain Severity (change) (NRS and VAS)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline vs. Followup
	Mean Difference (MD)	Saved!	Saved!	Net Mean Difference (NMD)	Saved!
	95% CI low (MD)	Saved!	Saved!	95% CI low (NMD)	Saved!
	95% CI high (MD)	Saved!	Saved!	95% CI high (NMD)	Saved!
	SD (MD)	Saved!	Saved!	SD (NMD)	Saved!
	p value (MD)	Saved!	Saved!	P value (NMD)	Saved!

Pain Interference (change) (MBPI)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline vs. Followup
	Mean Difference (MD)	Saved!	Saved!	Net Mean Difference (NMD)	Saved!
	95% CI low (MD)	Saved!	Saved!	95% CI low (NMD)	Saved!
	95% CI high (MD)	Saved!	Saved!	95% CI high (NMD)	Saved!
	SD (MD)	Saved!	Saved!	SD (NMD)	Saved!
	p value (MD)	Saved!	Saved!	P value (NMD)	Saved!

Depression (change) (HADS-D)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline vs. Followup
	Mean Difference (MD)	Saved!	Saved!	Net Mean Difference (NMD)	Saved!
	95% CI low (MD)	Saved!	Saved!	95% CI low (NMD)	Saved!
	95% CI high (MD)	Saved!	Saved!	95% CI high (NMD)	Saved!
	SD (MD)	Saved!	Saved!	SD (NMD)	Saved!
	p value (MD)	Saved!	Saved!	P value (NMD)	Saved!

Anxiety (change) (HADS-A)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline vs. Followup
	Mean Difference (MD)	Saved!	Saved!	Net Mean Difference (NMD)	Saved!
	95% CI low (MD)	Saved!	Saved!	95% CI low (NMD)	Saved!
	95% CI high (MD)	Saved!	Saved!	95% CI high (NMD)	Saved!
	SD (MD)	Saved!	Saved!	SD (NMD)	Saved!
	p value (MD)	Saved!	Saved!	P value (NMD)	Saved!

Quality of Life (change) (EQ-5D Index score)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline vs. Followup
	Mean Difference (MD)	Saved!	Saved!	Net Mean Difference (NMD)	Saved!
	95% CI low (MD)	Saved!	Saved!	95% CI low (NMD)	Saved!
	95% CI high (MD)	Saved!	Saved!	95% CI high (NMD)	Saved!
	SD (MD)	Saved!	Saved!	SD (NMD)	Saved!
	p value (MD)	Saved!	Saved!	P value (NMD)	Saved!

Sleep Quality/Interference (change) (MOSS)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (Nabilone 0.5...) vs. Placebo (Placebo)
Baseline vs. Followup
	Mean Difference (MD)	Saved!	Saved!	Net Mean Difference (NMD)	Saved!
	95% CI low (MD)	Saved!	Saved!	95% CI low (NMD)	Saved!
	95% CI high (MD)	Saved!	Saved!	95% CI high (NMD)	Saved!
	SD (MD)	Saved!	Saved!	SD (NMD)	Saved!
	p value (MD)	Saved!	Saved!	P value (NMD)	Saved!

Risk of Bias Assessment

1. What kind of study is this?

Choose whether this is an RCT or an Observational Study

2. Randomization Adequate?

ROB2.0


	Yes

3. Did the study attempt to enroll all (or a random sample of) patients meeting inclusion criteria (inception cohort)?

4. Allocation Concealment Adequate?

Ottawa


	Yes

5. Groups similar at baseline?


	Unclear

6. Did the study use accurate methods for ascertaining exposures and potential confounders (i.e., age, sex, other medications)?

7. Patients masked?


	Yes

8. Care provider masked?


	Yes

9. Outcome assessors masked?


	Yes

10. Were outcome assessors and/or data analysts blinded to the exposure being studied?

11. Intention-to-treat (ITT) analysis?


	Yes

12. Did the study perform appropriate statistical analyses on potential confounders (i.e. age, sex, other medications)?

13. Acceptable levels of overall attrition?


	Yes

14. Acceptable levels of differential attrition?


	Yes

15. Did the article report attrition or missing data?

16. Is there important differential loss to followup or overall high loss to followup or missing data?

17. Were outcomes prespecified and defined, and ascertained using accurate methods?

18. Assessment of Bias

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Extraction form for project: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain

Design Details

1. Trial Name

2. What kind of study is this?

3. Month/Year Study Included

4. Setting

5. Study Design

6. Crossover Design

7. Pain Population

8. Pain Condition

9. Prior Cannabis Exposure

10. Age Measure (Mean, Median)

11. Age, Years

12. Female %

13. Race, White %

14. Race, Black %

15. Race, Hispanic/Latino %

16. Race, Asian %

17. Race, Other %

18. Pain Duration Measure (Mean, Median)

19. Pain Duration, Months

20. Psychiatric Comorbidity %

21. Opioid Use at Baseline

22. N Randomized

23. N Analyzed

24. Treatment Duration, weeks

25. Assessment Time Category

26. Funding Source

27. Companion Paper

Arms

Arm Details

1. Dose Received, mean

High THC/CBD ratio

Placebo

Outcomes

Outcome Details

1. Other Outcomes Reported (primary)

2. Other AE Outcomes of Importance reported

3. Notes

Results

Categorical

Pain Response ≥30% (NRS)

Any Adverse Event

Continuous

Pain Severity (change) (NRS and VAS)

Pain Interference (change) (MBPI)

Depression (change) (HADS-D)

Anxiety (change) (HADS-A)

Quality of Life (change) (EQ-5D Index score)

Sleep Quality/Interference (change) (MOSS)

Risk of Bias Assessment

1. What kind of study is this?

2. Randomization Adequate?

3. Did the study attempt to enroll all (or a random sample of) patients meeting inclusion criteria (inception cohort)?

4. Allocation Concealment Adequate?

5. Groups similar at baseline?

6. Did the study use accurate methods for ascertaining exposures and potential confounders (i.e., age, sex, other medications)?

7. Patients masked?

8. Care provider masked?

9. Outcome assessors masked?

10. Were outcome assessors and/or data analysts blinded to the exposure being studied?

11. Intention-to-treat (ITT) analysis?

12. Did the study perform appropriate statistical analyses on potential confounders (i.e. age, sex, other medications)?

13. Acceptable levels of overall attrition?

14. Acceptable levels of differential attrition?

15. Did the article report attrition or missing data?

16. Is there important differential loss to followup or overall high loss to followup or missing data?

17. Were outcomes prespecified and defined, and ascertained using accurate methods?

18. Assessment of Bias

Resources
Cite
Usage

Contact
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