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


	December 2020

4. Setting

List country or continent


	Europe

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


	HIV-associated

9. Prior Cannabis Exposure


	Excluded use of conventional cannabinoids

10. Age Measure (Mean, Median)


	Mean

11. Age, Years

Input the mean or median age for the entire sample


	50

12. Female %

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


	3

13. Race, White %

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


	NR

14. Race, Black %

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


	NR

15. Race, Hispanic/Latino %

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


	NR

16. Race, Asian %


	NR

17. Race, Other %

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


	NR

18. Pain Duration Measure (Mean, Median)


	Mean

19. Pain Duration, Months


	157

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


	34

23. N Analyzed


	32

24. Treatment Duration, weeks

25. Assessment Time Category

26. Funding Source

27. Companion Paper


	None

Arms

Arm Name	Arm Description
Other cannabinoid	Cannabidivarin (CBDV oral solution 50 mg)/mL 400 mg (8 ml) daily
Placebo	Placebo oral solution

Arm Details

1. Dose Received, mean

Other cannabinoid


	400 mg/day

Placebo


	8 ml/day

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	All Participants	Baseline Followup
Continuous	Pain Interference (change)	BPI-Influence on Daily Living	All Participants	Baseline Followup
Continuous	Depression (change)	HADS-D	All Participants	Baseline Followup
Continuous	Anxiety (change)	HADS-A	All Participants	Baseline Followup
Continuous	Sleep Quality/Interference (change)	ISI	All Participants	Baseline Followup
Categorical	Any Adverse Event		All Participants	Followup
Categorical	Serious Adverse Events		All Participants	Followup
Categorical	Withdrawals Due to Adverse Events		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


	Diarrhea, dry mouth (3 cases each, unclear which group)

3. Notes

Results

Categorical

Pain Response ≥30% (NRS)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Other cannabinoid	Placebo
Followup
	Total (N analyzed)			Mean Difference (MD)
	Events			95% CI low (MD)
	Percentage			95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		Other cannabinoid	Placebo

Any Adverse Event

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Other cannabinoid	Placebo
Followup
	Total (N analyzed)			Mean Difference (MD)
	Events			95% CI low (MD)
	Percentage			95% CI high (MD)
				SD (MD)
				p value (MD)
				Odds Ratio (OR)
				95% CI low (OR)
				95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Other cannabinoid	Placebo

Serious Adverse Events

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Other cannabinoid	Placebo
Followup
	Total (N analyzed)			Mean Difference (MD)
	Events			95% CI low (MD)
	Percentage			95% CI high (MD)
				SD (MD)
				p value (MD)
				Odds Ratio (OR)
				95% CI low (OR)
				95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Other cannabinoid	Placebo

Withdrawals Due to Adverse Events

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Other cannabinoid	Placebo
Followup
	Total (N analyzed)			Mean Difference (MD)
	Events			95% CI low (MD)
	Percentage			95% CI high (MD)
				SD (MD)
				p value (MD)
				Odds Ratio (OR)
				95% CI low (OR)
				95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Other cannabinoid	Placebo

Continuous

Pain Severity (change) (NRS)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Other cannabinoid	Placebo		Other cannabinoid (Cannabidivari...) vs. Placebo (Placebo oral...)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
		Within Arm Comparisons			Net Comparisons
		Other cannabinoid	Placebo		Other cannabinoid (Cannabidivari...) vs. Placebo (Placebo oral...)
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) (BPI-Influence on Daily Living)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Other cannabinoid	Placebo		Other cannabinoid (Cannabidivari...) vs. Placebo (Placebo oral...)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
		Within Arm Comparisons			Net Comparisons
		Other cannabinoid	Placebo		Other cannabinoid (Cannabidivari...) vs. Placebo (Placebo oral...)
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
		Other cannabinoid	Placebo		Other cannabinoid (Cannabidivari...) vs. Placebo (Placebo oral...)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
		Within Arm Comparisons			Net Comparisons
		Other cannabinoid	Placebo		Other cannabinoid (Cannabidivari...) vs. Placebo (Placebo oral...)
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
		Other cannabinoid	Placebo		Other cannabinoid (Cannabidivari...) vs. Placebo (Placebo oral...)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
		Within Arm Comparisons			Net Comparisons
		Other cannabinoid	Placebo		Other cannabinoid (Cannabidivari...) vs. Placebo (Placebo oral...)
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) (ISI)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Other cannabinoid	Placebo		Other cannabinoid (Cannabidivari...) vs. Placebo (Placebo oral...)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
		Within Arm Comparisons			Net Comparisons
		Other cannabinoid	Placebo		Other cannabinoid (Cannabidivari...) vs. Placebo (Placebo oral...)
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


	Unclear

5. Groups similar at baseline?


	Yes

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?


	Unclear

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

ResourcesCiteUsage

ContactAboutContact

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

Other cannabinoid

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

Serious Adverse Events

Withdrawals Due to Adverse Events

Continuous

Pain Severity (change) (NRS)

Pain Interference (change) (BPI-Influence on Daily Living)

Depression (change) (HADS-D)

Anxiety (change) (HADS-A)

Sleep Quality/Interference (change) (ISI)

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
About
Contact