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


	Brazil

5. Study Design


	RCT

6. Crossover Design

Is this a crossover trial?


	Yes No

7. Pain Population


	Fibromyalgia

8. Pain Condition

Add specific condition here if specified


	Fibromyalgia

9. Prior Cannabis Exposure


	NR

10. Age Measure (Mean, Median)


	Mean

11. Age, Years

Input the mean or median age for the entire sample


	52

12. Female %

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


	100

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)


	NR

19. Pain Duration, Months


	NR

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.


	Previous use of opioids: Cannabis group: 25% Placebo group: 33%

22. N Randomized


	18

23. N Analyzed


	17

24. Treatment Duration, weeks

25. Assessment Time Category

26. Funding Source

27. Companion Paper


	None

Arms

Arm Name	Arm Description
High THC/CBD ratio	One drop of ~1.2 mg THC/0.02 mg CBD a day sublingually, with dose increased as needed throughout evaluations
Placebo	Placebo (olive oil)

Arm Details

1. Dose Received, mean

High THC/CBD ratio


	mean 3.6 drops/day

Placebo


	mean 4.3 drops/day

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Continuous	Pain Severity (Change)	Fibromyalgia Impact Questionnaire - Pain Component	All Participants	Baseline Followup
Continuous	Function/Disability (change)	FIQ	All Participants	Baseline Followup
Categorical	Withdrawals Due to Adverse Events		All Participants	Followup
Continuous	Depression (change)	FIQ	All Participants	Baseline Followup
Continuous	Anxiety (change)	FIQ	All Participants	Baseline Followup
Continuous	Quality of Life (change)	FIQ	All Participants	Baseline 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


	NA

3. Notes


	Treatment group Somnolence: 87.5% Dizziness: 25% Mouth dryness: 25% Placebo group Somnolence: 11%

Results

Categorical

Withdrawals Due to Adverse Events

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) (Fibromyalgia Impact Questionnaire - Pain Component)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (One drop of...) 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 (One drop of...) 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!

Function/Disability (change) (FIQ)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (One drop of...) 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 (One drop of...) 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) (FIQ)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (One drop of...) 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 (One drop of...) 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) (FIQ)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (One drop of...) 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 (One drop of...) 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) (FIQ)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		High THC/CBD ratio	Placebo		High THC/CBD ratio (One drop of...) 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 (One drop of...) 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?


	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?


	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

Withdrawals Due to Adverse Events

Continuous

Pain Severity (Change) (Fibromyalgia Impact Questionnaire - Pain Component)

Function/Disability (change) (FIQ)

Depression (change) (FIQ)

Anxiety (change) (FIQ)

Quality of Life (change) (FIQ)

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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