scholarly journals Long-term and serious harms of medical cannabis and cannabinoids for chronic pain: A systematic review of non-randomized studies

2021 ◽  
Author(s):  
Dena Zeraatkar ◽  
Matthew Cooper ◽  
Arnav Agarwal ◽  
Robin Vernooij ◽  
Gareth Leung ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Adverse Events ◽  
Cochrane Central Register ◽  
Medical Cannabis ◽  
Management Options ◽  
Serious Adverse Events ◽  
Randomized Studies

Objective: To establish the risk and prevalence of long-term and serious harms of medical cannabis and cannabinoids for chronic pain. Design: Systematic review and meta-analysis. Data sources: MEDLINE, EMBASE, PsycInfo, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to April 1, 2020. Study selection: Non-randomized studies reporting on harms of medical cannabis or cannabinoids in people living with chronic pain with ≥4 weeks of follow-up. Data extraction and synthesis: A parallel guideline panel provided input on the design and interpretation of the systematic review, including selection of adverse events for consideration. Two reviewers, working independently and in duplicate, screened the search results, extracted data, and assessed risk of bias. We used random-effects models for all meta-analyses and the GRADE approach to evaluate the certainty of evidence. Results: We identified 39 eligible studies that enrolled 12,143 patients with chronic pain. Very low certainty evidence suggests that adverse events are common (prevalence: 26.0%; 95% CI 13.2 to 41.2) among users of medical cannabis or cannabinoids for chronic pain, particularly any psychiatric adverse events (prevalence: 13.5%; 95% CI 2.6 to 30.6). However, very low certainty evidence indicates serious adverse events, adverse events leading to discontinuation, cognitive adverse events, accidents and injuries, and dependence and withdrawal syndrome are uncommon and typically occur in fewer than one in 20 patients. We compared studies with <24 weeks and ≥ 24 weeks cannabis use and found more adverse events reported among studies with longer follow-up (test of interaction p < 0.01). Palmitoylethanolamide was usually associated with few to no adverse events. We found insufficient evidence addressing the harms of medical cannabis compared to other pain management options, such as opioids. Conclusions: There is very low certainty evidence that adverse events are common among people living with chronic pain who use medical cannabis or cannabinoids, but that few patients experience serious adverse events. Future research should compare long-term and serious harms of medical cannabis with other management options for chronic pain, including opioids.

scholarly journals A Systematic Review of Pediatric and Adult In-Flight Medical Emergencies

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Christina Sul ◽  
Sherif M. Badawy
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Health Outcomes ◽  
Pediatric Population ◽  
Air Travel ◽  
Serious Adverse Events ◽  
Significant Events ◽  
Medical Emergencies ◽  
The Subject

In-flight medical emergencies (IMEs) are acute onboard events of illnesses or injuries with potential immediate risk to a passenger’s short- or long-term health, or life. IMEs are significant events that are related to public safety concerns. With the increasing amount of annual air travel every year, it is expected that the number of encountered IMEs will continue to grow. Thus, it will be critical to develop and implement appropriate measures to manage IMEs with the best possible outcome. Despite the fact that most IMEs are self-limited with no serious adverse events, serious IME can lead to death, disability, or other unfavorable health outcomes, particularly as a result of suboptimal medical care. In this article, we systematically reviewed the published up-to-date evidence on the subject of in-flight emergencies with a specific focus on pediatric population.

Imatinib Long Term Effects (ILTE) Study: An Independent, International Study in CML Patients.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1099-1099
Author(s):  
Carlo Gambacorti-Passerini ◽  
Dong-Wook Kim ◽  
François-Xavier Mahon ◽  
Giuseppe Saglio ◽  
Fabrizio Pane ◽  
...  
Keyword(s):  
Adverse Events ◽  
International Study ◽  
Imatinib Treatment ◽  
Long Term Effects ◽  
First Line ◽  
Eligibility Criteria ◽  
Serious Adverse Events ◽  
Second Cancers

Abstract Imatinib is an effective first line therapy for chronic myeloid leukemia (CML) and has substantially changed its biological and clinical behavior. Durable complete cytogenetic responses (CCyR) were reported in the majority of patients, with a rather benign side effect profile, despite the ‘off target’ inhibition of several other kinases, including Kit, PDGFR and Lck. Since available information is largely based on industry-sponsored trials and long-term field studies are lacking, the ILTE study was conceived as an industryindependent, academic, multicenter trial supported by the Italian Drug Safety Agency (AIFA). ILTE is an international study on a retrospective cohort and includes 31 centers in Europe, North/South America, Africa and Asia; therefore it is uniquely positioned to present a global picture of imatinib long-term effects. Consecutive patients with Ph+ CML who started imatinib between 01 September 1999 and 31 December 2004 were eligible if they were in Complete Cytogenetic Response (CCyR) after two years of imatinib treatment. Study endpoints were survival, serious adverse events (SAE, including second cancers), toxicities not qualifying as SAE (NSAE) but judged by the referring physician as substantially impacting quality of life, loss of CCyR, and development of PCR negativity. A total of 957 patients were enrolled, 92% of which met eligibility criteria. The median age of eligible patients was 50 (range 15–92) years; 59% of patients were males and the median follow-up was 3.1 years (excluding the first 2 years of treatment). As of Dec. 31 2007, 2564 person years were available for analysis. Eleven deaths were observed (only 3 of them caused by relapsed CML), with a standardized rate of 0.4/100 person years and an observed/expected ratio of 0.48 (95% CI = 0.24–0.85). One-hundred SAE were recorded (rate 3.9/100 person years, most frequent type “heart failure”), with 21% being considered related to imatinib. Second cancers were documented in 28 patients (rate 1.1/100 person years), with an observed/expected ratio of 1.27 (95% CI = 0.84–1.84). Among the 576 NSAE recorded (0.65/patient) the most frequent types were “edema, cramps, skin fragility, diarrhea”; 71% of them were related to imatinib. A total of 12 patients (1.4 %) discontinued imatinib because of toxicities during the period of observation. Thirty-four patients lost CCyR, corresponding to a rate of 1.4/100 person years (1.0 in patients with imatinib as first-line treatment, 1.5 in patients who were treated with imatinib &gt;6 months after diagnosis), with stable or increasing rates over time. Finally, 214 patients (24.5%) developed durable (&gt; 1 year) PCR negativity. In conclusion, the first report from ILTE shows that CML patients on imatinib die unfrequently of CML related causes, do not appear to have substantially higher second cancer rates than the general population, have mortality rates lower than expected in an age/sex matched population and do not show new types of imatinib-related adverse events. They also experience a low but steady rate of loss of CCyR and develop PCR negativity in approximately ¼ of cases. Follow-up and further analysis are ongoing. (Presented on behalf of the ILTE Investigators group)

scholarly journals Long-term follow-up on effectiveness and safety of etanercept in juvenile idiopathic arthritis: the Dutch national register

2008 ◽  
Vol 68 (5) ◽  
pp. 635-641 ◽  
Author(s):  
F H M Prince ◽  
M Twilt ◽  
R ten Cate ◽  
M A J van Rossum ◽  
W Armbrust ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Adverse Events ◽  
Rheumatoid Factor ◽  
Serious Adverse Events ◽  
American College Of Rheumatology ◽  
Systemic Jia ◽  
Long Term Follow Up ◽  
Remission Criteria

Objective:We undertook an observational study to obtain a complete overview of the long-term effectiveness and safety of etanercept in patients with different juvenile idiopathic arthritis (JIA) subtypes.Methods:At baseline we collected patient and disease characteristics of all Dutch patients with JIA who started treatment with etanercept. Disease activity was evaluated (at start of the study, after 3 months and then yearly) according to the JIA core set of the American College of Rheumatology paediatric definition for 30, 50 and 70% improvement (ACR Pedi 30, 50 and 70). Use of etanercept and concomitant drugs was monitored. Adverse events were recorded.Results:We included 146 patients with JIA with a median follow-up of 2.5 years per patient (range 0.3–7.3). JIA subtypes represented: 27% systemic, 8% polyarticular rheumatoid factor positive, 38% polyarticular rheumatoid factor negative, 19% oligoarticular extended, 3% enthesitis-related and 5% psoriatica. Most patients (77%) met the criteria of the ACR Pedi 30 in the first 3 months of treatment. For the majority of patients this improvement was sustained; 53 (36%) of all patients met the remission criteria. No other second-line agents were needed in 43 patients. Although patients with systemic JIA responded initially less to etanercept therapy than patients from other subtypes, those who did respond showed equal effectiveness in the long term. Serious adverse events rate was low (0.029 per patient year).Conclusions:Etanercept is effective and safe in JIA, even for a large proportion of the patients with systemic JIA. The greatest improvement occurred in the first 3 months of treatment, and was sustained for a long time in most patients (up to 75 months).

scholarly journals LO58: Long-term outcomes among emergency department syncope patients: a systematic review

CJEM ◽  
2018 ◽  
Vol 20 (S1) ◽  
pp. S27-S27
Author(s):  
C. Leafloor ◽  
P. Jiho Hong ◽  
L. Sikora ◽  
J. Elliot ◽  
M. Mukarram ◽  
...  
Keyword(s):  
Systematic Review ◽  
Emergency Department ◽  
Phase 1 ◽  
Adverse Outcomes ◽  
Cochrane Central Register ◽  
Phase 2 ◽  
Long Term Outcomes ◽  
One Year

Introduction: Approximately 50% of patients discharged from the Emergency Department (ED) after syncope have no cause found. Long-term outcomes among syncope patients are not well studied, to guide physicians regarding outpatient testing and follow-up. The objective of this study was to conduct a systematic review for long-term (one year) outcomes among ED patients with syncope. We aim to use the results of this review to guide us in prospective analysis of one year outcomes with our large database of syncope patients. Methods: We searched Cochrane Central Register of Controlled Trials, Medline and Medline in Process, PubMed, Embase, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) from the inception to June, 2017. We included studies that reported long-term outcomes among adult ED patients (16 years or older) with syncope. We excluded studies on pediatric patients, and studies that included syncope mimickers: pre-syncope, seizure, intoxication, loss of consciousness after head trauma. We also excluded case reports, letters to the editor and review articles. Outcomes included death, syncope recurrence requiring hospitalization, arrhythmias and procedural interventions for arrhythmias. We selected articles based on title and abstract review during phase-1 and conducted full article review during phase-2. Meta-analysis was performed by pooling the outcomes using random effects model (RevMan v.5.3; Cochrane Collaboration). Results: Initial literature search generated 2094 articles after duplicate removal. 50 articles remained after phase-1 (=0.85) and 16 articles were included in the systematic review after phase-2 (=0.86). The 16 included studies enrolled a total of 44,755 patients. Pooled analysis at 1-year follow-up showed the following outcomes: 7% mortality; 14% recurrence of syncope requiring hospitalization; one study reported that 0.6% of patients had a pacemaker inserted; and two studies reported 0.8 11.5% of patients suffered new arrhythmias. Conclusion: An important proportion of ED patients with syncope suffer outcomes at 1-year. Appropriate follow-up is needed to prevent long-term adverse outcomes. Further prospective research to identify patients at risk for long-term important cardiac outcomes and death is needed.

Imatinib Long Term Effects (ILTE) Study: An International Study to Evaluate Long-Term Effects in CML Patients.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2199-2199
Author(s):  
Dong-Wook Kim ◽  
Laura Antolini ◽  
François-Xavier Mahon ◽  
Francois Guilhot ◽  
Michael Deininger ◽  
...  
Keyword(s):  
Adverse Events ◽  
Conflicts Of Interest ◽  
International Study ◽  
Imatinib Treatment ◽  
Long Term Effects ◽  
First Line ◽  
Serious Adverse Events ◽  
Second Cancers

Abstract Abstract 2199 Poster Board II-176 Imatinib is an effective first line therapy for chronic myeloid leukemia (CML) and has substantially changed its biological and clinical behavior. Durable complete cytogenetic responses (CCyR) were reported in the majority of patients, with a rather benign side effect profile, despite the ‘off target’ inhibition of several other kinases, including Kit, PDGFR and Lck. Since available information is largely based on sponsored trials and long-term field studies are lacking, the ILTE study was conceived as an independent, academic, multicenter trial supported by the Italian Drug Safety Agency (AIFA) and Regione Lombardia. ILTE is an international study on a retrospective cohort and includes 31 centers in Europe, North/South America, Africa, Middle East and Asia; therefore it is uniquely positioned to present a global picture of imatinib long-term effects. Consecutive patients with Ph+ CML who started imatinib between 01 September 1999 and 31 December 2004 were eligible if they were in CCyR after two years of imatinib treatment. Study endpoints were (a) survival, (b), serious adverse events (SAE, including second cancers), (c) toxicities not qualifying as SAE (NSAE) but judged by the referring physician as substantially impacting quality of life, (d) loss of CCyR, and (e) development of PCR negativity. A total of 948 patients were enrolled, 88% of which met eligibility criteria after centers were visited and monitored. The median age of eligible patients was 51 (range 18-92) years; 59% of patients were males and the median follow-up was 4.0 years (excluding the first 2 years of treatment). As of Dec. 31 2008, 3255 person years were available for analysis. Twenty one deaths were observed (only 6 of them [28%] caused by relapsed CML), with a standardized rate of 0.6/100 person years and an observed/expected ratio of 0.7 (95% CI = 0.43-1.07, p=ns). A total of 138 SAE were recorded (rate 4.2/100 person years, most frequent type “heart failure”), with 19.5% being considered related to imatinib. Second cancers were documented in 29 patients (rate 0.9/100 person years), with an observed/expected ratio of 1.02. Among the 761 NSAE recorded (rate 23.4/100 person years) the most frequent types were cramps, asthenia,edema, skin fragility, diarrhea; 69% of them were considered related to imatinib. A total of 18 patients (2.2 %) discontinued imatinib because of toxicities during the period of observation. Forty patients lost CCyR, corresponding to a rate of 1.3/100 person years (1.0 in patients with imatinib as first-line treatment, 1.4 in patients who were treated with imatinib >6 months after diagnosis), with stable or increasing rates over time. Finally, 256 patients (36.0 %) developed durable (> 1 year) PCR negativity. In conclusion, this report from ILTE shows that CML patients on imatinib die unfrequently of CML related causes, do not appear to have substantially higher second cancer rates than the general population, have mortality rates similar to an age/sex matched population and do not show new types of imatinib-related adverse events. They also experience a low but steady rate of loss of CCyR and develop PCR negativity in approximately 1/3 of cases. Follow-up and further analysis are ongoing. (Presented on behalf ofthe ILTE Investigators group) Disclosures: No relevant conflicts of interest to declare.

scholarly journals Efficacy and safety of edaravone for acute intracerebral haemorrhage: protocol for a systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e039366
Author(s):  
Luda Feng ◽  
Ning Liang ◽  
Tingting Li ◽  
Qinyu Yang ◽  
Ping Jiang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Intracerebral Haemorrhage ◽  
Meta Analysis ◽  
Grey Literature ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Routine Treatment ◽  
Manual Search

IntroductionIntracerebral haemorrhage (ICH) is a life-threatening condition with no effective internal treatment options. However, edaravone is a promising therapeutic agent, although its beneficial effects are inconclusive based on previous systematic reviews and meta-analyses. While several trials in the last 8 years have reported the favourable long-term functional outcomes, a few reports indicated edaravone to be associated with an increase in adverse events.Methods and analysisThis protocol was performed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. We will perform the comprehensive and manual search for published articles, ongoing trials, dissertations and grey literature. The following databases will be searched from inception to 23 April 2020: Medline, Embase, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese scientific periodical database of VIP INFORMATION, Wanfang Data and SinoMed, with no language restrictions. All randomised controlled trials that (1) compared edaravone with placebo or no treatment, and (2) compared edaravone plus routine treatment or cointervention with routine treatment or cointervention for treating acute ICH will be included. Mortality and long-term dependency will be the primary outcomes. The incidence of adverse events will be assessed for safety evaluation. Two reviewers in pairs will independently carry out the article selection, data extraction and quality assessment. Assessment of the risk of bias and data synthesis will be performed using software Review Manager V.5.3. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the quality of the overall evidence.Ethics and disseminationThere are no ethical considerations associated with this updated systematic review and meta-analysis. The findings will be disseminated in peer-reviewed journals or conference presentations.PROSPERO registration numberCRD42019147801.

Golimumab for Rheumatoid Arthritis: A Systematic Review

2010 ◽  
Vol 37 (6) ◽  
pp. 1096-1104 ◽  
Author(s):  
JASVINDER A. SINGH ◽  
SHAHRZAD NOORBALOOCHI ◽  
GURKIRPAL SINGH
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
Adverse Events ◽  
Absolute Risk ◽  
Health Assessment ◽  
Risk Difference ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Serious Adverse Events ◽  
Percentage Difference

Objective.To perform a Cochrane systematic review of benefit (American College of Rheumatology 50% improvement criteria; ACR50) and safety (adverse events and withdrawals) of golimumab in patients with rheumatoid arthritis (RA).Methods.We searched the Cochrane Central Register of Controlled Trials (CENTRAL), OVID Medline, CINAHL, Embase, Science Citation Index (Web of Science), and Current Controlled Trials databases for randomized or controlled clinical trials of golimumab compared to placebo or disease-modifying antirheumatic drug in adults with RA. Two authors independently selected appropriate studies and abstracted study characteristics and safety and efficacy data and performed risk-of-bias assessment. We calculated mean differences for continuous measures, and relative risks for categorical measures.Results.Four randomized controlled trials with 1231 golimumab-treated and 483 placebo-treated patients were included. Of these, 436 were treated with golimumab at 50 mg every 4 weeks [a dosage approved by the US Food and Drug Administration (FDA)]. At an average of 4–6 months, compared to patients treated with placebo and methotrexate (MTX), patients treated with the FDA-approved dosage of golimumab and MTX were 2.6 times more likely to reach ACR50 (p = 0.005, 95% CI 1.3, 4.9; absolute percentage, 38% vs 15%) and 0.5 times as likely to have overall withdrawals (p = 0.005, 95% CI 0.3, 0.8; absolute percentage, 5% vs 10%). Golimumab-treated patients were significantly more likely than those taking placebo to achieve remission (22% vs 4%; p < 0.00001), and to have improvement in functional ability on the Health Assessment questionnaire [0.2 points lower (p < 0.00001, 95% CI 0.25, 0.15); absolute risk difference, −20% (95% CI −25% to −15%); relative percentage difference, −11% (95% CI −14% to −8.3%)]. The studies were too small and short to be powered sufficiently for safety outcomes, but no substantive statistically significant differences were noted between golimumab and placebo regarding adverse events, serious adverse events, infections, serious infections, lung infections, tuberculosis, cancer, withdrawals due to adverse events, and withdrawals due to inefficacy and deaths.Conclusion.At the approved dosage, in patients with active RA taking background MTX, golimumab is significantly more beneficial than placebo. The short-term safety profile is reasonable. Longterm surveillance studies are needed for safety assessment.

Five-year follow-up of patients enrolled in the NEAT 001/ANRS 143 randomized clinical trial: NEAT 001/ANRS 143 LONG TERM study

2020 ◽  
Vol 75 (6) ◽  
pp. 1618-1622
Author(s):  
François Raffi ◽  
Aurélie Gaultier ◽  
Anton Pozniak ◽  
Jean-Michel Molina ◽  
Heiko Jessen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Randomized Clinical Trial ◽  
Virological Failure ◽  
Tenofovir Disoproxil Fumarate ◽  
Integrase Inhibitor ◽  
Serious Adverse Events ◽  
Long Term Study

Abstract Background Few long-term data are available in subjects having initiated ART with an NRTI-sparing regimen. Objectives Outcomes of subjects enrolled in the NEAT 001/ANRS 143 randomized clinical trial (comparing ritonavir-boosted darunavir + raltegravir versus ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were retrospectively collected, through anonymized electronic case report forms, up to 6 years post-enrolment. Methods The last NEAT 001 visit (Week 96) was conducted in 745/805 randomized subjects (363/401 ritonavir-boosted darunavir + raltegravir and 382/404 ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine). Of these, 430 were enrolled in NEAT 001/ANRS 143 LONG TERM (NLT) study (201 raltegravir, 229 tenofovir disoproxil fumarate/emtricitabine), with a median follow-up of 44.4 months. Results During NLT follow-up, the proportion of AIDS, non-AIDS events, virological rebound and serious adverse events, discontinuation for virological failure and for adverse events did not differ between groups; discontinuations for virological failure since NEAT 001 inclusion were more frequent in subjects with baseline CD4 &lt;200 cells/mm3 (11.9% versus 5.3%; P = 0.077). At last follow-up, a quarter of subjects (22.2% for ritonavir-boosted darunavir + raltegravir and 29.7% for ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were still receiving their initial regimen. Integrase inhibitor exposure was not associated with weight gain (P = 0.48), while tenofovir disoproxil fumarate exposure was associated with a trend to higher creatinine increase (P = 0.067). Conclusions After a median of 5.6 years, subjects initiating ritonavir-boosted darunavir + raltegravir or ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine experienced few serious clinical adverse events. Most discontinuations were for reasons unrelated to adverse events or virological failure.

scholarly journals Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain: May 2021 Update

2021 ◽  
Author(s):  
Marian S. McDonagh ◽  
Jesse Wagner ◽  
Azrah Y. Ahmed ◽  
Benjamin Morasco ◽  
Devan Kansagara ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Adverse Events ◽  
Progress Report ◽  
Pain Severity ◽  
Short Term Treatment ◽  
Serious Adverse Events ◽  
Whole Plant ◽  
Increased Risk ◽  
The Impact

Overview This is the third quarterly progress report for an ongoing living systematic review on cannabis and other plant-based treatments for chronic pain. The first progress report was published in January 2021 and the second in March 2021. The draft systematic review was available for public comment from May 19 through June 15, 2021, on the Agency for Healthcare Research and Quality (AHRQ) Effective Health Care website. The systematic review synthesizes evidence on the benefits and harms of plant-based compounds (PBCs), such as cannabinoids and kratom, used to treat chronic pain, addressing concerns about severe adverse effects, abuse, misuse, dependence, and addiction. The purpose of this progress report is to describe the cumulative literature identified thus far. This report will be periodically updated with new studies as they are published and identified, culminating in an annual systematic review that provides a synthesis of the accumulated evidence. Main Points In patients with chronic (mainly neuropathic) pain with short-term treatment (4 weeks to <6 months): • Studies of cannabis-related products were grouped based on their tetrahydrocannabinol (THC) to cannabidiol (CBD) ratio using the following categories: high THC to CBD, comparable THC to CBD, and low THC to CBD. • Comparable THC to CBD ratio oral spray is probably associated with small improvements in pain severity and may be associated with small improvements in function. There was no effect in pain interference or serious adverse events. There may be a large increased risk of dizziness and sedation, and a moderate increased risk of nausea. • Synthetic THC (high THC to CBD) may be associated with moderate improvement in pain severity and increased risk of sedation, and large increased risk of nausea. Synthetic THC is probably associated with a large increased risk of dizziness. • Extracted whole-plant high THC to CBD ratio products may be associated with large increases in risk of withdrawal due to adverse events and dizziness. • Evidence on whole-plant cannabis, low THC to CBD ratio products (topical CBD), other cannabinoids (cannabidivarin), and comparisons with other active interventions was insufficient to draw conclusions. • Other key adverse event outcomes (psychosis, cannabis use disorder, cognitive deficits) and outcomes on the impact on opioid use were not reported. • No evidence on other plant-based compounds, such as kratom, met criteria for this review.

Medical Cannabis and Cannabinoids for Impaired Sleep: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

SLEEP ◽  
2021 ◽  
Author(s):  
Mahmood AminiLari ◽  
Li Wang ◽  
Samuel Neumark ◽  
Taranah Adli ◽  
Rachel J Couban ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Cancer Pain ◽  
Sleep Disturbance ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Medical Cannabis ◽  
Impaired Sleep ◽  
Small Improvement

Abstract Study Objectives We conducted a systematic review to explore the effectiveness of medical cannabis for impaired sleep. Methods We searched MEDLINE, EMBASE, CENTRAL and PsychINFO to January 2021 for randomized trials of medical cannabis or cannabinoids for impaired sleep vs. any non-cannabis control. When possible, we pooled effect estimates for all patient-important sleep-related outcomes and used the GRADE approach to appraise the certainty of evidence. Results Thirty-nine trials (5,100 patients) were eligible for review, of which 38 evaluated oral cannabinoids and 1 administered inhaled cannabis. The median follow-up was 35 days, and most trials (33 of 39) enrolled patients living with chronic cancer or noncancer chronic pain. Among patients with chronic pain, moderate certainty evidence found that medical cannabis probably results in a small improvement in sleep quality versus placebo (modeled risk difference [RD] for achieving the minimally important difference [MID], 8% [95% CI, 3 to 12]). Moderate to high certainty evidence shows that medical cannabis vs. placebo results in a small improvement in sleep disturbance for chronic non-cancer pain (modeled RD for achieving the MID, 19% [95% CI, 11 to 28]) and a very small improvement in sleep disturbance for chronic cancer pain (WMD of -0.19cm [95%CI, -0.36 to -0.03cm]; interaction p=0.03). Moderate to high certainty evidence shows medical cannabis, versus placebo, results in a substantial increase in the risk of dizziness (RD 29% [95%CI, 16 to 50], for trials with ≥3 months follow-up), and a small increase in the risk of somnolence, dry mouth, fatigue, and nausea (RDs ranged from 6% to 10%). Conclusion Medical cannabis and cannabinoids may improve impaired sleep among people living with chronic pain, but the magnitude of benefit is likely small.

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