The Safety and Efficacy of Low-Dose Naltrexone in Patients with Fibromyalgia: A Systematic Review.

Fibromyalgia (FM) is a chronic pain sensitivity syndrome characterized by diffuse musculoskeletal pain and many other systemic manifestations. Low-dose naltrexone (LDN) has been increasingly used as an off-label treatment option in FM. However, current evidence on the safety and efficacy of LDN in patients with FM is not well known. To systematically assess the current evidence on the safety and efficacy of LDN use in the treatment of FM. A comprehensive bibliographic search was conducted on EBM Reviews - Cochrane Central Register of Controlled Trials, EBM Reviews - Cochrane Database of Systematic, Embase, Ovid MEDLINE(R) and Epub Ahead of Print, In-Process, In-Data-Review & Other Non-Indexed Citations, Daily and Versions and Scopus databases in September 2022. Inclusion criteria were articles that were published in English, focusing on clinical trials involving LDN for the treatment of FM. Two reviewers independently screened and extracted the data. A qualitative analysis was used due to the high methodological heterogeneity between studies. The electronic search produced 805 articles. After applying the inclusion criteria, 9 articles (one RCT, two case reports, two case series, and four pilot trials) were selected for evaluation. LDN intervention protocols, study designs, and follow-up periods were different among the included studies. Overall, LDN was found to be effective in the symptomatic management of FM, and of the 78% of included studies that evaluated for safety, no severe adverse events were reported. Proving the efficacy and safety of low-dose naltrexone is a future possibility based on current study data, but the level of scientific evidence is limited. Future well-designed trials with large sample sizes are required.

Association of Neutralizing Antispike Monoclonal Antibody Treatment With Coronavirus Disease 2019 Hospitalization and Assessment of the Monoclonal Antibody Screening Score.

Objective: To test the hypothesis that the Monoclonal Antibody Screening Score performs consistently better in identifying the need for monoclonal antibody infusion throughout each "wave" of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant predominance during the coronavirus disease 2019 (COVID-19) pandemic and that the infusion of contemporary monoclonal antibody treatments is associated with a lower risk of hospitalization. Patients and Methods: In this retrospective cohort study, we evaluated the efficacy of monoclonal antibody treatment compared with that of no monoclonal antibody treatment in symptomatic adults who tested positive for SARS-CoV-2 regardless of their risk factors for disease progression or vaccination status during different periods of SARS-CoV-2 variant predominance. The primary outcome was hospitalization within 28 days after COVID-19 diagnosis. The study was conducted on patients with a diagnosis of COVID-19 from November 19, 2020, through May 12, 2022. Results: Of the included 118,936 eligible patients, hospitalization within 28 days of COVID-19 diagnosis occurred in 2.52% (456/18,090) of patients who received monoclonal antibody treatment and 6.98% (7,037/100,846) of patients who did not. Treatment with monoclonal antibody therapies was associated with a lower risk of hospitalization when using stratified data analytics, propensity scoring, and regression and machine learning models with and without adjustments for putative confounding variables, such as advanced age and coexisting medical conditions (eg, relative risk, 0.15; 95% CI, 0.14-0.17). Conclusion: Among patients with mild to moderate COVID-19, including those who have been vaccinated, monoclonal antibody treatment was associated with a lower risk of hospital admission during each wave of the COVID-19 pandemic.

Preoperative Management of Cardiovascular Medications: A Society for Perioperative Assessment and Quality Improvement (SPAQI) Consensus Statement.

Cardiovascular conditions such as hypertension, arrhythmias, and heart failure are common in patients undergoing anesthesia for surgical or other procedures. Numerous guidelines from various specialty societies offer variable recommendations for the perioperative management of these medications. The Society for Perioperative Assessment and Quality Improvement identified a need to provide multidisciplinary evidence-based recommendations for preoperative medication management. The society convened a group of 13 members with expertise in perioperative medicine and training in anesthesiology or internal medicine. The aim of this consensus effort is to provide perioperative clinicians with guidance on the management of cardiovascular medications commonly encountered during the preoperative evaluation. We used a modified Delphi process to establish consensus. Twenty-one classes of medications were identified: α-adrenergic receptor antagonists, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, angiotensin receptor-neprilysin inhibitors, ß-adrenoceptor blockers, calcium-channel blockers, centrally acting sympatholytic medications, direct-acting vasodilators, loop diuretics, thiazide diuretics, potassium-sparing diuretics, endothelin receptor antagonists, cardiac glycosides, nitrodilators, phosphodiesterase-5 inhibitors, class III antiarrhythmic agents, potassium-channel openers, renin inhibitors, class I antiarrhythmic agents, sodium-channel blockers, and sodium glucose cotransportor-2 inhibitors. We provide recommendations for the management of these medications preoperatively.

Preoperative Evaluation and Management of Patients With Select Chronic Gastrointestinal, Liver, and Renal Diseases.

Patients with chronic gastrointestinal, hepatic, and renal disease are frequently encountered in clinical practice. This is due in part to the rising prevalence of risk factors associated with these conditions. These patients are increasingly being considered for surgical intervention and are at higher risk for multiple perioperative complications. Many are able to safely undergo surgery but require unique considerations to ensure optimal perioperative care. In this review, we highlight relevant perioperative physiology and outline our approach to the evaluation and management of patients with select chronic gastrointestinal, hepatic, and renal diseases. A comprehensive preoperative evaluation with a multidisciplinary approach is often beneficial, and specialist involvement should be considered. Intraoperative and postoperative plans should be individualized based on the unique medical and surgical characteristics of each patient.

Ginseng for the Treatment of Chronic Fatigue Syndrome: A Systematic Review of Clinical Studies.

BACKGROUND: Chronic fatigue syndrome (CFS) is a complex and often disabling chronic condition emerging worldwide, with no curative or definitive therapy yet identified. Ginseng has been widely used to treat fatigue in other patient groups and conditions; however, a systematic review focusing solely on the impact of ginseng on fatigue in patients with CFS has not been performed. OBJECTIVE: This study aimed to assess the current state of evidence regarding ginseng for CFS. METHODS: Multiple databases were searched from inception to October 2020. All data was extracted independently and in duplicates. Outcomes of interest included the effectiveness and safety of ginseng in patients with CFS. RESULTS: 2 studies enrolling 68 patients were deemed eligible, including one randomized clinical trial and one prospective observational study. The certainty of evidence in the effectiveness outcome was low and moderate from both studies, while the safety evidence was very low as reported from one study. CONCLUSION: Study findings highlight a potential benefit of ginseng therapy in the treatment of CFS. However, we are not able to draw firm conclusions due to limited clinical studies. The paucity of data warrants limited confidence. There is a need for future rigorous studies to provide further evidence.

The Female-Predominant Persistent Immune Dysregulation of the Post-COVID Syndrome.

OBJECTIVE: To describe the clinical data from the first 108 patients seen in the Mayo Clinic post-COVID-19 care clinic (PCOCC). METHODS: After Institutional Review Board approval, we reviewed the charts of the first 108 patients seen between January 19, 2021, and April 29, 2021, in the PCOCC and abstracted from the electronic medical record into a standardized database to facilitate analysis. Patients were grouped into phenotypes by expert review. RESULTS: Most of the patients seen in our clinic were female (75%; 81/108), and the median age at presentation was 46 years (interquartile range, 37 to 55 years). All had post-acute sequelae of SARS-CoV-2 infection, with 6 clinical phenotypes being identified: fatigue predominant (n=69), dyspnea predominant (n=23), myalgia predominant (n=6), orthostasis predominant (n=6), chest pain predominant (n=3), and headache predominant (n=1). The fatigue-predominant phenotype was more common in women, and the dyspnea-predominant phenotype was more common in men. Interleukin 6 (IL-6) was elevated in 61% of patients (69% of women; P=.0046), which was more common than elevation in C-reactive protein and erythrocyte sedimentation rate, identified in 17% and 20% of cases, respectively. CONCLUSION: In our PCOCC, we observed several distinct clinical phenotypes. Fatigue predominance was the most common presentation and was associated with elevated IL-6 levels and female sex. Dyspnea predominance was more common in men and was not associated with elevated IL-6 levels. IL-6 levels were more likely than erythrocyte sedimentation rate and C-reactive protein to be elevated in patients with post-acute sequelae of SARS-CoV-2 infection.

Effectiveness of Monoclonal Antibodies in Preventing Severe COVID-19 With Emergence of the Delta Variant.

Anti-spike monoclonal antibodies have proven invaluable in preventing severe outcomes from COVID-19, including hospitalization and death. The rise of the SARS-CoV-2 delta variant begs the question of whether monoclonal antibodies maintain similar efficacy now as they had when the alpha and beta variants predominated, when they were first assessed and approved. We used a retrospective cohort to compare rates of severe outcomes in an epoch in which alpha and beta were predominant compared with delta. A total of 5356 patients were infused during the alpha/beta variant-predominant (n=4874) and delta variant-predominant (n=482) era. Overall, odds of severe infection were 3.0% of patients in the alpha/beta-predominant era compared with 4.9% in the delta-predominant cohort. The unadjusted odds ratio (OR) was higher for severe disease in the delta era (OR, 1.67; 95% CI, 0.96 to 2.89), particularly when adjusted for Charlson Comorbidity Index (adjusted OR, 2.04; 95% CI, 1.30 to 3.08). The higher odds of severe infection could be due to a more virulent delta variant, although the possibility of decreased anti-spike monoclonal antibody effectiveness in the clinical setting cannot be excluded. Research into the most effective strategies for using and improving anti-spike monoclonals for the treatment of emerging variants is warranted.

Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities.

BACKGROUND: Breakthrough coronavirus disease 2019 (COVID-19) may occur in fully vaccinated persons. METHODS: We assessed the clinical outcomes of breakthrough COVID-19 in fully vaccinated individuals. RESULTS: In this cohort of 1395 persons (mean age, 54.3 years; 60% female; median body mass index, 30.7) who developed breakthrough COVID- 19, there were 107 (7.7%) who required hospitalization by day 28. Hospitalization was significantly associated with the number of medical comorbidities. Antispike monoclonal antibody treatment was significantly associated with a lower risk of hospitalization (odds ratio, 0.227; 95% confidence interval, 0.128-0.403; P < .001). The number needed to treat (NNT) to prevent 1 hospitalization was 225 among the lowest risk patient group compared with NNT of 4 among those with highest numbers of medical comorbidity. CONCLUSIONS: Monoclonal antibody treatment is associated with reduced hospitalization in vaccinated high-risk persons with mild to moderate COVID-19.

Breakthrough COVID-19 after SARS-CoV-2 vaccination in solid organ transplant recipients: An analysis of symptomatic cases and monoclonal antibody therapy.

BACKGROUND: Solid organ transplant (SOT) recipients are at increased risk for complications from SARS-CoV-2 infection. Little is known regarding clinical course and outcomes of breakthrough COVID-19 in the fully vaccinated SOT population. We sought to describe our cohort of SOT recipients who developed symptomatic breakthrough COVID-19 after full vaccination. METHODS: We conducted a retrospective review of SOT recipients diagnosed with COVID-19 at least 14 days after completing SARS-CoV-2 vaccination. Patients were analyzed according to those presenting with mild-to-moderate and severe COVID-19, respectively. We described presenting characteristics, COVID-19 therapy, and analyzed outcomes including emergency department (ED) visits, hospitalization, and intensive care unit (ICU) admission. RESULTS: Thirty-five patients met inclusion criteria. These had a mean age of 60.8 years and kidney transplant was the most common SOT type. Five patients presented with severe COVID-19 at diagnosis, all requiring hospitalization without ICU admission. From the 30 patients who presented with mild-to-moderate infection, 28 received casirivimab-imdevimab. Four of these 28 (14.3%) had an ED visit, with one requiring hospital admission (3.4%). No patients required ICU admission. CONCLUSION: Breakthrough COVID-19 may occur in SOT recipients after full vaccination, though they appear to have acceptable outcomes. Anti-spike monoclonal antibody therapy for eligible SOT patients may have mitigated clinical progression and improved the outcomes. Further study with large cohorts is warranted.

Breakthrough COVID-19 and casirivimab-imdevimab treatment during a SARS-CoV-2 B1.617.2 (Delta) surge.

INTRODUCTION: The impact of vaccination and casirivimab-imdevimab monoclonal antibody treatment on the clinical outcome of COVID-19 during a period of SARS-CoV-2 Delta surge is not known. AIM AND METHODS: All patients with COVID-19 at our facilities in the US Midwest were enrolled to assess breakthrough cases among vaccinated individuals and to compare the rates of hospitalization between casirivimab-imdevimab treated versus untreated patients. The study period occurred in July 2021 during a period dominated by the Delta variant. RESULTS: The majority (68.1%) of 630 COVID-19 cases occurred in unvaccinated individuals. Among 403 patients eligible for monoclonal antibody treatment, the 28-day hospitalization rate was 2.6% of 112 patients who received treatment with casirivimab-imdevimab, compared to 16.6% of 291 eligible high-risk patients who did not receive casirivimab-imdevimab (Odds Ratio [OR]: 0.138, 95% confidence interval (CI): 0.0426-0.4477, p = 0.001). Casirivimab-imdevimab treatment was associated with lower rates of hospitalization among the vaccinated and unvaccinated cohorts. CONCLUSIONS: During a SARS-CoV-2 Delta surge, breakthrough COVID-19 occurred among vaccinated persons, especially among those with multiple medical comorbidities. Casirivimab-imdevimab treatment was associated with significantly lower rates of hospitalization in vaccinated and unvaccinated persons.

Monoclonal Antibody Therapy for COVID-19 in Solid Organ Transplant Recipients.

BACKGROUND: Bamlanivimab and casirivimab-imdevimab are authorized for emergency use treatment of mild to moderate coronavirus disease 2019 (COVID-19) in patients at high risk for developing severe disease or hospitalization. Their safety and efficacy have not been specifically evaluated in solid organ transplant recipients. METHODS: We retrospectively reviewed solid organ transplant recipients who received monoclonal antibody infusion for COVID-19 at Mayo Clinic sites through January 23, 2021. Outcomes included emergency department visit, hospitalization, mortality, and allograft rejection. RESULTS: Seventy-three patients were treated, most commonly with bamlanivimab (75.3%). The median age was 59 years, 63% were male, and the median Charlson comorbidity index was 5. Transplant type included 41 kidney (56.2%), 13 liver (17.8%), 11 heart (15.1%), 4 kidney-pancreas (5.5%), 2 lung (2.7%), 1 heart-liver, and 1 pancreas. Eleven (15.1%) patients had an emergency department visit within 28 days of infusion, including 9 (12.3%) who were hospitalized for a median of 4 days. One patient required intensive care unit admission for a nonrespiratory complication. No patients required mechanical ventilation, died, or experienced rejection. Ten adverse events occurred, with 1 seeking medical evaluation. Hypertension was associated with hospital admission (P < .05), while other baseline characteristics were similar. The median time from symptom onset to antibody administration was 4 days in nonhospitalized patients compared with 6 days among hospitalized patients (P < .05). CONCLUSIONS: Monoclonal antibody treatment has favorable outcomes with minimal adverse effects in solid organ transplant recipients with mild to moderate COVID-19. Earlier administration of monoclonal antibody therapy appears to be more efficacious.

Casirivimab-Imdevimab treatment is associated with reduced rates of hospitalization among high-risk patients with mild to moderate coronavirus disease-19.

BACKGROUND: Real-world clinical data to support the use of casirivimab-imdevimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed. This study aimed to assess the outcomes of casirivimab-imdevimab treatment of mild to moderate COVID-19. METHODS: A retrospective cohort of 696 patients who received casirivimab-imdevimab between December 4, 2020 and April 9, 2021 was compared to a propensity-matched control of 696 untreated patients with mild to moderate COVID-19 at Mayo Clinic sites in Arizona, Florida, Minnesota, and Wisconsin. Primary outcome was rate of hospitalization at days 14, 21 and 28 after infusion. FINDINGS: The median age of the antibody-treated cohort was 63 years (interquartile range, 52-71); 45·5% were ≥65 years old; 51.4% were female. High-risk characteristics were hypertension (52.4%), body mass index ≥35 (31.0%), diabetes mellitus (24.6%), chronic lung disease (22.1%), chronic renal disease (11.4%), congestive heart failure (6.6%), and compromised immune function (6.7%). Compared to the propensity-matched untreated control, patients who received casirivimab-imdevimab had significantly lower all-cause hospitalization rates at day 14 (1.3% vs 3.3%; Absolute Difference: 2.0%; 95% confidence interval (CI): 0.5-3.7%), day 21 (1.3% vs 4.2%; Absolute Difference: 2.9%; 95% CI: 1.2-4.7%), and day 28 (1.6% vs 4.8%; Absolute Difference: 3.2%; 95% CI: 1.4-5.1%). Rates of intensive care unit admission and mortality at days 14, 21 and 28 were similarly low for antibody-treated and untreated groups. INTERPRETATION: Among high-risk patients with mild to moderate COVID-19, casirivimab-imdevimab treatment was associated with a significantly lower rate of hospitalization. FUNDING: Mayo Clinic.

Implementation of a multisite, interdisciplinary remote patient monitoring program for ambulatory management of patients with COVID-19.

Established technology, operational infrastructure, and nursing resources were leveraged to develop a remote patient monitoring (RPM) program for ambulatory management of patients with COVID-19. The program included two care-delivery models with different monitoring capabilities supporting variable levels of patient risk for severe illness. The primary objective of this study was to determine the feasibility and safety of a multisite RPM program for management of acute COVID-19 illness. We report an evaluation of 7074 patients served by the program across 41 US states. Among all patients, the RPM technology engagement rate was 78.9%. Rates of emergency department visit and hospitalization within 30 days of enrollment were 11.4% and 9.4%, respectively, and the 30-day mortality rate was 0.4%. A multisite RPM program for management of acute COVID-19 illness is feasible, safe, and associated with a low mortality rate. Further research and expansion of RPM programs for ambulatory management of other acute illnesses are warranted.

Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19.

BACKGROUNDClinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) are needed.METHODS2335 Patients who received single-dose bamlanivimab infusion between November 12, 2020, and February 17, 2021, were compared with a propensity-matched control of 2335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states. The primary outcome was the rate of hospitalization at days 14, 21, and 28.RESULTSThe median age of the population was 63 years; 47.3% of the bamlanivimab-treated cohort were 65 years or more; 49.3% were female and 50.7% were male. High-risk characteristics included hypertension (54.2%), BMI greater than or equal to 35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs. 3.5%; risk ratio [RR], 0.41), 21 (1.9% vs. 3.9%; RR, 0.49), and 28 (2.5% vs. 3.9%; RR, 0.63). Secondary exploratory outcomes included lower intensive care unit (ICU) admission rates at days 14 (0.14% vs. 1%; RR, 0.14), 21 (0.25% vs.1%; RR, 0.25), and 28 (0.56% vs.1.1%; RR. 0.51) and lower all-cause mortality at days 14 (0% vs. 0.33%), 21 (0.05% vs. 0.4%; RR,0.13), and 28 (0.11% vs. 0.44%; RR, 0.26). Adverse events were uncommon with bamlanivimab, occurring in 19 of 2355 patients, and were most commonly fever (n = 6), nausea (n = 5), and lightheadedness (n = 3).CONCLUSIONSAmong high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization, ICU admission, and mortality compared with usual care.FUNDINGMayo Clinic.

Central Sensitization Phenotypes in Post Acute Sequelae of SARS-CoV-2 Infection (PASC): Defining the Post COVID Syndrome.

OBJECTIVE: To develop and implement criteria for description of post COVID syndrome based on analysis of patients presenting for evaluation at Mayo Clinic Rochester between November 2019 and August 2020. METHODS: A total of 465 patients with a history of testing positive for COVID-19 were identified and their medical records reviewed. After a thorough review, utilizing the DELPHI methods by an expert panel, 42 (9%) cases were identified with persistent central sensitization (CS) symptoms persisting after the resolution of acute COVID-19, herein referred to as Post COVID syndrome (PoCoS). In this report we describe the baseline characteristics of these PoCoS patients. RESULTS: Among these 42 PoCoS patients, the mean age was 46.2 years (median age was 46.5 years). Pain (90%), fatigue (74%), dyspnea (43%), and orthostatic intolerance (38%) were the most common symptoms. The characteristics of an initial 14 patients were utilized for the development of clinical criteria via a modified Delphi Method by a panel of experts in central sensitization disorders. These criteria were subsequently applied in the identification of 28 additional cases of suspected PoCoS. A 2-reviewer system was used to analyze agreement with using the criteria, with all 28 cases determined to be either probable or possible cases by the reviewers. Inter-reviewer agreement using these proposed defining criteria was high with a Cohen's alpha of .88. CONCLUSIONS: Here we present what we believe to be the first definitional criteria for Post COVID syndrome. These may be useful in clinical phenotyping of these patients for targeted treatment and future research.

Real-World Clinical Outcomes of Bamlanivimab and Casirivimab-Imdevimab Among High-Risk Patients With Mild to Moderate Coronavirus Disease 2019.

BACKGROUND: Bamlanivimab and casirivimab-imdevimab are authorized for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in high-risk patients. We compared the outcomes of patients who received these therapies to identify factors associated with hospitalization and other clinical outcomes. METHODS: Adult patients who received monoclonal antibody from 19 November 2020 to 11 February 2021 were selected and divided into those who received bamlanivimab (n = 2747) and casirivimab-imdevimab (n = 849). The 28-day all-cause and COVID-19-related hospitalizations were compared between the groups. RESULTS: The population included 3596 patients; the median age was 62 years, and 50% were female. All had ≥1 medical comorbidity; 55% had multiple comorbidities. All-cause and COVID-19-related hospitalization rates at 28 days were 3.98% and 2.56%, respectively. After adjusting for medical comorbidities, there was no significant difference in all-cause and COVID-19-related hospitalization rates between bamlanivimab and casirivimab-imdevimab (adjusted hazard ratios [95% confidence interval], 1.4 [.9-2.2] and 1.6 [.8-2.7], respectively). Chronic kidney, respiratory and cardiovascular diseases, and immunocompromised status were associated with higher likelihood of hospitalization. CONCLUSIONS: This observational study on the use of bamlanivimab and casirivimab-imdevimab in high-risk patients showed similarly low rates of hospitalization. The number and type of medical comorbidities are associated with hospitalizations after monoclonal antibody treatment.

The Association of Current Tobacco Status With Pain and Symptom Severity in Fibromyalgia Patients.

OBJECTIVE: To describe current tobacco use among patients with newly confirmed fibromyalgia and evaluate the association between tobacco use status and severity of reported pain and other fibromyalgia symptoms. PATIENTS AND METHODS: Participants in this study were adult patients (N=1068) with fibromyalgia who met American College of Rheumatology 2010/2011 clinical criteria for fibromyalgia at the time of initial presentation to a Midwest fibromyalgia clinic (June 1, 2018, through May 31, 2019). Multiple linear regression analyses were performed to assess the association of tobacco use status with the Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) scores. Covariates included in these analyses included age, sex, body mass index, depression, opioid medication use, and use of fibromyalgia-specific pharmacotherapy. RESULTS: The patients were largely women (87.0%; n=929), white (87.9%; n=939), and with an average ± SD age of 46.6±13.9 years. The WPI and SSS scores were significantly greater in current tobacco users compared with never tobacco users (WPI effect estimate [EE] = 1.03; 95% CI, 0.30 to 1.76; type III P=.020; SSS EE = 0.47; 95% CI, 0.11 to 0.84; type III P=.036). The WPI score was negatively associated with age (EE = -0.02 per year; 95% CI, -0.03 to -0.001 per year; P=.037) and no use of opioid medication (EE = -1.08; 95% CI, -1.59 to -0.57; P<.001) while positively associated with higher body mass index (EE = 0.03 per 1 kg/m2; 95% CI, 0.001 to 0.06 per kg/m2; P=.04) and higher Patient Health Questionnaire-9 score (EE = 0.12; 95% CI, 0.08 to 0.16; P<.001). CONCLUSION: The results of our study suggest that tobacco use is associated with greater pain and other symptom severity in patients with fibromyalgia. These findings have important clinical and research implications for patients with fibromyalgia who use tobacco and who may benefit from early identification and timely implementation of tobacco cessation treatment to decrease pain and improve overall quality of life.