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Efficacy of Acupuncture for Chronic Spontaneous Urticaria: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 176, No 12
Background: The effectiveness of acupuncture for patients with chronic spontaneous urticaria (CSU), reported in a few small-scale studies, is not convincing. Objective: To investigate whether acupuncture leads to better effects on CSU than sham acupuncture or waitlist control. Design: A multicenter, randomized, sham-controlled trial. (Chinese Clinical Trial Registry: ChiCTR1900022994) Setting: Three teaching hospitals in China from 27 May 2019 to 30 July 2022. Participants: 330 participants diagnosed with CSU. Intervention: Participants were randomly assigned in a 1:1:1 ratio to receive acupuncture, sham acupuncture, or waitlist control over an 8-week study period (4 weeks for treatment and another 4 weeks for follow-up). Measurements: The primary outcome was the mean change from baseline in the Weekly Urticaria Activity Score (UAS7) at week 4. Secondary outcomes included itch severity scores, self-rated improvement, and Dermatology Life Quality Index scores. Results: The mean change in UAS7 (range, 0 to 42) for acupuncture from baseline (mean score, 23.5 [95% CI, 21.8 to 25.2]) to week 4 (mean score, 15.3 [CI, 13.6 to 16.9]) was −8.2 (CI, −9.9 to −6.6). The mean changes in UAS7 for sham acupuncture and waitlist control from baseline (mean scores, 21.9 [CI, 20.2 to 23.6] and 22.1 [CI, 20.4 to 23.8], respectively) to week 4 (mean scores, 17.8 [CI, 16.1 to 19.5] and 20.0 [CI, 18.3 to 21.6], respectively) were −4.1 (CI, −5.8 to −2.4) and −2.2 (CI, −3.8 to −0.5), respectively. The mean differences between acupuncture and sham acupuncture and waitlist control were −4.1 (CI, −6.5 to −1.8) and −6.1 (CI, −8.4 to −3.7), respectively, which did not meet the threshold for minimal clinically important difference. Fifteen participants (13.6%) in the acupuncture group and none in the other groups reported adverse events. Adverse events were mild or transient. Limitation: Lack of complete blinding, self-reported outcomes, limited generalizability because antihistamine use was disallowed, and short follow-up period. Conclusion: Compared with sham acupuncture and waitlist control, acupuncture produced a greater improvement in UAS7, although the difference from control was not clinically significant. Increased adverse events were mild or transient. Primary Funding Source: The National Key R&D Program of China and the Science and Technology Department of Sichuan Province.
Gabapentinoids and Risk for Severe Exacerbation in Chronic Obstructive Pulmonary Disease: A Population-Based Cohort Study: Annals of Internal Medicine: Vol 177, No 2
Background: North American and European health agencies recently warned of severe breathing problems associated with gabapentinoids, including in patients with chronic obstructive pulmonary disease (COPD), although supporting evidence is limited. Objective: To assess whether gabapentinoid use is associated with severe exacerbation in patients with COPD. Design: Time-conditional propensity score–matched, new-user cohort study. Setting: Health insurance databases from the Régie de l’assurance maladie du Québec in Canada. Patients: Within a base cohort of patients with COPD between 1994 and 2015, patients initiating gabapentinoid therapy with an indication (epilepsy, neuropathic pain, or other chronic pain) were matched 1:1 with nonusers on COPD duration, indication for gabapentinoids, age, sex, calendar year, and time-conditional propensity score. Measurements: The primary outcome was severe COPD exacerbation requiring hospitalization. Hazard ratios (HRs) associated with gabapentinoid use were estimated in subcohorts according to gabapentinoid indication and in the overall cohort. Results: The cohort included 356 gabapentinoid users with epilepsy, 9411 with neuropathic pain, and 3737 with other chronic pain, matched 1:1 to nonusers. Compared with nonuse, gabapentinoid use was associated with increased risk for severe COPD exacerbation across the indications of epilepsy (HR, 1.58 [95% CI, 1.08 to 2.30]), neuropathic pain (HR, 1.35 [CI, 1.24 to 1.48]), and other chronic pain (HR, 1.49 [CI, 1.27 to 1.73]) and overall (HR, 1.39 [CI, 1.29 to 1.50]). Limitation: Residual confounding, including from lack of smoking information. Conclusion: In patients with COPD, gabapentinoid use was associated with increased risk for severe exacerbation. This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD. Primary Funding Source: Canadian Institutes of Health Research and Canadian Lung Association.
Chronotype, Unhealthy Lifestyle, and Diabetes Risk in Middle-Aged U.S. Women: A Prospective Cohort Study: Annals of Internal Medicine: Vol 176, No 10
Background: Evening chronotype may promote adherence to an unhealthy lifestyle and increase type 2 diabetes risk. Objective: To evaluate the role of modifiable lifestyle behaviors in the association between chronotype and diabetes risk. Design: Prospective cohort study. Setting: Nurses’ Health Study II. Participants: 63 676 nurses aged 45 to 62 years with no history of cancer, cardiovascular disease, or diabetes in 2009 were prospectively followed until 2017. Measurements: Self-reported chronotype using a validated question from the Morningness-Eveningness Questionnaire. The lifestyle behaviors that were measured were diet quality, physical activity, alcohol intake, body mass index (BMI), smoking, and sleep duration. Incident diabetes cases were self-reported and confirmed using a supplementary questionnaire. Results: Participants reporting a “definite evening” chronotype were 54% (95% CI, 49% to 59%) more likely to have an unhealthy lifestyle than participants reporting a “definite morning” chronotype. A total of 1925 diabetes cases were documented over 469 120 person-years of follow-up. Compared with the “definite morning” chronotype, the adjusted hazard ratio (HR) for diabetes was 1.21 (CI, 1.09 to 1.35) for the “intermediate” chronotype and 1.72 (CI, 1.50 to 1.98) for the “definite evening” chronotype after adjustment for sociodemographic factors, shift work, and family history of diabetes. Further adjustment for BMI, physical activity, and diet quality attenuated the association comparing the “definite evening” and “definite morning” chronotypes to 1.31 (CI, 1.13 to 1.50), 1.54 (CI, 1.34 to 1.77), and 1.59 (CI, 1.38 to 1.83), respectively. Accounting for all measured lifestyle and sociodemographic factors resulted in a reduced but still positive association (HR comparing “definite evening” vs. “definite morning” chronotype, 1.19 [CI, 1.03 to 1.37]). Limitations: Chronotype assessment using a single question, self-reported data, and homogeneity of the study population. Conclusion: Middle-aged nurses with an evening chronotype were more likely to report unhealthy lifestyle behaviors and had increased diabetes risk compared with those with a morning chronotype. Accounting for BMI, physical activity, diet, and other modifiable lifestyle factors attenuated much but not all of the increased diabetes risk. Primary Funding Source: National Institutes of Health.
Effect of Low-Dose Aspirin Versus Placebo on Incidence of Anemia in the Elderly: A Secondary Analysis of the Aspirin in Reducing Events in the Elderly Trial: Annals of Internal Medicine: Vol 176, No 7
Background: Daily low-dose aspirin increases major bleeding; however, few studies have investigated its effect on iron deficiency and anemia. Objective: To investigate the effect of low-dose aspirin on incident anemia, hemoglobin, and serum ferritin concentrations. Design: Post hoc analysis of the ASPREE (ASPirin in Reducing Events in the Elderly) randomized controlled trial. (ClinicalTrials.gov: NCT01038583) Setting: Primary/community care in Australia and the United States. Participants: Community-dwelling persons aged 70 years or older (≥65 years for Black persons and Hispanic persons). Intervention: 100 mg of aspirin daily or placebo. Measurements: Hemoglobin concentration was measured annually in all participants. Ferritin was measured at baseline and 3 years after random assignment in a large subset. Results: 19 114 persons were randomly assigned. Anemia incidence in the aspirin and placebo groups was 51.2 events and 42.9 events per 1000 person-years, respectively (hazard ratio, 1.20 [95% CI, 1.12 to 1.29]). Hemoglobin concentrations declined by 3.6 g/L per 5 years in the placebo group and the aspirin group experienced a steeper decline by 0.6 g/L per 5 years (CI, 0.3 to 1.0 g/L). In 7139 participants with ferritin measures at baseline and year 3, the aspirin group had greater prevalence than placebo of ferritin levels less than 45 µg/L at year 3 (465 [13%] vs. 350 [9.8%]) and greater overall decline in ferritin by 11.5% (CI, 9.3% to 13.7%) compared with placebo. A sensitivity analysis quantifying the effect of aspirin in the absence of major bleeding produced similar results. Limitations: Hemoglobin was measured annually. No data were available on causes of anemia. Conclusion: Low-dose aspirin increased incident anemia and decline in ferritin in otherwise healthy older adults, independent of major bleeding. Periodic monitoring of hemoglobin should be considered in older persons on aspirin. Primary Funding Source: National Institutes of Health and Australian National Health and Medical Research Council.
Modernizing the United States’ Public Health Infrastructure: A Position Paper From the American College of Physicians
The United States’ public health sector plays a crucial role in preventing illness and promoting health. Public health drove massive gains in life expectancy during the 20th century by supporting vaccination campaigns, promoting motor vehicle safety, and preventing and treating tobacco use. However, public health is underfunded and underappreciated, forcing the field to do more with fewer resources. In this position paper, the American College of Physicians (ACP) updates its 2012 policy recommendations on strengthening the nation’s public health infrastructure. ACP calls for effective coordination of public health activities, robust and stable year-to-year funding of public health services, a renewed and well-supported public health workforce, action to address health-related dis- and misinformation, modernized public health data systems, and greater coordination between public health and medical sectors.
Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary Disease
Background: In 2019, the U.S. Food and Drug Administration (FDA) approved the first generic maintenance inhaler for asthma and chronic obstructive pulmonary disease (COPD). The inhaler, Wixela Inhub (fluticasone–salmeterol; Viatris), is a substitutable version of the dry powder inhaler Advair Diskus (fluticasone–salmeterol; GlaxoSmithKline). When approving complex generic products like inhalers, the FDA applies a special “weight-of-evidence” approach. In this case, manufacturers were required to perform a randomized controlled trial in patients with asthma but not COPD, although the product received approval for both indications. Objective: To compare the effectiveness and safety of generic (Wixela Inhub) and brand-name (Advair Diskus) fluticasone–salmeterol among patients with COPD treated in routine care. Design: A 1:1 propensity score–matched cohort study. Setting: A large, longitudinal health care database. Patients: Adults older than 40 years with a diagnosis of COPD. Measurements: Incidence of first moderate or severe COPD exacerbation (effectiveness outcome) and incidence of first pneumonia hospitalization (safety outcome) in the 365 days after cohort entry. Results: Among 45 369 patients (27 305 Advair Diskus users and 18 064 Wixela Inhub users), 10 012 matched pairs were identified for the primary analysis. Compared with Advair Diskus use, Wixela Inhub use was associated with a nearly identical incidence of first moderate or severe COPD exacerbation (hazard ratio [HR], 0.97 [95% CI, 0.90 to 1.04]) and first pneumonia hospitalization (HR, 0.99 [CI, 0.86 to 1.15]). Limitations: Follow-up times were short, reflecting real-world clinical practice. The possibility of residual confounding cannot be completely excluded. Conclusion: Use of generic and brand-name fluticasone–salmeterol was associated with similar outcomes among patients with COPD treated in routine practice. Primary Funding Source: National Heart, Lung, and Blood Institute.