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Study Authors: Alex H. Krist, Karina W. Davidson, et al.; Carrie D. Patnode, Jillian T. Henderson, et al.; Brenna VanFrank, Letitia Presley-Cantrell
Target Audience and Goal Statement: Pulmonologists, primary care physicians
The goal of the updated U.S. Preventive Services Task Force (USPSTF) recommendation statement was to evaluate the benefits and harms of primary care interventions on tobacco use cessation in adults, including pregnant persons.
- What were the benefits and harms of primary care interventions on tobacco use cessation in adults, including pregnant persons?
Synopsis and Perspective:
In 1964, the U.S. Surgeon General released a report concluding that cigarette smoking was a cause of lung cancer in men, a probable cause of lung cancer in women, and the most important cause of chronic bronchitis. More than half a century later, another report was issued concluding that smoking cessation decreased the risk of all-cause mortality, cardiovascular diseases, chronic obstructive pulmonary disease, adverse reproductive health outcomes, and 12 types of cancer.
- Based on an updated evidence report, the U.S. Preventive Services Task Force (USPSTF) recommended that clinicians ask all adults, including pregnant persons, about their tobacco use, advise those who use tobacco to quit, and provide behavioral interventions and FDA-approved pharmacotherapies for tobacco cessation when appropriate.
- Note that the USPSTF found that the evidence for e-cigarettes as a smoking cessation tool was insufficient and that more research is needed on the benefits and harms of using tobacco cessation pharmacotherapies in pregnant persons.
Although the U.S. has made great strides from 1964 to 2020 in reducing smoking, further work needs to be done.
For example, the 2020 report from the U.S. Surgeon General found that, while 68% of adults who smoked reported wanting to quit — with around 55% reporting attempting to do so — only around 7% of smokers successfully quit in a given year.
As of 2019, an estimated 14% of U.S. adults smoked cigarettes, 4.5% used electronic cigarettes (e-cigarettes), and 7.2% of U.S. women who gave birth during 2016 reported smoking cigarettes while pregnant. Smoking during pregnancy can increase the risks of numerous adverse pregnancy outcomes, such as miscarriage and congenital anomalies, and complications in the offspring, including sudden infant death syndrome and impaired lung function in childhood.
Overall, tobacco use remains the leading preventable cause of disease and disability in the U.S., with more than 16 million people living with a smoking-related illness.
“Each year, more than half a million people die from smoking-related disease,” said USPSTF member Chien-Wen Tseng, MD. “There has never been a more important time to stop smoking. With the COVID-19 pandemic, people are paying more attention to their health, and quitting smoking is one of the most important things someone can do for their health.”
Recently, members of the USPSTF published an updated recommendation statement in JAMA, based on a supporting evidence review, stating that clinicians should ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and FDA-approved pharmacotherapies for tobacco cessation to nonpregnant adults. This ‘A’ recommendation is in keeping with the team’s 2015 guidance.
Similarly, the group recommended that clinicians ask all pregnant persons about tobacco use, advise them to stop using tobacco, and provide behavioral interventions for tobacco cessation (‘A’ recommendation). However, they concluded that the current evidence was insufficient to assess the balance of benefits and harms of pharmacotherapy interventions for tobacco cessation in pregnant persons (‘I’ statement).
Of note, the USPSTF also concluded that the current evidence was insufficient to assess the balance of benefits and harms of e-cigarettes for tobacco cessation in adults, including pregnant persons (‘I’ statement). “The USPSTF recommends that clinicians direct patients who use tobacco to other tobacco cessation interventions with proven effectiveness and established safety,” the statement read.
The updated evidence report included 67 reviews on pharmacotherapy and behavioral interventions, as well as nine trials (3,942 participants) addressing e-cigarettes for smoking cessation and seven trials (2,285 participants) on nicotine replacement therapy (NRT) use in pregnancy.
An association with increased quit rates at 6 months or longer was seen with combined pharmacotherapy and behavioral interventions (pooled risk ratio [RR] 1.83, 95% CI 1.68-1.98), NRT (RR 1.55, 95% CI 1.49-1.61), bupropion (RR 1.64, 95% CI 1.52-1.77), varenicline (RR 2.24, 95% CI 2.06-2.43), and behavioral interventions such as advice from physicians (RR 1.76, 95% CI 1.58-1.96) compared with minimal support or placebo. None of the drugs were associated with serious adverse events.
Compared with no intervention, behavioral interventions among pregnant persons were associated with greater smoking cessation during late pregnancy (RR 1.35, 95% CI 1.23-1.48).
The evidence base on e-cigarettes as a potential cessation tool increased over the years. However, the relevant evidence (five trials, 3,117 participants) was insufficient in adults, and the balance of benefits and harms could not be determined. Although two out of the five trials (2,008 participants) showed that smokers randomized to e-cigarettes containing nicotine with or without the co-use of NRT were found to have significantly greater rates of abstinence than those randomized to NRT alone or NRT plus non-nicotine e-cigarettes, continued use of e-cigarettes was high at 6- and 12-month follow-up.
Several recently published trials that were not included in the review also appeared to support a role for e-cigarettes in smoking cessation, although absolute success rates were still very low.
In a study from England with 886 cigarette users, switching to e-cigarettes was associated with greater cigarette abstinence at 1 year compared with NRT use (18% vs 9.9%). And in a study from New Zealand, which included 1,124 cigarette smokers, adding e-cigarettes to NRT increased cigarette smoking cessation at 6 months compared with NRT alone, with 7% versus 2% of participants abstaining, respectively.
A recently published Cochrane review of 50 studies involving 12,430 participants found “moderate-certainty evidence, limited by imprecision,” that e-cigarettes with nicotine increased quit rates at 6 months or longer compared with non-nicotine e-cigarettes and compared with NRT, and “very low-certainty evidence” that e-cigarettes with nicotine increased quit rates compared with behavioral support alone or no support.
Tseng told MedPage Today that none of the randomized trials or reviews included long-term safety data on e-cigarette use, because the products haven’t been on the market long enough to establish long-term risk.
“We know people are asking their doctors about e-cigarettes, but we don’t yet have enough data to give them clear answers about the benefits and harms, especially the long-term harms,” she said.
“The good news is the evidence shows that there are very effective ways to help people quit smoking, and one of the most effective strategies is behavioral counseling,” she added.
Relatively new pharmacology cessation strategies include combining long- and short-acting NRT and starting medication before a quit date — a practice known as pre-loading.
The task force also called for studies to address the many unanswered questions about “the effectiveness of e-cigarettes for smoking cessation, as well as potential short- and long-term harms of e-cigarette use, and to understand whether there are effective and safe pharmacotherapy options for pregnant persons.”
Source References: JAMA 2021; DOI: 10.1001/jama.2020.25019 and JAMA 2021; DOI: 10.1001/jama.2020.23541
Editorial: JAMA 2021; DOI: 10.1001/jama.2020.23608
Study Highlights and Explanation of Findings:
The USPSTF updated their 2015 guidance with a four-part recommendation statement for adults 18 and older, suggesting that while e-cigarettes may be useful for helping adult smokers quit, the evidence remains inadequate to support a formal recommendation.
Additionally, while the data were insufficient to assess the safety of established smoking cessation pharmacotherapies in pregnant persons who smoke, behavioral interventions can be useful for helping to quit smoking and improving perinatal outcomes.
In an accompanying commentary, Brenna VanFrank, MD, and Letitia Presley-Cantrell, PhD, of the CDC’s Office on Smoking and Health, wrote that systems-level changes in healthcare delivery can help clinicians deliver smoking cessation counseling and treatments.
They noted that team-based approaches, including chronic disease management models, “can mitigate the burden of screening and treatment delivery on any one individual” and that “delivery of clinical interventions can also be increased with the linkage of payment to cessation-related quality measures and the availability and dissemination of clinical practice guidelines.”
Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco