See related AFP article, Top 20 Research Studies of 2021 for Primary Care Physicians.
Clinical question
What is the likelihood that older adults with prediabetes will develop diabetes mellitus over an average of 6.5 years?
Bottom line
Older patients generally will not progress to diabetes; they will either, over an average of 6.5 years, stay at the prediabetic levels or revert to normal levels. If a patient makes it to their mid-70s without a diagnosis of diabetes, it is unlikely to occur.
Reference
Rooney MR, Rawlings AM, Pankow JS, et al. Risk of progression to diabetes among older adults with prediabetes [published correction appears in JAMA Intern Med. 2021:181(4):570]. JAMA Intern Med. 2021;181(3):511-519.
Study design: Randomized controlled trial (single-blinded)
Funding source: Industry and government
Setting: Emergency department
Synopsis
Prediabetes has a few definitions. This study evaluated 3,412 community-dwelling participants, including 2,482 patients who had an A1C level of 5.7% to 6.4% (n = 1,490) or a fasting glucose level of 100 mg per dL (5.55 mmol per L) to 125 mg per dL (6.94 mmol per L; n = 1,996), or both, in a community cohort of adults with a mean age of 75.5 years. Over 6.5 years of follow-up with 27% attrition, 9% of patients with elevated A1C levels progressed to diabetes and 13% regressed to normoglycemia. Of those with elevated fasting glucose levels, 8% developed diabetes and 44% returned to normoglycemia. These rates compare with a 3% development of diabetes in patients with normoglycemia at the start.
Allen F. Shaughnessy, PharmD, MMedED
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
What are the risks of overtreatment in patients 70 years or older with type 2 diabetes?
Bottom line
We now find ourselves practicing "quaternary prevention," which is protecting patients from overmedicalization and overtreatment. Case in point: The overtreatment of older patients with type 2 diabetes, meaning a consistent A1C level of less than 7%, is associated with hospitalization at least once for the treatment of hypoglycemia. An A1C level less than 7% coupled with treatment with a sulfonylurea or insulin magnifies the risk. A recent systematic review found a high prevalence of overtreatment in nursing home patients, especially those with dementia.
Reference
Ling S, Zaccardi F, Lawson C, et al. Glucose control, sulfonylureas, and insulin treatment in elderly people with type 2 diabetes and risk of severe hypoglycemia and death: an observational study. Diabetes Care. 2021;44(4):915-924.
Study design: Cohort (retrospective)
Funding source: Government
Setting: Outpatient (primary care)
Synopsis
From a database of almost 23,000 patients seen in general practice in the United Kingdom, these authors identified 6,288 patients at least 70 years old with type 2 diabetes and three consecutive A1C levels of less than 7%. Ninety percent of these patients were treated with a sulfonylurea. The authors matched these patients with up to three patients of similar age, sex, and duration of diabetes who did not have an A1C level of less than 7% and were not receiving a sulfonylurea or insulin treatment. Patients with tight control were 2.5 times more likely than the matched control patients to be hospitalized for severe hypoglycemia, though overall mortality rates, which were high in this age range, were not different between groups. Over 10 years of treatment, nearly 14% of patients aged 70 years and older will be hospitalized for severe hypoglycemia. In overtreated patients, the use of insulin or a sulfonylurea is associated with an increased risk of death or hospitalization.
Allen F. Shaughnessy, PharmD, MMedED
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
Do sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists reduce patient-oriented outcomes in patients with type 2 diabetes mellitus?
Bottom line
SGLT2 inhibitors, the diabetes medications ending in -flozin (such as dapagliflozin [Farxiga]), and GLP-1 receptor agonists, the -tide medications (such as dulaglutide [Trulicity]), decrease cardiovascular and renal outcomes to a greater extent than placebo or other treatments. They should be considered in addition to metformin and other glucose-lowering treatments for most patients with type 2 diabetes.
Reference
Palmer SC, Tendal B, Mustafa RA, et al. Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials. BMJ. 2021;372:m4573.
Study design: Meta-analysis (randomized controlled trials)
Funding source: Self-funded or unfunded
Setting: Various (meta-analysis)
Synopsis
The researchers searched three databases, including Cochrane CENTRAL, to identify randomized trials that compared SGLT2 inhibitors or GLP-1 receptor agonists with other treatment approaches. Two researchers independently screened studies for inclusion, extracted the data, and assessed the studies for risk of bias. Because there are a handful of drugs in each class that have not been directly compared with one another, the researchers completed a network meta-analysis, which combines direct and indirect evidence across studies to allow cross-comparison. They identified 764 trials including 421,346 patients, which allowed a view of the results according to patient baseline cardiovascular risk. The quality of the studies was generally high, with no heterogeneity for most outcomes. Both drug classes lowered all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, and kidney failure. SGLT2 inhibitors were more effective at reducing hospital admission, and GLP-1 receptor agonists were more likely to reduce nonfatal stroke. The absolute benefit of treatment varied based on underlying cardiac risk; for example, two to five fewer deaths per 1,000 patients over five years in patients at low risk and 24 to 48 fewer deaths per 1,000 patients at high risk. A calculator is available (https://magicevidence.org/match-it/200820dist/#!/) that estimates benefit at various risk levels.
Allen F. Shaughnessy, PharmD, MMedED
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
What effect do sodium-glucose cotransporter-2 (SGLT2) inhibitors have on mortality and cardiovascular and renal outcomes in patients with and without diabetes mellitus, heart failure, or kidney disease?
Bottom line
SGLT2 inhibitors—medications ending in -flozin, such as canagliflozin (Invokana), dapagliflozin (Farxiga), empagliflozin (Jardiance), and ertugliflozin (Steglatro)—reduce all-cause and cardiovascular mortality in patients regardless of the presence of type 2 diabetes, heart failure, or chronic kidney disease. Similar mortality reduction occurs in patients with diabetes regardless of comorbid heart failure, and in patients with heart failure regardless of the presence of diabetes. SGLT2 inhibitors also reduce the progression of renal disease in all patients.
Reference
Salah HM, Al'Aref SJ, Khan MS, et al. Effect of sodium-glucose cotransporter 2 inhibitors on cardiovascular and kidney outcomes–systematic review and meta-analysis of randomized placebo-controlled trials. Am Heart J. 2020;232:10–22.
Study design: Meta-analysis (randomized controlled trials)
Funding source: Self-funded or unfunded
Setting: Various (meta-analysis)
Synopsis
Two researchers independently searched three databases, including Cochrane CENTRAL, with the bibliographies of identified studies and abstracts of major cardiology meetings, to identify randomized studies in any language that evaluated the impact of treatment with an SGLT2 inhibitor in patients with or without heart failure or type 2 diabetes. Two researchers independently abstracted the data. The researchers followed PRISMA guidelines and assessed the quality of evidence. They included eight studies of 59,747 patients, comprising three studies that included patients without diabetes. Treatment with an SGLT2 inhibitor reduced the risk of mortality due to all causes (hazard ratio [HR] = 0.84; 95% CI, 0.78 to 0.91), cardiovascular mortality (HR = 0.84; 95% CI, 0.76 to 0.93), and hospitalization for heart failure (HR = 0.69; 95% CI, 0.64 to 0.74) compared with placebo, and reduced a composite of end-stage kidney disease, a doubling of the serum creatinine level, and kidney-related mortality (HR = 0.62; 95% CI, 0.56 to 0.70). There were similar mortality and renal benefits for patients with or without diabetes and patients with or without heart failure. Heterogeneity among study results was moderate for mortality outcomes and low for heart failure hospitalization and kidney outcomes.
Allen F. Shaughnessy, PharmD, MMedED
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
What interventions are effective in managing patients with chronic low back pain?
Bottom line
The interventions that are better than control in achieving at least a 30% reduction in pain are exercise, oral nonsteroidal anti-inflammatory drugs (NSAIDs), duloxetine (Cymbalta), and opioids, but discontinuations of the latter two treatments were common. Lower-quality data suggest that manipulation and topical capsaicin are also effective. It is possible the authors' inclusion criteria missed important studies.
Reference
Kolber MR, Ton J, Thomas B, et al. PEER systematic review of randomized controlled trials: management of chronic low back pain in primary care. Can Fam Physician. 2021;67(1):e20–e30.
Study design: Meta-analysis (randomized controlled trials)
Funding source: Government
Setting: Various (meta-analysis)
Synopsis
The authors performed 15 individual systematic reviews focusing on individual interventions for managing patients with chronic (at least three months' duration) low back pain. They searched the Medline, EMBASE, and Cochrane databases, as well as clinical trials registries to identify randomized trials. Two authors independently evaluated potential studies for inclusion and risk of bias. They included 63 trials with more than 16,000 participants. Several interventions resulted in no search results because they lacked a responder analysis: acetaminophen, cannabinoids, muscle relaxants, and antidepressants other than duloxetine. The quality of the included studies was mixed. The authors reported meaningful reductions in pain (at least a 30% reduction) as the primary outcome for the included studies. They included 18 studies of exercise, most commonly guided by a physiotherapist. After pooling, they estimated that 50% of exercising patients and 35% of control patients achieved meaningful pain relief (number needed to treat [NNT] = 7; 95% CI, 6 to 10). They reported that a significant proportion of patients who were randomized to receive an exercise intervention had sustained relief even after the intervention was completed (NNT = 6; 95% CI, 5 to 9). In four trials, oral NSAIDs were more effective than control (NNT = 6; 95% CI, 5 to 8) while patients were taking them. Four trials of duloxetine also found it to be more effective than control (NNT = 10; 95% CI, 7 to 18), but discontinuation of treatment due to adverse effects was more common with duloxetine (number needed to harm [NNH] = 11). Spinal manipulation (five trials; low-quality evidence) was more effective than control in achieving pain relief (57% vs. 39%; NNT = 6; 95% CI, 4 to 10). Three trials (overall lower quality) evaluated topical capsaicin for three weeks. It was effective (NNT = 6; 95% CI, 4 to 10) at the cost of a superficial burning. Acupuncture was more effective than control in eight trials (54% vs. 35%; NNT = 6; 95% CI, 5 to 7); however, when only higher-quality studies were included, it was no better than control. The authors identified six opioid trials lasting four to 12 weeks, which found that 39% of patients achieved relief compared with 32% of control patients (NNT = 16; 95% CI, 10 to 35), but discontinuation due to side effects was more common with opioids (27% vs. 5%; NNH = 5). In 10 trials of corticosteroid injections (overall poor quality), there was no difference in pain relief compared with controls. The authors found significant heterogeneity for many of the interventions. One trial each of gabapentin (Neurontin) and topical flurbiprofen (in tape form) found neither to be effective in achieving pain relief. The authors did not address function in their analyses.
Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, Mich.
Clinical question
Do muscle relaxants provide relief for nonspecific lower back pain?
Bottom line
Nonsteroidal anti-inflammatory drugs are a better choice for the treatment of low back pain. Despite benzodiazepine and nonbenzodiazepine muscle relaxants being used for almost 50 years to treat low back pain, the supporting evidence is of low certainty. None of the treatments will produce a clinically important difference over placebo.
Reference
Cashin AG, Folly T, Bagg MK, et al. Efficacy, acceptability, and safety of muscle relaxants for adults with non-specific low back pain: systematic review and meta-analysis. BMJ. 2021;374:n1446.
Study design: Meta-analysis (randomized controlled trials)
Funding source: Self-funded or unfunded
Setting: Various (meta-analysis)
Synopsis
The researchers searched eight databases, including the Cochrane Library, as well as conference abstracts and trial registries, identifying 49 trials (N = 6,505) that evaluated efficacy and acceptability. The authors included randomized clinical trials published in English, Italian, Portuguese, Spanish, German, and Dutch that compared a benzodiazepine or nonbenzodiazepine muscle relaxant with placebo, usual care, waiting list, or no treatment. In 16 trials, participants taking a nonbenzodiazepine muscle relaxant (n = 4,546) reported a pain intensity that was an average of 7.7 points lower (on a 100-point scale; 95% CI, 3.3 to 12.1) at two weeks than the average pain intensity reported by participants in a control group (a difference of less than 10 points is not clinically important). When examining only published studies, the difference in pain relief increased to an average of 10.2 points (95% CI, 4.7 to 15.6).
Analyzing studies with a low risk of bias or with a placebo control resulted in no difference in pain relief. In 22 trials that examined 3,404 patients for safety and tolerability, nonbenzodiazepine antispasmodics were more likely to cause an adverse event (relative risk = 1.6; 95% CI, 1.2 to 2.0) compared with control treatment, but were not less likely to be discontinued (relative risk = 1.5; 95% CI, 0.6 to 3.5). Antispasmodics and benzodiazepines produced no differences in pain intensity within two weeks or at weeks 3 through 13. There was significant heterogeneity among trial results for antispasmodics, with most of the benefit occurring in studies of the muscle relaxant thiocolchicoside, which is not marketed in the United States. There was no evidence of publication bias.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
Are patients reassured by negative magnetic resonance imaging findings for low back pain?
Bottom line
Information given to patients without context can be harmful. Patients with low back pain who were given the actual results of their magnetic resonance imaging (MRI), without interpretation by a physician, had greater pain, less self-efficacy, and lower function afterward, continuing even after six weeks of conservative treatment. On the other hand, patients told that their MRI was "normal, with age-related findings" responded better to treatment, had lower pain, improved self-efficacy, and higher function.
Reference
Rajasekaran S, Dilip Chand Raja S, Pushpa BT, et al. The catastrophization effects of an MRI report on the patient and surgeon and the benefits of 'clinical reporting': results from an RCT and blinded trials. Eur Spine J. 2021;30(7):2069-2081
Study design: Foundation
Allocation: Uncertain
Setting: Outpatient (specialty)
Synopsis
The goal of this study was to see whether faculty explanation of MRI findings helped or harmed patients. The researchers enrolled 44 patients with chronic low back pain without "red flags" or clinical indications for surgery. The patients were randomized, allocation concealment uncertain, either to be told that their routine MRI was "completely normal" and all findings were incidental or age-related or to be read the actual report that may have included terms such as "degeneration," "tears," "ruptures," "neural compression," or other typical incidental findings. All patients then were prescribed six weeks of conservative treatment (not described). Pain scores were similar at baseline (5 to 6 of a possible 9) and similar after receiving MRI results but were significantly lower in the "all normal" group after treatment (a decrease to 2.4). Pain scores rose slightly in the patients who received the actual results (6.2). Patients who received the actual report had a decrease on the Pain Self Efficacy Questionnaire-2 (PSEQ-2) from 8.19 to 7.0 (of a possible 60) immediately after receiving the report, indicating a worsening perception of their own self-efficacy. The score dropped further (average 6.2) after conservative treatment. Patients receiving the "all normal" results had a small increase in the PSEQ-2 (from 8.13 to 8.9) immediately after the results were shared and a further improvement (to 10.9) after 6 weeks. Functional status over six weeks, as measured by the 12-Item Short Form Health Survey, similarly decreased in the group given the actual report but improved in the "all normal" group.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
For acute muscle pain, which oral analgesic provides the best immediate relief?
Bottom line
A single dose of opioid analgesics provides similar acute pain relief compared with a single dose of a combination of acetaminophen and ibuprofen in patients with acute musculoskeletal pain in the emergency department. Opioids increase the likelihood of nausea or vomiting. There was no added benefit of 800 mg of ibuprofen compared with 400 mg. The study did not investigate the effect of an injectable analgesic, possibly because of the placebo effect. These results are similar to those of previous studies of opioids and different doses of ibuprofen.
Reference
Bijur PE, Friedman BW, Irizarry E, et al. A randomized trial comparing the efficacy of five oral analgesics for treatment of acute musculoskeletal extremity pain in the emergency department. Ann Emerg Med. 2021;77(3):345–356.
Study design: Randomized controlled trial (double-blinded)
Funding source: Foundation
Setting: Emergency department
Synopsis
The researchers enrolled 600 adults, primarily Latino, presenting to two emergency departments with a sprain, strain, fracture, or other musculoskeletal extremity pain, excluding back pain. The patients were randomly assigned, using concealed allocation, to receive a single dose of one of five combinations of analgesics: 1,000 mg of acetaminophen with either 400 mg or 800 mg of ibuprofen, 300 mg of acetaminophen with 30 mg of codeine, 300 mg of acetaminophen with 5 mg of hydrocodone, or 325 mg of acetaminophen with 5 mg of oxycodone. Pain scores before treatment were mostly 8 to 10 on a scale of 0 to 10 (with 10 being the worst pain). Pain scores dropped an average of three points in every group by 60 minutes after the medication dose, with no statistical difference among the groups. Within two hours, the decrease from baseline was an average 4.3 to 4.7 points, with no significant differences among the groups. A similar percentage of patients in each group (24%) received rescue pain medication within the first two hours. The likelihood of nausea or vomiting was significantly higher among patients who received an opioid analgesic, with one additional patient experiencing these adverse effects for every 25 patients treated with an opioid (number needed to treat = 20; 95% CI, 12 to 59). The study had the power to detect a difference of 1.3 points between treatments, if one existed.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
Which nondrug therapies are effective for chronic pain?
Bottom line
There is low-quality and, in some cases, moderate-quality evidence for a range of noninvasive and nondrug therapies for chronic pain. Exercise, yoga, massage, and mindfulness stress reduction are all relatively inexpensive, do not require interaction with the health system.
Reference
Skelly AC, Chou R, Dettori JR, et al. Noninvasive nonpharmacologic treatment for chronic pain: a systematic review update. Comparative Effectiveness Review no. 227. Agency for Healthcare Research and Quality, 2020. Accessed May 13, 2022. https://www.ncbi.nlm.nih.gov/books/NBK556229
Study design: Meta-analysis (randomized controlled trials)
Funding source: Government
Setting: Outpatient (any)
Synopsis
This is a lengthy report comprising a series of systematic reviews by the federal Evidence-Based Practice Center in Portland, Oregon. In addition to their staff, key informants, technical experts, and peer reviewers were consulted. This is a very experienced group of meta-analysts who also support the work of the United States Preventive Services Task Force. They searched PubMed and Cochrane Central for randomized trials of noninvasive, nonpharmacological treatments for chronic pain of the back, neck, knee, hip, or hand; fibromyalgia; and tension headache. They defined short term as one month to less than six months of follow-up, intermediate term as six months to less than 12 months, and long term as 12 months or longer. A total of 233 studies were included, and they were rated as good, fair, or poor based on randomization, concealment of allocation, masking, comparability of groups, attrition, and whether analysis was by intention to treat. This is a very detailed 607-page report, but they summarize interventions shown to have a benefit in the intermediate- or long-term by condition. For chronic low back pain: Exercise, massage, yoga, cognitive behavioral therapy, mindfulness-based stress reduction, acupuncture, spinal manipulation, low-level laser therapy, and rehabilitation all produced a reduction in pain and/or function. For chronic neck pain, there is evidence for exercise, massage, low-level laser therapy, acupuncture, and Pilates. For knee osteoarthritis:, only exercise and cognitive behavioral therapy were helpful. For hip osteoarthritis, there is evidence only for exercise and manual therapies. Patients with fibromyalgia benefitted from cognitive behavioral therapy, myofascial release massage, tai chi, qigong, acupuncture, rehabilitation, and exercise. Finally, the only therapy found to be effective for chronic tension headache was spinal manipulation. Overall, the strength of evidence was low for most interventions, there was little evidence regarding long-term benefits, and evidence on harms was not well reported.
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, Ga.
Clinical question
Is fecal immunochemical testing (FIT) an effective method of screening for colorectal cancer?
Bottom line
FIT every other year, over at least six years, identified fewer cancers and advanced adenomas initially, but surpassed a single sigmoidoscopy in detection after three rounds of testing. The increased detection may be because of greater participation in FIT than in sigmoidoscopy.
Reference
Randel KR, Schult AL, Botteri E, et al. Colorectal cancer screening with repeated fecal immunochemical test versus sigmoidoscopy: baseline results from a randomized trial. Gastroenterology. 2021;160(4):1085–1096.e5.
Study design: Randomized controlled trial (nonblinded)
Funding source: Government
Allocation: Concealed
Setting: Population-based
Synopsis
Using a national patient registry in two geographic areas of southeast Norway, the investigators randomly invited individuals 50 to 74 years of age (N = 139,291) for either a once-only screening with flexible sigmoidoscopy or FIT every other year for a maximum of four rounds. None of the patients who received an invitation to this study had ever undergone any colorectal cancer screening. Positive findings with either screening were confirmed by colonoscopy. More patients accepted the invitation for screening via FIT (58.4% in the first round and 68.4% after three cumulative rounds) compared with sigmoidoscopy (52.1%). Patients with a 10-mm or larger polyp or at least three adenomas with dysplasia or villous architecture were referred for colonoscopy. Sigmoidoscopy identified more stage I colorectal cancer than FIT (odds ratio = 0.72; 95% CI, 0.55 to 0.95), although overall identification of colorectal cancer was similar between the two means of screening. Colorectal cancer detection rates were higher after three cumulative rounds of FIT (0.49% vs. 0.27%), and the difference was particularly pronounced for lesions located in the proximal colon. Advanced adenoma detection rates were higher with sigmoidoscopy for the first two rounds of FIT but were better with FIT after three rounds. False positives cannot be calculated because not all screened participants had a colonoscopy. FIT may result in a higher diagnostic yield because patients were solicited up to four times whereas patients assigned to sigmoidoscopy were solicited just once, and more patients (68%) who were offered FIT received at least one screening compared with only 52% for sigmoidoscopy.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
Which over-the-counter products are effective in treating persons with chronic constipation?
Bottom line
In this limited systematic review without formal data synthesis, the authors conclude there is good evidence to recommend polyethylene glycol or senna as first-line laxatives and moderate evidence to support fiber supplements, fruits, stimulant laxatives, and magnesium-based products.
Reference
Rao SSC, Brenner DM. Efficacy and safety of over-the-counter therapies for chronic constipation: an updated systematic review. Am J Gastroenterol. 2021;116(6):1156-1181.
Study design: Systematic review
Funding source: Industry
Setting: Various (meta-analysis)
Synopsis
This pair of authors searched only two databases to identify English-language reports of randomized trials lasting at least four weeks that evaluated various over-the-counter products in managing adults with chronic constipation. They also limited their search to the past 15 years to update their previous systematic review from 2004. They do not describe any attempt at identifying studies missed by their search strategy or even looking for unpublished studies by searching any clinical trials registries. They used the U.S. Preventive Services Task Force framework to assess the methodologic quality of the included studies and to grade their recommendations. Using their initial search strategy, the authors identified 110 eligible studies. After further excluding agents that were not readily available, they ultimately evaluated 41 studies, ranging in size from nine to 368 participants. The report is a narrative review rather than a formal meta-analysis. The authors grouped their report into eight categories of agents: osmotic laxatives, fiber laxatives, stimulant laxatives, magnesium-based laxatives, fruit-based laxative, foods with prebiotics, surfactants, and miscellaneous agents. They identified nine studies of osmotic laxatives, all polyethylene glycol, and of variable quality. They conclude that polyethylene glycol was effective and well tolerated, and they recommend it as a first-line treatment (A recommendation). Although two different types of stimulant laxatives exist (diphenylmethane derivatives, such as bisacodyl and sodium picosulfate, and plant-based anthraquinones, such as senna, aloe, and cascara), they all act locally to stimulate colonic smooth muscle. Two studies, both high of quality, evaluated senna, but the authors found no studies that evaluated cascara. The authors conclude senna is effective (A recommendation), as are the diphenylmethane derivates (B recommendation). However, these stimulants also had increased potential need for dose reduction or intolerance. The authors found four new studies of magnesium-based products and concluded these were also effective (B recommendation). The authors identified five new studies of fruit-based products (kiwi, mango, ficus, and prune) and found they were generally effective and well tolerated (B recommendation). Additionally, they found one trial of yogurt with galacto-oligosaccharides, prunes, and linseed oil that showed increased stool frequency, easier defecation, and softer stools (B recommendation). Based on a single study, the benefits and adverse effects for rye bread with yogurt were a toss-up (C recommendation). Among fiber-based products, the research quality and their results are mixed. The authors conclude that psyllium and mixed-fiber products are effective (B recommendation), but there is insufficient research on inulin and polydextrose (I recommendation). Finally, they also conclude there is insufficient research on surfactants (I recommendation).
Henry C. Barry
Professor
Michigan State University
East Lansing, Mich.
Clinical question
Which patients with vague abdominal symptoms should be referred for further workup?
Bottom line
Using a cutoff of 3% risk (from The National Institute for Health and Care Excellence), dysphagia or changes in bowel habits in men and rectal bleeding in women should trigger referral for further workup to exclude cancer or inflammatory bowel disease (IBD). Symptoms such as abdominal pain, changes in bowel habits, or dyspepsia in patients older than 60 years should be investigated because they predict cancer or IBD in more than 3% of men and women.
Reference
Herbert A, Rafiq M, Pham TM, et al. Predictive values for different cancers and inflammatory bowel disease of 6 common abdominal symptoms among more than 1.9 million primary care patients in the UK: a cohort study. PLoS Med. 2021;18(8):e1003708.
Study design: Descriptive
Funding source: Government
Setting: Population-based
Synopsis
The authors worked with routinely collected electronic health record data of 1.9 million patients from 742 general practices in the United Kingdom collected between the years 2000 and 2017. They included data of all patients who had at least one visit for a vague abdominal symptom and looked to see whether that patient was given a diagnosis of cancer or IBD in the subsequent year. For patients with two or more symptoms, one symptom was chosen randomly as the primary symptom. The median age ranged from 54 to 63 years at first consultation. Changes in bowel habits in men were associated with a cancer diagnosis in 4.64% of cases and an IBD diagnosis in 2.82% of cases. Dysphagia in men was associated with cancer in 4.28% of cases, mainly esophageal cancer. In women, rectal bleeding was the greatest predictor: 2.39% for cancer and 2.57% for IBD. Dyspepsia was the symptom least likely to be associated with cancer or IBD. Abdominal bloating/distension and abdominal pain were associated with cancer or IBD less than 2% of the time. In patients 60 years or older, abdominal pain, changes in bowel habits, and dyspepsia predicted cancer or IBD in more than 3% of men and women.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
What is the best dose of aspirin for secondary prevention in persons with established atherosclerotic cardiovascular disease (ASCVD)?
Bottom line
There is no advantage to a 325-mg dose of aspirin for patients with established atherosclerotic cardiovascular disease, and people taking the higher dose often switched to the lower dose (although the reason is unclear). Just stick with 81 mg.
Reference
Jones WS, Mulder H, Wruck LM, et al. Comparative effectiveness of aspirin dosing in cardiovascular disease. N Engl J Med. 2021;384(21):1981-1990.
Study design: Randomized controlled trial (nonblinded)
Funding source: Government
Allocation: Uncertain
Setting: Population-based
Synopsis
The European Society of Cardiology recommends an 81-mg dose of aspirin for patients with ASCVD; U.S. guidance is less clear, and many patients are discharged with a 325-mg dose following a cardiovascular event. This pragmatic trial identified patients with established ASCVD and randomized them to receive 81 mg or 325 mg aspirin daily. Patients purchased the aspirin themselves and then had follow-up visits every three months or six months (the authors wanted to see whether more frequent visits affected trial participation — they did not). The primary outcome was a composite of death, hospitalization for myocardial infarction, or hospitalization for stroke. A total of 15,076 patients were randomized, with a median age of 68 years; 31% were women, 79% White, 9% Black, and 3% Hispanic. Slightly more than one-third had a previous myocardial infarction, whereas slightly more than half had undergone a previous revascularization. After a median follow-up of just more than two years, there was no significant difference between groups in the primary outcome (7.28% for 81 mg and 7.51% for 325 mg). There was also no difference in the likelihood of hospitalization for major bleeding (0.63% vs. 0.60%). Adherence was good, but 42% in the 325-mg group switched to the lower dose, compared with only 7% in the 81-mg group who switched to the higher dose. Patients taking the higher dose were also more likely to discontinue taking aspirin altogether. There was also no difference between groups for secondary outcomes, such as revascularization or hospitalization for transient ischemic attack. Data on adverse effects other than major bleeding was not reported.
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, Ga.
Clinical question
How well do the Framingham Risk Score and Pooled Cohort Equations estimate the risk of cardiovascular events in the general population?
Bottom line
Both the Framingham Risk Score and the Pooled Cohort Equations significantly overpredicted the five-year risk of a composite cardiovascular event outcome. This is consistent with other research and should give us pause as we use these risk scores to guide therapeutic decision-making. For example, a person with a 10-year risk of 10% probably has a true risk closer to 5%, leading to very different guideline recommendations for a statin.
Reference
Ko DT, Sivaswamy A, Sud M, et al. Calibration and discrimination of the Framingham Risk Score and the Pooled Cohort Equations. CMAJ. 2020;192:E442-9.
Study design: Decision rule (validation)
Funding source: Government
Allocation: Uncertain
Setting: Population-based
Synopsis
We increasingly rely on risk scores such as the Pooled Cohort Equation or the older Framingham Risk Score to make decisions about prescribing statins or aspirin. The Pooled Cohort Equation is recommended by current ACC/AHA guidelines because it is believed to better represent contemporary cardiovascular risk, which has been slowly declining since the Framingham Risk Score was first developed. These researchers used a linked database of medical records in Ontario, Canada. All patients had a primary care physician and health insurance. Residents with blood pressure and lipid values between 2010 and 2014 in the database were included, as long as they were collected within one year of each other. Of 133,892 originally identified, 33,897 were excluded because they were not 40 to 79 years of age or because they had documented hospitalization for a vascular diagnosis. Another 15,378 were excluded because information about tobacco use was missing. The final group had a mean age of 56 years, 17% were current smokers, 25% were taking an antihypertensive, and 14% were taking a statin. The researchers then calculated the patient's five-year risk of the cardiovascular composite outcome predicted by each risk score, in both cases a composite of cardiovascular death and hospitalization for vascular events such as stroke or myocardial infarction. The c-statistic (which is identical to the area under the receiver operating characteristic curve) was 0.74 for the Framingham Risk Score and 0.73 for the Pooled Cohort Equation (good discrimination) but was less accurate in men than in women. Both risk scores significantly overestimated risk, especially in men. For example, the observed risk of the composite outcome predicted by the Framingham Risk Score was 2.9%, and the Framingham Risk Score predicted a 5.8% risk. The Pooled Cohort Equation was no better, with an observed risk of 1.6% and a predicted risk of 3.5%. Overprediction of risk occurred in men and women and in all age groups and ethnicities. Discordance, which is (observed - expected)/observed was 183% in the youngest age group of 40 to 45 years and was only 44% in the oldest age group of 75 to 79 years.
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, Ga.
Clinical question
How do routine clinical measurements of systolic blood pressure compare with ideal blood pressure measurement?
Bottom line
Compared with measurements that follow the strict protocols used in research, blood pressure (BP) measurement in typical offices will be an average 4.6 to 7.3 mm Hg higher for systolic readings. This study also found wide variations in clinical BP readings compared with the reference standard. The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated that reducing a systolic BP to less than 120 mm Hg was associated with decreased mortality. However, most guidelines suggest a goal of less than 130 mm Hg, given that the SPRINT method of BP measurement was more accurate than the method used in usual clinical practice.
Reference
Drawz PE, Agarwal A, Dwyer JP, et al. Concordance between blood pressure in the systolic blood pressure intervention trial and in routine clinical practice. JAMA Intern Med. 2020;180(12):1655-1663.
Study design: Diagnostic test evaluation
Funding source: Government
Setting: Outpatient (any)
Synopsis
This study used data from the SPRINT trial with 3,074 participants (81% men, mean age 68.5 years) with three or more outpatient and trial BP measurements. The outpatient visits were recorded in the electronic health record. The SPRINT BP measurements were considered to be the reference standard; that is, the best approximation of the participants' true BP. These measurements were performed as outlined by the American Heart Association; BP was measured after five minutes of quiet rest using an automated device, with proper participant positioning (supported back, feet on the ground), appropriate cuff size and positioning, and a mean of three readings. The BPs that were documented in the electronic health record were obtained in whatever way the personnel in the 49 offices usually performed the measurements. The mean systolic BP measured in the offices was an average 4.6 to 7.3 mm Hg higher than the BP measured by the trial personnel, depending on whether the patients were receiving standard or intensive treatment. As has been demonstrated in other studies, office-based measurements ranged wildly from the research BP, from -30 mm Hg to +45 mm Hg, with 80% of the office BP measurements being higher than the trial measurements..
Allen F. Shaughnessy, PharmD, MMedED
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
Is the consumption of eggs associated with an increased risk of cardiovascular disease?
Bottom line
Egg consumption is not associated with the occurrence of cardiovascular events over an average of 12 years. A meta-analysis found that eating more than one egg per day, on average, was associated with a decreased likelihood of coronary artery disease (approximately 11%). This decrease may be due to a healthy user bias; that is, eating eggs may be associated with healthy habits.
Reference
Krittanawong C, Narasimhan B, Wang Z, et al. Association between egg consumption and risk of cardiovascular outcomes: a systematic review and meta-analysis. Am J Med. 2021;134(1):76–83.e2.
Study design: Meta-analysis (other)
Funding source: Self-funded or unfunded
Setting: Various (meta-analysis)
Synopsis
The authors searched five databases, including the Cochrane Library, and identified 23 observational studies of almost 1.4 million patients with an average follow-up of 12.3 years. One author selected the studies and two investigators independently abstracted the data. The studies' quality, evaluated by two investigators, was moderate to high for observational studies. There was no association between egg consumption and an increased risk of cardiovascular disease events, but there was a high degree of heterogeneity among the studies. Compared with eating no eggs or one egg per day on average, eating more than one egg per day on average was associated with a significantly decreased risk of coronary disease (hazard ratio = 0.89; 95% CI, 0.86 to 0.93) without evidence of heterogeneity, but there was no effect on the risk of stroke (moderate heterogeneity).
Allen F. Shaughnessy, PharmD, MMedED
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
Which treatments for chronic neuropathic pain can provide clinically meaningful improvement?
Bottom line
Given the balance of benefits and harms, there is moderately good evidence for anticonvulsants (pregabalin [Lyrica] and gabapentin [Neurontin] were similarly effective and well tolerated) and serotonin-norepinephrine reuptake inhibitors (SNRIs; with duloxetine [Cymbalta] and venlafaxine being similarly effective and well tolerated) for treating diabetic neuropathy and postherpetic neuralgia. Rubefacients (usually salicylates) appear to be effective but are less well studied with low-quality evidence. Acupuncture, opioids, and tricyclic antidepressants cannot be recommended based on current evidence.
Intervention |
Studies (Participants) |
NNT (95% CI) |
NNTH |
Quality |
Anticonvulsants |
40 (9,575) |
7 |
17 to 22 |
Moderate |
SNRIs |
8 (2,746) |
7 |
13 |
Moderate |
Rubefacients |
10 (2,344) |
7 |
25 |
Low |
Opioids |
6 (1,149) |
8 |
12 |
Low |
Reference
Falk J, Thomas B, Kirkwood J, et al. PEER systematic review of randomized controlled trials: management of chronic neuropathic pain in primary care. Can Fam Physician. 2021;67(5):e130–e140.
Study design: Meta-analysis (randomized controlled trials)
Funding source: Self-funded or unfunded
Setting: Various (meta-analysis)
Synopsis
This report describes findings from a series of meta-analyses of placebo-controlled randomized trials of at least three months' duration on the effectiveness of drug and nondrug treatments for chronic neuropathic pain, with a focus on diabetic neuropathy, postherpetic neuralgia, and trigeminal neuralgia. Only studies that provided results as the presence or absence of a clinically meaningful response, defined as at least a 30% improvement on a scale of pain and/or function, were included. Studies in pregnant patients, of acute pain, and those with an active comparator were excluded. The authors found no qualifying studies for trigeminal neuralgia, or for topical lidocaine or exercise as interventions. The authors identified 40 randomized controlled trials with moderate certainty of evidence for anticonvulsants; the bulk of the evidence was for pregabalin and gabapentin, and both were effective (number needed to treat [NNT] = 7 for one patient to respond; number need to harm [NNH] = 17 to 22 for withdrawal due to adverse events). Rubefacients (topical drugs that cause irritation and redness of skin) were studied in 10 randomized controlled trials with low certainty of evidence; low-dose patches or creams and high-potency patches were similarly effective (NNT = 7) and were generally well tolerated (NNH = 25 for withdrawal). The SNRIs duloxetine, venlafaxine, and desvenlafaxine (Pristiq) were studied in eight moderate-certainty studies, with an NNT of 7 for response and NNH of 13 for withdrawal. Opioids were studied in six low-certainty studies, with an NNT of 8 for one patient to respond but a similar NNH of 12 for withdrawal due to adverse events. Acupuncture was only studied in three trials with very low certainty; no significant benefit was detected, although the confidence interval is wide (relative risk = 1.81; 95% CI, 0.55 to 6.0). Tricyclic anti-depressants were studied in only two small, low-certainty studies and no significant benefit was seen in the appropriate random effects meta-analysis. Results are summarized in the accompanying table.
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, Ga.
Clinical question
Does increasing the dose of antidepressant above the minimum dose improve outcomes?
Bottom line
For new-generation antidepressants, including selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and mirtazapine (Remeron), initial titration over the first eight weeks of treatment provides no benefit over starting with the minimum dose in patients with moderate to severe depression. Unfortunately, this means we have to wait six to eight weeks to judge the response to treatment before moving to another medicine.
Reference
Furukawa TA, Salanti G, Cowen PJ, et al. No benefit from flexible titration above minimum licensed dose in prescribing antidepressants for major depression: systematic review. Acta Psychiatr Scand. 2020;141(5):401–409.
Study design: Meta-analysis (randomized controlled trials)
Funding source: Government
Setting: Various (meta-analysis)
Synopsis
These authors searched 10 databases, including Cochrane, as well as national drug licensing agencies' websites to identify 123 published and unpublished randomized controlled trials that enrolled more than 29,000 participants. The authors included studies published in any language that evaluated SSRIs, venlafaxine, or mirtazapine for the acute treatment of major depression that were administered at their respective minimum licensed dose or in a flexible dose regimen that allowed titration above the minimum dose. Patients, on average, had moderate to severe depression. Response was defined as 50% or greater reduction from baseline on an observer-rated depression severity scale. Overall, titrating above the minimum dose did not further increase the likelihood of response for any of the treatments, and sertraline (Zoloft) produced a better response, on average with the minimum dose (ratio of odds ratios = 0.72; 95% CI, 0.57 to 0.91). A big caveat: The studies were of short duration—usually eight weeks—which may not have allowed enough time to really see a response to titration. Patients taking venlafaxine may respond to a higher dose if they showed no response to the minimum dose. There was moderate heterogeneity among the studies and no evidence of publication bias or small study effect.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
What is the effect of a delayed-prescription approach for children with respiratory tract infection?
Bottom line
A strategy of providing education about the natural history of respiratory symptoms in children combined with giving a take-and-hold prescription (to be filled only if symptoms persisted) resulted in one in four of those children eventually receiving an antibiotic. However, it increased the number of children who used other medications to control symptoms, which indicates the parents' need to do something. Symptom severity and time to resolution, complications, and follow-up visits were similar whether children received immediate, delayed, or no antibiotic treatment. Immediate treatment resulted in more gastrointestinal symptoms. Similar results have been shown in adults.
Reference
Mas-Dalmau G, Villanueva López C, Gorrotxategi P, et al.; DAP Pediatrics Group. Delayed antibiotic prescription for children with respiratory infections: a randomized trial. Pediatrics. 2021;147(3):e20201323.
Study design: Randomized controlled trial (nonblinded)
Funding source: Government
Allocation: Concealed
Setting: Outpatient (primary care)
Synopsis
The investigators enrolled 436 children from 39 primary care centers. The children were between two and 14 years of age (most were 10 years or younger) and had pharyngitis, rhinosinusitis, acute bronchitis, or acute otitis media for which the treating pediatrician had reasonable doubts about the need to prescribe an antibiotic. Pediatricians who had access to rapid streptococcal testing did not include children with pharyngitis in this study. The children were randomly assigned using concealed allocation to receive no antibiotic treatment, a prescription for an antibiotic to be started immediately, or a prescription to be started only if the patient had a fever or felt much worse after 24 hours, or if the child did not start to feel better after four, seven, 15, or 20 days from symptom onset for acute otitis media, pharyngitis, rhinosinusitis, or acute bronchitis, respectively. All parents were told that it was normal for a child to feel slightly worse in the first days after a visit and the natural history of the respective condition was described (e.g., the cough of acute bronchitis could last for 20 days). Almost all (96%) of the children in the immediate antibiotic group received treatment, whereas only 25% of the delayed group and 12% in the no antibiotic group received an antibiotic. Symptoms took an average of eight days to disappear, regardless of treatment group. The duration of days with severe symptoms was similar in both groups. Nonantibiotic symptom treatment was more common in the delayed or no antibiotic group compared with the immediate treatment group (P < .001). Complications and unscheduled visits were similar across the groups. Gastrointestinal symptoms were higher with immediate treatment. Satisfaction was similar among all three groups.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
Is supplemental oral vitamin C plus iron replacement more effective than oral iron replacement alone in adults with iron deficiency anemia?
Bottom line
This study found no difference in hemoglobin or serum ferritin level after three months in adults with iron deficiency anemia who were treated with oral iron plus vitamin C vs. oral iron alone.
Reference
Li N, Zhao G, Wu W, et al. The efficacy and safety of vitamin C for iron supplementation in adult patients with iron deficiency anemia. A randomized clinical trial. JAMA Netw Open. 2020;3(11):e2023644.
Study design: Randomized controlled trial (single-blinded)
Funding source: Unknown/not stated
Allocation: Concealed
Setting: Outpatient (any)
Synopsis
Because vitamin C helps promote iron absorption, many clinicians recommend it as a supplement to oral iron for the treatment of iron deficiency anemia. These investigators identified 440 adults, 18 years or older, who met standard diagnostic criteria for iron deficiency anemia. Participants randomly received (concealed allocation assignment) ferrous succinate (100 mg) plus vitamin C (200 mg), or 100 mg ferrous succinate only, every eight hours. Individuals who assessed outcomes remained unaware of group assignments. Complete follow-up occurred for 98% of participants at three months. Using intention-to-treat analysis, no significant group differences occurred in the primary outcome of a change in hemoglobin level. Similarly, no significant group differences occurred in change in reticulocyte percentage or serum ferritin level. The proportion of patients with adverse events was comparable in both groups.
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Clinical question
Are short antibiotic courses as effective as longer courses for common infections?
Bottom line
American College of Physicians guidelines recommend five days of antibiotics for community-acquired pneumonia, five days for chronic obstructive pulmonary disease excerbation, five to seven days for uncomplicated pyelonephritis if using a quinolone, and five to six days for nonpurulent cellulitis. Longer courses may be necessary if there is no clinical improvement.
Guideline summary: https:// www.aafp.org/afp/2022/0200/p205.html
Reference
Lee RA, Centor RM, Humphrey LL, et al. Appropriate use of short-course antibiotics in common infections: best practice advice from the American College of Physicians. Ann Intern Med. 2021;174:822–827.
Study design: Practice guideline
Funding source: Self-funded or unfunded
Setting: Outpatient (any)
Synopsis
These guidelines, developed by the American College of Physician's High Value Care Committee, provide advice for care based on an assessment of the value (benefits, harms, and costs) of medical interventions. They were developed after a review of existing guidelines and systematic reviews. None of the participants declared financial conflict of interest. The committee included a public representative. The recommendations, and caveats, are listed in the table.
| Infection | Duration | Explanation | |
| Chronic obstructive pulmonary disease exacerbation | Five days | For exacerbations and acute uncomplicated bronchitis with increased sputum purulence with increased dyspnea and/or sputum volume |
|
| Community-acquired pneumonia | Five days | Extend for an additional five days in patients with documented vital sign abnormalities, inability to eat, and changes in mental status |
|
| Uncomplicated cystitis in women | Nitrofurantoin: five days Co-trimoxazole: three days Fosfomycin: single dose |
Reserve fluoroquinolones for resistant cases because of the risk of adverse effects | |
| Uncomplicated pyelonephritis | Fluoroquinolone: five to seven days Co-trimoxazole: 14 days |
Based antibiotic selection on sensitivity | |
| Nonpurulent cellulitis | Five to six days | Cephalosporin, penicillin, or clindamycin unless methicillin-resistant Staphylococcus aureus is documented |
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
What therapies are recommended for acute pain from non–low back musculoskeletal injuries?
Bottom line
The American College of Physicians and American Academy of Family Physicians collaborated to create guidelines on the management of non–low back musculoskeletal injuries. Based on a large systematic review and network meta-analysis, they give a strong recommendation for topical diclofenac as first-line therapy and a conditional recommendation for oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, acupressure, or transcutaneous electrical nerv stimulation (TENS). Opioids are not recommended because of greater adverse effects and risk of prolonged use.
Guideline summary: https:// www.aafp.org/afp/2020/1201/p697.html
Reference
Qaseem A, McLean RM, O'Gurek D, et al. Nonpharmacologic and pharmacologic management of acute pain from non–low back, musculoskeletal injuries in adults: a clinical guideline from the American College of Physicians and American Academy of Family Physicians. Ann Intern Med. 2020;173(9):739-748.
Study design: Practice guideline
Funding source: Self-funded or unfunded
Setting: Various (guideline)
Synopsis
These guidelines from the U.S. internal medicine and family physician societies started with a meta-analysis of studies that evaluated treatments for musculoskeletal pain other than in the low back. The writers evaluated patient-oriented outcomes: pain, function, satisfaction with care, and cost. The guideline panel included two members of the public. They used a network meta-analysis to compare options not directly studied with one another, which is good but not great. None of the authors had a financial conflict of interest. Evidence was evaluated using the standard GRADE methodology. A recommendation was labeled "strong" if it applies to most patients because the evidence was clear that benefits outweighed harms; "conditional" if it applies to most patients, but there is uncertainty in the evidence and patients' values and preferences should be more strongly considered. Based on moderate-certainty evidence, the groups strongly recommend initial treatment with a topical NSAID (only diclofenac is commercially available) because of demonstrated benefit on pain, function, and satisfaction with a low risk of side effects and a low cost. Given a moderate certainty of benefit and a moderate certainty of adverse effects, treatment with an oral NSAID is given a conditional recommendation. Acupressure and TENS may also be offered, though the certainty of evidence is low. Given low-certainty evidence, the group recommends against opioids for treatment (conditional recommendation).
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, Mass.
Clinical question
What is the optimal approach to screening for tobacco use in adults?
Bottom line
The U.S. Preventive Services Task Force found sufficient evidence to support the use of nicotine replacement therapy, bupropion, varenicline (Chantix), or behavioral interventions, with the combination of pharmacotherapy and behavioral interventions more effective than either alone. Effective behavioral interventions include advice from a physician or nurse, individual counseling, group behavioral interventions, telephone counseling, mobile phone–based interventions (including texting), health education, feedback, financial incentives, and social support.
In pregnancy, only behavioral interventions are recommended given the lack of evidence around pharmacotherapy in pregnancy.
Guideline summary: https:// www.aafp.org/afp/2021/0615/od1.html
Reference
Krist AH, Davidson KW, Mangione CM, et al. Interventions for tobacco smoking cessation in adults, including pregnant persons. US Preventive Services Task Force recommendation statement. JAMA. 2021;325(3):265-279.
Study design: Practice guideline
Funding source: Government
Setting: Population-based
Synopsis
In this updated review, the U.S. Preventive Services Task Force found sufficient evidence to support the use of nicotine replacement therapy, bupropion, varenicline, behavioral interventions, and the combination of pharmacotherapy and behavioral interventions for increasing the likelihood of successful smoking cessation in nonpregnant adults. In pregnancy, behavioral interventions are effective for smoking cessation, but the balance of benefits and harms of pharmacotherapy remains uncertain. Effective behavioral interventions include advice from a physician or nurse, individual counseling, group behavioral interventions, telephone counseling, mobile phone–based interventions (including texting), health education, feedback, financial incentives, and social support. The task force found inconsistent evidence about the use of e-cigarettes to aid in smoking cessation. No evidence of significant harm from either screening or pharmacotherapy was reported. The American College of Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians similarly recommend screening for tobacco use in adults, including pregnant people, and the similar use of pharmacotherapy and behavioral interventions to aid successful smoking cessation.
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Levels of Evidence definitions from Essential Evidence Plus
POEMs are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, please see http://www.essentialevidenceplus.com.