Recent Research

Acupuncture versus morphine for acute pain relief, outcomes data for physicians, beta-blockers at discharge after elective PCI, and more.


Acupuncture may be superior to morphine in relieving acute pain in ED patients, trial shows

For relieving moderate-to-severe acute pain in patients presenting to the ED, acupuncture may be superior to intravenous morphine and boasts a better safety profile, according to a recent randomized controlled trial.

Tunisian researchers randomized 150 adults to receive IV morphine (initial dose, 0.1 mg/kg body weight, followed by 0.05 mg/kg every 5 minutes or until treatment success was reached; maximum dose, 15 mg) and 150 adults to receive acupuncture from an ED doctor trained in medical acupuncture. Results were published in the November American Journal of Emergency Medicine.

The 2 study groups were comparable in terms of age, sex, and comorbidities, although there were significantly more patients with abdominal pain in the morphine group and more patients with low back pain in the acupuncture group. The primary outcome was pain relief (estimated by pain score at the start of the protocol and at multiple intervals afterward), and researchers also observed pain resolution time and adverse effects.

A drop in pain intensity of at least 50% was considered treatment success. The success rate was 92% in the acupuncture group and 78% in the morphine group (P<0.001). Mean resolution time ± SD was 16 ± 8 minutes in the acupuncture group and 28 ± 14 minutes in the morphine group (P<0.005).

No major adverse effect was recorded, but 89 patients (29.3%) experienced minor adverse effects: 85 (56.6%) in the morphine group and 4 (2.6%) in the acupuncture group. The most frequent adverse effects were dizziness in the morphine group (42%) and needle breakage in the acupuncture group (2.0%).

The main limitation of the trial was its lack of blinding, although the study authors noted that sham acupuncture would have been impossible because only 1 acupuncturist was involved. They also noted that the fairly homogeneous study population culturally accepts the practice of acupuncture, which would augment any placebo effect, and that they assessed intensity of pain with only the visual analogue and numeric rating scales. In addition, duration of acupuncture in the study was 20 to 30 minutes, whereas prior research suggests the highest therapeutic effect may be seen after 40 minutes, so the results may underestimate the treatment effect, they noted.

“Our data support that [acupuncture] is at least as efficacious as IV morphine in relieving acute pain in the ED. In our study, the safety profile of acupuncture was good and we did not record any major complications. This finding supports the further use of this nonpharmacologic pain relief technique in ED settings,” they wrote, noting that future studies should be performed in international populations.

Giving physicians outcome data reduced costs, improved quality at 1 hospital

One hospital's multifaceted effort to inform physicians about the costs and quality of their care successfully lowered costs of joint replacement, resulted in faster care for sepsis, and reduced laboratory expenses.

The pre-post observational study was conducted at University of Utah Health Care between 2012 and 2016. Researchers developed a tool to measure the actual cost of care (rather than charges) and convey that information to treating physicians. They also measured the variability of cost for different conditions and had clinicians select measures of quality of care. All these data were used to provide regular, comparative feedback to clinicians. Five pilot improvement projects were launched, and results from 3 (hip and knee replacement, hospitalist lab utilization, and sepsis) were reported in the Sept. 13 JAMA.

The researchers developed a composite index to measure the quality of total joint replacement and found that it improved from 54% at baseline to 80% after 1 year of the intervention (absolute change, 26%; 95% CI, 18% to 35%; P<0.001). Joint replacement costs also improved, by 7% during the implementation year and 11% the year after. The study also found reductions in hospitalists' lab costs, from a mean of $138 per day at baseline to $123 per day under the intervention, with no significant change in mean length of stay. For sepsis patients, the time to antibiotic administration was reduced, from 7.8 hours after meeting systemic inflammatory response syndrome criteria at baseline to 3.6 hours under the intervention.

The study authors concluded that their multifaceted tool succeeded in improving the value of care in 3 areas that showed high cost variation at baseline. “There may be benefit for individual physicians to understand actual care costs (not charges) and outcomes achieved for individual patients with defined clinical conditions,” they wrote. The authors noted several key components for improvement identified in this and other research, including regular feedback, clear targets, supportive tools, leadership focus, and multidisciplinary teams.

An accompanying editorial said this study “could not be more timely” given current pressures to improve the value of hospital care. The editorialists noted the importance of the intervention's finding specific areas where cost and value can be improved and focusing efforts on them, for example, modifying physical therapists' schedules so that they can get joint replacement patients out of bed on the day of surgery.

Beta-blockers at discharge may not improve outcomes after elective PCI in some older patients

Older patients who have a history of stable angina but no history of myocardial infarction (MI) or systolic heart failure may not benefit from beta-blocker use at discharge after elective percutaneous coronary intervention (PCI), according to a recent study.

Guidelines from the American College of Cardiology/American Heart Association strongly recommend beta-blockers in patients with previous MI or systolic heart failure. While it has been thought beta-blockers would also benefit coronary artery disease patients with stable angina who undergo PCI, there is little available evidence to support this hypothesis. Therefore, researchers examined data from hospitals in the National Cardiovascular Data Registry (NCDR) CathPCI registry to determine whether beta-blockers have an effect on outcomes in patients with stable angina after PCI. Patients with stable angina but no history of MI, systolic heart failure, or left ventricular ejection fraction below 40% who had elective PCI between January 2005 and March 2013 were included in the study, and predictors and trends of beta-blocker prescriptions at discharge were retrospectively analyzed.

The study's primary outcome was all-cause 30-day and 3-year mortality after discharge in patients ages 65 years and older for whom CMS fee-for-service data were available. Secondary outcomes were use of revascularization procedures (PCI or coronary artery bypass grafting) and cause-specific readmission for MI, stroke, and heart failure. A composite of these outcomes was also evaluated. The study results were published in the Aug. 22 JACC: Cardiovascular Interventions.

Overall, 755,215 patients from 1,443 facilities were included in the study, 71.4% of whom were discharged on beta-blockers. The mean age of the study population was 65.5 years; 64.3% were men, and 85.1% were white. At 3-year follow-up, 16.3% of the study population was at least 65 years of age and had CMS fee-for-service data available. In this group, no difference was seen in adjusted mortality rate (14.0% vs. 13.3%; adjusted hazard ratio [HR], 1.00; 95% CI, 0.96 to 1.03; P=0.84), MI (4.2% vs. 3.9%; adjusted HR, 1.00; 95% CI, 0.93 to 1.07; P=0.92), stroke (2.3% vs. 2.0%; adjusted HR, 1.08; 95% CI, 0.98 to 1.18; P=0.14), or revascularization (18.2% vs. 17.8%; adjusted HR, 0.97; 95% CI, 0.94 to 1.01; P=0.10) with a beta-blocker prescription versus without. An association was seen between beta-blockers at discharge and more readmissions for heart failure at 3-year follow-up (8.0% vs. 6.1%; adjusted HR, 1.18; 95% CI, 1.12 to 1.25; P<0.001). Results at 3-year follow-up were consistent with those at 30-day follow-up. During the study period, rates of prescription of beta-blockers at discharge increased gradually (P<0.001).

The researchers noted that their study included only 16.7% of those enrolled in the NCDR and therefore may not represent all of the NCDR patients. Those included were 65 years of age and older and had CMS data available, so the results may not be generalizable to younger patients or those without CMS data, they stressed. In addition, the researchers did not have access to drug claims data or information on frequency and severity of angina and could not control for residual confounding. However, they concluded that in this nonrandomized, observational study, beta-blocker use at discharge after elective PCI in older patients with stable angina but no previous MI, left ventricular systolic dysfunction, or systolic heart failure was not associated with postdischarge mortality, revascularization, or rehospitalization for MI or stroke at 30-day or 3-year follow-up.

“Notwithstanding the widespread use of [beta]-blockers for the treatment of hypertension and for angina control among patients with stable angina, our results demonstrate no difference in cardiovascular outcomes with the use of [beta]-blocker after elective PCI in routine clinical practice,” the authors wrote. They called their findings “hypothesis-generating” but said they highlight features associated with beta-blocker use, such as hypertension and previous or current heart failure, that are often linked to symptomatic coronary artery disease leading to elective PCI. Their results, they wrote, “suggest that the use of [beta]-blockers in this population should be customized based on other concomitant cardiovascular conditions and completeness of revascularization.”

The authors of an accompanying editorial pointed out that the study did not report whether all patients with stable coronary artery disease were naïve to beta-blocker therapy before PCI and agreed that confounding, as well as selection bias, may have affected the results. However, they said that this study in addition to others call the use of beta-blockers in patients with coronary artery disease after PCI into question and that it “seems increasingly difficult to justify the continued class IA/IB Clinical Practice Guideline recommendation for beta-blocker use by professional cardiovascular societies where the evidence of clinical benefit in patients without prior MI or heart failure/[left ventricular] dysfunction is largely lacking.”

Noting that a definitive randomized trial in this area is unlikely to be conducted, without new data to guide therapy, “clinicians will need to decide whether they will continue to extrapolate older scientific evidence of beta-blocker efficacy in selected post-MI populations from an earlier era before the advent of PCI and [optimal medical therapy] to the current era of contemporary clinical practice,” the editorialists wrote. They suggested that such decisions should be “guided more by physician judgment, and hence individualized to the level of patient benefit versus risk, because such definitive evidence is either imperfect or lacking.”

Drugs associated with fractures continued in patients who had fragility fractures

Patients who survive a fragility fracture typically continue to take drugs associated with increased fracture risk, a recent study found.

The retrospective cohort study included about 168,000 community-dwelling Medicare beneficiaries who survived a fracture of the hip, shoulder, or wrist between February 2015 and March 2016. All were enrolled in fee-for-service Medicare and were community-dwelling for at least 30 days of the 4 months after fracture treatment. Their mean age was 80 years and 53.2% were hospitalized for fracture treatment. Researchers tracked their use of drugs that increase fall risk, decrease bone density, or have an unclear fracture risk mechanism, as well as those that increase bone density.

In the 4 months before the fracture, about three-quarters of the patients were exposed to at least 1 nonopiate drug associated with increased fracture risk (77.1% of hip fractures, 74.1% of wrist fractures, and 75.9% of shoulder fractures). Approximately 7% of patients discontinued such drugs after the fracture, but about an equal percentage started a drug in the category after the fracture, so that the proportion of patients on the drugs did not change significantly, nor did the average number of fracture-associated drugs taken. Both before and after the fracture, about a quarter of patients took a drug to strengthen bone density. The study was published in the October JAMA Internal Medicine.

The results appear to reveal a missed opportunity to reduce the risk of secondary fractures, the study authors said. They noted that patients undergo medication reconciliation in the hospital, but it does not appear to reduce use of fracture-associated drugs, perhaps because physicians handling acute care are reluctant to modify chronic drug regimens prescribed by primary care clinicians or are unaware of associations between the drugs and fractures, the authors speculated. Automated decision support and better communication among primary care physicians, hospitalists, and orthopedic surgeons could potentially improve this situation, they said. Caveats of the study include that it wasn't able to tell which fracture-associated drugs may have provided health benefits that outweighed their risks.

There were important differences in the use of the drug classes associated with fractures, an accompanying commentary pointed out. Use of sedatives, proton-pump inhibitors, selective serotonin reuptake inhibitors, and antipsychotics increased after fractures, while oral glucocorticoids and thiazolidinediones decreased. The editorialist also expressed particular concern about the low use of bisphosphonates, writing, “Not treating patients with osteoporosis drugs after a fracture would be like discharging a patient after a myocardial infarction without drugs to prevent a subsequent infarction.”

Antiplatelet and statin use suboptimal after carotid artery stenting and endarterectomy

Antiplatelets and statins are underused among patients discharged from the hospital after carotid endarterectomy or carotid artery stenting, a recent study found.

The retrospective cohort study included 23,112 patients who underwent the procedures between January 2007 and June 2012 at U.S. hospitals participating in the Carotid Artery Revascularization and Endarterectomy registry. At discharge, 99% of carotid artery stent patients received a prescription for antiplatelet agents, while only 78% received a prescription for a statin. Among endarterectomy patients, the rates were 93% and 75%, respectively. Results were published online by Stroke on Aug. 9.

The study found that specialty of the physician performing the procedure predicted the likelihood of a prescription, with medical specialists being most likely to prescribe the drugs, followed by radiologists, then surgeons. Patients treated at suburban hospitals were also more likely to get antiplatelets and statins, followed by those at urban hospitals, then rural hospitals. The geographic location of the hospital predicted statin prescriptions (Northeast most likely, then Midwest and South, with the West least likely) but not antiplatelet use.

The study authors concluded that current use of these medications in such patients is suboptimal. “Identifying, explaining, and correcting unnecessary variation in antiplatelet therapy and statin utilization” among these patients is critically important, the authors said, noting that the medications have a Class I recommendation for use in such patients according to multispecialty guidelines.

The study was limited by its basis in a subset of all the patients who underwent carotid endarterectomy or carotid artery stenting during the study period, among other factors, the authors noted. However, because the data came from hospitals voluntarily participating in a registry, the results might overestimate the real-world use of these medications. In addition, patients who have carotid stenosis but do not undergo either procedure might be even less likely to receive prescriptions for antiplatelets or statins, the authors speculated.

Vasopressin may not improve septic shock treatment compared to norepinephrine

Early use of vasopressin to treat septic shock did not improve the number of kidney failure-free days compared with norepinephrine, according to a study.

Researchers performed a randomized, double-blind clinical trial in patients who had septic shock requiring vasopressors despite fluid resuscitation within a maximum of 6 hours after shock onset. The patients, from 18 U.K. ICUs, were assigned to vasopressin and hydrocortisone (n=101), vasopressin and placebo (n=104), norepinephrine and hydrocortisone (n=101), or norepinephrine and placebo (n=103).

The study's primary outcome was kidney failure-free days during the 28-day period after randomization, measured as the proportion of patients who never developed kidney failure and median number of days alive and free of kidney failure for patients who did not survive, who experienced kidney failure, or both. Secondary outcomes included rates of renal replacement therapy, mortality, and serious adverse events.

A total of 409 patients (median age, 66 years) were included in the study, with a median time to study drug administration of 3.5 hours after diagnosis of shock. Results were published Aug. 2 by JAMA.

The number of survivors who never developed kidney failure was 94 of 165 patients (57.0%) in the vasopressin group and 93 of 157 patients (59.2%) in the norepinephrine group (difference, −2.3%; 95% CI, −13.0% to 8.5%). The median number of kidney failure-free days for patients who did not survive, who experienced kidney failure, or both was 9 days (interquartile range [IQR], 1 to –24 days) in the vasopressin group and 13 days (IQR, 1 to –25 days) in the norepinephrine group (difference, −4 days; 95% CI, −11 to 5 days), the study found.

There was less use of renal replacement therapy in the vasopressin group than in the norepinephrine group (25.4% for vasopressin vs. 35.3% for norepinephrine; difference, −9.9%; 95% CI, −19.3% to −0.6%). There was no significant difference in mortality rates between groups, the researchers reported. In total, 22 of 205 patients (10.7%) had a serious adverse event in the vasopressin group compared to 17 of 204 patients (8.3%) in the norepinephrine group (difference, 2.5%; 95% CI, −3.3% to 8.2%).

“Among adults with septic shock, the early use of vasopressin compared with norepinephrine did not improve the number of kidney failure-free days,” the authors wrote. “Although these findings do not support the use of vasopressin to replace norepinephrine as initial treatment in this situation, the confidence interval included a potential clinically important benefit for vasopressin, and larger trials may be warranted to assess this further.”