Editors examine importance of six recent studies

Howard Bauchner, MD, JAMA editor-in-chief, comments on a study review published Sunday.

Howard Bauchner, MD, JAMA editor-in-chief, comments on a study review published Sunday.

The editors-in-chief of two leading medical publications addressed the importance of six recently published studies during the Sunday session “Discussion on the Edge: Reports of Recent Pulmonary Research Published in The New England Journal of Medicine and The Journal of the American Medical Association.”

Five of the six articles were published online Sunday, while the sixth article was published in December. The six studies focused on pulmonary medicine, while a similar session at 8:15 a.m. today will examine critical care studies.

NEJM articles
One arm of a study examining the treatment of idiomatic pulmonary fibrosis (IPF) patients using a combination of prednisone, azathioprine and N-acetyl cysteine (NAC) was stopped early because of excess mortality. On Sunday,The NEJM published a review of this study known as the PANTHER-IPF study.

“I think the data safety monitoring board for this study did a terrific job. It was pretty clear that these patients were not doing well on triple therapy, and therefore it made sense to stop the study,” said Jeffrey M. Drazen, MD, NEJM editor-in-chief. “We thought the description of the way the study was designed…was very useful.

“Interestingly, when the study first came in, they did not tell us about how the patients had died in the triple-therapy arm. In this article you’ll have the adjudication of the deaths in this study as to whether they were adjudicated to be respiratory or adjudicated to be other causes. Most deaths in the triple-therapy arm were adjudicated to be respiratory.”

PANTHER-IPF originally had three arms. The triple-therapy arm has been halted, but data are being collected for the other two arms—NAC plus placebo versus a placebo, said presenter Fernando J. Martinez, MD, University of Michigan Health System, Ann Arbor.

Another other article, published in December, examined the use of continuous positive airway pressure (CPAP) for treating metabolic syndrome patients with obstructive sleep apnea (OSA). Presenter Surendra K. Sharma, MD, PhD, All India Institute of Medical Sciences, New Delhi, reported that three months of CPAP therapy lowers blood pressure and partially reverses metabolic abnormalities.

“These types of studies have been done before. “What was new was the size and thoroughness of the study and that they did a crossover trial,” Dr. Drazen said, adding, “We think that this advanced the art. I don’t think this will be the last study, but it is the best.”

A third article, “Estrogen Promotes Pseudomonas Mucoidy and Exacerbations in Cystic Fibrosis (CF),” examined the effect of estrogen and oral contraceptives on CF. A study of estradiol levels and exacerbations in CF patients was conducted at the Royal College of Surgeons in Ireland and presented by Catherine M. Greene, PhD, senior lecture at the college.

The study reported that the exacerbation rate was lower in women receiving oral contraceptives and that estradiol levels correlated with infective exacerbations in menstruating women with CF, Dr. Greene said.

JAMA articles
The study “Benefits and Harms of low-dose CT Screening for Lung Cancer: A Systematic Review” examined the potential of using screenings to reduce deaths from lung cancer. Presenter Peter Bach, MD, Memorial Sloan-Kettering Cancer Center, New York, said that the study showed that low-dose CT screening may benefit those with an increased risk of lung cancer, such as high-risk smokers.

JAMA editors debated the benefits of the paper, published online today, said Howard Bauchner, MD, JAMA editor-in-chief. They concluded that their concerns were overridden by 150,000 lung cancer deaths in the U.S. annually.

“Often there is insufficient evidence to make robust decisions, but clinicians are faced with making those decisions,” he said. “We thought this paper could contribute to the  health and well being of people who live here. There has been little progress over the last decade, so this is the first hope we have that we can impact on those data, and we thought it was worthwhile publishing this paper.”

A second study review published today looked at the TIME2 trial which compared the use an indwelling pleural catheter (IPC) versus a chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion. Presenter Najib M. Rahman, DPhil, University of Oxford, United Kingdom, reported that IPC is not superior to talc pleurodesis and that both procedures improve breathlessness, quality of life and chest pain, although, more study is needed to address cost implications, length of hospital stay and non-inferiority. The study was fast-tracked by JAMA because of its potential impact on clinical care, Dr. Bauchner said.

“It is the right clinical question. These are patients with limited life expectancy. We thought it was important to conduct a rapid review,” he said.

A final JAMA study published today looked at the effect of using inhaled hypertonic saline in infants and children younger than age 6 with CF. Presenter Margaret Rosenfeld, MD, MPH, University of Washington, Seattle, said the treatment is accepted for treating older CF patients to help clear mucous.

The study showed that inhaled hypertonic saline offers no advantage over isotonic saline in decreasing pulmonary exacerbations in infants and young children with CF, she said.

Even though the study produced negative results, it was well designed and appropriately powered, Dr. Bauchner said. “The results of this study should influence practice. It should help clinicians who treat children with cystic fibrosis.”