Photobiomodulation therapy has been an FDA-approved treatment for inflammation and pain since 2011.
The first U.S. patient to receive photobiomodulation therapy for severe coronavirus disease 2019 (COVID-19) pneumonia responded positively to the treatment, according to the principal investigator of the pilot study.
Pneumonia and acute respiratory distress syndrome in COVID-19 patients are potentially deadly conditions. As of Sept. 10 in the United States, there had been more than 6.5 million confirmed cases of COVID-19, with more than 195,000 associated deaths, according to worldometer.
Details about the first treatment of a COVID-19 patient with photobiomodulation therapy (PBMT) was published last month in the American Journal of Case Reports.
The patient was a 57-year-old African American man presenting with a serious case of COVID-19 pneumonia at Lowell General Hospital in Massachusetts. The patient was placed in a prone position during the laser therapy for 28 minutes once a day for four consecutive days.
After the treatment, the patient's oxygen saturation increased from 93%-94% to 97%-100%, oxygen support was decreased from 2-4 liters per minute to 1 liter per minute, and the radiological assessment of lung edema score improved from 8 to 5. The patient also reported significant improvement in the Community-Acquired Pneumonia assessment tool. "Respiratory indices, radiological findings, oxygen requirements, and patient outcomes improved over several days and without need for a ventilator," the case report says.
The principal investigator for the PBMT pilot study, which features 10 patients, says the laser therapy had a significant impact on the first patient to receive the treatment. "It was remarkable watching him going through these four treatments and being discharged to a rehab facility the day after his last treatment," says Scott Sigman, MD, a practicing orthopedic surgeon at Orthopedic Surgical Associates of Lowell and team orthopedic physician at UMass Lowell.
Healthy dose of skepticism
A pair of critical care experts told HealthLeaders that much more research needs to be done before PBMT can be viewed as a viable treatment option for COVID-19 patients.
The improvements in the first patient to undergo PBMT may be related to the prone positioning during the treatment, says Abhijit Duggal, MD, assistant professor, Department of Pulmonary Critical Care and Allergy, Respiratory Institute, Cleveland Clinic, Cleveland.
"The data should be presented in terms of what the oxygen levels of patients were at four- to six-hour intervals after the photobiomodulation therapy. The improved oxygenation that was reported could have been a result of the therapy, but it is more likely that the improvement is associated with the prone positioning. What you need to know is what happened to the patient's oxygenation four hours later, eight hours later, or 12 hours later. If there was a trend in improved oxygenation without proning, that would be interesting to see. But that is not being reported in the case study."
The overall trajectory of COVID-19 patients with pneumonia or acute respiratory distress syndrome also must be considered, Duggal says. "We know that COVID-19 patients who are on 1 to 6 liters of oxygen usually have trajectories that improve around day three or four. Looking at the data in the case report, I did not see anything that I can say, 'Yes, this therapy by itself is showing a direct correlation with patient outcomes.'"
Until there are randomized controlled trials involving many patients, any new treatment for COVID-19 acute respiratory distress syndrome (ARDS) should be viewed skeptically, says David Kirk, MD, director of Pulmonary and Critical Care Medicine and director of eICU Service at WakeMed Health & Hospitals in Raleigh, North Carolina.
"At WakeMed, we believe that unproven therapies like hydroxychloroquine may have led to worse outcomes based on our internal data. Because of these facts, we have been very conservative to not jump on any unproven novel therapies unless they are done under research protocols. So, in general, we are skeptical of ARDS therapies, and we are worried that unproven therapies may make things worse instead of better."
Journey of discovery
So, how does an orthopedic surgeon with no experience treating lung injury become the principal investigator of a study on the use of laser technology in the treatment of COVID-19 pneumonia?
PBMT has been an FDA-approved treatment for inflammation and pain since 2011. Sigman has been using PBMT to treat inflammation and pain associated with acute joint injuries and chronic joint pain for nearly three years, with a success rate of about 78% in improvement of patient pain and inflammation.
"I wondered whether we could try the laser for the acute lung inflammation associated with COVID-19. I wondered whether it could work because it works well in orthopedic conditions," Sigman says.
Sigman's next step was to consult with his PBMT mentor, Professor Monica Monici of the University of Florence in Italy, one of the world's leading authorities in the study of the biology of laser treatment.
"She educated me on the process of the laser treatment, so I became much more comfortable using it for my patients. I called her in March and went over the details of what I was thinking about doing. She thought it was a good idea, and she gave me some initial parameters. But she is a molecular biologist, not a clinician, and she did not have experience in laser treatment of the lung fields," Sigman says.
The second step was finding clinicians who were familiar with the concept of using PBMT in the treatment of injured lungs. Sigman used a common research tool when doctors are unsure of their direction—Google.
"I was able to identify that there were two doctors—Soheila Mokmeli and Mariana Vetrici—who were MD-PhDs in Canada who were in the process of writing a paper about the theoretical use of laser treatment for COVID-19. I direct messaged Dr. Mokmeli, and she got back to me within an hour. I told her my idea and she said it was amazing," he says.
After consulting with Mokmeil, Sigman was able to determine the laser wavelength dose and duration of the laser treatment for COVID-19 patients with pneumonia or ARDS.
The next step was to convince the institutional review board at Lowell General Hospital to approve a pilot study. While the local IRB members were intrigued, they wanted to know whether the Food and Drug Administration would designate PBMT as a nonsignificant risk in the treatment of lung injury in COVID-19 patients, Sigman says. "I picked up the phone and called the FDA. Six hours later, the FDA called me back."
After several days of sending email back-and-forth with the FDA, Sigman got the greenlight. "The FDA was able to provide us with the documentation that my laser was a nonsignificant-risk device, which then allowed the IRB to give us permission to use this laser in a randomized trial."
Sigman and his colleagues at Lowell General Hospital are poised to publish results from a second COVID-19 patient in the Canadian Journal of Respiratory Therapy. "The case has been accepted for peer review—we are putting together the galley at this point. We will be able to announce the findings for that patient soon. The laser had a profound positive impact on that patient," he says.
The research team is compiling data from the pilot study and plans to submit that data to the New England Journal of Medicine, Sigman says.
Christopher Cheney is the senior clinical care editor at HealthLeaders.
The first U.S. coronavirus disease 2019 patient with lung injury treated with photobiomodulation therapy experienced improved respiratory indices, radiological findings, and oxygen requirements.
A pair of critical care experts are skeptical about the laser treatment and say much more research must be conducted.
Results of the laser treatment in a second coronavirus patient are set to be published this month in the Canadian Journal of Respiratory Therapy.