Cardiopulmonary and hematological effects of infrared LED photobiomodulation in the treatment of SARS-COV2, 2023, Pereira et al

Cardiopulmonary and hematological effects of infrared LED photobiomodulation in the treatment of SARS-COV2
Pâmela Camila Pereira, Carlos José de Lima, Adriana Barrinha Fernandes, Renato Amaro Zângaro, Antonio Balbin Villaverde

Background
COVID-19 disease is caused by SARS-CoV-2 which can trigger acute respiratory syndrome, which presents with dense alveolar and interstitial infiltrates and pulmonary edema, causing severe hypoxemia and significant alteration to pulmonary mechanics with reduced pulmonary compliance. The photobiomodulation technique alters cellular and molecular metabolism, showing promising results regarding the reduction of acute pulmonary inflammation.

Objective
To compare the photomodulation technique using near-infrared LED to conventional respiratory physiotherapy treatment in patients with COVID-19 in reversing acute conditions, reducing hospitalization time, and decreasing the need for oxygen therapy.

Methodology
The cohort was comprised of 30 patients undergoing COVID-19 treatment who were divided and allocated into two equal groups randomly: the LED group (LED), treated with infrared LED at 940 nm and conventional therapy, and the control group (CON), who received conventional treatment (antibiotic therapy for preventing superimposed bacterial infections, and physiotherapy) with LED irradiation off. Phototherapy used a vest with an array of 300 LEDs (940 nm) mounted on a 36 cm × 58 cm area and positioned in the patient's anterior thoracic and abdominal regions. The total power was 6 W, with 15 min irradiation time. Cardiopulmonary functions and blood count were monitored before and after treatment. The patients were treated daily for 7 days. Statistical analysis was conducted using a two-tailed unpaired Student's t-test at a significance level of α = 0.05.

Results
Post-treatment, the LED group showed a reduction in hospital discharge time and a statistically significant improvement for the following cardiopulmonary functions: Partial Oxygen Saturation, Tidal Volume, Maximum Inspiratory, and Expiratory Pressures, Respiratory Frequency, Heart Rate, and Systolic Blood Pressure (p < 0.05). Regarding blood count, it was observed that post-treatment, the LED group presented with significant differences in the count of leukocytes, neutrophils, and lymphocytes.

Conclusion
Photobiomodulation therapy can be used as a complement to conventional treatment of COVID-19, promoting the improvement of cardiopulmonary functions, and minimization of respiratory symptoms.

Link | PDF

 

Discussed (40 minutes) in

https://www.youtube.com/watch?v=ZdiUnmpOgqE

 

See also Near-Infrared Light Exposure Triggers ROS to Downregulate Inflammatory Cytokines Induced by SARS-CoV-2 Spike Protein in Human Cell Culture (2023, Antioxidants)

 

On a related note to the studies mentioned above, I wonder if anyone has a view on the clinical trial conducted for laser light therapy in Fibromyalgia that led to FDA approval in October 2022 for FibroLux, a laser-based therapy developed by the US-based firm, Multi Radiance Medical (www.multiradiance.com)?

A summary of the trial is available on the company website where it is described as: "A double-blind, placebo-controlled randomized evaluation of the effect of the MR5™ ACTIV PRO LaserShower (FibroLux) for the temporary relief of pain associated with fibromyalgia."

I'd always been skeptical of claims made for infrared and laser based therapies, but this product secured FDA approval specifically for treatment in Fibromyalgia. The hypothesis seems to revolve around the stimulation effect of laser light on mitochondria via the modulation of cytochrome c-oxidase (CCO) activity; it is further claimed that this stimulation prompts increased adenosine triphosphate (ATP) production, modulation of reactive oxygen species (ROS), release of nitric oxide, and induction of transcription factors.

I've copied some extracts on the trial design and outcomes below. One thing that confuses me is why 48.89% of the placebo group subjects (n=45) met the subject success criteria? That seems puzzlingly high to me but I'm probably missing something.

I'm not qualified to have an opinion either way on this product/treatment approach: I just found it interesting given how few FDA-approved treatments there are, and also how accessible this kind of treatment could potentially become (few side effects, usable at home).

All thoughts welcome! Including on whether this may be an area worthwhile exploring for ME.

***
Extracts from: 'A PHOTOCEUTICAL APPROACH TO TREATING FIBROMYALGIA — A SCIENTIFIC MONOGRAPH'

Study Design
The study was a prospective placebo-controlled, randomized, double-blind, parallel group, multi-center design conducted across three test sites.

Subjects
90 subjects were enrolled and completed the study: 45 were randomized to the active treatment group and 45 were randomized to the placebo group. Subjects were females aged 25 to 60 years with an ovulatory cycle, body mass index ≥ 18.5 kg/m², a baseline Visual Analog Scale (VAS) pain rating of ≥ 50 or a score on the Fibromyalgia Impact Questionnaire (FIQ) ≥ 50, and a diagnosis of fibromyalgia per the current American College of Rheumatology (ACR) criteria with symptoms present for greater than three months. Average age was 45.24 years.

Study Procedures
Subjects received nine treatment administrations with the FibroLux (active or placebo) to self-identified tender points across a three-week period: three treatments per week, each treatment two to three days apart. Subjects agreed to use only the medications, treatments, and therapies determined by the study investigator during the individualized medication stabilization phase of the study to relieve any fibromyalgia pain, as needed, throughout study participation.

Primary Endpoint
The aim of the study was to determine if the treatment effect of the FibroLux for the active treatment group was greater than that for the placebo treatment group. The study was predetermined to be considered a success if, using the Intent-To-Treat (ITT) analysis, the primary endpoint was statistically significant at the 0.05 level. Primary efficacy outcome measure was predefined as the difference in the proportion of subjects between active and control groups who achieved a clinically meaningful and statistically significant decrease in tender point count of 20% or greater at study endpoint, defined as end of the three-week treatment administration phase, relative to baseline, defined as the evaluation occurring before the first treatment administration. Overall study success was predefined as a 30% or greater difference in the proportion of individual subject successes between treatment groups. As each enrolled randomized subject in the clinical study completed all study visits and procedures, only the primary intent-to-treat (ITT) analysis was performed. Of the subjects who received the active treatments with the FibroLux, 86.67% met the individual subject success criteria compared with 48.89% of placebo group subjects. The difference of 37.78% in individual subject successes between treatment groups, in favor of the active treatment group, exceeded the pre-determined criteria of a 30% difference (p<0.0005).

Conclusion
Collectively, the study results demonstrated that the FibroLux delivers a safe and effective treatment for reducing fibromyalgia pain when administered three times a week over a consecutive three-week period

***

 

If the laser produced any sense of warmth at all the blinding would be invalid, and the trial similarly.

The results are otherwise extremely implausible.

 

According to https://classic.clinicaltrials.gov/ProvidedDocs/12/NCT04322812/SAP_001.pdf

They list verbatim responses from patients, therapists and assessors, justifying which group they thought the patient was allocated to, at end-point and 4 weeks post.

For was active/thought active, all but one referred to symptom improvement. At end-point one said "Heating of the region, reactions after treatment. Some moments I questioned if the laser was applied (placebo) because i did not feel what I mentioned above.". And at 4 weeks one said "Because I felt heating during application, reduced pain, and improved sleep."

For was active/thought placebo, one said "The temperature of the appliance, the same did not always make noise." and "I think that because of the speed of treatment in the stitches and because I feel no reaction as to the laser applied on site (hot or cold type)"

 

I think blinding would be a significant issue with the IR LEDs too. Looking up the specs for the LEDs they used, each one is 0.135W x 300 LEDs = 40W of heating. That's more power per unit area than an electric blanket, so you'd definitely feel the warmth.

But overall this seems almost too good to be true.

 

It does, including converting vitamin D, but this isn't even light. (Light is by definition at a range you can see.) Infra-red is really just heat. The temporary benefit of heat on pain has been known for centuries. It is not trivial but a hot water bottle will do.

So it seems clear that there was enough heat to feel, so the trial is a waste of time. They should have compared LED delivered heat with a HWB.

 

Years ago I set up two FIR heaters to create a sauna-type environment in my kitchen b/c I was experiencing terrible neck pain that lasted almost one year. The sauna relieved my neck pain after one session. It wasn't a coincidence.

 

Thanks everyone for all the replies and perspectives - useful as always in putting the study's conclusions into context.