Research is ongoing about the mechanism of LLLT. The effects of LLLT appear to be limited to a specified set of wavelengths of laser, and administering LLLT below the dose range does not appear to be effective. Photochemical reactions are well known in biological research, and LLLT make use of the first law in photochemistry (Grotthuss-Draper law): light must be absorbed by a chemical substance in order for a photochemical reaction to take place. In LLLT that chemical substance is represented by the respiratory enzyme cytochrome c oxidase which is involved in the electron transport chain in mitochondria, which is the generally accepted theory.
Concerns have been raised in the literature about brain stimulation techniques that rely upon low-level (low-power) lasers and light-emitting diodes (LEDs). The transcranial photobiomodulation or transcranial low level light therapy is limited in neuromodulation due to several reasons:
There is not enough information from clinical trials to compare the effectiveness of different types of devices or device parameters (wavelengths, power output, session time, area of actuation).
Veterinary clinics use cold laser devices to treat a wide variety of ailments, from arthritis to wounds, on dogs and cats. Very little research has been done on the effects of this treatment on animals. Brennen McKenzie, president of the Evidence-Based Veterinary Medicine Association, has stated that "research into cold laser in dogs and cats is sparse and generally low quality. Most studies are small and have minimal or uncertain controls for bias and error". While allowing that some studies show promising results, he reports that others do not. While believing that there is enough evidence to warrant further study, he concludes that there is not enough evidence to support routine clinical use of cold laser in animals.
Based on the results of a systematic review, there is no evidence to suggest that people with cancer or people who are at risk of getting cancer should avoid photobiomodulation.
There are some reports of mild pain or skin irritation after red light therapy. The long term effects on the skin or on the hair are not known. Eye protection is suggested for some devices. For skin applications, different wavelengths of light may result in different 'biological effects' depending on the person's skin type, race, and ethnicity. Clinical guideline suggest that a dermatologist is consulted before undergoing treatment.
For safety, if a person chooses to use red light therapy, a device that has been approved for use on humans by the country the person lives in is recommended. For example, in the US, it is suggested to only use devices approved by the FDA for dermatologic application.
The FDA filed a complaint for injunction in 2014, alleging that company QLaser PMA were marketing their devices as being able to treat “over 200 different diseases and disorders,” including cancer, cardiac arrest, deafness, diabetes, HIV/AIDS, macular degeneration, and venereal disease. This case resulted in a permanent injunction against the manufacture, marketing, sale, and distribution of those devices in 2015.
In 2017, the owner of QLaser, Robert Lytle, and two of QLaser's distributors were charged with a criminal conspiracy to commit fraud. Lytle pleaded guilty to one count of conspiracy to introduce misbranded medical devices into interstate commerce with the intent to defraud and mislead, and one count of criminal contempt in January 2018. Lytle was sentenced to serve 12 years in prison and made an initial restitution payment of $637,000. Lytle's conspirators were sentenced to 24 months and 15 months, respectively.
LLLT is shown to increase hair density and growth in both genders. The types of devices (hat, comb, helmet) and duration did not alter the effectiveness, with more emphasis to be placed on lasers compared to LEDs. Ultraviolet and infrared light are more effective for alopecia areata, while red light and infrared light is more effective for androgenetic alopecia.
Medical reviews suggest that LLLT is as effective or potentially more than other non invasive and traditional therapies such as minoxidil and finasteride but further studies such as RCTs, long term follow up studies, and larger double blinded trials need to be conducted to confirm the initial findings.
LLLT has been studied as a way to reduce pain and swelling in breast-cancer related lymphedema. The 2015 systematic review & meta-analysis by Smoot, Chiavola-Larson, et al found “Moderate-strength evidence supports LLLT in the management of [breast cancer related lymphoedema], with […] reductions in volume and pain immediately after conclusion of LLLT treatments. Greater reductions in volume [of lymph nodes or surrounding tissues] were found with the use of LLLT than in treatments without it.”
An ongoing area of research is the application of LLLT for increasing cell proliferation, including stem cells.
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