Showing posts with label Cuba. Show all posts
Showing posts with label Cuba. Show all posts

Thursday 13 December 2018

Low Level Laser Therapy (LLLT) for Autism – seems to work in Havana

Today’s post is all about one of the potential medical, but non-drug, interventions for autism. The others tend to involve electrical/magnetic stimulation of one kind or another.
Low level laser therapy (LLLT) was developed more than fifty years ago in Russia. Today in Western countries LLLT is often regarded as alternative medicine or just quackery.  There are some FDA approved devices.  In Russia and some East European countries LLLT is part of mainstream medicine.
Two people forwarded me a recent study that was carried out in Havana by a team from Cuba and Israel.
There are only 11 million Cubans, but there are a lot of Cuban doctors.  They have developed interesting drugs, some related to cancer, that are now being taken up by Western medicine.  Cuba actually leases out doctors to work in more than 50 developing countries around the world.
The results of the study are indeed interesting and there is a long list of possible mechanisms that may be involved.
The question we are left with is can you achieve a similar result with cheap LEDs (light emitting diodes), or do you need a genuine laser (that confusingly use a different kind of diode).  I do not know the answer, but there is definitely a difference.  

Let’s start with the background to LLLT

 In Russia (formerly USSR) study of biomodulation action (BMA) mechanisms of low-intensity laser irradiation (LILI) began in 1964, immediately after the development of lasers. During the period from 1965 to 1972 several dozens of scientific conferences were held, hundreds of studies were published. Generally, secondary mechanisms and results of LILI effect on patients with various diseases were studied. This data was immediately implemented into practical medicine in the fields of oncology, surgery, dermatology and dentistry, and since 1974 low level laser therapy (LLLT) is included in the standard of state medical care. For 50 years no less than 1000 books were published (monographs, collections, methodical and clinical materials), thousands of researches were carried out. Primary mechanism and patterns of interaction of LILI with acceptors within cells can be represented in the following order: absorption of photon’s energy – emergence of a local temperature gradient – release of Ca2+ from intracellular stores – stimulating Ca2+–dependent processes. Understanding of this process allowed the explanation of all known secondary effects, optimized methods and extremely increased effectiveness of LLLT. Owing to the knowledge of BMA mechanisms of LILI, numerous associated and combined LLLT techniques were developed and are widely used nowadays: locally, on the projection of internal organs, laser acupuncture, reflexology, intracavitary, transdermal and intravenous laser blood illumination, magnetic-laser therapy, laser phoresis, laser-vacuum massage, biomodulation, etc. About 400 000 laser therapeutic devices are used in Russian practical healthcare. Unique, having no analogues in the world devices, are produced – red pulsed laser diodes (wavelength 635 nm, power 5-40 W, pulse duration 100 ns, frequency 10 000 Hz) are designed specially for effective laser therapy. 

About 400 000 laser therapeutic devices are used in Russian practical healthcare; about half of them are used in professional medicine (clinics), and half of them – at patients’ home for independent use. Around the world only lasers designed for other purposes (technical) are used, which are not always effective in medicine. The peculiarity of Russian laser therapeutic apparatus is the development and production of special lasers, designed specifically for therapy. For example, unique, having no analogues in the world, devices are produced - red pulsed laser diodes (wavelength 635 nm, power 5-40 W, pulse duration 100 ns, frequency 10 000 Hz) are designed specially for effective laser therapy.
Laser therapy is widely used in almost all medicine fields: obstetrics and gynecology, gastroenterology, cardiology, dermatology and cosmetology, neurology, oncology, otolaryngology, pediatrics, pulmonology, dentistry, traumatology and orthopedics (diseases of musculoskeletal system), urology and andrology, phthisiology, etc. 

Cheap LEDS vs Expensive Lasers? This paper says you cannot cut corners.

The question of lasers' exclusivity, as well as the degree of influence of special properties of low-intensity laser illumination (LILI), such as coherence, polarity and monochromaticity, on the effectiveness of low level laser therapy (LLLT) continues to cause arguments.
The study analyzes publications from 1973 to 2016, in which laser and conventional light sources are compared, and the following conclusions are drawn. First, there are a lot of publications with incorrect comparison or unfounded statements. Secondly, other sources of light are often meant by LILI without any justification. Thirdly, all studies, in which the comparison is carried out correctly and close parameters of the impact and the model are used, have a firm conclusion that laser light is much more effective. Fourthly, it is uniquely identified that the most important parameter that determines the efficiency of lasers is monochromaticity, i.e., a much narrower spectral width than for all other light sources.

Only laser light sources can be used for LLLT! 

Here is the Cuban study on autism using lasers:-

The study examined the efficacy of low-level laser therapy, a form of photobiomodulation, for the treatment of irritability associated with autistic spectrum disorder in children and adolescents aged 5–17 years. Twenty-one of the 40 participants received eight 5-min procedures administered to the base of the skull and temporal areas across a 4-week period (test, i.e., active treatment participants). All the participants were evaluated with the Aberrant Behavior Checklist (ABC), with the global scale and five subscales (irritability/agitation, lethargy/social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech), and the Clinical Global Impressions (CGI) Scale including a severity of-illness scale (CGI-S) and a global improvement/change scale (CGI-C). The evaluation took place at baseline, week 2 (interim), week 4 (endpoint), and week 8 (postprocedure) of the study. The adjusted mean difference in the baseline to study endpoint change in the ABC irritability subscale score between test and placebo participants was _15.17 in favor of the test procedure group. ANCOVA analysis found this difference to be statistically significant (F ¼ 99.34, p < 0.0001) compared to the baseline ABC irritability subscale score. The study found that low-level laser therapy could be an effective tool for reducing irritability and other symptoms and behaviors associated with the autistic spectrum disorder in children and adolescents, with positive changes maintained and augmented over time. 

A pulsed laser of 635 nm with a power output of 15 mW and a red 635 nm LED were used as treatment and placebo, respectively.

 A significant literature exists on the ability of low-level light therapy (LLLT) to penetrate the skull. Low-energy light passes the skull and a therapeutic effect likely exists. LLLT systems employ the so-called quantum optically induced transparency effect. This effect controls optical properties of dense media enhancing transparency contrast by a factor of five. Therefore, the skull, spine, or joints can be penetrated even with moderate intensity light reaching deep layers in muscles, connective tissue, and even bone, enabling transcranial effects of LLLT.
LLLT achieves a therapeutic effect by employing non-ionizing light, including lasers, light-emitting diodes, or broadband light in the visible red (600–700 nm) and near-infrared (780–1100 nm) spectra. LLLT is a nonthermal process occurring when a chromophore is exposed to a suitable wavelength of light. Chromophores are responsible for the color associated with biological compounds such as hemoglobin and cytochromes. With chromophore absorption of a photon of light, an electron transits to an excited state, with a physiologic effect occurring when photons dissociate the inhibitory signaling molecule nitric oxide (NO) from cytochrome-C-oxidase, increasing the electron transport, mitochondrial membrane potentials, and production of mitochondrial products such as ATP and NADH. Other effects include the production of reactive oxygen species (ROS) which activate transcription factors, leading to the cellular proliferation and migration.

Based on these complex characteristics, LLLT possesses physiologically modifying properties associated with light characteristics such as wavelength and irradiance, varied by exposure parameters, such as energy density, irradiation duration, and treatment frequency. On the basis of the above, we investigated behavioral and cognitive changes in ASD as a consequence of the delivery of red LLLT.

2.4 Procedure
All the 40 participants completed the course according to the protocol. Twenty-one of them were randomized to the test (active treatment) procedure group, and 19 were randomized to the placebo procedure group. Participants received eight 5-min laser light applications to the base of the skull and temporal areas with the Erchonia® EAL Laser (active or sham) across a 4-week period: two applications per week, 3–4 days apart at the investigator’s test site.A pulsed laser of 635 nm with a power output of 15 mW and a red 635 nm LED were used as treatment and placebo, respectively. Participants were required to maintain their regular medication schedule and treatment regimens, as reported at the baseline evaluation, to treat symptoms related to autistic disorder throughout the study time. All of them complied with this requirement.  

Twenty out of the 21 active treatment participants showed some degree of improvement in autism-related symptoms at endpoint relative to baseline. The majority (13) received ratings of “much improved”. No placebo group participant demonstrated improvement in symptoms at endpoint relative to baseline. The majority (17) demonstrated “no change”, and the remaining 2 placebo participants rated “minimally worse”. We found that the ABC global and five subscale scores decreased progressively and significantly from baseline across each of the three successive evaluation points; the decrease progressed over time, including a 4-week followup during which no further LLLT occurred. Conversely, the placebo group demonstrated no significant change across the study duration, demonstrating the effectiveness of LLLT in reducing ASD-associated symptoms.

Either the researchers have cheated, which has been known to happen, or Low Level Laser Therapy (LLLT) is indeed a worthwhile therapy for much autism.  The question of safety should be carefully considered.

Judging by the drugs the participants had been taking, they were not kids with trivial autism.

According to the current FDA standards, an FDA cleared LLLT device (also called a cold laser) can be sold for 3 main issues: 
·        Pain Control

·        Inflammation Reduction

·        Increased Blood Flow  

The cheapest FDA approved laser device that would be vaguely equivalent to the device used in the trial in Cuba costs $2500 in the US.
Hopefully, one day someone will compare the effect on subjects with autism of cheap LED devices versus true laser devices.

This press release was highlighted by our reader RD:-

Erchonia Submits Data to US FDA to Support Low-Level Laser 510(k) Market Clearance for Autism
Quadruple-Blind laser study proves success in treating Autism in children and adolescents.
“The results are so strong, nobody can argue them.”

MELBOURNE, Fla. (PRWEB)September 05, 2018
Erchonia, the World Leader in Low Level Laser technology, announces today that they have submitted data to the US FDA to support a 510(k) market clearance for Autism.
The clinical trial was a quadruple-blind (Participant, Care Provider, Investigator and Outcome Assessor), randomized, placebo-controlled, and crossover clinical trial. The study was designed to treat autistic children with the 640nm Erchonia Spectrum Laser as the active device or a 640nm LED or light emitting diode as a placebo device, which had the same power output. FDA input was obtained prior to clinical trial and implemented into the protocol.
Both test and placebo patients were treated twice a week for 4 weeks. Post-treatment follow-up on both sets of patients was performed after 4 weeks, 8 weeks, and 6 months. At the end of 6 months, patients from the LED placebo group were crossed over and then given Erchonia’s Spectrum Laser treatment protocol. The results were documented and submitted to the US FDA for a 510(k) market clearance De Novo Application.
The inclusion criteria consisted of autistic children between the ages of 5 to 17 years old, and progress was measured by using the ABC or Aberrant Behavior Checklist as the primary diagnosis. The ABC 58-point symptom checklist was used to assess and classify behaviors of irritability and agitation; lethargy and social withdrawal, stereotypic behavior, hyperactivity and noncompliance, and inappropriate speech in children with developmental disorders. The ABC tests were performed at baseline, 2 weeks, and 4 weeks during the treatments phase, and 4 weeks, 8 weeks, and 6 months post-treatment in both the treated and placebo groups.
“This is a well-designed trial that shows evidence supporting the use of Low Level Laser Therapy in children and adolescents with autism,” said Dr. Morales-Quezada, Associate Research Director at Spaulding-Labushagne Neuromodulation Center. “Moreover, the technique proved to be safe and well tolerated by the study participants. The active intervention showed to be more effective than the placebo (sham) device in treating symptoms of autistic disorder, and this statistically significant treatment effect was observed for all clinical outcomes, by the end of the intervention period and after the 6 months follow-up. This evidence offers a new treatment option to be considered for children and adolescents with autism.”
Calixto Machado, MD, PhD, FAAN, President of the Cuban Society of the Clinical Neurophysiology Institute of Neurology and Neurosurgery agreed, “Results are so strong, nobody can argue them.”
Steven Shanks, President of Erchonia stated, “This study from a scientific perspective is one of the most stringent ways to perform a clinical trial. The original placebo patients have now acted as their own control group. The LED that was used as a placebo showed no results even though we used the same wavelength and power output.”
The Erchonia Spectrum Laser implemented in this clinical trial was a prototype laser and is not currently sold. While waiting for the 510(k) market clearance, Erchonia will start the development process for the new Erchonia Spectrum Laser.
Erchonia would like to thank Calixto Machado, MD, PhD, FAAN, Mauricio Chinchilla, MD, Yanin Ferrer, MD, and the University of Havana for their dedication to research and helping Erchonia with its latest achievement.
About Erchonia. Erchonia created the low-level laser category in January 2002 when the FDA granted Erchonia the very 1st 510(k) market clearance for any low-level laser. This new study further sets Erchonia apart from its competitors based on their commitment to research and numerous 510(k) market clearances obtained through blind and controlled clinical trials.