Our very own local doctor, Dr. Richard Neel, MD, MPH was chosen to speak on a panel of several doctors, scientists, and researchers from all over the world this past Tuesday, December 1. When we first interviewed Dr. Neel this past March, about the idea that melatonin could be used to treat the virus that has resulted in a worldwide pandemic, it was just a really big idea. But when the first COVID patient came to him, this retired Air Force doctor who also holds a MPH and many other accolades, quickly put that big idea into action with remarkable results. He has since fielded calls from all over the US and all over the World.
At the international teleconference this past week, doctors, scientists and researchers discussed melatonin as a treatment for COVID-19, and we are proud to report that our courageous local doctor was introduced as the world’s leading physician in this subject area, having treated more than 1,000 patients using his recommended regimen of high dose melatonin, vitamin C, and vitamin D.
Dr. Harold Pupko, President of the North York branch of the Ontario Medical Association in Canada, was the mediator of the conference. The association is made up of 500 Canadian physicians of all specialties.
“One of my mandates as president is to promote the exploration of medically innovative ideas and to try to break down the barriers that stand in the way of delivering those innovations to our patients. Tonight is an example of putting those principles into action….Tonight we will have an opportunity to hear from 4 distinguished speakers,” Pupko said.
The first speaker was Dr. Russel Reiter, PhD of San Antonio, Professor of Cell Biology, who has 4 honorary Doctor of Medicine degrees, 1 internationally recognized science degree, and many other accolades for his important research. Reiter is listed in the top 1% of world scientists in terms of published research works. He discussed the scientific process by which melatonin helps covid patients (in words and terms best understood by scientists).
After his presentation, he also answered questions from doctors and researchers.
Among those conversations, Reiter stated, “Melatonin is not a perfect molecule, there’s no such thing. But I think it’s the best thing we currently have for treating covid and likely some other conditions….with certainly less toxicity than many other drugs we currently use.”
“No overdose of melatonin has ever been reported to the extent that people have died, or even an animal from too much melatonin,” Reiter said. “And many studies have been done in attempt to identify what is referred to as the ‘lethal dose’ for animals, but that ‘lethal dose’ has never been established,” despite research efforts.
Dr. Richard Neel was the second speaker, and he was introduced by Dr. Pupko, “Tonight we have an opportunity to consider what we call a paradigm shift. What if covid could be treated in the community, avoiding the need for hospitalization as much as possible?”
“Since March, Dr. Neel has been putting this theory into practice and has to my knowledge, more experience doing that than any physician in the world,” Dr. Pupko said.
“It is an honor and a pleasure to be part of this panel tonight,” Neel said. “I have been treating covid patients with melatonin since March…We have treated well over 1,000 patients, and also patients with all of the co-morbidities who have also done well. Patients with diabetes, COPD, Asthma, Cancer. I’ve treated patients from 11 months old – all the way up to patients in their 90s.”
“One of the great things about melatonin is its versatility in dosing. I roughly dose at 1 mg per kg per day. For most patients that works out to about 100 mg per day. Most patients I’ve found preferred to take roughly 20 mg three times a day and 40mg at bedtime.” (Doses for children and pregnant women were discussed separately.)
“Most patients respond really rapidly, sometimes within hours or within 24 hours,” Dr. Neel said. “The first patient that I treated was a gentleman in his 40’s. He was running a fever of 103.5 for several days, had shortness of breath, body aches, loss of smell and taste and so on.”
“I stated him on 40mg melatonin that night, and he never ran another fever….His cough was much better in the morning and resolved in the next 3 days. His symptoms resolved rapidly….This patient was so short of breath when I first talked to him that he could hardly finish a sentence without stopping to take a couple of breaths.”
“About 3 days later, his wife came down with the fever and the body aches and cough. I started her on melatonin that evening as well and she was symptom free the following morning and never had any more symptoms of the virus,” Neel added. “I have had two patients that were hospitalized on high oxygen concentrations that managed to get melatonin, and both had normal oxygen saturations by the following morning.”
“I’ve had less than a handful of patients that ended up in the hospital,” Neel said.
He gave one more anecdotal example.
“I had a group of 60 migrant workers that I treated, ages 20-40, living in a bunkhouse. About 8 of those gentlemen came down with symptoms of the virus at once, and we started them on 100 mg melatonin per day. The other 52 were given 40mg per day as a prophylaxis, and not a single one of the other 52 came down with any symptoms of the virus. So, since then, I have since treated a lot of family members who have a someone in the household with the virus, with 40 mg as a profalaxis, and a great majority of those family members never developed symptoms of the virus either.”
“Children for the most part, I don’t treat at all. Most of them don’t need the melatonin, but those who have started running fevers and coughs for my dosing schedule, I’ll normally suggest for children 0-2 years old a dose of 1-2 mg of the melatonin given four times a day, if they needed it. It’s amazing, you give them the melatonin, and the fever goes away in about 30 minutes, and most of them only needed a few doses. The 2-6 years old I dose up to 20mg a day, with 2-5 mg 4 times a day. For 6-12 years old I am doing roughly 40mg a day, at 5-10mg QID. For children over 12, I generally dose them based on their weight just like the adults.”
He noted that melatonin does enhance contractions, so it is to be used judiciously if pregnant, and in close contact with your doctor.
“I do know of at least one hospital which is using 40mg QID,” Dr. Neel said.
“I do use other things in addition to the melatonin,” said Dr. Neel. “Melatonin does work really well as a monotherapy, but I also start them on Vitamin D, Vitamin C. Some patients especially the asthmatics and patients with pretty bad COPD, I usually start on steroids and maybe a Zpack, especially if they are coming to me after already having the virus for a week or so. I prefer to talk to patients individually on those things; I don’t normally shotgun this approach. Doxycycline has also worked well for the secondary infections. I also use albuterol in some of the patients that are coming to me short of breath.”
Dr. Castillo treating patients at Manila Doctor’s Hospital
Philippines Dr. Rafael Castillo, who was the next speaker, has vast experience treating hospitalized patients with Covid-19 using melatonin.
“Thanks for the opportunity to share with you our clinical experience on using melatonin as an adjunctive treatment for COVID-19 pneumonia patients requiring hospitalization. At first, we tried all sorts of medications, including hydroxycloroquine and azithromycin, but we were not saving our patients, we had a high mortality particularly that first month. It was like trying to chase an enemy in the dark.”
“You admit a patient who is still okay while you are making rounds, and then in the middle of the night you are called because the patient is in severe respiratory distress and the patient is being intubated. It became quite obvious that the main problem was no longer the virus itself, but the resulting cytokine storm and inflammation that followed the initial viral infection. So we were barking up the wrong tree. We were focusing on antiviral agents, when it’s no longer the main problem in hospitalized patients. In stage II and III it’s really more the inflammation that gets the patients hospitalized.”
“Initially we thought the mechanical ventilation was the best thing for our patients, but again….we found that it was not the best way to go.”
As hospitals became overrun and healthcare workers exhausted, he proposed an idea to shift the burden off the front line and hospitals by treating the covid cases at the community level.
“It empowered the primary care physicians. Many of them came to us saying ‘we don’t feel confident in treating covid patients, so what can we do for them?’ So we had to equip with something. We introduced the Primordial system to boost the immune system MAZE CD system (standing for Melatonin, Vitamin A, Zinc, Vitamin E, Vitamin C, and Vitamin D– called the Primordial Covid Strategy. If we give these to our patients who were at high risk of developing covid or were already having symptoms.”
“Initially it was quite a challenge to get everyone to use the melatonin, particularly at the doses we recommended,” Castillo said.
He shared that he has for years prescribed melatonin for patients with inflammation, though before covid, they had not used doses above 20mg per day.
“For covid we thought that we really need a much bigger dose than 20 mg so we started with 30mg and gradually increased it to 76 mg per day, and our experience in the first month was quite good already,” Castillo said, noting that he had the opportunity to meet other doctors and researchers like Reiter who were instrumental in this going forward.
He spoke of a study in which 10 high-risk patients were treated with 36-72mg melatonin per day for Covid at Manila Doctors Hospital in the Philippines. Five of these patients were their own frontline healthcare workers.
“Three of these 10 patients had moderate/severe ARDS. In 4-5 days after initiating the high dose melatonin, ALL of the 10 patients stabilized and/or exhibited improvement, and all survived. None required mechanical ventilation,” Castillo said, noting that they were discharged from the hospital in an average of 7.3- 8.6 days.
“Comparing that to other covid patients who were not given melatonin, but practically all of the other treatments, gives us an inkling of what melatonin can do,” Dr. Castillo said. “Again this is just for perspective…But on average those who were not given melatonin required an average hospitalization of 13 days. Of those who were not given melatonin, more than a quarter of them (4/15) required mechanical ventilation, and 12 of the 34 died 35%. The only side effect reported was sleepiness,” Castillo said.
“We felt that we needed to validate this with a well designed trial so we immediately drafted a randomized a double blind controlled trial….One of the biggest challenges was of course the funding. President Dueterte got wind of our study and he personally endorsed our study on nationwide television, and because of his endorsement we got an immediate funding….The trial is currently ongoing and hopefully bey the end of the first quarter of next year it will be completed. Meanwhile, because it will take some time to compile the results of the randomized double blind control trial, and meanwhile patients were dying, we felt that we should come out with a statement on the use of high-dose melatonin, with a focus on hospitalized patients. Our Secretary of Health joined in the crafting of this message. We circularized the MAC19 PRO initiative through practically all medical societies.”
The dosages varied for the severity of disease, and a full list of recommended doses can be found in the actual document itself.
For hospitalized inpatients, the MAC19 PRO Initiative (co-authored by Dr. Castillo) recommends: “Those with hypoxemia but no ARDs, we started on 4mg per kg per day. Those with mild ARDS we started at 6mg per kg per day. Those with moderate to severe ARDS with started at 8mg per day. We used up to 600 mg per day in three-four divided doses in a good number of our patients,” Castillo said. (SEE FULL instructions in the actual document link by Dr. Castillo below).
“It is very difficult to quantify the impact of the recommendations we made, but I would say it did help….The feedback we are getting is that there is a remarkable difference in covid cases, and more importantly, the number of transmissions is also reduced,” Castillo said.
The paper that was put out to hospitals over there is titled “Melatonin as adjunctive treatment in Covid-19 patients pneumonia patients requiring hospitalization: an initiative to avert healthcare exhaustion in the Philippines.”
They also recommended to give: vitamin C, 3-6 g/day; zinc, 50-100 mg/day; vitamin D, 5000-10,000 u/day; virgin coconut oil, 15 cc TID (three times a day).
(Read more on the MAC10 PRO Initiative in the Philippines at: https://lifestyle.inquirer.net/368256/how-to-use-melatonin-on-covid-19-patients/#ixzz6g3Uu8y1D)
As a Prophylaxis
“So what are you all recommending in terms of dosage for prophylaxis?” one doctor asked.
“We are recommending anywhere from 6-20mg for high risk patients, and most of our healthcare workers are recommended to take 20mg per day in divided doses,” Castillo said.
“I agree,” Dr. Neel noted. “I think anywhere from 10-20 mg per day.”
Dr. Brown speaks about another unique intravenous melatonin trial ongoing
Dr. Gregory Brown, of Canada, also spoke.
“It’s interesting to talk to many physicians who are skeptical still. I am glad to hear that this trial is underway,” Dr. Brown said. “Two weeks ago I was on a call originating in Spain hosted by Dr. Dario Acuña-Castroviejo, and an exciting event took place there. There is a randomly controlled trial underway there that is rather unique. It is a trial on 18 patients using intravenous melatonin. The trial is complete as of a few days ago and the data analysis is now underway so will be getting results on that very soon. The reason is that the oral absorption of melatonin is variable person to person, and blood levels are very different. Intravenous gives you more control on that, so it will be very interesting.”
“A colleague of mine, Daniel Cardinelli, was a keynote speaker at that event. He published a paper titled ‘Can melatonin be a potential “silver bullet” in treating Covid-19 patients?'”
Brown also proposed another question on the topic of melatonin and covid.
“There is a huge variability in melatonin levels,” Brown noted, “So is it possible that low melatonin levels are a risk factor, and does that lead to susceptibility?”
“In fact in some studies, melatonin levels have been up to 20 times higher than somebody the same age. If some people have low levels of melatonin and some have high levels of melatonin, could that be a reason that some people are prone to develop diseases like covid, and the reason that some people with high melatonin are protected?”
Cleveland Clinic has ongoing trials
The Cleveland Clinic provided an overview of a randomized double blind control trial using covid outpatients with mild to moderate symptoms. Part of the uniqueness of the study is that they are using only melatonin that is approved by the FDA.
Could the brand matter?
Neel added that “I have had some patients who if they weren’t responding to treatment as fast as I think they should, I will have them switch brands, and sure enough, they suddenly started improving. I have certainly had better experience using sublingual.”
Brown noted that Natrol and NatureMade are the two manufacturers approved by the US.
Concerns
One doctor asked Dr. Retier, “Can you expand on the concern over drug interactions?”
“Every drug that has ever been tested in every any species, anywhere, has been tested in the presence in melatonin, because melatonin exists in every organism that we can identify,” Dr. Reiter said. “Therefore, at least in terms of physiological levels of melatonin, drugs cannot be tested without determining it’s interaction with physiological levels. Now if you take more than physiological concentrations, it could be different, but….As long as melatonin has been used since the early 1990s, I have never heard of any serious drug interactions at any dose.”
“The theoretical possibilities are listed online, and that will turn some people off, so can you comment on that?” said the moderator.
“The fact is that the content of physiological levels of melatonin in the body is much higher than you might think, and so when you take a certain amount by mouth and only a certain amount ends up in the bloodstream it’s…it’s not a high amount, really,” Dr. Brown commented.
‘I agree,” Reiter said. He also added that “With regard to the long term side effects, that’s a catch 22. We know a lot of drugs have very serious long term effects such as Doxorubicin, and yet they get approval.”
Pupko pointed out that, “Melatonin is different than drugs like hydroxychloroquine because you needed a doctor to get hydroxychloroquine. This (discussion on melatonin) is empowering people with information, because melatonin is an over the counter product,” Pupko said.
Reiter said, “I would like to reinforce the importance of clinical trials if for no other reason to convince the physicians.”
Dr. Cardinalli discusses melatonin/vaccination connection
Dr. Daniel Cardinalli, of Argentina, pointed out that “One would think that vaccines will with work together with melatonin to increase the immune response, and I think this is a possibility we have to consider very seriously in the future.”
“When we use 9mg of melatonin per day which is the regular dose we can use, we can see even with those low amounts, is that the number of days in the ward decrease significantly as opposed to those who not received melatonin.”
Dr. Retier said they are researching this topic as we speak.
Dr. Cardinalli also pointed out the interval of doses may be key to its success.
More evidence
One doctor questioned, “In my mind inflammation and oxidative stress are double edged swords. We don’t want to completely eliminate them. So I’m wondering once you get beyond the optimal dose, and we don’t know what the optimal dose is, could we start seeing some negative effects of using too much?”
Dr. Reiter answered, “Well, there’s no history of that. Melatonin has been used in humans for 30 years, and it has been used in tens of thousands of animal studies, and that is not a complicating factor in terms of producing negative effects.”
Amid much excitement from researchers, scientists, and doctors on this international discussion, some still echoed the medical community’s want of “more evidence.”
“I think we really do need the randomized, controlled trials, and that’s why we are doing it. The basis is there, but we need more evidence,” one doctor said.
Dr. Neel quickly answered, “I agree, we need trials. However, there are people out there dying every day too–so I decided to bite the bullet and try it, and it works.”
The same doctor quickly replied, “On that note, I should say I told my family to stock up on melatonin, and I would try it myself.”
Pupko made many thoughtful contributions to the 2 and a half hour conversation, and closed with some important thoughts.
“I think after months into this, we are at a point where we all have the melatonin in our cupboards,” Pupko said.
And yet, with all of the science, research, and important discoveries by pioneering physicians like Dr. Neel, many of those same doctors who “would take it themselves,” are reluctant to administer melatonin to patients in doses larger than the standard pharamaclogical dose of 10mg per day.
“With Richard’s amazing results, that are almost hard to believe, I would like as a take home message to say that it is possible to treat covid from home, that is possible to take burden off the medical community, if only the medical community will wake up to what we are proposing tonight,” Dr. Pupko said.
He added later, “Those of us who understand what we know about melatonin will use it for ourselves and have it for ourselves, and I sleep better at night knowing I have it. But I wake up every morning listening to the news and it breaks my heart that people are dying, and that those people might be dying unnecessarily. Especially our elderly. There’s real resistance to this idea. So I have mixed feelings. We have Academics, and absolutely we need to do science. I don’t want to undermine science. That’s not the message I want to give people, but this is a matter of life and death,” Pupko said.
The SARS-2 COVID-19 pandemic has led to the death of more than 1.54 million people worldwide.
“Sure a majority of people will get over covid with no problems, but many others out there are dying. And there is also the issue of the long haulers that’s coming up now, so even younger people who aren’t necessarily dying from this, are having a lot of chronic health issues. So what are the ethics here? The ethics to me is if we have a treatment versus no treatment, go for the treatment. I personally am going to take melatonin if I come down with covid, and I think everybody on this panel is going to as well, based on Dr. Neel’s work,” Pupko said.
Please remember, this article is informational only about this innovative idea, and not a substitute for a doctor’s advice.
By Kayleen Holder
Editor