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CLINICAL STUDY

Effects of melatonin in age-related macular degeneration

Study: Effects of melatonin in age-related macular degeneration
Publication: Ann N Y Acad Sci . 2005 Dec;1057:384-92. doi: 10.1196/annals.1356.029.
Date published: December 29, 2005
Authors: Changxian Yi, Xiaoyan Pan, Hong Yan, Mengxiang Guo, Walter Pierpaoli
Summary: Age-related macular degeneration (AMD) is the leading cause of severe visual loss in aged people. Melatonin has been shown to have the capacity to control eye pigmentation and thereby regulate the amount of light reaching the photoreceptors, to scavenge hydroxyradicals and to protect retinal pigment epithelium (RPE) cells from oxidative damage. Therefore, it is reasonable to think that the physiological decrease of melatonin in aged people may be an important factor in RPE dysfunction, which is a well known cause for initiation of AMD. Our purpose is to explore a new approach to prevent or treat AMD. We began case control study with a follow-up of 6 to 24 months. One hundred patients with AMD were diagnosed and 3 mg melatonin was given orally each night at bedtime for at least 3 months. Both dry and wet forms of AMD were included. Fifty-five patients were followed for more than 6 months. At 6 months of treatment, the visual acuity had been kept stable in general. Though the follow up time is not long, this result is already better than the otherwise estimated natural course. The change of the fundus picture was remarkable. Only 8 eyes showed more retinal bleeding and 6 eyes more retinal exudates. The majority had reduced pathologic macular changes. We conclude that the daily use of 3 mg melatonin seems to protect the retina and to delay macular degeneration. No significant side effects were observed.
“Within 6 months 90% of the trial participants had improved their AMD condition. The improvements continued until the trial ended at 24 months.”

The study included 55 to 100 patients with both wet and dry macular degeneration for a period of 6 months, with two years of follow up exams. The participants were given a, patented, formulation, now called, ARMeD™ to learn if a healing response was possible.

  • 100 patients with both wet and dry ARMD were monitored for 6 months,
  • Subjects took 3mg of the bonded melatonin formula nightly,
  • The age of patients were 55 to 82, the average age being 71,
  • Approximately two thirds were men,
  • Patients were evaluated, including actual fundus pictures taken at the beginning and at every 2-months thereafter,
  • 15 patients had diabetes; 11 had received cataract operations; 32 had some degree of senile cataract; 3 had received laser treatment; none had received any form of ARMD treatment.

Dr. Changxian Yi stated; “Our purpose was to explore a new approach to prevent and/or treat ARMD.” The study was also monitored by, world renowned endocrine specialist and melatonin expert, DR. Walter Pierpaoli.

Results After first 6 months:

  • 93% of patients have arrested or improved their ARMD condition,
  • 54% of patients report additional ophthalmic improvements,
  • 78% of patients had varying levels of sleep improvement and general overall improved feeling of well being,
  • 0% felt worse during treatment and no side effects were noted,.
  • This recent study suggests that more than 90% of patients can benefit within a 6 month period.

At the end of the study the vast majority had dramatically reduced pathologic macular changes. Additionally the patients reported better vision with improvements to glare, dryness, clarity and comfort.

Dr. Changxian Yi’s theory was that a specific combination of melatonin, selenium and zinc would have the capacity to control eye pigmentation and thereby regulate the amount of light reaching the photoreceptors in the eye. The unique nutrient combination in the tablets would also scavenge hydroxyradicals and help to protect retinal pigment epithelium cells from oxidative/free radical damage which is considered to be a precursor to ARMD.

The patients were then evaluated at regular periods and the initial results were dramatic, at 2-3 months of treatment the visual acuity had been stabilized, no further degeneration had occurred. A significant step toward helping those who suffer with this disease, but that was just the beginning…

The study (published in Ann. NY Acad. Sci. 1057:384-392) further revealed that 90% of the participants had, to varying degrees, reversed their ARMD within the first 6 months. The improvements continued until the trial ended at 24 months, with no reported side effects.

For the trial participants, who continued past 6 months onto 12-months of nightly use, the changes in their fundus pictures were remarkable, (please note the before and after eye pictures presented within this article in figures 1-3).

Figure 1

image_a

Figure 1: The left slide shows the eye of a 67 year old male before treatment, his vision has been deteriorating for 2 years. The right picture shows the same eye 2 months later after ingestion of one tablet every night at bed time. He now has stable visual acuity of 0.3 with remarkable improvements in sub-retinal macular hemorrhage. In this study of 100 patients, 90% had, to varying degrees, regressed or reversed their ARMD within the first 6 monthsSource: Changxian Yi et al, effects of melatonin in age-related macular degeneration, Ann NY Acad Sci, 1057:384-392,2005


Figure 2

image_b

Figure 2: The left slide shows the eye of a 71-year old female with ARMD who after 6-months had her vision improve from 0.2 to 0.4 (as indicated in the right slide).


 Figure 3

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Figure 3: A 58 year old male whose visual acuity at the start (left slide) was 0.2. This improved to 0.4 after 6-months of regular use. The sub-retinal hemorrhage and exudates was remarkably absorbed.

The study authors stated “Melatonin has been shown to have the capacity to control eye pigmentation and thereby regulate the amount of light reaching the photoreceptors, to scavenge hydroxyradicals and to protect retinal pigment epithelium (RPE) cells from oxidative damage. Therefore, it is reasonable to think that the physiological decrease of melatonin in aged people may be an important factor in RPE dysfunction

Study on effects of melatonin in AMD concludes that daily use of 3 mg melatonin protects retina and delays macular degeneration.

Dr. Pierpaoli’s views

When asked about this recent finding, Dr. Pierpaoli stated; “Many people are aware of melatonin’s role in jet-lag, or as a potent antioxidant. Our research with this particular synergistic combination has highlighted its ability to re-synchronize the endocrine system as well as circadian rhythms of the wake-sleep cycles.

I note that while much has been discussed about the amazing ability of melatonin to, control eye pigmentation, regulate the amount of light reaching the photoreceptors and other functions in relation to eye structure; I surmise that the rebalancing of hormones and improvement of repair functions through the improved circadian sleep cycles are equally significant factors pointing to this formula’s ability to favorably impact both wet and dry age related macular degeneration.”

Dr. Pierpaoli went on to say; “We’ve seen many miraculous reversals of diseases in our patients with this formula. This latest study showing that it can even reverse age-related macular degeneration is truly a breakthrough in treating this condition.”

Asked whether there may be further studies targeting ARMD and melatonin, Dr. Pierpaoli said; “We accept that additional studies are needed to further confirm these results, however we are delighted that a vital benefit to slow, halt and even reverse ARMD has been discovered. Whatever the outcome of further research into these pathways and actions, the fact remains that thousands, even millions of people can now benefit from this research to protect their vision.”