Age-related Macular Degeneration Clinical Trial
Official title:
¿Es Util la Acupuntura en la Degeneracion Macular? Prospective Study of Efficacy of Acupuncture in Macular Diseases
This is a single-arm study designed to assess the efficacy of acupuncture (Traditional Chinese Medicine) for chronic macular diseases of several types. All participants received acupuncture and massage and there is not a placebo group because it is not considered a good form to evaluate in Chinese Medicine due to, acupuncturing being a procedure is not as blind as is desired. As a control of the results in this trial, the outcomes could be contrasted against those reported in known medical publications and against expectations of the progress of the damage without treatment.
Background.
WHO has included retinal diseases between conditions treatable by acupuncture and Traditional
Chinese Medicine (TCM) has been used for retinal diseases in hospitals of China and in other
parts of the world many years ago. Acupuncture and periocular massage act stimulating the
vital energy to restore the normal function of the body.
Currently, most common treatments in Western Medicine, anti-VEGF, only are indicated for less
than 10 percent of cases, which are the wet form or neovascular of AMD (NV-AMD) and they have
restrictions for use, additionally, their cost and requirements are limiting for populations
in all countries.
Objectives. The primary purpose of this study is to confirm the objective response among
subjects with macular diseases treated with acupuncture and massage. The results of
conventional treatment are published in similar trials and some of our patients have had
intraocular injections previously.
It is important to feature the affordability of this therapy for low-income populations that
do not have specialists or facilities nearby or for many governments that complain about the
huge burden of the treatment of there diseases. In Colombia, the average cost of each
intraocular injection by the time of this trial was about US 3.500 and it can be repeated
every month, it requires a retina specialist and a surgical room, that is out of reach for
many people in the country.
We did not calculate the costs of our treatment because the research team did voluntary
labor, and the devices are at a very low cost, about US 0.50 in each session. Acupuncture
treatment does not require special facilities as surgical rooms required in treatments with
intraocular injections. The participants were not paid, they came from different economic
conditions, some better, others from poorest neighborhoods or some from the rural areas.
This study includes 3 phases: Selection, Treatment, and Follow-up phases.
The selection phase included confirmed diagnosis by clinical register and OCT, Ophthalmologic
assessment, and consent of the patient.
Macular diseases. In this trial, some patients had NV AMD in one or both eyes, dry AMD,
myopic maculopathy or Stargardt disease. For TCM it is possible to treat all as damage of
similar category.
Why no control group. There was no control group due to ethical reasons, leave the impairment
without treatment in these mostly very sad persons. The second reason is the well-known
difficulty to mask a procedure like acupuncture. another third reason is the possibility to
contrast the results of this trial with those of similar studies conducted in eyes with
conventional treatment.
In the phase of treatment, Patients received a session of acupuncture according to a standard
protocol of points, and a periocular massage that was taught to the patient to be
self-performed daily. The acupuncture sessions were scheduled every week initially, the
evaluation of response was realized every 2 months by ophthalmologic exam and was asked to
participants an optical coherence tomography (OCT) that would be realized every 6 months.
Depending on the results of ophthalmologic assessment the sessions were extended gradually to
every 2, 3, 5 until 13 weeks. Although tomographic assessments had been scheduled every 6
months, only a few of the participants accomplish with that due to economic limitations.
Treatment continued until 24 months
All patients in the follow-up phase of this trial were monitored according to the Safety
Follow-up protocol and the defined procedures and evaluations.
The final results were collected and analyzed.
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