By Harriet Hall
This post is dedicated to two people who are frequent commenters on SBM, Stephen S. Rodrigues and Peter Moran. Rodrigues is an MD/acupuncturist who tries to persuade us that acupuncture is effective. Moran is a retired surgeon who objects to insulting language and thinks more can be accomplished by trying to better understand why people turn to CAM and by explaining the facts and reasons politely and dispassionately. He has claimed that he “could probably help [Rodrigues] understand better why his views are not having much impact.”
I recently wrote about supplements for age-related macular degeneration (AMD). There is evidence that the supplement mixture tested in the AREDS trial slows the progression of moderate to advanced disease. That is based on a good scientific study, although the study has not been replicated and there is reason to interpret its results with caution. Dr. Rodrigues commented with a link to a website advertising the Santa Fe acupuncture protocol, saying that he uses the method in his office and it helps some of his patients with AMD. The website claims that the Santa Fe acupuncture protocol will reverse vision loss from macular degeneration in 4 days or your money back. That is a bold claim. I will try to explain, as politely as possible, why I reject the claim, and why the evidence for it is unacceptable.
Two kinds of AMD: dry and wet
90% of AMD patients have dry AMD, where there is a thinning and breakdown of the retinal epithelial cells that support the photoreceptor cells (the rods and cones). It is asymptomatic in the early stages; then, as the disease progresses, visual acuity is lost and the unsupported photoreceptor cells die off. There is no medical or surgical treatment for dry AMD.
The other 10% have wet AMD, where blood vessels proliferate, leak, interfere with vision, and eventually destroy photoreceptor cells. Conventional treatment can’t cure AMD; it can slow progression of the disease but until the recent introduction of anti-VEGF drugs it seldom improved visual acuity. Treatments include injecting potentially dangerous medications directly into the eye, intravenous injection of drugs with retinal photoactivation, photocoagulation with lasers (which can cause immediate reduction in visual acuity of three lines on the eye chart), and surgical removal of retinal lesions.
Why people turn to CAM
I fully understand the attraction of the Santa Fe protocol. People with AMD are desperate; they are going blind, and conventional treatments offer them little or no hope and are frankly scary. When they are told that an alternative treatment can reverse the damage that has already occurred, and when they are told the treatment is supported by testimonials, scientific studies, and a money-back guarantee, how could they not grasp at the only available straw of hope? Hope makes people feel better; but raising false hopes only to have them collapse after a substantial investment of time and money would ultimately make them feel worse. Does this protocol offer true hope or false hope? Let’s examine the evidence.
I can understand the attraction for acupuncturists, too. They want to believe they can help patients with a condition that can’t be treated any other way. Their patients report improvement and thank them profusely. Those who don’t improve are not likely to come back, so practitioners don’t see their successes in perspective with their failures. Confirmation bias takes over. Practitioners are gratified and reinforced. That kind of personal experience is very powerful but can be misleading. As Mark Crislip says, the three most dangerous words in medicine are “In my experience.” Humans regularly misperceive and misinterpret the meaning of their experiences, and that’s why we have to rely on the scientific method to correct our errors.
What is the Santa Fe protocol?
Dr. Alston C. Lundgren is a family physician turned acupuncturist. His website claims that his Santa Fe protocol is the only documented treatment to reverse vision loss in cases of both wet and dry AMD.
Apparently there are several versions of the protocol, as he added treatments through the years. On his website he describes three components:
- Small steel studs are inserted in regions of the ear whose nerve endings have been shown to correspond with specific areas of the brain. By stimulating these nerves, cortisone and oxygen-rich blood are induced in the region of the retina.
- Needle electrodes are inserted in the fat around the eyeball and are stimulated with a mild electrical current. These electrodes stimulate the retina and surrounding tissues and probably increase blood flow to the retina.
- In Spring 2007, a 3rd component was added – electrically stimulating the scalp over the visual cortex which occupies a considerable portion of the brain.
In one of his links, he describes his protocol as combining five types of acupuncture:
- German Ear Acupuncture to indirectly stimulate the optic nerve, the retina, and production of cortisol. (David Alimi, MD, Professor of Neurology and Ear Acupuncture at the University of Paris Medical School has demonstrated the one-to-one correspondence between points on the ear and areas of the brain.)
- Canadian Neuroanatomic Acupuncture with needle/electrodes surrounding the orbit which may increase blood circulation or directly affect the retina itself when electrically stimulated.
- Chinese scalp acupuncture – electrical stimulation over the visual cortex of the brain, hence reversing the damage of a stroke there.
- Japanese scalp acupuncture at points identified as stimulating the optic nerve and probably other areas of the brain involved in vision.
- French Energetics acupuncture to stimulate classic Chinese points affecting the eye, increase parasympathetic stimulus, and add energy to the patient for self-healing.
He says he has performed over 10,000 treatments on 1,500 patients and has improved the vision of 85% of them. He states that black eyes are a very common complication, so he routinely uses ice packs. He charges $250 per treatment, and typically administers five treatments on five successive days.
Dr. Lundgren is the only one who has published data on his method. He has no articles listed in PubMed. His website provides references, but they are all either articles he has written for an acupuncture journal that is not listed in PubMed (I couldn’t find it in any list of medical journal impact factors either) or PowerPoints he has presented at conferences. They all cover essentially the same material at different points in his journey, reporting data from his patients.
His published study
The most recent published article is this one published in the journal Medical Acupuncturein 2005. It reports a 69% improvement in vision. I will concentrate on the evidence for the Santa Fe protocol as presented in that study.
It reports a case series of 108 consecutive patients with ophthalmologist-diagnosed AMD who were treated by him at his clinic in New Mexico. 32% had wet AMD; 50% had dry AMD; 18% didn’t know which type they had. The patients gave informed consent, but there is no mention of oversight by an IRB. Treatment consisted of three acupuncture techniques:
- Auricular acupuncture to indirectly stimulate appropriate parts of the brain
- Neuro-anatomical acupuncture to directly stimulate the retina and periorbital tissue
- French Energetic Liver cerebral circulation stimulation to enhance eye function
For auricular acupuncture he says he does not clean the surface of the ear before inserting needles unless there is gross contamination. He leaves the needles in the ear until they fall out, anywhere from 2 days to more than a month later. He installs a gold semi-permanent needle (a stud?) for chronic stimulation of the most electrically active point. He applies electrical stimulation to the needles in techniques 2 and 3, but I couldn’t tell from his write-up whether he also uses electricity on the ear. He reports elsewhere that he treats daily for 5 days; but in this study he used weekly treatments, saying patients did not benefit from more than 3 treatments per week, and claiming that gaps of up to 4 months between treatments had no effect on the degree of improvement achieved. Each treatment session lasted 25-35 minutes. Patients were treated until they either dropped out or showed no further gains in 2 consecutive vision tests. He does not say how many patients dropped out. He says visual acuity improvements “did not seem to deteriorate for a year-and-a-half” but he provides no data. He describes other subjective improvements reported by patients: color vision seemed to improve (said to have been confirmed by testing in “several” patients), less contrast required for reading, improved ability to see in dim light or drive at night, straight objects no longer had wavy edges, scotomas shrank and disappeared, the “film over vision” or “fog” disappeared.