A surprising link between UFOs and acupuncture

“Modern medical science may not have room for this kind of thinking.” — Richard C. Niemtzow, M.D., Ph.D., MPH

Do you remember when the National Enquirer offered a million-dollar reward for anyone who could prove that UFOs were extraterrestrial?

Flashback more than 30 years ago…

In 1974-1975, the Enquirer had compiled what it called a “Blue Ribbon UFO Panel” of scientists from the most known UFO groups of that time: the Center for UFO Studies (CUFO), the Midwest UFO Network (MUFON), the Aerial Phenomena Research Organization, and the National Investigations Committee on Aerial Phenomena. (Only MUFON and CUFOS still exist.) This Blue Ribbon Panel reviewed the reports that flooded into the tabloid. While no one was able to prove the existence of a UFO, the Enquirer sent out reporters to cover countless stories and published the best of them.

One of the Enquirer reporters during those years, as well as a member of its Blue Ribbon Panel, was Dr. J. Allen Hynek, an astrophysicist who was said to have been a consultant to the U.S. Air Force’s Project Sign and Project Blue Book — a USAF project that ran from 1947 to 1969 to investigate UFOs and determine if they were a national security threat. He was a professor and chairman of the Department of Astronomy at Northwestern University in Evanston, Illinois, and founded CUFOS in 1973.

When the Air Force discontinued Project Blue Book, by the way, after investigating 12,618 sightings, it reported: "As a result of these investigations and studies and experience gained from investigating UFO reports since 1948, the conclusions of Project BLUE BOOK are:(1) no UFO reported, investigated, and evaluated by the Air Force has ever given any indication of threat to our national security;(2) there has been no evidence submitted to or discovered by the Air Force that sightings categorized as "unidentified" represent technological developments or principles beyond the range of present-day scientific knowledge; and(3) there has been no evidence indicating that sightings categorized as "unidentified" are extraterrestrial vehicles." And regarding reports that the remains of extraterrestrial visitors are or have been stored at Wright-Patterson AFB, it said: "There are not now nor ever have been, any extraterrestrial visitors or equipment on Wright-Patterson Air Force Base."

Every issue of the National Enquirer seemed to have a UFO abduction story during much of the 1970s. Many readers may remember these scary stories that kept countless youngsters up at night and were shared in whispers by the light of flashlights, scarier than any ghost story, because these were supposedly real.

The power of suggestion was alive and well, as there seemed to suddenly be an epidemic of UFO sightings and alien abductions. Beliefs in UFOs, as space ships from alien planets was widespread. A National Enquirer poll conducted on March 3, 1974 reported that 92.7% of its readers believed UFOs from other planets were visiting earth. A Roper poll that same year found 40% of Americans believed in UFOs. Beliefs in UFOs weren’t restricted to tabloid readers, either. A June 1, 1976, survey even reported that 64% of Mensa International members thought UFOs were spaceships from other planets. It seemed easy to forget that “consensus is not science,” when even smart, degreed people believed.

…Another Project VISIT member, Dr. Richard Niemtzow, has developed a profile of what the humanlike space beings look like from the characteristics most frequently mentioned by abduction victims. ‘He's got no nose, his eyes and ears are slanted, his mouth is small, and he's got no teeth,’ the Galveston, Tex., physician reported. ‘He's four feet tall, hairless, with a lot of gray coloring. His arms are a little long - like a monkey's. His head is a little larger than a human being who is that tall. He's emotionless and quite possibly communicates almost entirely by telepathy.’ — “Similar Descriptions of UFO Humanoids Come from All Over the World,” National Enquirer (March 6, 1979)

In 1979, a handful of scientists and engineers formed a group called Project VISIT [Vehicle Internal Systems Investigative Team], based in Friendswood, Texas. It was headed by John F. Schuessler with Dr. Richard C. Niemtzow, M.D., both active in MUFON, a UFO group founded in 1969. Dr. Niemtzow had been the Radiation Consultant for MUFON since 1977, a position he continues to hold today. John Schuessler, went on to become the International Director MUFON from 2000 to 2006.

Their Project VISIT investigated more than a hundred reports of alien abductions and published several case reports of their findings in MUFON UFO Journal and other Ufology publications. In the August 1979 issue of MUFON UFO Journal, for example, Dr. Niemtzow and Schuessler described the reported paralysis that affects abductees. The process “seems to involve large diameter nerves associated with voluntary movement of striated muscle as opposed to the impunity of small diameter nerves found in regulatory functions delegated to the autonomous nervous system,” they wrote.

In describing the humanoid physiology of the aliens that they’d uncovered through Project VISIT, they said it suggested the humanoids are composed of smooth, not striated muscle. “Nevertheless, the humanoids are prone to a rather limited behavior pattern, somewhat expressionless, if not stereotyped, apparently less dependent on striated muscle systems. Perhaps we are dealing with a quasiautomatic intelligence, if not a cloned species.”

Their description of the aliens resembled the quotes in the National Enquirer and popular depictions of the aliens as Grays:

[T]hese small humanoids are most likely deprived of oxygenated blood and devoid of any cellular blood composition. This also includes the lymphatic system. Furthermore, they are lacking a digestive and excretory system. Rationalization of the data is extremely difficult not have examined a humanoid, but arguments supporting and refuting these statements are numerous. If we accept that life in the universe follows many derivatives, we are not surprised that UFO literature negates these humanoids of wearing life support systems. We would expect it to be rather difficult for them to adapt directly to our Earth conditions unless adaption [sic] means privation of certain biological components which would eliminate the problem…

We do wish to communicate that this information is comfortable to live with when UFO literature reinforces evidence that the small humanoid appears ageless, has a barely visible mouth, may use a food pill for nourishment, lack a spacesuit, etc. We realize that this paper is highly speculative, but it represents an area that needs to be seriously addressed.

At the 1980 MUFON Symposium in Seguin, Texas, Dr. Niemtzow said there have been countless cases where humans have been badly frightened by menacing close encounters with brilliantly luminous, craft-like objects. “Frequently, medical injuries have resulted to the witnesses, apparently due to the energy fields involved,” he said. The abductees’ lives have been disrupted but “while trying to alert society, they have been further shocked by receiving ridicule, rather than respectful attention.” He reported that Project VISIT had learned that UFOs have bright interior lighting; abductees undergo a medical-type examination with apparently highly sophisticated equipment; many suffer burns; and time loss, from 20 minutes to 3 hours, is common. Dr. Niemtzow described the crew members as “four feet tall, hairless, grey in color, with no nose, a small mouth and large slanted eyes. The Grey humanoid is emotionless and communicates by telepathy.”

In an article in the May 1980 issue of Mufon UFO Journal, entitled, “Evaluation of Medical Injuries Resulting from UFO Close Encounters,” Dr. Niemtzow wrote a guide to doctors for lab tests, skin biopsies and X-rays in order to verify a close encounter in a patient. The tests purportedly would prove the witness had been transported to a space ship and been subjected to prolonged weightlessness, had been prevented from receiving nourishment and undergone experimentation:

Many of the witnesses of close encounters associated with the UFO phenomenon report substantial medical injuries. These injuries may be classified into three categories. The first category is of a temporary nature, dealing with paralysis, dizziness, nausea, vomiting, headache, blindness, perception of odors, and high frequency audio sounds. The second category deals with the more chronic effects usually associated with skin lesions, which may represent direct pathology through unknown mechanisms. These skin lesions, which previously were described as burns produced by ionizing radiation, do not compare clinically, as we know it, to ultraviolet radiation or megavoltage photon or electron skin reactions as described in classical radiotherapy. The third category may involve parapsychological manifestations which may interrupt normal emotional behavior.

The untoward effects of UFO, close encounters clearly demonstrates the possible existence of the phenomenon.

In 1981, Dr. Niemtzow organized Project UFOMD (Unidentified Flying Object Medical Doctor), announcing in the November issue of MUFON UFO Journal that he hoped to assess at least twelve cases of medical injuries resulting from UFO close encounters over the next two years. Despite good publicity and a 24-hour hotline, he later reported that only two cases surfaced, one case refused to have his lesion biopsied and the other proved to be a hoax. In that 1984 article, “Physiological and Radiation Effects from Intense Luminous Unidentified Objects,” published in UFO Phenomena International Annual Review (of the Italian UFO group, CISU, Centro Italiano Studi Ufologici), he called for a similar international network of medical doctors to study abductions. By the time he wrote this article, he’d gone on to become a Colonel in the U.S. Air Force. He said the phenomena of intense luminous UFOs have been reported worldwide, including by GEPAN (Groupe d'Études des Phénomènes Aérospatiaux) in France.

His descriptive accounts of the cases epitomize the scary scenarios that saturated popular media and tabloids during that era:

Most observations are made from 17.00 hours to 24.00 hours [5 pm to midnight]. Suburbs are the site of most frequent observations. Most cases have at least two witnesses whose ages vary from 21 to 59 years old and favour significantly the male sex. The majority of the observations are under clear cloudless skies. The duration of the observation is variable from less than 10 seconds to greater than 1 hour. Most objects appear at a distance of 150 m to less than 1 Km. Normally the object is observed with the naked eye and appears round and circular, like a suspended ball. The size depends upon the distance observed and is variable. Most often the colour is orange, but appears in change colour in proportion to its velocity. The flight pattern is usually straight or a large curve. For the most part, the object moves very slowly but the accelerations are very impressive. The observation is usually silent and the object is frequently observed initially near or on the ground.

Dr. Niemtzow then described medical injuries from intense luminous UFOs, speculating that they might be due to effects of non-ionizing and ionizing radiation. Ionizing radiation, he said, produces biological damage to living tissue and lethal or sublethal symptoms that can lead to nausea, vomiting, skin burns and hair loss. The effects of nonionizing radiation were described even more ominously as causing slow, progressive behavioral changes, acoustic stimulations, hypotension and slow heart beat and depressed immunities; with microwave exposure able to cause cataracts and retinal damage, diarrhea and endocrinological changes.

He described the symptoms reported from UFO close encounters, which were those every abductee that came forward during this era seemed to experience:

The most common initial complaint is the surprised observation of a very intense luminous object at least 150 meters from the observer. The light is blinding and causes the individual to turn away… a rapid paralysis ensues…Visual movements and breathing are conserved. The mechanism of the nerve paralysis is unknown. Speech is not possible nor can the observer ambulate despite the will to escape. Difficulty in breathing and a fast heart rate are reported perhaps produced by fear and anxiety. Visual observation is possible as well as olfactory sensing of odors. Sometimes the observer hears a pulsing sound which seems to "fill the entire head". The strange sounds emitted from the phenomenon and detected by the patient may be the so-called microwave "hearing effect". After about 15 minutes the observer appears calmed and experiences parapsychological manifestations in the form of telepathic communication.

As the luminous object disappears there is rapid resolution of the paralysis. The observer may be aware of an unaccountable time loss and may complain in the next hours of nausea, vomiting, loss of appetite, conjunctivitis and diarrhea. First degree and second degree burns have been reported. Unusual skin markings or peeling and hair loss may occur in the following days. Sometimes there are no after-effects. The individual reports chronic nightmares and insomnia… Hypnosis has been reported useful in analysing the events. Many victims may undergo severe psychosocial changes.

He concluded by saying, “as this paper has shown, the medical manifestations are very real and appear to have a clinical pattern like other medical diseases. It is our responsibility to investigate further.” But what these reports really showed (beyond the outright hoaxes) was, of course, the powerful nocebo effects of suggestion, also called mass hysteria.

Dr. Niemtzow, fluent in French, having received his medical degree from Universite de Montpellier Faculte de Medecine, was invited to France by the Prime Minister to make recommendations for future UFO research by the French Government through its department, GEPAN. Since 1977, the national space agency of France, CNES (Centre National d'Études Spatiales), has officially investigated UFO reports. [In 1988, GEPAN was expanded to investigate all re-entry phenomena from space and became SEPRA (Service d'Expertise des Phénomènes de Rentrées Atmosphériques).]

In June 1985, Dr. Niemtzow went to France, along with Dr. J. Allen Hynek, and met with numerous officials at the National Space Center in Paris. He also presented his paper, “Physiological and radiation effects from intense luminous unidentified flying objects.” His report of his France trip was described in the August 1985 issue of MUFON UFO Journal, where he was careful to point out that he went as a private citizen and GEPAN Consultant, not in his official capacity as a Radiation Oncologist and Major in the U.S. Air Force, stationed at Andrews AFB in Maryland.

Fast forward…

This week, the Baltimore Sun reported that the Air Force will begin teaching “battlefield acupuncture” to physicians being deployed to Iraq and Afghanistan to treat wounded troops suffering from pain. This technique was developed by Colonel Richard Niemtzow, an Air Force physician, acupuncturist and senior advisor to the Air Force Surgeon General, said the paper. “This is one of the fastest pain attenuators in existence — the pain can be gone in five minutes,” said Dr. Niemtzow. The ear acts as a “monitor” of signals passing from body sensors to the brain, he said. Those signals can be intercepted and manipulated to stop pain or for other purposes.

According to Col. Anyce Tock, chief of medical services for the Air Force Surgeon General, the service has authorized 32 active-duty physicians to begin "battlefield acupuncture" training. Last summer, Dr. Niemtzow had also trained U.S. Army Rangers in the method, said the paper. Dr. S. Ward Casscells, the Pentagon's assistant secretary for health affairs, told USA TODAY in October that the Pentagon is spending $5 million to study alternative modalities to treat troops suffering from combat stress or brain damage, including acupuncture, meditation, yoga and the use of animals. Most Americans feel the men and women serving our country deserve the highest quality, science-based medical care, which made this news story especially disturbing.

Dr. Niemtzow is, in fact, Chief Medical Consultant for Alternative and Complementary Medicine for the U.S. Air Force Surgeon General and is the first full-time acupuncturist in the Armed Forces. He is also Director of the American Academy of Medical Acupuncture, a member of the Editorial Board of the Chinese Journal of Integrative Medicine, President of the Medical Acupuncture Research Foundation, and Editor in Chief of Medical Acupuncture, the journal of the American Academy of Medical Acupuncture.

Malcolm Grow Medical Center at Andrews AFB, wrote Dr. Niemtzow, is a de facto training center for Air Force physicians who are completing their acupuncture training. Their clinic also treats patients who come from surrounding military centers. “Currently, our treatment modalities include needling body acupoints, auriculotherapy, electroacupuncture (Craig), microcurrent, laser techniques, piezoelectric stimulation, electroauriculotherapy, some Korean hand acupuncture, YNSA, and dry needling for trigger points,” he said.

Their military clinic uses acupuncture to treat fibromyalgia, protruding disks, reflex sympathetic dystrophy, degenerative disk disease, spinal stenosis, frozen shoulder, peripheral neuropathy secondary to diabetes or chemotherapy, torticolis, overuse syndromes, abdominal pain of unknown etiology, tendonitis, carpal tunnel syndrome, arthritis, osteoarthritis, migraines, etc. “We also treat patients for obesity, nicotine abuse, dry mouth and dry eyes from various etiologies, hot flashes, chronic fatigue along with depression, and dermatological conditions such as eczema,” he said.

“Acupuncture is not ‘magic,’ but a definite science that may even eclipse Newtonian physics,” he wrote, adding:

Yet on the other hand, as we begin to talk about energies and spirits that are so important in our art, this notion may conjure up the slightest sense of magic. We become "wizards" when we place our needles into the symbolic points of our belief, and direct the flow of energy through the channels known to our ancestors. After all, it is our patient's desire to become cured. Are we wizards or healers or a little of both? Modern medical science may not have room for this kind of thinking… Many of us can see even deeper than the molecular structures of the atoms that make up the chemicals in our bodies and thus, as acupuncture became ingrained in our souls, we acquired some of the wizard and healer qualities.

His editorials in Medical Acupuncture now discuss electroacupuncture stimulators and his research into sinusoidal output stimulating acupuncture looking at various waveform outputs. “The electromagnetic spectrum offers many possibilities for stimulating acupuncture points,” he wrote in one Medical Acupuncture editorial.

The placement of needles in the acupuncture point, which is a physiological complex of blood and lymphatic vessels, nerve fibers and conjunctive tissues, may also influence sub-atomic changes in the energy flowing through the meridian. The needle, having thermo-electric properties, may act as a promoter of electron movements in and out of this complex system… Higher up on the electromagnetic spectrum at a wavelength of about 600-1000 nanometers is the clinically useful area of photon emission that we call "laser." The "light" is monochromatic and highly coherent, and we are interested in low-energy emission in the 5-400 milliwatt output range. The useful energy passes through the skin and may be directed onto the acupuncture point. The absorption of this photo energy at the acupuncture site can produce biochemical, electrical and bio-energetic reactions. Some laser devices have Nogier's frequencies superimposed on the laser emission…

His battlefield acupuncture is not a new project and he has been actively promoting it in the military for years. As Dr. Niemtzow said in a 2003 editorial, he had given a lecture to the Defense Advanced Research Projects Agency on January 27, 2003 to promote it. He proposed that combat troops be taught ear acupuncture to be given to themselves or by the buddy system in combat settings, saying it can be taught to troops in less than an hour. He claimed “the attenuation of pain from these small needles injected into the cingulate gyrus and thalamus points may at times equal or surpass that of narcotics without the side effects of mental deprivation,” which would enable military missions to be continued without interruption.

He also taught his battlefield acupuncture at Walter Reed Army Medical Center, urging doctors to use it for soldier amputees in the hospital, saying “success is achieved rapidly with the ‘Battlefield Acupuncture’ technique, and residual low-level pain may be further reduced with a piezo electrical stimulator or a modified Craig Technique.” He said his ear acupuncture is very efficient. “We also observed that some patients who initially do not respond to auriculotherapy, and are then treated with Korean Hand Acupuncture, experience a ‘renewed success’ with auriculotherapy. For some reason the neuron-physiological pathway ‘opens up.’”

The importance of sound clinical trials and the scientific process

Even while beliefs in alternative modalities attempt to sound and be scientific, by definition, they are not grounded in science because once a modality has been soundly scientifically demonstrated, it is no longer alternative. Clearly, all acupuncture advocates are not ufologists because for many years it was first thought acupuncture might have a biological plausability that was not yet recognized, but that is no longer the case. It is so easy and natural to get caught up in popular beliefs that may have no sound basis, though, when we're not diligent to examine them for ourselves using the scientific process.

None of the studies on his website Dr. Niemtzow cited to suggest acupuncture is a successful treatment for obesity or for xerostiomia and xerophthalmia for radiation patients, were designed as research or to be a fair test of acupuncture, he wrote. Reading the studies finds this to be the case. The small, short-term weight loss studies, for example, had no control group. All of the participants were given ear acupuncture and told it would control their appetites. They were also instructed to eliminate from their diets all starches, potatoes, rice, noodles, cereals, sauces, dairy products, eggs, cheese, butter, ice cream, all sugar, alcohol, yellow vegetables, tomatoes, onions or “any vegetables that are not green.” While attrition wasn’t reported, according to the studies, “the number of patients participating in the study steadily decreased over the 12-week period.” The acupuncture technique used on a mere twelve radiation patients wasn’t a randomized controlled trial at all and only reported that after a single session “an increased degree of salivation was subjectively present” among these patients.

The evidence for using battlefield acupuncture to treat acute and chronic pain in military personnel came from a study conducted at Malcolm Grow Medical Center and funded by the Samueli Institute for Information Biology under a contract with the Department of Defense. This study was different from those on his website, as this one was a registered clinical trial and supposedly designed to prove the efficacy of ear acupuncture. The results of this pilot study were published in Military Medicine. It failed, however, under the principles of a fair test of a modality.

Biological plausibility. The authors began by stating:

Acupuncture theory is based on the premise that energy called Qi, travels along twelve prescribed pathways or meridians within the body and is responsible for maintaining good health. Blockages, deficiencies or disturbances in the flow of Qi results in disease. Acupuncture employs needles to stimulate specific points on the body for the purpose of regulating this energy flow.

If claims of bioenergy fields exist, “then some two hundred years of physics, chemistry, and biology has to be re-evaluated,” said Dr. Victor J. Stenger of the Department of Physics and Astronomy at the University of Hawaii in Manoa. Those making such unscientific claims have an enormous burden of proof, he said.

Selection bias. The authors said they screened active duty male and female military personnel and their dependents between the ages of 18 and 50 who came into their emergency room with acute pain syndrome for possible inclusion in the study. They didn’t reveal how many were screened, but said that 40% of the eligible patients screened agreed to participate. They randomly selected 50 patients into the treatment group and 50 into a control group. The two groups differed significantly in several ways. Compared to the intervention group, the control group had higher pain scores at the beginning of the study (7.78 versus 6.98), had more females, and were in poorer health with “more emotional problems.” No information was provided on the medical conditions, the reasons for pain or the treatment received by each group, meaning countless confounding factors were not controlled for.

Intervention bias — not placebo controlled. Both groups continued to receive standard emergency room care, including prescriptions for pain as needed, with the intervention group also getting acupuncture. The study participants and the acupuncturist were not blinded, only the ER staff were by having the participants ears taped over so they couldn’t see who had received acupuncture. The placebo effect was not controlled for by giving the control group sham acupuncture.

Reporting bias — self-reported, subjective. The participants were asked to complete a form rating their pain from 0 to 10 and leave it at the front desk before leaving the ER, to report their pain scale at a follow-up phone call, and to record their pain medication use for 24 hours.

Attrition bias. A total of 13% of the participants were lost at follow-up at 24 hours, with no information on which group they came from or how they differed from those who completed the study. A total of another 27% of participants didn’t get or fill a prescription at the ER at all, but no information was provided on which intervention arm they were in.

Untenable findings. The study participants pain scores 24 hours following admission showed a 3.4 point drop among the intervention group and 3 point drop in control group; no statistical difference. No information was provided on how long each group was in the ER and how quickly after their first pain medications or medical treatments, and/or acupuncture, their initial pain report in the ER had been completed, making it impossible to evaluate or compare. Never the less, the authors noted that the intervention group reported a 23% reduction in pain before leaving the ER compared to the control group.

This brings us to several new helpful articles on evaluating clinical trials and how good randomized controlled clinical trials are designed to eliminate things that can lead us to conclusions that aren’t real. Dr. Edzard Ernst, M.D., Ph.D., FRCP, FRCPEd, chair of the department of complementary medicine at the University of Exeter, recently reviewed an acupuncture trial and reminded us “how cautious we often have to be when making causal inferences based on the results of pragmatic randomized clinical trials.”

The purpose and importance of a well-designed clinical trial, he said, is to eliminate a host of factors that explain a perceived effect of a therapy, such as the natural course of the condition, other concurrent actions that may not be declared, and regression towards the mean. What cannot be overlooked, however, are things that can be different between groups and explain the differences seen with an intervention, such as the placebo effect and the social desirability of a treatment; the therapist-patient interactions and subjective changes brought about in how a patient feels; disappointment in being allocated to a control group among those who might believe in or have hoped for a treatment; and, of course, the specific therapeutic effects of the treatment being studied.

He emphasized the importance of minimizing confounders in trials by using blinding and placebos, but said a common assumption about placebos is wrong. The placebo effect is not a constant, he explained. “If today acupuncture is ‘in’, it may generate higher expectations, and hence a more pronounced placebo response” than even the physiotherapeutic intervention. “Once the novelty factor wears off, its placebo effect could decrease.”

It’s easy to overlook the social desirability or popularity of a modality and the phenomenon of patients responding to someone treating them with kindness and empathy, and reporting that they feel better, when in fact, their symptoms haven’t improved and there is no actual clinical improvement. This points out the importance of objective clinical endpoints, but it also highlights that a “placebo-controlled” trial doesn’t mean the placebo effect was actually controlled.

The treatment experience of all participants in a clinical trial need to be as similar as possible, with the only variable different between the intervention group and control group being the live acupuncture treatment. His article in the current issue of the Journal of Postgraduate Medicine deserves to be required reading for all clinicians. In it, he explained how a randomized “controlled” clinical trial of acupuncture for pain that is designed as:

A + B compared to B

will usually generate false positive results and wrongly appear to show a benefit of “A” (acupuncture) as compared to the control group “B” receiving standard care. These trials are not free of bias, he explains. “In recent years, we have seen a plethora of RCTs adopting a design where patients are randomized to receive either usual care (the control group) or usual care plus the experimental treatment,” he said. At first glance, such comparisons may seem reasonable but, on closer inspection, these are not fair scientific tests of an experimental intervention. 'A plus B' will invariably amount to more than 'B' alone. “Even in cases where treatment ‘A’ is a pure placebo, its placebo and other nonspecific effects could lead to a better outcome in the experimental group than in the control group.”

Examining 200 randomized controlled clinical trials of acupuncture for pain, he found that this design actually fails to control for the placebo effect. In contrast, more recent trials which control for the placebo effect by using non-penetrating sham devices in the control group have shown that true acupuncture is not superior to sham acupuncture. This isn’t always recognized by clinicians who read published studies, he cautioned, and many people improperly equate “randomized controlled clinical trial” with the highest level of reliability.

But even the use of sham acupuncture devices can be cleverly gotten around, making it especially important to carefully examine clinical trial protocols.

One way is to prescreen a group of subjects by giving them real acupuncture “to evaluate their response to acupuncture” and only enrolling into the study those who report a reduction in pain. Then, after the participants have been exposed to real acupuncture, they are randomized into a real acupuncture group and a sham acupuncture group, but the sham acupuncturists are instructed to use less pressure and rotate the needles more gently than in real acupuncture. In other words, this removes the blinding as those in the control group are more likely to suspect they’re being given sham acupuncture. This was the flaw in a new study published last month in Behavioral Brain Research reported as scientifically demonstrating analgesic effects of acupuncture via functional MRI and PET scans. Previously, in 2005, Boston researchers had shown that when sham acupuncture is used in subjects believing it to be the intervention, similar changes were seen in their fMRIs.

Another way the use of sham acupuncture in an improperly designed study can mislead us was brilliantly demonstrated in a registered clinical trial led by Dr. Ted J. Kaptchuk, associate professor of medicine at Harvard Medical School in Boston. A significant aspect of the placebo effect is the therapeutic ritual and supportive interaction between a care provider and a patient. Without ensuring that the intervention group receiving acupuncture and the control group receiving sham acupuncture both have the same experience, the placebo effect can be improperly attributed to the acupuncture intervention.

For instance, if the sham acupuncture is quickly and impersonally administered to one group, while the acupuncture group is given lots of warm attention, interaction, empathy and a positive expectation is communicated, it can create a heightened placebo effect in the acupuncture intervention group. In other words, benefits cannot be credibly attributed to an intervention without separating it from the placebo effect — both study arms need to have the same experience, which was what sham acupuncture was originally intended to accomplish. [Sham acupuncture covered here.]

In this study, published in the May issue of the British Medical Journal, Dr. Kaptchuk and colleagues conducted a six week, three-arm randomized controlled trial of 262 adults with irritable bowel syndrome. These participants had been diagnosed using Rome II criteria and had a score of ≥150 on the symptom severity scale. The researchers randomly assigned them to a group receiving no interventions at all, a group receiving just sham acupuncture, and a third group receiving sham acupuncture that was augmented by attention from a warm, empathetic, confident practitioner. Not surprisingly, more patients reported feeling relief of their symptoms with the sham acupuncture that was accompanied by a therapeutic ritual and greater attention, warmth and empathy from a provider. The effects were directly related to the degree of treatment interventions: 28% on observation, 44% in the limited sham acupuncture group, and 62% in the augmented sham acupuncture group reported symptom relief during the study. Similar benefits were seen for their reported severity of symptoms and quality of life.

As the authors concluded, the placebo effect can yield statistically and clinically significant effects, and factors contributing to the placebo effect can be progressively combined to resemble a dose escalation effect. Not only did this study demonstrate how powerful the placebo effect is and how easily it can mislead us to believe an intervention works, but it demonstrated the importance of using hard clinical outcomes to evaluate the effectiveness of a medical treatment. These authors noted that whether the placebo effect actually resulted in any biological changes or was due to shifts in the selective attention to diffuse symptoms couldn’t be answered without clinical measures.

Which brings us to an article just published in the American Journal of Medicine by Dr. Ernst. Acupuncture’s renaissance began in 1971, he said, when it was first suggested that acupuncture might plausibly work by releasing endorphins in the brain or act via the gate control mechanism. This resulted in a surge of studies and long list of conditions for which acupuncture was alleged to be proven beneficial. “Most of the clinical studies, however, lacked scientific rigor,” he wrote.

Most experts have remained unconvinced of acupuncture’s true value, he said, suspecting the reported results are largely due to patient expectations. Others have questioned the validity of the body of evidence, noting not a single study in the Chinese literature contained a single negative study. A major methodological flaw in most acupuncture studies has been poor control for placebo effects, which led to the development of those nonpenetrating needles that patients can’t tell from real acupuncture.

Acupuncture studies are a complex mélange of different acupuncture techniques, conditions and study designs, making the evidence hard for the public to sort out. To help, systematic reviews, such as by Cochrane Collaborative, tend to be more rigorous, transparent, independent and up-to-date than others, he noted. The benefits of acupuncture are not supported by the conclusions of these articles. Even those suggesting possible relief for nausea and headaches are problematic as they’ve failed when repeated using sham acupuncture with nonpenetrating, collapsible needles. Dr. Errnst went on to review other clinical trials, with problematic designs, such as using only nonspecific, subjective outcomes.

Placebo - what's the harm?

Some suggest that if an alternative modality works by placebo effect, it still works and question the harm in that. Doctors debated the ethics of using deception in the British Medical Journal and most believed that trust between patients and their clinicians is important, and trust requires truthfulness. Using placebos to deceive patients not only fails to empower them with understanding of their body’s own healing and the natural course of most diseases, but it creates a paternalism and jeopardizes the mutual relationship between a patient and doctor. This can even be medically dangerous, said one doctor, making patients more vulnerable to fraud, dependent, and “strengthens medical arrogance, infantilizing patients even more.” As today’s healthcare costs skyrocket, leading to increasing numbers of people unable to afford insurance, and financially-strapped public healthcare systems having to ration care and deny it to those in need, the ethics of promoting drugs and interventions that are shams deserve even more scrutiny.

Sound science will never change the intensity of beliefs or lessen fears for some. Sadly, the results are not always harmless. Dr. Ernst concluded his commentary by saying:

So, after three decades of intensive research, is the end of acupuncture nigh? Given its many supporters, acupuncture is bound to survive the current wave of negative evidence, as it has survived previous threats. What has changed, however, is that, for the first time in its long history, acupuncture has been submitted to rigorous science — and conclusively failed the test.

© 2008 Sandy Szwarc