President Nixon’s trip to the People’s Republic of China last year resulted in an unexpected side effect: an interest by Americans in Chinese medicine, particularly the ancient art of acupuncture. As a result, the Food and Drug Administration has developed regulations on acupuncture in this country to protect American patients.
Ever since President Nixon visited China last year, American newspapers have been filled with reports of Chinese who have undergone surgery. without pain, while awake, with acupuncture needles. Still other reports of people whose intolerable pain has been alleviated completely by acupuncture have focused additional attention on this ancient art.
According to the definition of Chinese traditional medicine, acupuncture is the treatment of disease—not just alleviation of pain—by inserting very fine needles into the body at specific points called loci. The practice of acupuncture dates back to 2500 B.C., and is described in the oldest Chinese book on medicine, Huang Ti Nei-Ching.
In old Chinese culture, the acupuncturist is a man to be respected and trusted. His techniques stem from the ancient Chinese philosophy of life, which teaches that the entire universe works in perfect harmony between Nature and man.
According to this philosophy, man is subject to universal laws. The forces behind life and death are in the form Ch’i (Vital Energy). The general flow of Ch’i through the body is controlled by the interplay of two opposing forces, the Yin and the Yang. Yin represents negative: night, cold, dark, female and the interior of the body. Yang is the opposite: positive, day, hot, light, male and the exterior of the body.
In the universe, the philosophy says, the harmonious workings of Yin and Yang express themselves in the rising and setting of the sun, the sprouting and ripening of the crop, and other Nature cycles. Storms, earthquakes and natural disasters are the result of an imbalance between Yin and Yang.
In man, health results from the balance of Yin and Yang. All diseases, the philosophy says, are due to an imbalance of these forces.
Ch’i circulates through the 12 organs of the body by means of 12 hypothetical primary channels (meridians), which correspond to the 12 months of the year. These 12 channels have a direct connection with every part of the body, and thus furnish the best access to the scat of any disturbance. The acupuncture loci are along the 12 channels through which acupuncture needles can be inserted. The loci, 360 in number, correspond to the number of days in the lunar year.
An acupuncture practitioner first locates the energy imbalance by taking the patient’s pulse. He then seeks to restore the balance by insertion of needles into one or several loci, and by leaving them in for a designated period. The equilibrium of Yin and Yang is then expected to be restored and the disease is then cured. If the disease cannot be cured by acupuncture, herbs are prescribed.
Acupuncture is based on the premise that any disease has two main phases, the invisible and the visible. The first represents an energy imbalance or disturbance before it has shown itself in body tissues or processes as symptoms.
The highest art of the traditional acupuncture practitioner is to treat the energy imbalance at that point to prevent the disease from ever occurring. The second phase of a disturbed energy balance comes when the unchecked first stage imbalance begins to manifest itself in outward symptoms.
Modern Chinese medicine is marked by a fusion of traditional medicine with extensive Western scientific research and clinical studies.
Acupuncture to produce analgesia for surgical operations was first used in China only in 1958. Several operations using this technique were observed by a number of eminent physicians and journalists who accompanied the President on his trip. One journalist, James Reston of the New York Times, underwent an emergency appendectomy in Peking and acupuncture was used successfully to relieve postoperative pain. His and others’ reports on the use of acupuncture in surgery. during which time the patient is awake, cooperative and free of pain, are indeed exciting.
Acupuncture anesthesia purports to permit patients to undergo surgery while they are completely conscious. To obtain the analgesic action, the acupuncturist inserts needles in the specific loci 20 to 30 minutes before the operation. It is important that the patient experience the Teh Ch’i sensation-the feeling of soreness, swelling, heaviness and numbness accompanying needle insertion. This sensation in the patient has to be maintained throughout the operation by twirling the needles. The patient senses pressure at the site of the operation but is without pain.
There are other exciting aspects of acupuncture that involve underlying physiological concepts. The performance of open-chest surgery without the lungs collapsing cannot be explained in the light of our present understanding of physiology. Yet physicians who accompanied the President brought back motion pictures of patients undergoing such open-chest surgery with no obvious respiratory or other physical distress.
Several recent theories have been propounded on how and why acupuncture works.
The “Spinal-Gate” theory was advanced in 1965 by Dr. Ronald Melzack of McGill University and Dr. Patrick Wall of University College. London, both of whom were concerned with the general mechanisms of pain rather than with acupuncture itself. Their theory holds that stimulation of the large, so-called “A-delta” fibers in the sensory nerves closes a hypothetical gate in the spinal cord. This would block pain impulses which travel along a different set of smaller nerve fibers from traveling up the cord to the brain.
But this would block only pain traveling along peripheral nerves leading to and from the spinal cord, that is, from the neck down. The theory does not explain how acupuncture needles stuck in the face reduce pain in surgery of the abdomen. Recently, Dr. Pang L. Man of Wayne State University School of Medicine and Dr. Calvin H. Chen of Northville State Hospital, Michigan, have suggested there may be a second gate (Two-Gate Theory) in the thalamus of the brain that. closes to prevent pain sensations from reaching the cerebral cortex from below or above the spinal cord.
Dr. George Wald, Harvard Nobel Laureate, has reported that Prof. Chang Hsiang-tung at Shanghai’s Academy of Sciences has a similar theory that there appears to be at least “four gates” that control and channel pain impulses. This theory holds that in the central nervous system the activity of the larger nerve fibers depresses the activity of the smallest nerve fibers, including those that transmit pain, and that this happens at all levels of the central nervous system, in the spinal cord, the brain stem, the thalamus, and in the cerebral cortex.
There arc several other less involved theories based on the hypothesis that the effects are due to some form of hypnotherapy, needle hypnosis, or autosuggestion.
In some hospitals in China, up to 80 percent of the surgical operations have been performed with the use of acupuncture. Patients are given a choice of undergoing the operation under the conventional Western anesthesia or under acupuncture.
Recent developments in acupuncture in China have emphasized treatment of the deaf-mute and the blind. Many new loci have been found for treating these patients, but the prime therapeutic value of acupuncture is for functional disturbances, alleviation of pain and reduction of muscular spasms.
In this country a number of individuals, institutions and medical centers have embarked on research programs to evaluate the technique in relief of pain or as an anesthetic. In an effort to control the use of acupuncture and keep it in its proper research perspective, several States, including New York and California. have placed restrictions on its use. These States have taken the position that acupuncture can be performed only by licensed medical practitioners, and that the use of acupuncture for the relief of pain or for surgical anesthesia is an experimental procedure that should be restricted to research to determine whether it is safe and effective.
The Food and Drug Administration is involved in acupuncture because the needles and other paraphernalia come under the authority of the Food, Drug, and Cosmetic Act as medical devices. The law requires that such products be properly labeled, in this case, as prescription medical devices.
In FDA’s view, in this country acupuncture is an experimental technique whose safety and efficacy has not been established. A group of Chinese acupuncture practitioners recently pointed out in Shanghai that acupuncture cannot be used for all patients and all diseases. They urged American physicians to approach the practice of acupuncture cautiously.
In an effort to provide appropriate labeling for acupuncture materials, FDA published a notice on March 9 that the label for this equipment bear, in addition to the usual information such as name and address of the manufacturer, this statement:
“Caution: Experimental device limited to investigational use by or under the direct supervision of licensed medical or dental practitioners. . . . This device to be used only under conditions designed to protect the patient as a research subject and where the scientific protocol for investigation has been reviewed and approved by an appropriate institutional review committee or where conditions for such use are in accordance with state law.”
This means, according to the proposed FDA labeling, that a physician should receive from a patient an “informed consent” before using acupuncture on him. The doctor should explain to the patient what the procedure is, what the discomforts and risks are expected to be, what benefits are anticipated, what alternate procedures are available, and advise the patient that he can withdraw at any time.
This “informed consent,” oral or written, cannot include any language through which the patient waives any of his legal rights or releases the physician or the institution from liability for negligence.
This labeling proposal is designed to provide a means for experimental use of acupuncture medical devices under conditions which would protect the patient. All investigational plans must be approved in advance by an institutional committee and must comply with State laws.
FDA is concerned that acupuncture does not fall into the category of “quackupuncture.” FDA believes those sponsoring the modality should be given the opportunity, through valid scientific research conducted by competent, trained investigators, to produce evidence of its safety and efficacy.
FDA opposes the clinical use of acupuncture by poorly trained practitioners who have indulged in short crash courses or are self-taught. The practice by licensed medical practitioners of hiring Eastern-trained, unlicensed practitioners to treat patients is comparable to a surgeon hiring a technician to do his operations while he collects the fees.
Arthritis sufferers who have tried many things for relief of pain, and migraine victims whose chronic headaches are not relieved by drugs, are desperate for relief. The publicity given to acupuncture in this country tends to make them gullible victims for the so-called acupuncture clinics run by medical practitioners of dubious expertise and medical ability. Some of them are less concerned about establishing the safety and efficacy of acupuncture as a possible valuable adjunct to the practice of medicine than they are about the patient’s pocketbook and his ability to pay for the costly office visits.
At the present time, we in the United States need information and concepts which will permit us to distinguish between competent and incompetent pursuit and practice of this particular form of medicine in our efforts to protect the consumer-patient.
This article was originally published in the May 1973 issue of FDA Consumer. At that time, Joseph B. Davis, M.D., was director of the Division of Scientific Review in the FDA’s Office of Medical Services and Lillian Yin, Ph.D., was in the Division of Classification and Research in the Office of Medical Services.
This page was posted on February 20, 2005.