The Blind Spots of Modern Medicine as Seen from “Double-Blind Experiments”

22,418 characters2010.12.30

 

Is medicine a science? The usual answer is yes, or at least that “medicine is not merely a science,” but in any case, one believes that medicine is first of all a science, or at least “scientific.”

Like other modern sciences, the “scientificness” of medicine is embodied in its goals and methods: the goal of science is to reveal the (natural, reductionist) causes and laws of things; the method of science is quantitative and experimental.

The scientificness of modern medicine is first grounded in biology and physiology. But even the most stubborn reductionists will admit that medicine is not physiology, and that besides studying physiological phenomena, the basic theme of medicine is ultimately “to cure the sick and save lives.” So does medicine, as a study of curing the sick and saving lives, have scientificness beyond physiology? Of course it does. And what most fully embodies medicine’s character as a “science of healing” is probably the use of “double-blind experiments.”

The idea of blinding or double blinding was proposed quite early, but its widespread application in the medical field was probably a matter of the twentieth century; thus some people call double blinding “a major scientific advance of the twentieth century”[1]. Double blinding is used to test the effects of drugs or treatments, but its significance is by no means limited to pharmacology; it has even become a sign and symbol of medicine’s modernization or scientificness. People have said: “Double-blind studies have initiated a medical revolution… Medicine must be built on the basis of double-blind studies, and this proposition has come to be understood as a movement toward ‘evidence-based medicine.’”[2] Modern medicine uses double blinding to regulate and advertise itself, and when Zhang Gongyao and others attack Chinese medicine, double blinding also becomes their most frequently used weapon—how many Chinese medicines have passed the strict test of double blinding? Indeed, even if Zhang Gongyao’s claim that “so far, no Chinese herbal formula has been confirmed by double-blind studies”[3] is probably an exaggeration, it can still be believed that Chinese herbal medicine does indeed fare poorly in the face of double-blind tests.

But what does this mean? Is double blinding the core law of medicine? Has the place of double blinding in medicine been overestimated? What exactly has this “medical revolution,” marked by double blinding, overthrown? Has it merely dispelled ignorance and superstition? Starting from double blinding, this article will explore the nature of medicine and the relation between medicine and science, and will offer some understanding of the contemporary significance of Chinese medicine.

 

If the place of double blinding in medicine has been overestimated, that is in the context of those who use double blinding as the supreme criterion to advertise modern medicine and negate traditional medicine; but in other contexts, the status of double blinding has clearly been underestimated. Many works on the history of medicine or general introductions to medicine say nothing at all about double blinding[4]. This neglect is not accidental, nor does it mean that the significance of double blinding in the history of medical development is truly trivial. It is rather like the mathematical-experimental method in physics: this method has already become an obvious foundation of physics, and ordinary histories of physics recount the various achievements physics has obtained—on the basis of its fundamental method—but pay relatively little attention to the development of the experimental method itself, through which those achievements were attained and on the basis of which they were recognized. Thus, although with the development of statistics and manufacturing techniques the experimental methods and environment of physics also underwent tremendous changes in the twentieth century, general histories of physics would not make much of it here. The history of medicine works the same way: historians’ skipping over double blinding precisely confirms its crucial status.

For the scientization of medicine, double blinding is obviously not a cause, but rather an outcome, or a sign. The various features of modern medicine as science are embodied in double blinding. Just like the rise of the mathematical-experimental method, science’s “methods” have never been completely neutral tools; they always contain certain specific metaphysical presuppositions or value notions.

So what is double blinding in medicine? Simply put, it is the arrangement of two groups of patients: one is the experimental group, to whom the drug (or other treatment) under test is administered; the other is the control group, to whom a “placebo” (such as sugar pills), believed to have no therapeutic effect, is administered. And ensuring that patients in both groups do not know whether they are taking the “real drug” or the “fake drug” is called “blinding.” Ensuring at the same time that the doctor administering the treatment also does not know the truth is “double blinding.” As for making the researcher who does the statistics unaware of the truth as well, that becomes “triple blinding.”

The main significance of double blinding lies in excluding the so-called “placebo effect” and other possible confounders. The placebo effect refers to the fact that some drugs actually have no therapeutic effect (for example, sugar pills or starch), but because patients believe they have taken an effective drug, they gain a positive mental state that promotes recovery from illness. And cases in which the placebo “works” also include natural recovery, as well as biased reports by patients or doctors about the condition of the body, and so on.

At first glance, double blinding seems to be an indisputable scientific method: if a treatment cannot pass the double-blind test, then it is no different from taking sugar pills. So isn’t it only natural to use double blinding to negate those traditional prescriptions—and even traditional medicine—that are equivalent to sugar pills?

However, things are not so clear-cut. Double blinding is not the unique key to testing any prescription or medical treatment; rather, the very possibility of double blinding is itself based on a particular set of medical practices and concepts of pharmacology and pathology. Let us look at this from the following points.

1. The way drugs are used:

What is tested in double-blind experiments is generally the medicines of modern Western medicine: independent “drugs” mass-produced through chemical or biotechnological means, targeted at a particular disease or symptom. But this concept of “drug” does not necessarily have a completely corresponding counterpart in Chinese medicine and other types of medicine. Chinese medicine has the concepts of medicinal materials and formulas, but neither is fully equivalent to the status of drugs in double-blind experiments. Medicinal materials in Chinese medicine are independent entities; each herb has a clear classification and individuality. But when it comes to treating disease, what functions as the tool is not a single medicinal material, but a “formula.” A formula is often composed of multiple medicinal materials in proportions arranged according to the relationship of “chief, deputy, assistant, and envoy.” So if one were to use double blinding to test them, what exactly should be the object under test? A single medicinal material? But Chinese medicine does not originally use single medicinal materials to treat disease, and a single medicinal material does not correspond to a specific illness, so how would one select the corresponding patients to test its effect? Then what about using double blinding to test a formula? The problem is that a formula is not a standardized mass-produced product; it is prescribed for specific people, not for a particular disease. Chinese medicine has the idea of treating the same disease in different ways and different diseases in the same way; even if one found the same batch of patients, one still could not simply prescribe according to a uniform pattern.

In short, the mass-produced drugs and mass-produced patients required in double-blind experiments are difficult for Chinese medicine practice to provide, and the reason they are difficult to provide is not a lack of capability, but rather the result of its basic therapeutic ideas and medical methods. Whether this medical paradigm itself is reasonable or effective is a separate matter, but in any case, double blinding itself is not suitable for evaluating medical practice under this paradigm.

Of course, in the face of large-scale epidemic outbreaks, Chinese medicine will also prescribe universal formulas for mass distribution, and “mass-produced formulas and mass-produced patients” become reality. But prescriptions still need to be adjusted according to differences in season and locality. For example, in the famous case of using “Baihu Tang” to treat an encephalitis epidemic, Japanese encephalitis was prevalent around Shijiazhuang in 1955, and Guo Keming proposed treating it with Baihu Tang, which was said to be remarkably effective; yet when Japanese encephalitis broke out in Beijing in 1956, Baihu Tang was used again but no effect was seen. Later, the famous doctor Pu Fuzhou was invited to provide guidance, and he held that “in 1955, Shijiazhuang had long periods of clear weather without rain, dryness and fire were in command, Yangming had internal heat, and the condition belonged to summer warmth, so using Baihu Tang to clear heat and drain fire naturally worked; whereas in 1956, Beijing had more rainfall and the weather was humid and hot, … so the method was changed to promoting Yang and dispelling dampness, using medicines that should relieve damp heat and aromatically transform turbidity, with immediate effect.”[5]

It should be noted that citing certain statements from Chinese medicine does not necessarily mean that I fully believe them. In fact, there are also various different statements and ideas within Chinese medicine itself. As for the above statement, anti-Chinese-medicine critics may explain that what is called efficacy is nothing more than the natural process by which an epidemic, after its initial outbreak, tends to subside on its own, and this sounds quite reasonable too. And to confirm the effectiveness of Chinese medicinal formulas, doing double-blind experiments is indeed useful, for example by randomly selecting two groups of patients in an epidemic area for a comparative trial. Here I do not deny the role of double-blind experiments; if the formula is indeed ineffective, and it proves that Chinese medicine lacks good methods for controlling certain epidemics, then that should be frankly accepted. But in any case, on the one hand, the situation of mass-produced formulas for mass-produced patients is a secondary and rare form in the traditional practice of Chinese medicine; on the other hand, even with respect to this form, the significance of double-blind experiments is greatly discounted. At most, they can negate a certain treatment that happens not to work at the time, but they cannot establish a more universal conclusion; the reproducibility of the experiment is lacking.

2. The mode of medical practice:

In a typical double-blind experiment, what role does the doctor play? On the one hand, he is the drug administrator: he prescribes to the patient, without knowing the truth, a certain drug he knows nothing about at all (the test drug or the placebo). On the other hand, he is the diagnostician: he judges the development of the patient’s condition and reports it as an experimental record— which patients experienced relief or recovery after taking the medicine. We note that here, the doctor’s act of prescribing and his act of diagnosis are completely separated; or rather, the act of prescribing is entirely symbolic for the doctor. The doctor simply takes the drug with his left hand from the pharmaceutical company or the experiment designer, and immediately passes it to the patient with his right hand. He is completely ignorant of the drug’s contents and mechanism, and should of course be completely ignorant of them. Diagnosis has nothing to do with prescribing: the doctor will not adjust the content of the medication according to the diagnosed development of the condition—he simply does not know the content of the medicine, and of course will not pay attention to changes in the condition according to the content of the medication. If one can find appropriate physiological indicators to assess the development of the condition, then perhaps the doctor is also merely symbolic as far as diagnosis is concerned; the doctor is just a porter, and his task is to get the medicine into the patient’s hands and the patient in front of the examination equipment. Although total ignorance is only the result of special controls in double-blind experiments, modern medical practice probably also contains this tendency: the attenuation and instrumentalization of the doctor’s role, as well as the division and fragmentation of the process of diagnosis and treatment. Just as the patient’s body is divided into separate regions, the patient’s process of diagnosis and treatment also becomes a series of mutually independent events; entering medicine is like stepping onto an assembly line, undergoing a sequence of continuous yet mutually severed procedures, and the doctor is like an assembler on the line, merely performing a mechanical and instrumental function.

Of course, even modern Western medicine is not completely reduced to an assembly line, let alone traditional Chinese medicine and other medical models. In the diagnostic and treatment activities of Chinese medicine, the doctor’s role must be substantive, the center of the entire diagnostic and treatment practice; the prescription and the condition alike must be coordinated and grasped by the doctor. The doctor cannot prescribe while knowing nothing of the contents of the formula. And once the prescription is made, it is not decisive either; the doctor will use the contents of the formula to probe the condition and, according to the effect and the development of the illness, adjust the proportions or even the ingredients of the formula at any time (the fact that contemporary Chinese medicine has produced mass-produced patent medicines, or formulas that can be taken for months once prescribed, is already the result of assimilation by Western medicine).

3. The concept of disease:

As mentioned above, the drugs in double blinding are aimed at disease, not at the patient, and thus “mass-produced” patients can be made available for testing. But leaving aside for the moment the issue of reducing patients to disease, there are also obvious differences among different medical paradigms in their understanding of disease. The binary distinction that “Western medicine distinguishes diseases, Chinese medicine distinguishes patterns” is of course too categorical, but there are indeed differences in focus or tendency in the diagnostic and treatment process. Western medicine takes organic disease as the object of diagnosis and treatment, and therefore can define it relatively clearly, forming definite groups of subjects. But although Chinese medicine also concerns itself with identifying illness, the focus of its treatment is the “pattern type” (zhengxing). According to individual differences and the development of the illness, the same disease may have many different pattern types, and the strategy of treatment must be determined around the pattern type. For example, even with the same coronary heart disease (chest impediment), “it can at least be divided into five different pattern types: blood stasis, phlegm congealing, qi stagnation, cold congealing, and yang deficiency. Danshen and honghua have the effect of activating blood and dispelling stasis; suppose their efficacy rate for blood-stasis-type coronary heart disease is 100%, but their effect on other pattern types may not be good. Calculated this way, the overall efficacy rate for all coronary heart disease would only be 20% or 30% at most…. So the total efficacy rate of simple blood-activating and stasis-dispelling drugs cannot possibly be too high. If one insists on making it very high, then one can only fake it.”[6] So it would seem that, with respect to a specific disease, a particular Chinese medicinal formula should in theory not be able to pass a controlled experiment. Then can subjects be selected according to Chinese medicine’s standards? For example, by finding only patients with blood-stasis-type chest impediment to test and see how effective a blood-activating and stasis-dispelling formula really is. In theory, of course, this is feasible and should be actively explored; but compared with Western diseases, the Chinese medicine concept of pattern differentiation is clearly less adaptable to the requirements of double-blind experiments, because pattern types are not determined on the basis of organic pathology, but depend more on subjective experiential judgment. It is difficult to form mechanical operational standards or quantitative test data, and even in a single person, the pattern type will vary with changes in the living environment and the stage of the disease process. Defining a clear subject group is feasible in theory, but in practice it is obviously much more difficult. This means that in the face of double-blind experiments, Chinese medicine is at a disadvantage from the outset. Double-blind experiments can indeed help Chinese medicine examine itself, but this “physical examination standard” was after all tailor-made for Western medicine.

4. The evaluation of therapeutic efficacy:

Finally, there is the question of how the efficacy itself is understood. The reason double-blind experiments are so highly praised is first of all that they clearly exclude the so-called “placebo effect.” The placebo effect is regarded as a fake therapeutic effect, yet it is indeed some kind of therapeutic effect; so since it is after all effective for treatment, why exclude it?

The basic reason is probably that its efficacy is entirely psychological rather than physical. Indeed, we believe that the efficacy brought by the placebo effect does not originate in sugar pills or starch, but must it be wholly ignored simply because it does not have such a definite physical carrier? One author points out: the placebo effect “marks out the patient’s beliefs, and imaginative activity provides medicine with a decisive auxiliary supplement. It highlights the limitations of an overly ‘technical’ doctor-patient relationship. But medical discourse generally attributes the enhancement of this efficacy to the patient’s credulity, … relating it to nothing medical, and even denying it.”[7]

According to Daniel Moerman’s reanalysis of 31 double-blind experiments of a certain drug (mecamylamine), he found that the effect of the placebo showed cultural differences: in all the experiments, mecamylamine’s effect remained stable at around 76%, but the placebo’s efficacy varied enormously, averaging 48%, with fluctuations “ranging from 10% to 90%… the six experiments conducted in Germany showed a clearly significant placebo effect (63%).”[8] “Biomedicine’s attitude toward the placebo very much reflects biomedicine’s dismissive attitude. Moerman points out that if, as he found in his research on placebo efficacy, a drug’s effect could fluctuate within such a wide range as 10%–90%, biomedical researchers would all begin studying what causes such differences, especially how to ensure that 90% high cure rate. Yet Moerman notes that the placebo effect is studied from the opposite direction: people study it in order to control or minimize its effect; medical research focuses on the efficacy of other drugs outside the placebo effect. The placebo is merely an obstacle in the process.”[9]

Then why don’t people study the placebo effect in order to use it systematically instead of trying to eliminate it? Collins and Pinch believe that “one answer is direct and obvious: suppose you ask a patient, ‘Do you prefer real treatment or placebo treatment?’ The patient will of course say, ‘I want real treatment.’ … Although placebo therapy is a useful and important part of existing medical treatment methods, you cannot ask people to endorse ‘more use of placebo in medical treatment.’ Can you do that?”[10]

But the reason people find it hard to endorse “placebos” is itself related to the way modern medicine defines and understands them—the placebo effect is nothing but a result of credulity. To ask whether one is willing to accept a placebo is equivalent to asking whether one is willing to be fooled, and the usual answer is of course no. Yet in fact, the true role of the “placebo” is precisely to shoulder that part of explanation that lies beyond the limits of modern medical science. That is to say, besides the efficacy that can be scientifically grasped and defined by modern medicine—the efficacy borne by a material pill—any efficacy for which no materialist, ready-made way of explanation can be found is all, once and for all, swept under the name of “placebo effect.” Leaving aside any mysterious or occult effect, to speak only of social-cultural-psychological influences: could they not, like physical pathology, have all sorts of modes of action? Can they really all be lightly subsumed under the patient’s credulity and imagination? If, instead of asking the patient “Are you willing to be credulous?”, one asked, “Are you willing to try certain treatments that cannot yet be scientifically established?”, would the situation be different?

In this respect, the concerns of traditional Chinese medicine are relatively comprehensive. In addition to prescribing material remedies, it also pays attention to communication with and encouragement of the patient, and to achieving therapeutic effects through non-material adjustments such as social environment, daily routine, and rhythm of life. Of course, whether these non-material adjustments are indeed effective can also be verified by designing certain comparative trials, but double-blind experiments do in fact naturally exclude these things. This is because such activities require deep and sincere communication between doctor and patient, and because they are more strongly subjective and individualized, they obviously cannot meet the requirements of double blinding.

 

Having said all this, I am not trying to deny the significance of double blinding, still less to deny the objectivity of double-blind experiments. But what should be noted is that while double blinding provides modern science with a guarantee of objectivity and scientificness, it also brings corresponding occlusions, reinforcing a particular mindset and mode of practice. And those medical paradigms excluded by double blinding, because they cannot adapt to the concepts and methods of double-blind experiments, are not necessarily good things either. But in any case, we should try to step outside the bounds set by double blinding and broaden our horizons, so that we can evaluate the significance of traditional or alternative medicine in a more open and fair-minded way.

 

References

[U.S.] Robert Hahn: Disease and Treatment: How Anthropology Sees It, translated by Hemu, Eastern Publishing Center, 2010

Li Candong: Being in Chinese Medicine: Entering the World of Chinese Medicine, China Traditional Chinese Medicine Press, 2010

Ou Jiecheng: When Chinese Medicine Meets Western Medicine: History and Reflection, SDX Joint Publishing Company, 2005

[U.K.] Pary Collins, Trevor Pinch: Dr. Golem: Medicine as Science and Medicine as Salvation, translated by Lei Ruipeng, Shanghai Century Publishing Group, 2009

Zhang Daqing: Fifteen Lectures on the History of Medicine, Peking University Press, 2007.

Wang Yifang: Is Medicine a Science? — Dialogues on the Humanities of Medicine, Guangxi Normal University Press, 2008

[France] David Le Breton: A History of the Human Body and Modernity, translated by Wang Yuanyuan, Shanghai Literature and Art Publishing House, 2010

Kathryn Montgomery: How Doctors Think: Clinical Judgment and Medical Practice, chief translator Zheng Minghua, People’s Medical Publishing House, 2010

Compiled by Zheng Muming, Zhou Zenghuan, and Lin Xinhong: Medical Humanities Reader, People’s Publishing House, 2006

[U.S.] Lois N. Magner: A History of Medicine, chief translator Liu Xueli, Shanghai People’s Publishing House, 2009

[U.K.] Roy Porter: The Cambridge Illustrated History of Medicine, chief translator Zhang Daqing, Shandong Pictorial Publishing House, 2007


[1] Stephan Beunatman: “Double-Blind Studies: A Major Scientific Advance of the Twentieth Century,” translated by Zhang Gongyao, see http://zhgybk.blog.hexun.com/4494079_d.html, date cited: December 29, 2010

[2] Same as above

[3] Same as above, see Zhang Gongyao’s note 3

[4] For example, [U.S.] Lois N. Magner: A History of Medicine, chief translator Liu Xueli, Shanghai People’s Publishing House, 2009; [U.K.] Roy Porter: The Cambridge Illustrated History of Medicine, chief translator Zhang Daqing, Shandong Pictorial Publishing House, 2007; Zhang Daqing: Fifteen Lectures on the History of Medicine, Peking University Press, 2007; Xu Qin: Introduction to Western Medicine, Sun Yat-sen University Press, 2009; Zheng Muming, Zhou Zenghuan, and Lin Xinhong, eds.: Medical Humanities Reader, People’s Publishing House, 2006; and so on.

[5] Li Candong: Being in Chinese Medicine: Entering the World of Chinese Medicine, China Traditional Chinese Medicine Press, 2010, p. 53.

[6] Li Candong: Being in Chinese Medicine: Entering the World of Chinese Medicine, China Traditional Chinese Medicine Press, 2010, p. 56.

[7] [France] David Le Breton: A History of the Human Body and Modernity, translated by Wang Yuanyuan, Shanghai Literature and Art Publishing House, 2010, p. 129.

[8] See [U.S.] Robert Hahn: Disease and Treatment: How Anthropology Sees It, translated by Hemu, Eastern Publishing Center, 2010, p. 109.

[9] Same as above, p. 115.

[10] [U.K.] Pary Collins, Trevor Pinch: Dr. Golem: Medicine as Science and Medicine as Salvation, translated by Lei Ruipeng, Shanghai Century Publishing Group, 2009, p. 28.

Translated from the Chinese original with AI assistance. The original text is authoritative.

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