Abstract
In the last editorial, we refreshed our knowledge of clinical research and, in particular, of the precise linear sequence of its phases, at least in pharmacological research: 1 from the search for pathophysiological mechanisms to be addressed by potential new drugs, through phase I, II, and III studies, to postmarketing studies in the real-life therapeutic setting. This is, from bench to bedside.
And we looked at whether this approach is a law of nature or actually man-made and whether it is always and fundamentally the case when health decisions are made. And we have seen that this is not necessarily the case with nonpharmacological interventions (e.g., intercessory prayer, parachute use when jumping from aircraft). That the lack of evidence, but also negative studies, do not always refute practical experience and do not necessarily lead to changes in practice! Especially when there are centuries, if not millennia, of clinical experience with the intervention.
And this leads us directly to integrative and complementary medicine, which actually does not begin in the laboratory, but in centuries or millennia of application and experience. In contrast to drug therapy, its often nonpharmacological interventions (e.g., acupuncture, mindfulness-based therapies, yoga) generally do not require approval. The fact that this also applies to nursing, psychotherapy, surgery, and even parts of general medicine is often forgotten, and this lack of approval is presented as a special feature, even an anomaly, of integrative and complementary medicine.
And in Germany, for example, only registration, not approval, is required even for traditional drugs, in particular homeopathic remedies, traditional herbal medicines, and anthroposophic medicines. This means that their effectiveness only has to be proven on the basis of traditional experience of use, but not on the basis of clinical studies. 2 Similar regulations also exist in other countries.
Integrative and complementary medicine has some special features that distinguish it from biomedicine:
3,4
it is often not (purely) pharmacological; it is applied independently of research findings or lack thereof; it is based on other models of the development of diseases and their treatment; it treats each patient individually and uniquely, even when the pathology is the same; it almost always includes multimodal interventions or uses “Whole Medical Systems,”
to name but a few. Let us look at these points in detail.
We have already addressed points one and two. Point 3 is particularly interesting as it addresses a fundamental misconception: many people implicitly and quite naturally assume that integrative and complementary medicine differs from conventional medicine in that the former is not evidence-based and the latter is. Australian actor, musician, poet, and comedian Tim Minchin—without noticing it—gets to the heart of this barely questioned cognitive bias: in his humorous poem “Storm,” the protagonist smugly and arrogantly dismantles an anti-scientific homeopathy user with the sentences, “By definition, […] Alternative Medicine […] has either not been proven to work or been proven not to work. Do you know what they call alternative medicine that’s been proven to work? Medicine.” 5
And this idea that alternative, but also complementary and even integrative medicine, is fundamentally never evidence-based, while conventional medicine always is, stubbornly survives, even though both premises have been clearly refuted. 6 But what then is integrative and complementary medicine? Probably the most frequently quoted definition, that of the National Center for Complementary and Integrative Health (NCCIH), defines it, like most others, only by distinguishing it from mainstream medicine. 7 But that is no help to us. Not only because conventional medicine, mainstream medicine, biomedicine, or whatever we want to call it, is not clearly defined either. But above all because it is unclear why complementary and integrative medicine actually is not part of it. The naïve assumption that it is due to evidence is ruled out because the world is not so simple after all. 6
The Austrian Ministry of Social Affairs, Health, Care and Consumer Protection makes an intriguing suggestion in this context: “The term complementary medicine covers a broad spectrum of disciplines and treatment methods that are based on different models of disease development and treatment than those of conventional medicine.” 4 And indeed, the vast majority of assumptions about the mechanisms of action of these methods originate from non-Western cultures (e.g., Traditional Chinese Medicine or Ayurveda) or prescientific models of thought (e.g., homeopathy or humoral pathology). And it is hardly surprising that institutions based on Western scientific reasoning, such as universities and university hospitals, are put off by this. And at least I am not even very surprised that so many experienced scientists confuse unscientific hypotheses about mechanisms of action with a lack of scientific evidence.
There naturally are hypotheses and also evidence of mechanisms of action, e.g., of acupuncture, which are based on Western scientific thinking. 8 However, ideas based on traditional Chinese philosophy will continue to dominate among both users and critics.
And in other approaches too, mechanisms are not the starting point for every therapeutic innovation, as they are in conventional medicine, but are primarily of academic interest. Yoga, for example: in 2012, the research group of Helene M. Langevin, now the director of the NCCIH, launched a study in which carrageenan-induced inflammation was caused in rats’ lumbar connective tissues. The rats then showed altered gait and increased mechanical sensitivity of the tissues of the low back, i.e., they behaved like rats with low back pain.
The rats were then randomized to a yoga and a sham intervention. Really, they were! The animals in the intervention group were lifted gently by the tail and mechanically encouraged to grab onto the edge of the table with their front paws. So, they were made to actively stretch, similar to a yoga pose. This was repeated twice daily for a total of 12 days. For the sham procedure, animals were handled and held by the tail in the same manner as the stretch animals but were not lifted by the tail. Compared to the control group, behavioral, mechanical, and also local inflammatory symptoms were significantly reduced in the intervention group. 9
And not only is this probably the only animal model study on yoga, it was presumably only set up because millions of people practice yoga to relieve their back pain. 10 And because, building on this, numerous large and high-quality studies have scientifically shown that yoga can effectively and safely reduce chronic back pain. 11
And this led to the question of how. The (partial) answer provided by the study is highly interesting from an academic point of view and will also have further increased the acceptance of yoga and related therapies in universities and university hospitals. However, if this study had not existed, and even if it had not confirmed the hypotheses, the use of yoga to reduce back pain would probably not have changed. Precisely because findings on biological mechanisms of action are exciting, but neither necessary nor sufficient for the use of integrative and complementary medical procedures. Quite the opposite of conventional medicine. 3
We will discuss points 4 and 5 as well as the summarizing implications in the third and final part of this editorial.
Stay healthy and stay curious.
Footnotes
Author Disclosure Statement
No competing financial interests exist.
Funding Information
No funding was received for this article.