MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

integrative medicine

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I recently received this unexpected and surprising email:

Dear Friend,

I wanted to point out an article that published last month in the New England Journal of Medicine Catalyst that gets to the root of why we are not solving the nation’s current epidemics of chronic pain, obesity, opioids, suicide, and cardiovascular disease.

My co-authors included Dr. Eric Schoomaker, the former surgeon general of the Army; Dr. Tracy Gaudet, who leads cultural transformation at the Veterans Health Administration; and Dr. James Marzolf, the chief health and data analyst in Dr. Gaudet’s office.

In the article Finding the Cause of the Crises: Opioids, Pain, Suicide, Obesity, and Other “Epidemics”, we show how our nation’s response to our current epidemics are tackling the wrong problems.

For example, take the opioid epidemic. The response has been to restrict opioids and focus on other drugs. This narrow approach is compounding the problem. The root cause is that we don’t manage chronic pain appropriately. We need a major roll out of non-pharmacological approaches for pain.

Instead of treating pain with a pill, we need to pay attention to the whole person in mind, body, and spirit. When we do this, we may find that non-drug approaches to treating the person are more appropriate, and treat not only the pain, but the suffering that often accompanies it.

The article describes how systems like the Military and Veterans Health Administration are doing this with transformative approaches that embrace whole person, integrative health.

The good news is that the answers are out there. The entire nation can do this, and we can start now.

Be well.

Dr. Wayne Jonas

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In case you don’t know who my ‘friend’ Wayne is (I did mention him before here and here, for instance), here is a concise summary of his background. As you doubtlessly do know, the NEJM is a (perhaps even the most) respected medical journal. I therefore tried to find the article there and was amazed not to find it. Then I realised that Wayne said it was published not in the NEJM but in the ‘New England Journal of Medicine Catalyst’, a very different proposition.

The New England Journal of Medicine Catalyst brings health care executives, clinical leaders, and clinicians together to share innovative ideas and practical applications for enhancing the value of health care delivery. From a network of top thought leaders, experts, and advisors, our digital publication, quarterly events, and qualified Insights Council provide real-life examples and actionable solutions to help organizations address urgent challenges affecting health care.

But what about the paper that Wayne so warmly recommends? It turns out to be little more than a promotional stunt for integrative medicine. Here is an excerpt from it:

It is often a surprise to people that two of the largest health care systems in the country are trying to radically redesign what they do to provide more whole-person and integrative care. These two systems are run by the Department of Defense (DoD) and the Veterans Health Administration (VHA) and collectively care for over 20 million people. The nation can learn from their efforts.

The need for reform emerged after the turn of this century when leaders in the DoD and VHA began to hold informal meetings under the title “From Healthcare to Health.” Over the course of those meetings, the participants recognized the failure of their health care systems to get at the underlying causes of chronic disease. In 2009, they secured the support of the Chairman of the Joint Chiefs of Staff to change overall military doctrine and guidance to a radically holistic approach called “Total Force Fitness,” which subsequently led to health and community innovations. An example of these redesign innovations was the Defense and Veterans’ Pain Management Task Force and Report and the resulting strategy that preceded the National Academy of Medicine’s report on pain in America.

Other innovations included the Healthy Base Initiative and the Performance Triad, the latter of which focuses on the importance of asking all patients about their sleep, nutrition, and physical activity. All services — Army, Navy, Air Force, Coast Guard, and Special Forces — continue to shift to whole-person models that seek to implement behavioral and complementary approaches. For example, >6000 providers have been trained in and routinely use Battlefield Acupuncture for pain.

The transformation currently underway in the VHA, which goes under the name “Whole Health,” is also an offshoot of that leadership dialogue from 20 years ago. In the Whole Health approach, the emphasis is to empower and equip people to take charge of their health and well-being. In this approach, trained peers help veterans explore their sense of mission and purpose, and well-being programs focus on skill-building and support for self-care. These elements, in addition to person-centered, holistic clinical care, create the Whole Health delivery system. VHA facilities are shifting from a system designed around points of clinical care (in which the primary focus is on disease management) to one that is based in a partnership across time (in which the primary focus is on whole health). Clinical encounters are essential but not sufficient. This health system is designed to focus not only on treatment, but also on self-empowerment, self-healing, and self-care.

This radical redesign is built on decades of VHA work enhancing its integrative approaches with innovations such as Patient-Aligned Care Teams, Primary Care Mental Health Integration, peer-to-peer support, group access to mental health services, and the increasing use of complementary medicine approaches. These changes laid the groundwork for the kind of radical redesign now underway in the VHA and that is needed in all national health care delivery systems.

In 2011, the VHA established an Office of Patient Centered Care and Cultural Transformation to further redefine health care delivery and to oversee this unique approach. Whole Health has begun rapid deployment across the entire VHA system, starting with 18 VHA medical centers in 2018 and with a planned expansion to all VHA medical centers by the end of 2022. System-wide implementation will require an estimated $556 million over 5 years.

When fully implemented, operating costs for this shift are projected to represent 1% of the VHA annual budget. This implementation will involve hiring almost 6,400 new staff, the majority for positions that did not previously exist in the VHA, including health coaches and peer health partners, nutritionists, acupuncturists, and yoga instructors. Whole Health is building access through group visits, peer-to-peer support, and the development of Personal Health Plans for every veteran — something everyone in the country could use. In addition, new payment codes have been created, allowing providers to capture and cover their time and efforts using relative value units (RVUs) and to track productivity.

Will Whole Health help to cure what ails health care? Current models suggest that it will. With improvement in health outcomes, there will be a reduction in the need for existing clinical and biomedical services. These models predict increased access and more proactive population health management. With the addition of these new Whole Health services, we project a 24.5% increase in access when fully deployed — without the addition of a single hospital bed or medical specialist. In addition, Whole Health exceeds cost neutrality and is conservatively estimated to return $2.19 for every dollar invested over 6 years.

These returns reflect net cost avoidance and are derived from reductions in the need and demand for existing clinical health services — exactly what the nation needs in order to reduce chronic disease crises and contain costs. The per capita savings or cost avoidance is modest, averaging $535 per veteran annually over the 6-year period. Cumulatively, however, this totals over $6.2 billion in cost avoidance. Given that the Whole Health approach will improve the health of veterans, many of whom are dealing with complex issues such as chronic pain, mental health conditions, and opioid use at a cost of about $1 per day per veteran, it is a financially sound, cost-effective change from the current health care paradigm.

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So, does this change my mind about integrative medicine?

I’m afraid not! And Wayne fails to provide the slightest evidence that his concepts amount to more than wishful thinking (note how he first mentions predictions of cost savings and, in the next paragraph, pretends they are a reality). I simply do not believe that adding a few unproven therapies to our routine healthcare and wrapping the mixture into politically correct platitudes will improve anything. This cannot work from a theoretical standpoint and, crucially, there is no empirical evidence that it does improve anything else but the income stream of charlatans.

If healthcare needs reform, then let’s reform it! Adding cow pie to apple pie is not a solution, it merely spoils what we have already. I am saying this now since 17 years when I published my first comment on integrative medicine. It was entitled Integrative medicine: not a carte blanche for untested nonsense. I do still think that it sums up the issue succinctly.

The fact that homeopathy is under siege in France, has been discussed before. Now even the international media have picked up the story. Here are some excerpts from an interesting article in Bloomberg:

… The looming brawl gets to the heart of conflicting visions of the state’s involvement in the country’s health system at a time of eroding quality and services. Jobs are also at stake: France is home to Boiron SA, the leader in a global homeopathy market estimated at more than $30 billion.

Boiron’s pills and tinctures have long coexisted with conventional care in France, prescribed by regular doctors and dispensed in almost every pharmacy. Ending public support for the remedies would discredit homeopathy and “send a shock wave” through the industry worldwide, says Boiron’s chief executive officer, Valerie Poinsot. “We’ve been caught in this storm for the past year,” Poinsot says. “Why the hostility, when we contribute to caring for patients?”

Facing a possible backlash, Boiron, based in Lyon, teamed with rivals Weleda AG of Switzerland and closely held family group Lehning to fund a campaign called MyHomeoMyChoice. The push has garnered just over 1 million signatures in an online petition and placed bright-colored posters framed with the recognizable little white pills at pharmacies across the country. “Homeopathy has treated generations of French patients,” says one slogan. “Why deprive future generations?”

For now, French people can walk into any pharmacy and buy a tube of Arnica granules — recommended for shocks and bruises — or roughly a thousand other similar remedies for 1.6 euros ($1.80) with a prescription, because the state health system shoulders about 30% of its cost. In some cases, private insurers cover the remainder and patients pay nothing. That may all soon change. A science agency is wrapping up a study of the relative benefits of alternative medicine that will inform the government’s position: Keep the funding, trim it or scrap it altogether.

If the government cuts funding, Boiron would instantly feel the pain. Poinsot estimates that sales of reimbursed treatments could plummet by 50% in France, where the company brings in almost half its revenue. The company’s stock price has lost about 13% since May 15, when a French newspaper wrote that the panel reviewing homeopathy funding would probably rule against it…

In France, the controversy first erupted last year when the influential Le Figaro newspaper published a letter from a doctor’s collective called FakeMed lambasting alternative medicines. The authors called for ending support of “irrational and dangerous” therapies with “no scientific foundation.” The ensuing debate prompted Health Minister Agnes Buzyn to place funding under review and ask the country’s High Authority for Health to rule on homeopathy’s scientific merits…

David Beausire, a doctor in palliative care at the hospital in Mont de Marsan, in southwest France, is among those who signed the FakeMed letter. Beausire, who sees many terminally ill patients, said he regularly gets people who consult too late because they first explored alternative medicine paths that include homeopathy. “I am not an extremist,” he says. But homeopathy’s reimbursement by the state health system gives it legitimacy when “there’s no proof that it works.”…

Stung by accusations of quackery, Antoine Demonceaux, a doctor and homeopath in Reims, founded a group called SafeMed last November to relay the message that homeopathy has a role to play alongside standard care. He points to the growing number of cancer centers offering consultations to relieve treatment-related symptoms, such as nausea, with homeopathic medicine. Demonceaux says neither he nor his colleagues would ever use homeopathy as a substitute for treatments intended to, say, shrink tumors. “A general practitioner or a specialist who’d claim to be a homeopath and to cure cancer with homeopathy? Just sack him,” he says. “Let’s get real. We are doctors.”

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On the whole, this is a good report which – as far as I can see – describes the situation quite well and provides interesting details. What, however, with this articles and many like it is this: journalists (and others) are too often too lethargic or naïve to check the veracity of the claims that are being made during these disputes. For instance, it would not have been all that difficult to discover that:

  1. Hahnemann called clinicians who used homeopathy alongside conventional treatments ‘traitors‘! He categorically forbade it and denied that such an approach merits the name ‘HOMEOPATHY’. In other words, let’s get real and let’s not pull wool over the eyes of the public (and let’s be honest, it is not possible to practice homeopathy within the boundaries of medical ethics).
  2. Many homeopaths do advocate homeopathy as a sole treatment for cancer and other serious conditions (see for instance here, here and here).

The obvious risk of such lack of critical thinking is that homeopathy might be kept refundable on the basis of big, fat lies. And clearly, that would not be in the interest of anyone (with the exception of family Boiron, of course).

So-called alternative medicine (SCAM) is a seriously dangerous option for cancer patients who aim at curing their cancer with it. One cannot warn patients often and strongly enough, I believe. But when it comes to supportive cancer treatment (care that does not aim at changing the natural history of the disease), SCAM might have a place. I said ‘might’ because its exact role is far from clear.

The aim of this study was to investigate the effects of a complex, nurse-led, supportive care intervention using SCAM on patients’ quality of life (QoL) and associated patient-reported outcomes. In this prospective, pragmatic, bicentric, randomized controlled trial, women with breast or gynaecologic cancers undergoing a new regimen of chemotherapy (CHT) were randomly assigned to routine supportive care plus intervention (intervention group, IG) or routine care alone (control group, CG). The intervention consisted of SCAM applications and counseling for symptom management, as well as SCAM information material. The primary endpoint was global QoL measured with the EORTC-QLQ-C30 before and after SCAM.

In total, 126 patients were randomly assigned into the IG and 125 patients into the CG. The patients’ medical and socio-demographic characteristics were homogenous at baseline and at follow-up. No group effects on QoL were found upon completion of CHT, but there was a significant group difference in favour of the IG, 6 months later. IG patients did also experience significant better emotional functioning and less fatigue.

The authors concluded that the tested supportive intervention did not improve patients’ QoL outcomes directly after CHT (T3), but was associated with significant QoL improvements when considering the change from baseline to the time point T4, which could be assessed 6 months after patients’ completion of CHT. This delayed effect may have resulted due to a strengthening of patients’ self-management competencies.

A prospective, pragmatic, bicentric, randomized controlled trial! Doesn’t this sound rigorous? In fact, this term merely hides a trial that was destined to generate a positive result. As it followed the infamous A+B versus B design, it hardly had a chance to not come out positive.

The only thing I find amazing is that the short-term results failed to be statistically significant. Far too many SCAM researchers, it seems to me, view science as a tool for promoting their dubious ideas.

The use of SCAM with the aim of improving QoL might be helpful. But this assumption cannot be accepted on the basis of opinion; we need good science to find out which forms of SCAM are worth employing. Sadly, studies like the above are not in this category.

If you ask me, it is high time that this misleading nonsensical and unethical pseudo-research stops!

Many cancer patients use so-called alternative medicine (SCAM) such as Traditional Chinese Medicine (TCM). On this blog, we have repeatedly discussed whether this does more good than harm. This study sheds new light on the question. Specifically, it aims to explore the benefits of TCM therapy in the long-term survival of patients with hepatocellular carcinoma in China.

In total, 3483 patients with HCC admitted to the Beijing Ditan Hospital of Capital Medical University were enrolled. The researchers used 1:1 frequency matching by sex, age, diagnosis time, Barcelona Clinic Liver Cancer staging, and type of treatments to compare the TCM users (n = 526) and non-TCM users (n = 526). A Cox multivariate regression model was employed to evaluate the effects of TCM therapy on the HR value and Kaplan-Meier survival curve for mortality risk in HCC patients. A log-rank test was performed to analyse the effect of TCM therapy on the survival time of HCC patients.

The Cox multivariate analysis indicated that TCM therapy was an independent protective factor for 5-year survival in patients with HCC. The Kaplan-Meier curve also showed that after PS matching, TCM users had a higher overall survival rate and a higher progression-free survival rate than non-TCM users. TCM users, regardless of the classification of etiology, tumor stage, liver function level, or type of treatment, all benefited significantly from TCM therapy. The most commonly used Chinese patent medications used were Fufang Banmao Capsule, Huaier Granule, and Jinlong Capsule.

The authors concluded that using traditional Chinese medications as adjuvant therapy can probably prolong median survival time and improve the overall survival among patients with HCC. Further scientific studies and clinical trials are needed to examine the efficiency and safety.

I was unable to access the full article and therefore am unable to provide a detailed critique of it. From reading the abstract, I should point out, however, that this was not an RCT. To minimise bias, the researchers used a matching technique to generate two comparable groups. Such methods can be successful in matching for the named parameters, but they cannot match for the plethora of variables that might be relevant but were not measured. Therefore, the survival difference between the two groups might be due not to the therapies they received, but to the fact that the groups were not comparable in terms of factors that impact on survival.

Another important point about this paper is the obvious fact that it originates from China. We know from several independent investigations that such studies almost never report negative findings. We also know that TCM is a hugely important export item for China. Adding two and two together should therefore make us sceptical. I for one take the present findings with more than a pinch of salt.

A new paper reminds us that so-called alternative medicine (SCAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of SCAM may cause harm to patients through interactions with prescribed medications or by patients choosing to forego evidence-based care. SCAM may also put financial strain on patients as most SCAM expenditures are paid out-of-pocket.

Despite these drawbacks, patients continue to use SCAM due to a range of reasons, e.g. media promotion of SCAM therapies, dissatisfaction with conventional healthcare, a desire for more holistic care. Given the increasing demand for SCAM, many medical institutions now offer SCAM services. Several leaders of SCAM centres based at a highly respected academic medical institution have publicly expressed anti-vaccination views, and non-evidence-based philosophies run deep within SCAM.

Although there are financial incentives for institutions to provide SCAM, it is important to recognize that this legitimizes SCAM and may cause harm to patients. The poor regulation of SCAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy.

As I have tried to point out many times, the potential for harm caused by the increasing integration of SCAM can thus be summarised as follows:

  1. direct harm due to adverse effects such as toxicity of an herbal remedy, stroke after chiropractic manipulation, pneumothorax after acupuncture;
  2. direct harm through the use of bogus diagnostic techniques;
  3. direct harm by using materials from endangered species;
  4. indirect harm through incompetent advice such as recommendation not to immunize or discontinue prescribed medications;
  5. neglect due to using SCAM instead of an effective therapy for a serious condition;
  6. harm due to medicalising trivial states of reduced well-being;
  7. financial harm due to the costs of SCAM;
  8. harm through making a mockery of evidence-based medicine;
  9. harm caused by undermining rational thinking in the society at large;
  10. harm caused by inhibiting medical progress and research.

In case you see other ways in which SCAM can cause harm, please let me know by posting a comment.

One of the most difficult things in so-called alternative medicine (SCAM) can be having a productive discussion with patients about the subject, particularly if they are deeply pro-SCAM. The task can get more tricky, if a patient is suffering from a serious, potentially life-threatening condition. Arguably, the discussion would become even more difficult, if the SCAM in question is relatively harmless but supported only by scarce and flimsy evidence.

An example might be the case of a cancer patient who is fond of mindfulness cognitive therapy (MBCT), a class-based program designed to prevent relapse or recurrence of major depression. To contemplate such a situation, let’s consider the following hypothetical exchange between a patient (P) and her oncologist (O).

P: I often feel quite low, do you think I need some treatment for depression?

O: That depends on whether you are truly depressed or just a bit under the weather.

P: No, I am not clinically depressed; it’s just that I am worried and sometimes see everything in black.

O: I understand, that’s not an unusual thing in your situation.

P: Someone told me about MBCT, and I wonder what you think about it.

O: Yes, I happen to know about this approach, but I’m not sure it would help you.

P: Are you sure? A few years ago, I had some MBCT; it seemed to work and, at least, it cannot do any harm.

O: Yes, that’s true; MBCT is quite safe.

P: So, why are you against it?

O: I am not against it; I just doubt that it is the best treatment for you.

P: Why?

O: Because there is little evidence for it and even less for someone like you.

P: But I have seen some studies that seem to show it works.

O: I know, there have been trials but they are not very reliable.

P: But the therapy has not been shown to be ineffective, has it?

O: No, but the treatment is not really for your condition.

P: So, you admit that there is some positive evidence but you are still against it because of some technicalities with the science?

O: No, I am telling you that this treatment is not supported by good evidence.

P: And therefore you want me to continue to suffer from low mood? I don’t call that very compassionate!

O: I fully understand your situation, but we ought to find the best treatment for you, not just one that you happen to be fond of.

P: I don’t understand why you are against giving MBCT a try; it’s safe, as you say, and there is some evidence for it. And I have already had a good experience with it. Is that not enough?

O: My role as your doctor is to provide you with advice about which treatments are best in your particular situation. There are options that are much better than MBCT.

P: But if I want to try it?

O: If you want to try MBCT, I cannot prevent you from doing so. I am only trying to tell you about the evidence.

P: Fine, in this case, I will give it a go.

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Clearly this discussion did not go all that well. It was meant to highlight the tension between the aspirations of a patient and the hope of a responsible clinician to inform his patient about the best available evidence. Often the evidence is not in favour of SCAM. Thus there is a gap that can be difficult to breach. (Instead of using MBCT, I could, of course, have used dozens of other SCAMs like homeopathy, chiropractic, Reiki, etc.)

The pro-SCAM patient thinks that, as she previously has had a good experience with SCAM, it must be fine; at the very minimum, it should be tried again, and she wants her doctor to agree. The responsible clinician thinks that he ought to recommend a therapy that is evidence-based. The patient feels that scientific evidence tells her nothing about her experience. The clinician insists that evidence matters. The patient finds the clinician lacks compassion. The clinician feels that the most compassionate and ethical strategy is to recommend the most effective therapy.

As the discussion goes on, the gap is not closing but seems to be widening.

What can be done about it?

I wish I knew the answer!

Do you?

As you know, I have repeatedly written about integrative cancer therapy (ICT). Yet, to be honest, I was never entirely sure what it really is; it just did not make sense – not until I saw this announcement. It left little doubt about the nature of ICT.

As it is in German, allow me to translate it for you [the numbers added to the text refer to my comments below]:

ICT is a method of treatment that views humans holistically [1]. The approach is characterised by a synergistic application (integration) of all conventional [the actual term used is a derogatory term coined by Hahnemann to denounce the prevailing medicine of his time], immunological, biological and psychological insights [2]. In this spirit, also personal needs and subjective experiences of disease are accounted for [3]. The aim of this special approach is to offer cancer patients an individualised, interdisciplinary treatment [4].

Besides surgery, chemotherapy and radiotherapy, ICT also includes hormone therapy, hyperthermia, pain management, immunotherapy, normalisation of metabolism, stabilisation of the psyche, physical activity, dietary changes, as well as substitution of vital nutrients [5].

With ICT, the newest discoveries of cancer research are being offered [6], that support the aims of ICT. Therefore, the aims of the ICT doctor include continuous research of the world literature on oncology [7]…

Likewise, one has to start immediately with measures that help prevent metastases and tumour progression [8]. Both the maximization of survival and the optimisation of quality of life ought to be guaranteed [9]. Therefore, the alleviation of the side-effects of the aggressive therapies are one of the most important aims of ICT [10]…

HERE IS THE GERMAN ORIGINAL

Die integrative Krebstherapie ist eine Behandlungsmethode, die den Menschen in seiner Ganzheit sieht und sich dafür einsetzt. Ihre Behandlungsweise ist gekennzeichnet durch die synergetische Anwendung (Integration) aller sinnvollen schulmedizinischen, immunologischen, biologischen und psychologischen Erkenntnisse. In diesem Sinne werden auch die persönlichen Bedürfnisse und die subjektiven Krankheitserlebnisse berücksichtigt. Ziel dieser besonderen Therapie ist es, dass dem Krebspatienten eine individuell eingerichtete und interdisziplinär geplante Behandlung angeboten wird.

Zur integrativen Krebstherapie gehört neben der operativen Tumorbeseitigung, Chemotherapie und Strahlentherapie auch die Hormontherapie, Hyperthermie, Schmerzbeseitigung, Immuntherapie, Normalisierung des Stoffwechsels, Stabilisierung der Psyche, körperliche Aktivierung, Umstellung der Ernährung sowie die Ergänzung fehlender lebensnotwendiger Vitalstoffe.

Mit dieser Behandlungsmethode werden auch die neuesten Entdeckungen der Krebsforschung angeboten, die die Ziele der Integrativen Krebstherapie unterstützen. Deshalb sind die ständigen Recherchen der umfangreichen Ergebnisse der Onkologie-Forschung in der medizinischen Weltliteratur auch Aufgabe der Mediziner in der Integrativen Krebstherapie…

Ebenso sollte auch sofort mit den Maßnahmen begonnen werden, die helfen, dieMetastasen Bildung und Tumorprogredienz zu verhindern. Nicht nur die Maximierung des Überlebens, sondern auch die Optimierung der Lebensqualität sollen gewährleistet werden. Deshalb ist auch die Linderung der Nebenwirkungen der aggressiven Behandlungsmethoden eines der wichtigsten Ziele der Integrativen Krebstherapie….

MY COMMENTS

  1. Actually, this describes conventional oncology!
  2. Actually, this describes conventional oncology!
  3. Actually, this describes conventional oncology!
  4. Actually, this describes conventional oncology!
  5. Actually, this describes conventional oncology!
  6. Actually, this describes conventional oncology!
  7. Actually, this describes conventional oncology!
  8. Actually, this describes conventional oncology!
  9. Actually, this describes conventional oncology!
  10. Actually, this describes conventional oncology!

ICT might sound fine to many consumers. I can imagine that it gives confidence to some patients. But it really is nothing other than the adoption of the principles of good conventional cancer care?

No!

But in this case, ICT is just a confidence trick!

It is a confidence trick that allows the trickster to smuggle no end of SCAM into routine cancer care!

Or did I miss something here?

Am I perhaps mistaken?

Please, do tell me!

The objective of this ‘real world’ study was to evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.

A total of 1,087 hospitalized patients with CAD from 4 hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups:

  1. Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group). IM therapy meant that the patients accepted the conventional treatment of Western medicine and the treatment of Chinese herbal medicine including herbal-based injection and Chinese patent medicine as well as decoction for at least 7 days in the hospital or 3 months out of the hospital.
  2. Conventional treatment alone (CT group).

The endpoint was a major cardiac event [MCE; including cardiac death, myocardial infarction (MI), and the need for revascularization].

A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% received IM therapy. During the 2-year follow-up, the total incidence of MCE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).

The authors concluded that in a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.

What the authors call ‘real world setting’ seems to be a synonym of ‘lousy science’, I fear. I am not aware of good evidence to show that herbal injections and concoctions are effective treatments for CAD, and this study can unfortunately not change this. In the methods section of the paper, we read that the treatment decisions were made by the responsible physicians without restriction. That means the two groups were far from comparable. In their discussion section, the authors state; we found that IM therapy was efficacious in clinical practice. I think that this statement is incorrect. All they have shown is that two groups of patients with similar diagnoses can differ in numerous ways, including clinical outcomes.

The lessons here are simple:

  1. In clinical trials, lack of randomisation (the only method to create reliably comparable groups) often leads to false results.
  2. Flawed research is currently being used by many proponents of  SCAM (so-called alternative medicine) to mislead us about the value of SCAM.
  3. The integration of dubious treatments into routine care does not lead to better outcomes.
  4. Integrative medicine, as currently advocated by SCAM-proponents, is a nonsense.

You probably know what yoga is. But what is FODMAP? It stands for fermentable oligosaccharides, disaccharides, monosaccharides and polyols, more commonly known as carbohydrates. In essence, FODMAPs are carbohydrates found in a wide range of foods including onions, garlic, mushrooms, apples, lentils, rye and milk. These sugars are poorly absorbed, pass through the small intestine and enter the colon . There they are fermented by bacteria a process that produces gas which stretches the sensitive bowel causing bloating, wind and sometimes even pain. This can also cause water to move into and out of the colon, causing diarrhoea, constipation or a combination of both. Irritable bowel syndrome (IBS) makes people more susceptible to such problems.

During a low FODMAP diet these carbohydrates are eliminated usually for six to eight weeks.  Subsequently, small amounts of FODMAP foods are gradually re-introduced to find a level of symptom-free tolerance. The question is, does the low FODMAP diet work?

This study examined the effect of a yoga-based intervention vs a low FODMAP diet on patients with irritable bowel syndrome. Fifty-nine patients with IBS undertook a randomised controlled trial involving yoga or a low FODMAP diet for 12 weeks. Patients in the yoga group received two sessions weekly, while patients in the low FODMAP group received a total of three sessions of nutritional counselling. The primary outcome was a change in gastrointestinal symptoms (IBS-SSS). Secondary outcomes explored changes in quality of life (IBS-QOL), health (SF-36), perceived stress (CPSS, PSQ), body awareness (BAQ), body responsiveness (BRS) and safety of the interventions. Outcomes were examined in weeks 12 and 24 by assessors “blinded” to patients’ group allocation.

No statistically significant difference was found between the intervention groups, with regard to IBS-SSS score, at either 12 or 24 weeks. Within-group comparisons showed statistically significant effects for yoga and low FODMAP diet at both 12 and 24 weeks. Comparable within-group effects occurred for the other outcomes. One patient in each intervention group experienced serious adverse events and another, also in each group, experienced nonserious adverse events.

The authors concluded that patients with irritable bowel syndrome might benefit from yoga and a low-FODMAP diet, as both groups showed a reduction in gastrointestinal symptoms. More research on the underlying mechanisms of both interventions is warranted, as well as exploration of potential benefits from their combined use.

Technically, this study is an equivalence study comparing two interventions. Such trials only make sense, if one of the two treatments have been proven to be effective. This is, however, not the case. Moreover, equivalence studies require much larger sample sizes than the 59 patients included here.

What follows is that this trial is pure pseudoscience and the positive conclusion of this study is not warranted. The authors have, in my view, demonstrated a remarkable level of ignorance regarding clinical research. None of this is all that unusual in the realm of alternative medicine; sadly, it seems more the rule than the exception.

What might make this lack of research know-how more noteworthy is something else: starting in January 2019, one of the lead authors of this piece of pseudo-research (Prof. Dr. med. Jost Langhorst) will be the director of the new Stiftungslehrstuhl “Integrative Medizin” am Klinikum Bamberg (clinic and chair of integrative medicine in Bamberg, Germany).

This does not bode well, does it?

Shiatsu has been mentioned here before (see for instance here, here and here). It is one of those alternative therapies for which a plethora of therapeutic claims are being made in the almost total absence of reliable evidence. This is why I am delighted each time a new study emerges.

This proof of concept study explored the feasibility of ‘hand self-shiatsu’ as an intervention to promote sleep onset and continuity for young adults with SRC. It employed a prospective case-series design, where participants, athletes who have suffered from concussion, act as their own controls. Baseline and follow-up data included standardized self-reported assessment tools and sleep actigraphy. Seven athletes, aged between 18 and 25 years, participated. Although statistically significant improvement in actigraphy sleep scores between baseline and follow-up was not achieved, metrics for sleep quality and daytime fatigue showed significant improvement.

The authors concluded from these data that these findings support the hypothesis that ‘hand self-shiatsu has the potential to improve sleep and reduce daytime fatigue in young postconcussion athletes. This pilot study provides guidance to refine research protocols and lays a foundation for further, large-sample, controlled studies.

How very disappointing! If this was truly meant to be a pilot study, it should not mention findings of clinical improvement at all. I suspect that the authors labelled it ‘a pilot study’ only when they realised that it was wholly inadequate. I also suspect that the study did not yield the result they had hoped for (a significant improvement in actigraphy sleep scores), and thus they included the metrics for sleep quality and daytime fatigue in the abstract.

In any case, even a pilot study of just 7 patients is hardly worth writing home about. And the remark that participants acted as their own controls is a new level of obfuscation: there were no controls, and the results are based on before/after comparisons. Thus none of the outcomes can be attributed to shiatsu; more likely, they are due to the natural history of the condition, placebo effects, concomitant treatments, social desirability etc.

What sort of journal publishes such drivel that can only have the effect of giving a bad name to clinical research? The Journal of Integrative Medicine (JIM) is a peer-reviewed journal sponsored by Shanghai Association of Integrative Medicine and Shanghai Changhai Hospital, China. It is a continuation of the Journal of Chinese Integrative Medicine (JCIM), which was established in 2003 and published in Chinese language. Since 2013, JIM has been published in English language. They state that the editorial board is committed to publishing high-quality papers on integrative medicine... I consider this as a bad joke! More likely, this journal is little more than an organ for popularising TCM propaganda in the West.

And which publisher hosts such a journal?

Elsevier

What a disgrace!

 

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