Of all the many forms of so-called alternative medicine (SCAM), essential oils (EOs) are perhaps the most popular and least harmful – at least this is what we are supposed to believe. The truth is, as so often in SCAM, a little different.

Some EOs are claimed to have anticonvulsant activity and might benefit people with epilepsy. Lemongrass, lavender, clove, dill, and other EOs containing constituents such as asarone, carvone, citral, eugenol, or linalool are good candidates for evaluation as antiepileptic drugs. Conversely, other EOs are suspected to have pro-convulsant properties. These EOs are present in many balms and oils available freely over the counter. The effect of exposure to these EOs and occurrence of seizure has not been studied systematically. The aim of this study was therefore to evaluate the relationship between essential oils and the first episode of seizure and breakthrough seizures in known epileptic patients.

This multi-center prospective study was conducted in four hospitals in India over four years. Every person presenting with the first episode of seizure or breakthrough seizure was asked about exposure to EOs, mode of exposure, time to onset of a seizure in relation to exposure, duration of seizure, type of seizure, and antiepileptic drug therapy.

During the four-year period, there were 55 patients with essential oil-related seizures (EORS). 22 (40 %) had essential oil-induced seizures (EOIS) and 33 (60 %) had essential oil-provoked seizures (EOPS). The female: male ratio was 1:1.1, the age of the patients ranged from 8 months to 77 years. In the EOIS group, 95 % had generalized tonic-clonic seizures and 5% had focal impaired awareness seizures. In the EOPS group, 42.4 % had focal impaired awareness seizures, 27.3 % generalized tonic-clonic seizures, 15 % focal to bilateral tonic-clonic seizures, and 15 % focal aware motor seizures. EOs implicated were preparations containing eucalyptus and camphor.

The authors concluded that exposure to essential oils of eucalyptus and camphor is an under-recognized cause of the first and breakthrough seizure. Identifying the true causative factor will prevent unnecessary antiepileptic drug therapy and future recurrence.

These results are, of course, far from conclusive. However, they seem important enough to bear in mind and to stimulate further research. Meanwhile, patients with epilepsy might be well advised to be cautious with essential oils, particularly those from eucalyptus and camphor.

French researchers aimed to assess the efficacy of osteopathic manipulation for fibromyalgia (FM) in a randomized clinical trial. Patients were randomized to osteopathic or sham treatment. Treatment was administered by experienced physical medicine physicians, and consisted of six sessions per patient, over 6weeks. Treatment credibility and expectancy were repeatedly evaluated.

For the osteopathic treatment, the patient was first placed in a prone position. Each vertebra from C7 to L5 was mobilized in a dorsoventral direction by progressive pressure on the spinous process (SP), and in rotation by applying pressure on the lateral surface of the SP (bilaterally). The sacral bone was repeatedly mobilized in nutation–counternutation (5–10 times). The piriformis muscles were progressively stretched. The hip joint was then progressively mobilized in extension combined with abduction and adduction to stretch the adductor, abductor, and flexor muscles (10 times). The shoulders were progressively mobilized, one by one, with a repeated circumduction movement of the glenohumeral joint (10 times). The patient was then placed in a supine position, for the following maneuvers. At the neck, bimanual traction was performed, followed by repeated mobilization in lateral flexion and in rotation (both sides, five times, 3–5 times each). At the shoulders, we first performed cranial traction of both arms and then repeated caudal traction of one arm and then the other, by blocking the clavicle, thereby opening the acromioclavicular and glenohumeral joints (three times). At the hips, repeated tractions were performed on the legs (three times) and the hip joint was mobilized by circumduction movements. Finally, the patient was placed in the lateral decubitus position for mobilization of the lumbar and thoracolumbar spine. Thrust manipulations were allowed at any level, according to the patient’s complaint.

The sham treatment followed the same order, but the maneuvers were stopped halfway through to prevent joint mobilization at the spine. At the hips and shoulders, the stretching techniques were also stopped halfway. The joint techniques were simulated, with no significant mobilization. Thrust manipulation was forbidden.

Patients completed standardized questionnaires at baseline, during treatment, and at 6, 12, 24, and 52 weeks after randomization. The primary outcome was pain intensity (100-mm visual analog scale) during the treatment period. Secondary outcomes included fatigue, functioning, and health-related quality of life. Primarily intention-to-treat analyses were adjusted for credibility, using multiple imputations for missing data.

In total, 101 patients (94% women) were included. Osteopathic treatment did not significantly decrease pain relative to sham treatment (mean difference during treatment: −2.2mm; 95% confidence interval, −9.1 to 4.6mm). No significant differences were observed for secondary outcomes. No serious adverse events were observed, despite a likely rebound in pain and altered functioning at week 12 in patients treated by osteopathy. Patient expectancy
was predictive of pain during treatment, with a decrease of 12.9mm (4.4–21.5mm) per 10 points on the 0–30 scale. Treatment credibility and expectancy were also predictive of several secondary outcomes.

The authors concluded that osteopathy conferred no benefit over sham treatment for pain, fatigue, functioning, and quality of life in patients with FM. These findings do not support the use of osteopathy to treat these patients. More attention should be paid to the expectancy of patients in FM management.

The French team should be congratulated on this excellent piece of research. This is a very well conducted and reported study. It should serve as a blueprint to researchers of manual therapies for future trials. The results are clear and not unexpected: osteopathy is little more than a theatrical placebo.

By guest blogger Les Rose

This is a follow-up to Edzard’s post back in October last year, about a paper by Christina Ross, entitled “Energy Medicine: Current Status and Future Perspectives”. You will see from the post, and from the paper itself, that it is a curious mish-mash of scraps of real science and a large volume of speculative and invented garbage. Its opening gambit majors on physics, which caught the attention of Richard Rasker, who has a background in medical instrumentation, and whose comments were insightful and excoriating.

Edzard and I wrote to the editors of the journal, pointing out the paper’s misleading content and requesting a retraction. In particular, we asked if the paper had been reviewed by a physicist. Here is what they responded:

“This paper underwent appropriate scientific peer review. We don’t intend to retract the paper, but we encourage you to submit an official Letter to the Editor through the Journal’s website. This approach would give the author of this paper the opportunity to respond to your critiques.”

This was received on 28th October 2020. Note that they did not answer our question about a review by a physicist. The journal limits letters to 500 words, and the paper warranted rather more analysis than that, so in partnership with Richard, we posted a detailed critique on my own blog. The plan was to refer to the blog post in the letter, which we submitted on 12th November. We suggested that the paper’s poor scientific underpinnings (to put it mildly) should be sufficient reason for retraction. At the very least, we requested that our critique and the paper itself be subjected to proper scientific review, and that our letter be published alongside the paper. Well here we are five months later and still, our letter has not been published.

The journal Global Advances in Health and Medicine specialises in so-called `integrative medicine’, which is a euphemism for shoehorning quackery into mainstream practice without the inconvenience of doing rigorous research. It publishes papers on such groundbreaking disciplines as shamanic journeying and intention host devices. The joint editors are in post at Wake Forest School of Medicine, where Christina L Ross, the author of the paper at issue, is on the staff.

But let’s return to the main story. Our letter was submitted in the usual way via the Manuscript Central website, and its status remains at `awaiting reviewer selection’. We have never heard of a letter to the editor requiring peer review. One month after submitting it, ie 12th December, SAGE Publishing finally acknowledged receiving our letter, and told us it was under review from their legal team and their editors. It seemed odd that it needed legal review. I replied thus on 20th December:

“Thanks for the update. We wrote directly to the editors asking them to retract the paper, but they refused, and advised us to write a letter for publication. This was so that the author could reply publicly. We still want that to happen. I am not sure why this is a legal matter, it is about science. In the interests of transparency, please tell us when our letter will be published.”

By 9th January 2021, there was no reply to this, so I chased up SAGE Publishing, who replied on 12th:

“The status in the system is misleading, as your Letter is not in need of any peer review. As you are aware, SAGE provides Editors and/or authors with the opportunity to respond to any Letters we receive. If they choose to do so, it is our policy that the Letter and any responses are published together all at once. However, before any adequate response can be put together, an investigation of the issues raised must first be completed. Although you are correct that this is not a Legal matter,

the nature of the complaints we have received prompted us to seek their guidance, and we will be publishing a Statement of Concern on this article while finishing this investigation. Your Letter has been waiting out this process, which unfortunately has taken slightly longer than usual due to all of the recent holidays and office closures. I do appreciate that you are anxious to see this matter resolved, and am sorry for any further frustration this has caused. The original author has been given a deadline to provide her comments, and upon receiving her response, your Letter will be published immediately. I expect this will happen within the next 2-3 weeks, but can certainly keep you updated going forward.”

The emphasis is mine. I asked what happens if the author doesn’t wish to respond, and was told that “we would then move forward with publishing your Letter on its own”. The deadline for the author to respond was stated to be “the end of next week”, ie 22nd January. So I was fully expecting the letter to be published a few days after that, and certainly by the end of January. But on 27th I was told that the author did not want to respond, and that they “do not yet have a firm publication date to share, but I have a meeting to discuss this with the Editors this week”. So the assurance highlighted above, about immediate publication, was valueless.

A few days later, on 31st January, an expression of concern was published, stating that several(!) complaints about the science of the paper had been received. By 17th February I was getting somewhat exasperated, and wrote again to the publishing editor:

“I am trying to be patient, but I really don’t see why a letter to the editors can take months to be published, in this day and age. Other journals such as the BMJ publish rapid responses in hours. I realise that our letter is critical of your journal’s peer review process, but delaying publication for so long does not look good. Surely you can publish the letter and respond in some way as publisher of the article in question? Some sort of response seems appropriate, in view of the original author’s silence. As we have raised this issue, readers may well appreciate some insight into your peer review process.

“I note that the journal’s editors are colleagues of the author. How do you manage this conflict of interest?”

The publishing editor did not reply directly to this, and passed it to the joint editor in chief Professor Remy Coeytaux. After a further two weeks I still had not heard anything from either party, so again I chased them up. The reply from Professor Coeytaux on 3rd March is worth reading in full:

“I ask for your forgiveness and understanding for the time this process is taking. By way of introduction and explanation, I am the co-Editor-in-Chief who has collaborated with Dr. Christina Ross in the past. Our other co-Editor-in-Chief, Dr. Suzanne Danhauer, has no relationship with the author of the paper in question. As is typical for medical journals, Global Advances in Health and Medicine does not have a policy that precludes members of the same academic institution as the Editors-in-Chief from submitting manuscripts for review and possible publication.

“Manuscripts submitted to the Journal are assigned to either Dr. Danhauer or myself. We then assign the manuscripts to Associate Editors as indicated. Dr. Ross’ manuscript was assigned to Dr. Danhauer. I had no role whatsoever in the peer review process or decision making for this manuscript. Throughout that process, there was no conflict of interest to manage. To re-iterate, Dr. Danhauer had no conflict with Dr. Ross and I had no involvement in any way or at any time in or with the peer review process.

“All of us at the Journal are taking your concerns seriously. Dr. Danhauer and I have complementary scientific expertise. She is a psychologist by training, while I am a physician and epidemiologist by training. We decided that I should be the one to manage the process of arriving at the most appropriate resolution to the concerns that you have brought to our attention. Your Letter to the Editor was assigned to me, and I am personally managing the process of seeking independent input from an additional set of peer reviewers for Dr. Ross’ original paper. By “personally,” I mean that I have not relegated this important task to one of our Associate Editors.

“We have very nearly completed the process on our end. We are awaiting the comments of one final peer reviewer. We expect to have that process completed within the next three weeks.

“I should also note that we believe it is appropriate for us to wait to publish your Letter to the Editor until we have completed our internal review process that we initiated in response to your concerns. It is for this reason that we have not yet published your Letter. I would like to take this opportunity to ask you, please, to send me another copy of your Letter to the Editor after deleting the reference to the internet link. It is the Journal’s policy to not publish such links. I would like to ask you, please, to send the revised letter to me directly in a PDF format via email attachment.

“Thank you for engaging in this scientific discourse and for your patience during the process.”

Some of this is very odd. He admits to being Ross’ collaborator but says this is not a conflict of interest. The journal’s instructions for authors do not say anything about `internet links’. It is perfectly normal for academic papers to use URLs as references. This looks suspiciously like an exercise in damage limitation. Hence I deleted the embedded hyperlink in the text and added the URL as a reference at the end. I replied the next day, and asked whether the current peer reviewers include those from outside the field of complementary and/or alternative medicine. I have not heard anything further from Professor Coeytaux or the publisher.

Is it really so time-consuming to find an authoritative reviewer? I put the word out, and got a response from Professor Jim Al-Khalili OBE FRS FinstP. He is a very well-known TV presenter on science topics, and as well as an eminent physicist and a professor for the public engagement in science. He could not be more appropriate to review this paper, and here is what he said:

“This notion that the body has ‘different kinds of energy’ is utter nonsense and a clear sign that someone does not have a firm background in science. If we do want to explore what different kinds of energy living organisms have then we can say there is kinetic energy due to macroscopic motion controlled by, say, muscles, then there is thermal energy due to vibrations of the molecules within our cells, chemical energy due to the thousands of biochemical reactions taking place inside cells, and finally electromagnetic energy from for example, the tiny induced magnetic fields due to moving charged particles in ion channels. None of these forms of energy is mysterious and the wording in this paper referring to detecting ‘subtle energies’ or resonances is utterly unscientific. While scanners, such as MRI, x-ray, PET or CT machines can image the body by measuring interactions with, for example, magnetic fields or responses to bombarding electromagnetic radiation, there is no mystery here. We know how they work. After all, it was physicists who invented these machines based on our understanding of the laws of physics. To buy into any of the notions in this paper would mean that the whole edifice of modern physics has to be demolished and rebuilt. And if anyone thinks that may be necessary then I would argue they really have not studied science at all and do not understand the scientific method.

“Basically, the science that this paper challenges is the very science that has allowed us to understand the workings of the body in the first place. You cannot call upon science (quantum field theory) to justify unscientific ideas that would mean that quantum field theory has to be thrown away. Also, using scientific jargon to make something sound clever when it’s not should not fool anyone, and certainly not serious scientific research journals.”

One has to wonder how Ross obtained a degree in physics. I sent this to Professor Coeytaux on 22nd March, pointing out how quick and easy it was to get such a review. I said that the paper had obviously not received “appropriate scientific review”, and asked for a response by return explaining the status of our letter. You guessed it, I have heard nothing.

I always try to go for the ball and not the player, but it’s worth looking in a bit more detail at Christina Ross’ academic credentials. She styles herself as Dr, but her PhD is from Akamai University in Hawaii. Although the university proudly displays a statement of accreditation, it is from the Accreditation Service for International Schools Colleges and Universities (ASIC). This is not listed by the US Department of Education as a recognised accreditation body. It is actually a UK company that validates visas for international students, but its credibility is quite doubtful:

“The legitimacy of ASIC’s international accreditation service is unclear and some of its internationally-accredited institutions have been deemed ‘diploma mills’ offering worthless qualifications.”

Ross is also a `Board Certified Polarity Practitioner’. Americans love the term `board certified’, it lends considerable gravitas. But anyone can set up a board and issue certificates. What is polarity therapy? Well, as is usual with quackery, it is a personality cult, which combines various evidence-free modalities and doesn’t clearly say what use it is. I don’t think I need to look into `Certified Energy Medicine Practitioner’ any further.

So this is what happens when pseudoscience is called out in academia. SAGE Publishing is obviously not a bit concerned about science, despite their assurances, or they would never have launched a journal such as this. The editors do not worry about conflicts of interest or scientific evidence. They try to obfuscate when detailed criticism is published. The author does not even attempt to defend what she has written. I assume all of them are hoping that we will get weary of this and give up. They are wrong about that as well.

My recent book discusses 20 of the worst and 20 of the best so-called alternative treatments. Some people are surprised and ask HOW DID YOU MANAGE TO FIND 20? WHAT THERAPIES ARE YOU TALKING ABOUT? As the book is in German, I have for non-German speakers the translated list and my concluding remarks from the book about the 20 best:

• Alexander technique
• Autogenic training
• Chondroitin
• Feldenkrais technique
• Fish oil
• Glucosamine
• Hypnotherapy
• Hypericum
• Garlic
• Laughing therapy
• Lymphdrainage
• Music therapy
• Oil pulling
• Pilates
• Progressive muscle relaxation
• Cupping
• Tai chi
• Triggerpoint therapy
• Visualization
• Yoga

When I look at the ’20 best’, I notice a few things that are perhaps worth highlighting again. The most striking thing is certainly that they are often therapies that are so close to conventional medicine that they can hardly be counted as alternative medicine anymore. Autogenic training, chondroitin, Feldenkrais therapy, fish oil, glucosamine, hypnotherapy, St. John’s wort, laughter therapy, lymphatic drainage, music therapy, and trigger point therapy are all procedures that are now at least partially integrated into conventional medicine. This brings to mind Tim Minchin’s bon mot, “You know what they call alternative medicine that’s been proven to work? – Medicine.”

The ’20 best’ can be roughly divided into three main categories:

1. physical therapies such as Alexander Technique, Feldenkrais Therapy, Lymphatic Drainage, Pilates, Tai Chi, and Yoga.
2. relaxation therapies such as autogenic training, hypnotherapy, laughter therapy, music therapy, progressive muscle relaxation, and visualization.
3. pharmacological therapies such as chondroitin, fish oil, glucosamine, St. John’s wort, and garlic.

That exercise, relaxation, and pharmacology can be effective is probably no surprise to anyone. In other words, unlike the ’20 Most Questionable’, almost all of the ’20 Best’ are supported by some plausibility. Very rarely does one find a therapy that is both implausible and effective. Among the procedures discussed in this book, this is the case only for Feldenkrais therapy.

In the review of the ’20 Best’, I have repeatedly emphasized that the evidence, while positive, is seriously flawed and therefore not as convincing as one might wish. There may be several reasons for this:

– In most cases, there is too little research funding available to conduct a sufficient number of good studies.
– Even if the money were available, the expertise (and occasionally the will) to test the methods scientifically is often lacking.
– Clinical trials of alternative medicine are often considerably more difficult to design and conduct than studies in conventional medicine. For instance, it is not always easy to find an adequate placebo. For example, what is an appropriate placebo for a study of hypnotherapy that allows patients to be blinded?

It follows that we must occasionally turn a blind eye, but ultimately cannot be completely certain that the procedure in question is in fact anything more than a placebo.

While the ’20 Most Questionable’ include many procedures that have been touted as panaceas, this is rarely the case with the ’20 Best’. On the contrary, most of the treatments in this category are effective for only a very few indications. Here the saying of one of my clinical teachers comes to mind, “If a therapy is supposed to be good for everything, it most likely won’t work for anything.”

What further strikes me as important is the fact that while all of the methods mentioned are effective, they are invariably symptomatic. None of the ’20 Best’ represents a causal therapy that can address a disease causally and thus actually cures it. This is in stark contrast to the many claims of healing made by alternative medicine providers, who all too often advertise their methods as addressing the root cause of a condition.

If we take a close look at the ’20 best’, we must finally also ask ourselves which of these methods are actually better than the conventional treatment of the same condition. All 20 have been positively evaluated by me in terms of their benefit/risk ratio. But this does not mean that they are superior to conservative therapy with respect to this important criterion. St. John’s wort is the most likely to meet this condition; it is as effective as conventional antidepressants for mild to moderate depression and has fewer side effects than them. Its benefit/risk ratio is thus superior to that of conventional antidepressants. I am not sure about any of the other treatments in the ’20 Best’ category.

Researchers of so-called alternative medicine (SCAM) don’t come more impressive than Wayne Jonas. Here is what he has to say about himself:

ABOUT DR. WAYNE JONAS

• Integrative Health Expert, Family Physician, Researcher, and Author
• Former Director NIH Office of Alternative Medicine
• Former Director World Health Organization Center for Traditional Medicine
• Former Director of Medical Research Fellowship at Walter Reed Army Institute of Research
• Retired Lt. Colonel United States Army Medical Corps
• Practicing Family Physician at Fort Belvoir Community Hospital Pain Clinic
• Clinical Professor of Family Medicine, Georgetown University
• Executive Director of Samueli Integrative Health Programs

Wayne Jonas, MD, is a board-certified, practicing family physician, an expert in integrative health and health care delivery, and a widely published scientific investigator. Additionally, Dr. Jonas is a retired Lieutenant Colonel in the Medical Corps of the United States Army. From 2001-2016, he was President and Chief Executive Officer of Samueli Institute, a non-profit medical research organization supporting the scientific investigation of healing processes in the areas of stress, pain and resilience.

Dr. Jonas was the Director of the Office of Alternative Medicine at the National Institutes of Health from 1995-1999, and prior to that served as the Director of the Medical Research Fellowship at the Walter Reed Army Institute of Research. He is a Fellow of the American Academy of Family Physicians.

His research has appeared in peer-reviewed journals such as the Journal of the American Medical Association, Nature Medicine, the Journal of Family Practice, the Annals of Internal Medicine, and The Lancet. Dr. Jonas received the 2015 Pioneer Award from the Integrative Healthcare Symposium, the 2007 America’s Top Family Doctors Award, the 2003 Pioneer Award from the American Holistic Medical Association, the 2002 Physician Recognition Award of the American Medical Association, and the 2002 Meritorious Activity Prize from the International Society of Life Information Science in Chiba, Japan.

Dr. Jonas is currently the Executive Director of Samueli Integrative Health Programs, an effort supported by Henry and Susan Samueli to empower patients and doctors by providing solutions that enhance health, prevent disease, and relieve chronic pain.

Could such a high-flyer be a candidate for membership in THE ALTERNATIVE MEDICINE HALL OF FAME? In other words, is he as adept in avoiding the publication of negative conclusions as all these geniuses who are already members?

• Harald Walach (various SCAMs, Germany)
• Andreas Michalsen ( various SCAMs, Germany)
• Jennifer Jacobs (homeopath, US)
• Jenise Pellow (homeopath, South Africa)
• Adrian White (acupuncturist, UK)
• Michael Frass (homeopath, Austria)
• Jens Behnke (research officer, Germany)
• John Weeks (editor of JCAM, US)
• Deepak Chopra (entrepreneur, US)
• Cheryl Hawk (US chiropractor)
• David Peters (osteopathy, homeopathy, UK)
• Nicola Robinson (TCM, UK)
• Peter Fisher (homeopathy, UK)
• Simon Mills (herbal medicine, UK)
• Gustav Dobos (various SCAMs, Germany)
• Claudia Witt (homeopathy, Germany/Switzerland)
• George Lewith (acupuncture, UK)
• John Licciardone (osteopathy, US)

Let’s see. My Medline search for ‘Jonas WR, clinical trial‘ generated 74 hits, of which 11 papers referred to clinical trials or systematic reviews of SCAMs. Here are their conclusions or key passages from the abstracts:

1. It is possible that individualised homeopathy entails specific psychotherapeutic processes in addition to possible therapeutic action of the homeopathic remedy, but the relative contributions of each remain to be determined.
2. This study indicates that niacinamide may have a role in the treatment of osteoarthritis. Niacinamide improved the global impact of osteoarthritis, improved joint flexibility, reduced inflammation, and allowed for reduction in standard anti-inflammatory medications when compared to placebo.
3. Based on the results of our review, acupuncture appears to be effective for treating headaches and, although more research is needed, seems to be a promising treatment option for anxiety, sleep disturbances, depression and chronic pain.
4. The database on studies of homeopathy and placebo in psychiatry is very limited, but results do not preclude the possibility of some benefit.
5. These results are consistent with the finding from the previous study that individualized homeopathic treatment decreases the duration of diarrhea and number of stools in children with acute childhood diarrhea.
6. Observational research into uncontrolled homeopathic practice documents consistently strong therapeutic effects and sustained satisfaction in patients.
7. When laboratory studies were compared to clinical studies in the areas of hands-on healing and distance healing across the quality criteria for internal validity, distance healing studies scored better than hands-on healing studies, and laboratory studies fared better than clinical studies.
8. Three independent systematic reviews of placebo-controlled trials on homeopathy reported that its effects seem to be more than placebo, and one review found its effects consistent with placebo. There is also evidence from randomized, controlled trials that homeopathy may be effective for the treatment of influenza, allergies, postoperative ileus, and childhood diarrhea.
9. Participants in the acupuncture group experienced a 23% reduction in pain before leaving the ER, while average pain levels in participants in the standard medical care group remained basically unchanged. (p < 0.0005). However, both groups experienced a similar reduction in pain 24 hours following treatment in the ER.
10. There was a trend towards less narcotic usage in the Traumeel patients. No statistically beneficial effect from Traumeel was demonstrated for mucositis. We could not confirm that Traumeel is an effective treatment for mucositis in children undergoing HSCT.
11. Acupuncture was effective for reducing PTSD symptoms.

Considering the above CV of Wayne Jonas, the quantity of this collective output seems a bit underwhelming. But can Wayne join THE ALTERNATIVE MEDICINE HALL OF FAME nevertheless? Who could refuse such an influential author of exclusively positive conclusions?

WELCOME WAYNE JONAS!

The notion of an alternative cancer cure is, as I have pointed out ad nauseam, a contradiction in terms (I am sure this sentence will prompt protests; so please, do send me links to reliable studies that prove it to be incorrect). It suggests that oncologists are a somewhat sadistically deranged group of professionals who would reject a promising therapy simply because it originates not from within the mainstream of medicine. Yet, some proponents of so-called alternative medicine (SCAM) claim that, even though there might be not a single SCAM that cures cancer, the use of a tailor-made mixture of several SCAMs could be beneficial, particularly if employed in addition to conventional cancer treatments. In fact, ‘integrated oncologists’ often claim that employing a package of diverse SCAMs will prolong the live of cancer patients.

But are they correct?

In this post, I will investigate by discussing the few studies that have tested this hypothesis.

In 2003, a Norwegian study examined the association between SCAM-use and cancer survival. Survival data were obtained with a follow-up of 8 years for 515 cancer patients. A total of 112 patients had used SCAM. In total, 350 patients died during the follow-up period. Death rates were higher in SCAM-users (79%) than in those who did not use SCAM (65%). The hazard ratio of death for SCAM-use compared with no use was 1.30. The authors of this paper concluded that the use of SCAM seems to predict a shorter survival from cancer.[1]

In 2013, Korean researchers evaluated whether SCAM-use influenced the survival and health-related quality of life (HRQOL) of terminal cancer patients. They prospectively studied a cohort of 481 cancer patients. During a follow-up of 164 person-years, 466 patients died. Compared with non-users, SCAM-users did not survive longer. The use of mind-body interventions or prayer was even associated with significantly worse survival. SCAM users reported significantly worse cognitive functioning and more fatigue than nonusers. In sub-group analyses, users of alternative medical treatments, prayer, vitamin supplements, mushrooms, or rice and cereal reported significantly worse HRQOL. The authors conclude that SCAM did not provide any definite survival benefit, CAM users reported clinically significant worse HRQOLs.[2]

A 2017 study from Malaysia evaluated whether the use of SCAM among newly diagnosed breast cancer patients was associated with delays in presentation, diagnosis or treatment of breast cancer. A total of 340 newly diagnosed patients were included in this study. The prevalence of SCAM use was 46.5%. The use of SCAM was associated with delays in presentation, diagnosis and treatment of breast cancer. The authors concluded that the use of SCAM was significantly associated with delay in presentation and resolution of diagnosis.[3]

A 2017 US study was aimed at determining whether SCAM use impacts on the prognosis of breast cancer patients. A total of 707 patients with stage I-IIIA breast cancer completed a 30-month post-diagnosis interview including questions on SCAM use. During the observation period, 70 breast cancer-specific deaths and 149 total deaths were reported, and 60.2 % of participants reported SCAM use post-diagnosis. No associations were observed between SCAM use and breast cancer-specific or total mortality. The authors concluded that SCAM use was not associated with breast cancer-specific mortality or total mortality.[4]

Another 2018 study from the US investigated SCAM use and its impact on survival. The researchers included 281 patients with nonmetastatic breast, prostate, lung, or colorectal cancer who chose SCAM, administered as sole anticancer treatment. The results show that SCAM use was independently associated with greater risk of death compared with conventional cancer therapy (CCT). The authors concluded that SCAM utilization for curable cancer without any CCT is associated with greater risk of death.[5]

The same group of researchers compared overall survival of patients with cancer receiving CCT with or without SCAM. They used the National Cancer Database on 1 901 815 patients from 1500 Commission on Cancer-accredited centres across the US who were diagnosed with non-metastatic breast, prostate, lung, or colorectal cancer between January, 2004, and December, 2013. Patients were matched on age, clinical group stage, comorbidity, insurance type, race/ethnicity, year of diagnosis, and cancer type. The entire cohort comprised 1 901 815 patients with cancer, 258 patients in the SCAM group and 1 901 557 patients in the control group. The results of this study showed that patients who received SCAM were more likely to refuse additional CCT, and had a higher risk of death. The results suggest that mortality risk associated with SCAM was mediated by the refusal of CCT.[6]

Collectively, these studies do not demonstrate that SCAM use leads to a better prognosis of cancer patients. On the contrary, several investigations have suggested the opposite effect. There are several possibilities to explain why SCAM use shortens the life of cancer patients:

• Some of the therapies in question might have a direct adverse effect on cancer progression, for instance, by being toxic or by interacting with conventional cancer drugs.
• Patients who choose to use SCAM might be more ill that those who do not employ it. The Malaysian study³ quoted above suggests that this is a possibility. In several studies, however, this factor has been taken into account and is therefore an unlikely explanation.
• Patients who opt for SCAM might take conventional cancer treatments less seriously or even shun them completely. The last two of the above-cited studies seem to suggest that this is the most likely explanation.

Whatever the explanation, the fact is that SCAM, in whatever shape or form, does not improve the natural history of cancer… That is unless you can show me convincing evidence to the contrary.

REFERENCES

[1] Risberg T, Vickers A, Bremnes RM, Wist EA, Kaasa S, Cassileth BR. Does use of alternative medicine predict survival from cancer? Eur J Cancer. 2003 Feb;39(3):372-7. doi: 10.1016/s0959-8049(02)00701-3. PMID: 12565991.

[2] Yun YH, Lee MK, Park SM, Kim YA, Lee WJ, Lee KS, Choi JS, Jung KH, Do YR, Kim SY, Heo DS, Kim HT, Park SR. Effect of complementary and alternative medicine on the survival and health-related quality of life among terminally ill cancer patients: a prospective cohort study. Ann Oncol. 2013 Feb;24(2):489-494. doi: 10.1093/annonc/mds469. Epub 2012 Oct 30. PMID: 23110809.

[3] Mohd Mujar NM, Dahlui M, Emran NA, Abdul Hadi I, Wai YY, Arulanantham S, Hooi CC, Mohd Taib NA. Complementary and alternative medicine (CAM) use and delays in presentation and diagnosis of breast cancer patients in public hospitals in Malaysia. PLoS One. 2017 Apr 27;12(4):e0176394. doi: 10.1371/journal.pone.0176394. PMID: 28448541; PMCID: PMC5407802.

[4] Neuhouser ML, Smith AW, George SM, Gibson JT, Baumgartner KB, Baumgartner R, Duggan C, Bernstein L, McTiernan A, Ballard R. Use of complementary and alternative medicine and breast cancer survival in the Health, Eating, Activity, and Lifestyle Study. Breast Cancer Res Treat. 2016 Dec;160(3):539-546. doi: 10.1007/s10549-016-4010-x. Epub 2016 Oct 21. PMID: 27766453; PMCID: PMC5558457.

[5] Johnson SB, Park HS, Gross CP, Yu JB. Use of Alternative Medicine for Cancer and Its Impact on Survival. J Natl Cancer Inst. 2018 Jan 1;110(1). doi: 10.1093/jnci/djx145. PMID: 28922780.

[6] Johnson SB, Park HS, Gross CP, Yu JB. Complementary Medicine, Refusal of Conventional Cancer Therapy, and Survival Among Patients With Curable Cancers. JAMA Oncol. 2018 Oct 1;4(10):1375-1381. doi: 10.1001/jamaoncol.2018.2487. PMID: 30027204; PMCID: PMC6233773.

Adverse effects of so-called alternative medicine (SCAM) are, in my view, the most important and the most under-researched subject in the realm of SCAM. When I started my job at Exeter in 1993 declaring that I intended to make it a focus of my research, the SCAM scene was first puzzled and subsequently annoyed. SCAM proponents argued that the important risks in medicine are not in SCAM but in conventional medicine. I countered:

1. that I would like to see some evidence to support this statement;
2. that, as long as SCAM proponents would not produce sound evidence, the statement amounted to a mere assumption which needed urgent testing;
3. that, when considering the safety of SCAM, we need to consider both the direct risks (for instance, adverse effects of a homeopathic or herbal remedy) and the indirect risks (for instance, the risks of consulting a homeopath or herbalist and adhering to their advice);
4. that, in any case, the absolute risks were not as important as the risk/benefit balance for each SCAM;
5. that we needed to research the risks of SCAMs much better in order to consider their risk/benefit profiles.

Since then, I have had hundreds (perhaps even thousands) of discussions, disputes and quarrels about this, repeatedly also in the comments section of this blog. Even though the issues are often complex, most of the ensuing circular argument can be condensed into a short dialogue between a fictional QUACK and a fictional SCIENTIST:

• QUACK: There are no adverse effects associated with my SCAM; after all, it’s been around for a very long time and we would by now know about any problems.
• SCIENTIST: But how can you be so sure without a reliable monitoring of adverse effects?
• QUACK: There is no need for one, because my SCAM safe.
• SCIENTIST: This what you think.
• QUACK: Alright, then show me some peer-reviewed articles about adverse effects of SCAM.
• SCIENTIST: How about this pile of papers reporting adverse effects of your SCAM?
• QUACK: That’s just a collection of anecdotes! Anecdotes are not evidence! Show me the systematic research.
• SCIENTIST: Here is a pile of systematic reviews on the subject. Happy?
• QUACK: No, these are systematic reviews of case reports. Case reports are just anecdotes.
• SCIENTIST: [slightly impatient] That’s because there is no monitoring of adverse effects in your field.
• QUACK: There is no need, because it’s safe, and you have no evidence to show otherwise.
• SCIENTIST: The burden of proof is not on my but on your shoulders.
• QUACK: I have given you the proof – after hundreds of years of using my SCAM, there is no evidence of adverse effects.
• SCIENTIST: [very impatient] Go yonder and multiply.
• QUACK: You see, you have no evidence to prove that my SCAM is not safe, instead you just claim that it’s unsafe and even insult me.
• SCIENTIST: I give up.

Instead of going through such discussions again and again, in future, I will just provide commentators on this blog with a link to this post. That should save both time and nerves.

What is the ‘DRX9000 decompression system’? It is a table attached to Space Age-looking controls that allegedly stretches the disks of the vertebrae, allowing protrusions to be pulled back into place and thus taking pressure off nerve roots. The website of Excite Medical informs us that the DRX9000® has been cleared by the FDA to treat patients suffering with incapacitating lower back pain and sciatica caused by herniated discs, degenerative discs, and posterior facet syndrome.

This sounds almost as though it is evidence based, doesn’t it?

But is it?

My Medline search resulted in three papers about the device (if anyone knows of more, please let me know):

1. Background: This study‘s goal was a retrospective chart audit of 100 outpatients with discogenic low back pain (LBP) lasting more than 12 weeks treated with a 2-month course of motorized spinal decompression via the DRX9000 (Axiom Worldwide, Tampa, FL, U.S.A.).Methods: Patients at a convenience sample of four clinics received 30-minute DRX9000 sessions daily for the first 2 weeks tapering to 1 session/week. Treatment protocol included lumbar stretching, myofascial release, or heat prior to treatment, with ice and/or muscle stimulation afterwards. Primary outcome was verbal numerical pain intensity rating (NRS) 0 to 10 before and after the 8-week treatment.Results: Of the 100 initial subjects, three withdrew their protected health information, and three were excluded because their LBP duration was less than 12 weeks. The remaining 94 subjects (63% female, 95% white, age = 55 (SD 16) year, 52% employed, 41% retired, LBP median duration of 260 weeks) had diagnoses of herniated disc (73% of patients), degenerative disc disease (68%), or both (27%). Mean NRS equaled 6.05 (SD 2.3) at presentation and decreased significantly to 0.89 (SD 1.15) at end of 8-week treatment (P < 0.0001). Analgesic use also appeared to decrease (charts with data = 20) and Activities of Daily Living improved (charts with data = 38). Follow-up (mean 31 weeks) on 29/94 patients reported mean 83% LBP improvement, NRS of 1.7 (SD 1.15), and satisfaction of 8.55/10 (median 9).Conclusions: This retrospective chart audit provides preliminary data that chronic LBP may improve with DRX9000 spinal decompression. Randomized double-blind trials are needed to measure the efficacy of such systems.
2. Background: Because previous studies have suggested that motorized non-surgical spinal decompression can reduce chronic low back pain (LBP) due to disc degeneration (discogenic low back pain) and disc herniation, it has accordingly been hypothesized that the reduction of pressure on affected discs will facilitate their regeneration. The goal of this study was to determine if changes in LBP, as measured on a verbal rating scale, before and after a 6-week treatment period with non-surgical spinal decompression, correlate with changes in lumbar disc height, as measured on computed tomography (CT) scans.Methods: A retrospective cohort study of adults with chronic LBP attributed to disc herniation and/or discogenic LBP who underwent a 6-week treatment protocol of motorized non-surgical spinal decompression via the DRX9000 with CT scans before and after treatment. The main outcomes were changes in pain as measured on a verbal rating scale from 0 to 10 during a flexion-extension range of motion evaluation and changes in disc height as measured on CT scans. Paired t-test or linear regression was used as appropriate with p < 0.05 considered to be statistically significant.Results: We identified 30 patients with lumbar disc herniation with an average age of 65 years, body mass index of 29 kg/m2, 21 females and 9 males, and an average duration of LBP of 12.5 weeks. During treatment, low back pain decreased from 6.2 (SD 2.2) to 1.6 (2.3, p < 0.001) and disc height increased from 7.5 (1.7) mm to 8.8 (1.7) mm (p < 0.001). Increase in disc height and reduction in pain were significantly correlated (r = 0.36, p = 0.044).Conclusions: Non-surgical spinal decompression was associated with a reduction in pain and an increase in disc height. The correlation of these variables suggests that pain reduction may be mediated, at least in part, through a restoration of disc height. A randomized controlled trial is needed to confirm these promising results.
3. Objectives: This study aims to compare the efficiency of conventional motorized traction (CMT) with non-surgical spinal decompression (NSD) using the DRX9000™ device in patients with low back pain associated with lumbar disc herniation (LDH).Patients and methods: Between March 2009 and September 2009, a total of 48 patients (29 females, 19 males; mean age 43.1±9.8 years; range, 18 to 65 years) were randomized into two groups. The first group (n=24) underwent CMT and the second group (n=24) underwent NSD for a total of 20 sessions over six weeks. The patients were evaluated before and after the treatment. Pain was assessed using the Visual Analog Scale (VAS), functional status using the Oswestry Disability Index (ODI), quality of life using the Short Form-36 (SF-36), state of depression mood using the Beck Depression Inventory (BDI), and the global assessment of the illness using the Patient’s Global Assessment of Response to Therapy (PGART) and Investigator’s Global Assessment of Response to Therapy (IGART) scales. Results: There was no significant difference in the evaluation outcomes before the treatment between the groups. However, a statistically significant decline was found in the VAS, ODI, and BDI scores after the treatment in both groups (all p<0.001). Except for two subgroups, no significant changes were observed in the SF-36 form. Assessment of “marked improvement” was globally most frequently reported one in both groups. No significant difference was observed in the evaluation outcomes after treatment between the groups. Conclusion: Our study results show that both CMT and NSD are effective methods in pain management and functional status and depressive mood improvement in patients with LDH, and NSD is not superior to CMT in terms of pain, functionality, depression and quality of life.

Studies one and two are retrospective and thus useless for establishing cause and effect. Study 3 is an RCT, but as an equivalence study it is desperately underpowered. Most likely, it merely demonstrates that both of the tested treatments are ineffective.

In other words, there seems to be no good evidence that the DRX9000 works for low back pain (LBP). This can hardly come as a surprise to anyone who has kept up with the evidence. What is more, traction can also cause significant harm. The current Cochrane review concludes that traction, either alone or in combination with other treatments, has little or no impact on pain intensity, functional status, global improvement and return to work among people with LBP.

Yet, the claims for the device are grandiose. According to a recent article in NBCnews (from which I take the liberty of citing passages below), the company behind the DRX9000, Excite Medical, claims that nearly 9 out of 10 patients who qualify for treatment on the DRX9000 will get relief. Excite Medical also says that 2,400 of its systems are in use in 45 nations and shows it off at trade shows everywhere from Las Vegas to Dusseldorf, Germany, and Dubai, United Arab Emirates. Chiropractors across the United States buy the machines from Excite Medical, often using the same claims as the manufacturers — sometimes even going beyond them.

But a FairWarning investigation — based on review of lawsuits, scientific studies, government documents, chiropractic websites and interviews with experts — found that the claims of success for spinal decompression stretch the truth, enticing patients to pay thousands of dollars for a treatment that has never been proven in scientifically rigorous studies to live up to its stupendous billing.

Despite a spate of state regulatory actions in the 2000s against Axiom Worldwide, the original manufacturer of the DRX9000, and chiropractors for making unproven claims, they still permeate the internet. And federal and state regulators who can sanction false claims now show little evidence that they are interested in reining them in…

“This non-surgical spinal decompression system … is scientifically Proven By Mayo Clinic, Duke University, Stanford, and Johns Hopkins University School of Medicine!” according to the website for GO Chiropractic in Illinois, which offers treatment with the DRX9000. Jamie Stephens, one of the chiropractors who runs Go Chiropractic, said in an email, “We have seen nothing but outstanding results from this technology,” and referred further questions to Excite Medical, which he said provided his advertising materials…

Excite Medical says [the treatment] typically runs about $3,500 for a full course of sessions on the DRX9000…

Chiropractors who paid as much as $125,000 for the device also got a package of suggested promotional materials, including the claim the DRX9000 was used in a scientific study that showed an 86 percent success rate. Many of the chiropractors took out newspaper ads that included the claims.

In later lawsuits, chiropractors complained that they were duped by Axiom. One, James Spiering in Texas, described being flown, plane fare and hotel paid, to Axiom headquarters in Florida, where he was told he would recover his investment in four months and clear $1.7 million in five years. Spiering said he was shown videos full of “fraudulent” claims. The parties settled out of court in 2010 for an undisclosed amount.

Regulators across the U.S. also had started to take notice of the DRX9000’s claims of extraordinary success. Over the course of three years or so, the Oregon attorney general, the Florida attorney general and a group of 11 California district attorneys all filed suits against Axiom or a former chiropractor who created some of its marketing. The suits ended in penalties — $1.125 million in the California case — and Axiom agreed to only make claims based on reliable scientific evidence, according to news stories and settlement documents.

_______________________________

What does that tell us?

I think it suggests that:

• LBP patients will try any rubbish that promises help.
• Chiropractors and other back pain quacks often could not care less about the evidence.
• Money is the driving force behind most back pain quackery.

There are many others who are much better placed to write about Randi who passed away on 20 October 2020. I only met him a few times and therefore cannot claim that I knew him well. Yet, I admired him, and he was one of my heroes. In that, I am certainly not alone; sceptics all over the world worshipped James Randi.

I will not attempt to do justice to his incredible legacy. I will merely try to offer my personal respects to a truly great man. I heard of JR first when he was recruited by the editor of Nature, John Maddox, to check out Benveniste’s lab and try to reproduce his surprising results on an in-vitro model of homeopathy. At the time, I thought this was a weird idea, but when I read up about JR’s background, it seemed a smart move. When he then identified the error in Benveniste’s work, I was not surprised. Randi had the gift of a sharp intellect, a detective and a arch sceptic.

Many years later, in 2008, I decided to edit a multi-author book entitled HEALING, HYPE OR HARM, and I invited JR to contribute a chapter. I felt honoured when he accepted the offer and sent me his chapter ‘AN AMATEUR’S VIEW OF THE SCAM SCENE’. In classical JR-style, it opened with the sentence: At the outset, let me make one thing perfectly clear: my qualifications concerning this subject, alternative/complementary medicine, here referred to as CAM, consist mostly of common sense, a wide-ranging experience of flimflam, and extensive exposure to a great variety of scam artists. After that, I received Christmas cards from him every year.

Eventually, I did meet JR in person. This was around 2010 on the occasion of sceptics meetings in New Orleans and Berlin. I introduced myself to him, he looked at me intensely, shook my hand and said: “Ahh, that’s you!”, and we had a little chat. By that time JR had become quite frail; his health was visibly in decline. This, however, did not stop him to remain active, influecial and inspirational; it seemed that JR was unstoppable.

His decades of achievements are perhaps best summarised by the hist of honours and awards bestowed on him. The list below is from his Wiki page:

Randi finished the book chapter in my book with the following remark: … several aquaintances have described my work as being anti-Darwinian, in that it interfers with the natural selection process with which we are so familiar. I will leave you to ponder on that matter.

Now he has left us, and sceptics around the world will miss him dearly.