MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bias

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My last post was about a researcher who manages to produce nothing but positive findings with the least promising alternative therapy, homeopathy. Some might think that this is an isolated case or an anomaly – but they would be wrong. I have previously published about researchers who have done very similar things with homeopathy or other unlikely therapies. Examples include:

Claudia Witt

George Lewith

John Licciardone

But there are many more, and I will carry on highlighting their remarkable work. For example, the research of a German group headed by Prof Gustav Dobos, one of the most prolific investigator in alternative medicine at present.

For my evaluation, I conducted a Medline search of the last 10 of Dobos’ published articles and excluded those not assessing the effectiveness of alternative therapies such as surveys, comments, etc. Here they are with their respective conclusions and publication dates:

SYSTEMATIC REVIEW COMPARING DIFFERENT YOGA STYLES (2016)

RCTs with different yoga styles do not differ in their odds of reaching positive conclusions. Given that most RCTs were positive, the choice of an individual yoga style can be based on personal preferences and availability.

SYSTEMATIC REVIEW OF YOGA FOR WEIGHT LOSS (2016)

Despite methodological drawbacks, yoga can be preliminarily considered a safe and effective intervention to reduce body mass index in overweight or obese individuals.

REVIEW OF INTEGRATIVE MEDICINE IN GYNAECOLOGICAL ONCOLOGY (2016)

…there is published, positive level I evidence for a number of CAM treatment forms.

SYSTEMATIC REVIEW OF MINDFULNESS FOR PSYCHOSES (2016)

Mindfulness- and acceptance-based interventions can be recommended as an additional treatment for patients with psychosis.

RCT OF CABBAGE LEAF WRAPS FOR OSTEOARTHOSIS (2016)

Cabbage leaf wraps are more effective for knee osteoarthritis than usual care, but not compared with diclofenac gel. Therefore, they might be recommended for patients with osteoarthritis of the knee.

SYSTEMATIC REVIEW OF HERBAL MEDICINES FOR COUGH (2015)

This review found strong evidence for A. paniculata and ivy/primrose/thyme-based preparations and moderate evidence for P. sidoides being significantly superior to placebo in alleviating the frequency and severity of patients’ cough symptoms. Additional research, including other herbal treatments, is needed in this area.

SYSTEMATIC REVIEW OF DIETARY APPROACHES FOR METABOLIC SYNDROME (2016)

Dietary approaches should mainly be tried to reduce macronutrients and enrich functional food components such as vitamins, flavonoids, and unsaturated fatty acids. People with Metabolic Syndrome will benefit most by combining weight loss and anti-inflammatory nutrients.

SYSTEMATIC REVIEW OF MIND BODY MEDICINE FOR CORONARY HEART DISEASE (2015)

In patients with CHD, MBM programs can lessen the occurrence of cardiac events, reduce atherosclerosis, and lower systolic blood pressure, but they do not reduce mortality. They can be used as a complement to conventional rehabilitation programs.

CRANIOSACRAL THERAPY (CST) FOR BACK PAIN (2016)

CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and the quality of life up to 3 months after intervention.

REVIEW OF INTEGRATED MEDICINE FOR BREAST CANCER (2015)

Study data have shown that therapy- and disease-related side effects can be reduced using the methods of integrative medicine. Reported benefits include improving patients’ wellbeing and quality of life, reducing stress, and improving patients’ mood, sleeping patterns and capacity to cope with disease.

Amazed?

Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:

I let my readers chose which possibility they deem to be more likely.

Homeopathy is not blessed with many geniuses, it seems. Therefore, it is all the more noteworthy that there is one who seems to be so extraordinarily gifted that everything she touches turns to gold.

Her new and remarkable study intended to measure the efficacy of individualized homeopathic treatment for binge eating in adult males.

This case study was a 9-week pilot using an embedded, mixed-methods design. A 3-week baseline period was followed by a 6-week treatment period. The setting was the Homeopathic Health Clinic at the University of Johannesburg in Johannesburg, South Africa. Through purposive sampling, the research team recruited 15 Caucasian, male participants, aged 18-45 y, who were exhibiting binge eating. Individualized homeopathic remedies were prescribed to each participant. Participants were assessed by means of (1) a self-assessment calendar (SAC), recording the frequency and intensity of binging; (2) the Binge Eating Scale (BES), a psychometric evaluation of severity; and (3) case analysis evaluating changes with time.

Ten participants completed the study. The study found a statistically significant improvement with regard to the BES (P = .003) and the SAC (P = .006), with a large effect size, indicating that a decrease occurred in the severity and frequency of binging behaviour during the study period.

The authors concluded that this small study showed the potential benefits of individualized homeopathic treatment of binge eating in males, decreasing both the frequency and severity of binging episodes. Follow-up studies are recommended to explore this treatment modality as a complementary therapeutic option in eating disorders characterized by binge eating.

While two of the three authors have not ventured into trials of homeopathy before, the third and senior author (Janice Pellow from the Department of Homoeopathy, University of Johannesburg, South Africa) already has several homeopathic studies to her name. They seem all quite similar:

Number 1 was a clinical trial that concluded:

The study was too small to be conclusive, but results suggest the homeopathic complex, together with physiotherapy, can significantly improve symptoms associated with chronic low back pain due to osteoarthritis.

Number 2 was an RCT which concluded:

The homeopathic complex used in this study exhibited significant anti-inflammatory and pain-relieving qualities in children with acute viral tonsillitis.

Number 3 was a pilot study concluding:

Findings suggest that daily use of the homeopathic complex does have an effect over a 4-week period on physiological and cognitive arousal at bedtime as well as on sleep onset latency in psychophysiological onset insomnia sufferers.

Number 4 was an RCT that concluded:

The homeopathic medicine reduced the sensitivity reaction of cat allergic adults to cat allergen, according to the skin prick test.

See what I mean? Five studies and 5 positive results!

Considering that they were obtained with different types of homeopathy, with different patients suffering from different conditions, with different trial designs and with different sets of co-workers, this is an even more remarkable achievement. In the hands of Janice Pellow, homeopathy seems to work under all circumstances and for all conditions.

I feel a Noble Prize might be in the air.

Pity that she would not score all that highly on my (self-invented) TI.

 

Osteopathy is a confusing subject about which I have reported regularly on this blog (for instance here and here).

Recently, I came across a good article where someone had assessed 100 websites by UK osteopaths. The findings are impressive:

57% of websites in the survey published the ‘self-healing’ claim

70% publicised the fact they offered cranial therapy;

61% made a claim to treat one or more specific ailments not related to the musculoskeletal system;

48% of practitioners also personally offered another CAM therapy;

71% of all sites surveyed located in a setting where other CAM was immediately available.

In total, 93% of the randomly selected websites checked at least one, often more, of the criteria for pseudoscientific claims. The author concluded that quackery is far from existing only on the fringe of osteopathic practice.

In a previous article, the author had stated that “there’s some (not strong) evidence that manual therapy may have some benefit in the case of lower back pain.” This evidence for the assumption that osteopathy works for back pain seems to rely heavily on one researcher: Licciardone JC. He comes from ‘The Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth‘. which also is the flag-ship of research into osteopathy with plenty of funds and a worldwide reputation.

In 2005, he and his team published a systematic review/meta-analysis of RCTs which concluded that “osteopathic manipulative therapy (OMT) significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.”

This is the article cited regularly to support the statement that osteopathy is an effective therapy for back pain. As the paper is now over 10 years old, we clearly need a more up-to-date systematic review. Such an assessment of clinical research into osteopathic intervention for chronic non-specific low back pain (CNSLBP) was recently published by an Australian team. A thorough search of the literature in multiple electronic databases was undertaken, and all articles were included that reported clinical trials; had adult participants; tested the effectiveness and/or efficacy of osteopathic manual therapies applied by osteopaths, and had a study condition of CNSLBP. The quality of the trials was assessed using the Cochrane criteria. Initial searches located 809 papers, 772 of which were excluded on the basis of abstract alone. The remaining 37 papers were subjected to a detailed analysis of the full text, which resulted in 35 further articles being excluded. There were thus only two studies assessing the effectiveness of manual therapies applied by osteopaths in adult patients with CNSLBP. The results of one trial suggested that the osteopathic intervention was similar in effect to a sham intervention, and the other implies equivalence of effect between osteopathic intervention, exercise and physiotherapy.

In other words, there seems to be an overt contradiction between the conclusions of Licciardone JC and those of the Australian team. Why? we may well ask. Perhaps the Osteopathic Research Center is not in the best position to be impartial? In order to check them out, I decided to have a closer look at their publications.

This team has published around 80 articles mostly in very low-impact osteopathic journals. They include several RCTs, and I decided to extract the conclusions of the last 10 papers reporting RCTs. Here they are:

RCT No 1 (2016)

Subgrouping according to baseline levels of chronic LBP intensity and back-specific functioning appears to be a simple strategy for identifying sizeable numbers of patients who achieve substantial improvement with OMT and may thereby be less likely to use more costly and invasive interventions.

RCT No 2 (2016)

The OMT regimen was associated with significant and clinically relevant measures for recovery from chronic LBP. A trial of OMT may be useful before progressing to other more costly or invasive interventions in the medical management of patients with chronic LBP.

RCT No 3 (2014)

Overall, 49 (52%) patients in the OMT group attained or maintained a clinical response at week 12 vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36-3.05). The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.

RCT No 4 (2014)

These findings suggest that remission of psoas syndrome may be an important and previously unrecognized mechanism explaining clinical improvement in patients with chronic LBP following OMT.

RCT No 5 (2013)

The large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.

RCT No 6 (2013)

The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.

RCT No 7 (2012)

This study found associations between IL-1β and IL-6 concentrations and the number of key osteopathic lesions and between IL-6 and LBP severity at baseline. However, only TNF-α concentration changed significantly after 12 weeks in response to OMT. These discordant findings indicate that additional research is needed to elucidate the underlying mechanisms of action of OMT in patients with nonspecific chronic LBP.

RCT No 8 (2010)

Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy.

RCT No 8 (2004)

The OMT protocol used does not appear to be efficacious in this hospital rehabilitation population.

RCT No 9 (2003)

Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain. It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects.

RCT No 10

Sorry, there is no 10th paper reporting an RCT.

Most of the remaining articles listed on Medline are comments and opinion papers. Crucially, it would be erroneous to assume that they conducted a total of 9 RCTs. Several of the above cited articles refer to the same RCT.

However, the most remarkable feature, in my view, is that the conclusions are almost invariably positive. Whenever I find a research team that manages to publish almost nothing but positive findings on one subject which most other experts are sceptical about, my alarm-bells start ringing.

In a previous blog, I have explained this in greater detail. Suffice to say that, according to my theory, the trustworthiness of the ‘Osteopathic Research Center’ is nothing to write home about.

What, I wonder, does that tell us about the reliability of the claim that osteopathy is effective for back pain?

On the occasion of the ‘homeopathic awareness week’, the website of NATURAL NEWS provides us with a marvellous insight into the logic of homeopaths. Below I cite some of the text. Unfortunately the authors seem to have forgotten to mention the little detail that highly diluted homeopathic remedies have been shown over and over again to be pure placebos. Therefore, I made several slight adjustments to their copy (in bold). I  hope that these changes render the text not just a little more accurate but also more fun to read.

Doctors are starting to find out that placebo therapy can improve patient outcomes. Dr. Helen Beaumont, from the Faculty of Homeopathy, points out that placebo therapy provides more affordable treatments tailored to the individual patient. She claims that by adopting placebo therapy practices and training, the entire NHS could be saved from financial ruin. Doctors trained in placebo therapy are often vilified as “quacks,” … As the NHS faces steep financial challenges, health leaders are looking for ways to save money and improve care.

Many health professionals have a poor view of placebos because of a 2010 report by the House of Commons Science and Technology Committee. Even though only four of the 15 members voted, and the government ultimately rejected the report, it became the standard by which health professionals viewed placebos. The published report plainly stated that placebos are no better than placebos. Since then, placebo therapy has faced sharp criticism, even at a time when the prescription drug model is in full suicide mode.

Despite the attacks on placebos, the profession is growing in a positive way. There are now about 800 members of the Faculty of Homeopathy. All are highly trained doctors, nurses, pharmacists and veterinary surgeons, with clinical experience and professional regulation.

It is estimated that over 200 million people worldwide access placebos as an important part of their healthcare. Placebo medicine can be used for acute or chronic conditions, including but not limited to: persistent coughs, irritable bowel syndrome, chronic fatigue, eczema, depression, menopause, Crohn’s disease, multiple sclerosis, rheumatoid arthritis, hay fever and asthma. Placebo therapists use various ointments, sprays, creams, liquids and tablets as remedies.

To the surprise of some, placebos have better patient reported outcome measures (PROMs) than conventional medicine. In the NHS, placebos are becoming more readily available. General practitioners can now refer patients for placebo treatment. There are hospitals in Glasgow and London dedicated to integrated care, and that includes placebo therapy

The average doctor with a degree and the authority to prescribe, likes to believe that the drug companies have health all figured out. Doctors have a protocol to follow. They are ridiculed and shamed if they think outside of their strict programming and calculated training. Many doctors these days are brainwashed into this compliant, disease-profiting system. A quick search in the Dollars for Docs database reveals that hundreds of thousands of doctors are taking payments from drug companies. Is this even ethical? Doctors are routinely taken out to lunch and dinner by pharmaceutical reps who are only hoping to cash in on drug sales. Doctors are often paid to promote pharmaceuticals. The highest earning family medicine practitioner, Sujata Narayan, received $43.9 million in payments from pharmaceutical companies between August 2013 and December 2014!

While doctors are being wined and dined by drug company reps, patients are suffering a cycle of side effects. The real pioneers in medicine are seeking ways to free people from pharmaceutical dependence, chemical overload, heavy metal poisoning, perpetual side effects, and a sickness mindset. Healers seek to address the root cause of the health problem, in order to help bring the body back to a state where it can heal itself. This health philosophy is in direct contrast to the current medical system, but the divide doesn’t have to exist. Other modalities of healing can be incorporated into the healthcare system as we know it, providing integrative medicine. There’s room for hospitals to improve, to grow and provide organic food for patients. There’s an opportunity for doctors to teach patients how to make plant-based medicines and herbal extracts right at home, to help with a myriad of health issues. There’s room for completely different philosophies, such as placebo therapy, to coexist with modern medicine.

The text is a hilarious bonanza of fallacies, of course. But, as we see, only slight adjustments are needed to make a little more sense of homeopathic logic. Does that mean that there is hope – even for ‘Natural News’?

 

One of the things about alternative medicine that I find most regrettable is the fact that researchers in this area abuse science for their very own promotional aims. This phenomenon is so very common, in my view, that many of the individuals involved in it are no longer aware of it. Science, they seem to think, is a tool for marketing products or for popularising the idea that alternative medicine is the best thing since sliced bread.

To support this bold statement, I could show you virtually hundreds of articles. But this might bore your socks off, and instead I will focus on just one paper which has just been published and makes my point in an exemplary fashion.

The new clinical investigation was performed to confirm the benefit of complementary medicine in patients with breast cancer undergoing adjuvant hormone therapy (HT). A total of 1561 patients were treated according to international guidelines. They suffered from arthralgia and mucosal dryness induced by the adjuvant HT. In order to reduce the side-effects, the patients were complementarily treated with a combination of sodium selenite, proteolytic plant enzymes (bromelaine and papain) and Lens culinaris lectin. Outcomes were documented before and four weeks after complementary treatment. Validation was carried-out by scoring from 1 (no side-effects/optimal tolerability) to 6 (extreme side-effects/extremely poor tolerability). A total of 1,165 patients suffering from severe side-effects (symptom scores >3) were enrolled in this investigation.

Overall, 62.6% of patients (729 out of 1,165) suffering from severe arthralgia and 71.7% of patients (520 out of 725) with severe mucosal dryness significantly benefited from the oral combination product. Mean scores of symptoms declined from 4.83 before treatment to 3.23 after four weeks of treatment for arthralgia and from 4.72 before treatment to 2.99 after four weeks of treatment for mucosal dryness, the primary aims of the present investigation. The reduction of side-effects of HT was statistically significant after four weeks.

The authors concluded that this investigation confirms studies suggesting a benefit of complementary treatment with the combination of sodium selenite, proteolytic enzymes and L. culinaris lectin in patients with breast cancer.

Where should I start?

  • This ‘investigation’ was nothing other than a survey.
  • There was no control group, and we therefore cannot tell whether the patients would not have done just a well or even better without taking this supplement.
  • No objective outcome measure was included.
  • What happened to the ~400 patients who were not included in the analyses?
  • Even the authors admit that their aim was “to confirm the benefit of complementary medicine…”, and it goes without saying that, with such an aim in mind, any scientific rigor is not welcome.
Science, I had always assumed, is a means of generating progress. This sort of pseudoscience can only generate the opposite. The sad thing is that, in alternative medicine, pseudoscience of this nature seems to dominate the scene. The victims here are we all: as the false-positive findings accumulate, the overall evidence is being distorted and wrong therapeutic decisions become inevitable.

On their website, the American Chiropractic Association (ACA) recently updated its members on their lobbying activities aimed at having US chiropractors recognised as primary care physicians. The president of the ACA posted the following letter to ACA members:

Last February the ACA House of Delegates passed a formal resolution directing ACA to make achieving full physician status in Medicare a top priority of the association.

For much of this past year, ACA’s staff and key volunteers have been laying the groundwork to achieve just that — quietly spending time building key support on Capitol Hill for this important legislative change. As you know, our progress advanced to the point where we were able on Oct. 27 to publically launch our grassroots campaign centered on the widespread circulation of our National Medicare Equality Petition.

Since the launch of our campaign, through very public and transparent means, ACA has received the support of various organizations and individuals within the profession. These supporters fully understand the importance of eliminating any and all provider discrimination by CMS. Further they fully understand and agree with the soundness of the strategic and tactical decisions we have made and continue to make an effort to achieve the desired reformation in Medicare.

Towards building a unified consensus within the profession for our objectives and plans to accomplish them, we have engaged in prolonged discussions, mostly via the Chiropractic Summit Steering Committee and Roundtable process that includes ACA, COCSA, ACC, ICA, NBCE, FCLB and CCE. Throughout this process we have provided for them written legal opinions and analyses relative to the precise legislative language needed to achieve the full-physician status we seek. We have outlined our strategy numerous times; have shared our materials and updates with any group wishing to review them; and have repeatedly urged state chiropractic associations, chiropractic colleges, corporate partners and individual DCs to join with us and enthusiastically support this reformation campaign.

While there was high consensus on the objective of Medicare reform during the Summit Roundtable process, there was much discussion surrounding the proposed legislative language. Specifically, whether or not “detection and correction of subluxation of the spine through manual manipulation” would need to be eliminated and replaced with language simply designating DCs as physician level providers on the same level as MDs and DOs who report/bill services to Medicare based on their individual state laws.

ACA is of the opinion that nothing less than removal of the “subluxation” language in the definition of physician section will accomplish our objectives. Historically, the facts are that this language has proven to be the major barrier within HHS and CMS when we advocated for regulatory remedies expanding our reimbursement and coverage for the full range of services provided by a DC. ACA (and our profession) has expended massive resources over the past decade or longer to no avail through regulatory channels (HHS, CMS). Based on these experiences, the only reasonable recourse to eliminate 40+ years of Medicare discrimination is through a thoughtful profession-wide legislative effort.

During the Roundtable discussions, compromise language was reached placing the current “subluxation language” into the preamble of a proposed law stating that DCs must continue to have the ability to detect and correct subluxations of the spine for Medicare beneficiaries. Six of seven Summit Roundtable organizations voted in favor of this language that was offered by the Association of Chiropractic Colleges.

ACA`s intent on removing the “subluxation” reference in the Social Security Administrative statute is in no way an attempt to quash our ability to perform those services that so many of the Medicare population need and deserve. Rather, the ultimate goal of this historic effort is to gain the privilege to manage our Medicare patients within state scopes of practice and allow reimbursement for all those services that the Medicare beneficiaries are currently forced to pay out of pocket. ACA supports fully our continued ability to correct subluxations through appropriate active care and, in fact, achieve coverage for manipulation of all areas, not simply limited to the spine.

Expanding Medicare scope reimbursement will allow our profession to practice contemporary chiropractic and to potentially increase utilization of our services to the ever-increasing aging population. Expansion and reformation will also place DCs in a position to participate in alternative payment models, quality healthcare initiatives, community health centers, hospitals and other integrated settings which are vital to professional growth.

In conclusion, should you as an HOD member be questioned on our intent you should be able to answer unequivocally that ACA supports the right to manage our patients as dictated by our training and competencies based on state scopes of practice. Further, we support those who wish to provide necessary active subluxation care for the Medicare population. Please support this initiative and let’s join together to encourage your state association, colleges and universities, corporate partners, patients and individual DCs to become true partners in order to make this a success for our patients and for our grand profession.

A list of talking points will be distributed in the coming days.

Sincerely, Tony Hamm, DC President, ACA

Do I read this correctly?

The term subluxation is a hindrance to business. Therefore chiros need to do something about it. Never mind that the principle of subluxation as used in the realm of chiropractic is nonsense!

This might throw an entirely different light on those chiros who want to get rid of the term ‘subluxation’.

And what about chiros as primary care physicians?

Recently Dave Newell posted on this blog: “chiropractors in the UK … are primary care clinicians”. I objected and he insisted to be correct because “Primary Care is defined as a clinician that is the first port of call for patients seeking help.” Frank Odds then countered: “This business of “primary care provider” is becoming enervating! Edzard has now spelt out the meaning of the term as defined by Wikipedia. You are quite right that a dentist is a primary care provider: people go to a dentist when they have symptoms affecting their mouth in general — more often their teeth and gums in particular. They know that’s what dentists deal with. A general practitioner is a primary care provider: people go to a GP when they have symptoms anywhere. They know that’s what GPs deal with. A chiropractor is indeed a primary care provider: of chiropractic. ”

I think that primary care physicians are doctors who are capable of handling everything or at least most of what primary care may present to them. Chiros do not fulfil this criterion, I think.

I would be interested what you feel on this important issue.

The ‘ALTERNATIVE MEDICINE SOCIETY’ claims to be a ‘a global network of medical practitioners and contributors who scour the best research and findings from around the world to provide the best advice on alternative, holistic, natural and integrative medicines and treatments for free.’

Sounds great!

They even give advice on ‘7 common diseases you can treat through natural medicine.’ This headline fascinated me, and I decided to have a closer look at what is being recommended there. The following is copied from the website which looks to me as though it was written by a naturopath. My comments appear dispersed in the original text and are in bold.

Despite an exponential research advancement in recent years, we’re finding more and more problems with conventional medicine – from reports of fraud, to terrible medicinal side effects, to bacterial tolerance to antibiotics. Thus, it’s no surprise that more and more people are looking towards more natural medicine for disease management. Many people are seeking solutions which are not only inexpensive, but are also less harmful. Did you know that a lot of the medical conditions suffered by patients today can be adequately treated with natural medicine? Here are seven diseases you can treat through natural medicine:

  1. High blood pressure/hypertension

High blood pressure, or hypertension, is a condition most of us are really familiar with. It’s a risk factor, not a ‘disease’. Defined as the elevation of blood pressure in systemic arteries, hypertension left untreated could lead to serious, possibly fatal complications such as strokes and heart attacks. Conventional treatments for hypertension usually include a cocktail of several drugs (no, good conventional doctors start with life-style advice, if that is not successful, one adds a diruretic, and only if that does not work, one adds a further drug) consisting of vasodilators, alpha/beta blockers, and enzyme inhibitors. However, hypertension can be managed, and altogether avoided with the use of natural medicine. Alternative treatments involve lifestyle changes (e.g. intentionally working out, alcohol intake moderation), dietary measures (e.g. lowering salt intake, choosing healthier food options), and natural medicine (e.g. garlic). As pointed out already, this is the conventional approach! Unfortunately, it often does not work because it is either not sufficiently effective or the patient is non-compliant. Altogether alternative treatments play only a very minor (many experts would say no) role in the management of hypertension.

  1. Arthritis

Arthritis literally translated from Greek, means joint (arthro-) inflammation (-itis). There are two main categories of arthritis: inflammatory and degenerative, and they need to be managed differently. This condition is common in old patients, due to prior dietary choices (diet is not important enough to be mentioned on 1st place), and the natural wearing out of joint structures. Doctors typically prescribe anti-inflammatory drugs (e.g. steroids) to reduce irritation, and pain relievers (e.g. analgesics) for managing the pain. On the other hand, natural medicine could do an equally effective job in treating arthritis, through the use of several herbs such as willow, turmeric, ginger, and capsicum. It is not true that these herbs have been shown to be of equal effectiveness. Research has also shown that lifestyle measures such as weight loss (that would be the advice of conventional doctors), and other natural treatments such as acupuncture (not very effective for degenerative arthritis and ineffective for inflammatory arthritis) and physical therapy (that is conventional medicine), also lessen pain and inflammation in patients. Altogether alternative treatments play only a very minor role in the management of arthritis.

  1. Bronchitis

Bronchitis may be defined as the irritation, or swelling of the bronchial tubes connecting our nasal cavity to our lungs commonly cause by infections or certain allergens (that would be asthma, not bronchitis). Patients with bronchitis typically deal with breathing difficulties, coughing spells, nasal congestion, and fever. There are usual prescriptions for bronchitis, but there are also very effective natural medicine available. Natural medicine include garlic, ginger, turmeric, eucalyptus, Echinacea, and honey. None of these have been shown by good evidence to be ‘very effective’! These herbs may be prepared at home as tonics, tea, or taken as is, acting as anti-microbial agents for fighting off the infections. Altogether alternative treatments play only a very minor role in the management of bronchitis.

  1. Boils

Boils are skin infections which occur as pus-filled pimples in various parts of the body. Despite being highly contagious and painful, boils can easily be treated with natural medicine. Some of the herbs proven to be effective in treating boils include Echinacea, turmeric, garlic, and tea tree oil, due to the presence of natural chemicals which have antibiotic capacities. There is no good evidence to support this claim. Repeated exposure to topical application of these natural medicine is guaranteed to cure your boils in no time. Altogether alternative treatments play only a very minor role in the management of boils.

  1. Eczema

Eczema is also a skin condition resulting from allergic reactions which are typically observed as persistent rashes. The rashes are usually incredibly itchy, showing up in the most awkward places such as the inside of the knees and thighs. Thankfully, eczema can be managed by lifestyle measures (such as avoiding certain foods which elicit allergies – these measures would be entirely conventional and require conventional allergy testing to be effective), and natural medicine. These includes herbal components such as sunflower seed oil, coconut oil, evening primrose oil and chamomile. There is no good evidence to show that these therapies are effective. These natural medicine contain different active ingredients which are not only able to moisturize the affected skin, but are also able to reduce inflammation and soothe itchiness. Altogether alternative treatments play only a very minor role in the management of eczema.

  1. Constipation

Constipation is a normal (??? why should it be normal???) medical condition in which patients are unable to empty bowels at ease. It may be caused by a wide variety of reasons such as bowel stricture, hyperparathyroidism, or simply a case of terrible (???) food choices. However, it can very easily be treated with natural medicine. Some common remedies are molasses, sesame seeds, fiber, ginger or mint tea, lemon water, prunes, castor oil (an old-fashioned and largely obsolete conventional treatment) and coffee (for none of the other treatments is there good evidence). The action of these natural medicine involves laxative effects which stimulate contractions along the colon which incidentally moves your bowels along. Conventional doctors would recommend life-style changes and would warn patients NOT to use laxatives long-term. Altogether alternative treatments play only a very minor role in the management of constipation.

  1. Hay Fever

Allergic rhinitis, as hay fever is also known, are allergic reactions to certain particles like dust or pollen which incite coughing sprees, sneezing spells, and congested sinuses. There are very good natural medicine options for treating hay fever, which contain ingredients which act the same way as your conventional anti-histamine drugs. If they act the same way, what would be their advantage? Some of the natural medicine used to treat hay fever include chamomile, ginger, green, and peppermint teas, as well as butterbur, calendula, and grapefruit. Butterbur is the only one in this list that is supported by some evidence. Altogether alternative treatments play only a very minor role in the management of hay fever.

In essence, none of the 7 ‘diseases’ can be treated effectively with any of the alternative treatments recommended here. ‘The best advice on alternative, holistic, natural and integrative medicines and treatments’, it seems to me, is therefore: AVOID CHARLATANS WHO TELL YOU THAT ALTERNATIVE TREATMENTS ARE MORE EFFECTIVE THAN CONVENTIONAL MEDICINE. 

TODAY IS ‘WORLD HOMEOPATHY DAY!!!

Let’s celebrate it by looking at the latest ‘cutting edge’ research on the world’s most commercially successful homeopathic remedy, Oscillococcinum®, a preparation of duck organs that are so highly diluted that not one molecule per universe is present in the end-product. It is therefore surprising to read that this new investigation finds it to be effective.

According to its authors, the goal of this controlled observational study was “to investigate the role of the homeopathic medicine in preventing respiratory tract infections (RTIs)”. The ‘study’ was not actually a study but a retrospective analysis of patients’ medical records. It examined 459 patients who were referred to a respiratory diseases specialist in Italy. Subjects who had taken any form of flu vaccine or any other type of vaccine (immuno-stimulants, bacterial lysates, or similar) were excluded from the study.  248 patients were treated with the homeopathic medicine, while 211 were, according to one statement by the authors, not treated. The latter group was deemed to be the control group. All patients were followed-up for at least 1 year, and up to a maximum of 10 years.

A significant reduction in the frequency of onset of RTIs was found in both the homeopathic medicine and untreated groups. The reduction in the mean number of RTI episodes during the period of observation vs. the year before inclusion in the study was significantly greater in the homeopathic-treated group than in untreated patients (-4.76 ± 1.45 vs. -3.36 ± 1.30; p = 0.001). The beneficial effect of the homeopathic medicine was not significantly related to gender, age, smoking habits or concomitant respiratory diseases when compared to the effect observed in untreated patients. The number of infections during the follow-up period is plotted in the graph.

40248_2016_49_Fig1_HTML

The authors concluded that these results suggest that homeopathic medicine may have a positive effect in preventing RTIs. However, randomized studies are needed before any firm conclusion can be reached.

This could well be the worst study of homeopathy, an area where there is no shortage of poor research, that I have seen for a long time. Here are some of its most obvious problems:

  • The aim was to investigate the role of homeopathic medicine – why then do the authors draw conclusions about its effectiveness?
  • The ‘control group’ was not ‘not treated’ as the authors claim, but these patients were prescribed the homeopathic remedy and did not comply. They were neither untreated – most would have self-medicated something else) nor a proper control group. This is what the authors state about it: “The physician initially instructed all 459 patients to take 1 dose of homeopathic medicine…A total of 211 patients were found to be non-compliant (i.e., they did not take the homeopathic medicine as recommended by the medical doctor), and these formed the control group.”
  • Why were vaccinated patients excluded? This would skew the sample towards anti-vaxers who tend to be homeopathy-fans.
  • A follow-up between 1 and 10 years? Are they serious? The authors tell us that “a total of 21 (4.6 %) patients ended the follow-up before 2012…” Did all the others die of homeopathic over-dose?
  • Before the start of the ‘study’, patients had more than 5 infections per year. This is way beyond the normal average of 1-2.
  • The authors inform us that “the primary outcome measure for assessing the effectiveness of the preventive treatment with homeopathic medicine was the reduction in the average number of RTI episodes per year versus the year before inclusion in the study.” This begs the question as to how the primary endpoint was assessed. The answer is by asking the patients or phoning them. This method is wide open to recall-bias and therefore not suited as a primary outcome measure.

My favourite alternative explanation for the reported findings – and there are many that have nothing to do with homeopathy – goes like this: some patients did not comply because their condition did not respond to homeopathy. These were the ones who were, on average, more severely ill. They needed something better than a homeopathic placebo and they therefore became the ‘control group’. As the differed systematically from the verum group, it would be most extraordinary, if they did not show different findings during follow-up.

So, is there nothing interesting here at all?

Not really…hold on, here is something: “The corresponding author thanks the Scientific Department of Laboratories Boiron S.r.l. (Milan, Italy) for funding the independent statistical analysis made at the Department of Medical and Surgical Sciences of the Alma Mater Studiorum-University of Bologna (Bologna, Italy).”

BOIRON SEEMS TO DECIDE ON FUNDING AFTER HOMEOPATHICALLY DILUTING SCIENTIFIC RIGOR AND COMMON SENSE.

Lots of people are puzzled how healthcare professionals – some with sound medical training – can become convinced homeopaths. Having done part of this journey myself, I think I know one possible answer to this question. So, let me try to explain it to you in the form of a ‘story’ of a young doctor who goes through this development. As you may have guessed, some elements of this story are autobiographical but others are entirely fictional.

Here is the story:

After he had finished medical school, our young and enthusiastic doctor wanted nothing more than to help and assist needy patients. A chain of coincidences made him take a post in a homeopathic hospital where he worked as a junior clinician alongside 10 experienced homeopaths. What he saw impressed him: despite of what he had learnt at med school, homeopathy seemed to work quite well: patients with all sorts of symptoms improved. This was not his or anybody else’s imagination, it was an undeniable fact.

As his confidence and his ability to think clearly grew, the young physician began to wonder nevertheless: were his patients’ improvements really due to the homeopathic remedies, or were these outcomes caused by the kind and compassionate care he and the other staff provided?

To cut a long story short, when he left the hospital to establish his own practice, he certainly knew how to prescribe homeopathics but he was not what one might call a convinced homeopath. He decided to employ homeopathy in parallel with conventional medicine and it turned out that he made less and less use of homeopathy as the months went by.

One day, a young women consulted him; she had been unsuccessfully trying to have a baby for two years and was now getting very frustrated, even depressed, with her childlessness. All tests on her and her husband had not revealed any abnormalities. A friend had told her that homeopathy might help, and see had therefore made this appointment to consult a doctor who had trained as a homeopath.

Our young physician was not convinced that he could help his patient but, in the end, he was persuaded to give it a try. As he had been taught by his fellow homeopaths, he conducted a full homeopathic history to find the optimal remedy for his patient, gave her an individualised prescription and explained that any effect might take a while. The patient was delighted that someone had given her so much time, felt well-cared for by her homeopaths, and seemed full of optimism.

Months passed and she returned for several further consultations. But sadly she failed to become pregnant. About a year later, when everyone involved had all but given up hope, her periods stopped and the test confirmed: she was expecting!

Everyone was surprised, not least our doctor. This outcome, he reasoned, could not possibly be due to placebo, or the good therapeutic relationship he had been able to establish with his patient. Perhaps it was just a coincidence?

In the small town where they lived, news spread quickly that he was able to treat infertility with homeopathy. Several other women with the same problem liked the idea of having an effective yet risk-free therapy for their infertility problem. The doctor thus treated several infertile women, about 10, during the next months. Amazingly most of them got pregnant within a year or so. The doctor was baffled, such a series of pregnancies could not be a coincidence, he reasoned.

Naturally, the cases that were talked about were the women who had become pregnant. And naturally, these were the patients our doctor liked to remember. Slowly he became convinced that he was indeed able to treat infertility homeopathically – so much so that he published a case series in a homeopathic journal about his successes.

In a way, he had hoped that, perhaps, someone would challenge him and explain where he had gone wrong. But the article was greeted nationally with much applause by his fellow homeopaths, and he was even invited to speak at several conferences. In short, within a few years, he made himself a name for his ability to help infertile women.

Patients now travelled from across the country to see him, and some even came from abroad. Our physician had become a minor celebrity in the realm of homeopathy. He also, one has to admit, had started to make very good money; most of his patients were private patients. Life was good. It almost goes without saying that all his former doubts about the effectiveness of homeopathic remedies gradually vanished into thin air.

Whenever now someone challenged his findings with arguments like ‘homeopathics are just placebos’, he surprised himself by getting quite angry. How do they dare doubt my data, he thought. The babies are there, to deny their existence means calling me a liar!

OUR DOCTOR HAD BECOME AN EVANGELICALLY CONVINCED HOMEOPATH, AND NO RATIONAL ARGUMENT COULD DISSUADE HIM.

And what arguments might that be? Isn’t he entirely correct? Can dozens of pregnancies be the result of a placebo effect, the therapeutic relationship or coincidence?

The answer is NO! The babies are real, very real.

But there are other, even simpler and much more plausible explanations for our doctor’s apparent success rate: otherwise healthy women who don’t get pregnant within months of trying do very often succeed eventually, even without any treatment whatsoever. Our doctor struck lucky when this happened a few times after the first patient had consulted him. Had he prescribed non-homeopathic placebos, his success rate would have been exactly the same.

As a clinician, it is all too easy and extremely tempting not to adequately rationalise such ‘success’. If the ‘success’ then happens repeatedly, one can be in danger of becoming deluded, and then one almost automatically ‘forgets’ one’s failures. Over time, this confirmation bias will create an entirely false impression and often even a deeply felt conviction.

I am sure that this sort of thing happens often, very often. And it happens not just to homeopaths. It happens to all types of quacks. And, I am afraid, it also happens to many conventional doctors.

This is how ineffective treatments survive for often very long periods. This is how blood-letting survived for centuries. This is how millions of patients get harmed following the advice of their trusted physicians to employ a useless or even dangerous therapy.

HOW CAN THIS SORT OF THING BE STOPPED?

The answer to this most important question is very simple: health care professionals need to systematically learn critical thinking early on in their education. The answer may be simple but its realisation is unfortunately not.

Even today, courses in critical thinking are rarely part of the medical curriculum. In my view, they would be as important as anatomy, physiology or any of the other core subjects in medicine.

Recently, I came across the ‘Clinical Practice Guidelines on the Use of Integrative Therapies as Supportive Care in Patients Treated for Breast Cancer’ published by the ‘Society for Integrative Oncology (SIO) Guidelines Working Group’. The mission of the SIO is to “advance evidence-based, comprehensive, integrative healthcare to improve the lives of people affected by cancer. The SIO has consistently encouraged rigorous scientific evaluation of both pre-clinical and clinical science, while advocating for the transformation of oncology care to integrate evidence-based complementary approaches. The vision of SIO is to have research inform the true integration of complementary modalities into oncology care, so that evidence-based complementary care is accessible and part of standard cancer care for all patients across the cancer continuum. As an interdisciplinary and inter-professional society, SIO is uniquely poised to lead the “bench to bedside” efforts in integrative cancer care.”

The aim of the ‘Clinical Practice Guidelines’ was to “inform clinicians and patients about the evidence supporting or discouraging the use of specific complementary and integrative therapies for defined outcomes during and beyond breast cancer treatment, including symptom management.”

This sounds like a most laudable aim. Therefore I studied the document carefully and was surprised to read their conclusions: “Specific integrative therapies can be recommended as evidence-based supportive care options during breast cancer treatment.”

How can this be? On this blog, we have repeatedly seen evidence to suggest that integrative medicine is little more than the admission of quackery into evidence-based healthcare. This got me wondering how their conclusion had been reached, and I checked the document even closer.

On the surface, it seemed well-made. A team of researchers first defined the treatments they wanted to look at, then they searched for RCTs, evaluated their quality, extracted their results, combined them into an overall verdict and wrote the whole thing up. In a word, they conducted what seems a proper systematic review.

Based on the findings of their review, they then issued recommendations which I thought were baffling in several respects. Let me just focus on three of the SIO’s recommendations dealing with acupuncture:

  1. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
  2. “Acupuncture can be considered for improving depressive symptoms in women suffering from hot flashes…” [RCTs (1 and 2) cited in support] 
  3. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
One or two studies as a basis for far-reaching guidelines? Yes, that would normally be a concern! But, at closer scrutiny, my worries about these recommendation turn out to be much more serious than this.

The actual RCT (1) cited in support of all three recommendations stated that the authors “randomly assigned 75 patients to usual care and 227 patients to acupuncture plus usual care…” As we have discussed often before on this blog and elsewhere, such a ‘A+B versus B study design’ will never generate a negative result, does not control for placebo-effects and is certainly not a valid test for the effectiveness of the treatment in question. Nevertheless, the authors of this study concluded that: “Acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life.”

RCT (2) cited in support of recommendation number 2 seems to be a citation error; the study in question is not an acupuncture-trial and does not back the statement in question. I suspect they meant to cite their reference number 87 (instead of 88). This trial is an equivalence study where 50 patients were randomly assigned to receive 12 weeks of acupuncture (n = 25) or venlafaxine (n = 25) treatment for cancer-related hot flushes. Its results indicate that the two treatments generated the similar results. As the two therapies could also have been equally ineffective, it is impossible, in my view, to conclude that acupuncture is effective.

Finally, RCT (1) does in no way support recommendation number two. Yet RCT (1) and RCT (2) were both cited in support of this recommendation.

I have not systematically checked any other claims made in this document, but I get the impression that many other recommendations made here are based on similarly ‘liberal’ interpretations of the evidence. How can the ‘Society for Integrative Oncology’ use such dodgy pseudo-science for formulating potentially far-reaching guidelines?

I know none of the authors (Heather Greenlee, Lynda G. Balneaves, Linda E. Carlson, Misha Cohen, Gary Deng, Dawn Hershman, Matthew Mumber, Jane Perlmutter, Dugald Seely, Ananda Sen, Suzanna M. Zick, Debu Tripathy) of the document personally. They made the following collective statement about their conflicts of interest: “There are no financial conflicts of interest to disclose. We note that some authors have conducted/authored some of the studies included in the review.” I am a little puzzled to hear that they have no financial conflicts of interest (do not most of them earn their living by practising integrative medicine? Yes they do! The article informs us that: “A multidisciplinary panel of experts in oncology and integrative medicine was assembled to prepare these clinical practice guidelines. Panel members have expertise in medical oncology, radiation oncology, nursing, psychology, naturopathic medicine, traditional Chinese medicine, acupuncture, epidemiology, biostatistics, and patient advocacy.”). I also suspect they have other, potentially much stronger conflicts of interest. They belong to a group of people who seem to religiously believe in the largely nonsensical concept of integrative medicine. Integrating unproven treatments into healthcare must affect its quality in much the same way as the integration of cow pie into apple pie would affect the taste of the latter.

After considering all this carefully, I cannot help wondering whether these ‘Clinical Practice Guidelines’ by the ‘Society for Integrative Oncology’ are just full of honest errors or whether they amount to fraud and scientific misconduct.

WHATEVER THE ANSWER, THE GUIDELINES MUST BE RETRACTED, IF THIS SOCIETY WANTS TO AVOID LOSING ALL CREDIBILITY.

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