MD, PhD, FMedSci, FSB, FRCP, FRCPEd

risk

The BMJ has always been my favourite Medical journal. (Need any proof for this statement? A quick Medline search tells me that I have over 60 publications in the BMJ.) But occasionally, the BMJ also disappoints me a great deal.

One of the most significant disappointments was recently published under the heading of STATE OF THE ART REVIEW. A review that is ‘state of the art’ must fulfil certain criteria; foremost it should be informative, unbiased and correct. The paper I am discussing here has, I think, neither of these qualities. It is entitled ‘Management of chronic pain using complementary and integrative medicine’, and here is its abstract:

Complementary and integrative medicine (CIM) encompasses both Western-style medicine and complementary health approaches as a new combined approach to treat a variety of clinical conditions. Chronic pain is the leading indication for use of CIM, and about 33% of adults and 12% of children in the US have used it in this context. Although advances have been made in treatments for chronic pain, it remains inadequately controlled for many people. Adverse effects and complications of analgesic drugs, such as addiction, kidney failure, and gastrointestinal bleeding, also limit their use. CIM offers a multimodality treatment approach that can tackle the multidimensional nature of pain with fewer or no serious adverse effects. This review focuses on the use of CIM in three conditions with a high incidence of chronic pain: back pain, neck pain, and rheumatoid arthritis. It summarizes research on the mechanisms of action and clinical studies on the efficacy of commonly used CIM modalities such as acupuncture, mind-body system, dietary interventions and fasting, and herbal medicine and nutrients.

The full text of this article is such that I could take issue with almost every second statement in it. Obviously, this would be too long and too boring for this blog. So, to keep it crisp and entertaining, let me copy the (tongue in cheek) ‘letter to the editor’ some of us published in the BMJ as a response to the review:

“Alternative facts are fashionable in politics these days, so why not also in healthcare? The article by Chen and Michalsen on thebmj.com provides a handy set of five instructions for smuggling alternative facts into medicine.

1. Create your own terminology: the term ‘complementary and integrated medicine’ (CIM) is nonsensical. Integrated medicine (a hotly disputed field) already covers complementary and conventional medicine.

2. Pretend to be objective: Chen and Michalsen elaborate on the systematic searches they conducted. But they omit hundreds of sources which do not support their message, which cherry-picks only evidence for the efficacy of the treatments they promote.

3. Avoid negativity: they bypass any material that might challenge what they include. For instance, when discussing therapeutic risks, they omit the disturbing lack of post-marketing surveillance: the reason we lack information on adverse events. They even omit to mention the many fatalities caused by their ‘CIM’.

4. Create an impression of thoroughness: Chen and Michalsen cite a total of 225 references. This apparent scholarly attention to detail masks their misuse of many of they list. Reference 82, for example, is employed to back up the claim that “satisfaction was lowest among complementary medicine users with rheumatoid arthritis, vasculitis, or connective tissue diseases”. In fact, it shows nothing of the sort.

5. Back up your message with broad generalisations: Chen and Michalsen conclude that “Taken together, CIM has an increasing role in the management of chronic pain, but high quality research is needed”. The implication is that all the CIMs mentioned in their figure 1 are candidates for pain control – even discredited treatments such as homeopathy.

In our view, these authors render us a service: they demonstrate to the novice how alternative facts may be used in medicine.”

James May, Edzard Ernst, Nick Ross, on behalf of HealthWatch UK

END OF QUOTE

I am sure you have your own comments and opinions, and I encourage you to post them here or (better) submit them to the BMJ or (best) both.

The question whether spinal manipulative therapy (SMT) is effective for acute low back pain is still discussed controversially. Chiropractors (they use SMT more regularly than other professionals) try everything to make us believe it does work, while the evidence is far less certain. Therefore, it is worth considering the best and most up-to-date data.

The  aim of this paper was to systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. The research question was straight forward: Is the use of SMT in the management of acute (≤6 weeks) low back pain associated with improvements in pain or function?

A through literature search was conducted to locate all relevant papers. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. The main outcome measures were pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks.

Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, −9.95 [95% CI, −15.6 to −4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, −0.39 [95% CI, −0.71 to −0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.

The authors concluded that among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.

This meta-analysis has been celebrated by chiropractors around the world as a triumph for their hallmark therapy, SMT. But there have also been more cautionary voices – not least from the lead author of the paper. Patients undergoing spinal manipulation experienced a decline of 1 point in their pain rating, says Dr. Paul Shekelle, an internist with the West Los Angeles Veterans Affairs Medical Center and the Rand Corporation who headed the study. That’s about the same amount of pain relief as from NSAIDs, over-the-counter nonsteroidal anti-inflammatory medication, such as ibuprofen. The study also found spinal manipulation modestly improved function. On average, patients reported greater ease and comfort engaging in two day-to-day activities — such as finding they could walk more quickly, were having less difficulty turning over in bed or were sleeping more soundly.

It’s not clear exactly how spinal manipulation relieves back pain. But it may reposition the small joints in the spine in a way that causes less pain, according to Dr. Richard Deyo, an internist and professor of evidence-based medicine at the Oregon Health and Science University. Deyo wrote an editorial published along with the study. Another possibility, Deyo says, is that spinal manipulation may restore some material in the disk between the vertebrae, or it may simply relax muscles, which could be important. There may also be mind-body interaction that comes from the “laying of hands” or a trusting relationship between patients and their health care provider, he says.

Deyo notes that there are many possible treatments for lower back pain, including oral medicine, injected medicine, corsets, traction, surgery, acupuncture and massage therapy. But of about 200 treatment options, “no single treatment is clearly superior,” he says.

In another comment by Paul Ingraham the critical tone was much clearer: “Claiming it as a victory is one of the best examples I’ve ever seen of making lemonade out of science lemons! But I can understand the mistake, because the review itself does seem positive at first glance: the benefits of SMT are disingenuously summarized as “statistically significant” in the abstract, with no mention of clinical significance (effect size; see Statistical Significance Abuse). So the abstract sounds like good news to anyone but the most wary readers, while deep in the main text the same results are eventually conceded to be “clinically modest.” But even even that seems excessively generous: personally, I need at least a 2-point improvement in pain on a scale of 10 to consider it a “modest” improvement! This is not a clearly positive review: it shows weak evidence of minor efficacy, based on “significant unexplained heterogeneity” in the results. That is, the results were all over the place — but without any impressive benefits reported by any study — and the mixture can’t be explained by any obvious, measurable factor. This probably means there’s just a lot of noise in the data, too many things that are at least as influential as the treatment itself. Or — more optimistically — it could mean that SMT is “just” disappointingly mediocre on average, but might have more potent benefits in a minority of cases (that no one seems to be able to reliably identify). Far from being good news, this review continues a strong trend (eg Rubinstein 2012) of damning SMT with faint praise, and also adds evidence of backfiring to mix. Although fortunately “no RCT reported any serious adverse event,” it seems that minor harms were legion: “increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.” That’s a lot of undesirable outcomes. So the average patient has a roughly fifty-fifty chance of up to roughly maybe a 20% improvement… or feeling worse to some unknown degree! That does not sound like a good deal to me. It certainly doesn’t sound like good medicine.”

END OF QUOTE

As I have made clear in many previous posts, I do fully agree with these latter statements and would add just three points:

  1. We know that many of the SMT studies completely neglect reporting adverse effects. Therefore it is hardly surprising that no serious complications were on record. Yet, we know that they do occur with sad regularity.
  2. None of the studies controlled for placebo effects. It is therefore possible – I would say even likely – that a large chunk of the observed benefit is not due to SMT per se but to a placebo response.
  3. It seems more than questionable whether the benefits of SMT outweigh its risks.

CBC news (Canada) reported yesterday that, more than a decade ago, the Manitoba Chiropractic Health Care Commission had been tasked to review the cost effectiveness of chiropractic services. It therefore prepared a report in 2004 for the Manitoba province and the Manitoba Chiropractors Association. Since then, this report has been kept secret. The report makes 37 recommendations, including:

  • Manitoba Health should limit its funding to “chiropractic treatment of acute lower back pain.”
  • Manitoba Health should provide “limited coverage of the treatment of neck pain.” The report called the literature around the efficacy of chiropractic care for neck pain “ambiguous or at best weakly supportive” and noted such treatment carried a “not insignificant safety risk.”
  • Manitoba Health should not fund chiropractic treatment anyone under 18 “as the literature does not unequivocally justify” the “efficacy or safety” of such treatment.

A Manitoba Ombudsman’s Office report from 2012 might shed some light on why the Manitoba Chiropractic Health Care Commission’s report was never made public. Someone had attempted to get a copy of the report, but large parts of it were redacted. “Access to this record was refused on the basis that disclosure would be harmful to a third party’s business interest,” the ombudsman report notes, “and harm the economic or financial interests or negotiating position of a public body.”

The report also challenged claims that chiropractic treatments can be address a wide variety of medical conditions. It stated that there was not enough evidence to conclude chiropractic treatments are effective in treating muscle tension, migraines, HIV, carpal tunnel syndrome, gastrointestinal problems, infertility or cancer, or as a preventive care treatment. It also said there was not enough evidence to conclude chiropractic treatments are effective for children.

The report urged Manitoba Health to establish a monitoring system to keep a closer eye on “the advertising practices of the Manitoba Chiropractors Association and its members to ensure claims regarding treatments are restricted to those for which proof of efficacy and safety exist.” It suggested the government should have regulatory powers over chiropractic ads.

A recent CBC I-Team investigation found Manitoba chiropractors advertising treatment for a wide range of conditions including Alzheimer’s, autism and pediatric services. The commission report contained sharp criticisms of previous reports that suggested funding chiropractic care could save the health-care system money. Dr. Pranlal Manga authored two widely cited reports which claim that by offering publicly funded chiropractic care, provinces can cut health-care costs. “The Manga study on Manitoba must be rejected as a guide to public policy,” the commission report states, “because its assumptions, methodology and costing of recommendations are all deeply flawed.” The reports states, “What limited evidence the Commission has suggests he [Manga] grossly exaggerates possible medical savings.” Dr. Manga did not respond to CBC’s repeated attempts to contact him.

The commission report also made recommendations around the use of X-ray machines by chiropractors. It suggested chiropractors not own and operate X-ray machines “Given the restrictive conditions under which X-rays are advisable, their poor correlation with low-back problems, their apparent limitation as a guide to appropriate treatment …[and] the apparent complete lack of monitoring [of] the use of X-ray by chiropractors.”  Instead, it recommended consulting with radiologists when imaging is deemed necessary. “The Commission is of the view that the public interest, and even chiropractic itself, would be better served if chiropractors had access to radiologists for this service, rather than perform it themselves,” the report said.

All three report authors declined comment. Calls to Dave Chomiak, who was health minister at the time the report was prepared, were not returned. In an email to CBC, Manitoba Chiropractors Association president Perry Taylor said, “I personally have never seen this 13-year-old document and [it] pre-dates my time as President. As such I have no comment on this.” The CBC I-Team offered to go through the report with Taylor but he did not respond.

MY COMMENT:

This report seems to confirm much of what we have discussed repeatedly on this blog: Chiropractic is not nearly as effective and safe as chiropractors try to make us believe. To hide this fact is certainly dishonest and unethical, but it is in some ways understandable: this knowledge would directly threaten the income of most chiropractors.

Yesterday I commented on another post: “the conflict of interest seems obvious: if homeopaths speak the truth, they are out of business. therefore, they are taught untruths from the first day of their training and eventually end up believing them. there is only one solution, as far as I can see: regulators must prevent them from making false claims. if not, this will go on for another 200 years and damage many patients’ health”. In the light of the above report, I will now re-phrase this: the conflict of interest seems obvious: if chiropractors allowed the truth to be known, they would soon be out of business. Therefore, they are taught untruths from the first day of their training and many end up believing them. There is only one solution, as far as I can see: regulators must prevent chiropractors from making false claims. If not, this abuse will go on for another 120 years and damage many patients’ health.

Charlotte Leboeuf-Yde, DC,MPH,PhD, is professor in Clinical Biomechanics at the University of Southern Denmark and works at the French-European Institute of Chiropractic in Paris. She is a chiropractor with extensive research experience, for example, she was one of the first chiropractors to have studied adverse reactions of spinal manipulation.

Charlotte certainly knows a thing or two about adverse effects of spinal manipulation, and I have always found her work interesting. Therefore, I was delighted to find a recent blog post where she discussed the Cassidy study of 2008 and two opposed views on the validity of this much-discussed paper.

One team (Paulus &Thaler) argued, Charlotte explained, that the Cassidy case-control study is faulty, because vertebro-basilar stroke in general was not separated from stroke specifically caused by vertebral artery dissections, the presumed culprit in cervical spinal manipulation. According to Paulus & Thaler, this would potentially result in a dilution of ‘real’ manipulative-related strokes among all other causes of stroke that are much more common. They argue that the Cassidy-analyses therefore were polluted by this misclassification, whereas the other team (Murphy et al) vehemently disagrees.

The final word is clearly not yet pronounced on this issue, Charlotte concluded, and both teams agree that research has to address various methodological challenges to obtain a trustable answer. Nevertheless, without an international collaboration involving prospective cases this seems an almost impossible task, particularly in view of the rarity of the condition; problems in capturing all cases (going from the reversible to the permanent injuries); the likely large anatomical and physiological variations between individuals; and the daunting task of obtaining relevant and precise descriptions of treatments from a multitude of practitioners.

In the meantime, Charlotte concluded, “practitioners and patients have to make a decision, similarly to judging risk in other walks of life, such as, should I take the plane or stay at home?”

I have always thought highly of Charlotte’s work, however, her conclusion made me doubt whether my high opinion of her reasoning was justified.

Should I take the plane or stay at home?

This question is not remotely similar to the question “should I have chiropractic upper neck manipulation or not?”

Here are a the two main reasons why:

  • Taking the plane of demonstrably effective in transporting you from A to B, while neck manipulation is not demonstrably effective for anything.
  • If you want to go from A to B [assuming B is far way], you need to fly. If you have neck pain or other symptoms, you can employ plenty of therapies other than neck manipulations.

Charlotte Leboeuf-Yde, DC,MPH,PhD, may be a professor in Clinical Biomechanics etc., etc., however, logical and critical thinking do not seem to be her forte.

So, how should we deal with the risks of chiropractic neck manipulations? I think, we should deal with them as responsible healthcare professionals deal with any other suspected therapeutic risks: we must ask whether the known risks of the treatment outweigh the known benefits (as they do with spinal manipulation). If that is so, we have an ethical, legal and moral duty not to employ the therapy in question in routine care. At the same time, we must focus or research efforts on producing full clarity about the open questions. It’s called the precautionary principle!

Tui Na is a massage technique that is based on the Taoist principles of TCM. It involves a range of manipulations usually performed by an operator’s finger, hand, elbow, knee, or foot applied to muscle or soft tissue at specific parts of the body. According to one website of TCM-proponents “Tui Na makes use of various hand techniques in combination with acupuncture and other manipulation techniques. To enhance the healing process, the practitioner may recommend the use of Chinese herbs. Many of the techniques used in this massage resemble that of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing and shaking. In Tui Na massage, the muscles and tendons are massaged with the help of hands, and an acupressure technique is applied to directly affect the flow of Qi at different acupressure points of the body, thus facilitating the healing process. It removes the blockages and keeps the energy moving through the meridians as well as the muscles. A typical session of Tui Na massage may vary from thirty minutes to an hour. The session timings may vary depending on the patient’s needs and condition. The best part of the therapy is that it relaxes as well as energizes the person. The main benefit of Tui Na massage is that it focuses on the specific problem, whether it is an acute or a chronic pain associated with the joints, muscles or a skeletal system. This technique is very beneficial in reducing the pain of neck, shoulders, hips, back, arms, highs, legs and ankle disorders. It is a very effective therapy for arthritis, pain, sciatica and muscle spasms. Other benefits of this massage therapy include alleviation of the stress related disorders like insomnia, constipation, headaches and other disorders related to digestive, respiratory and reproductive systems. The greatest advantage of Tui Na is that it focuses on maintaining overall balance with both physical and mental health. Any one who wants to avoid the side effects of drugs or a chemical based treatment can adopt this effective massage technique to alleviate their pain. Tui Na massage therapy is now becoming a more common therapy method due to its focus on specific problems rather than providing a general treatment.”

This clearly begs the question IS IT EFFECTIVE?

This systematic review assessed the evidence of Tui Na for cervical radiculopathy. Seven databases were searched. Randomised controlled trials (RCTs) incorporating Tui Na alone or Tui Na combined with conventional treatment were included. Five studies involving 448 patients were found. The pooled analysis from the 3 trials indicated that Tui Na alone showed a significant lowering immediate effects on pain score with moderate heterogeneity compared to cervical traction. The meta-analysis from 2 trials revealed significant immediate effects of Tui Na plus cervical traction in improving pain score with no heterogeneity compared to cervical traction alone. None of the RCTs mentioned adverse effects. There was very low quality or low quality evidence to support the results.

The authors concluded that “Tui Na alone or Tui Na plus cervical traction may be helpful to cervical radiculopathy patients, but supportive evidence seems generally weak. Future clinical studies with low risk of bias and adequate follow-up design are recommended.”

In my view, this is a misleading conclusion. A correct one would have been: THE CURRENT EVIDENCE IS INSUFFICIENT TO DRAW ANY CONCLUSIONS ABOUT THE EFFECTIVENESS OF TUI NA.

Why?

Here are some of the most obvious reasons:

Personally, I am getting very tired of conclusions stating ‘…XY MAY BE EFFECTIVE/HELPFUL/USEFUL/WORTH A TRY…’ It is obvious that the therapy in question MAY be effective, otherwise one would surely not conduct a systematic review. If a review fails to produce good evidence, it is the authors’ ethical, moral and scientific obligation to state this clearly. If they don’t, they simply misuse science for promotion and mislead the public. Strictly speaking, this amounts to scientific misconduct.

How Jackfruit Kills Cancer… This title hardly left any doubt that jackfruit (Artocarpus heterophyllus Lam) is effective in curing cancer. The website continued in this vein:

“Jackfruit contains phytonutrients like lignans, saponins, and isoflavones, which have anticancer, antihypertensive, anti-ulcer, antioxidant, and anti-aging properties (2).

Lignans are tissue-selective phytoestrogens that have anti-estrogenic effects in reproductive tissues that can be beneficial in preventing the hormone-associated cancers of the breast, uterus, ovary, and prostate. It may also help maintain bone density (3).

Isoflavones are also beneficial phytoestrogens that have been proven to reduce the risk of breast, endometrial, and prostate cancers (4,5).

Saponins, on the other hand, kill cancer cells by directly binding to cells as well as boosting white blood cell activity and preventing cell differentiation and proliferation (6,7).

Hình ảnh có liên quan

Lastly, the cancer-preventing abilities of the fruit are due in part to dietary TF-binding lectins (8). The pulp has the ability to reduce the mutagenicity of carcinogens and combat the proliferation of cancer cells (9).

In addition, the fruit contains carotenoids, flavonoids, and polyphenols that lower blood pressure, fight stomach ulcers, boost metabolism, support nerve function, and play a role in hormone synthesis. They also contain polysaccharides that boost immunity by interacting with white blood cells, including T cells, monocytes, macrophages, and polymorphonuclear lymphocytes (10).

Each part of the fruit and tree can be used: the flowers help stop bleeding in open wounds, prevent ringworm infestations, and heal cracks in dry feet while the root is used to treat skin diseases, asthma, and diarrhea. Additionally, the wood has a sedative and abortifacient effect…”

END OF QUOTE

To many desperate cancer patients, this would sound convincing, not least because the references provided by the author look sophisticated and seem to back up most of the claims made.

But where are the references to clinical trials showing that jackfruit does cure this or that type of cancer? Where is the evidence that it does “lower blood pressure, fight stomach ulcers, boost metabolism, support nerve function, and play a role in hormone synthesis”? Where are the data to prove that it does “boost immunity”?

I did conduct a ‘rough and ready’ Medline search and found precisely nothing; not a single clinical trial that would confirm the multiple claims made above.

You are not surprised?

Neither am I!

But what about the desperate cancer patients?

How many fell for the scam? How many gave up their conventional cancer treatments and used jackfruit instead? How many consumers know that it is not unusual for plants to contain lignans, saponins, isoflavones and many other ingredients that have amazing effects in vitro? How many know that this rarely translates into meaningful health effects in human patients?

We will never know.

One thing we do know, however, is that articles like this one can cost lives, and that alternative cancer cures are and always will be a myth.

Is spinal manipulative therapy (SMT) dangerous? This question has kept us on this blog busy for quite some time now. To me, there is little doubt that SMT can cause adverse effects some of which are serious. But many chiropractors seem totally unconvinced. Perhaps this new overview of reviews might help to clarify the issue. Its aim was to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.

The authors searched five electronic databases from inception to December 8, 2015 and included reviews on any type of studies, patients, and SMT technique. The primary outcome was SAEs. The quality of the included reviews was assessed using a measurement tool to assess systematic reviews (AMSTAR). Since there were insufficient data for calculating incidence rates of SAEs, they used an alternative approach; the conclusions regarding safety of SMT were extracted for each review, and the communicated opinion were judged by two reviewers independently as safe, harmful, or neutral/unclear. Risk ratios (RRs) of a review communicating that SMT is safe and meeting the requirements for each AMSTAR item, were calculated.

A total of 283 eligible reviews were identified, but only 118 provided data for synthesis. The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT is safe, 15 (13%) expressed that SMT is harmful, and 49 reviews (42%) were neutral or unclear. Thirteen reviews reported incidence estimates for SAEs, roughly ranging from 1 in 20,000 to 1 in 250,000,000 manipulations. Low methodological quality was present, with a median of 4 of 11 AMSTAR items met (interquartile range, 3 to 6). Reviews meeting the requirements for each of the AMSTAR items (i.e. good internal validity) had a higher chance of expressing that SMT is safe.

The authors concluded that it is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.

This article is valuable, if only for the wealth of information one can extract from it. There are, however, numerous problems. One is that the overview included mostly reviews of the effectiveness of SMT for various conditions. We know that studies of SMT often do not even mention AEs. If such studies are then pooled in a review, they inevitably generate an impression of safety. But this would, of course, be a false-positive result!

The authors of the overview are aware of this problem and address it in the following paragraph: “When only considering the subset of reviews, where the objective was to investigate AEs (37 reviews), then 8 reviews (22%) expressed that SMT is safe, 13 reviews (35%) expressed that SMT is harmful and 16 reviews (43%) were neutral or unclear regarding the safety of SMT. Hence, there is a tendency that a bigger proportion of these reviews are expressing that SMT is harmful compared to the full sample of reviews…”

To my surprise, I found several of my own reviews in the ‘neutral or unclear’ category. Here are the verbatim conclusions of three of them:

  1. It is concluded that serious cerebrovascular complications of spinal manipulation continue to be reported.
  2. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome.
  3. These data indicate that mild and transient adverse events seem to be frequent. Serious adverse events are probably rare but their incidence can only be estimated at present.

I find it puzzling how this could be classified as neutral or unclear. The solution of the puzzle might lie in the methodology used: “we appraised the communicated opinions of each review concerning the safety of SMT based on their conclusions regarding the AEs and SAEs. This was done by two reviewers independently (SMN, LK), who judged the communicated opinions as either ‘safe’, ‘neutral/unclear’ or ‘harmful’, based on the qualitative impression the reviewers had when reading the conclusions. The reviewers had no opinion about the safety/harmfulness of SMT before commencing the judgements. Cohen’s weighted Kappa was calculated for the agreement between the reviewers, with a value of 0.40–0.59 indicating ‘fair agreement’, 0.60–0.74 indicating ‘good agreement’ and ≥0.75 indicating ‘excellent agreement’. Disagreements were resolved by a third reviewer (MH).”

In other words, the categorisation was done on the basis of subjective judgements of two researchers. It seems obvious that, if their attitude was favourable towards SMT, their judgements would be influenced. The three examples from my own work cited above indicates to me that their verdicts were indeed far from objective.

So what is the main message here? In my view, it can be summarized in the following quote from the overview: “a bigger proportion of these reviews are expressing that SMT is harmful …”

Yes, yes, yes – I know that, if you are a chiropractor (or other practitioner using mostly SMT), you are unlikely to agree with this!

Perhaps you can agree with this statement then:

As long as there is reasonable doubt about the safety of SMT, and as long as we cannot be sure that SMT generates more good than harm, we should be very cautious using it for routine healthcare and do rigorous research to determine the truth (it’s called the precautionary principle and applies to all types of healthcare).

Traditional and folk remedies have been repeatedly been reported to contain toxic amounts of lead. I discussed this problem before; see here, here, and here. Recently, two further papers were published which are relevant in this context.

In the first article, Indian researchers presented a large series of patients with lead poisoning due to intake of Ayurvedic medicines, all of whom presented with unexplained abdominal pain.

In a retrospective, observational case series from a tertiary care center in India, the charts of patients who underwent blood lead level (BLL) testing as a part of workup for unexplained abdominal pain between 2005 and 2013 were reviewed. The patients with lead intoxication (BLLs >25 μg/dl) were identified and demographics, history, possible risk factors, clinical presentation and investigations were reviewed. Treatment details, duration, time to symptomatic recovery, laboratory follow-up and adverse events during therapy were recorded.

BLLs were tested in 786 patients with unexplained abdominal pain, and high levels were identified in 75 (9.5%) patients of which a majority (73 patients, 9.3%) had history of Ayurvedic medication intake and only two had occupational exposure. Five randomly chosen Ayurvedic medications were analyzed and lead levels were impermissibly high (14-34,950 ppm) in all of them. Besides pain in abdomen, other presenting complaints were constipation, hypertension, neurological symptoms and acute kidney injury. Anemia and abnormal liver biochemical tests were observed in all the 73 patients. Discontinuing the Ayurvedic medicines and chelation with d-penicillamine led to improvement in symptoms and reduction in BLLs in all patients within 3-4 months.

The authors of this paper concluded that the patients presenting with severe recurrent abdominal pain, anemia and history of use of Ayurvedic medicines should be evaluated for lead toxicity. Early diagnosis in such cases can prevent unnecessary investigations and interventions, and permits early commencement of the treatment.

The second article German researchers analysed 20 such ‘natural health products’ (NHPs) from patients with intoxication symptoms. Their findings revealed alarming high concentrations of mercury and/or lead (the first one in “therapeutic” doses). 82 % of the studied NHPs contained lead concentrations above the EU limit for dietary supplements. 62 % of the samples exceeded the limit values for mercury. Elevated blood lead and mercury levels in patients along with clinical intoxication symptoms corroborate the causal assumption of intoxication (s).

The authors concluded that, for NHPs there is evidence on a distinct toxicological risk with alarming low awareness for a possible intoxication which prevents potentially life-saving diagnostic steps in affected cases. In many cases patients do not communicate the events to their physicians or the local health authority so that case reports (e.g. the BfR-DocCentre) are missing. Thus, there is an urgent need to raise awareness and to initiate more suitable monitory systems (e.g. National Monitoring of Poisonings) and control practice protecting the public.

The authors of the 2nd paper also reported a detailed case report:

Patient, male, 31 with BMI slightly below normal, non-smoker, was referred to the neurological department of the university clinic with severe peripheral poly neuropathy and sensory motor symptoms with neuropathic pain. The patient was in good general state of health until approximately 3 weeks before hospital admission; he spent his holiday in Himalaya region and came back with headaches and fatigue. He was taking pain medication without any relieve; his routine blood values were normal. He claimed to take no further medications. Since poly neuropathy and fatigue could be caused by pesticides or other poisoning, i.e. heavy metals, we have been consulted for taking a detailed exposure history. While in the clinic, 3 different NHPs were found in form of globules, (a, b, c for morning, lunch time and evening respectively), which he imported from his trip to Asia and ingested 3 times a day against stress. We have analyzed these 3 NHPs and found: 45 μg/g, 53,000 μg/g and 28 μg/g lead (for morning, midday and evening globules, respectively) and additionally 15.72 μg/g mercury in the “evening globules”. Since, his blood metal levels were: 340 μg/L Pb and 15 μg/L Hg a diagnosis of heavy metal intoxication was made. Slowly occurring clinical recovery after starting chelation therapy corroborated with the causal assumption proposed. He was released for further consultancy to his family physician. The administrated treatment and the improvement of his status corroborate lead and mercury intoxication.

The researchers finish their paper with this stark warning: In many countries, even in Germany, no comprehensive nutria vigilance- or poisoning monitoring system exists, from which the application of natural health products and the consequent intoxication can be estimated. There is also an urgent need for comprehensive scientifically evaluated studies based on efficient national monitoring to protect the consumer from heavy metal intoxications. There are no comparable surveillance systems like the US ABLES program for lead- and no surveillance systems for mercury exposures allowing any comparisons. Exposure to lead and mercury from environmental sources remains an overlooked and serious public health risk.

In the realm of alternative medicine, the Internet is a double-edged sword. It can be most useful to many, particularly to those who are able to think critically. To those who do not have this ability, it can be outright dangerous. We have researched this area in several way and always arrived at this very conclusion. For instance, we evaluated websites providing advice for cancer patients and concluded that “the most popular websites on complementary and alternative medicine for cancer offer information of extremely variable quality. Many endorse unproven therapies and some are outright dangerous.”

This makes it abundantly clear that, for some, the Internet can become a danger to their health and life. Recently I was reminded of this fact when I saw this website entitled ‘Foods that will naturally cleanse your arteries’. Its message is instantly clear, particularly as it provides this impressive drawing.

.

The implication here is that we can all clear our arteries of atherosclerotic plaques by eating the right foods. The site also lists the exact foods. Here they are:

START OF QUOTE

Salmon

Salmon is one of the best heart foods as it is packed with healthy fats which reduce cholesterol, triglycerides, and inflammation. However you must make sure that the fish is organic.

 

Orange juice

Orange juice is rich in antioxidants which strengthens the blood vessels and lowers blood pressure. Simply drink 2 glasses of fresh orange juice a day and you’re good to go.

 

Coffee

According to numerous studies 2-4 cups of coffee a day can significantly reduce the risk of stroke and heart attack by 20%. However don’t drink excessively as it may cause problems with your digestion.

 

Nuts

Nuts are packed with omega-3 fatty acids, healthy properties and unsaturated fats which regulate your memory, cholesterol and prevent joint pain.

 

Persimmon fruit

The persimmon fruit is packed with fiber and sterols which help lower cholesterol. It makes a great addition to salads and cereals

 

Turmeric

Curcumin, the active ingredient in turmeric provides a large variety of health benefits. It helps reduce tissue inflammation and prevents overactive fat accumulation. Feel free to add it to your meals or to your tasty cup of tea.

 

Green tea

Aside from having a soothing effect, green tea helps energize the whole body, boost the metabolism and lower the absorption of cholesterol. Just drink 1-2 cups of green tea a day and you have nothing to worry about.

 

Cheese

Cheese can also help lower blood pressure and cholesterol.

 

Watermelon

Watermelon is the most delicious summer fruit. But aside from its amazing taste, it also improves the production of nitric oxide which enhances the function of the blood vessels.

 

Whole grain

Whole grains are rich in fiber content which helps lower cholesterol and cholesterol accumulation in the arteries. Consume more whole grain bread, brown rice and oats.

 

Cranberries

Cranberries have been long known to be the richest source of potassium. Due to this, they can easily lower bad cholesterol and increase the good one. 2 glasses of cranberry juice a day can lower the risk of heart attack by 40%.

 

Seaweed

Seaweeds are packed with vitamins, proteins, minerals and carotenoids which easily regulate your blood pressure.

 

Cinnamon

Cinnamon prevents buildups in the arteries and lower cholesterol.

 

Pomegranate

It is an exotic fruit that provides a healthy portion of phytochemicals. These improve the production of nitric oxide, and boost circulation. Add pomegranate seeds to your salads.

 

Spinach

It is high in folic acid and potassium. You need this to lower your blood pressure, strengthen muscles, and prevent heart attack.

 

Broccoli

Broccoli is rich in vitamin K, which help lower blood pressure and cholesterol when eaten steam-cooked or raw.

 

Olive oil

Olive oil helps maintain your health at its peak. Be sure to use cold-pressed oil as it is rich in healthy fats which lower cholesterol and reduce the risk of heart attack by 40%.

 

Asparagus

Asparagus prevents inflammation, clogging and lowers cholesterols. Implement it to dishes, noodles, soups or potatoes.

 

Blueberries

Blueberries are high in potassium and as we mentioned above, potassium is the key to reducing bad cholesterol and increasing the good one. Drink 2 glasses of blueberry juice a day.

 

Avocado

Avocadoes are without a doubt – one of the healthiest fruits known to man. They’re rich in healthy fat and improve the balance of bad and good cholesterol.

 

END OF QUOTE

As far as I know, there is no good evidence for the claim that any of these 20 foods will clear arteriosclerotic arteries. There is some evidence for fish oil and some for green tea to reduce the risk of cardiovascular disease. But surely, this is quite a different matter than reversing atherosclerotic plaques.

What’s the harm? I believe the potential for harm is obvious: people at high risk of suffering a major cardiovascular event who read such nonsense and believe it might think they can abandon the treatments, drugs and life-styles they have been advised to follow and take. Instead they might eat a bit more of the 20 ingredients listed above. If they did that, many would die.

I think many of us who know better have become far too tolerant of dangerous nonsense of such nature. We tend to think that either nobody is as stupid as to follow such silly advice, or we assume that taking a bit of daft advice will not do much harm. I fear we are wrong on both accounts.

 

 

Yes, I am afraid it is Dana Ullman again!

On the last post, he commented: “If you actually think that homeopathic medicines will KILL people, then, we all must assume that you think that conventional medicines create MASS MURDERS.”

In my view, this is a sad comment indeed. It reveals that a homeopath who has, after all, been in the business for decades has really very little idea about what makes an intervention a potentially good or a bad treatment.

Is it its efficacy?

No!

Is it its safety?

No!

IT IS THE RATIO OF THE TWO!!!

For the Ullmans of this world, I provide two very simple examples:

  1. One could prevent a common cold effectively with interferon. Why don’t we do this routinely? Because the benefit would not out-weigh its harm.
  2. We all know that chemotherapy can have terrible adverse effects. Why do we nevertheless use it for cancer? Because the benefits of saving a life out-weigh all the significant harm chemotherapy might do.

The conclusion is simple: to be useful, a therapy must demonstrably generate more good than harm. If there is no effectiveness, the risk/benefit balance can never be positive, even if the risks are relatively small. But risk/benefit balance can still be favourable, even if the therapy causes considerable harm.

This hardly is rocket science, is it? But the Ullmans of this world do refuse to get it, and that is sad, in my view. This ignorance is the basis for the fundamentally misguided advice they issue to their patients day in, day out.

What is more, the Ullmans of this world stubbornly deny that anyone can do significant harm with homeopathic remedies; they evidently think that homeopathy cannot kill patients. Yet they are evidently wrong.

Whenever the simple rules of risk/benefit are ignored, even apparently harmless treatments, like highly diluted homeopathic remedies, can – and sadly will – kill patients.

I suspect that the Ullmans of this world are still in closed-minded denial about this point. Let me therefore quote a few of my own posts where cases of ‘death by homeopathy’ have been mentioned:

I fear that the Ullmans of this world will still not be convinced. Perhaps a look at this website might do the trick? No, probably not – changing one’s mind vis a vis facts requires intelligence. They will carry on claiming that, in comparison, “conventional medicines creates MASS MURDERS”.

And this is where we go full circle and I start again explaining about the balance of risk and benefit…

GIVE ME STRENGTH!!!

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