Rapidly rising in popularity, kratom is hailed by some as a readily available pain remedy that is safer than traditional opioids, an effective addiction withdrawal aid and a pleasurable recreational tonic. But kratom also is assailed as a dangerous and unregulated drug that can be purchased on the Internet, a habit-forming substance that authorities say can result in opioid-like abuse and death.
Last week, the Food and Drug Administration announced that the herbal supplement kratom possesses the properties of an opioid, thus escalating the government’s effort to slow usage of this alternative pain reliever. The FDA states that the number of deaths associated with kratom use has increased to a total of 44, up from a total of 36 since the FDA’s November 2017 report. In the majority of deaths that FDA attributes to kratom, subjects ingested multiple substances with known risks, including alcohol. The presence of multiple drugs makes it difficult to determine the role any one of them played.
So, what is kratom, and why might it be dangerous?
A recent review explains that the leaves of Mitragyna speciosa (commonly known as kratom), a tree endogenous to parts of Southeast Asia, have been used traditionally for their stimulant, mood-elevating, and analgesic effects. The plant’s active constituents, mitragynine and 7-hydroxymitragynine, have been shown to modulate opioid receptors, acting as partial agonists at mu-opioid receptors and competitive antagonists at kappa- and delta-opioid receptors. Both alkaloids are G protein-biased agonists of the mu-opioid receptor and therefore, may induce less respiratory depression than classical opioid agonists. The Mitragyna alkaloids also appear to exert diverse activities at other brain receptors (including adrenergic, serotonergic, and dopaminergic receptors), which may explain the complex pharmacological profile of raw kratom extracts. Kratom exposure alone has not been causally associated with human fatalities to date. However, further research is needed to clarify the complex mechanism of action of the Mitragyna alkaloids and unlock their full therapeutic potential.
Another review adds that, by the early 2000s, kratom was increasingly used in the US as a natural remedy to improve mood and quality of life and as substitutes for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There has been no documented threat to public health that would appear to warrant emergency scheduling of the products and placement in Schedule I of the CSA carries risks of creating serious public health problems. Banning kratom, risks creating public health problems that do not presently exist.
A third review explains that there are no published human pharmacologic, pharmacokinetic, or drug interaction studies on kratom or mitragynine, making it virtually impossible to fully understand kratom‘s therapeutic potential and risks and the populations most likely to benefit or experience harm from its use. Kratom has been used to ameliorate opioid withdrawal symptoms but also induces withdrawal. Human pharmacologic, pharmacokinetic and clinical data are of low quality precluding any firm conclusions regarding safety and efficacy. Kratom does cause a host of adverse effects without clear guidance for how they should be treated. There are numerous assessments where people have been unable to stop using kratom therapy and withdrawal signs and symptoms are problematic. Kratom does not appear in normal drug screens and, when taken with other substances of abuse, may not be recognized.
A systematic review evaluated all studies on kratom use and mental health published between January 1960 and July 2017. Its findings indicate kratom‘s potential as a harm reduction tool, most notably as a substitute for opioids among people who are addicted. Kratom also enhances mood and relieves anxiety among many users. For many, kratom‘s negative mental health effects – primarily withdrawal symptoms – appear to be mild relative to those of opioids. For some users, however, withdrawal is highly uncomfortable and maintaining abstinence becomes difficult.
In Europe, as of 2011, kratom has become a controlled drug in Denmark, Latvia, Lithuania, Poland, Romania and Sweden. In the UK, since 2016, the sale, import, and export of kratom are prohibited.
On balance, my conclusion is that we urgently need more data and meanwhile should avoid this ‘herbal drug’.
This announcement caught my eye:
START OF 1st QUOTE
Dr Patrick Vickers of the Northern Baja Gerson Centre, Mexico will deliver a two hour riveting lecture of ‘The American Experience of Dr Max Gerson, M.D.’
The lecture will present the indisputable science supporting the Gerson Therapy and its ability to reverse advanced disease.
Dr Vickers will explain the history and the politics of both medical and governmental authorities and their relentless attempts to surpress this information, keeping it from the world.
‘Dr Max Gerson, Censored for Curing Cancer’
“I see in Dr Max Gerson, one of the most eminent geniuses in medical history” Nobel Prize Laureate, Dr Albert Schweitzer.
END OF 1st QUOTE
Who is this man, Dr Patrik Vickers, I asked myself. And soon I found a CV in his own words:
START OF 2nd QUOTE
Dr. Patrick Vickers is the Director and Founder of the Northern Baja Gerson Clinic. His mission is to provide patients with the highest quality and standard of care available in the world today for the treatment of advanced (and non-advanced) degenerative disease. His dedication and commitment to the development of advanced protocols has led to the realization of exponentially greater results in healing disease. Dr. Vickers, along with his highly trained staff, provides patients with the education, support, and resources to achieve optimal health.
Dr. Patrick was born and raised outside of Milwaukee, Wisconsin. At the age of 11 years old, after witnessing a miraculous recovery from a chiropractic adjustment, Dr. Patrick’s passion for natural medicine was born.
Giving up careers in professional golf and entertainment, Dr. Patrick obtained his undergraduate degrees from the University of Wisconsin-Madison and Life University before going on to receive his doctorate in Chiropractic from New York Chiropractic College in 1997.
While a student at New York Chiropractic College(NYCC), Dr. Patrick befriended Charlotte Gerson, the last living daughter of Dr. Max Gerson, M.D. who Nobel Peace Prize Winner, Dr. Albert Schweitzer called, ” One of the most eminent geniuses in medical history. “
Dr. Gerson, murdered in 1959, remains the most censured doctor in the history of medicine as he was reversing virtually every degenerative disease known to man, including TERMINAL cancer…
END OF 2nd QUOTE
I have to admit, I find all this quite upsetting!
Not because the ticket for the lecture costs just over £27.
Not because exploitation of vulnerable patients by quacks always annoys me.
Not even because the announcement is probably unlawful, according to the UK ‘cancer act’.
I find it upsetting because there is simply no good evidence that the Gerson therapy does anything to cancer patients other than making them die earlier, poorer and more miserable (the fact that Prince Charles is a fan makes it only worse). And I do not believe that the lecture will present indisputable evidence to the contrary – lectures almost never do. Evidence has to be presented in peer-reviewed publications, independently confirmed and scrutinised. And, as far as I can see, Vickers has not authored a single peer-reviewed article [however, he thrives on anecdotal stories via youtube (worth watching, if you want to hear pure BS)].
But mostly I find it upsetting because it is almost inevitable that some desperate cancer patients will believe ‘Dr’ Vickers. And if they do, they will have to pay a very high price.
Sorry, but something I stated in my last post was not entirely correct!
I wrote that “I could not find a single study on Schuessler Salts“.
Yet, I do know of a ‘study’ of Schuessler Salts after all; I hesitate to write about it because it is an exceedingly ugly story that goes back to the ‘Third Reich’, and some people do not seem to appreciate me reporting about my research on this period.
The truth, however, is that I already did mention the Schuessler salts before on this blog: “…in 1941 a research unit was established in ‘block 5’ [of the Dachau Concetration Camp] which, according to Rascher’s biographer, Sigfried Baer, contained his department and a homeopathic research unit led by Hanno von Weyherns and Rudolf Brachtel (1909-1988). I found the following relevant comment about von Weyherns: “Zu Jahresbeginn 1941 wurde in der Krankenabteilung eine Versuchsstation eingerichtet, in der 114 registrierte Tuberkulosekranke homöopathisch behandelt wurden. Leitender Arzt war von Weyherns. Er erprobte im Februar biochemische Mittel an Häftlingen.” My translation: At the beginning of 1941, an experimental unit was established in the sick-quarters in which 114 patients with TB were treated homeopathically. The chief physician was von Weyherns. In February, he tested Schuessler Salts [a derivative of homeopathy still popular in Germany today] on prisoners.”
Wikipedia provides further details: [Im Dritten Reich] konnten erstmals mit staatlicher Billigung und Förderung Untersuchungen durchgeführt werden, in denen die behauptete Wirksamkeit „biochemischer“ Arzneimittel überprüft wurde. Solche Versuche fanden auch in den Konzentrationslagern Dachau und Auschwitz statt, unter Leitung des Reichsarztes SS Ernst-Robert Grawitz. Dabei wurden unter anderem künstlich herbeigeführte Fälle von Blutvergiftung und Malaria weitgehend erfolglos behandelt. Für die Häftlinge nahmen diese Experimente in den meisten Fällen einen tödlichen Ausgang.
My translation: During the Third Reich, it became possible for the first time possible to conduct with governmental support investigations into the alleged effectiveness of ‘biochemical’ Schuessler Salts. Such tests were carried out in the concentration camps of Dachau and Auschwitz under the leadership of Reichsarzt SS Ernst-Robert Grawitz. They involved infecting prisoners with sepsis and malaria and treating them – largely without success. Most of the prisoners used for these experiments died.
I also found several further sources on the Internet. They confirm what was stated above and also mention the treatment of TB with Schuessler Salts. Furthermore, they state that the victims were mostly Polish priests:
- Versuchsstation im Krankenrevier des KZ Dachau, in der Tuberkulosekranke mit homöopathischen Mitteln behandelt werden. Leitender Arzt ist Dr. von Weyherns, 114 Versuchspersonen sind registriert.
- Zu Jahresbeginn 1941 wurde in der Krankenabteilung eine Versuchsstation eingerichtet, in der 114 registrierte Tuberkulosekranke homöopathisch behandelt wurden. Leitender Arzt war von Weyherns.
- Dr. Rudolph Kießwetter, (andere Schreibweise: Kiesewetter), Biochemiker aus Magdeburg, spritzte 10 Häftlingen Eiter in die Oberschenkel bzw. in die Venen, 7 starben. (Experimente mit Entzündungen: vgl. Sulfonamid-Experimente von Karl Gebhardt)
- Mitte Juni 1942 wurde Heinrich Schütz Leiter der Biochemischen Versuchsstation im Krankenrevier des Konzentrationslagers Dachau. Dort erprobte er biochemische Heilmittel an Häftlingen, die er mit bakteriellen Eitererregern infiziert hatte. Die Opfer waren vor allem polnische Priester im Pfarrerblock (KZ Dachau). Hintergrund war die These, dass Krankheiten auf einer Störung der Gewebesalze in den Körperzellen beruhen und durch Mineralzufuhr in homöopathischer Verdünnung geheilt werden könnten. Obwohl die meisten Versuche mit dem Tod der Erkrankten endeten, wurden die biochemischen Mittel weiter erprobt, ungeachtet der Tatsache, dass mit den Sulfonamiden wirksame Medikamente zur Verfügung standen. Bei diesen Versuchen halfen ihm unter anderem Waldemar Wolter und Karl Babor.
- Ab Mitte Juni 1942 waren Babor und Waldemar Wolter Assistenzärzte in der „Biochemischen Versuchsstation“ im KZ Dachau. Dort wurden unter der Leitung von Heinrich Schütz an Häftlingen Sepsisversuche durchgeführt, um die Wirksamkeit von biochemischen Heilmethoden gegenüber Sulfonamiden bei Infektionen zu testen. Insgesamt wurden zwischen Mitte und Ende 1942 vier Versuchsreihen durchgeführt. Bei den äußerst schmerzhaften und inhumanen Versuchen, bei denen Häftlingen auch der eigene Eiter injiziert wurde, starben mindestens 28 Häftlinge.
The last source claims that at least 28 prisoners died as a result of these unspeakably cruel experiments.
The most detailed account (and even there, it is just 2 or 3 pages) about these experiments that I could find is in the superb and extremely well-researched book ‘AUSCHWITZ, DIE NS MEDIZIN UND IHRE OPFER’ by Ernst Klee. In it (p 146), Klee cites Grawitz’s correspondence with Himmler where Grawitz discloses that, prior to the Dachau ‘Schuessler experiments’, there were also some in Auschwitz where all three victims had died. Apparently Grawitz tried to persuade Himmler to stop these futile and (even for his standards) exceedingly cruel tests; the prisoners suffered unimaginable pain before their deaths. However, Himmler reprimanded him sharply and instructed him to continue. Dr Kiesswetter was subsequently recruited to the team because he was considered to be an expert on the clinical use of Schuessler Salts.[Another book entitled ‘Der Deutsche Zentralverein homöopathischer Ärzte im Nationalsozialismus‘ also mentions these experiments. Its author claims that Weyherns was not a doctor but a Heilpraktiker (all other sources agree that he was a medic). In general, the book seems to down-play this deplorable story and reads like an attempt to white-wash German homeopathy during the Third Reich] .
Klee concludes his chapter by reporting the post-war fate of all the doctors involved in the ‘Schuessler experiments’:
Dr Waldemar Wolter was sentenced to death and executed.
Dr Hermann Pape disappeared.
Dr Rudolf Kiesswetter disappeared.
Dr Babor fled to Addis Abeba.
Dr Laue died.
Dr Heinrich Schuetz managed to become a successful consultant in Essen. Only in 1972, he was charged and tried by a German court to 10 years of jail. Several of his colleagues, however, certify that he was too ill to be imprisoned, and Schuetz thus escaped his sentence.
Why do I dwell on this most unpleasant subject?
Surely, this has nothing to do with today’s use of Schuessler Salts!
Do I do it to “smear homeopathy and other forms of complementary medicine with a ‘guilt by association’ argument, associating them with the Nazis“, as Peter Fisher once so stupidly put it?
I have other, more important reasons:
- I do not think that the evidence regarding Schuessler Salts is complete without these details.
- I believe that these are important historical facts.
- I feel that the history of alternative medicine during the Third Reich is under-researched and almost unknown (contrary to that of conventional medicine for which a very large body of published evidence is now available).
- I feel it should be known and ought to be much better documented than it is today.
- I fear that we live in times where the memory of such atrocities might serve as a preventative for a resurgence of fascism in all its forms.
This is a fascinating new review of upper neck manipulation. It raises many concerns that we, on this blog, have been struggling with for years. I take the liberty of quoting a few passages which I feel are important and encourage everyone to study the report in full:
The Minister of Health, Seniors and Active Living gave direction to the Health Professions Advisory Council (“the Council”) to undertake a review related to high neck manipulation.
Specifically, the Minister directed the Council to undertake:
1) A review of the status of the reserved act in other Canadian jurisdictions,
2) A literature review related to the benefits to patients and risks to patient safety associated with the procedure, and
3) A jurisprudence review or a review into the legal issues that have arisen in Canada with respect to the performance of the procedure that touch upon the risk of harm to a patient.
In addition, the Minister requested the Council to seek written input on the issue from:
- Manitoba Chiropractic Stroke Survivors
- Manitoba Chiropractic Association
- College of Physiotherapists of Manitoba
- Manitoba Naturopathic Association
- College of Physicians and Surgeons of Manitoba
- other relevant interested parties as determined by the Council
… The review indicated that further research is required to:
- strengthen evidence for the efficacy of cervical spinal manipulations (CSM) as a treatment for neck pain and headache, “as well as for other indications where evidence currently does not exist (i.e., upper back and should/arm pain, high blood pressure, etc.)”
- establish safety and efficacy of CSM in infants and children
- assess the risk versus benefit in consideration of using HVLA cervical spine manipulation, which also involve cost-benefit analyses that compare CSM to other standard treatments.
… the performance of “high neck manipulation” or cervical spine manipulation does present a risk of harm to patients. This risk of harm must be understood by both the patient and the practitioner.
Both the jurisprudence review and the research literature review point to the need for the following actions to mitigate the risk of harm associated with the performance of cervical spine manipulation:
- Action One: Ensure that the patient provides written informed consent prior to initiating treatment which includes a discussion about the risk associated with cervical spine manipulation.
- Action Two: Provide patients with information to assist in the early recognition of a serious adverse event.
The British press recently reported that a retired bank manager (John Lawler, aged 80) died after visiting a chiropractor in York. This tragic case was published in multiple articles, most recently in THE SUN. Personally, I find this regrettable – not the fact that the press warns consumers of chiropractic, but the tone and content of the articles.
Let me explain this by citing the one in THE SUN of today. Here is the critical bit that concerns me:
Ezvard Ernst, Emeritus Professor of Complementary Medicine at Exeter University, published a study showing at least 26 people had died as a result. He said: “The evidence is not in favour of chiropractic treatments. Nobody knows how many have suffered severe complications or died.” Edvard Ernst, Professor of Complementary Medicine, says many have suffered complications or died from chiropractors treatments… A study from Exeter University shows at least 26 people have died as a result of treatment.
And what is wrong with this?
The answer is lots:
- My first name is consistently misspelled (a triviality, I agree).
- I am once named as Emeritus Professor and once as Professor of Complementary Medicine. The latter is wrong (another triviality, perhaps, but some of my more demented critics have regularly accused me of carrying wrong titles)
- The mention of 26 deaths after chiropractic treatments is problematic and arguably misleading (see below).
- Our ‘study’ was not a study but a systematic review (another triviality?).
Now you probably think I am being pedantic, but I feel that the article is regrettable not so much by what it says but by what it fails to say. To understand this better, I will below copy my emails to the journalist who asked for help in researching this article.
- My email of 17/10 answering all 7 of the journalist’s specific questions:
- 1. Why are you sceptical of chiropractic?
- I have researched the subject for more than 2 decades, and I know that the evidence is not in favour of chiropractic
- 2. How many people do you believe have died in Britain as a result of being treated by a chiropractor? If it’s not possible to say, can you estimate?
- nobody knows how many patients have suffered severe complications or deaths. there is no system to monitor such events that is comparable to the post-marketing surveillance of conventional medicine. we did some research and found that the under-reporting of cases of severe complications was close to 100% in the UK.
- 3. What is so dangerous about chiropractic? Is there a particular physical treatment than endangers life?
- manipulations that involve rotation and over-extension of the upper spine can lead to a vertebral artery breaking up. this causes a stroke which sometimes is fatal.
- 4. Is the industry well regulated?
- UK chiropractors are regulated by the General Chiropractic Council. it is debatable whether they are fit for purpose (see here:http://edzardernst.com/2015/02/the-uk-general-chiropractic-council-fit-for-purpose/)
- 5. Should we be suspicious of claims that chiropractic can cure things like IBS and autism?
- such claims are not based on good evidence and therefore misleading and unethical. sadly, however, they are prevalent.
- 6. Who trains chiropractors?
- there are numerous colleges that specialise in that activity.
- 7. Is it true Prince Charles is to blame for the rise in popularity/prominence of chiropractic?
- I am not sure. certainly he has been promoting all sorts of unproven treatments for decades.
- My email of 18/10 answering 3 further specific questions
- 1. Would you actively discourage anyone from being treated by a chiropractor?
yes, anyone I feel responsible for
2. Are older people particularly at risk or could one wrong move affect anyone?
older people are at higher risk of bone fractures and might also have more brittle arteries prone to dissection
3. If someone has, say, a bad back or stiff neck what treatment would you recommend instead of chiropractic?
I realise every case is different, but you are sceptical of all complementary treatments (as I understand it) so what would you suggest instead?
I would normally consider therapeutic exercises and recommend seeing a good physio.
- 3. My email of 23/10 replying to his request for specific UK cases
- the only thing I can offer is this 2001 paper
- where we discovered 35 cases seen by UK neurologists within the preceding year. the truly amazing finding here was that NONE of them had been reported anywhere before. this means under-reporting was exactly 100%.
END OF QUOTES
I think that makes it quite obvious that much relevant information never made it into the final article. I also know that several other experts provided even more information than I did which never appeared.
The most important issues, I think, are firstly the lack of a monitoring system for adverse events, secondly the level of under-reporting and thirdly the 50% rate of mild to moderate adverse-effects. Without making these issues amply clear, lay readers cannot possibly make any sense of the 26 deaths. More importantly, chiropractors will now be able to respond by claiming: 26 deaths compare very favourably with the millions of fatalities caused by conventional medicine. In the end, the message that will remain in the heads of many consumers is this: CONVENTIONAL MEDICINE IS MUCH MORE DANGEROUS THAN CHIROPRACTIC!!! (The 1st comment making this erroneous point has already been published: Don’t be stupid Andy. You wanna discuss how many deaths occur due to medication side effects and drug interactions? There is a reason chiros have the lowest malpractice rates.)
Don’t get me wrong, I am not accusing the author of the SUN-article. For all I know, he has filed a very thoughtful and complete piece. It might have been shortened by the editor who may also have been the one adding the picture of the US starlet with her silicone boobs. But I am accusing THE SUN of missing a chance to publish something that might have had the chance of being a meaningful contribution to public health.
Perhaps you still think this is all quite trivial. Yet, after having experienced this sort of thing dozens, if not hundreds of times, I disagree.
This press-release caught my eye today. It relates to an article that does not seem to be available yet (at least when I looked it was not on Medline). As it is highly relevant to issues that we have repeatedly discussed on this blog, let me quote the important sections of the press-release instead:
To investigate alternative medicine use and its impact on survival compared to conventional cancer treatment, the researchers studied 840 patients with breast, prostate, lung, and colorectal cancer in the National Cancer Database (NCDB) — a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society. The NCDB represents approximately 70% of newly diagnosed cancers nationwide. Researchers compared 280 patients who chose alternative medicine to 560 patients who had received conventional cancer treatment.
The researchers studied patients diagnosed from 2004 to 2013. By collecting the outcomes of patients who received alternative medicine instead of chemotherapy, surgery, and/or radiation, they found a greater risk of death. This finding persisted for patients with breast, lung, and colorectal cancer. The researchers concluded that patients who chose treatment with alternative medicine were more likely to die and urged for greater scrutiny of the use of alternative medicine for the initial treatment of cancer.
“We now have evidence to suggest that using alternative medicine in place of proven cancer therapies results in worse survival,” said lead author Dr. Skyler Johnson. “It is our hope that this information can be used by patients and physicians when discussing the impact of cancer treatment decisions on survival.”
Dr. Cary Gross, co-author of the study, called for further research, adding, “It’s important to note that when it comes to alternative cancer therapies, there is just so little known — patients are making decisions in the dark. We need to understand more about which treatments are effective — whether we’re talking about a new type of immunotherapy or a high-dose vitamin — and which ones aren’t, so that patients can make informed decisions.”
END OF QUOTE
Regular readers of my blog will not be surprised; we have discussed similar findings before:
Korean researchers evaluated whether complementary/alternative medicine (CAM) -use influenced the survival and health-related quality of life (HRQOL) of terminal cancer patients. From July 2005 to October 2006, they prospectively studied a cohort study of 481 cancer patients. During a follow-up of 163.8 person-years, they identified 466 deceased patients. Their multivariate analyses of these data showed that, compared with non-users, CAM-users did not have better survival. Using mind-body interventions or prayer was even associated with significantly worse survival. CAM users reported significantly worse cognitive functioning and more fatigue than nonusers. In sub-group analyses, users of alternative medical treatments, prayer, vitamin supplements, mushrooms, or rice and cereal reported significantly worse HRQOL. The authors conclude that “CAM did not provide any definite survival benefit, CAM users reported clinically significant worse HRQOLs.”
A Norwegian study examined the association between CAM-use and cancer survival. Survival data were obtained with a follow-up of 8 years for 515 cancer patients. A total of 112 patients used CAM. During the follow-up period, 350 patients died. Death rates were higher in CAM-users (79%) than in those who did not use CAM (65%). The hazard ratio of death for CAM-use compared with no use was 1.30. The authors of this paper concluded that “use of CAM seems to predict a shorter survival from cancer.”
This study from the US was aimed at determining whether CAM use impacts on the prognosis of breast cancer patients. Health Eating, Activity, and Lifestyle (HEAL) Study participants (n = 707) were diagnosed with stage I-IIIA breast cancer. Participants completed a 30-month post-diagnosis interview including questions on CAM use (natural products such as dietary and botanical supplements, alternative health practices, and alternative medical systems), weight, physical activity, and comorbidities. Outcomes were breast cancer-specific and total mortality, which were ascertained from the Surveillance Epidemiology and End Results registries in Western Washington, Los Angeles County, and New Mexico. Cox proportional hazards regression models were fit to data to estimate hazard ratios (HR) and 95 % confidence intervals (CI) for mortality. Models were adjusted for potential confounding by socio-demographic, health, and cancer-related factors. Among the 707 participants, 70 breast cancer-specific deaths and 149 total deaths were reported. 60.2 % of participants reported CAM use post-diagnosis. The most common CAM were natural products (51 %) including plant-based estrogenic supplements (42 %). Manipulative and body-based practices and alternative medical systems were used by 27 and 13 % of participants, respectively. No associations were observed between CAM use and breast cancer-specific (HR 1.04, 95 % CI 0.61-1.76) or total mortality (HR 0.91, 95 % CI 0.63-1.29). The authors concluded that CAM use was not associated with breast cancer-specific mortality or total mortality. Randomized controlled trials may be needed to definitively test whether there is harm or benefit from the types of CAM assessed in HEAL in relation to mortality outcomes in breast cancer survivors.
Some forms of CAM might be effective in supportive or palliative care of cancer patients. However, if it is used or recommended as a cancer therapy, our alarm bells should start ringing.
I just found the new article; here is its abstract:
There is limited available information on patterns of utilization and efficacy of alternative medicine (AM) for patients with cancer. We identified 281 patients with nonmetastatic breast, prostate, lung, or colorectal cancer who chose AM, administered as sole anticancer treatment among patients who did not receive conventional cancer treatment (CCT), defined as chemotherapy, radiotherapy, surgery, and/or hormone therapy. Independent covariates on multivariable logistic regression associated with increased likelihood of AM use included breast or lung cancer, higher socioeconomic status, Intermountain West or Pacific location, stage II or III disease, and low comorbidity score. Following 2:1 matching (CCT = 560 patients and AM = 280 patients) on Cox proportional hazards regression, AM use was independently associated with greater risk of death compared with CCT overall (hazard ratio [HR] = 2.50, 95% confidence interval [CI] = 1.88 to 3.27) and in subgroups with breast (HR = 5.68, 95% CI = 3.22 to 10.04), lung (HR = 2.17, 95% CI = 1.42 to 3.32), and colorectal cancer (HR = 4.57, 95% CI = 1.66 to 12.61). Although rare, AM utilization for curable cancer without any CCT is associated with greater risk of death.
The Daily Star reported that 9 children have died in Tripura Para of Sitakunda during the last week. At least 46 other children in the remote hilly area are suffering from the same unidentified disease which has not yet been identified. The children aged between one and 12 suffer from fever and other symptoms include body rash, breathing problems, vomiting and blood in stool.
None of the fatalities was taken to a hospital, and two of them were treated homeopathically. The three-year-old Rupali had fever and a rash all over her body for three days. “We took her to a man who practices homeopathy. He lives some two kilometres away. He had given Rupali some medicines”, said her uncle. Asked why they did not take the child to a hospital, Pradip said the next health complex was 15 kilometres away from their home. Besides, they did not have money to buy medicines which would have been prescribed by doctors.
Shimal Tripura was also among the children who died. His father Biman Tripura said the two-year-old boy had been suffering from fever for six days. Shimal was also taken to a local man who practices homeopathy.
“The disease could not be identified immediately,” said a spokesperson. Asked whether the disease could be transmitted by mosquitoes, he said, “It does not seem so. If it was, then why only children were being affected?” A medical team from the Institute of Epidemiology, Disease Control and Research in Dhaka was dispatched for Sitakunda, he said, adding that the local primary school was shut down to prevent the spread of the disease.
I have often pointed out that homeopathy can be deadly – not usually via its remedies (highly diluted homeopathic have no effects whatsoever) but via homeopaths who do not know what they are doing. It seems that here we have yet further tragic cases to confirm this point. Nine children were reported to have died. Two of them received homeopathic remedies and 7 seemed to have had no treatment at all. This looks like a very sad statistic indicating that homeopathy is as bad as no treatment at all.
The ‘Daily Mail’ is not a paper famed for its objective reporting. In politics, this can influence elections; in medicine, it can endanger public health.
A recent article is a case in point, I think.
START OF QUOTE
Traditional Chinese medicines could help prevent heart disease and the progression of pre-diabetes, according to research. Some herbal treatments proved as effective in lowering blood pressure as Western drugs and improved heart health by lowering cholesterol, scientists found. Certain alternative medicines could lower blood sugar and insulin levels, too.
Chinese medicines could be used alongside conventional treatments, say researchers from Shandong University Qilu Hospital in China. Or they can be beneficial as an alternative for patients intolerant of Western drugs, they said in their review of medical studies over a ten-year period. Senior review author from the university’s department of traditional Chinese medicine said: ‘The pharmacological effects and the underlying mechanisms of some active ingredients of traditional Chinese medications have been elucidated. Thus, some medications might be used as a complementary and alternative approach for primary and secondary prevention of cardiovascular disease.”
It’s potentially good news for people living with diabetes, which is now a global epidemic and has proved a tricky condition to manage for many people. High blood pressure is very common too, affecting more than one in four adults in the UK, although many won’t show symptoms and realise it. If untreated, it increases your risk of serious problems including heart disease, the number one killer globally.
The Chinese have used herbs for treating diseases for thousands of years and have become increasingly popular in Europe and North America, mainly as complement to Western medicine. But the researchers also warn that much of the research conducted have limitations and so their long-term effects are not proven.
Herbs for high blood pressure
The blood pressure-lowering effect of herb zhongfujiangya was found to be similar to that of oral anti-hypertension medication benazeprilm, which goes by the brand name Lotensin. Similarly, patients treated for eight weeks with herbal tiankuijiangya had a lower reading than those given a placebo. Herbal Jiangya tablets were found to ‘significantly lower’ systolic blood pressure, that is the amount of pressure in your arteries during contraction of your heart muscle compared to a fake treatment. The herb Jiangyabao also had a significant effect compared to a placebo, but just at night. But overall, compared to the drug Nimodipine, a calcium channel blocker, it worked just as well. Qiqilian capsules also proved more effective compared to a placebo.
Herbs for diabetes
The team report some Chinese medicines medications – such as xiaoke, tangminling, jinlida, and jianyutangkang – have a ‘potent’ effect on lowering blood sugar levels and b-cell function, which controls the release of insulin. Some remedies – such as tangzhiping and tianqi – might prevent the progression of pre-diabetes to diabetes, they note.
Herbs for cholesterol
The researchers looked at research on dyslipidemia, the term for unbalanced or unhealthy cholesterol levels. They found that jiangzhitongluo, salviamiltiorrhiza and pueraria lobata, and zhibitai capsule all have a ‘potent lipid-lowing effect’.
Herbs for heart disease
Some traditional Chinese medicines such as qiliqiangxin, nuanxin, shencaotongmai, and yangxinkang, might be effective in improving function in patients with chronic heart failure, they wrote.
Limitations with trials
But Western scientists often reject Chinese medicine for specific reasons, warned Dr Zhao’s team. Chinese medicines are frowned upon because they do not go through the same exhaustive approval process as trials conducted domestically, they pointed out. Plus, one treatment can be made of many different ingredients with various chemical compounds, making it hard to pinpoint how their benefits work. ‘One should bear in mind that traditional Chinese medicine medications are usually prescribed as complex formulae, which are often further manipulated by the practitioner on a personalized basis,’ said Dr Zhao.
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Apart from the fact that this article is badly written, it is also misleading to the point of being outright dangerous. Regular readers of my blog will be aware that Chinese research is everything but reliable; there are practically no Chinese TCM-trials that report negative results. Furthermore, the safety of Chinese herbal preparations is as good as unknown and they are often contaminated with toxic substances as well as adulterated with synthetic drugs. Most of these preparations are also unavailable outside China. Moreover, Chinese herbal treatments are usually individualised (mixtures are tailor-made for each individual patient), and there is no good evidence that this approach is effective. Crucially, the trial evidence is often of such poor quality that it would be a dangerous mistake to trust these findings.
None of these important caveats, it seems, are important enough to get a mention in the Daily Mail.
Don’t let the truth get in the way of a sensational story!
Let’s just for a moment imagine what would happen if people took the Mail article seriously (is there anyone out there who does take the Mail seriously?). In a best case scenario, they would take Chinese herbs in addition to their prescribed medication. This might case plenty of unwanted side-effects and herb-drug interactions. In addition, people would lose a lot of their hard-earned cash. In a worst case scenario, they would abandon their prescribed medication for dubious Chinese herbal mixtures. This could cause thousands of premature deaths.
With just a little research, I managed to find the original article on which the Mail’s report was based. Here is its abstract:
Traditional Chinese medicine (TCM) has more than 2,000 years of history and has gained widespread clinical applications. However, the explicit role of TCM in preventing and treating cardiovascular disease remains unclear due to a lack of sound scientific evidence. Currently available randomized controlled trials on TCM are flawed, with small sample sizes and diverse outcomes, making it difficult to draw definite conclusions about the actual benefits and harms of TCM. Here, we systematically assessed the efficacy and safety of TCM for cardiovascular disease, as well as the pharmacological effects of active TCM ingredients on the cardiovascular system and potential mechanisms. Results indicate that TCM might be used as a complementary and alternative approach to the primary and secondary prevention of cardiovascular disease. However, further rigorously designed randomized controlled trials are warranted to assess the effect of TCM on long-term hard endpoints in patients with cardiovascular disease.
In my view, the authors of this review are grossly over-optimistic in their conclusions (but nowhere near as bad as the Mail journalist). If the trials are of poor quality, as the review-authors admit, no firm conclusions should be permissible about the usefulness of the therapies in question.
As the Mail article is obviously based on a press release (several other papers worldwide reported about the review as well), it seems interesting to note what the editor of the Journal of the American College of Cardiology (the journal that published the review) recently had to say about the responsibility of journalists and researchers:
START OF QUOTE
…I would like to suggest that journalists and researchers must share equally in shouldering the burden of responsibility to improve appropriate communication about basic and clinical research.
First, there is an obligation on the part of the researchers not to inflate the importance of their findings. This has been widely recognized as damaging, especially if bias is introduced in the paper…
Second, researchers should take some responsibility for the creation of the press release about their research, which is written by the media or press relations department at their hospital or society. Press releases are often how members of the media get introduced to a particular study, and these releases can often introduce errors or exaggerations. In fact, British researchers evaluated 462 press releases on biomedical and health-related science issued by 20 leading U.K. universities in 2011, alongside their associated peer-reviewed research papers and the news stories that followed (n = 668). They found that 40% of the press releases contained exaggerated advice, 33% contained exaggerated causal claims, and 36% contained exaggerated inference to humans from animal research. When press releases contained such exaggeration, 58%, 81%, and 86% of news stories, respectively, contained further exaggeration, compared with rates of 17%, 18%, and 10% in the news when the press releases were not exaggerated. Researchers should not be excused from being part of the press release process, as the author(s) should at least review the release before it gets disseminated to the media. I would even encourage researchers to engage in the process at the writing stage and to not allow their hospital’s or society’s public relations department to extrapolate their study’s results. Ultimately, the authors and the journals in which the studies are published will be held accountable for the information that trickles into the headlines, not the public relations departments, so we must make sure that the information is accurate and representative of the study’s actual findings.
END OF QUOTE
Sound advice indeed.
Now we only need to ALL follow it!!!
The new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ have already been the subject of the previous post. Today, I want to have a closer look at a small section of these guidelines which, I think, is crucial. It is entitled ‘HARMS OF NONPHARMACOLOGIC THERAPIES’. I have taken the liberty of copying it below:
“Evidence on adverse events from the included RCTs and systematic reviews was limited, and the quality of evidence for all available harms data is low. Harms were poorly reported (if they were reported at all) for most of the interventions.
Low-quality evidence showed no reported harms or serious adverse events associated with tai chi, psychological interventions, multidisciplinary rehabilitation, ultrasound, acupuncture, lumbar support, or traction (9,95,150,170–174). Low-quality evidence showed that when harms were reported for exercise, they were often related to muscle soreness and increased pain, and no serious harms were reported. All reported harms associated with yoga were mild to moderate (119). Low-quality evidence showed that none of the RCTs reported any serious adverse events with massage, although 2 RCTs reported soreness during or after massage therapy (175,176). Adverse events associated with spinal manipulation included muscle soreness or transient increases in pain (134). There were few adverse events reported and no clear differences between MCE and controls. Transcutaneous electrical nerve stimulation was associated with an increased risk for skin site reaction but not serious adverse events (177). Two RCTs (178,179) showed an increased risk for skin flushing with heat compared with no heat or placebo, and no serious adverse events were reported. There were no data on cold therapy. Evidence was insufficient to determine harms of electrical muscle stimulation, LLLT, percutaneous electrical nerve stimulation, interferential therapy, short-wave diathermy, and taping.”
The first thing that strikes me is the brevity of the section. Surely, guidelines of this nature must include a full discussion of the risks of the treatments in question!
The second thing that is noteworthy is the fact that the authors confirm the fact I have been banging on about for years: clinical trials of alternative therapies far too often fail to mention adverse effects. I have often pointed out that the failure to report adverse effects in clinical trials is an unacceptable violation of medical ethics. By contrast, the guideline authors seem not to feel strongly about this omission.
The third thing that is noteworthy is that the guidelines evaluate the harms of the treatments purely on the basis of the adverse effects reported in the clinical trials and systematic reviews included in their efficacy assessments. This is nonsensical for at least two reasons:
- The guideline authors themselves are aware that the trials very often fail to mention adverse effects.
- For any assessment of harm, one has to go far beyond the evidence of clinical trials, because trials tend to be too small to pick up rare adverse effects, and because they are always conducted under optimally controlled conditions where adverse effects are less likely to occur than in real life.
Together, these features of the assessment of harms explain why the guideline authors arrive at conclusions which are oddly misguided; I would even feel that they resemble a white-wash. Here are two of the most overt misjudgements:
- no harms associated with acupuncture,
- only trivial harm associated with spinal manipulations.
The best evidence we have today shows that acupuncture leads to mild adverse effects in about 10% of all cases and is also associated with very severe complications (e.g. pneumothorax, cardiac tamponade, infections, deaths) in an unknown number of patients. More details can be found for instance here, here, here and here.
And the best evidence available shows that spinal manipulation leads to moderately severe adverse effects in ~50% of all cases. In addition, we know of hundreds of cases of very severe complications resulting in stroke, permanent neurological deficits or deaths. More details can be found for instance here, here, here and here.
In the introduction, I stated that this small section of the guidelines is crucial.
The reason is simple: any responsible therapeutic decision has to be based not just on the efficacy of the treatment in question but on its risk/benefit balance. The evidence shows that the risks of some alternative therapies can be considerable, a fact that is almost totally neglected in the guidelines. Therefore, the recommendations of the new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ are in several aspects not entirely correct and need to be reconsidered.
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:
- It is concluded that serious cerebrovascular complications of spinal manipulation continue to be reported.
- The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome.
- 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).