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

Monthly Archives: June 2019

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

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

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

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

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

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

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

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

Spinal manipulation is an umbrella term for numerous manoeuvres chiropractors, osteopaths, physiotherapists and other clinicians apply to their patients’ vertebral columns.  Spinal manipulations are said to be effective for a wide range of conditions. But how do they work? What is their mode of action? A new article tries to address these questions. here is its abstract:

Spinal manipulation has been an effective intervention for the management of various musculoskeletal disorders. However, the mechanisms underlying the pain modulatory effects of spinal manipulation remain elusive. Although both biomechanical and neurophysiological phenomena have been thought to play a role in the observed clinical effects of spinal manipulation, a growing number of recent studies have indicated peripheral, spinal and supraspinal mechanisms of manipulation and suggested that the improved clinical outcomes are largely of neurophysiological origin. In this article, we reviewed the relevance of various neurophysiological theories with respect to the findings of mechanistic studies that demonstrated neural responses following spinal manipulation. This article also discussed whether these neural responses are associated with the possible neurophysiological mechanisms of spinal manipulation. The body of literature reviewed herein suggested some clear neurophysiological changes following spinal manipulation, which include neural plastic changes, alteration in motor neuron excitability, increase in cortical drive and many more. However, the clinical relevance of these changes in relation to the mechanisms that underlie the effectiveness of spinal manipulation is still unclear. In addition, there were some major methodological flaws in many of the reviewed studies. Future mechanistic studies should have an appropriate study design and methodology and should plan for a long-term follow-up in order to determine the clinical significance of the neural responses evoked following spinal manipulation.

I have to admit, this made me laugh. Any article that starts with the claim spinal manipulation is an effective intervention and speaks about its observed clinical effects without critically assessing the evidence for it must be ridiculous. The truth is that, so far, it is unclear whether spinal manipulations cause any therapeutic effects at all. To take them as a given, therefore discloses a bias that can only be a hindrance to any objective evaluation.

Yet, perhaps unwittingly, the paper raises an important question: do we need to search for a mode of action of treatments that are unproven? It is a question, of course, that is relevant to all or at least much of SCAM.

Do we need to research the mode of action of acupuncture?

Do we need to research the mode of action of energy healing?

Do we need to research the mode of action of reflexology?

Do we need to research the mode of action of homeopathy?

Do we need to research the mode of action of Bach flower remedies?

Do we need to research the mode of action of cupping?

Do we need to research the mode of action of qigong?

In the absence of compelling evidence that a mode of action (other than the placebo response) exists, I would say: no, we don’t. Such research might turn out to be wasteful and carries the risk of attributing credibility to treatments that do not deserve it.

What do you think?

 

Time for celebrations and congratulations!

Why?

You might remember the story; over a year ago, I reported that a SCAM practitioner was suing a critic:

‘Doctor’ Colleen Huber (DCH) is the US naturopath who is currently suing Britt Hermes. For me, this is enough reason to do a bit of reading and find out who DCH is and what motivates her. Here is what I found out (I added some * to the quotes [all in italics] and comments below).

DCH has an impressive presence on the Internet. One website, for instance, tells us that DCH is a Naturopathic Medical Doctor* in Tempe, Arizona. Her clinic, Nature Works Best Cancer Clinic, has had the most successful results of any clinic in the world reporting its results over the last 9 years **.

Dr. Huber authored the largest and longest study*** in medical history on sugar intake in cancer patients, which was reported in media around the world in 2014. Her other writing includes her book, Choose Your Foods Like Your Life Depends On Them ****, and she has been featured in the books America’s Best Cancer Doctors and Defeat Cancer. Dr. Huber’s academic writing has appeared in The Lancet *****, the International Journal of Cancer Research ***** and Molecular Mechanisms *****,  and other medical journals ******. Her research interests are in the use of therapeutic approaches targeting metabolic aspects of cancer…

*I am puzzled by this title. Is it an official one? I only found this, and it omits the ‘medical’: Currently, 20 states, five Canadian provinces, the District of Columbia, and the U.S. territories of Puerto Rico and the U.S. Virgin Islands have passed laws regulating naturopathic doctors. Learn more about licensure from the Association of Accredited Naturopathic Medical Colleges. It seems that Arizona is the only state where the ‘medical’ is allowed. However, don’t take this to mean that DCH went to medical school.

** ‘most successful results of any clinic in the world’? Really? Where are the comparative statistics?

*** the study had all of 317 patients and was published in an obscure, non-Medline listed journal.

**** currently ranked  #1,297,877 in Books on Amazon.

***** no such entries found on Medline.

****** sorry, but my Medline search for ‘huber colleen’ located only 2 citations, both on arthritis research conducted in an US Pfizer lab and therefore probably not from ‘our’ DCH.

Another website on or by DCH informs us that her outfit Nature Works Best is a natural cancer clinic located in Tempe, Arizona, that focuses on natural, holistic, and alternative cancer treatments. Our treatments have proved to be an effective alternative to traditional chemotherapy and radiation, which we do not use in our treatments. Rather, we have developed a natural method of treating cancers based on intravenous vitamin therapy which may include Vitamin-C, Baking Soda, and other tumor fighting agents as well as a simple food plan. *

Our team of naturopathic medical doctors have administered an estimated 31,000 IV nutrient treatments, used for all stages and types of tumors. As of July 2014, 80% of patients who completed our treatments alone went into remission, 85% of patients who completed our treatments and followed our food plan went into remission. **

* Give me a break! Vitamin-C and Baking Soda are claimed to have proved to be an effective alternative to traditional chemotherapy and radiation ? I would like to see the data before I believe this!

** Again, I would like to see the data before I believe this!

Finally, a further website proudly repeats that her academic writing has appeared in The Lancet and Cancer Strategies Journal, and other medical journals. It even presents an abstract of her published work; here it is:

Recent recommendations for the more widespread prescription of statin drugs in the U.S. have generated controversy.  Cholesterol is commonly thought to be the enemy of good health.  On the other hand, previous research has established the necessity of cholesterol in production of Vitamin D and steroid hormones, among other purposes, some of which have been shown to have anti-cancer effect.  We compare total serum cholesterol (TC) in cancer survivors vs cancer fatalities, and we assess the value of deliberately lowering TC among cancer patients.  We also examined diet in the survivors as well as those who then died of cancer.

In this original previously unpublished research, we conducted a double-blind retrospective case series, in which we looked back at data from all 255 cancer patients who came to and were treated by our clinic with either current dietary information, and/or a recent serum TC level, measured by an unaffiliated laboratory or an unaffiliated clinic over the previous seven years, comparing TC in the surviving cancer patients versus those cancer patients who died during that time.

Surviving cancer patients had 24.0 points higher mean total cholesterol than the mean for deceased cancer patients.  A number of dietary differences between cancer survivors and those who then died of cancer were also found to be notable.

Caution is advised before attempting to lower cholesterol in cancer patients with close to normal TC levels.  Those cancer patients with higher TC were more likely to survive their cancer.

I don’t know about you, but I am not impressed. Surviving cancer patients had 24.0 points higher mean total cholesterol than the mean for deceased cancer patients. Has DCH thought of the possibility that moribund patients quite simply eat less? In which case, the observed difference would be a meaningless epiphenomenon.

At this point, I stopped my reading; I now knew more than I needed to know about DCH (if you want to read more, I recommend this or this post).

As I mentioned at the beginning of this post, DCH is currently suing Britt Hermes for libel…

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Yesterday Britt Hermes reported that she has won the court case:

On May 24, 2019, the District Court (Landgericht) of Kiel, Germany ruled against naturopathic cancer quack Colleen Huber in a defamation lawsuit she brought against me. Huber filed suit in September 2017 over my opinions about the dubious treatments and human subjects research at her cancer clinic in Tempe, Arizona (USA), and also over my suspicions that Huber was cybersquatting domains in my name…

In a blog post from December 2016, I theorized that Huber or someone in her close orbit had registered domains using my first and last names to misrepresent my position on naturopathic “doctors.” You can view the archive of brittmariehermes.com from 31 March 2016 here. In my post, I also wrote about Huber’s dubious cancer treatments of intravenous baking soda, mega-doses of intravenous vitamin C, and a strict sugar-free diet. Huber advocates against state-of-the-art oncology, especially chemotherapy and radiation, because she thinks these therapies strengthen cancer…

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I am sure that many readers of the blog want to join me in congratulating Britt.

VERY WELL DONE INDEED!

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

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

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

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

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

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

Indian doctors have just published the case of a 38-year old man with cirrhosis of the liver due to compensated non-alcoholic fatty-liver-disease. He presented with acute worsening of his chronic liver disease. The acute event was not discernible even after extensive work up. Eventually, a transjugular liver biopsy revealed features suggestive of severe alcoholic hepatitis.

The patient and the family denied occult alcohol use when questioned over multiple times. According to the authors, the culprit ‘alcohol’ was found to be the homoeopathy medicines: the patient had been consuming a homeopathic remedy over a month for treatment of Gilbert’s syndrome. The researchers retrieved and tested the homoeopathy drug for alcohol content and found it contained 18% of ethanol. This, they felt, confirmed their diagnosis of alcoholic liver disease caused by the regular consumption of a homeopathic remedy.

Why did the patient help from a homeopath? Gilbert’s syndrome doesn’t usually require any treatment at all. Two weeks into his new treatment, the patient claimed he was feeling drowsy and slurring his speech, as if intoxicated. The liquid homeopathic formulation was therefore reduced at this stage. A further two weeks passed when his eyes yellowed, his urine darkened, and his legs began to swell. A liver tests confirmed a spike in his bilirubin 10 times above normal, with liver enzymes also elevated. All signs were thus pointing to an acute form of hepatitis commonly associated with alcohol binges. With the patient adamant he hadn’t touched alcohol, the doctors looked for other causes of hepatitis. None were found. When the patient admitted using homeopathy, his doctors thought to have found an explanation for the problem.

Despite starting the patient on a range of treatments and referring him to a liver transplant centre for further management, the damage to the patient’s liver proved to be irreversible. One month and 12 days later, the patient developed multiple organ failure and passed away. The authors of this case report point out “at risk patients and the general population need to be educated regarding the fact that complementary and alternative medications are not without side-effects.”

I do agree with their comment, but I very much doubt that their diagnosis of homeopathy-induced liver disease was correct. If the alcohol in the homeopathic remedy truly had been the cause, the patient would have needed to consume well in excess of one litre of it per day. The authors do not tell us about the volume of consumption, but I doubt that a patient would be able to afford such an orgy in homeopathy.

Highly diluted homeopathic remedies contain nothing, it is often said. This is not entirely true. In the case of solid preparations (globuli), they do contain sugar, and in the case of liquid remedies, they contain alcohol. Yet, as a source of either ingredient, they are neither practical nor economical. I fear therefore that the medical team of the diseased man are mistaken when accusing homeopathy of being the cause of their patient’s death.

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