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

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

But are they correct?

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

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

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

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

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

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

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

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

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

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

REFERENCES

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

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

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

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

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

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

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

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

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

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

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

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

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

But is it?

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

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

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

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

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

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

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

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

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

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

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

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

_______________________________

What does that tell us?

I think it suggests that:

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

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

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

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

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

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

Year Award or honor
1977 Visiting Magician of the Year, Academy of Magical Arts & Sciences at the Magic Castle in Hollywood.[158]
1978 Garden State Magicians’ award.[158]
1981 Asteroid 3163 Randi was named after James Randi,[159] who had always been an active amateur observer. His friend Carl Sagan encouraged his interest.[18]
Certificate of appreciation at the MIT Club of Boston.[158]
Designated Grand Master of Magic by Hocus Pocus Magazine.[158]
1983 Blackstone Cup, International Platform Association as Outstanding Speaker (won again in 1987).[158]
1984 Honorary membership, Bay Surgical Society of Los Angeles.[158]
1986 A $273,000 MacArthur Foundation Fellowship was awarded to James Randi for his investigations of the claims of Uri Geller and TV “faith healers[160]
Honorary membership, Israeli Society for Promoting the Art of Magic.[158]
1987 Special fellowship, Academy of Magical Arts & Sciences in Los Angeles.[158]
Certificate of Appreciation, Ring 254 of the International Brotherhood of Magicians.[158]
Award of Merit, Assembly 22 of the Society of American Magicians.[158]
1988 National Consumer Service Award, National Council Against Health Fraud.[158]
International Ambassador of Magic, Society of American Magicians.[158]
1989 Joseph A. Burton Forum Award, American Physical Society.[161]
Gold Medal, University of Ghent.[158]
1990 Humanist Distinguished Service Award, American Humanist Association.[158]
Thomas Paine Award, Baton Rouge Proponents of Rational Inquiry & Scientific Methods.[158]
1992 Commemorative Medal with Golden Wreath, Hungarian Society for the Dissemination of Scientific Knowledge.[158]
1996 Distinguished Skeptic Award, Committee for Skeptical Inquiry (CSICOP).[158][162]
1997 Lifetime Achievement Award, International Brotherhood of Magicians.[158]
“One of the 100 Best People in the World, people who make our lives richer or larger or happier,” Esquire magazine.[158]
Award, Science & Engineering Society of the National Security Agency.[158]
1999 “In Defense of Reason” Special Lifetime Achievement Award, Comitato Italiano per il Controllo dell Affermazioni sui Paranormale.[158]
2000 Distinguished Lecturer Award, Nova Southeastern University.[158]
2002 Presidential Citation, International Brotherhood of Magicians.[158]
2003 First Richard Dawkins Award.[30]
2007 Philip J. Klass Award.[163]
2008 Lifetime Achievement Award, Independent Investigations Group (IIG). Previous recipients Carl Sagan and Harry Houdini.[158][164]
2009 In Praise of Reason Award, Committee for Skeptical Inquiry.[158]
2010 Elected a Committee for Skeptical Inquiry Fellow.[165]
2012 Lifetime Achievement Fellowship, Academy of Magical Arts.[166]
Lifetime Achievement Award, American Humanist Association.[167]
2016 Heinz Oberhummer Award, 2016[168]
Lifetime Achievement Award, Humanist Association of Canada.[169]
James Randi is one of very few members of the UK Magic Circle to be granted their highest order: Member of the Inner Magic Circle With Gold Star (MIMC).

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

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

The new kid on the SCAM block seems to be hydrogen-rich water (HRW). It is pure water infused with hydrogen molecules and can be purchased in pouches and cans or made at home using special, commercially available devices. Health writers and entrepreneurs have been everything but timid in publishing claims about HRW. This is from one of thousands of sites promoting it:

1. Antioxidant And Anti-inflammatory Properties

Studies show that consuming hydrogen-rich water for a few weeks at a time can reduce reactive oxygen metabolites (ROMs) in the bloodstream, which can damage cells while sustaining blood oxidation levels needed to ensure health. The result is a reduction in and inflammation, which effectively reduces cell damage and leads to an improved quality of life. Decreased oxidative stress is also a valuable factor which helps prevent metabolic syndrome and soften the impact of neurodegenerative disease. Hydrogen-rich water, through its power to combat oxidative stress, is a promising remedy for these and other diseases. Its anti-inflammatory properties are already used to treat rheumatoid arthritis, one of the most prominent and debilitating conditions caused by high levels of inflammation in the body.

2. May Treat And Prevent Metabolic Syndrome

Metabolic syndrome, which includes obesity, high cholesterol, high blood pressure, and often causes a range of cardiovascular illnesses, is a rapidly growing problem among American adults. Early studies show that hydrogen-rich water health benefits include staving off metabolic syndrome and reversing negative metabolic symptoms because of its ability to reverse the effects of oxidative stress on the body. In fact, studies have shown that consuming hydrogen-rich water decreases the “bad” cholesterol, also known as serum-LDL cholesterol while improving HDL function — the “good” cholesterol.  This effect, in turn, prevents against the development of a number of debilitating cardiovascular issues.

3. Slows The Development Of Neurodegenerative Diseases

By fighting in important brain tissues, hydrogen-rich water fights a key cause of conditions like Parkinson’s disease and , both of which feature cognitive and behavioral impairment and decline. Because it consumes a high level of oxygen, the brain is prone to oxidative stress. Hydrogen-rich water elicits effects in the brain that counter the ability of oxidative stress to kill dopamine cells and damage proteins that maintain cognitive functioning. When used daily by patients of Alzheimer’s, hydrogen-rich water has been shown to restore neural proliferation, thereby inhibiting cognitive decline. Especially promising is the demonstrated ability of H2-rich water consumption to combat cognitive impairment even in its latest stages and to alleviate the harm of brain injury — again, because of its ability to ameliorate oxidative stress on brain tissue. In fact, some researchers recommend daily consumption of hydrogen-rich water as a long-term preventative treatment against dementia and neurodegenerative disease and as a part of a recovery program for brain injury from stroke or surgery.

4. May Treat And Prevent Insulin Resistance And Type 2 Diabetes

Recent studies demonstrate that hydrogen-rich water health benefits include having a normalizing effect on glucose in the body. In combination with powerful antioxidant properties, hydrogen-rich water improves insulin circulation and sensitivity, while also increasing levels of certain compounds that build insulin resistance. The end product is improved glucose metabolism, which can both prevent and slow the development of Type 2 Diabetes Mellitus and insulin resistance.

5. Improves Dental Health

As shown above, oxidative stress causes a number of ailments. One of the most common is dental decay. Fortunately, consuming hydrogen-rich water has been proven to treat conditions associated with dental deterioration, such as periodontal disease, because of its ability to fight oxidative stress, in addition to its effective anti-inflammatory properties. Drinking water containing molecular hydrogen targets periodontal disease at the source by suppressing inflammation in the oral tissue.  Hydrogen-rich water also prevents age-related oxidative damage to oral tissue, thereby offsetting dental decay.

6. Combats Muscle Fatigue

One compelling study of male soccer players found that, by consuming hydrogen-rich water before exercise, these athletes could reduce blood lactate levels and improve muscle function during exercise. After exercise, these athletes experienced lower levels of muscle fatigue and were able to recover faster. Because it also treats exercise-induced dehydration, hydrogen-rich water is a promising remedy for athletes. According to Biethan, “more and more athletes are picking up on it” to improve their athletic performance and recovery.

And how does HRW work? What is its mode of action? Nobody seems to know! During the last months, there have been several controlled clinical trials of HRW. Regardless of what condition they address, they all arrived at positive conclusions:

  1. In conclusion, these results suggest that supplementation with hydrogen-rich water may have a beneficial role in prevention of T2DM and insulin resistance.
  2. HRW significantly attenuates oxidative stress in CHB patients, but further study with long-term treatment is required to confirm the effect of HRW on liver function and HBV DNA level.
  3. Two weeks of HRW intake may help to maintain PPO in repetitive sprints to exhaustion over 30 minutes.
  4. Thus, hydrogen-rich water appeared to alleviate the mFOLFOX6-related liver injury.
  5. appears that orally administered H2 as a blend of hydrogen-generating minerals might be a beneficial agent in the management of body composition and insulin resistance in obesity.
  6. Although preliminary, the results of this trial perhaps nominate HRW as an adjuvant treatment for mild-to-moderate NAFLD. These observations provide a rationale for further clinical trials to establish safety and efficacy of molecular hydrogen in NAFLD.
  7. To conclude, acute pre-exercise supplementation with HRW reduced blood lactate at higher exercise intensities, improved exercise-induced perception of effort, and ventilatory efficiency.

Aprart from producing uniformly positive results, these studies have another common feature: they are methodologically flimsy. Probably the most rigorous trial of HRW was published earlier this year. Perhaps it is worth having a look at it:

An international team of researchers conducted a randomized, double-blinded, placebo-controlled trial in 60 subjects (30 men and 30 women) with metabolic syndrome. An initial observation period of one week was used to acquire baseline clinical data followed by randomization to either placebo or high-concentration HRW (> 5.5 millimoles of H2 per day) for 24 weeks.

High-concentration HRW was prepared via hydrogen-producing tablets (HRW Natural Health Products Inc., New Westminster BC, Canada) while the placebo was prepared as a placebo drink similar in taste, dissolution, and appearance to HRW. Placebo capsules, also donated by HRW Natural Health Products Inc. (New Westminster, BC, Canada), contained identical ingredients to the hydrogen supplement, but instead of metallic magnesium the placebo contained various forms of magnesium salts (i.e. tartrate, malate, chloride) and similar organic acids to prevent any pH buffering effect from the conjugate bases of the alkaline salts.

The participants consumed 1 tablet 3 x daily in 250 mL of 12-18°C water. They were advised to drink the product in one gulp as soon as the tablet finished dissolving on an empty stomach/morning. This method of H2 administration would provide >5.5 millimoles H2/day.

Supplementation with high-concentration HRW significantly reduced blood cholesterol and glucose levels, attenuated serum haemoglobin A1c, and improved biomarkers of inflammation and redox homeostasis as compared to placebo. Furthermore, H2 tended to promote a mild reduction in body mass index and waist-to-hip ratio.

The authors concluded that the results from our study suggest that supplementation with high-concentration HRW produced via H2-producing tablets improves body composition, favorably modulates fatty acid and glucose metabolism, and improves inflammation and redox homeostasis in subjects with metabolic syndrome. Therefore, long-term treatment with high-concentration hydrogen-rich water may be used as an adjuvant therapy to decrease the features of metabolic syndrome. However, a larger prospective clinical trial is warranted to further determine the biological effects of HRW in this subject population.

The authors of this study, which was conducted in Moradabad India and supported by Slovak Research and Development Agency; Scientific grant agency of the Ministry of Education of the Slovak Republic, and by HRW Natural Health Products Inc., have the following affiliations:

  • Centre of Experimental Medicine, Institute for Heart Research, Slovak Academy of Sciences, Bratislava, Slovak Republic.
  • Molecular Hydrogen Institute, Enoch, UT, USA.
  • Hospital and Research Institute, Moradabad, India.
  • Era Medical College, Lucknow, India.
  • Applied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia.
  • Faculty of Health Sciences, University of Pécs, Pécs, Hungary.
  • Medical Faculty, Pharmacobiochemical Laboratory of 3rd Medical Department, Comenius University Bratislava, Bratislava, Slovakia.
  • Laboratory of Pathophysiology, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan.
  • Third Internal Clinic, Faculty of Medicine, Comenius University, Bratislava, Slovakia.
  • Center of Nutrition Research, International College of Nutrition, Moradabad, India.

In the last two years, the 1st author of this new trial has published over a dozen expeimental papers on HRW; all of them report positive findings. Whenever I see a treatment that never fails to produce positive results, regardless of the conditions it is applied to, I start asking myself, are these findings not too good to be true?

Am I the only one to smell a rat?

When I started this blog almost precisely 8 years ago, I had no idea that I would take to it. Those who know me personally would probably confirm that I and a blog go about as well together as fire and water. But here we are:

THIS IS POST NUMBER 2000!

 

Unquestionably, this is a reason to celebrate. And I have decided that I will do this with a ‘homeopathic proving’. If you have followed some of the recent comments, there are some who cannot stop telling me that I must do a proving, otherwise I understand nothing about homeopathy. I have repeatedly replied that I have done my share of provings but they never produced any result. The homeopathy-fans then wanted to have proof of my provings, and I answered that there is no proof. Then they wanted to know the exact details, but I cannot remember them because they were some 35 years ago. Consequently, they imply that I am a liar. This does not bother me much; on the contrary, according to the ‘like cures like’ assumption, this must mean that I am a 100% truthful person. So, I am flattered by their insinuations.

Anyway, the occasion of POST NUMBER 2000 calls for Champagne – more precisely, for homeopathic Champagne.

Yes, there is such a remedy

Provings are best carried out with the mother tincture. So, in anticipation of today, my wife and I invited two friends to conduct a proving on a bottle on Dom Perignon 2008. Expensive stuff, I know, but good science has never been cheap.

As we opened the bottle, the excitement reached fever pitch. The bouquet was perfect, the robe elegant, the bubbles fine and steady. As the first drops reached out lips, we were transported to Champagne heaven! Patiently we waited for the first symptoms to show: nothing!

Perhaps it’s a question of dose, I thought and refilled the glassed. Nobody protested.

If anything, the second glass was even better.

We waited.

Then, suddenly, the first symptoms seemed to appear: one of us started giggling without apparent reason. Soon all of us normally very introvert people started laughing, talking, relaxing, being sociable. As a good scientist, I noted all this down to generate a proper drug picture of the remedy.

The third glass was greeted with impatience. At this stage we were in full swing: we laughed, told jokes and had a good time. I carried on making notes discretely, while everyone was enjoying themselves. To my shame, I have to admit that, at that stage, we broke off the Champagne proving by opening and consuming a bottle of red wine.

The next day, I looked at my notes and composed the following drug picture of Champagne:

  • unmotivated giggling,
  • laughing,
  • being sociable,
  • telling jokes,
  • having a good time,
  • being relaxed.

The question that the world of homeopathy is dying to get answered is, of course, what must a patient suffer from to be effectively treated with homeopathic Champagne? Well, thanks to my homoeopathically trained mind and my thoroughly developed scientific method, I am now in a position to answer it: if you patient is happy, sociable, relaxed and generally has a good time, you, dear homeopath, must urgently prescribe homeopathic Champagne to stop all this and turn him into a uptight sociopath who hates life.

 

PS

I know very well that the success of my blog is due to the interesting comments it receives.

So:

THANKS EVERYONE!

.

 

A number of German health insurances are offering integrated care contracts for homeopathy (ICCHs) that cover the reimbursement of homeopathy. But the effectiveness and cost-effectiveness of these contracts are highly questionable. Now a team of German researchers evaluated the effectiveness and cost-effectiveness of treatment after an additional enrolment in an ICCH in a comparative, prospective, observational study (sponsored by the health insurance company Techniker Krankenkasse).

The participants in the ICCH (HOM group) were compared with matched (on diagnosis, sex and age) insured individuals (CON group) who received usual care alone. Those insured with either

  • migraine or headache,
  • allergic rhinitis,
  • asthma,
  • atopic dermatitis,
  • depression

were included. Primary effectiveness outcomes were the baseline adjusted scores of diagnosis-specific questionnaires (e.g. RQLQ, AQLQ, DLQI, BDI-II) after 6 months. Primary cost-effectiveness endpoints were the baseline adjusted total costs from an insurer perspective in relation to the achieved quality-adjusted life years (QALYs). Costs were derived from health claims data and QALYs were calculated based on SF-12 data.

Data from 2524 participants (1543 HOM group) were analysed. The primary effectiveness outcomes after 6 months were statistically significant in favour of the HOM group for:

  • migraine or headache (Δ = difference between groups, days with headache: – 0.9, p = 0.042),
  • asthma (Δ-AQLQ(S): + 0.4, p = 0.014),
  • atopic dermatitis (Δ-DLQI: – 5.6, p ≤ 0.001),
  • depression (Δ-BDI-II: – 5.6, p ≤ 0.001).

Only the BDI-II differences reached the minimal clinically important difference.

For all diagnoses, the adjusted mean total costs over 12 months were higher in the HOM group from an insurer perspective, with

  • migraine or headache,
  • atopic dermatitis,
  • depression

suggesting cost-effectiveness in terms of additional costs per QALY gained.

The authors concluded that after an additional enrolment in the ICCH, the treatment of participants with depression showed minimally clinically relevant improvements. From an insurer perspective, treatment with an ICCH enrolment resulted in higher costs over all diagnoses but seemed to be cost-effective for migraine or headache, atopic dermatitis and depression according to international used threshold values. Based on the study design and further limitations, our findings should be considered cautiously and no conclusions regarding the effectiveness of specific treatment components can be made. Further research is needed to overcome limitations of this study and to confirm our findings.

Normally, I find newly published studies by conducting Medline searches. This one, I found because the insurance company in question, the Techniker Krankenkasse, is already using it for their advertising. No wonder – this is not a scientific study but a clever marketing coup!

THE RESULTS OF THIS ‘STUDY’ WERE CLEAR, EVEN BEFORE THE FIRST PATIENT WAS RECRUITED. 

Imagine you are a patient with one of the 5 conditions listed above, and you evidently like homeopathy – so much so that you approach your insurance and ask to get cover for homeopathy at extra cost to yourself. These were the patients of experimental group. They were compared to patients who could not care less about homeopathy and thus did not get this extra cover.

Who do you think claims to feel better in a self-administered questionnaire?

Is there anyone surprised at the findings of this study?

Well, actually I am a little surprised. Not that the results were positive, but that the results were not more positive. With such a monsterous bias built in the ‘study’, I would have expected much larger differences.

And I am surprised about something else too: how come BMC Health Services Research publishes such promotional marketing masquerading as scientific research?

This clever marketing coup can in no way determine the effectiveness of homeopathy. For that, we need RCTs of which there are already plenty; and we all know what they show: the effects of homeopathy are indistinguishable from those of placebo.

This means there is no proven effectiveness. And what did the director of NICE England once tell me?

WHERE THERE IS NO EFFECTIVENESS, THERE CAN ALSO BE NO COST-EFFECTIVENESS!

Across the world, researchers are frantically trying to find a treatment for COVID-19. Thus many trials have been initiated – and some are better than others.

The aim of this study was to develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.

A putative ARDS-suppressing drug Keguan-1 was evaluated in a randomized, controlled two-arm trial. The two groups were:

  1. A control therapy receiving alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively.
  2. The experimental group receiving the control therapy plus Keguan-1 19.4 g twice daily. The new formula was derived from 3 different formulae, Yinqiao Powder (银翘散), Sangju Drink (桑菊饮), and Sanren Decoction (三仁汤), named “Keguan-1” (meaning anti-coronavirus 1 in Chinese) with 7 components: Lonicera japonica Thunb. (Jinyinhua, lot. 19040301) 30 g, Forsythia suspensa (Thunb.) Vahl, (Lianqiao, lot. 19040221) 30 g, Morus alba L. (Sangye, lot. 19045321) 15 g, Chrysanthemum morifolium Ramat. (Juhua, lot. 19040811) 10 g,
    Coix lacryma-jobi L. var. mayuen (Roman.) Stapf, Yiyiren, lot. 19025161) 30 g, Fritillaria thunbergii Miq. (Zhebeimu, lot. 19041161) 15 g, and Prunus armeniaca L. var. ansu Maxim. (Kuxingren, lot. 19045591) 9 g. The powder versions of the drugs for the 7 components of Keguan-1 were obtained from Beijing Tcmages Pharmaceutical Co. Ltd. (Beijing, China) and mixed in the defined ratio.

After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.

An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm).

The results show that, compared with the control arm, the experimental group exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).

The authors (who almost out-number the patients in the study) concluded that Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients.

The mixture used in this trial is adventurous, to put it mildly (although the authors state that they report the development of a TCM-medicine “We have reported here the development of Keguan-1, a new CM drug that was specifically designed for suppressing ARDS development in patients of COVID-19 and/or of other RDI” they actually do nothing of the sort). The trial design is flimsy, to put it politely. And the conclusion is unjustified, to put it scientifically.

One might even say that – pandemic or not – it is irresponsible to conclude from a sample size of 2 x 24 on the safety and efficacy of any therapy – TCM or not.

 

Excessive eccentric exercise of inadequately conditioned skeletal muscle results in focal sites of injury within the muscle fibres. These injuries cause pain which usually is greatest about 72 hours after the exercise. This type of pain is called delayed-onset muscle soreness (DOMS) and provides an accessible model for studying the effects of various treatments that are said to have anaesthetic activities; it can easily be reproducibly generated without lasting harm or ethical concerns.

In so-called alternative medicine (SCAM) DOMS is employed regularly to test treatments which are promoted for pain management. Thus several acupuncture trials using this method have become available. Yet, the evidence for the effects of acupuncture on DOMS is inconsistent which begs the question whether across all trials an effects emerges.

The aim of this systematic review therefore was to explore the effects of acupuncture on DOMS. Studies investigating the effect of acupuncture on DOMS in humans that were published before March 2020 were obtained from 8 electronic databases. The affected muscles, groups, acupuncture points, treatment sessions, assessments, assessment times, and outcomes of the included articles were reviewed. The data were extracted and analysed via a meta-analysis.

A total of 15 articles were included, and relief of DOMS-related pain was the primary outcome. The meta-analysis showed that there were no significant differences between acupuncture and sham/control groups, except for acupuncture for DOMS on day 1 (total SMD = -0.62; 95% CI = -1.12∼0.11, P < 0.05) by comparing with control groups.

The authors concluded that acupuncture for DOMS exhibited very-small-to-small and small-to-moderate effects on pain relief for the sham and no acupuncture conditions, respectively. Evidence indicating the effects of acupuncture on DOMS was little because the outcome data during the follow-up were insufficient to perform an effective meta-analysis.

A mere glance at the Forrest plot reveals that acupuncture is unlikely to have any effect on DOMS at all. The very small average effect that does emerge originates mainly from one outlier, the 2008 study by Itoh et al. This trial was published by three acupuncturists from the Department of Clinical Acupuncture and Moxibustion, Meiji University of Integrative Medicine, Kyoto, Japan. It has numerous weaknesses, for instance there are just 10 volunteers in each group, and can therefore be safely discarded.

In essence, this means that there is no good evidence that acupuncture is effective at reducing pain caused by DOMS.

As mentioned already yesterday, NICE published a draft report on pain treatments. The draft is now open to public consultation until 14 September 2020, and some of my readers might want to comment. It suggests that people with chronic primary pain (CPP) should not get pain-medication of any type, but be offered supervised group exercise programmes, some types of psychological therapy, or acupuncture.

No recommendation is made for manual therapy, but a lengthy document evaluates with the subject in some detail. Here are what I consider to be the key passages from its clinical evidence section:

Mixed modality manual therapy versus usual care/acupuncture/dry needling
Pain reduction
Low quality evidence from 2 studies with a total of 52 participants showed no clinically important difference between mixed modality manual therapy and usual care at time points up to 3 months. Low quality evidence from 1 study with a total of 33 participants showed a clinically important benefit of mixed modality manual therapy over usual care at time points after 3 months. Low quality evidence from 1 study with a total of 26 participants showed no clinically important difference between mixed modality manual therapy and acupuncture/dry needling at time points up to 3 months.

Soft tissue technique versus usual care/acupuncture/dry needling
Pain reduction
Low quality evidence from 3 studies with a total of 286 participants showed a clinically important benefit of soft tissue technique over usual care at time points up to 3 months. Very low quality evidence from 2 studies with a total of 115 participants showed a clinically important benefit of acupuncture/dry needling over soft tissue technique at time points up to 3 months.

Manipulation/mobilisation versus usual care/acupuncture/dry needling

Pain reduction
Low quality evidence from 1 study with a total of 30 participants showed a clinically important benefit of manipulation/mobilisation over usual care at time points up to 3 months. Very low quality evidence from 1 study with a total of 24 participants showed no clinically important difference between manipulation/mobilisation and acupuncture/dry needling at time points up to 3 months.

Manual therapy interventions compared with each other
Pain reduction
Moderate quality evidence from 1 study with a total of 63 participants showed a clinically important benefit of mixed modality manual therapy over soft tissue technique at time points up to 3 months. Low quality evidence from 1 study with a total of 63 participants showed a clinically important benefit of mixed modality manual therapy over soft tissue technique at time points after 3 months. Low quality evidence from 1 study with a total of 30 participants showed a clinically important benefit of mixed modality manual therapy over manipulation/mobilisation at time points up to 3 months. Very low quality evidence from 3 studies with a total of 125 participants showed a clinically important benefit of manipulation/mobilisation over soft tissue technique at time points up to 3 months. Low quality evidence from 1 study with a total of 68 participants showed no clinically important difference between manipulation/mobilisation and soft tissue technique at time points after 3 months.

In my view, this is a sound assessment of effectiveness. Nonetheless, I should to mention a few critical points.

Manual therapy is a very heterogeneous group of interventions. Massage and spinal manipulation, for instance, are very different in almost every respect. It would therefore be more constructive to name the techniques more precisely. Evaluating them together makes little sense to me and is hardly different from an assessment of all pharmacological treatments.

Much more important is the fact that the document lacks an assessment of harms. All I did find was a comment saying ‘THERE WAS NO EVIDENCE OF HARM’. This statement is certainly misleading. Perhaps the clinical trials did not report adverse effects, but this is (as I have often pointed out) because these studies usually defy research ethics by failing to mention them. As we have discussed ad nauseam on this blog (for instance here, here and here), spinal manipulation has regularly been associated with severe harms many times.

As NICE do not suggest to recommend manual therapy for CPP, this is perhaps not so crucial in this particular instance. However, I do believe that, for completeness of the evidence as well as for the credibility of the research, an in-depth assessment of the risks is paramount when it comes to the assessment of any therapy.

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