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

research

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Some consumers believe that research is by definition reliable, and patients are even more prone to this error. When they read or hear that ‘RESEARCH HAS SHOWN…’ or that ‘A RECENT STUDY HAS DEMONSTRATED…’, they usually trust the statements that follow. But is this trust in research and researchers justified? During 25 years that I have been involved in so-called alternative medicine (SCAM), I have encountered numerous instances which make me doubt. In this post, I will briefly discuss some the many ways in which consumers can be mislead by apparently sound evidence (for an explanation as to what is and what isn’t evidence, see here).

ABSENCE OF EVIDENCE

I have just finished reading a book by a German Heilpraktiker that is entirely dedicated to SCAM. In it, the author makes hundreds of statements and presents them as evidence-based facts. To many lay people or consumers, this will look convincing, I am sure. Yet, it has one fatal defect: the author fails to offer any real evidence that would back up his statements. The only references provided were those of other books which are equally evidence-free. This popular technique of making unsupported claims allows the author to make assertions without any checks and balances. A lay person is usually unable or unwilling to differentiate such fabulations from evidence, and this technique is thus easy and poular for misleading us about SCAM.

FAKE-EVIDENCE

On this blog, we have encountered this phenomenon ad nauseam: a commentator makes a claim and supports it with some seemingly sound evidence, often from well-respected sources. The few of us who bother to read the referenced articles quickly discover that they do not say what the commentator claimed. This method relies on the reader beeing easily bowled over by some pretend-evidence. As many consumers cannot be bothered to look beyond the smokescreen supplied by such pretenders, the method usually works surprisingly well.

An example: Vidatox is a homeopathic cancer ‘cure’ from Cuba. The Vidatox website clains that it is effective for many cancers. Considering how sensational this claim is, one would expect to find plenty of published articles on Vidatox. However, a Medline search resulted in one paper on the subject. Its authors drew the following conclusion: Our results suggest that the concentration of Vidatox used in the present study has not anti-neoplastic effects and care must be taken in hiring Vidatox in patients with HCC. 

The question one often has to ask is this: where is the line between misleading research and fraud?

SURVEYS

There is no area in healthcare that produces more surveys than SCAM. About 500 surveys are published every year! This ‘survey-mania’ has a purpose: it promotes a positive message about SCAM which hypothesis-testing research rarely does.

For a typical SCAM survey, a team of enthusiastic researchers might put together a few questions and design a questionnaire to find out what percentage of a group of individuals have tried SCAM in the past. Subsequently, the investigators might get one or two hundred responses. They then calculate simple descriptive statistics and demonstrate that xy % use SCAM. This finding eventually gets published in one of the many third-rate SCAM journals. The implication then is that, if SCAM is so popular, it must be good, and if it’s good, the public purse should pay for it. Few consumers would realise that this conclusion is little more that a fallacious appeal to popularity.

AVOIDING THE QUESTION

Another popular way of SCAM researchers to mislead the public is to avoid the research questions that matter. For instance, few experts would deny that one of the most urgent issues in chiropractic relates to the risk of spinal manipulations. One would therefore expect that a sizable proportion of the currently published chiropractic research is dedicated to it. Yet, the opposite is the case. Medline currently lists more than 3 000 papers on ‘chiropractic’, but only 17 on ‘chiropractic, harm’.

PILOT-STUDIES

A pilot study is a small scale preliminary study conducted in order to evaluate feasibility, time, cost, adverse events, and improve upon the study design prior to performance of a full-scale research project. Yet, the elementary preconditions are not fulfilled by the plethora of SCAM pilot studies that are currently being published. True pilot studies of SCAM are, in fact, very rare. The reason for the abundance of pseudo-pilots is obvious: they can easily be interpreted as showing encouragingly positive results for whatever SCAM is being tested. Subsequently, SCAM proponents can mislead the public by claiming that there are plenty of positive studies and therefore their SCAM is supported by sound evidence.

‘SAFE‘ STUDY-DESIGNS

As regularly mentioned on this blog, there are several ways to design a study such that the risk of producing a negative result is minimal. The most popular one in SCAM research is the ‘A+B versus B’ design. In this study, for instance, cancer patients who were suffering from fatigue were randomised to receive usual care or usual care plus regular acupuncture. The researchers then monitored the patients’ experience of fatigue and found that the acupuncture group did better than the control group. The effect was statistically significant, and an editorial in the journal where it was published called this evidence “compelling”. Due to a cleverly over-stated press-release, news spread fast, and the study was celebrated worldwide as a major breakthrough in cancer-care.

Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual alone, and the former is therefore more than likely to produce a better result. This will be true, even if acupuncture is a pure placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.

A more obvious method for generating false positive results is to omit blinding. The purpose of blinding the patient, the therapist and the evaluator of the group allocation in clinical trials is to make sure that expectation is not a contributor to the result. Expectation might not move mountains, but it can certainly influence the result of a clinical trial. Patients who hope for a cure regularly do get better, even if the therapy they receive is useless, and therapists as well as evaluators of the outcomes tend to view the results through rose-tinted spectacles, if they have preconceived ideas about the experimental treatment.

Failure to randomise is another source of bias which can mislead us. If we allow patients or trialists to select or chose which patients receive the experimental and which get the control-treatment, it is likely that the two groups differ in a number of variables. Some of these variables might, in turn, impact on the outcome. If, for instance, doctors allocate their patients to the experimental and control groups, they might select those who will respond to the former and those who don’t to the latter. This may not happen with intent but through intuition or instinct: responsible health care professionals want those patients who, in their experience, have the best chances to benefit from a given treatment to receive that treatment. Only randomisation can, when done properly, make sure we are comparing comparable groups of patients. Non-randomisation can easily generate false-positive findings.

It is also possible to mislead people with studies which do not test whether an experimental treatment is superior to another one (often called superiority trials), but which assess whether it is equivalent to a therapy that is generally accepted to be effective. The idea is that, if both treatments produce similarly positive results, both must be effective.  Such trials are called non-superiority or equivalence trials, and they offer a wide range of possibilities for misleading us. If, for example, such a trial has not enough patients, it might show no difference where, in fact, there is one. Let’s consider a simple, hypothetical example: someone comes up with the idea to compare antibiotics to acupuncture as treatments of bacterial pneumonia in elderly patients. The researchers recruit 10 patients for each group, and the results reveal that, in one group, 2 patients died, while, in the other, the number was 3. The statistical tests show that the difference of just one patient is not statistically significant, and the authors therefore conclude that acupuncture is just as good for bacterial infections as antibiotics.

Even trickier is the option to under-dose the treatment given to the control group in an equivalence trial. In the above example, the investigators might subsequently recruit hundreds of patients in an attempt to overcome the criticism of their first study; they then decide to administer a sub-therapeutic dose of the antibiotic in the control group. The results would then seemingly confirm the researchers’ initial finding, namely that acupuncture is as good as the antibiotic for pneumonia. Acupuncturists might then claim that their treatment has been proven in a very large randomised clinical trial to be effective for treating this condition. People who do not happen to know the correct dose of the antibiotic could easily be fooled into believing them.

Obviously, the results would be more impressive, if the control group in an equivalence trial received a therapy which is not just ineffective but actually harmful. In such a scenario, even the most useless SCAM would appear to be effective simply because it is less harmful than the comparator.

A variation of this theme is the plethora of controlled clinical trials in SCAM which compare one unproven therapy to another unproven treatment. Perdicatbly, the results would often indicate that there is no difference in the clinical outcome experienced by the patients in the two groups. Enthusiastic SCAM researchers then tend to conclude that this proves both treatments to be equally effective. The more likely conclusion, however, is that both are equally useless.

Another technique for misleading the public is to draw conclusions which are not supported by the data. Imagine you have generated squarely negative data with a trial of homeopathy. As an enthusiast of homeopathy, you are far from happy with your own findings; in addition you might have a sponsor who puts pressure on you. What can you do? The solution is simple: you only need to highlight at least one positive message in the published article. In the case of homeopathy, you could, for instance, make a major issue about the fact that the treatment was remarkably safe and cheap: not a single patient died, most were very pleased with the treatment which was not even very expensive.

OMISSION

A further popular method for misleading the public is the outright omission findings that SCAM researchers do not like. If the aim is that the public believe the myth that all SCAM is free of side-effects, SCAM researchers only need to omit reporting them in clinical trials. On this blog, I have alerted my readers time and time again to this common phenomenon. We even assessed it in a systematic review. Sixty RCTs of chiropractic were included. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT.

Most trails have many outcome measures; for instance, a study of acupuncture for pain-control might quantify pain in half a dozen different ways, it might also measure the length of the treatment until pain has subsided, the amount of medication the patients took in addition to receiving acupuncture, the days off work because of pain, the partner’s impression of the patient’s health status, the quality of life of the patient, the frequency of sleep being disrupted by pain etc. If the researchers then evaluate all the results, they are likely to find that one or two of them have changed in the direction they wanted (especially, if they also include half a dozen different time points at which these variables are quatified). This can well be a chance finding: with the typical statistical tests, one in 20 outcome measures would produce a significant result purely by chance. In order to mislead us, the researchers only need to “forget” about all the negative results and focus their publication on the ones which by chance have come out as they had hoped.

FRAUD

When it come to fraud, there is more to chose from than one would have ever wished for. We and others have, for example, shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. This strange phenomenon indicates that something is amiss with Chinese acupuncture research. This suspicion was even confirmed by a team of Chinese scientists. In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively. The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.

A survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.

I hasten to add that fraud in SCAM research is certainly not confined to China. On this blog, you will find plenty of evidence for this statement, I am sure.

CONCLUSION

Research is obviously necessary, if we want to answer the many open questions in SCAM. But sadly, not all research is reliable and much of SCAM research is misleading. Therefore, it is always necessary to be on the alert and apply all the skills of critical evaluation we can muster.

 

I have to thank one of our regular commentators for inspiring me to write this post. He recently contributed this insight about homeopathic provings:

If you didn’t experience anything from a proving you didn’t perform it properly.

It is an argument that, in different forms and shapes, I have heard very often. Essentially it holds that, if an investigation or a test fails to produce the desired result, the methodology must have been faulty. Donald Trump is, I fear, about to use it in the upcoming US election: if he is voted out, he will claim that there was too much fraud going on. Therefore, he cannot accept the result as valid. Thus it is his democratic duty to remain in post, he is likely to claim.

In medicine, the argument has been popular since millennia. In our book TRICK OR TREATMENT?, we recount the story of blood letting. Based on the doctrine of the 4 humours, it was believed for centuries to be a panacea. If someone died after losing litres of blood to the believers in the doctrine, the assumption was not that he had been bled to death, but that he had sadly not received enough of the ‘cure all’. Eventually, some bright chap had the novel idea of running a rigorous test of blood-letting, and it turned out that the patients who had received the treatment had a worse chance of survival than those who had escaped it. Aaaahhh !!!, shouted the blood-letters, this shows that the concept of the scientific test is flawed.

Checking the methodological rigour of clinical studies (or homeopathic provings) can be a tricky and tedious business. It requires proper learning and experience – qualities that SCAM fanatics rarely possess. Amongst other things, one needs to know about:

  • trial design,
  • statistics,
  • sources of bias,
  • confounding,
  • and the many tricks people use to hide flaws in published studies.

This is not easy and it takes time – lots of time – to acquire the necessary skills. Having discussed such issues with enthusiasts of so-called alternative medicine (SCAM) for decades, I realise that it would be unrealistic to expect of them to spend all this time learning all these complicated things (they have to make a living, you know!). I therefore propose an entirely new and much simpler method of differentiating between valid and invalid research of SCAM. It rests on merely 2 golden rules:

  1. Any research methodology is valid, if it produces the desired result.
  2. Any research methodology is invalid, if it fails to produce the desired result.

In analogy to these two rules, one can easily extrapolate further. For instance, one can state that:

  • any person who generates or promotes the desired result is honest;
  • any person who contradicts the desired result is corrupt (bought by ‘Big Pharma’).

I am sure my readers all see the beauty of this revolutionary, new system: it’s easy to learn, practical to apply, it avoids controversy and it takes full account of the previously much-neglected needs of the SCAM fraternity.

I have to admit that I had not heard of Dr Bernhoft before. I was alerted to him through the discussions about him on this blog. So, I had a look. What I found amazed me.

On his website, Bernhoft states the following:

Dr. Bernhoft is one of the nation’s leading practitioners in the field of environmental medicine. He comes to his expertise not only through extensive academic and professional training and decades as a practicing physician and surgeon, but also from the uniquely motivating perspective of having been a patient himself who had to fight desperately for his life and was literally forced to find a way to heal himself from an illness that left his MD colleagues at a loss for diagnosis and treatment…

His personal quest for survival carried him into cutting-edge advanced medicine, including gene-environment interactions. He found out that his gene which codes for an enzyme called MTHFR was hypoactive, and a second, which produces GSTM1 was absent, leaving him susceptible to poisoning by a wide range of metals and chemicals…

Because of his unique personal experience, combined with his outstanding professional credentials, he is one of the most effective spokespeople in the cause of environmental healing.

His ‘outstanding professional credentials’ consist of amongst others ‘28 peer reviewed medical articles‘, he claims. My Medline search located just 11:

  1. Cadmium toxicity and treatment. Bernhoft RA.ScientificWorldJournal. 2013 Jun 3;2013:394652. doi: 10.1155/2013/394652. Print 2013.PMID: 23844395 Free PMC article. Review.
  2. Mercury toxicity and treatment: a review of the literature.Bernhoft RA.J Environ Public Health. 2012;2012:460508. doi: 10.1155/2012/460508. Epub 2011 Dec 22.PMID: 22235210 Free PMC article. Review.
  3. Clinical detoxification: elimination of persistent toxicants from the human body.Genuis SJ, Sears ME, Schwalfenberg G, Hope J, Bernhoft R.ScientificWorldJournal. 2013 Jun 6;2013:238347. doi: 10.1155/2013/238347. Print 2013.PMID: 23844383 Free PMC article. No abstract available.
  4. Incorporating environmental health in clinical medicine.Genuis SJ, Sears M, Schwalfenberg G, Hope J, Bernhoft R.J Environ Public Health. 2012;2012:103041. doi: 10.1155/2012/103041. Epub 2012 May 17.PMID: 22675371 Free PMC article. No abstract available.
  5. Cholangitis after endoscopic sphincterotomy in patients with stricture of the biliary duct.Kracht M, Thompson JN, Bernhoft RA, Tsang V, Gibson RN, Blumgart LH.Surg Gynecol Obstet. 1986 Oct;163(4):324-6.PMID: 3764637
  6. Composition and morphologic and clinical features of common duct stones.Bernhoft RA, Pellegrini CA, Motson RW, Way LW.Am J Surg. 1984 Jul;148(1):77-85. doi: 10.1016/0002-9610(84)90292-7.PMID: 6742333
  7. Pigment sludge and stone formation in the acutely ligated dog gallbladder.Bernhoft RA, Pellegrini CA, Broderick WC, Way LW.Gastroenterology. 1983 Nov;85(5):1166-71.PMID: 6618107
  8. Vesicular transport of horseradish peroxidase during chronic bile duct obstruction in the rat.Renston RH, Zsigmond G, Bernhoft RA, Burwen SJ, Jones AL.Hepatology. 1983 Sep-Oct;3(5):673-80. doi: 10.1002/hep.1840030508.PMID: 6618434
  9. Peritoneovenous shunt for refractory ascites: operative complications and long-term results.Bernhoft RA, Pellegrini CA, Way LW.Arch Surg. 1982 May;117(5):631-5. doi: 0.1001/archsurg.1982.01380290081014.PMID: 7073482
  10. Biliary stricture.Way LW, Bernhoft RA, Thomas MJ.Surg Clin North Am. 1981 Aug;61(4):963-72. doi: 10.1016/s0039-6109(16)42492-8.PMID: 7280936
  11. The effects of a low level of dietary cadmium on blood pressure, ’24Na, ’42K, andwater retention in growing rats.Doyle JJ, Bernhoft RA, Sandstead HH.J Lab Clin Med. 1975 Jul;86(1):57-63.PMID: 1151143
Few, if any of them identify him as a leading expert in anything. Confused by this contradiction, I re-consulted Bernhoft’s website and found this:
We carry a wide selection of physician grade supplements, from beneficial probiotics, trace minerals, fish oils and other multivitamins that help detoxify and support the immune system. 
That puzzled even more. As far as I am aware, the term ‘physician grade’ is not a officially recognised qualifier; it seems to be a meaningless word that misleads consumers. More importantly, I can find no good evidence that probiotics, trace minerals, fish oils and other multivitamins help detoxify and support the immune system. Could this be another invented myth?
But my confusion was about to increase even further when I noticed that Bernhoft has another website; and on this one he no longer is an expert in in environmental medicine, but ‘an Ojai California Bioidentical Hormones Specialist‘. Is this another invented term?, I asked myself.
Now, I was understandably keen to learn more and discovered that Bernhoft makes many claims on his website:

The following are typical symptoms of hormone imbalance in both men and women:

  • Hot flashes and night sweats
  • Fatigue
  • Anxiety, depression, and irritability
  • Low libido
  • Memory lapses and trouble concentrating
  • Weight gain
  • Headaches
  • Insomnia and sleep apnea
  • Lack of muscle tone

Regardless of your age, gender, or specific symptoms, you can find relief with Bioidentical Hormone Replacement Therapy (BHRT).

Naturally, I am keen to learn what conditions Bernhoft’s BHRT can cure. Brace yourself, the list is long:

Women’s Conditions Treated With Bioidentical Hormones

Robin A. Bernhoft, M.D. at the Bernhoft Center for Advanced Medicine specializes in Bioidentical Hormone balancing for women, which includes addressing the symptoms of hormonal imbalance and customizing individual treatment programs using Bioidentical Hormone Replacement Therapy. Robin A. Bernhoft, M.D. will test each woman’s hormone levels to determine deficiencies, dominances, and imbalances, and he will work closely with each woman to find the correct dosages to restore optimal health. Some of the conditions that Doctor Bernhoft uses Bioidentical Hormone Replacement Therapy to treat in women include:

ADRENAL FATIGUE SYNDROME

When you suffer from chronic or poorly managed stress, your adrenal glands do not release the level of cortisol you require to remain healthy and emotionally stable. You may struggle with anxiety, depression, insomnia, fatigue, cravings for sweets, and several other symptoms due to adrenal fatigue. Along with proper nutrition, balancing your hormones with Bioidentical Hormone Replacement Therapy helps you manage stress better by bringing your cortisol levels in balance.

ALOPECIA

Having too much of the estrogen hormone or an underactive thyroid may cause you to lose hair on your head, arms, legs, or pubic area. If you are diabetic, poor blood sugar control can also cause this problem. Robin A. Bernhoft, M.D. can take a quick blood test to determine if hormonal imbalance is causing this issue. If so, replacing your body’s lost hormones with Bioidentical ones can help you re-grow scalp and body hair.

ANXIETY AND DEPRESSION

When feelings of anxiety and depression are unrelated to a specific life event, they are often the result of unbalanced levels of estrogen, progesterone, and cortisol. You may feel weepy, irritable, nervous, guilty, and many other troublesome emotions. Having a hysterectomy or going through menopause tends to increase your risk of anxiety and depression. When anti-depressant medication doesn’t work, it’s more likely you’re experiencing hormonal depression that is treatable with Bioidentical Hormone Replacement Therapy.

CHRONIC HEADACHES

Women who are approaching middle age complain of chronic headaches more often than younger women do. This is often because of pending menopause or being at a certain point in their menstrual cycle. An unbalanced amount of the hormone progesterone may also be the cause of this misery. If Robin A. Bernhoft, M.D. discovers a problem with your progesterone, he may recommend that you start Bioidentical Hormone Replacement Therapy along with a daily dose of the vitamin B12.

CHRONIC FATIGUE SYNDROME

It’s normal to feel tired when you are under stress or don’t get enough sleep, but chronic fatigue lasting throughout the day is probably a sign of hormonal imbalance. Unfortunately, it causes other problems such as irritability, depression, and lowered resistance to illnesses. Low estrogen levels are often the cause of severe fatigue in women. Balancing your hormones with Bioidentical Hormone Replacement Therapy gives you the energy you need to meet everyday responsibilities and enjoy satisfying relationships.

CYSTITIS

Cystitis, or bladder infections, occurs when bacteria from outside of the body enter through the urinary tract and cause an infection. Hormonal changes that begin in perimenopause may also cause recurring bladder infections. This is because the bladder, urethra, and vagina lose muscle tone and strength as levels of estrogen slowly decline. Fortunately, you can correct this imbalance by receiving Bioidentical Hormone Replacement Therapy. When the muscles near your bladder are stronger, it’s harder for bacteria to invade.

FIBROIDS

Uterine fibroids are masses of tissue that grow within the wall of your uterus, in it, or on it. It can result in irregular menstrual bleeding or uterine cancer in rare cases. Normally, estrogen stimulates cell growth in your body while progesterone balances it. Fibroids may be the result of unbalanced levels of estrogen, cortisol, xenoestrogens, and progesterone. Bringing all of these necessary hormones in balance with Bioidentical Hormone Replacement Therapy can help to reduce the risk of fibroids.

INSOMNIA

Insomnia, which is the consistent inability to fall or stay asleep, is both a cause and an effect of hormone imbalance. The hormonal changes of PMS, perimenopause, and menopause can all cause sleeplessness. Chronic insomnia can also make hormone imbalance worse. When your hormones are balanced through Bioidentical Hormone Replacement Therapy, it has a less inhibiting effect on your ability to fall asleep and stay asleep throughout the night.

IRRITABLE BOWEL SYNDROME

IBS is a term that describes pain with bowel movements, urge frequency, a feeling of incomplete bowel emptying, abdominal distension, and several other symptoms. Many women report worsening IBS symptoms just before their period starts. This may occur due to the fluctuation of estrogen and progesterone in the second half of the cycle. Having unbalanced levels of estrogen and progesterone can slow motility in the gut. However, balancing these hormones can greatly alleviate IBS.

LOW SEXUAL LIBIDO

Lack of desire for physical intimacy is due to an imbalance in the amounts of estrogen, progesterone, and testosterone in your body. When the latter two hormones start declining, it may cause estrogen dominance. This problem is also associated with weight gain, mood swings, and painful intercourse, all of which further decrease your libido. Balancing estrogen in your body so it doesn’t dominate other hormones is essential to restore your desire for sex.

MENOPAUSE

Menopause is the clinical term for 12 consecutive months without a menstrual period. As you start menopause, your estrogen, progesterone, and testosterone hormones may fluctuate wildly. Although there are dozens of symptoms associated with menopause, the most common ones include hot flashes, night sweats, low libido, mood swings, and weight gain. Replacement therapy with Bioidentical Hormones can help eliminate or reduce multiple symptoms at the same time.

PERIMENOPAUSE

Although the average age of menopause is 51, you may begin perimenopause as early as your mid 30s. Common symptoms include breast tenderness, changes in the menstrual cycle, skin changes, sexual dysfunction, and loss of bone density. These problems occur due to decreasing levels of estrogen and other essential hormones as you age. If your blood work confirms hormonal imbalance, Bioidentical Hormone Replacement Therapy can help you feel more comfortable.

SYMPTOMS OF PRE-MENSTRUAL SYNDROME

In a normal menstrual cycle, estrogen rises for the first two weeks and then begins to fall. During the second half of the cycle, this process repeats itself with progesterone. If you’re highly sensitive to hormonal changes, you may experience worsening symptoms of PMS. Some of these include bloating, irritability, fatigue, tension, and weight gain. If your PMS symptoms are severe enough to interfere with your quality of life, consider Bioidentical Hormone Replacement Therapy with Doctor Robin A. Bernhoft.

THYROID DISORDERS

You have a thyroid imbalance when your thyroid, which is a small nodule at the base of your neck, produces too little or too much of this hormone. When you go to a traditional doctor complaining of fatigue or difficulty losing weight, he or she may test your TSH level. However, this may not be enough to determine hormone imbalance. Robin A. Bernhoft, M.D. conducts several medical tests to see if you are a good candidate for Bioidentical Hormone Replacement Therapy.

Men’s Conditions Treated With Bioidentical Hormones

Robin A. Bernhoft, M.D. also specializes in Bioidentical Hormone Replacement Therapy for men, which includes addressing symptoms of hormonal imbalance and customizing individual treatment programs using Bioidentical Hormones. Robin A. Bernhoft, M.D. will apply the newest and most effective methods for restoring optimal hormone balance using Bioidentical Hormone Replacement Therapy. He offers medically supervised programs, which include the most advanced delivery methods to help bring hormone levels back into balance. His programs can also treat the symptoms of andropause, helping men regain their health and confidence. Some of the conditions Robin A. Bernhoft, M.D. uses Bioidentical Hormone Replacement Therapy to treat in men include:

ADRENAL FATIGUE

Your adrenal glands release the hormone cortisol in response to stress, exercise, excitement, and low blood sugar. As you age, your body has a harder time balancing your cortisol levels. This can cause unrelenting fatigue, anxiety, sexual problems, and a wide range of other symptoms due to cortisol imbalance in your adrenal glands. Hormone restoration through Bioidentical Hormone Replacement Therapy can help speed up sluggish adrenal glands and provide you with more energy.

ALOPECIA (HAIR LOSS)

Dihydrotestosterone (DHT), which is part of the testosterone hormone, is responsible for hair loss on your scalp, face, chest, back, arms, legs, and groin area. When this hormone is unbalanced, it causes the follicles of your hair to regress and die. High levels of DHT can result in premature balding or thinning hair. If a full head of hair is important to you, remember that Bioidentical Hormone Replacement Therapy can stimulate hair growth.

ANDROPAUSE

By the time men reach age 70, they may have only 10 percent of the testosterone hormone they had at age 25. This explains why many men begin experiencing symptoms associated with low testosterone around age 40. Andropause is a term that describes the many physical and emotional changes that occur due to the imbalance of hormones. Testosterone replacement is essential to help you experience long-term symptom relief.

ANXIETY AND DEPRESSION

Low levels of testosterone cause an overall feeling of discontent in some men, which is the hallmark characteristic of hypogonadism. Balanced levels of this hormone are so essential that men with hypogonadism receive a diagnosis of clinical depression 400 times more often than men with normal hormone levels do. If you feel hopeless, low on energy, and irritable, ask Robin A. Bernhoft, M.D. to check your testosterone level. Bioidentical Hormone Replacement Therapy can help balance your hormones and improve your outlook on life.

CHRONIC FATIGUE

When fatigue is chronic, you lack the energy to focus or keep up with everyday responsibilities. Declining levels of testosterone are often to blame for this problem. Chronic fatigue is also worsened by other symptoms of andropause, including night sweats, insomnia, sleep apnea, increased stress, and irritability. It’s important to note that all-day fatigue is different than feeling tired. Fortunately, balancing your testosterone and other hormones with Bioidentical Hormone Replacement Therapy helps to improve fatigue and all of its associated symptoms.

CHRONIC HEADACHES

Cortisol, the stress hormone, can go into overdrive when you are under constant, unrelenting stress. This can cause daily headaches of varying intensity. The drop in testosterone starting at age 30 can also play a role in chronic headaches; Robin A. Bernhoft, M.D. can pinpoint an exact cause with a simple blood test. If your hormones are unbalanced, treatment with Bioidentical Hormone Replacement Therapy can help alleviate headache pain.

ERECTILE DYSFUNCTION

You have erectile dysfunction when you can’t get an erection at all or maintain one long enough for satisfying sexual activity. A diminished level of testosterone is the typical cause. This also happens when the brain fails to signal the release of nitrous oxide, which is responsible for blood flow to the penis. Too much of the stress hormone cortisol also plays a role in erectile dysfunction. Balancing testosterone and cortisol with Bioidentical Hormone Replacement Therapy can eliminate or improve this problem.

GASTROINTESTINAL DISORDERS

Gas, bloating, constipation, diarrhea, heartburn, belching, and slow digestion may all be related to imbalanced hormones in your body. Specifically, these problems could originate due to problems with normal thyroid functioning due to too much cortisol or estrogen. Many traditional doctors don’t treat digestion problems correctly because they don’t understand the connection to hormones. When diet, exercise, and medication aren’t working, consider replacing lost hormones through Bioidentical Hormone Replacement Therapy with Doctor Bernhoft.

INSOMNIA

Because testosterone normally replenishes itself while you are sleeping, struggling with insomnia lowers your testosterone production. This causes a vicious cycle because low testosterone levels cause many sleep disturbances, including insomnia and sleep apnea. While difficulty falling or staying asleep and decreased testosterone production are both normal signs of aging, you don’t have to allow them to affect your quality of life. Providing your body the testosterone it needs through Bioidentical Hormone Replacement Therapy can greatly improve restful sleep.

IRRITABLE BOWEL SYNDROME

Elevated stress levels and a weakened immune system can both cause IBS, which may present itself as abdominal pain, gas, bloating, or frequent diarrhea. In many cases, both stress and immune system deficiency are related to unbalanced levels of hormones. This can trigger an attack of IBS. Determining what triggers your symptoms, including certain foods and hormone imbalance, is the first step to helping you feel better. Bioidentical Hormone Replacement Therapy helps to balance the hormones responsible for triggering IBS symptoms.

LOW LIBIDO

The desire to have sex less often and erectile dysfunction are often related, but it’s possible to have one without the other. Testosterone stimulates the nerves in the brain to become sexually aroused, so this sensation naturally diminishes as you age. Smoking, drinking too much alcohol, and a poor diet are additional reasons your libido may be low. When combined with a healthy lifestyle, therapy with Bioidentical Hormones helps to improve your sexual desire and functioning.

LOW TESTOSTERONE

Low testosterone, which your doctor may also refer to as male menopause, hypogonadism, or andropause, is the term used to describe the multitude of symptoms many men experience as they approach middle age. Your testosterone production actually starts declining one percent every year at age 30. Sexual dysfunction, mood problems, weight gain, and low energy are common problems associated with low testosterone that are correctable with Bioidentical Hormone Replacement Therapy.

THYROID DISORDERS

Low thyroid levels in men can cause cold intolerance, fatigue, hair loss, weight gain, dry skin, and constipation; as many as one in seven men struggle with hypothyroidism. When the thyroid produces an excess of hormones, hyperthyroidism is the result. This condition has many additional symptoms, including muscle weakness, trembling hands, insomnia, and heart palpitations. Having your thyroid level checked by a hormone specialist such as Robin A. Bernhoft, M.D. and completing Bioidentical Hormone Replacement Therapy are essential to help you feel better.

Ojai, California Bioidentical Hormone Replacement Therapy specialist, Robin A. Bernhoft, M.D. at the Bernhoft Center for Advanced Medicine has helped countless men and women to overcome conditions related to hormonal imbalance or decline. Before beginning a Bioidentical Hormone Replacement Therapy program, Robin A. Bernhoft, M.D. tests the levels of all essential hormones in order to get to the root of patients’ imbalances. He then designs a personalized program using dosages that are unique to each patient. Vast numbers of men and women have been able to achieve peak levels of health with Doctor Bernhoft’s specialized Bioidentical Hormone Replacement Therapy programs.

Yes, I did try to find evidence for these claims. It’s a big job and a frustrating one too, as I was less than successful.

Now I am positively exhausted! Maybe I too need some of Bernhoft’s BHRT ?

 

I have discovered ‘Google Scholar’!

Yes, of course, I knew about it, but I never used it much. In particular, I did not know it has a huge page just on me. So I had a good look at it (who would be able to resist?) and found many things of interest – for instance, the fact that (as of yesterday) my papers have been cited a total of 86 759 times, and that 4 of them have been cited more that a thousand times.

Here they are:

Interactions between herbal medicines and prescribed drugs AA Izzo, E Ernst

Drugs 61 (15), 2163-2175
1517* 2001
Fibrinogen as a cardiovascular risk factor: a meta-analysis and review of the literature

E Ernst, KL Resch
Annals of internal medicine 118 (12), 956-963
1491 1993
Influence of context effects on health outcomes: a systematic review

Z Di Blasi, E Harkness, E Ernst, A Georgiou, J Kleijnen
The Lancet 357 (9258), 757-762
1458 2001
The prevalence of complementary/alternative medicine in cancer: a systematic review

E Ernst
Cancer: Interdisciplinary International Journal of the American Cancer …
1124 1998

Two things are perhaps noteworthy here, I feel:

  1. Only 2 of the 4 papers are on research in so-called alternative medicine (SCAM).
  2. In the 4th paper, they forgot to add Barrie Cassileth who was its co-author.

Scanning my own articles, the real revelation was how much I owe to others, how many co-workers I have had, how many of them I had completely forgotten about, and how many have already gone forever.

So, allow me to take this opportunity to honour those who have passed away (in the order they appear on the page).

  • ARPAD MATRAI was a brilliant scientist, Olympic swimmer for Hungary, and close friend. He came to London in 1980 to work in my lab. After I had left, I attracted him to Munich where we had several hugely productive years together – until he died of leukaemia in 1988.
  • JOHN DORMANDY see here.
  • VERONIKA FIALKA was my senior registrar in Vienna and became a good friend. After I had left Vienna, she took over my position as head of the department. We then somehow lost contact and, one day, I received the sad news of her early death.
  • NASSIM KANJI was my PhD student at Exeter. She did very well, and we published several papers on autogenic training together.
  • PETER FISHER see here.
  • GEORGE LEWITH see here.
  • CHRIS SILAGY was a brilliant GP and researcher. We did not have much contact except for one paper we had together.
  • JOHN GARROW see here.
  • ANDREW HERXHEIMER see here.
  • WALLACE SAMPSON was a famous and brilliant US sceptic. We had various contacts and shared one paper.
  • P T FLUTE was head of haematology at St George’s Hospital, London while I worked there. I remember him as kind and supportive.

I owe more gratitude to these (and all my other) co-authors than I will ever be able to express.

 

In the wake of both the NEJM and the LANCET withdrawing two potentially influential papers due unanswered questions about the source and reliability of the data, one has to ask how good or bad the process of peer review is.

Peer review is the evaluation of work by one or more people with similar competences as the producers of the work (peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. It normally involves multiple steps:

  1. Authors send their manuscript to a journal of their choice for publication.
  2. The journal editor has a look at it and decides whether to reject it straight away (for instance, because the subject area is not of interest) or whether to send it out to referees for examination (often to experts suggested by the authors of the submission).
  3. The referees (usually 2 or 3) have the opportunity to reject or accept the invitation to review the submission.
  4. If they accept, they review the paper and send their report to the editor (usually following a deadline).
  5. The editor tries to come to a decision about publication; often the referees are not in agreement, and a further referee has to be recruited.
  6. Even if the submission is potentially publishable, the referees will have raised several points that need addressing. In such cases, the editor sends the submission back to the original authors asking them to revise the article.
  7. The authors do their revision (often following a deadline) and re-submit their paper.
  8. Now the editor can decide to either publish it or send it back to the referees asking them whether they feel their criticisms have been adequately addressed.
  9. Depending on the referees’ verdicts, the editor makes the final decision and informs all the involved parties accordingly.
  10. If the paper was accepted, it then goes into production.
  11. When this process is finished, the authors receive the proofs for final a check.
  12. Eventually, the paper is published and the readers of the journal may scrutinise it.
  13. Often this prompts comment which may get published.
  14. In this case, the authors of the original paper may get invited to write a reply.
  15. Finally the comments and the reply are published in the journal side by side.

The whole process takes time, sometimes lots of time. I have had papers that took almost two years from submissions to publications. This delay seems tedious and, if the paper is important, unacceptable (if it is not important, it should arguably not be published at all). Equally unacceptable is the fact that referees are expected to do their reviewing for free. The consequence is that many referees do their reviewing less than well.

When I was still at Exeter, I had plenty of opportunity to see the problems of peer review from the reviewers perspective. At a time, I accepted about 5 reviews per week, and in total I surely have reviewed over 1000 papers. I often recommended inviting a statistician to do a specialist review of the stats. Only rarely were such suggestions accepted by the journal editors. Very often I recommended rejecting a submission because it was rubbish, and occasionally, I told the editor that there was a strong suspicion of the paper being fraudulent. The editors very often (I estimate in about 50% of cases) ignored my suggestions and comments and published the papers nonetheless. If the editor did follow my advice to reject a paper, I regularly saw it published elsewhere later (usually in a less well-respected journal). Several times, an author of a submission contacted me directly after seeing my criticism of his paper. Occasionally this resulted in unpleasantness, once or twice even in threats. Eventually I realised that improving the publications in the realm of SCAM was a Sisyphean task, became quite disenchanted with all this and accepted less and less reviews. Today, I do only very few.

I had even more opportunity to see the peer review process from the author’s perspective. All authors must have suffered from unfair or incompetent reviews and most will have experienced the frustrations of the endless delays. Once (before my time in alternative medicine) a reviewer rejected my paper and soon after published results that were uncannily similar to mine. In alternative medicine, researchers tend to be rather emotional about their subject. Imagine, for instance, the review you might get from Dana Ullmann of a trial of homeopathy that fails to show what he believes in.

Finally, since 40 years, I have also had the displeasure of experiencing peer review as an editor. This often seemed like trying to sail between the devil and the deep blue sea. Editors want to fill their journals with the best science they can find. But all too often, they receive the worst science they can imagine. They are constantly torn by tensions pulling them in opposite directions. And they have to cope not just with poor quality submissions but also with reviewers who miss deadlines and do their work badly.

So, peer review is fraught with problems! The trouble is that there are few solutions that would keep a better check on the reliability of science. Peer review, it often seemed to me, is the worst idea, except for all others. If peer review is to survive (and I think it probably will), there are a few things that could, from my point of view, be done to improve it:

  1. Make it much more attractive for the referees. Payment would be the obvious thing – and by Jove, the big journals like the LANCET and NEJM could afford it. But recognising refereeing academically would be even more important. At present, academic careers depend largely of publications; if they also depended on reviewing, experts would queue up to do it.
  2. The reports of the referees should get independently evaluated according to sensible criteria. These data could be conflated an published as a criterion of academic standing. Referees who fail to to a good job would spoil their chances to get re-invited for this task.
  3. Speed up the entire process. Waiting months on months is hugely counter-productive for all concerned.
  4. Today many journals ask authors for the details of experts who are potential reviewers of their submission and then send the paper in question to them for review. I find this ridiculous! No author I know of has ever resisted the temptation to name people who are friends or owe a favour. Journals should afford the extra work to find who the best independent experts on any particular subject are.

None of this is simple or fool-proof or even sure to work well, of course. But surely it is worth trying to get peer-review right. The quality of future science depends on it.

Someone alerted me to a short article (2008) of mine that I had forgotten about. In it, I mention the 32 Cochrane reviews of acupuncture available at the time and the fact that they showed very little in favour of acupuncture. This made me wonder to what extent the situation might have changed in the last 12 years. So, I made a renewed attempt at evaluating this evidence. The entire exercise comes in three parts:

  1. My original paper from 2008
  2. The current evidence from Cochrane reviews
  3. Comments on the new evidence

PART 1

Acupuncture has a long history of ups and downs. Its latest renaissance started in 1971, when a journalist in President Nixon’s press corps experienced symptomatic relief after being treated for postoperative abdominal distension. He reported this experience in The New York Times, which triggered a flurry of interest and research. In turn, it was discovered that needling might release endorphins in the brain or act via the gate control mechanism. Thus, plausible modes of action seemed to have been found, and the credibility of acupuncture increased significantly. Numerous clinical trials were initiated, and their results often suggested that acupuncture is clinically effective for a surprisingly wide range of conditions. Both a World Health Organization report and a National Institutes of Health consensus conference provided long lists of indications for which acupuncture allegedly was of proven benefit.

Many of the clinical studies, however, lacked scientific rigor. Most experts therefore remained unconvinced about the true value of acupuncture, particularly as a treatment for all ills. Some investigators began to suspect that the results were largely due to patient expectation. Others showed that the Chinese literature, a rich source of acupuncture trials, does not contain a single negative study of acupuncture, thus questioning the reliability of this body of evidence.

A major methodological challenge was the adequate control for placebo effects in clinical trials of acupuncture. Shallow needling or needling at non-acupuncture points had been used extensively for this purpose. Whenever the results of such trials did not show what acupuncture enthusiasts had hoped, they tended to claim that these types of placebos also generated significant therapeutic effects. Therefore, a negative result still would be consistent with acupuncture being effective. The development of non-penetrating needles was aimed at avoiding such problems. These “stage dagger”-like devices are physiologically inert and patients cannot tell them from real acupuncture. Thus, they fulfil the criteria for a reasonably good placebo.

The seemingly difficult question of whether acupuncture works had become complex—what type of acupuncture, for what condition, compared with no treatment, standard therapy, or to placebo, and what type of placebo? Meanwhile, hundreds of controlled clinical trials had become available, and their results were far from uniform. In this situation, systematic reviews might be helpful in establishing the truth, particularly Cochrane reviews, which tend to be more rigorous, transparent, independent, and up-to-date than other reviews. The traditional Chinese concept of acupuncture as a panacea is reflected in the fact that 32 Cochrane reviews are currently (January 2008) available, and a further 35 protocols have been registered. The notion of acupuncture as a “heal all” is not supported by the conclusions of these articles. After discarding reviews that are based on only 3 or fewer primary studies, only 2 evidence-based indications emerge: nausea/vomiting and headache. Even this evidence has to be interpreted with caution; recent trials using the above-mentioned “stage-dagger” devices as placebos suggest that acupuncture has no specific effects in either of these conditions.

Further support for the hypothesis that acupuncture is largely devoid of specific therapeutic effects comes from a series of 8 large randomized controlled trials (RCTs) initiated by German health insurers (Figure). These studies had a similar, 3-parallel-group design: pain patients were randomized to receive either real acupuncture, shallow needling as a placebo control, or no acupuncture. Even though not entirely uniform, the results of these studies tend to demonstrate no or only small differences in terms of analgesic effects between real and placebo acupuncture. Yet, considerable differences were observed between the groups receiving either type of acupuncture and the group that had no acupuncture at all.

The most recent, as-yet-unpublished trial also seems to confirm the “placebo hypothesis.” This National Institutes of Health-sponsored RCT included 640 patients with chronic back pain. They received either individualized acupuncture according to the principles of traditional Chinese medicine, or a standardized form of acupuncture, or sham acupuncture. The results demonstrate that acupuncture added to usual care was superior to usual care alone, individualized acupuncture was not more effective than standardized acupuncture, and neither type of real acupuncture was more effective than sham acupuncture.

Figure

Schematic representation of the recent acupuncture trials all following a similar 3-group design. These 8 randomized controlled trials related to chronic back pain, migraine, tension headache, and knee osteoarthritis (2 trials for each indication). Their total sample size was in excess of 5000. Patients in the “no acupuncture” group received either standard care or were put on a waiting list. Sham acupuncture consisted of shallow needling at non-acupuncture points. Real acupuncture was semi-standardized. The differences between the effects of both types of acupuncture and no acupuncture were highly significant in each study. The differences between sham and real acupuncture were, with the exception of osteoarthritis, not statistically significant.

Enthusiasts employ such findings to argue that, in a pragmatic sense, acupuncture is demonstrably useful: it is clearly better than no acupuncture at all. Even if it were merely a placebo, what really matters is to alleviate pain of suffering patients, never mind the mechanism of action. Others are not so sure and point out that all well-administrated treatments, even those that generate effects beyond placebo, will induce a placebo response. A treatment that generates only non-specific effects (for conditions that are amenable to specific treatments) cannot be categorized as truly effective or useful, they insist.

So, after 3 decades of intensive research, is the end of acupuncture nigh? Given its many supporters, acupuncture is bound to survive the current wave of negative evidence, as it has survived previous threats. What has changed, however, is that, for the first time in its long history, acupuncture has been submitted to rigorous science—and conclusively failed the test.

[references in the original paper]

Part 2 will be posted tomorrow.

Guest post by Christian Lehmann

It’s the end of February. We see the first death, in the Oise department, near Paris, of a French citizen who has not recently travelled abroad. For doctors concerned about what is happening in China, this is the red alert. In spite of of the little notices posted by the health minister, Agnes Buzyn, at airports, the coronavirus has made it onto French soil. Nobody knows at that point how it will spread. Almost nobody, apart from those responsible for it, yet knows that France has completely run down its stocks of masks. Doctors themselves do know that the health service has only held out, for as long as it has, on the backs of its care personnel. Some are assessing the scale of what is to come.

The announcement by Didier Raoult about the spectacular effectiveness of a synthetic antimalarial, chloroquine, has brought enormous relief, followed immediately for many of us health professionals by growing doubts about an accumulation of errors: Raoult denies any toxicity, urges people to “fall upon” a medication requiring sensitive handling. When we locate the Chinese article on which Didier Raoult is basing his crisis communication, we are stupefied. No need for specialised knowledge in statistical methodology to understand that there is something seriously wrong. No numerical data. Nobody knows what dosage has been given, to what type of patient, nor how many have been treated. The article has not been “peer reviewed”, that is to say reviewed by professional equals; decoded, it has the effect of a simple announcement. So of course at this chaotic time we tell ourselves that, given a revelation of such importance, the Chinese wanted to act as quickly as possible, to inform the whole world. And Didier Raoult, who routinely advises, as he explains with delicious modesty, the Chinese, « the world’s best virologists », has probably been entitled to the first fruits of this revelation.

On Youtube, on 28 February, he posts a weird interview, “Why would the Chinese be mistaken?”, in which he repeatedly takes up his interviewer with obvious irritation. “No, that’s not the question that you should be asking me. You should be asking me….” An informal group of doctors and tweeters pass around the link. We are rubbing our eyes in disbelief. What Didier Raoult is passing off as an interview is nothing more then an audience accorded to one of his media aides. We advise him, sarcastically, to make a professional cut of the video before broadcasting it. An hour later the video disappears and returns in a more professional form which could create the illusion of a genuine interview. And rapidly, in the Press which is beginning to turn its microphones towards the Professor from Marseille, he modifies his stance, without ever acknowledging the radical changes.

Chloroquine, spectacular and miraculous only yesterday, disappears as if by magic, replaced from one day to the next by hydroxychloroquine (Plaquenil), a different medicine, less common. Though its chemical structure is close to that of the antimalarial medication, hydroxychloroquine is used primarily in rheumatic conditions such as rheumatoid polyarthritis, or immune conditions such as lupus. So at least it isn’t lying around in large quantities in medicine cabinets. And its cardiac toxicity, very real, is slightly lower then that of chloroquine. Didier Raoult puts forward HCQ as an immense discovery, continuing in his usual manner to ridicule his detractors. “The doctors who criticise me are neither in my field nor up to my weight”. He flays the inaction of embittered petty health officials, only fit to follow the diktats of the authorities, who, bogged down in their catastrophic crisis management, dare not intervene. And his posturing as a refractory Gaul, a loudmouth taking on the system, gains sympathy, from those to whom he gives hope, from those who understand that the State does not tell them everything, and from those looking for a hero to fit in with their stereotypes: the man on his own against the establishment, the White Knight taking on Big Pharma, the Hippocratic colossus besieged by hordes of soulless ants.

No one among those who hold out their microphones to him, not one asks him the question which we are all asking, GPs, cardiologists, pharmaceutical specialists, emergency specialists, resuscitation specialists – by what sleight of hand has Didier Raoult exchanged his miracle medicine, in 48 hours, openly and publicly? And how is it that no one has noticed the sleight-of-hand? Has this man who makes such a big deal of his image on social networks suddenly become aware of the risk of being confronted about chloroquine with a justifiable public outcry and with deaths by self-medication?

While the World Health Organisation is sounding alarm bells, in the context of overall mistrust with regard to scientific opinion, of confrontation with regard to government, of growing awareness ( belated and sometimes disproportionate) of the influence of Big Pharma, and as the initial fear gives way to real panic for some with the registration of each new case, Didier Raoult piles up Facebook likes, fans, sites to his glory. And for us, fearful, begins the long registration of flagrant mistruths delivered as revealed truths, which this professor will never have the honestly to set right.

For Didier Raoult, a minimum of intellectual integrity would demand that he admits having changed horses in midstream. That he admits that the concern of his despised detractors was well founded, with respect to chloroquine to which many have access without knowing its dangers ( Nivaquine is very often used in suicides). And, because Didier Raoult withdraws nothing, he continues to stash away all the profits of his media coverage. Every supporter of the Wise Man of Marseille piles in with testimony. Their brother, sister, uncle, the father-in-law of their hairdresser has been taking the Professor’s medicine ( Which one? ) for eight years in Africa and has never had a problem, so that’s the real proof that his detractors are just jealous, or, even worse, backed by “the lobbies”.

And untiringly we repeat the fundamental truths:

  • Yes chloroquine has existed for years
  • Yes it is widely used
  • But for a different treatment, the prevention of malaria
  • And in dosages 5 to 10 times smaller
  • And in large dosages it causes cardiac arrest
  • And it has never been effective in fighting a virus
  • Not this virus nor any other
  • And the same is true for hydroxychloroquine
  • In fact it’s rather the opposite

In fact what is being patiently stated by the upholders of the scientific method is very counter-intuitive, almost inaudible, because they are telling worried and disorientated people, who have put their trust and their hope in one man, that in his assertions………nothing makes sense.

These are exceptional times and they need exceptional measures. Therefore, I am yet again deviating from my policy of focussing exclusively on SCAM and welcome my French colleague Dr Lehmann posting a series of articles on the hydroxychloroquine story.

Guest post by Christian Lehmann

 

THE ELEPHANT IN THE ROOM

This pandemic diary was begun just before lock down, already four weeks ago, and yet I have scarcely touched on the elephant in the room. Our personal elephant is called Didier Raoult. White-haired with age, venerable in appearance, he has been number one in the press, constantly in capitals in online news headlines, waking hopes, feeding passions. And arousing the interest of a plethora of epidemiologists of renown, from Valerie Boyer to Donald Trump, by way of Alain Soral and Alexandre Benalla.

Everything begins on 25 February 2020, when the microbiology professor from Marseille posts his famous video “Coronavirus, game over”, since more modestly re-baptised “Coronavirus, towards a way out of the crisis?”.

Standing in front of a student audience out of camera, Didier Raoult reveals “a last-minute scoop, a very important piece of news”: the Chinese, whom he regularly advises, rather than seeking a vaccine or new products have been “repositioning”, trying old molecules, “known, old, without toxicity,” among them chloroquine, which has shown itself to be effective in a daily dose of 500 mg per day “with a spectacular improvement and it is recommended for all clinically positive cases of coronavirus. This is excellent news, it is probably the easiest respiratory infection of all to treat” Here, the whole roomful laughs, with pleasure, with relief, and I remember sharing these sentiments, briefly, but completely. Because this was 26th of February, because like others I felt confusedly that the reassurances with which Agnes Buzyn ( then the French Health Minister) was inundating us were built on sand, and that the virus would only laugh at little notices in airports.

I knew Didier Raoult only by name, as a columnist in Point, I had read some of his articles and I had felt simultaneously soothed by his smooth eloquence, attracted by some of his iconoclastic stances, but also sometimes rather irritated by his Mandarin-style fake cool posturing. At the end of February, I immediately reposted the video in the medical forums, on the walls of worried friends, explaining that, if the suggestions of Didier Raoult were confirmed, we would have escaped with a scare which would soon be dispelled by this “magic bullet”, this “game changer”.

Then between two consultations in my GP’s office, later that afternoon, I watched that video “Game Over” again. How could such an important piece of news have reached me by means of a Youtube video? Where were the overseas publications, the much vaunted Chinese study, the releases from AgenceFrancePresse, Reuters, the first articles from the New York Times and the Guardian, proclaiming from the rooftops that the pandemic we had so much feared was in fact only a technical hitch, easily controllable by a widely available drug. It was at that second viewing that I balked. As a GP who had worked in cardiac resuscitation some years ago, I was brought up short by hearing Didier Raoult talking up a medicine “well known, and devoid of any toxicity”. If chloroquine or Nivaquine, to give it its commercial name, is celebrated for the prevention of malaria, it is also a medicine known for its frightening toxicity as soon as the dose is exceeded, with the risk of irreversible visual damage and extremely serious problems with cardiac rhythm which can prove fatal. To say that chloroquine is without toxicity problems is in fact an error, all the more so because the dose suggested by “the Chinese”, without an iota of proof at this stage, is five times larger than the customary dose, 500 mg instead of 100 mg.

Deeply uneasy, I’m in discussion with doctor friends on Twitter when the video makes its appearance there. We know nothing at this point about Didier Raoult’s past, or about his Marseille Institute. Neither the enmity felt towards him by the Parisian intelligentsia represented by Agnes Buzyn and her husband, nor the fact that his institute has just lost its INSERM and CNRS accreditations, nor the stance adopted by him a month earlier explaining that coronavirus would never escape from China and that it was ridiculous to get worked up about it because “the world has gone mad, something or other happens and three Chinese die and that brings about a world-scale alert”.

Some of us, practitioners and first responders, knew well the toxicity of chloroquine, that it was to be handled with care, and that was about all we said on Twitter. It was already too much. The next day in a 20 minute interview Didier Raoult brushed away his detractors. “Malicious gossip, I don’t give a damn about it. When a medication has been shown to work on 100 people while all the world is busy having a nervous breakdown, and there’s some idiots who say there’s no certainty that it works, I’m not interested! It would honestly be medical misconduct not to use chloroquine to treat Chinese coronavirus”. And he drives the point home. “People who have lived in Africa like me took chloroquine every day. Everybody who went to hot countries took it throughout their time there, and for two months after they came home. Billions of people have taken this medication. And it costs nothing: ten centimes per pill. It is a medication which is extremely reliable and it’s the cheapest imaginable. So this is super amazing news. Everybody who learns about these benefits should fall upon it.” This is no longer a mistake, this is grave medical misconduct. Nobody who knows about therapeutics would use such words so lightly.

Cardiologists, resuscitation specialists, emergency doctors, GPs, public-health specialists, we are all alarmed. Our first warnings are vehement and rational, reaffirming the toxicity of chloroquine in cardiology, and the majority of us insisting on the senseless and significant risk which Didier Raoult is running. Because it is familiar, prescribed for long stays in Africa in packages of 100 tablets, chloroquine is lying around in many medicine cabinets. To declare as a fact that we should “fall upon it” in this agonising pandemic context is to encourage unrestrained self medication, and to endanger life. Incoherent, dangerous, this announcement disturbs us deeply. Incredulous, not for a moment do we imagine just what Didier Raoult will unleash, nor that the nightmare had already begun.

 

Here is an open letter published yesterday, initiated by SENSE ABOUT SCIENCE and signed by many UK scientists and other experts. If you agree with it, you can still add your name to the signatories (see below):

 

 

Dear Mr Johnson

We urge you to start publishing the government’s evolving plans for coronavirus testing, and the evidence they are based on.

Testing is key to understanding the risks and to how people can get back to work and normal life. It is what major decisions will be based on, but there are also limits to what it can tell us.

People are frustrated and confused about the scientific and logistical challenges of testing and what the government is doing about it. The internet and media are awash with rumours and the public are valiantly trying to work their way through fragments of information. People in senior positions in healthcare, in government departments, in research and in the related industries are struggling to see whether their input is needed and how to give it.

Why is testing delayed? Is there a shortage of tests? Is there a shortage of chemicals? Do they only work 30% of the time? Will there be tests to see whether someone’s had the virus? Can people test themselves or does it have to be done by a clinic? These are just a handful of the many questions being asked. Scientists and government representatives are trying to answer them but it’s a losing battle with volume and reach.

The UK government’s response to this epidemic started by levelling with people in a clear way about the emerging evidence and transparency on the government’s evolving thinking about that evidence. Of course, continuing to tell people what is happening has become complex and challenging. But that won’t be brought under control by limiting communication to behavioural instructions or by your efforts to clamp down on misinformation. The government cannot clamp down on misinformation without substituting information in its place. Would the government please maintain its commitment to evidence transparency and put its evolving plans and evidence on testing on an open site where the public, experts and government agencies can follow them and to which those who are trying to address confusion can direct people.

Yours faithfully

Tracey Brown OBE, director, Sense about Science

Carl Heneghan, director, Centre for Evidence Based Medicine

Justine Roberts, CEO, Mumsnet

Emma Friedmann, campaign director, FACSaware

Professor Sarah Harper, The Oxford Institute of Population Ageing, University of Oxford

Mairead MacKenzie, Independent Cancer Patient Voices

Rose Woodward, Founder, Patient & Advocate, Kidney Cancer Support Network

Dr Bu’Hussain Hayee PhD FRCP AGAF, Clinical Lead for Gastroenterology

I.Chisholm-Bunting, School of Nursing and Allied Health

Rachael Jolley, editor in chief, Index on censorship

Caroline Fiennes, director, Giving Evidence

Dr Ritchie Head, director, Ceratium

Tommy Parker, KiActiv

Professor Annette Dolphin FRS, FMedSci, President of British Neuroscience Association

Dr James May, Vice Chair, Healthwatch and GP

Peter Johnson, Patient representative with respiratory conditions

A. P. Dawid, FRS Emeritus Professor of Statistics, University of Cambridge

Stafford Lightman FMedSci FRS, Professor of Medicine, University of Bristol

Dr Christie Peacock CBE PhD FRAgS FRSB Hon DSc, Founder and Chairman, Sidai Africa (Kenya) Ltd

Caroline Richmond, Medical journalist

Professor Stephan Lewandowsky FAcSS, Chair in Cognitive Psychology, University of Bristol

Hugh Pennington CBE, Emeritus Professor of Bacteriology, University of Aberdeen

Prof. Wendy Bickmore FRS, FRSE, FMedSci, Director: MRC Human Genetics Unit, University of Edinburgh

Benjamin Schuster-Böckler, PhD, Research Group Leader, Ludwig Institute for Cancer Research

Dr Max Pemberton, Daily Mail columnist and NHS Doctor

Diana Kornbrot, Emeritus Professor of Mathematical Psychology, University of Hertfordshire

Professor Patrick Eyers, Chair in Cell Signalling, University of Liverpool

Lelia Duley, Emeritus Professor, University of Nottingham

Edzard Ernst, Emeritus Professor University of Exeter

Ianis Matsoukas, Biomedical Sciences, University of Bolton

Dr Lorna Gibson, Radiology Registrar, New Royal Infirmary of Edinburgh

Sylvia Schröder, Senior Research Fellow, UCL

Dr Emma Dennett, St George’s University of London.

Ellie Wood, School of GeoSciences, University of Edinburgh

Sophie Faulkner, clinical doctoral research fellow / occupational therapist

Dr Maya Hanspal, research assistant, UK Discovery Lab

Dr John Baird, University of Aberdeen

Martin Stamp, managing director, Ionic Information

Saša Jankovic, Journalist

Kate Ravilious, Freelance Science Writer

Charise Johnson, policy advisor

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Bissera Ivanvoa, Research Assistant in Linguistics, The University of Leeds

Baroness Jolly, House of Lords

Dr. Simon Keeling MSc, PhD, RMet, FRMetS, The weather centre

Laurie van Someren, Aleph One Ltd

Prof Chris Kirk, former Hon. Sec. Royal Society of Biology.

Sergio Della Sala, Professor of Human Cognitive Neuroscience, University of Edinburgh

Dr. Wilber Sabiiti,Senior Research fellow in Medicine, University of St Andrews

Prof. Bob Brecher, Director, Centre for Applied Philosophy, Politics and Ethics, University of Brighton

Dr Sabina Michnowicz, UCL Hazard Centre

David Orme, Research Assistant, Cortex Lab

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Dr Ricky Nathvani, Imperial College London.

Rita F. de Oliveira, Senior lecturer Sport and Exercise Science, London South Bank University

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Dr Simon Underdown, FSA, FRSB, Director – Centre for Environment and Society

Matthew A Jay, PhD Student in Legal Epidemiology, University College London

Michael Butcher, Chairman, dataLearning Ltd

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Professor Ianis G. Matsoukas PhD (Biomedical Sciences), University of Bolton

Emeritus Professor Nigel Brown, Blackah-Brown Consulting

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Mandy Payne, Freelance Medical Editor

Lyssa Gold, University of St Andrews

Please email hello@senseaboutscience.org with your name and description if you wish to add yourself to the letter.

A new appointment in the realm of so-called alternative medicine (SCAM) has just been announced:

Friends of Science in Medicine (FSM) President, Assoc Professor Ken Harvey MB BS (Melb), FRCPA, AM congratulates Professor Jon Wardle, nurse and naturopath, with postgraduate qualifications in public health, law and health economics, on being appointed to Southern Cross University’s (SCU) Maurice Blackmore Chair of Naturopathic Medicine in Lismore. Professor Wardle has also been appointed as Foundation Director of the National Centre for Naturopathic Medicine (NCNM) funded with $10 Million from the Blackmore Foundation set up to sponsor research into ‘complementary medicine’.

Vice Chancellor, Professor Adam Shoemaker BA (Hons), PhD (ANU), researcher in Indigenous literature and culture, said the benefits of basing the NCNM at Southern Cross were enormous, “Being in a region like the Northern Rivers of New South Wales means we have brilliant local networks in this field. We are also supported by a local community who, like the University, are really receptive to trying new things in order to create a healthier future”.

Professor Harvey comments, “Professor Wardle certainly has challenges ahead. The Northern Rivers region is the anti-vax capital of Australia and some naturopaths advise against vaccination. Degree courses in naturopathy such as the Torrens Bachelor of Health Science (Naturopathy) degree, include studies of homeopathy, iridology and flower essence therapy. None have scientific evidence of efficacy”.

FSM has long argued that health care should be based on scientifically sound research, published in peer-reviewed journals of accepted standing. FSM is equally concerned about medical practitioners offering unproven and often exploitative treatments as it is about complementary medicine practitioners. Professor Harvey said, “some naturopaths practicing in Lismore, associated with SCU, work at clinics that use unverified laboratory tests to make dubious diagnoses and recommend treatment programs that lack evidence of efficacy”.

Professor Harvey (and FSM) conclude that there is an urgent need for evidence-based science to be applied to naturopathy. They trust that Professor Wardle will emulate Professor Edzard Ernst, Foundation Professor of Complementary Medicine at Exeter University, by applying accepted scientific standards to the evaluation of naturopathic interventions.

The March 24 opening of the NCNM in Lismore will feature a panel discussion on the future of health care with guest speakers: Professor Kerryn Phelps AM, former President of the Australasian Integrative Medicine Association, Marcus Blackmore AM, naturopath and Executive Director of Blackmores Ltd, which markets vitamin and herbal products, and Professor Jon Wardle. FSM hopes that the panel will discuss some of the issues raised above.

Sounds exciting, but is Wardle up to the job?

Judging from his publication record, he is certainly a naturopath through and through. He has published lots of papers; as far as I can see most of them are surveys of some sort or another. Many leave me somewhat bewildered. Two examples must suffice:

No 1

Objectives: To explore the recommendations of naturopathic medicine for the management of endometriosis, dysmenorrhea, and menorrhagia, drawing on traditional and contemporary sources.

Design: Content analysis.

Setting: Australia, Canada, and the United States of America (USA).

Subjects: Contemporary sources were identified from reviewing naturopathic higher education institutions’ recommended texts, while traditional sources were identified from libraries which hold collections of naturopathic sources. Sources were included if they were published from 1800 to 2016, were in English, published in Australia, Canada, or the USA, and reported on the topic. Included sources were as follows: 37 traditional texts; 47 contemporary texts; and 83 articles from naturopathic periodicals.

Results: Across included sources, the most reported disciplines were herbal medicine, clinical nutrition, mineral medicines, homeopathy, hydrotherapy, and chemical-based medicines. Herbal medicines were extensively reported from all sources for the management of endometriosis, dysmenorrhea, and menorrhagia. Clinical nutrition was only recommended from contemporary sources for all three conditions. Mineral medicines were mentioned in both traditional and contemporary sources, but were only recommended for dysmenorrhea and menorrhagia. There were limited recommendations for homeopathy and hydrotherapy treatments in all conditions across all sources. Chemical-based medicines were only mentioned for dysmenorrhea and menorrhagia, and recommendations ceased after 1922. Recommendations for endometriosis were not present in any of the traditional sources, across all reported disciplines.

Conclusions: The findings of this article provide insights into the documented historical and contemporary treatments within naturopathic medicine for endometriosis, dysmenorrhea, and menorrhagia. While philosophical principles remain the core of naturopathic practice, the therapeutic armamentarium appears to have changed over time, and a number of the original naturopathic treatments appear to have been retained as key elements of treatment for these conditions. Such insights into naturopathic treatments will be of particular interest to clinicians providing care to women, educators designing and delivering naturopathic training, and researchers conducting clinical and health service naturopathic research.

No 2

Complementary and alternative medicine (CAM) is an increasingly prevalent part of contemporary health care. Whilst there have been some attempts to understand the dynamics of CAM integration in the health care system from the perspective of conventional care providers and patients, little research has examined the view of CAM practitioners. This study aims to identify the experiences of integration within a conventional healthcare system as perceived by naturopaths. Qualitative semi-structured interviews were conducted using a purposeful sample of 20 practising naturopaths in South East Queensland, Australia to discuss their experiences and perceptions of integrating with conventional medical providers. Analysis of the interviews revealed five broad challenges for the integration of CAM according to naturopaths: competing paradigms between CAM and conventional medicine; co-option of CAM by conventional medical practitioners; the preservation of separate CAM and conventional medical worlds by patients and providers due to lack of formalised relations; negative feedback and biases created through selective or limited experience or information with CAM; and indifferent, reactive and one-sided interaction between CAM and conventional medical providers. Naturopaths support the integration of health services and attempt to provide safe and appropriate care to their patients through collaborative approaches to practice. The challenges identified by naturopaths associated with integration of CAM with conventional providers may impact the quality of care of patients who choose to integrate CAM and conventional approaches to health. Given the significant role of naturopaths in contemporary health-care systems, these challenges require further research and policy attention.

So, is Jon Wardle up to the job?

The answer obviously depends on what the job is.

If it is about publishing 100 more surveys that show nothing of much value and are essentially SCAM-promotion, then he ought to be fine. If it is about rigorously testing which SCAMs generate more good than harm, then ‘Houston, we have a problem’!

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