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

supplements

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I want to thank our friend ‘OLD BOB’ for alerting me to Patrick Holford’s comment on a recent trial of vitamin C for COVID-19. Here are three short quotes from Holford:

… Overall, 5 out 26 people (19%) died in the vitamin C group while 10 out of 28 (36%) receiving the placebo died. That means that vitamin C almost halved the number of deaths. Those on vitamin C were 60% more likely to survive.

… Of those most critically ill, 4 people (18%) in the vitamin C group died, compared to 10 (50%) in the placebo group. That’s two-thirds less deaths. Statistically this meant that of those most critically ill who were given vitamin C, they were 80% less likely to die…

… now there is another proven treatment – vitamin C…

And here is the abstract of the actual trial Holford refers to:

Background: No specific medication has been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19.

Methods: This randomized, controlled, clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 hours for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way. The primary outcome was invasive mechanical ventilation-free days in 28 days(IMVFD28). Secondary outcomes were 28-day mortality, organ failure, and inflammation progression.

Results: Only fifty-six critical COVID-19 patients were ultimately recruited due to the early control of the outbreak. There was no difference in IMVFD28 between two groups. During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO2/FiO2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P=0.01). Patients with SOFA scores ≥3 in the HDIVC group exhibited a trend of reduction in 28-day mortality (P=0.06) in univariate survival analysis. IL-6 in the HDIVC) group was lower than that in the placebo group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P=0.04) on day 7.

Conclusion: This pilot trial showed that HDIVC might show a potential signal of benefit for critically ill patients with COVID-19, improving oxygenation even though it failed to improve IMVFD28.

The following points are, I think, worth mentioning:

  • This was, according to its authors, a PILOT study.
  • It was far too small (n=56) to provide reliable results on mortality.
  • The trial authors know that and interpret their findings with sufficient caution.
  • The primary endpoint, the IMVFD28, showed NO significant difference between the groups.
  • The secondary endpoint: HDIVC infusion exhibited a non-significant trend of reduction in 28-day mortality (P=0.06).
  • In more severe patients (SOFA score ≥3), univariate survival analysis and Cox regression showed a similar results (P=0.07, HR, 0.32 [95% CI 0.10-1.06]).

And what does all of this mean? It means that, in this pilot study, vitamin C failed to produce a significant result. Only in a subgroup analysis related to a secondary endpoint was there a slight advantage of vitamin C. This effect is, of course, interesting and needs further investigation (I am sure that is happening as we speak). It could have some clinical significance but, just as likely, it could just be due to chance. There is not way of knowing which is which.

In other words, to hype the findings and to even make statements such as ‘now there is another proven treatment, vitamin C’ is not just exaggerated, it is irresponsible.

This begs the question: why does Mr Holford do it? In case you don’t already know about this man, go on the Internet, and you will quickly find possible answers. Here is an excerpt from his Wiki page which might give you a clue:

Patrick Holford is a British author and entrepreneur who endorses a range of controversial vitamin tablets. As an advocate of alternative nutrition and diet methods, he appears regularly on television and radio in the UK and abroad. He has 36 books in print in 29 languages. His business career promotes a wide variety of alternative medical approaches such as orthomolecular medicine, many of which are considered pseudoscientific by mainstream science and medicine.

Holford’s claims about HIV and autism are not in line with modern medical thought, and have been criticised for putting people in danger and damaging public health.

In 2006 Holford was discovered to be using his PR advisor to delete critical content from his Wikipedia page…

Holford has been the subject of criticism for his promotion of medically dubious techniques and products including hair analysis, his support of the now struck off doctor Andrew Wakefield, and advocating the use of “non-drug alternatives for mental health” for which he has been given an award by the Church of Scientology-backed Citizens Commission on Human Rights.

SAY NO MORE!

This study assessed the patterns of dietary supplement usage among cancer survivors in the United States in a population-based setting. National Health and Nutrition Examination Survey (NHANES) datasets (1999-2016) were accessed, and adult respondents (≥ 20 years old) with a known status of cancer diagnosis and a known status of dietary supplements intake were included. Multivariable logistic regression analysis was then used to assess factors associated with dietary supplements intake. Moreover, and to evaluate the impact of dietary supplements on overall survival among respondents with cancer, multivariable Cox regression analysis was conducted.

A total of 49,387 respondents were included in the current analysis, including a total of 4,575 respondents with cancer. Among respondents with cancer, 3,024 (66.1%) respondents reported the use of dietary supplements; while 1,551 (33.9%) did not report the use of dietary supplements. Using multivariable logistic regression analysis, factors associated with the use of dietary supplements included:

  • older age (OR: 1.028; 95% CI: 1.027-1.030);
  • white race (OR for black race vs. white race: 0.67; 95% CI: 0.63-0.72);
  • female gender (OR for males vs. females: 0.56; 95% CI: 0.53-0.59),
  • higher income (OR: 1.13; 95% CI: 1.11-1.14),
  • higher educational level (0.59; 95% CI: 0.56-0.63),
  • better self-reported health (OR: 1.36; 95% CI: 1.17-1.58),
  • health insurance (OR: 1.35; 95% CI: 1.27-1.44),
  • history of cancer (OR: 1.20; 95% CI: 1.10-1.31).

Using multivariable Cox regression analysis and within the subgroup of respondents with a history of cancer, the use of dietary supplements was not found to be associated with a difference in overall survival (HR: 1.13; 95% CI: 0.98-1.30).

The authors concluded that dietary supplement use has increased in the past two decades among individuals with cancer in the United States, and this increase seems to be driven mainly by an increase in the use of vitamins. The use of dietary supplements was not associated with any improvement in overall survival for respondents with cancer in the current study cohort.

Many cancer patients, when they first get diagnosed, are tested for vitamin D levels and found to be low or borderline. Consequently, they get a prescription for supplements. Other than this, there is rarely an indication to take any vitamins or other dietary supplements. Yet, cancer patients take them because they think these ‘natural’ preparations can do no harm (and because the industry can be persuasive [there is big money at stake] and the odd breed of ‘integrated’ oncologists might even recommend them). Sadly, this assumption is not correct. The biggest danger, in my view, is the possibility of supplements to interact with one of the many drugs that cancer patients need to take. So, in a way, it is reassuring that, on average, there is no detrimental effect on overall survival.

The paper will probably also reignite the perennial discussion about the effects of vitamin C on the natural history of cancer. My understanding is that there is none (and this verdict seems to be supported by the findings reported here). But I am, of course, aware that this is a ‘hot potato’ and that some readers will think differently. To them I say: please show me the evidence.

Several strands of evidence have indicated that vitamin D supplementation might be helpful for COVID-19 infections. Now we also have a study testing whether it works.

Spanish researchers evaluated the effect of calcifediol treatment on Intensive Care Unit Admission and Mortality rate among patients hospitalized for COVID-19 in a randomized, double blind clinical trial. A total of 76 consecutive patients hospitalized with COVID-19 infection and clinical picture of acute respiratory infection (confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale) were included. All patients received as best available therapy the same standard care. This consisted of a combination of:

  • hydroxychloroquine (400 mg every 12 h on the first day, and 200 mg every 12 h for the following 5 days),
  • azithromycin (500 mg orally for 5 days.

Eligible patients were allocated at a 2 calcifediol : 1 no calcifediol ratio through electronic randomization on the day of admission to take oral calcifediol (0.532 mg), or not. Patients in the calcifediol group continued with oral calcifediol (0.266 mg) on day 3 and 7, and then weekly until discharge or ICU admission. Outcomes of effectiveness included rate of ICU admission and deaths.

Of the 50 patients treated with calcifediol, one required admission to the ICU (2%), while of 26 untreated patients, 13 required admission (50 %). Univariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment versus without Calcifediol treatment: 0.02 (95 %CI 0.002-0.17). Multivariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment vs Without Calcifediol treatment ICU (adjusting by Hypertension and T2DM): 0.03 (95 %CI: 0.003-0.25). Of the patients treated with calcifediol, none died, and all were discharged, without complications. The 13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged. Of the 13 patients admitted to the ICU, two died and the remaining 11 were discharged.

The authors concluded as follows:

Our pilot study demonstrated that administration of calcifediol may improve the clinical outcome of subjects requiring hospitalization for COVID-19. Whether that would also apply to patients with an earlier stage of the disease and whether baseline vitamin D status modifies these results is unknown. Therefore, a multicenter randomized controlled trial using calcifediol, properly matched (Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome (COVIDIOL)), in 15 Spanish hospitals, funded by Clinical Research Program at COVID-19 “Progreso y Salud” Foundation and Foundation for Biomedical Research of Córdoba (FIBICO), Spain, (registered as NCT04366908 in NIH Trialnet database) will be carried out with the number of patients recalculated from the data provided by this study.

An interesting perspective of the new COVIDIOL trial with the recently available information, could be to evaluate calcifediol associated to dexamethasone or other corticoid vs. dexamethasone or other corticosteroid, since dexamethasone, which has potent anti-inflammatory actions, has recently been shown to reduce mortality in hospitalized patients on Covid-19 who are on respiratory assistance; so that treatment guidelines have been updated to recommend the use of glucocorticoids (including dexametasone), now proposed as the best available treatment in many hospitals around the world.

It is undeniable that this trial has several important limitations (and its authors are very honest to point them out). However, it is equally undeniable, in my view, that it is an important contribution to our current knowledge.

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 ?

 

The ketogenic diet (KD) is a currently popular high-fat, low-carbohydrate diet; it limits the intake of glucose which results in the production of ketones by the liver and their uptake as an alternative energy source by the brain. KD is an effective treatment for intractable epilepsy. In addition, it is being promoted as a so-called alternative medicine (SCAM) for a wide range of conditions, including:

  • weight loss,
  • cognitive and memory enhancement,
  • type II diabetes,
  • cancer,
  • neurological and psychiatric disorders.

However, these indications are not supported by good evidence.

A side effect of KD is “keto flu,” a syndrome of transient symptoms generally reported as occurring within the first few weeks of adhering to the diet. These symptoms can feel similar to the flu and are caused by the body adapting to a new diet consisting of very little carbohydrates.

Ketones are by-products of fat breakdown and become the main energy source when following the KD. Normally, fat is reserved as a secondary fuel source to use when glucose is not available. This switch to burning fat for energy is called ketosis. It occurs during specific circumstances, including starvation, fasting … or KD. The KD reduces carbohydrates typically to under 50 grams per day. This drastic reduction may cause withdrawal-like symptoms, similar to those experienced when weaning off an addictive substance.

A recent paper aimed to characterize the pattern of symptoms, severity and time course of keto flu as related by users of online forums. Online forums referring to “keto flu,” “keto-induction,” or “keto-adaptation” in the URL were identified. Passages describing personal experiences of keto flu were categorized with reference to pattern of symptoms, severity, time course, and remedies proposed.

The search criteria identified 75 online forums, 43 met inclusion criteria and contained 448 posts from 300 unique users. Seventy-three made more than one post (mean 3.12, range 2-11). Descriptors of personal experience of keto flu, reported by 101 of 300 users, included 256 symptom descriptions involving 54 discrete symptoms. Commonest symptoms were “flu,” headache, fatigue, nausea, dizziness, “brain fog,” gastrointestinal discomfort, decreased energy, feeling faint and heartbeat alterations.

Symptom reports peaked in the first and dwindled after 4 weeks. Resolution of keto flu symptoms was reported by 8 users between days 3 and 30 (median 4.5 ). Severity of symptoms, reported by 60 users in 40 forums, was categorized as mild (N = 15), moderate (N = 23), or severe (N = 22). Eighteen remedies were proposed by 121 individual users in 225 posts. The following treatments were most frequently recommended (numbers represent the number of times of each recommendation was made):

Increase sodium intake 58
Supplement with electrolytes 38
Drink broth (including bone broth, stock cubes) 27
Increase magnesium 25
Increase potassium 24

I find this paper interesting, not least because of the unusual methodological approach. It seems to confirm that, even though the KD is often recommended as safe, it is associated with significant side-effects. One adverse effect remained unmentioned, while leading to more people discontinuing the diet than any other side-effect: the fact that the diet is quite unpalatable on the long-run and soon puts people off eating. This, of course, might be one mechanism by which KD leads to weight loss.

During the last decades, the sales-figures for so-called alternative medicine (SCAM) have been increasing steadily and substantially. A recent report predicts this trend to continue:

… The global market for alternative and complementary medicines is projected to experience substantial growth in the next few years. The rising expenditure of the healthcare facilities is considered as the major factor that is likely to encourage the growth of the overall market in the coming years. In addition, the increasing number of initiatives being taken by Governments across the globe to promote alternative and complementary medicines is projected to accelerate the market’s growth. Thanks to these factors, the global alternative and complementary medicine market is likely to exhibit a promising growth rate in the near future.

A significant rise in the number of initiatives by NGOs and government organizations to encourage the use of alternative and complementary medicines is estimated to bolster global market in the near future. In addition to this, technological advancements in this field and the rising inclination of consumers towards these medicines and practices are likely to offer lucrative growth opportunities for the leading players operating in the alternative and complementary medicine market across the globe. However, the lack of scientific results is expected to hamper the overall growth of the market in the next few years…

From a regional perspective, Europe is considered as one of the leading segment, thanks to the significant revenue contribution in the last few years. This region is expected to account for a large share of the global alternative and complementary medicine market with the rising use of botanicals. In addition to this, the increasing awareness among consumers regarding the availability of effective alternative and complementary medicines and the benefits they offers are expected to encourage the growth of the Europe market in the coming years.

Furthermore, with the rising popularity of medical tourism, the alternative and complementary medicine market in Asia Pacific is projected to witness a steady growth in the next few years. Moreover, the presence of a large number of new players operating in this region is likely to offer promising growth opportunities over the forecast period. The Middle East and Africa segment is anticipated to experience a healthy growth in the alternative and complementary medicine market in the near future.

The global market for alternative and complementary medicines is presently at a highly competitive stage and is predicted to experience an intense level of competition among the leading players in the coming years. The prominent players in the market are focusing on the expansion of the product portfolio so as to attract a large number of consumers across the globe. This is likely to help them in creating a brand name and acquiring a leading position in the global market. Some of the leading players operating in the alternative and complementary medicine market across the globe are Herb Pharm, Yoga Tree, Quantum Touch Inc., Helio USA Inc., Pure encapsulations, Inc., Pacific Nutritional Inc., Deepure Plus, Herbal Hills, Iyengar Yoga Institute, The Healing Company, and Nordic Naturals.

Yes, I know, this is little more than hot air mixed with platitudes and advertisements to purchase the full report. I used to buy such documents for my department and research but was invariably disappointed. They provide are expensive and of very little of value.

Yet, one thing has been confirmed over the years: the prediction of steady growth of the SCAM-industry is rarely wrong (certain sections, such as homeopathy, have been shrinking in some regions, but the industry as a whole is financially healthy). The scientific evidence seems to get less and less convincing, yet consumers buy more and more of these products. They may do little good and have the potential to cause quite a bit of harm, but consumers continue to waste their money on them.

The question is: why?

There are, of course, many reasons. An important one is that the gullible public wants to believe in SCAM, and the SCAM-industry is highly skilled in misleading us. What is worse: many governments, instead of limiting the damage, are mildly or even overtly supportive of the SCAM-industry.

Whenever I contemplate this depressing state of affairs, I realise that my blog is important. It is only a drop in the ocean, I know, but still…

 

 

 

When I discuss published articles on this blog, I usually focus on recent papers. Not so today! Today I write about a small study we published 17 years ago. It was conducted in Canada by researchers whom I merely assisted in designing the protocol and interpreting the findings.

They trained 8 helpers to pretend being customers of health food stores. They entered individually into assigned stores; the helpers had been informed to browse in the store until approached by an employee. At this time they would declare that their mother has breast cancer. They disclosed information on their mother’s condition, use of chemotherapy (Tamoxifen) and physician visits, only if asked. The helpers would then ask what the employee recommend for this condition. They followed a structured, memorized, pretested questionnaire that asked about product usage, dosage, cost, employee education and product safety or potential for drug interactions.

The helpers recorded which products were recommended by the health food store employees, along with the recommended dose and price per product as well as price per month. Additionally, they inquired about where the employee had obtained information on the recommended products. They also noted whether the employees referred them on to SCAM practitioners or recommended that they consult a physician. Full notes on the encounters were written immediately after leaving the store.

The findings were impressive. Of the 34 stores that met our inclusion criteria, 27 recommended SCAMs; a total of 33 different products were recommended. Here are some further findings:

  • Essiac was recommended most frequently.
  • The mean cost of the recommended products per month was $58.09 (CAD) (minimum $5.28, median $32.99, maximum $600).
  • Twenty-three employees (68%) did not ask whether the patient took prescription medications.
  • Fifteen (44%) employees recommended visiting a healthcare professional; these included: naturopaths (9), physicians (5) and nutritionists (1).
  • Health food store employees relied on a variety of sources of information. Twelve employees (35%) said they had received their information from books, 5 (15%) from a supplier, 3 (9%) had formal education in SCAM, 2 (6%) had in-store training, and 12 (35%) did not disclose their sources of information.

Since our paper has been published, several other investigations have addressed similar issues. Here are a few excerpts:

But why do I mention all this today?

The answer is that firstly, I think it is important to warn consumers of the often dangerous advice they might receive in HFSs. Secondly, I feel it would worthwhile to do further research, check whether the situation has changed and repeat a similar study today. Ideally, a new investigation should be conducted in different locations comparing several countries. If you have the possibility to plan and conduct such an experiment, please drop me a line.

Glucosamine is currently one of the most popular of all dietary supplements. It is marketed as a treatment for arthritis, and there is some evidence that it is moderately helpful for this indication. But evidence had been accumulating to suggest that glucosamine might have other effects as well. The latest analysis evaluated the associations of regular glucosamine use with all-cause and cause-specific mortality in a large prospective cohort.

This population-based prospective cohort study included 495 077 women and men from the UK Biobank study. Participants were recruited from 2006 to 2010 and were followed up through 2018. The investigators evaluated all-cause mortality and mortality due to cardiovascular disease (CVD), cancer, respiratory and digestive disease. Hazard ratios (HRs) and 95% CIs for all-cause and cause-specific mortality were calculated using Cox proportional hazards models with adjustment for potential confounding variables.

At baseline, 19.1% of the participants reported regular use of glucosamine supplements. During a median follow-up of 8.9 years (IQR 8.3-9.7 years), 19 882 all-cause deaths were recorded, including 3802 CVD deaths, 8090 cancer deaths, 3380 respiratory disease deaths and 1061 digestive disease deaths. In multivariable adjusted analyses, the HRs associated with glucosamine use were 0.85 (95% CI 0.82 to 0.89) for all-cause mortality, 0.82 (95% CI 0.74 to 0.90) for CVD mortality, 0.94 (95% CI 0.88 to 0.99) for cancer mortality, 0.73 (95% CI 0.66 to 0.81) for respiratory mortality and 0.74 (95% CI 0.62 to 0.90) for digestive mortality. The inverse associations of glucosamine use with all-cause mortality seemed to be somewhat stronger among current than non-current smokers (p for interaction=0.00080).

The authors concluded that regular glucosamine supplementation was associated with lower mortality due to all causes, cancer, CVD, respiratory and digestive diseases.

Previous epidemiological investigations indicated that glucosamine use might play a role in prevention of cancer, cardiovascular disease and other diseases. This suggests that the finding is more than the result of a large ‘fishing expedition’ to which epidemiological studies are sadly prone. It we are indeed dealing with a true phenomenon, we should ask by what mechanism these remarkable outcomes might be achieved. It is well documented that glucosamine has powerful anti-inflammatory effects. Therefore it is conceivable that such anti-inflammatory mechanisms are the cause for the observed outcomes.

How do we prove or disprove the hypothesis that glucosamine reduces the mortality of a range of diseases? A reasonable starting point would be to consult the good old Hill criteria of causality:

(1) The strength of association is small to moderate – certainly not strong

(2) The consistency of the findings is quite remarkable; that is unless dozens of epidemiological studies that failed to yield and association were never published.

(3) The specificity of the association with diseases linked to inflammation is also impressive (with the caveat above).

(4) Temporality seems also not a problem, as far as I can see.

(5) Biological gradient needs further testing, I think.

(6) Plausibility is not a problem, since there is a possible mechanism that could explain the findings.

(7) The same applies to coherence.

(8) Experiment is needed, but it is far from easy to conduct clinical trials where mortality is an endpoint.

(9) Analogy is realised through the well-established concept of (cardiovascular) risk factors.

What does all this actually mean?

It means, I think, that glucosamine could well have clinical effects that go far beyond easing the pain of arthritis. However, we cannot be sure. Once again, it boils down to the need of robust clinical trial data. The subject certainly seems important enough to consider this option.

 

By guest blogger Loretta Marron

If scientists were fearful of a clinical trial’s producing negative results, would they even pursue it? A draft Chinese regulation issued in late May aims to criminalise individual scientists and organisations whom China claims damage the reputation of Traditional Chinese Medicine (TCM).

Beijing has a reputation for reprimanding those who decry TCM. Such criticism is blocked on Chinese Internet. Silencing doctors is becoming the norm.

In January 2018, former anaesthetist, Tan Qindong, was arrested and spent more than three months in detention after criticising a widely advertised, best-selling ‘medicinal’ TCM liquor. Claiming that it was a ‘poison’, he believed that he was protecting the elderly and vulnerable patients with high blood pressure. Police claimed that a post on social media damaged the reputation of the TCM ‘liquor’ and of the company making it. Shortly after release, he suffered post-traumatic stress and was hospitalised.

On 30 December 2019, Chinese ophthalmologist, the late Dr Li Wenliang, was one of the first to recognise the outbreak of COVD-19. He posted a private warning to a group of fellow doctors about a possible outbreak of an illness resembling severe acute respiratory syndrome (SARS). He encouraged them to protect themselves from infection. Days later, after his post when viral, he was summoned to the Public Security Bureau in Wuhan and forced to “admit to lying about the existence of a worrying new virus”. Li was accused of violating the provisions of the “People’s Republic of China Public Order Management and Punishment Law” for spreading “unlawful spreading of untruthful topics on the internet” and of disturbing the social order. He was made to sign a statement that he would “halt this unlawful behaviour”.

In April 2020, Chinese physician Yu Xiangdong, a senior medico who worked on the front line battling COVID-19, posted on Weibo, a Twitter-like site, a criticism of the use of antibiotics and TCM to treat COVID-19. He was demoted from his positions as assistant dean at the Central Hospital in the central city of Huangshi and director of quality management for the city’s Edong Healthcare Group. Well known for promoting modern medicine amongst the Chinese, Yu had almost a million followers on social media. All his postings vanished.

Beijing insists that TCM has been playing a crucial role in COVID-19 prevention, treatment and rehabilitation. Claims continue to be made for “effective TCM recipes”. However, no randomised clinical trial has been published in any reputable journal.

TCM needs proper scrutiny, but criticising it could land you years in prison. If the benefits of suggested herbal remedies are to be realised, good clinical studies must be encouraged. For TCM, this might never be permitted.

Don’t think for a moment that you are safe in Australia.

Article 8.25 of the Free Trade Agreement Between the Government of Australia and the Government of the People’s Republic of China reads:

Traditional Chinese Medicine Services (“TCM”)

  1. Within the relevant committees to be established in accordance with this Agreement, and subject to available resources, Australia and China shall cooperate on matters relating to trade in TCM services.
  2. Cooperation identified in paragraph 2 shall:

(a)    include exchanging information, where appropriate, and discussing policies, regulations and actions related to TCM services; and

(b)   encourage future collaboration between regulators, registration authorities and relevant professional bodies of the Parties to facilitate trade in TCM and complementary medicines, in a manner consistent with all relevant regulatory frameworks. Such collaboration, involving the competent authorities of both Parties – for Australia, notably the Department of Health, and for China the State Administration of Traditional Chinese Medicine – will foster concrete cooperation and exchanges relating to TCM.

The objective of this study was to identify adverse drug reactions (ADR) associated with the use of so-called alternative medicine (SCAM) in Malaysia and to define factors which are associated with the more serious reactions. For this purpose, all ADR associated with the use of SCAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR.

From a total of 74 997 reports in the database, 930 (1.2%) involved SCAM products. From a total of 930 reports, 242 (26%) were serious ADR with 36 deaths. Six people died as a result of taking the SCAM, while another 30 cases were possibly associated with the SCAM products. Among the 36 mortality cases, adulterants were detected in 30% of cases. Examples of adulterants were dexamethasone, avanafil, nortadalafil and banned drugs such as phenylbutazone and sibutramine

About a third of the reports involved used SCAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the SCAM products were used for chronic illnesses (odds ratio [OR] 1.99, confidence interval [CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02).

The authors concluded that the prevalence of serious ADR associated with SCAM products is high. Factors identified with serious ADR included ethnicity, SCAM users with pre-existing diseases, use of SCAM for chronic illnesses and concomitant use of SCAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of SCAM products.

The authors also point out that underreporting of ADRs remains a major ongoing issue in pharmacovigilance. Many SCAM consumers may not be vigilant or may be unaware of ADR they experience due to misconceptions on the
safety of SCAM products. Most doctors rarely ask their patients about the use of SCAM.

To this, I would add that SCAM providers do their utmost to give the impression that their products are natural and therefore safe. Furthermore the press is far too often perpetuating the myth, and the regulators tend to turn a blind eye.

I expect that some readers of this post will now point out that the rate of SCAM-related ADRs is very small compared to that of conventional drugs. They would be correct, of course. But they would also miss the point that the value of a treatment is not determined by its risk alone. It is determined by the risk/benefit balance. Where there is no effectiveness, this balance is negative, even if the risk is tiny.

So, now let me challenge the defenders of SCAM to name a few SCAMs that are demonstrably associated with a positive risk/benefit balance.

 

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