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

supplements

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About 85% of German children are treated with herbal remedies. Yet, little is known about the effects of such interventions. A new study might tell us more.

This analysis accessed 2063 datasets from the paediatric population in the PhytoVIS data base, screening for information on indication, gender, treatment, co-medication and tolerability. The results suggest that the majority of patients was treated with herbal medicine for the following conditions:

  • common cold,
  • fever,
  • digestive complaints,
  • skin diseases,
  • sleep disturbances
  • anxiety.

The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events.

The authors concluded that the results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.

If you are a fan of herbal medicine, you will be jubilant. If, on the other hand, you are a critical thinker or a responsible healthcare professional, you might wonder what this database is, why it was set up and how exactly these findings were produced. Here are some details:

The data were collected by means of a retrospective, anonymous, one-off survey consisting of 20 questions on the user’s experience with herbal remedies. The questions included complaints/ disease, information on drug use, concomitant factors/diseases as well as basic patient data. Trained interviewers performed the interviews in pharmacies and doctor’s offices. Data were collected in the Western Part of Germany between April 2014 and December 2016. The only inclusion criterion was the intake of herbal drugs in the last 8 weeks before the individual interview. The primary endpoint was the effect and tolerability of the products according to the user.

And who participated in this survey? If I understand it correctly, the survey is based on a convenience sample of parents using herbal remedies. This means that those parents who had a positive experience tended to volunteer, while those with a negative experience were absent or tended to refuse. (Thus the survey is not far from the scenario I often use where people in a hamburger restaurant are questioned whether they like hamburgers.)

So, there are two very obvious factors other than the effectiveness of herbal remedies determining the results:

  1. selection bias,
  2. lack of objective outcome measure.

This means that conclusions about the clinical effects of herbal remedies in paediatric patients are quite simply not possible on the basis of this survey. So, why do the authors nevertheless draw such conclusions (without a critical discussion of the limitations of their survey)?

Could it have something to do with the sponsor of the research?

The PhytoVIS study was funded by the Kooperation Phytopharmaka GbR Bonn, Germany.

Or could it have something to do with the affiliations of the paper’s authors:

1 Institute of Pharmacy, University of Leipzig, Brüderstr. 34, 04103, Leipzig, Germny. nieberkaren@gmx.de.

2 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 573, Bonn, Germany. nieberkaren@gmx.de.

3 Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.

4 ClinNovis GmbH, Genter Str. 7, 50672, Cologne, Germany.

5 Bayer Consumer Health, Research & Development, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295, Darmstadt, Germany.

6 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 53173, Bonn, Germany.

7 Institute of Pharmaceutical Biology, Goethe University Frankfurt, Max-von-Laue-Str. 9, 60438, Frankfurt, Germany.

8 Chair of Naturopathy, University Medicine Rostock, Ernst-Heydemann Str. 6, 18057, Rostock, Germany.

WHAT DO YOU THINK?

Even the NEW SCIENTIST seems alarmed about Gwyneth and her activities:

Psychic readings, energy healing and vampire facials are just a few of the adventures had by actor and alternative health guru Gwyneth Paltrow and her team in her forthcoming Netflix series The Goop Lab. Goop, Paltrow’s natural health company, has already become a byword for unrestrained woo, but the TV series takes things to the next level.

Don’t make the mistake of thinking you can stick your fingers in your ears and pretend it isn’t happening. There is unlikely to be any escape from The Goop Lab after it is released on 24 January, judging by the current explosion of interest in Goop’s latest offering, a candle scented like Paltrow’s vagina, which has reportedly sold out…

Yet, I am sure we got her all wrong!

Good old Gwennie is really one of us – she is a true sceptic!

Think about it; it’s the only explanation.

When she first started dabbling in woo, she only wanted to test us. I’ll just display a few cupping marks and see how they react, she thought.

Image result for gwyneth paltrow, cupping

Then she saw that most people were so gullible that they bought it. Of course, she thought, if they buy it, I might as well take their money. In her attempt to see how far she can push her boat out, she decided to conduct a sceptical experiment and went further and further. This is when she started to focus on her vagina – jade eggs, steaming it, etc. Surely, she thought, eventually they must realise that I am a sceptic taking the Mikey!

But they never did realise it; at least not so far.

So, she decided to do something even more brazen and sell candles to dispense the smell of her vagina in the homes of her fans. That will do it, she felt, now they will realise what I want to achieve with all this.

But what happened? They sold out in no time (actually, both the candles and the gullible public)! That was a surprise even to our Gwennie. She thought she had seen it all, but she was wrong.

Image result for gwenyth paltro, vagina

Now she is trying to think of something even more outrageous – but she admits, it’s not easy. What can be a more obvious and disgusting hoax than filling people’ homes with the smell of my genitals and let them pay through their noses for the pleasure? she asks herself.

Yes, poor old Gwennie is at loss! Stuck in her own vagina, so to speak.

Perhaps you can help her? Please suggest what vaginal gimmick she might sell next to make her position inescapably clear to even the dumbest of the gullible. Just mention your ideas in the comment section below; I have a feeling she is an avid reader of this blog. Gwennie might even show herself generous; if she likes your innovation, she will certainly make it worth your while.

Because, by Jove, she can afford to be generous. Apparently her business is now worth a quarter of a billion US$. But we must not be envious. Knowing that she did all this merely to stimulate sceptical thinking in the general public, you will not be surprised to learn what she intends to do with all this dosh: once she has succeeded in demonstrating to all the gullible pin heads and devotees that she really is on the side of the angles, she will donate all of it to sceptic organisations across the globe.

So, sceptics of the world: stop snarling at my friend Gwennie, rejoice and prepare for a major windfall.

 

Are you hungover today? you will be pleased to hear that so-called alternative medicine (SCAM) has a lot to offer – at least this is what its enthusiasts think.

Homeopaths swear by Nux Vomica as the first remedy to think of with hangover headaches, but it is also excellent for headaches from overwork, indigestion headaches and headaches accompanying constipation. Use it when your headache is worse when you cough or bend down, and headaches that aggravate when you move your eyes. If you have overeaten and drunk too much alcohol, you may also feel nauseous and want to vomit to make yourself feel better but find you cannot. If this describes your symptoms then Nux Vomica is the remedy for you.

When I worked as a homeopath, I and others often tried this treatment – it never worked. More importantly, there is not a jot of evidence that it does.

Some people recommend artichoke extract. I say: forget it. Here is why:

BACKGROUND:

Extract of globe artichoke (Cynara scolymus) is promoted as a possible preventive or cure for alcohol-induced hangover symptoms. However, few rigorous clinical trials have assessed the effects of artichoke extract, and none has examined the effects in relation to hangovers. We undertook this study to test whether artichoke extract is effective in preventing the signs and symptoms of alcohol-induced hangover.

METHODS:

We recruited healthy adult volunteers between 18 and 65 years of age to participate in a randomized double-blind crossover trial. Participants received either 3 capsules of commercially available standardized artichoke extract or indistinguishable, inert placebo capsules immediately before and after alcohol exposure. After a 1-week washout period the volunteers received the opposite treatment. Participants predefined the type and amount of alcoholic beverage that would give them a hangover and ate the same meal before commencing alcohol consumption on the 2 study days. The primary outcome measure was the difference in hangover severity scores between the artichoke extract and placebo interventions. Secondary outcome measures were differences between the interventions in scores using a mood profile questionnaire and cognitive performance tests administered 1 hour before and 10 hours after alcohol exposure.

RESULTS:

Fifteen volunteers participated in the study. The mean number (and standard deviation) of alcohol units (each unit being 7.9 g, or 10 mL, of ethanol) consumed during treatment with artichoke extract and placebo was 10.7 (3.1) and 10.5 (2.4) respectively, equivalent to 1.2 (0.3) and 1.2 (0.2) g of alcohol per kilogram body weight. The volume of nonalcoholic drink consumed and the duration of sleep were similar during the artichoke extract and placebo interventions. None of the outcome measures differed significantly between interventions. Adverse events were rare and were mild and transient.

INTERPRETATION:

Our results suggest that artichoke extract is not effective in preventing the signs and symptoms of alcohol-induced hangover. Larger studies are required to confirm these findings.

Is there anything else you might want to try? I am afraid the answer is NO. Here is our systematic review on the subject:

OBJECTIVE:

To assess the clinical evidence on the effectiveness of any medical intervention for preventing or treating alcohol hangover.

DATA SOURCES:

Systematic searches on Medline, Embase, Amed, Cochrane Central, the National Research Register (UK), and ClincalTrials.gov (USA); hand searches of conference proceedings and bibliographies; contact with experts and manufacturers of commercial preparations. Language of publication was not restricted.

STUDY SELECTION AND DATA EXTRACTION:

All randomised controlled trials of any medical intervention for preventing or treating alcohol hangover were included. Trials were considered if they were placebo controlled or controlled against a comparator intervention. Titles and abstracts of identified articles were read and hard copies were obtained. The selection of studies, data extraction, and validation were done independently by two reviewers. The Jadad score was used to evaluate methodological quality.

RESULTS:

Fifteen potentially relevant trials were identified. Seven publications failed to meet all inclusion criteria. Eight randomised controlled trials assessing eight different interventions were reviewed. The agents tested were propranolol, tropisetron, tolfenamic acid, fructose or glucose, and the dietary supplements Borago officinalis (borage), Cynara scolymus (artichoke), Opuntia ficus-indica (prickly pear), and a yeast based preparation. All studies were double blind. Significant intergroup differences for overall symptom scores and individual symptoms were reported only for tolfenamic acid, gamma linolenic acid from B officinalis, and a yeast based preparation.

CONCLUSION:

No compelling evidence exists to suggest that any conventional or complementary intervention is effective for preventing or treating alcohol hangover. The most effective way to avoid the symptoms of alcohol induced hangover is to practise abstinence or moderation.

Yes, it’s true, the only sound advice is moderation!

According to WebMed, the shark cartilage (tough elastic tissue that provides support, much as bone does) used for medicine comes primarily from sharks caught in the Pacific Ocean. Several types of extracts are made from shark cartilage including squalamine lactate, AE-941, and U-995.

Shark cartilage is most famously used for cancer. Shark cartilage is also used for osteoarthritis, plaque psoriasis, age-related vision loss, wound healing, damage to the retina of the eye due to diabetes, and inflammation of the intestine (enteritis).

A more realistic picture is pained by this abstract:

The promotion of crude shark cartilage extracts as a cure for cancer has contributed to at least two significant negative outcomes: a dramatic decline in shark populations and a diversion of patients from effective cancer treatments. An alleged lack of cancer in sharks constitutes a key justification for its use. Herein, both malignant and benign neoplasms of sharks and their relatives are described, including previously unreported cases from the Registry of Tumors in Lower Animals, and two sharks with two cancers each. Additional justifications for using shark cartilage are illogical extensions of the finding of antiangiogenic and anti-invasive substances in cartilage. Scientific evidence to date supports neither the efficacy of crude cartilage extracts nor the ability of effective components to reach and eradicate cancer cells. The fact that people think shark cartilage consumption can cure cancer illustrates the serious potential impacts of pseudoscience. Although components of shark cartilage may work as a cancer retardant, crude extracts are ineffective. Efficiencies of technology (e.g., fish harvesting), the power of mass media to reach the lay public, and the susceptibility of the public to pseudoscience amplifies the negative impacts of shark cartilage use. To facilitate the use of reason as the basis of public and private decision-making, the evidence-based mechanisms of evaluation used daily by the scientific community should be added to the training of media and governmental professionals. Increased use of logical, collaborative discussion will be necessary to ensure a sustainable future for man and the biosphere.

To be clear: there is no good evidence that the supplements commercially available currently are effective for any condition.

Now, there is more news on this topic:

The objective of this study was to analyse labelling practices and compliance with regulatory standards for shark cartilage supplements sold in the United States. The product labels of 29 commercial shark cartilage supplements were assessed for compliance with U.S. regulations. Claims, including nutrient content, prohibited disease, and nutritional support statements, were examined for compliance and substantiation.

Overall, 48% of the samples had at least one instance of non-compliance with labelling regulations. The most common labelling violations observed were:

  • missing a domestic address/phone number,
  • non-compliant nutrient content claim,
  • missing/incomplete disclaimer,
  • missing statement of identity,
  • prohibited disease claims,
  • incomplete “Supplement Facts” label.

The use of prohibited disease claims and nutritional support statements without the required disclaimer is concerning from a public health standpoint because consumers may delay seeking professional treatment for a disease.

The authors concluded that the results of this study indicate a need for improved labelling compliance among shark cartilage supplements.

In summary, it seems that shark cartilage supplements are bad for all concerned:

  • Patients who rely on them might hasten their death.
  • Sharks are becoming an endangered species.
  • Consumers are being mislead and misinformed.

There is just one party smiling: the supplement manufacturers who make a healthy profit destroying the health of gullible consumers and patients.

This review provides published data on so-called alternative medicine (SCAM)-related liver injuries (DILI) in Asia, with detail on incidences, lists of most frequently implicated herbal remedies, along with analysis of patient population and their clinical outcomes.

Its authors conclude that SCAM use is widely prevalent in Asia and is associated with, among other adverse effects, hepatotoxicity. Both proprietary as well as non-proprietary or traditional SCAMs have been implicated in hepatotoxicity. Acute hepatocellular pattern of liver injury is the most common type of liver injury seen, and the spectrum of liver-related adverse events range from simple elevation of liver enzymes to the very serious ALF and ACLF, which may, at times, require liver transplant.

SCAM-related liver injury is one among the major causes for hepatotoxicity, including ALF and ACLF worldwide, with high incidence among Asian countries. Patient outcomes associated with SCAM-DILI are generally poor, with very high mortality rates in those with chronic liver disease. Stringent regulations, at par with that of conventional modern medicine, are required, and may help improve safety of patients seeking SCAM for their health needs. Regional surveillance including post-marketing analysis from government agencies associated with drug regulation and control in tandem with national as well as regional level hepatology societies are important for understanding the true prevalence of DILI associated with SCAM. An integrated approach used by practitioners combining conventional and traditional medicine to identify safety and efficacy of SCAMs is an unmet need in most of the Asian countries. Endorsement of scientific methodology with good quality preclinical and clinical trials and abolishment of unhealthy publication practices is an area that needs immediate attention in SCAM practice. Such holistic standard science-based approaches could help ameliorate liver disease burden in the general and patient population.

I congratulate the authors to this excellent paper. It contains a wealth of information and is well worth reading in full. The review will serve me as a valuable source of data for many years to come.

So-called alternative medicine (SCAM) is, compared to ‘Big Pharma’, a tiny and benign cottage industry – at least this is what we are often told and what many consumers believe. If you are one of them, this report might make you rethink your position.

The global market for SCAM is expected to generate a revenue of US$ 210.81 billion by 2026. It is projected to expand by 17.07% from 2019 to 2026. Factors such as the increasing adoption and usage of natural supplements/wellness medicine coupled with government initiatives to promote SCAM are assumed to be the main causes ot this increase. An increase in the costs of conventional medicine and the trend towards wellness are likely to boost the SCAM market.

Further key findings from the report suggest:
• The market is driven by high adoption of herbal dietary supplements and other wellness therapies like yoga, and acupuncture
• Botanical has become the most prominent form of alternative medicine as the segment was observed to hold the largest market share in terms of revenue 2018
• Europe and Asia Pacific in combination are anticipated to hold a major market share in terms of revenue over the forecast period
• Developing regions such as Latin America and Middle East Africa are set to witness considerable growth in demand over the forecast period driven by high cost of conventional medicine and lack of their availability in certain countries
• Some of the key players and wellness institutes active in the complementary and alternative medicine market are Columbia Nutritional Inc.; Herb Pharm; Herbal Hills; Helio USA Inc.; Deepure Plus; Nordic Naturals; Pure encapsulations, Inc.; and other wellness institutes like Iyengar Yoga Institute; John Schumacher’s Unity Woods Yoga Center; Yoga Tree; The Healing Company; and Quantum Touch Inc.

So, little SCAM turns out to be not so little after all!

In fact, there are billions at stake. And that perhaps might explain why little SCAM often behaves as badly as does the dreaded, much maligned ‘Big Pharma’. Just look at what some German homeopathic firms were up to in the past. One could almost think that their ethics have been homeopathically diluted. The ‘dirty methods’ of little SCAM can be at least as dirty as those of ‘Big Pharma’, in my experience.

But don’t let’s be beastly to the Germans!! The SCAM industry in most other countries is much the same.

And who could blame them?

After all, they are fighting against a Ku Klux Klan of evil sceptics.

Controlled clinical trials are methods for testing whether a treatment works better than whatever the control group is treated with (placebo, a standard therapy, or nothing at all). In order to minimise bias, they ought to be randomised. This means that the allocation of patients to the experimental and the control group must not be by choice but by chance. In the simplest case, a coin might be thrown – heads would signal one, tails the other group.

In so-called alternative medicine (SCAM) where preferences and expectations tend to be powerful, randomisation is particularly important. Without randomisation, the preference of patients for one or the other group would have considerable influence on the result. An ineffective therapy might thus appear to be effective in a biased study. The randomised clinical trial (RCT) is therefore seen as a ‘gold standard’ test of effectiveness, and most researchers of SCAM have realised that they ought to produce such evidence, if they want to be taken seriously.

But, knowingly or not, they often fool the system. There are many ways to conduct RCTs that are only seemingly rigorous but, in fact, are mere tricks to make an ineffective SCAM look effective. On this blog, I have often mentioned the A+B versus B study design which can achieve exactly that. Today, I want to discuss another way in which SCAM researchers can fool us (and even themselves) with seemingly rigorous studies: the de-randomised clinical trial (dRCT).

The trick is to use random allocation to the two study groups as described above; this means the researcher can proudly and honestly present his study as an RCT with all the kudos these three letters seem to afford. And subsequent to this randomisation process, the SCAM researcher simply de-randomises the two groups.

To understand how this is done, we need first to be clear about the purpose of randomisation. If done well, it generates two groups of patients that are similar in all factors that might impact on the results of the study. Perhaps the most obvious factor is disease severity; one could easily use other methods to make sure that both groups of an RCT are equally severely ill. But there are many other factors which we cannot always quantify or even know about. By using randomisation, we make sure that there is an similar distribution of ALL of them in the two study groups, even those factors we are not even aware of.

De-randomisation is thus a process whereby the two previously similar groups are made to differ in terms of any factor that impacts on the results of the trial. In SCAM, this is often surprisingly simple.

Let’s use a concrete example. For our study of spiritual healing, the 5 healers had opted during the planning period of the study to treat both the experimental group and the control group. In the experimental group, they wanted to use their full healing power, while in the control group they would not employ it (switch it off, so to speak). It was clear to me that this was likely to lead to de-randomisation: the healers would have (inadvertently or deliberately) behaved differently towards the two groups of patients. Before and during the therapy, they would have raised the expectation of the verum group (via verbal and non-verbal communication), while sending out the opposite signals to the control group. Thus the two previously equal groups would have become unequal in terms of their expectation. And who can deny that expectation is a major determinant of the outcome? Or who can deny that experienced clinicians can manipulate their patients’ expectation?

For our healing study, we therefore chose a different design and did all we could to keep the two groups comparable. Its findings thus turned out to show that healing is not more effective than placebo (It was concluded that a specific effect of face-to-face or distant healing on chronic pain could not be demonstrated over eight treatment sessions in these patients.). Had we not taken these precautions, I am sure the results would have been very different.

In RCTs of some SCAMs, this de-randomisation is difficult to avoid. Think of acupuncture, for instance. Even when using sham needles that do not penetrate the skin, the therapist is aware of the group allocation. Hoping to prove that his beloved acupuncture can be proven to work, acupuncturists will almost automatically de-randomise their patients before and during the therapy in the way described above. This is, I think, the main reason why some of the acupuncture RCTs using non-penetrating sham devices or similar sham-acupuncture methods suggest that acupuncture is more than a placebo therapy. Similar arguments also apply to many other SCAMs, including for instance chiropractic.

There are several ways of minimising this de-randomisation phenomenon. But the only sure way to avoid this de-randomisation is to blind not just the patient but also the therapists (and to check whether both remained blind throughout the study). And that is often not possible or exceedingly difficult in trials of SCAM. Therefore, I suggest we should always keep de-randomisation in mind. Whenever we are confronted with an RCT that suggest a result that is less than plausible, de-randomisation might be a possible explanation.

 

On Twitter, I recently found this remarkable advertisement:

Naturally, it interested me. The implication seemed to be that we can boost our immune system and thus protect ourselves from colds, the flu and other infections by using this supplement. With the flu season approaching, this might be important. On the other hand, the supplement might be unsafe for many other patients. As I had done a bit of research in this area, I needed to know more.

According to the manufacturer’s information sheet, Viracid

  • Provides Support for Immune Challenges
  • Strengthens Immune Function
  • Maintains Normal Inflammatory Balance

The manufacurer furthermore states the following:

Our body’s immune system is a complex and dynamic defense system that comes to our rescue at the first sign of exposure to an outside invader. The dynamic nature of the immune system means that all factors that affect health need to be addressed in order for it to function at peak performance. The immune system is very sensitive to nutrient deficiencies. While vitamin deficiencies can compromise the immune system, consuming immune enhancing nutrients and botanicals can support and strengthen your body’s immune response. Viracid’s synergistic formula significantly boosts immune cell function including antibody response, natural killer (NK) cell activity, thymus hormone secretions, and T-cell activation. Viracid also helps soothe throat irritations and nasal secretions, and maintains normal inflammatory balance by increasing antioxidant levels throughout the body.

This sounds impressive. Viracid could thus play an important role in keeping us healthy. It could also be contra-indicated to lots of patients who suffer from autoimmune and other conditions. In any case, it is worth having a closer look at this dietary supplement. The ingredients of the product include:

  • Vitamin A,
  • Vitamin C,
  • Vitamin B12,
  • Pantothenic Acid,
  • Zinc,
  • L-Lysine Hydrochloride,
  • Echinacea purpurea Extract,
  • Acerola Fruit,
  • Andrographis paniculata,
  • European Elder,
  • Berry Extract,
  • Astragalus membranaceus Root Extract

Next, I conducted several literature searches. Here is what I did NOT find:

  • any clinical trial of Viracid,
  • any indication that its ingredients work synergistically,
  • any proof of Viracid inducing an antibody response,
  • or enhancing natural killer (NK) cell activity,
  • or thymus hormone secretions,
  • or T-cell activation,
  • or soothing throat irritations,
  • or controlling nasal secretions,
  • or maintaining normal inflammatory balance,
  • any mention of contra-indications,
  • any reliable information about the risks of taking Viracid.

There are, of course, two explanations for this void of information. Either I did not search well enough, or the claims that are being made for Viracid by the manufacturer are unsubstantiated and therefore bogus.

Which of the two explanations apply?

Please, someone – preferably the manufacturer – tell me.

The ‘College of Medicine and Integrated Health’ (CMIH) has been the subject of several previous blog posts (see for instance here, here and here). Recently, they have come up with something new that, in my view, deserves a further comment.

The new ‘SELF CARE TOOL KIT’ began, according to the CMIH, in 2009 with a national multi-centre project commissioned by the UK Department of Health, to consider the best way to integrate self care into family practice. The project involved two large family health centres and two university departments. One output was the Self Care Library (SCL).

The Self Care Library (SCL) is an online patient resource providing free evidence-based information about self-care.  The funding for the SCL did, however, not survive, and the facility was assigned to the CMIH. Thanks to funding from ‘Pukka Herbs Vitamins, Herbal Remedies & Health Supplements‘, the CMIH was able to transfer the content and to begin updating entries. Simon Mills, the coordinator of the original project who is now employed by Pukka, has led this transformation and helped the College set up the new parent portal, Our Health Directory.

The Self Care Toolkit is thus the new SCL. All concerned with this project are experienced in clinical practice and can separate the theory from real life needs. We all have academic lives as well so can be hard-nosed with the evidence base as well.

_______________________________________________________________

The above text is essentially based on the information provided by the CMIH. A few critical remarks and clarifications might therefore be in order:

  • What does ‘separate the theory from real life needs’ mean? Does it mean that the scientific evidence can be interpreted liberally (see below)?
  • Is it a good idea to have a commercial sponsor for such a project?
  • Is it wise that the main person in charge is on the payroll of a manufacturer of dietary supplements?
  • Is there any oversight to minimise undue bias and prevent the public from being misled?
  • Is it really true that all people involved have academic lives? Simon Mills (who once was a member of my team) has no longer an academic appointment, as far as I know.

But, you are right, these are perhaps mere trivialities. Let’s see what the ‘Self Care Tool Kit’ actually delivers. I have chosen the entry on DEPRESSION to check its validity. Here it is:

_______________________________________________________________

It isn’t likely that taking extra vitamins will make much difference to low mood or depression. It is true that many people don’t get quite enough B, C and D vitamins in their food. And it’s also true that the brain and nervous system need these vitamins. Because they don’t get stored in the body, our daily diet has to supply them. Research has shown that people with low blood levels of the B vitamin folic acid are more likely to be depressed and less likely to do well on anti-depressant medicines. So, if you are eating a very poor diet, taking extra vitamins just might help. It’s also worth remembering that alcohol, refined sugars, nicotine and caffeine all take these vitamins out of the body. Yet most people who feel depressed probably won’t benefit from taking vitamins alone. To ensure that you get a good balance of these vitamins, try to eat more whole-foods, fruits, vegetables, nuts and seeds.

Some people say that taking high doses of vitamin C (1-2 g and more a day) helps lift their mood. There is a little research to support this and none showing that high doses of vitamin C actually help clinical depression. Vitamin C levels fall after surgery or inflammatory disease. The body needs more vitamin C when coping with stress, pregnancy and breast feeding. Aspirin, tetracycline and contraceptive pills take vitamin C out of the body. Smokers also need extra vitamin C because nicotine removes it. Fresh fruit and vegetables are the best sources of vitamin C.

Doctors are increasingly concerned about low vitamin D, especially in the Asian community. A lack of vitamin D can lead to depression. Oily fish and dairy products are good sources of vitamin D, and sunlight helps the body make vitamin D. Do you get enough sunshine and eat a good diet? It is estimated that worldwide over 1 billion people get too little vitamin D.

Evidence
Taking supplements of vitamins B and D might help some people, whose diet is poor, but more research is needed.

Safety
Very high doses of vitamins and minerals can upset the body and cause side-effects. Get medical advice if you intend to take large doses. To ensure that you get a good balance of these vitamins, try to eat more whole-foods, fruits, vegetables, nuts and seeds.

Cost
If your diet is poor and you don’t get into the sun, ask your doctor about a vitamin D blood test. If it’s normal, there’s no point in taking vitamin D. If it’s low, your GP will prescribe it for you or you can buy a vitamin D supplement.

___________________________________________________________________

In my view, this text begs several questions:

1) Am I right in thinking that phraseology such as the one below will encourage patients suffering from depression to try the supplements mentioned?

  • people with low blood levels of the B vitamin folic acid are more likely to be depressed and less likely to do well on anti-depressant medicines..
  • Some people say that taking high doses of vitamin C (1-2 g and more a day) helps lift their mood…
  • There is a little research to support this and none showing that high doses of vitamin C actually help clinical depression…
  • A lack of vitamin D can lead to depression.
  • Taking supplements of vitamins B and D might help some people…
  • … your GP will prescribe it for you or you can buy a vitamin D supplement.

2) How does that tally with the latest evidence? For instance:

3) The CMIH state: ‘This site gives you information NOT medical advice.’  But, in view of the actual text above, is this true?

4) Depression is a life-threatening condition. Is there a risk that patients trust the CMHI’s (non-) advice and commit suicide because of its ineffectiveness?

5) Do Pukka, the sponsor of all this, happen to supply most of the self care remedies promoted in the ‘Self Care Tool Kit’?

The answer to the last question, I am afraid, is YES!

We have looked at curcumin several (tumeric) times before (see here, here and here). It seems to have a fascinating spectrum of pharmacological activities. But do they translate into clinical usefulness? To answer this question, we obviously need clinical trials. Unfortunately, not many have become available. Here are two recent studies:

Due to the potential benefits of curcumin in the ischemic heart disease, this study was performed to evaluate whether pretreatment with curcumin may reduce myocardial injury following elective percutaneous coronary intervention (PCI). A randomized clinical trial was performed on 110 patients undergoing elective PCI. The intervention group (n = 55) received a single dose of 480 mg nanomicelle curcumin orally and the standard treatment before PCI, while the control group (n = 55) received only the standard treatment., Serum concentrations of CK-MB and troponin I was measured before, 8 and 24 h after the procedure to assess myocardial damage during PCI. The results showed that the raise of CK-MB in curcumin group was half of the control group (4 vs. 8 cases) but was not significant. There were no significant differences in CK-MB levels at 8 (P = .24) and 24 h (P = .37) after PCI between the curcumin and the control group. No significant difference was also found in troponin I levels at 8 (P = 1.0) and 24 h (P = .35) after PCI between the groups. This study did not support the potential cardioprotective benefit of curcumin against pre-procedural myocardial injury in patients undergoing elective PCI.


Ground and mashed turmeric

Inflammation along with oxidative stress has an important role in the pathophysiology of unstable angina which leads to acute myocardial infarction, arrhythmias and eventually heart failure. Curcumin has anti-inflammatory and anti-oxidant effects and thereby, it may reduce cardiovascular complications. This randomized controlled trial aimed to investigate the effects of curcumin on the prevention of atrial and ventricular arrhythmias and heart failure in patients with unstable angina.

Materials and Methods:

Forty patients with unstable angina who met the trial inclusion and exclusion criteria, participated in this double-blind randomized clinical trial. The patients were randomized into two groups: curcumin (80 mg/day for 5days) and placebo (80 mg/day for 5days). Cardiac function was evaluated by two-dimensional echocardiography devices at baseline (immediately after hospitalization) and 5 days after the onset of the trial. Atrial and ventricular arrhythmias were recorded by Holter monitors in cardiology ward, Ghaem academic hospital, Mashhad, Iran. Progression to heart failure, myocardial infarction, and pulmonary and cardiopulmonary resuscitation events as well as mortality were recorded daily throughout the study.

Results:

There were no significant differences between the two groups in atrial and ventricular arrhythmias (p=0.2), and other echocardiographic parameters (Ejection fraction, E, A, E/A ratio, Em, and pulmonary artery pressure) at baseline and five days after the start of the trial.

Conclusion:

Nanocurcumin administered at the dose of 80 mg/day for five days had no effect in the incidence of cardiovascular complications in patients with unstable angina.

Clinical trials are not a good tool for proving a negative; they rarely can prove that a therapy is totally useless. Therefore, we cannot be sure that the many fascinating pharmacological activities of curcumin do not, after all, translate into some clinical benefit. However, what we can say with a high degree of certainty is this: currently there is no good evidence to show that curcumin is effective in treating any human condition.

Perhaps there is a more general lesson here about herbal medicine. Many plants have exiting pharmacological activities such as anti-biotic or anti-cancer activity which can be shown in-vitro. These are then hyped by entrepreneurs and enthusiasts of so-called alternative medicine (SCAM). Such hype fools many consumers and is thus good for business. But in-vitro activity does not necessarily mean that the therapy is clinically useful. There are many reasons for this, e.g. toxicity, lack of absorption. The essential test is always the clinical trial.

IN-VIVO VERITAS!

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