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

herbal medicine

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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?

If you, like many of us, have heavily ‘toxed’, you might now consider ‘detoxing’. What I mean is that we have probably all over-indulged a bit over the holidays. Unless you were the guest of someone, you had to pay dearly for it (Champagne is not cheap!). And now, a whole industry of ‘detox’ entrepreneurs tells you to pay again – this time, for detox.

As you payed ‘through your nose’ for the ‘tox’, you might as well use the same orifice for the ‘detox’. An Indian tradition called Nasiyam (or Nasyam? or Nasya? – I am confused!)  makes it possible. This website explains:

Nasal Instillation (Nasyam) is the practice of instilling medicated oils, fresh juices of leaves or flowers in the nostrils … Nasyam is specially directed towards the purification of various parts related to the head…

I don’t know about you, but I always felt that all my parts were related to my head! So, Nasyam is for purification of all my parts? The announcement below – I picked it up on Twitter – is much clearer: detox through the nasal doorway! Who would refuse such an offer after the festivities of late?

This sounds fascinating, I thought. Thus I ran a quick Medline search but only found this abstract:

BACKGROUND:

Ardita (facial paralysis) is a medical condition that disfigures or distorts the facial appearance of the sufferer causing facial asymmetry and malfunction. Ardita patients may benefit from considering alternative treatments such as Ayurveda, including Taila Nasya (nasal instillation of medicated oil).

OBJECTIVES:

To synthesize the best available evidence on the effectiveness of different Nasya oils in the treatment of Ardita.

INCLUSION CRITERIA TYPES OF PARTICIPANTS:

Studies conducted on adult sufferers (18-70 years) of Ardita (chronic or acute) in any setting were considered. Studies including participants who were pregnant or suffered allergic rhinitis, fever, intracranial tumor/hemorrhage and bilateral facial palsy were excluded.

INTERVENTION(S)/COMPARATOR(S):

Standalone treatment of Nasya (at all dosages and frequencies) compared to Nasya in combination with other Ayurvedic treatments was considered. Comparisons between different interventions including Taila Nasya alone, Taila Nasya in combination with other Ayurvedic interventions and Ayurvedic interventions that did not include Taila Nasya were also considered.

OUTCOMES AND MEASURES:

Changes in Ardita symptoms, including facial distortion, speech disorders and facial pain, were measured.

TYPES OF STUDIES:

All quantitative study designs (experimental, quasi-experimental and observational) were considered.

SEARCH STRATEGY:

Relevant studies were identified following a comprehensive literature search. References provided within these key studies identified additional resources. Indian universities were also contacted for results of Ardita studies undertaken in their institutions.A three-step search strategy aimed to find studies of published and unpublished studies was undertaken. Studies published in the English language were considered for inclusion, irrespective of publication date/year. Following an initial limited search of MEDLINE and CINAHL, the text words contained in the title and abstract, and of the index terms used to describe each articles were analyzed. From the identified keywords and index terms, searches were undertaken across all relevant databases such as PubMed, CINHAL, Cochrane (CENTRAL), Scopus, Centre for Review and Dissemination databases, Turning Research into Practice (TRIP), EMBASE, EBM Reviews, DHARA, Google Scholar, MedNar and ProQuest Dissertations. Finally, reference lists of identified theses and articles were searched for additional studies. Universities and website operators related to Ayurvedic research in India were contacted, including the National Institute of Ayurveda for relevant studies. Besides this, the University of Adelaide librarian was contacted to retrieve those studies identified in the reference lists of theses and articles.

METHODOLOGICAL QUALITY:

Studies were critically assessed by the review author and a secondary reviewer prior to inclusion in the review using the standardized critical appraisal instrument from the Joanna Briggs Institute.

DATA EXTRACTION:

Data was extracted by the primary reviewer using the standardized data extraction tool from the Joanna Briggs Institute.

DATA SYNTHESIS:

Different interventions and comparators across studies precluded meta-analysis. Narrative synthesis was performed.

RESULTS:

Only two pseudo randomized studies with a small number of participants met inclusion criteria and were included in the review. One study with 20 participants, divided equally into two groups compared the effectiveness of two nasal instillations in alleviating four Ardita symptoms. The second study of 15 participants each in two groups compared the effectiveness of nasal instillation with placement of medicated oil on the head on seven Ardita symptoms. Observational measurements of Ardita symptoms were graded as Mild, Moderate or Marked at baseline and after one month. The study conducted on 30 participants using Nasya intervention showed participants had better relief from the symptoms of facial pain, speech disorder and earache within the range of 78.2% to 90.9%, graded as Marked. Along with statistical data available in the studies, this review found low levels of evidence favoring Taila Nasya intervention. The review did not include any studies examining effectiveness of Nasya compared to conventional treatment for Ardita.

CONCLUSIONS:

This review presents extremely limited evidence from only two small experimental studies that administration of Nasya oil alone may provide some relief from Ardita symptoms of facial distortion, speech disorder, inability to shut eyelids/upward eye rolling and dribbling of saliva in adult patients. No strong conclusions may be drawn from the evidence included in the review due to the limited number of studies, limited number of participants and poor quality of studies.

IMPLICATIONS FOR PRACTICE:

Practitioners should advice Ardita patients that there is extremely limited evidence suggesting the potential effectiveness of Nasya oils alone or Nasya in conjunction with other Ayurvedic treatments in managing symptoms. However, given the absence of a strong evidence base, practitioners should be guided by clinical wisdom and patient preference.

IMPLICATIONS FOR RESEARCH:

Well controlled clinical trials comparing standalone Nasya therapy to other Ayurvedic treatments and/or conventional medicine for Ardita symptoms need to be conducted to examine the relative effectiveness of different Nasya oils in treating.

I think you agree, that’s nothing to write home about.

So, on second thought I might give Nasya (or whatever it is called) a miss. The same applies, by the way, to any other form of detox.

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!

I have to admit, I only read the DAILY MAIL, if I have to (and certainly not today). This is probably why I missed this article announcing the 1st traditional Chinese medicine to be licensed in the UK.

The plant Sigesbeckia, which has an unpleasant smell, is renowned for its ability to treat aches and pains – including those caused by arthritis.  It is the active ingredient in Phynova Joint and Muscle Relief Tablets, which have just been licensed by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency.

The directive also made it more difficult for medicines to get a licence as it demanded they had to have been in use for 30 years, of which at least 15 years had to be in the EU. Some Western herbal medicines have managed to gain licences in a process costing thousands of pounds to verify their ingredients. But the Phynova tablets are the first traditional Chinese medicine to be approved.

Robert Miller, chief executive of Oxford-based Phynova, said he was ‘extremely proud’, adding: ‘This has come from years of working with our Chinese colleagues. ‘Britain can now benefit from having access to high quality, regulated Chinese medicines.’ He also said that the company is planning to apply for a licence for a second traditional Chinese medicine, a cold and flu remedy.

Dr Chris Etheridge, a medical herbalist and adviser to Potter’s Herbals, celebrated the ‘good news’, adding that Sigesbeckia, which is not commonly used in the West, ‘offers an alternative to those who prefer not to take non-steroidal anti-inflammatory drugs for muscle and joint pain’.

But Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, warned that the new product demonstrates the difficulties the EU rules created for supplying herbal products safely to the public.  He said it is ‘almost impossible to satisfy the licensing conditions’.  He added that some people have therefore turned to the internet to buy unlicensed products, but this means they have ‘no idea whether they are safe or effective’.

How exciting!

Exciting enough to do a quick search for the evidence. Are there any clinical trials to show or suggest that this herbal remedy does anything other than filling the bank account of the manufacturer? Sadly, the answer seems to be NO! At least, I could not find a single such study (if anyone knows more, I’d be pleased to stand corrected).

Frustrated I looked at the website of the manufacturer. Here I found this:

Exclusively containing Sigesbeckia extract, Phynova Joint and Muscle Relief Tablets is a traditional herbal medicinal product used for the relief of backache, rheumatic, joint and muscle pain as well as minor sports injuries. Sigesbeckia has been used for thousands of years around the world to relieve painful joints and muscles.

Benefits

– Relief from joint & muscle pain
– Gentle on the stomach
– No known side effects
– No known drug indications or contraindications
– Can be taken with or without food

And this:

What can Sigesbeckia be used to treat?

Traditionally used for arthritic pain, rheumatic pain, back pain and sciatica. Today, Sigesbeckia can be used for;

Backache

Back pain can occur through a sprain or strain, spasms, nerve compression, herniated discs and other problems in your lower, middle and upper back.

Poor posture, lifting and stretching, sudden movements placing strain on your lower back and sports injuries, are amongst the main culprits for causing back pain.

Minor sports injuries

Minor sports injuries can be caused by an accident such as a fall or blow, not warming up properly before exercise, pushing yourself too hard and not using the appropriate equipment or perhaps poor technique.

Rheumatic and muscular pain

Common causes of rheumatic and muscle pain can be due to; tension and stress, lack of minerals, certain medication, dehydration, sprains and strains, sleep deficiency, too much physical activity and sometimes other underlying health conditions and diseases.

General aches and pains in muscles and joints

Overexertion due to a new exercise routine or from a sprain or strain can cause general aches and pains in muscles and joints. But so too can modern day busy life. The impact on our bodies can trigger aches and pains in your muscles and joints and lower your resistance to illness and disease.

The Benefit of Sigesbeckia extract

One of the benefits of Sigesbeckia extract, as used in approved licensed products, is that it has no known side effects or interactions with other medications according to the Summary of Product Characteristics (SmPC). Always check that the product you purchase is an approved Traditional Herbal Medicine Product in the UK.

In summary: Look after your joints and muscles with Sigesbeckia

Our bodies are all different, and our approach and tolerances will vary. Used for over a thousand years and known for its anti-inflammatory and mobility benefits alongside being used for joint and muscle pain; Sigesbeckia is a herbal medicine that works best when used over time.

Looking for a traditional remedy for joint and muscle relief? Why not try Sigesbeckia?

But again no sign of a clinical trial to back up this plethora of therapeutic claims. How can this be? The answer lies in the directive mentioned in the Mail article. To obtain a licence that enables the manufacturer to make therapeutic claims, a herbal remedy merely needs to demonstrate that it has been in use for 30 years, of which at least 15 years had to be in the EU.

I think I understand the intention of the directive. But I would nevertheless have thought that, 4 years after obtaining a license, the manufacturer could have conducted a study to test whether the product works. In my view this should be a moral and ethical, if not legal obligation. The ‘test of time’ is woefully insufficient and unreliable and no basis for generating progress or securing the best interests of patients.

Considering the total lack of efficacy and safety data, do you agree that the above comment by Michael McIntyre are ironic to the extreme? And do you agree that manufacturers who manage to obtain such a license should be obliged to deliver a proof of efficacy within a reasonable period of time?

Tiger Balm (TB) ointments are Chinese topical remedies, often used for pain relief available as over-the-counter medications. TB is clearly popular, but does it work? The aim of this systematic review was to find out by assessing the efficacy, safety and tolerability of TB ointments.

A total of 12 studies were included (five on TB ointments efficacy, whereas seven on their safety and tolerability). Two cases of dermatitis and one of cheilitis likely ascribable to the use of TB ointments have been reported. Based on available studies, it might be estimated that around 4% [95% CI, 3%-5%] of patients with history of contact skin allergy could be positive if patch tested with TB ointments, therefore caution is recommended in the use of TB among these subjects.

The authors concluded that, according to retrieved evidence, TB ointments might be useful for the management of pain due to tension headache, and they seem capable of increasing leg blood flow if combined with massage. Considering available evidence on topical products with camphor, TB ointments shouldn’t be used in children, as well as in pregnant or lactating women. Chronic use, large amounts of balm, and the application on damaged skin must be avoided too. Further studies are recommended.

I had to laugh out loud when reading these conclusions:

  1.  That TB MIGHT be useful is hardly worth writing home about. A systematic review should tell us whether there is any good evidence THAT it is useful.
  2.  That TB seems capable of increasing leg blood flow is also nonsense. Firstly, anything increases blood flow IF COMBINED WITH MASSAGE. Secondly, why would anyone want to increase leg blood flow? Ahh of course: if you have leg ischaemia, e. g. in intermittent claudication. But then increasing blood flow of the skin of the leg is likely to be counter-productive, as this would shunt blood away from the already oxygen-starved muscles.

So, what evidence is there that TB might be effective? It turns out that there is all of ONE small randomised clinical trial that is over 20 years old which delivers a positive result. In view of this, I find it hard to resist re-writing the conclusions as follows:

TB IS A CHINESE REMEDY THAT CAN CAUSE ADVERSE EFFECTS AND FOR WHICH THERE IS NO GOOD EVIDENCE OF EFFICACY. ITS RISK/BENEFIT BALANCE IS THEREFORE NOT DEMONSTRABLY POSITIVE.

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.

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.

In a paper discussed in a previous blog, Ioannidis et al published a comprehensive database of a large number of scientists across science. They used Scopus data to compile a database of the 100,000 most-cited authors across all scientific fields based on their ranking of a composite indicator that considers six citation metrics (total citations; Hirsch h-index; coauthorship-adjusted Schreiber hm-index; number of citations to papers as single author; number of citations to papers as single or first author; and number of citations to papers as single, first, or last author). The authors also added this caution:

Citation analyses for individuals are used for various single-person or comparative assessments in the complex reward and incentive system of science. Misuse of citation metrics in hiring, promotion or tenure decision, or other situations involving rewards (e.g., funding or awards) takes many forms, including but not limited to the use of metrics that are not very informative for scientists and their work (e.g., journal impact factors); focus on single citation metrics (e.g., h-index); and use of calculations that are not standardized, use different frames, and do not account for field. The availability of the data sets that we provide should help mitigate many of these problems. The database can also be used to perform evaluations of groups of individuals, e.g., at the level of scientific fields, institutions, countries, or memberships in diversely defined groups that may be of interest to users.

It seems thus obvious and relevant to employ the new metrics for defining the most ‘influential’ (most frequently cited) researchers in so-called alternative medicine (SCAM). Doing this creates not one but two non-overlapping tables (because ‘complementary&alternative medicine’ is listed both as a primary and a secondary field (not sure about the difference)). Below, I have copied a small part of these tables; the first three columns are self-explanatory; the 4th relates to the number of published articles, the 4th to the year of the author’s first publication, the 5th to the last, the 6th column is the rank amongst 100 000 scientists of all fields who have published more than a couple of papers.

TABLE 1

Ernst, E. University of Exeter gbr 2253 1975 2018 104
Davidson, Jonathan R. T. Duke University usa 426 1972 2017 1394
Kaptchuk, Ted J. Harvard University usa 245 1993 2018 6545
Eisenberg, David M. Harvard University usa 127 1991 2018 8641
Lundeberg, Thomas 340 1983 2016 17199
Linde, Klaus Technische Universitat Munchen deu 276 1993 2018 19488
Schwartz, Gary E. University of Arizona usa 264 1967 2018 21893
Eloff, J.N. University of Pretoria zaf 204 1997 2018 23830
Birch, Stephen McMaster University can 244 1985 2018 31925
Wilson, Kenneth H. Duke University usa 76 1976 2017 40760
Kemper, Kathi J. Ohio State University usa 181 1988 2017 45193
Oken, Barry S. Oregon Health and Science University usa 121 1974 2018 51325
Pittler, M.H. 155 1997 2016 53183
Postuma, Ronald B. McGill University can 159 1998 2018 61018
Patwardhan, Bhushan University of Pune ind 144 1989 2018 64465
Krucoff, Mitchell W. Duke University usa 261 1986 2016 66028
Chiesa, Alberto 87 1973 2017 82390
Baliga, Manjeshwar Shrinath 142 2002 2018 83030
Mischoulon, David Harvard University usa 194 1992 2018 91705
Büssing, Arndt University of Witten/Herdecke deu 207 1980 2018 95907
Langevin, Helene M. Harvard University usa 67 1999 2018 98290
Creath, Katherine 84 1984 2017 99709
Kuete, Victor University of Dschang cmr 239 2005 2018 128347

TABLE 2

White, Adrian University of Plymouth gbr 294 1990 2016 16714
Astin, John A. California Pacific Medical Center usa 50 1994 2014 21379
Kelly, Gregory S. 37 1985 2011 31037
Walach, Harald University of Medical Sciences Poznan pol 246 1996 2018 31716
Berman, Brian M. University of Maryland School of Medicine usa 211 1986 2018 34022
Lewith, George University of Southampton gbr 380 1980 2018 34830
Kidd, Parris M. University of California at Berkeley usa 38 1976 2011 36571
Jonas, Wayne B. 187 1992 2018 42445
MacPherson, Hugh University of York gbr 143 1996 2018 49923
Bell, Iris R. University of Arizona usa 142 1984 2015 51016
Patrick, Lyn 21 1999 2018 57086
Ritenbaugh, Cheryl University of Arizona usa 172 1981 2018 63248
Boon, Heather University of Toronto can 188 1988 2017 69066
Aickin, Mikel University of Arizona usa 149 1996 2014 72040
Lee, Myeong Soo 430 1996 2018 72358
Lao, Lixing University of Hong Kong hkg 247 1990 2018 74896
Witt, Claudia M. Charite – Universitatsmedizin Berlin deu 238 2001 2018 78849
Sherman, Karen J. 136 1984 2017 82542
Verhoef, Marja J. University of Calgary can 190 1989 2016 84314
Smith, Caroline A. University of Western Sydney aus 135 1979 2018 94130
Miller, Alan L. 30 1980 2016 94421
Paterson, Charlotte University of Bristol gbr 71 1995 2017 95130
Milgrom, Lionel R. London Metropolitan University gbr 107 1979 2017 112943
Adams, Jon University of Technology NSW aus 294 1999 2018 128486
Litscher, Gerhard Medical University of Graz aut 245 1986 2018 133122
Chen, Calvin Yu-Chian China Medical University Taichung chn 130 2007 2016 164522

No other researchers are listed in the ‘Complementary&Alternative Medicine’ categories and made it into the list of the 100 000 most-cited scientists.

To make this easier to read, I have ordered all SCAM researchers according to their rank in one single list and, where known to me, added the respective focus in SCAM research (ma = most areas of SCAM):

  1. ERNST EDZARD (ma)
  2. DONALDSON JONATHAN
  3. KAPTCHUK TED (acupuncture)
  4. EISENBERG DAVID (TCM)
  5. WHITE ADRIAN (acupuncture)
  6. LUNDEBERG THOMAS (acupuncture)
  7. LINDE KLAUS (homeopathy)
  8. ASTIN JOHN (mind/body)
  9. SCHWARTZ GARRY (healing)
  10. ELOFF JN
  11. KELLY GREGORY
  12. WALLACH HARALD (homeopathy)
  13. BIRCH STEVEN (acupuncture)
  14. BERMAN BRIAN (acupuncture)
  15. LEWITH GEORGE (acupuncture)
  16. KIDD PARRIS
  17. WILSON KENNETH
  18. JONAS WAYNE (homeopathy)
  19. KEMPER KATHIE (ma)
  20. MACPHERSON HUGH (acupuncture)
  21. BELL IRIS (homeopathy)
  22. OKEN BARRY (dietary supplements)
  23. PITTLER MAX (ma)
  24. PATRICK LYN
  25. RITENBAUGH CHERYL (ma)
  26. POSTUMA RONALD
  27. PATWARDHAN BHUSHAN
  28. KRUCOFF MICHELL
  29. BOON HEATHER
  30. AICKIN MIKEL (ma)
  31. LEE MYEONG SOO (TCM)
  32. LAO LIXING (acupuncture)
  33. WITT CLAUDIA (ma)
  34. CHIESA ALBERTO
  35. SHERMAN KAREN (acupuncture)
  36. BALIGA MANJESHWAR
  37. VERHOEF MARIA (ma)
  38. MISCHOULON DAVID
  39. SMITH CAROLINE (acupuncture)
  40. MILLER ALAN
  41. PATERSON CHARLOTTE (ma)
  42. BUESSING ARNDT (anthroposophical medicine)
  43. LANGEVIN HELENE (ma)
  44. CREATH KATHERINE
  45. MILGROM LIONEL (homeopathy)
  46. KUETE VICTOR
  47. ADAMS JON (ma)
  48. LITSCHER GERHARD
  49. CHEN CALVIN

The list is interesting in several regards. Principally, it offers individual SCAM researchers for the first time the opportunity to check their international standing relative to their colleagues. But, as the original analysis in Ioannidis’s paper contains much more data than depicted above, there is much further information to be gleaned from it.

For instance, I looked at the rate of self-citation (not least because I have sometimes been accused of overdoing this myself). It turns out that, with 7%, I am relative modest and well below average in that regard. Most of my colleagues are well above that figure. Researchers who have exceptionally high self-citation rates include Buessing (30%), Kuete (43%), Adams (36%), Litscher (45%), and Chen (53%).

The list also opens the possibility to see which countries dominate SCAM research. The dominance of the US seems fairly obvious and would have been expected due to the size of this country and the funds the US put into SCAM research. Considering the lack of funds in the UK, my country ranks surprisingly high, I find. No other country is well-represented in this list. In particular Germany does not appear often (even if we would classify Wallach as German); considering the large amounts of money Germany has invested in SCAM research, this is remarkable and perhaps even a bit shameful, in my view.

Looking at the areas of research, acupuncture and homeopathy seem to stand out. Remarkably, many of the major SCAMs are not or not well represented at all. This is in particular true for herbal medicine, chiropractic and osteopathy.

The list also confirms my former team as the leaders in SCAM research. (Yes, I know: in the country of the blind, the one-eyed man is king.) Pittler, White and Lee were, of course, all former co-workers of mine.

Perhaps the most intriguing finding, I think, relates to the many SCAM researchers who did not make it into the list. Here are a few notable absentees:

  1. Behnke J – GERMANY (homeopathy)
  2. Bensoussan A – AUSTRALIA (acupuncture)
  3. Brinkhaus B – GERMANY  (acupuncture)
  4. Bronfort G  – US  (chiropractic)
  5. Chopra D – US (mind/body)
  6. Cummings M – UK (acupuncture)
  7. Dixon M – UK (ma)
  8. Dobos G – GERMANY (ma)
  9. Fisher P – UK (homeopathy)
  10. Fonnebo V – NORWAY (ma)
  11. Frass M – AUSTRIA (homeopathy)
  12. Goertz C – US (chiropractic)
  13. Hawk C -US (chiropractic)
  14. Horneber M – GERMANY (ma)
  15. Jacobs J – US (homeopathy)
  16. Jobst K – UK (homeopathy)
  17. Kraft K – GERMANY (naturopathy)
  18. Lawrence D – US (chiropractic)
  19. Long CR – US (chiropractic)
  20. Meeker WC – US (chiropractic)
  21. Mathie R – UK (homeopathy)
  22. Melchart – GERMANY (ma)
  23. Michalsen A – GERMANY (ma)
  24. Mills S – UK (herbal medicine)
  25. Peters D – UK (ma)
  26. Reilly D -US (homeopathy)
  27. Reily D – UK (homeopathy)
  28. Robinson N – UK (ma)
  29. Streitberger K – GERMANY (acupuncture)
  30. Tuchin PJ – US (chiropractic)
  31. Uehleke – GERMANY (naturopathy)
  32. Ullman D – US (homeopathy)
  33.  Weil A – US (ma)

I leave it to you to interpret this list and invite you to add more SCAM researchers to it.

 

(thanks to Paul Posadski for helping with the tables)

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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