herbal medicine
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:
- 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.
- 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):
- ERNST EDZARD (ma)
- DONALDSON JONATHAN
- KAPTCHUK TED (acupuncture)
- EISENBERG DAVID (TCM)
- WHITE ADRIAN (acupuncture)
- LUNDEBERG THOMAS (acupuncture)
- LINDE KLAUS (homeopathy)
- ASTIN JOHN (mind/body)
- SCHWARTZ GARRY (healing)
- ELOFF JN
- KELLY GREGORY
- WALLACH HARALD (homeopathy)
- BIRCH STEVEN (acupuncture)
- BERMAN BRIAN (acupuncture)
- LEWITH GEORGE (acupuncture)
- KIDD PARRIS
- WILSON KENNETH
- JONAS WAYNE (homeopathy)
- KEMPER KATHIE (ma)
- MACPHERSON HUGH (acupuncture)
- BELL IRIS (homeopathy)
- OKEN BARRY (dietary supplements)
- PITTLER MAX (ma)
- PATRICK LYN
- RITENBAUGH CHERYL (ma)
- POSTUMA RONALD
- PATWARDHAN BHUSHAN
- KRUCOFF MICHELL
- BOON HEATHER
- AICKIN MIKEL (ma)
- LEE MYEONG SOO (TCM)
- LAO LIXING (acupuncture)
- WITT CLAUDIA (ma)
- CHIESA ALBERTO
- SHERMAN KAREN (acupuncture)
- BALIGA MANJESHWAR
- VERHOEF MARIA (ma)
- MISCHOULON DAVID
- SMITH CAROLINE (acupuncture)
- MILLER ALAN
- PATERSON CHARLOTTE (ma)
- BUESSING ARNDT (anthroposophical medicine)
- LANGEVIN HELENE (ma)
- CREATH KATHERINE
- MILGROM LIONEL (homeopathy)
- KUETE VICTOR
- ADAMS JON (ma)
- LITSCHER GERHARD
- 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:
- Behnke J – GERMANY (homeopathy)
- Bensoussan A – AUSTRALIA (acupuncture)
- Brinkhaus B – GERMANY (acupuncture)
- Bronfort G – US (chiropractic)
- Chopra D – US (mind/body)
- Cummings M – UK (acupuncture)
- Dixon M – UK (ma)
- Dobos G – GERMANY (ma)
- Fisher P – UK (homeopathy)
- Fonnebo V – NORWAY (ma)
- Frass M – AUSTRIA (homeopathy)
- Goertz C – US (chiropractic)
- Hawk C -US (chiropractic)
- Horneber M – GERMANY (ma)
- Jacobs J – US (homeopathy)
- Jobst K – UK (homeopathy)
- Kraft K – GERMANY (naturopathy)
- Lawrence D – US (chiropractic)
- Long CR – US (chiropractic)
- Meeker WC – US (chiropractic)
- Mathie R – UK (homeopathy)
- Melchart – GERMANY (ma)
- Michalsen A – GERMANY (ma)
- Mills S – UK (herbal medicine)
- Peters D – UK (ma)
- Reilly D -US (homeopathy)
- Reily D – UK (homeopathy)
- Robinson N – UK (ma)
- Streitberger K – GERMANY (acupuncture)
- Tuchin PJ – US (chiropractic)
- Uehleke – GERMANY (naturopathy)
- Ullman D – US (homeopathy)
- 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!
An article in the Sydney Morning Herald might be interesting to some readers. It informs us that, after more than 25 years of running, the University of Technology Sydney (UTS) intends to stop offering its degree in Traditional Chinese Medicine (TCM). A review of the Chinese Medicine Department found it should be wound up at the end of 2021 because
- it was no longer financially viable,
- did not produce enough research,
- and did not fit with the “strategic direction” of the science faculty.
The UTS’s Chinese medicine clinic, which offers acupuncture and herbal treatments, would also close. Students who don’t finish by the end of 2021 will either move to another health course, or transfer to another university (Chinese medicine is also offered by the University of Western Sydney, RMIT in Melbourne, and several private colleges).
TCM “is a historical tradition that pre-dated the scientific era,” said the president of Friends of Science, Associate Professor Ken Harvey. “There’s nothing wrong with looking at that using modern scientific techniques. The problem is people don’t, they tend to teach it like it’s an established fact. If I was a scientifically-orientated vice chancellor I would worry about having a course in my university that didn’t have much of a research profile in traditional Chinese medicine.”
But a spokesman for the University of Technology Sydney said the debate over the scientific validity of Chinese medicine had nothing to do with the decision, and was “in no way a reflection of an institutional bias against complementary health care”. Personally, I find this statement surprising. Should the scientific validity of a subject not be a prime concern of any university?
In this context, may I suggest that the UTS might also have a critical look at their ‘AUSTRALIAN RESEARCH CENTRE IN COMPLEMENTARY AND INTEGRATIVE MEDICINE‘. They call themselves ‘the first centre worldwide dedicated to public health and health services research on complementary and integrative medicine’. Judging from the centre director’s publications, this means publishing one useless survey after another.
As most of us know, the use of so-called alternative medicine (SCAM) can be problematic; its use in children is often most problematic:
- There are hardly any SCAMs that have been shown to work for paediatric conditions.
- Most SCAMs can cause considerable harm to children.
- Some might even amount to child abuse.
- Most SCAM practitioners lack adequate training to treat children.
- Many SCAM providers offer dangerous advice to parents.
- Parents are sometimes unable to differentiate between nonsense and medicine.
- Informed consent can present a trick subject when treating children.
In this context, the statement from the ‘Spanish Association Of Paediatrics Medicines Committee’ is of particular value and importance:
Currently, there are some therapies that are being practiced without adjusting to the available scientific evidence. The terminology is confusing, encompassing terms such as “alternative medicine”, “natural medicine”, “complementary medicine”, “pseudoscience” or “pseudo-therapies”. The Medicines Committee of the Spanish Association of Paediatrics considers that no health professional should recommend treatments not supported by scientific evidence. Also, diagnostic and therapeutic actions should be always based on protocols and clinical practice guidelines. Health authorities and judicial system should regulate and regularize the use of alternative medicines in children, warning parents and prescribers of possible sanctions in those cases in which the clinical evolution is not satisfactory, as well responsibilities are required for the practice of traditional medicine, for health professionals who act without complying with the “lex artis ad hoc”, and for the parents who do not fulfill their duties of custody and protection. In addition, it considers that, as already has happened, Professional Associations should also sanction, or at least reprobate or correct, those health professionals who, under a scientific recognition obtained by a university degree, promote the use of therapies far from the scientific method and current evidence, especially in those cases in which it is recommended to replace conventional treatment with pseudo-therapy, and in any case if said substitution leads to a clinical worsening that could have been avoided.
Of course, not all SCAM professions focus on children. The following, however, treat children regularly:
- acupuncturists
- anthroposophical doctors
- chiropractors
- craniosacral therapists
- energy healers
- herbalists
- homeopaths
- naturopaths
- osteopaths
I believe that all SCAM providers who treat children should consider the above statement very carefully. They must ask themselves whether there is good evidence that their treatments generate more good than harm for their patients. If the answer is not positive, they should stop. If they don’t, they should realise that they behave unethically and quite possibly even illegally.
This image caught my eye on facebook. It links to an article that makes a multitude of claims for a dietary supplement by the name of ‘smarter curcumin’:
Promotes Comfort & Flexibility
Studies have shown that curcumin may work by reducing certain key inflammation-promoting enzymes in the body. In some studies curcumin performed well in promoting comfort and flexibility without the side-effects; providing a natural supplement alternative. Athletes and weekend warriors alike are also using it for muscle and joint health recovery, too.
Supports Healthy Joints
Antioxidants play a role in keeping our joints healthy. Your body uses antioxidants to combat free radicals. Free radicals are unstable particles that are created as a result of millions of chemical reactions in the body. They can cause oxidative stress and damage on a cellular level. When scientists examine the blood and joint fluid of patients that are suffering with joint discomfort, often times there is an increased activity of free radicals and lower levels of antioxidants. Curcumin being rich in antioxidants, can give you a healthy supply.
Age-Reducing Beauty – Skin, Hair, and Body
Curcumin, being a very powerful natural antioxidant, helps reduce and neutralize free radicals, which damage and destroy your cells and DNA causing accelerated aging. Since most ageing disorders are driven by oxidative stress, this makes curcumin a very important daily supplement for aging adults.
Healthy Immune Balance
Your immune system is a network of various organs, tissues, and cells that work together to protect your body. Curcumin not only helps to enhance the responses of certain antibodies and cells within the immune system but may also help downregulate the expression of certain proinflammatory substances.
Promotes Cardio Health
A healthy heart consists of many factors, especially eating healthy and routine exercise. Adding curcumin as part of your healthy diet may have many benefits to protect your heart. Oxidized LDL (Low-density lipoprotein) particles (that have been disrupted by free radicals) may produce inflammation in the cardiovascular system. Studies suggest that the antioxidant effects of curcumin can help fight those free radicals.
Improves Digestion
Curcumin has been shown to calm the digestive system, helping to relieve gas, bloating, and other stomach and bowel issues. It works differently than probiotics or enzymes – naturally soothing the gut, and reducing the overproduction of acid.
Support Liver Health
Your liver plays an important role in stabilizing and balancing the maintenance of your body. The health of your liver can be directly related to oxidative stress and proinflammatory substances. Curcumin may help boost antioxidant defenses to help the liver detoxify and restore balance.
Supports Brain Health
The connection between inflammation and cognitive health cannot be overstated. Neurons are especially susceptible to inflammation and the release of inflammatory compounds in the body can be neurotoxic. Curcumin may help protect those precious brain cells.
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What fascinates me here is not so much the plethora of therapeutic claims. As far as I can see, most of them are not supported by what I would call good evidence. But I have grown so used to bogus claims in SCAM, that they rarely make me bat an eyelash.
What fascinates me most is the extraordinary picture evidently designed to attract our attention. Many people might have no idea what it depicts, other than a running leopard in a strange environment. Others will realise that the environment is an artery, and the chasing animal therefore seems to imply that the supplement enhances arterial blood flow.
But why? There is no evidence that curcumin has this effect, and the above therapeutic claims are largely unrelated to improvements of the blood circulation.
The artery is filled with red cells in their typical disc shape. It is, however, a shape red cells never have while submitted to flow in arteries. While circulating, they tend to attain a parachute-like shape:
Red cells form a disc shape only when they are motionless. Perhaps the picture really implies that curcumin generates a stagnation of blood flow? No, this is also not in line with reality; in stagnant blood, red cells aggregate and look like this:
So, you see why this image is puzzling. It seems to be aimed at people who are aware that it depicts something medical, yet too ignorant to realise that almost everything is wrong with it.
And why would anyone design an image like this? Could it be that only people naïve enough to think this picture makes any sense are likely to believe the tall tales offered in the text?
