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

herbal medicine

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Green tea is said to have numerous health benefits. Recently, a special green tea, matcha tea, is gaining popularity and is claimed to be more powerful than simple green tea. Matcha tea consumption is said to lead to higher intake of green tea phytochemicals compared to regular green tea.

But what is matcha tea? This article explains:

The word matcha literally means “powdered tea”. Drinking a cup or two of the tea made from this powder could help you tackle your day feeling clear, motivated and energized, rather than foggy, stressed out, and succumbing to chaos.

Matcha tea leaves are thrown a lot of shade (literally). They’re grown in the dark. The shade growing process increases matcha’s nutrients, especially chlorophyll, a green plant pigment that allows plants to absorb energy from sunlight. Chlorophyll is rich in antioxidants, and gives matcha it’s electrifying green colour. Shade growing also increases the amount of L-theanine, which is the amino acid known for promoting mental clarity, focus, and a sense of calm. It’s called nature’s “Xanax” for a reason.

The high amino acid content is also what gives matcha it’s signature umami taste. Umami is the “fifth” taste that describes the savory flavor of foods like miso, parmesan cheese, chicken broth, spinach, and soy sauce. You know you’ve got a premium matcha when you taste balanced umami flavors, hints of creaminess, and the slightest taste of fresh cut grass. You shouldn’t need to add any sweetener to enjoy sipping it. When choosing a high quality matcha powder, it’s important to remember: a strong umami flavour = higher in amino acids = the more L-theanine you’ll receive.

Once matcha leaves are harvested, they get steamed, dried, and ground up into a fine powder that you can mix with hot or cold water. The key difference here is that you’re actually consuming the nutrients from the entire leaf— which is most concentrated in antioxidants, amino acids, and umami flavour. This is unlike traditional brewed tea, where you’re only drinking the dissolvable portions of the leaf that have been steeped in water.

The article also names 5 effects of matcha tea:

1. Promotes Relaxation, Mood, and Mental Focus

2. Supports Healthy Cognitive Function

3. Supports Detoxification

4. Fights Physical Signs of Aging

5. Promotes a Healthy Heart

None of the sources provided do actually confirm that matcha tea conveys any of these benefits in humans. My favourite reference provided by the author is the one that is supposed to show that matcha tea is a detox remedy for humans. The article provided is entitled Low-dose dietary chlorophyll inhibits multi-organ carcinogenesis in the rainbow trout. Who said that SCAM-peddlers have no sense of humour?

Joking aside, is there any evidence at all to show that matcha tea has any health effects in humans? I found two clinical trials that tested this hypothesis.

Trial No1:

Intake of the catechin epigallocatechin gallate and caffeine has been shown to enhance exercise-induced fat oxidation. Matcha green tea powder contains catechins and caffeine and is consumed as a drink. We examined the effect of Matcha green tea drinks on metabolic, physiological, and perceived intensity responses during brisk walking. A total of 13 females (age: 27 ± 8 years, body mass: 65 ± 7 kg, height: 166 ± 6 cm) volunteered to participate in the study. Resting metabolic equivalent (1-MET) was measured using Douglas bags (1-MET: 3.4 ± 0.3 ml·kg-1·min-1). Participants completed an incremental walking protocol to establish the relationship between walking speed and oxygen uptake and individualize the walking speed at 5- or 6-MET. A randomized, crossover design was used with participants tested between Days 9 and 11 of the menstrual cycle (follicular phase). Participants consumed three drinks (each drink made with 1 g of Matcha premium grade; OMGTea Ltd., Brighton, UK) the day before and one drink 2 hr before the 30-min walk at 5- (n = 10) or 6-MET (walking speed: 5.8 ± 0.4 km/hr) with responses measured at 8-10, 18-20, and 28-30 min. Matcha had no effect on physiological and perceived intensity responses. Matcha resulted in lower respiratory exchange ratio (control: 0.84 ± 0.04; Matcha: 0.82 ± 0.04; p < .01) and enhanced fat oxidation during a 30-min brisk walk (control: 0.31 ± 0.10; Matcha: 0.35 ± 0.11 g/min; p < .01). Matcha green tea drinking can enhance exercise-induced fat oxidation in females. However, when regular brisk walking with 30-min bouts is being undertaken as part of a weight loss program, the metabolic effects of Matcha should not be overstated.

Trial No 2:

Matcha tea is gaining popularity throughout the world in recent years and is frequently referred to as a mood-and-brain food. Previous research has demonstrated that three constituents present in matcha tea, l-theanine, epigallocatechin gallate (EGCG), and caffeine, affect mood and cognitive performance. However, to date there are no studies assessing the effect of matcha tea itself. The present study investigates these effects by means of a human intervention study administering matcha tea and a matcha containing product. Using a randomized, placebo-controlled, single-blind study, 23 consumers participated in four test sessions. In each session, participants consumed one of the four test products: matcha tea, matcha tea bar (each containing 4g matcha tea powder), placebo tea, or placebo bar. The assessment was performed at baseline and 60min post-treatment. The participants performed a set of cognitive tests assessing attention, information processing, working memory, and episodic memory. The mood state was measured by means of a Profile of Mood States (POMS). After consuming the matcha products compared to placebo versions, there were mainly significant improvements in tasks measuring basic attention abilities and psychomotor speed in response to stimuli over a defined period of time. In contrast to expectations, the effect was barely present in the other cognitive tasks. The POMS results revealed no significant changes in mood. The influence of the food matrix was demonstrated by the fact that on most cognitive performance measures the drink format outperformed the bar format, particularly in tasks measuring speed of spatial working memory and delayed picture recognition. This study suggests that matcha tea consumed in a realistic dose can induce slight effects on speed of attention and episodic secondary memory to a low degree. Further studies are required to elucidate the influences of the food matrix.

Not impressed?

Me neither!

However, I was impressed when I looked up the costs of matcha tea: £17.95 for 30 g of powder does not exactly seem to be a bargain. So, matcha tea does after all help some people, namely all those engaged in flogging it to the gullible SCAM fraternity.

 

Kampo, the traditional Japanese herbal medicine, developed out of traditional Chinese herbal medicine after it was introduced into Japan in the 7th century. In the early 20th century, Kampo was further influenced by modern Western medicine and science. The Kampo system is a pragmatic and simplified version of Chinese herbal medicine. Kampo medicines are standardised and not normally individualised as in Chinese herbal medicine. They are based on the symptoms of the patient, interpreted in the tradition of Kampo. Kampo diagnostic criteria consider hypofunction and hyperfunction, heat and cold, superficies and interior, and yin and yang.

Today, Kampō is fully integrated into the Japanese national health care system, and numerous Kampo preparations are registered in Japan and reimbursable from public funds. In Japan, Kampo is thus not a so-called alternative medicine (SCAM), but outside this country it clearly is.

Standardised Kampo formulas contain mixtures of herbal ingredients. They are manufactured under proper quality control. The most commonly used plants include liquorice, ginger and Chinese peony root. Most Japanese doctors routinely prescribe Kampo medicines, and most patients combine Kampo with Western medicine. Since 2002, the teaching of Kampo has been included in Japanese curricula of medical and pharmacy education. The efficacy of Kampo medicines is often less solidly documented than one would hope or expect. There is a remarkable shortage of high-quality clinical trials.

As Kampo medicines contain pharmacologically active ingredients, they can also cause adverse effects and might interact with synthetic drugs. Yet, the risks of Kampo are currently woefully under-investigated. And this is why an analysis of adverse events associated with Kampo formulations that was just published is particularly important.

The researchers obtained reports of adverse events associated with ethical Kampo formulations from the domestic adverse-event data from July 30, 2003, to March 31, 2018. Adverse events were then categorized, and the relationships between categories of adverse events and crude drugs were analysed.

There were 4,232 reported adverse events associated with Kampo. They related to liver injury, 1,193; lung injury, 1,177; pseudoaldosteronism, 889; mesenteric phlebosclerosis, 223; drug eruption, 185; and others, 565. Among events related to both liver injury and lung injury, approximately 70% were suspected to be induced by Kampo formulations containing Scutellariae Radix.

The pseudoaldosteronism-related events, which are induced by Glycyrrhizae Radix, included several events related to muscle injury, heart failure, and arrhythmia. Events related to mesenteric phlebosclerosis, believed to be induced by long-term use of Kampo formulas containing Gardeniae Fructus, increased remarkably during the study period. Among the events related to drug eruption, approximately 35% were suspected to be induced by Kampo formulations containing Ephedrae Herba.

The authors concluded that Kampo medicines may cause various adverse events. The present results provide valuable information regarding adverse events associated with Kampo medicines from the viewpoint of patient safety.

While this paper presents invaluable data, its authors offer little by way of critical discussion. There is hardly any good evidence to show that any of the Kampo formulas are effective. Thus a discussion needs to be had about the question whether they generate more good than harm. The authors are completely silent on this important issue, and I suspect the reason might be that Kampo is a bit of a ‘holy cow’ in Japan that must not be questioned.

The numbers of adverse events are impressively high, but we do not know how they compare to adverse events in other areas of healthcare. For instance, it would be valuable to have comparative data indicating how many adverse events occurred with Kampo compared to synthetic drugs per 1 000 patients using them.

Thus we are left with the conclusion that, once proper post-marketing methods are employed to monitor SCAM, we are likely to realise that adverse events do occur more frequently than SCAM enthusiasts might have predicted. In my view, it is high time that we have effective adverse event monitoring in all areas of SCAM.

‘Acute-on-chronic liver failure’ (ACLF) is an acute deterioration of liver function in patients with pre-existing liver disease. It is usually associated with a precipitating event and results in the failure of one or more organs and high short term mortality.

An international team of researchers published a analysis examining data regarding drugs producing ACLF. They evaluated clinical features, laboratory characteristics, outcome, and predictors of mortality in patients with drug-induced ACLF. They identified drugs as precipitants of ACLF among prospective cohort of patients with ACLF from the Asian Pacific Association of Study of Liver (APASL) ACLF Research Consortium (AARC) database. Drugs were considered precipitants after exclusion of known causes together with a temporal association between exposure and decompensation. Outcome was defined as death from decompensation.

Of the 3,132 patients with ACLF, drugs were implicated as a cause in 10.5% of all cases and other non-drug causes in 89.5%. Within the first group, so-called alternative medications (SCAMs) were the commonest cause (71.7%), followed by combination anti-tuberculosis therapy drugs (27.3%). Alcoholic liver disease (28.6%), cryptogenic liver disease (25.5%), and non-alcoholic steatohepatitis (NASH) (16.7%) were common causes of underlying liver diseases. Patients with drug-induced ACLF had jaundice (100%), ascites (88%), encephalopathy (46.5%), high Model for End-Stage Liver Disease (MELD) (30.2), and Child-Turcotte-Pugh score (12.1). The overall 90-day mortality was higher in drug-induced (46.5%) than in non-drug-induced ACLF (38.8%).

The authors concluded that drugs are important identifiable causes of ACLF in Asia-Pacific countries, predominantly from complementary and alternative medications, followed by anti-tuberculosis drugs. Encephalopathy, bilirubin, blood urea, lactate, and international normalized ratio (INR) predict mortality in drug-induced ACLF.

The fact that some SCAMs can damage the liver has long been known. Here, for example, is 2003 our review of herbal medicine and liver problems:

Systematic literature searches were performed on Medline, Embase, The Cochrane Library, Amed and Ciscom. To identify additional data, searches were conducted by hand in relevant medical journals and in our own files. The screening and selection of articles and the extraction of data were performed independently by the two authors. There were no restrictions regarding the language of publication. In order to be included articles were required to report data on hepatotoxic events associated with the therapeutic use of herbal medicinal products.

Single medicinal herbs and combination preparations are associated with hepatotoxic events. Clinically, the spectrum ranges from transient elevations of liver enzyme levels to fulminant liver failure and death. In most instances hepatotoxic herbal constituents are believed to be the cause, while others may be due to herb-drug interactions, contamination and/or adulteration.

A number of herbal medicinal products are associated with serious hepatotoxic events. Incidence figures are largely unknown, and in most cases a causal attribution is not established. The challenge for the future is to systematically research this area, educate all parties involved, and minimize patient risk.

Despite these warnings, progress is almost non-existent. If anything the problem seems to increase in proportion with the rise in the use of SCAM. Hence, one cannot but agree with the conclusion of a more recent overview: The actual incidence and prevalence of herb-induced liver injury in developing nations remain largely unknown due to both poor pharmacovigilance programs and non-application of emerging technologies. Improving education and public awareness of the potential risks of herbals and herbal products is desirable to ensure that suspected adverse effects are formally reported. There is need for stricter regulations and pre-clinical studies necessary for efficacy and safety.

“Eating elderberries can help minimise influenza symptoms.” This statement comes from a press release by the University of Sydney. As it turned out, the announcement was not just erroneous but it also had concealed that the in-vitro study that formed the basis for the press-release was part-funded by the very company, Pharmacare, which sells elderberry-based flu remedies.

“This is an appalling misrepresentation of this Pharmacare-funded in-vitro study,” said associate professor Ken Harvey, president of Friends of Science in Medicine. “It was inappropriate and misleading to imply from this study that an extract was ‘proven to fight flu’.” A University of Sydney spokeswoman confirmed Pharmacare was shown a copy of the press release before it was published.

This is an embarrassing turn of events, no doubt. But what about elderberry (Sambucus nigra) and the flu? Is there any evidence?

A systematic review quantified the effects of elderberry supplementation. Supplementation with elderberry was found to substantially reduce upper respiratory symptoms. The quantitative synthesis of the effects yielded a large mean effect size. The authors concluded that these findings present an alternative to antibiotic misuse for upper respiratory symptoms due to viral infections, and a potentially safer alternative to prescription drugs for routine cases of the common cold and influenza.

WHAT?!?!

The alternative to antibiotic misuse can only be the correct use of antibiotics. And, in the case of viral infections such as the flu, this can only be the non-use of antibiotics. My trust in this review, published in a SCAM journal of dubious repute, has instantly dropped to zero.

Perhaps a recent overview recently published in THE MEDICAL LETTER provides a more trustworthy picture:

No large randomized, controlled trials evaluating the effectiveness of elderberry for prevention or treatment of influenza have been conducted to date. Elderberry appears to have some activity against influenza virus strains in vitro. In two small studies (conducted outside the US), adults with influenza A or B virus infection taking elderberry extract reported a shorter duration of symptoms compared to those taking placebo. Consuming uncooked blue or black elderberries can cause nausea and vomiting. The rest of the plant (bark, stems, leaves, and root) contains sambunigrin, which can release cyanide. No data are available on the safety of elderberry use during pregnancy or while breastfeeding. CONCLUSION — Prompt treatment with an antiviral drug such as oseltamivir (Tamiflu, and generics) has been shown to be effective in large randomized, controlled trials in reducing the duration of influenza symptoms, and it may reduce the risk of influenza-related complications. There is no acceptable evidence to date that elderberry is effective for prevention or treatment of influenza and its safety is unclear.

Any take-home messages?

Yes:

  1. Elderberry supplements are not of proven effectiveness against the flu.
  2. The press officers at universities should be more cautious when writing press-releases.
  3. They should involve the scientists and avoid the sponsors of the research.
  4. In-vitro studies can never tell us anything about clinical effectiveness.
  5. SCAM-journals’ articles must be taken with a pinch of salt.
  6. Consumers are being misled left, right and centre.

Radix Salviae Miltiorrhizae (Danshen) is a herbal remedy that is part of many TCM herbal mixtures. Allegedly, Danshen has been used in clinical practice for over 2000 years.

But is it effective?

The aim of this systematic review was to evaluate the current available evidence of Danshen for the treatment of cancer. English and Chinese electronic databases were searched from PubMed, the Cochrane Library, EMBASE, and the China National Knowledge Infrastructure (CNKI), VIP database, Wanfang database until September 2018. The methodological quality of the included studies was evaluated by using the method of Cochrane system.

Thirteen RCTs with 1045 participants were identified. The studies investigated the lung cancer (n = 5), leukemia (n = 3), liver cancer (n = 3), breast or colon cancer (n = 1), and gastric cancer (n = 1). A total of 83 traditional Chinese medicines were used in all prescriptions and there were three different dosage forms. The meta-analysis suggested that Danshen formulae had a significant effect on RR (response rate) (OR 2.38, 95% CI 1.66-3.42), 1-year survival (OR 1.70 95% CI 1.22-2.36), 3-year survival (OR 2.78, 95% CI 1.62-4.78), and 5-year survival (OR 8.45, 95% CI 2.53-28.27).

The authors concluded that the current research results showed that Danshen formulae combined with chemotherapy for cancer treatment was better than conventional drug treatment plan alone.

I am getting a little tired of discussing systematic reviews of so-called alternative medicine (SCAM) that are little more than promotion, free of good science. But, because such articles do seriously endanger the life of many patients, I do nevertheless succumb occasionally. So here are a few points to explain why the conclusions of the Chinese authors are nonsense:

  • Even though the authors claim the trials included in their review were of high quality, most were, in fact, flimsy.
  • The trials used no less than 83 different herbal mixtures of dubious quality containing Danshen. It is therefore not possible to define which mixture worked and which did not.
  • There is no detailed discussion of the adverse effects and no mention of possible herb-drug interactions.
  • There seemed to be a sizable publication bias hidden in the data.
  • All the eligible studies were conducted in China, and we know that such trials are unreliable to say the least.
  • Only four articles were published in English which means those of us who cannot read Chinese are unable to check the correctness of the data extraction of the review authors.

I know it sounds terribly chauvinistic, but I do truly believe that we should simply ignore Chinese articles, if they have defects that set our alarm bells ringing – if not, we are likely to do a significant disservice to healthcare and progress.

Prince Charles is visiting Germany. According to the British press, he will say (or, by now, probably has said):

“… Our countries and our people have been through so much together… As we look towards the future, I can only hope that we can also pledge to redouble our commitment to each other and to the ties between us… For some of us, of course, these connections are particularly personal…

And right he is!

Charles is Britain’s staunchest supporter of and meddler in SCAM, while the Germans seem to be the most prolific innovators of SCAM.

Just think of

  • von Bingen, Hildegard – inventor of a form of herbal medicine;
  • Hahnemann, Samuel – inventor of homeopathy;
  • Hamer, Ryke Geerd – inventor of New German Medicine;
  • Huneke, Ferdinand – inventor of neural therapy;
  • Kneipp, Sebastian – co-inventor of naturopathy;
  • Mesmer, Anton – inventor of hypnotherapy;
  • Morlell, Franz – inventor of bioresonance;
  • Reckeweg, Hans -inventor of homotoxicology;
  • Schimmel, Helmut – co-inventor of the Vega test;
  • Schulz, Heinrich – inventor of autogenic training;
  • Steiner, Rudlof – inventor of anthroposophical medicine;
  • Voll, Reinhold – inventor of a form of electroacupuncture;
  • Wegman, Ita – co-inventor of anthroposophical medicine.

Why did I compile this list?

Actually, I am not quite sure. But now that it is in front of me, a few thoughts go through my mind:

  1. Germany seems to be the promised land for quacks; in addition to the list above, think of the Heilpraktiker or the German alternative cancer clinics.
  2. On this blog, we have discussed most of these SCAMs, yet the list gave me several ideas for future posts;
  3. With only three exceptions, these SCAMs are fairly recent. They were invented when conventional medicine was already making big strides towards progress. There was no need for them. Why then were they invented?
  4. Almost all of these treatments were the brainchild of a single person. Could this be a hallmark for quackery?
  5. With only two exceptions, the inventors were male. Is the innovation of SCAM a male prerogative?
  6. With just one or two exceptions, these SCAMs are ineffective, useless and superfluous. Not attributes, of course, that would link them to Charles!

 

Exactly 20 years ago, I published a review concluding that the generally high and possibly growing prevalence of complementary/alternative medicine use by children renders this topic an important candidate for rigorous investigation. Since then, many papers have emerged, and most of them are worrying in one way or another. Here is the latest one.

This Canadian survey assessed chiropractic (DC) and naturopathic doctors’ (ND) natural health product (NHP) recommendations for paediatric care. It was developed in collaboration with DC and ND educators, and delivered as an on-line national survey. NHP dose, form of delivery, and indications across paediatric age ranges (from newborn to 16 years) for each practitioner’s top five NHPs were assessed. Data were analysed using descriptive statistics, t-tests, and non-parametric tests.

Of the 421 respondents seeing one or more paediatric patients per week, 172 (41%, 107 DCs, 65 NDs) provided 440 NHP recommendations, categorized as:

  • vitamins and minerals (89 practitioners, 127 recommendations),
  • probiotics (110 practitioners, 110 recommendations),
  • essential fatty acids (EFAs: 72 practitioners, 72 recommendations),
  • homeopathics (56 practitioners, 66 recommendations),
  • botanicals (29 practitioners, 31 recommendations),
  • other NHPs (33 practitioners, 34 recommendations).

Indications for the NHP recommendations were tabulated for NHPs with 10 or more recommendations in any age category:

  • 596 total indications for probiotics,
  • 318 indications for essential fatty acids,
  • 138 indications for vitamin D,
  • 71 indications for multi-vitamins.

Good evidence regarding the efficacy, safety, and dosing for NHP use in children is scarce or even absent. Therefore, the finding that so many DCs and NDs recommend unproven NHPs for use in children is worrying, to say the least. It seems to indicate that, at least in Canada, DCs and NDs are peddling unproven, mostly useless  and potentially harmful children.

In an earlier, similar survey the same group of researchers had disclosed that the majority of Canadian DCs and NDs seem to see infants, children, and youth for a variety of health conditions and issues, while, according to their own admission, not having adequate paediatric training.

Is this a Canadian phenomenon? If you think so, read this abstract:

AIM:

This systematic review is aimed at estimating the prevalence of complementary and alternative medicine (CAM)-use by paediatric populations in the United Kingdom (UK).

METHOD:

AMED, CINAHL, COCHRANE, EMBASE and MEDLINE were searched for English language peer-reviewed surveys published between 01 January 2000 and September 2011. Additionally, relevant book chapters and our own departmental files were searched manually.

RESULTS:

Eleven surveys were included with a total of 17,631 paediatric patients. The majority were of poor methodological quality. Due to significant heterogeneity of the data, a formal meta-analysis was deemed inappropriate. Ten surveys related to CAM in general, while one was specifically on homeopathy. Across all surveys on CAM in general, the average one-year prevalence rate was 34% and the average lifetime prevalence was 42%. In surveys with a sample size of more than 500, the prevalence rates were considerably lower than in surveys with the sample size of lower than 500. Herbal medicine was the most popular CAM modality, followed by homeopathy and aromatherapy.

CONCLUSIONS:

Many paediatric patients in the UK seem to use CAM. Paediatricians should therefore have sufficient knowledge about CAM to issue responsible advice.

This means, I fear, that children are regularly treated by SCAM practitioners who are devoid of the medical competence to do so, and  who prescribe or recommend treatments of unknown value, usually without the children needing them.

Why are regulators not more concerned about this obvious abuse?

Fructus Psoraleae is the seed of Psoralea corylifolia Linn. It is the main ingredient of the herbal mixtures such as Qubaibabuqi, popular in China, India and other countries. It has been used for medicinal purposes for millennia. Thus many proponents would claim that it must be risk-free.

A recent case-report  suggests that it might not be as safe as often assumed.

A 53-year-old woman was diagnosed with vitiligo in September 2017 and was treated with oral Qubaibabuqi tablets (15 tablets three times daily; Xinjiang Yinduolan Uyghur Pharmaceutical Company Limited, Urumqi, China), 10 mg of prednisone acetate tablets (Xinhua Pharmaceutical Company Limited, Zibo, China) once daily, and narrowband-ultraviolet B (NB-UVB) phototherapy (Sigma household narrowband-ultraviolet phototherapy instrument [SS-01B] pocket portable; Shanghai Sigma High Technology Co., Ltd. Shanghai, China) every other day. The prednisone acetate tablets were self-discontinued 3 months later; however, she continued to take Qubaibabuqi tablets orally and NB-UVB phototherapy was undertaken at home.

After approximately 7 months of treatment, the patient developed a severe, diffuse yellow staining of the skin and sclera in March 2018. On admission, she was diagnosed with acute cholestatic hepatitis associated with Fructus Psoraleae. Despite receiving active treatment, her condition rapidly deteriorated and she died 5 days later due to acute liver failure and multiple organ dysfunction. There are 6 further reported cases of liver injury associated with Fructus Psoraleae described in the English language literature. Cases of acute liver failure associated with the use of Fructus Psoraleae have not been previously described.

The authors of the case-report concluded that as a main ingredient in the Qubaibabuqi tablet formula, Fructus Psoraleae has potential hepatotoxicity. This potentially fatal adverse effect should be considered when physicians prescribe Qubaibabuqi tablets.

Psoralea corylifolia Linn (also known as Bu-gu-zh, Bu Ku Zi, Bol-gol-zhee, Boh-Gol-Zhee, Babchi, and Bakuchi) is a plant grown in China, India, Sri Lanka, Burma, and other countries, which is considered an important herbal medicine. It is used in TCM to tonify the kidneys, particularly kidney yang and essence. It is used for helping the healing of bone fractures, for lower back and knee pain, impotence, bed wetting, hair loss, and vitiligo. A recent review named it as one of the main herbs causing liver problems (other herbs included Polygonum multiflorum, Corydalis yanhusuo, and Rheum officinale).

Another review found that Psoralea corylifolia has cardiotonic, vasodilator, pigmentor, antitumor, antibacterial, cytotoxic, and anti-helminthic properties. About one hundred bioactive compounds have been isolated from seeds and fruits; the most important ones belong to coumarins, flavonoids, and meroterpenes groups. Psoralea corylifolia is part of many Ayurvedic and Chinese herbal mixtures.

Despite of the popularity of Psoralea corylifolia in the treatment of a very wide range of conditions, and despite the pharmacological studies into its potential therapeutic uses, there is an almost complete void as to clinical trials testing its clinical effectiveness.

The case-report is a poignant and tragic reminder of the often-neglected fact that neither a long history of usage nor popularity of a (herbal) treatment are reliable indicators for safety.

The present trial evaluated the efficacy of homeopathic medicines of Melissa officinalis (MO), Phytolacca decandra (PD), and the combination of both in the treatment of possible sleep bruxism (SB) in children (grinding teeth during sleep).

Patients (n = 52) (6.62 ± 1.79 years old) were selected based on the parents report of SB. The study comprised a crossover design that included 4 phases of 30-day treatments (Placebo; MO 12c; PD 12c; and MO 12c + PD 12c), with a wash-out period of 15 days between treatments.

At baseline and after each phase, the Visual Analogic Scale (VAS) was used as the primary outcome measure to evaluate the influence of treatments on the reduction of SB. The following additional outcome measures were used: a children’s sleep diary with parent’s/guardian’s perceptions of their children’s sleep quality, the trait of anxiety scale (TAS) to identify changes in children’s anxiety profile, and side effects reports. Data were analyzed by ANOVA with repeated measures followed by Post Hoc LSD test.

Significant reduction of SB was observed in VAS after the use of Placebo (-1.72 ± 0.29), MO (-2.36 ± 0.36), PD (-1.44 ± 0.28) and MO + PD (-2.21 ± 0.30) compared to baseline (4.91 ± 1.87). MO showed better results compared to PD (p = 0.018) and Placebo (p = 0.050), and similar result compared to MO+PD (p = 0.724). The sleep diary results and TAS results were not influenced by any of the treatments. No side effects were observed after treatments.

The authors concluded that MO showed promising results in the treatment of possible sleep bruxism in children, while the association of PD did not improve MO results.

Even if one fully subscribed to the principles of homeopathy, this trial raises several questions:

  1. Why was it submitted and then published in the journal ‘Phytotherapy’. All the remedies were given as C12 potencies. This has nothing to do with phytomedicine.
  2. Why was a cross-over design chosen? According to homeopathic theory, a homeopathic treatment has fundamental, long-term effects which last much longer than the wash-out periods between treatment phases. This effectively rules out such a design as a means of testing homeopathy.
  3. MO is used in phytomedicine to induce sleep and reduce anxiety. According to the homeopathic ‘like cures like’ assumption, this would mean it ought to be used homeopathically to treat sleepiness or for keeping patients awake or for making them anxious. How can it be used for sleep bruxism?

Considering all this, I ask myself: should we trust this study and its findings?

What do you think?

“Most of the supplement market is bogus,” Paul Clayton*, a nutritional scientist, told the Observer. “It’s not a good model when you have businesses selling products they don’t understand and cannot be proven to be effective in clinical trials. It has encouraged the development of a lot of products that have no other value than placebo – not to knock placebo, but I want more than hype and hope.” So, Dr Clayton took a job advising Lyma, a product which is currently being promoted as “the world’s first super supplement” at £199 for a one-month’s supply.

Lyma is a dietary supplement that contains a multitude of ingredients all of which are well known and available in many other supplements costing only a fraction of Lyma. The ingredients include:

  • kreatinin,
  • turmeric,
  • Ashwagandha,
  • citicoline,
  • lycopene,
  • vitamin D3.

Apparently, these ingredients are manufactured in special (and patented) ways to optimise their bioavailabity. According to the website, the ingredients of LYMA have all been clinically trialled with proven efficacy at levels provided within the LYMA supplement… Unless the ingredient has been clinically trialled, and peer reviewed there may be limited (if any) benefit to the body. LYMA’s revolutionary formulation is the most advanced and proven super supplement in the world, bringing together eight outstanding ingredients – seven of which are patented – to support health, wellbeing and beauty. Each ingredient has been selected for its efficacy, purity, quality, bioavailability, stability and ultimately, on the results of clinical studies.

The therapeutic claims made for the product are numerous:

  • it will improve your hair, skin and nails (80% improvement in skin smoothness, 30% increase in skin moisture, 17% increase in skin elasticity, 12% reduction in wrinkle depth, 47% increase in hair strength & 35% decrease in hair loss)
  • it will support energy levels in both the body and the brain (increase in brain membrane turnover by 26% and increase brain energy by 14%),
  • it will improve cognitive function,
  • it will enhance endurance (cardiorespiratory endurance increased by 13% compared to a placebo),
  • it will improve quality of life,
  • it will improve sleep (reducing insomnia by 70%),
  • it will improve immunity,
  • it will reduce inflammation,
  • it will improve your memory,
  • it will improve osteoporosis (reduce risk of osteoporosis by 37%).

These claims are backed up by 197 clinical trials, we are being told.

If true, this would be truly sensational – but is it true?

I asked the Lyma firm for the 197 original studies, and they very kindly sent me dozens papers which all referred to the single ingredients listed above. I emailed again and asked whether there are any studies of Lyma with all its ingredients in one supplement. Then I was told that they are ‘looking into a trial on the final Lyma formula‘.

I take this to mean that not a single trial of Lyma has been conducted. In this case, how do we be sure the mixture works? How can we know that the 197 studies have not been cherry-picked? How can we be sure that there are no interactions between the active constituents?

The response from Lyma quoted the above-mentioned Dr Paul Clayton stating this: “In regard to LYMA, clinical trials at this stage are not necessary. The whole point of LYMA is that each ingredient has already been extensively trialled, and validated. They have selected the best of the best ingredients, and amalgamated them; to enable consumers to take them all in a convenient format. You can quite easily go out and purchase all the ingredients separately. They aren’t easy to find, and it would mean swallowing up to 12 tablets and capsules a day; but the choice is always yours.”

It’s kind, to leave the choice to us, rather than forcing us to spend £199 each month on the world’s first super-supplement. Very kind indeed!

Having the choice, I might think again.

I might even assemble the world’s maximally evidence-based, extra super-supplement myself, one that is supported by many more than 197 peer-reviewed papers. To not directly compete with Lyma, I could use entirely different ingredients. Perhaps I should take the following five:

  • Vitamin C (it has over 61 000 Medline listed articles to its name),
  • Vitanin E (it has over 42 000 Medline listed articles to its name),
  • Collagen (it has over 210 000 Medline listed articles to its name),
  • Coffee (it has over 14 000 Medline listed articles to its name),
  • Aloe vera (it has over 3 000 Medline listed articles to its name).

I could then claim that my extra super-supplement is supported by some 300 000 scientific articles plus 1 000 clinical studies (I am confident I could cherry-pick 1 000 positive trials from the 300 000 papers). Consequently, I would not just charge £199 but £999 for a month’s supply.

But this would be wrong, misleading, even bogus!!!, I hear you object.

On the one hand, I agree.

On the other hand, as Paul Clayton rightly pointed out: Most of the supplement market is bogus.

 

 

 

 

*If my memory serves me right, I met Paul many years ago when he was a consultant for Boots (if my memory fails me, I might need to order some Lyma).

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