Guest post by Jan Oude-Aost
ADHD is a common disorder among children. There are evidence based pharmacological treatments, the best known being methylphenidate (MPH). MPH has kind of a bad reputation, but is effective and reasonably safe. The market is also full of alternative treatments, pharmacological and others, some of them under investigation, some unproven and many disproven. So I was not surprised to find a study about Ginkgo biloba as a treatment for ADHD. I was surprised, however, to find this study in the German Journal of Child and Adolescent Psychiatry and Psychotherapy, officially published by the “German Society of Child and Adolescent Psychiatry and Psychotherapy“ (Deutsche Gesellschaft für Kinder- und Jugendpsychiatrie und Psychotherapie). The journal’s guidelines state that studies should provide new scientific results.
The study is called “Ginkgo biloba Extract EGb 761® in Children with ADHD“. EGb 761® is the key ingredient in “Tebonin®“, a herbal drug made by “Dr. Wilma Schwabe GmbH“. The abstract states:
“One possible treatment, at least for cognitive problems, might be the administration of Ginkgo biloba, though evidence is rare.This study tests the clinical efficacy of a Ginkgo biloba special extract (EGb 761®) (…) in children with ADHD (…).“
“Eine erfolgversprechende, bislang kaum untersuchte Möglichkeit zur Behandlung kognitiver Aspekte ist die Gabe von Ginkgo biloba. Ziel der vorliegenden Studie war die Prüfung klinischer Wirksamkeit (…) von Ginkgo biloba-Extrakt Egb 761® bei Kindern mit ADHS.“ (Taken from the English and German abstracts.)
The study sample (20!) was recruited among children who “did not tolerate or were unwilling“ to take MPH. The unwilling part struck me as problematic. There is likely a strong selection bias towards parents who are unwilling to give their children MPH. I guess it is not the children who are unwilling to take MPH, but the parents who are unwilling to administer it. At least some of these parents might be biased against MPH and might already favor CAMmodalities.
The authors state three main problems with “herbal therapy“ that require more empirical evidence: First of all the question of adverse reactions, which they claim occur in about 1% of cases with “some CAMs“ (mind you, not “herbal therapy“). Secondly, the question of drug interactions and thirdly, the lack of information physicians have about the CAMs their patients use.
A large part of the study is based on results of an EEG-protocol, which I choose to ignore, because the clinical results are too weak to give the EEG findings any clinical relevance.
Before looking at the study itself, let’s look at what is known about Ginkgo biloba as a drug. Ginkgo is best known for its use in patients with dementia, cognitive impairment und tinnitus. A Cochrane review from 2009 concluded:
“There is no convincing evidence that Ginkgo biloba is efficacious for dementia and cognitive impairment“ .
The authors of the current Study cite Sarris et al. (2011), a systematic review of complementary treatment of ADHD. Sarris et al. mention Salehi et al. (2010) who tested Ginkgo against MPH. MPH turned out to be much more effective than Ginkgo, but Sarris et al. argue that the duration of treatment (6 weeks) might have been too short to see the full effects of Ginkgo.
Given the above information it is unclear why Ginkgo is judged a “possible“ treatment, properly translated from German even “promising”, and why the authors state that Ginkgo has been “barely studied“.
In an unblinded, uncontrolled study with a sample likely to be biased toward the tested intervention, anything other than a positive result would be odd. In the treatment of autism there are several examples of implausible treatments that worked as long as parents knew that their children were getting the treatment, but didn’t after proper blinding (e.g. secretin).
This study’s aim was to test clinical efficacy, but the conclusion begins with how well tolerated Ginkgo was. The efficacy is mentioned subsequently: “Following administration, interrelated improvements on behavioral ratings of ADHD symptoms (…) were detected (…).“ But the way they where “detected“ is interesting. The authors used an established questionnaire (FBB-HKS) to let parents rate their children. Only the parents. The children and their teachers where not given the FBB-HKS-questionnaires, inspite of this being standard clinical practice (and inspite of giving children questionnaires to determine changes in quality of life, which were not found).
None of the three problems that the authors describe as important (adverse reactions, drug interactions, lack of information) can be answered by this study. I am no expert in statistics but it seems unlikely to me to meaningfully determine adverse effects in just 20 patients especially when adverse effects occur at a rate of 1%. The authors claim they found an incidence rate of 0,004% in “700 observation days“. Well, if they say so.
The authors conclude:
“Taken together, the current study provides some preliminary evidence that Ginkgo biloba Egb 761® seems to be well tolerated in the short term and may be a clinically useful treatment for children with ADHD. Double-blind randomized trials are required to clarify the value of the presented data.“
Given the available information mentioned earlier, one could have started with that conclusion and conducted a double blind RCT in the first place!
The trends of this preliminary open study may suggest that Ginkgo biloba Egb 761® might be considered as a complementary or alternative medicine for treating children with ADHD.“
So, why do I care? If preliminary evidence “may suggest“ that something “might be considered“ as a treatment? Because I think that this study does not answer any important questions or give us any new or useful knowledge. Following the journal’s guidelines, it should therefore not have been published. I also think it is an example of bad science. Bad not just because of the lack of critical thinking. It also adds to the misinformation about possible ADHD treatments spreading through the internet. The study was published in September. In November I found a website citing the study and calling it “clinical proof“ when it is not. But child psychiatrists will have to explain that to many parents, instead of talking about their children’s health.
I somehow got the impression that this study was more about marketing than about science. I wonder if Schwabe will help finance the necessary double-blind randomized trial… See more at: http://summaries.cochrane.org/CD003120/DEMENTIA_there-is-no-convincing-evidence-that-ginkgo-biloba-is-efficacious-for-dementia-and-cognitive-impairment#sthash.oqKFrSCC.dpuf
While the previous post was about seeing a traditional herbalist (who prescribe their own herbal mixtures, tailor-made for each individual patient), this post provides essential information for those consumers who are tempted to take a commercially available herbal remedy available in pharmacies, health food shops, over the Internet etc. These remedies are usually bought by consumers and then be self-administered, or (less frequently) they might be prescribed/recommended/sold by a clinician such as a doctor, naturopath, chiropractor etc. Typically, they contain just one (or relatively few) herbal extracts and are used under similar assumptions as conventional medicines: one (hopefully well-tested) remedy is employed for treating a defined condition, diagnosed according to validated and generally accepted criteria (for instance, St John’s Wort for depression or Devil’s claw for back pain). This approach is sometimes referred to as ‘rational phytotherapy’ – it is certainly more rational than the traditional herbalism referred to in my previous post. The manufacture, promotion and sale of commercial herbal remedies (in many countries marketed as ‘dietary supplements’) has grown into a multi-billion dollar industry.
Here are a few essentials you ought to know before you decide to take such an herbal remedy:
- Many people claim that herbal medicine is effective because many of our modern drugs are based on plants. The latter part of this claim is true, of course, but this does not necessarily mean that herbal remedies are effective. The drugs derived from plants contain one single, well-defined, extensively researched molecule (by definition, this makes them conventional drugs and not herbal remedies), while herbal remedies are based on entire (parts of) plants; thus they contain many pharmacologically active molecules. This often means that it is difficult or impossible to tell what dose of which ingredient is being administered and what pharmacological actions can be expected.
- Even though national regulations differ greatly, herbal remedies generally do not have to be supported by evidence for efficacy in order to be legally available. This means that a given remedy might or might not have been tested in clinical trials to determine whether it works for the condition advertised. In fact, only very few (less than 30, I estimate) herbal remedies are supported by sound evidence for efficacy; thousands do not meet this criterion.
- The extremely wide-spread notion that herbal remedies are by definition natural and therefore safe is nothing but a promotional myth. Plants contain many chemicals which can have pharmacological activity. This means they might be therapeutic, but it also means that they might be toxic (traditionally the most powerful poisons originated from the plant kingdom). If anyone uses the ‘natural = safe fallacy’ remind him/her of hemlock, poison ivy etc.
- In addition to potential toxicity of an herbal ingredient, there are other important safety issues to be considered. Most importantly, herbal remedies can interact with prescribed medicines. For instance, St John’s Wort (one of the best-studied herbal remedies in this respect) powerfully interacts with about 50% of all prescription drugs – in fact, it lowers their level in the blood which means that a patient on anti-coagulants would lose her anti-coagulant protection and might suffer from a (potentially fatal) blood clot.
- In many countries, including the US, the regulation of herbal remedies is so lax, that there is no guarantee that an herbal remedy which is being legally sold is safe. The regulators are only allowed to intervene once there are reports of adverse effects. This means that the burden of proof of safety is effectively reversed which obviously exposes consumers to incalculable risks.
- The quality of the herbal product is equally poorly regulated in most countries. A plethora of investigations in the US, for instance, has shown that the dose of the herbal ingredient printed on the label of a commercial product can range virtually from 0 – 100%. Similarly there is little safe-guard that the ingredients listed on the label correspond to the ones in the preparation. This means that it is worth purchasing not just well-researched herbal remedies but also those marketed by high quality manufacturers via respectable outlets.
- Any regulation of herbal remedies, even the European one that is often praised as protecting consumers adequately, is null and void once consumers go on the Internet and purchase their herbal remedies from one of the many dubious sources found there in truly alarming profusion. Bogus claims, inferior quality and even outright dangerous products abound, and it is often impossible to tell the acceptable from the fraudulent product.
Here I am not writing about herbal medicine in general – parts of which are supported by some encouraging evidence (I will therefore post more than one ‘seven things to remember…’ article on this subject) – here I am writing about the risks and benefits of consulting a traditional herbal practitioner. Herbalists come in numerous guises depending what tradition they belong to: Chinese herbalist, traditional European herbalist, Ayurvedic practitioner, Kampo practitioner etc. If you consult such a therapist, you should be aware of the following issues.
- Worldwide, the treatment by traditional herbal practitioners is by far the most common form of herbal medicine; it is more common than to use specific, well-tested herbs to treat specific conventionally diagnosed conditions (an approach that might best be called ‘rational phytotherapy’).
- Herbalists often use their very own diagnostic methods (think, for instance, of ‘tongue and pulse diagnoses’ used by Chinese herbalists) and reject (or are untrained to use) conventional diagnostic methods. The traditional diagnostic techniques of herbalists have either not been validated at all or they have been tested and found to be not valid.
- Herbalists usually do not recognise conventional disease categories. Instead they arrive at a diagnosis according to their specific philosophy which has no grounding in reality (for instance, energy imbalance in traditional Chinese herbalism).
- Herbalists individualise their treatments, meaning that 10 patients suffering from depression, for instance, might receive 10 different, tailor-made prescriptions according to their individual characteristics (and none of the 10 patients might receive St John’s Wort, the only herbal remedy that actually is proven to work for depression).
- Typically, such prescriptions contain not one herbal ingredient, but are mixtures of many – up to 10 or 20 – herbs or herbal extracts.
- Even though the efficacy of the individualised herbal approach can, of course, be tested in rigorous trials, and even though about a dozen such studies are available today, there is currently no good evidence to show that it is effective.
- The risk of harm through these individualised herbal mixtures can be considerable: the more ingredients, the higher the likelihood that one of them has toxic effects or that one interacts with a prescription medicine. Essentially, this means that there is no good evidence that individualised herbal treatments as used by so many herbal practitioners across the globe generates more good than harm.
If you have diabetes, chances are that you need life-long treatment. Before effective anti-diabetic medications became available, diabetes amounted to a death sentence. Fortunately, these times are long gone.
…unless, of course, you decide to listen to the promises of alternative practitioners many of whom offer a cure for diabetes. Here is just one website of hundreds that does just that. The following is an abbreviated quote where I have changed nothing, not even the numerous spelling mistakes:
Modern medicine has no permanent cure for diabetes but alternative medicines like yoga ,mudra,ayurveda is very useful to control and even cure diabetes.Ayurveda is an alternative medicine to cure diabetes.
Alternative medicine like ayurveda is a best to cure diabetes naturally.
A serious disorder of the glands,of pancreas to be exact,is diabetes,or madhumeha as described in ayurveda.It is one of the most insidious disorders of the metabolism and,if left undiagnosed or untreated,it may lead to rapid emaciation and ultimately death…
Ayurveda medicines to cure diabetes
In ayurveda the following medicines have been recommended for this disease
Shiljita ————————–240 mg
Nyagrodadhi churna ———3 gm
These should be given twice after meals with decoction of arni.
Vasantakusumakara rasa —120 mg
Shudha Shilajit ————–240 mg
Nag Bhasma —————–120 mg
Haldi ————————–500 mg
Amlaki Churna ————-500 mg
Twice daily with powder of rose-apple stones.Twice daily with honey.
Chadraprabha Vati ——– 500 mg
Mudra the alternative treatment to cure diabetes naturally
Mudra is a non medical and no cost treatment to cure diabetes.You can perform mudras at any time or any position.It is an effective way of treatment you can get better result if you practice it regularly .
It goes without saying that none of these treatments would cure diabetes. A Cochrane review concluded that there is insufficient evidence at present to recommend the use of these interventions in routine clinical practice. It also goes without saying that not many patients would fall for the nonsense proclaimed on this or so many other websites. But even just one single patient dying because of some charlatan promising a cure for life-threatening diseases is one patient too many.
I know, I have written about this guy before – and I am likely to do so again – he is just too outstanding to pass by!
A few days ago, he was in the headlines again: the Conservative health committee member David Tredinnick insisted that herbal medicine and even astrology should be given to patients in order to plug a growing hole in the NHS-budget: “I have referred to the fact that in some cultures astrology is part of healthcare because they need to have a voice and I’ve got up and said that,” he told Channel Four News. “But I also think we can reduce the bill by using a whole range of alternative medicine including herbal medicine, acupuncture, homeopathy…We could probably save five per cent of the [NHS] budget.”
Unbelievably, a man with such views is a member of the science and technology committee! This really does instil trust in politics!!!
His track record regarding the promotion of quackery might even dwarf that of Prince Charles; earlier this year he told MPs that astrology should be used to replace some “conventional” medicines on the NHS: “I am absolutely convinced that those who look at the map of the sky for the day that they were born and receive some professional guidance will find out a lot about themselves and it will make their lives easier,” he told the Commons. “I hope that in future we stop looking just at increasing the supply of drugs and consider the way that complementary and alternative medicine can reduce the demand for drugs, reduce pressures on the health service, increase patient satisfaction, and make everyone in this country happier.”
Speaking recently while thousands of NHS workers were on strike, he defended their pay freeze, stating that NHS’s budget was “finite”. However, asked whether he planned to take his own upcoming 9% pay rise, he refused to answer: “I’m not getting drawn on MPs pay… I’m not answering that question on this programme because we’re dealing with the health service.” Pushed further, he suggested that the rise was necessary in order to make MPs “good public servants… All members of parliament will be given a pay rise which is been set by an independent authority. Most of those members of parliament will take that pay rise because that is what is deemed necessary to have good public servants,” he insisted.
But is he really a “good public servant” ???
Addressing parliament about its ‘evidence check’ on homeopathy which came out squarely against it, Tredinnick once stated: “It is my belief that the advice the Clerks provided to the Science and Technology Committee Chairman was inadequate, in that the evidence taken by the Committee in its evidence check on homeopathy was biased, as they did not call representatives of the homeopathic profession and instead chose a professor who did not represent the alternative medicine world. They chose the one person who would give an answer that suited those who were in opposition.” The professor he refers to is Edzard Ernst, I think! When I was invited to give evidence to the committee, Tredinnick was in the audience; I saw him as we were waiting to go in and even had a chat with him. So, he must remember that sitting next to me were several defenders of homeopathy, amongst them the Queen’s homeopath himself.
Perhaps Tredinnick just forgot!
He couldn’t be lying, could he?
No, a good public servant wouldn’t do that!
Cardiovascular (and most other types of) patients frequently use herbal remedies in addition to their prescribed medicines. Can this behaviour create problems? Many experts think so.
The aim of a new study was to investigate the effect of herbal medicine use on medication adherence of cardiology patients. All patients admitted to the outpatient cardiology clinics, who had been prescribed at least one cardiovascular drug before, were asked to complete a questionnaire. Participants were asked if they have used any herbals during the past 12 months with an expectation of beneficial effect on health. Medication adherence was measured by using the Morisky Scale. High adherence was defined as a Morisky score lower than 2 and a score of 2 or more was seen as low adherence.
A total of 390 patients participated in this study; 29.7% of them had consumed herbals in the past 12 months. The median Morisky score was significantly higher in herbal users than non-users. The number of herbals used was moderately correlated with the Morisky score. In stepwise, multivariate logistic regression analysis, herbal use was significantly associated with low medication adherence.
From these findings, the authors conclude that herbal use was found to be independently associated with low medication adherence in our study population.
So far, the main known risk of herbal medicine use was the possibility that there might be herb-drug interactions. To the best of my knowledge, nobody has yet studied the possibility that herbal medicine users might neglect to take their prescribed drugs. The results of this investigation are somewhat worrying but they do make sense. Some patients who buy and take herbal remedies might think that they do not need to regularly take their prescribed medications because they already take herbal medicine which takes care of their health problem. They might even have been told by their herbalist that the herbal remedies suffice.
If that is so, and if the phenomenon can be confirmed in further investigations, it should be relevant not just in cardiology but in all fields of medicine. And if that is true for herbal remedies, it might also be the case for other types of alternative medicine. In other words, alternative medicine use might be a marker for poor adherence to prescribed medication. I feel that this hypothesis merits further study.
It goes without saying that poor adherence to prescribed drugs can be a very dangerous habit. Clinicians should therefore warn their patients and tell them that herbal remedies are no replacement of prescription drugs.
If you believe herbalists, the Daily Mail or similarly reliable sources, you come to the conclusion that herbal medicines are entirely safe – after all they are natural, and everything that is natural must be safe. However, there is plenty of evidence that these assumptions are not necessarily correct. In fact, herbal medicines can cause harm in diverse ways, e. g. because:
- one or more ingredients of a plant are toxic,
- they interact with prescribed drugs,
- they are contaminated, for instance, with heavy metals,
- they are adulterated with prescription drugs.
There is no shortage of evidence for any of these 4 scenarios. Here are some very recent and relevant publications:
German authors reviewed recent case reports and case series that provided evidence for herbal hepatotoxicity caused by Chinese herbal mixtures. The implicated remedies were the TCM products Ban Tu Wan, Chai Hu, Du Huo, Huang Qin, Jia Wei Xia Yao San, Jiguja, Kamishoyosan, Long Dan Xie Gan Tang, Lu Cha, Polygonum multiflorum products, Shan Chi, ‘White flood’ containing the herbal TCM Wu Zhu Yu and Qian Ceng Ta, and Xiao Chai Hu Tang. the authors concluded that stringent evaluation of the risk/benefit ratio is essential to protect traditional Chinese medicines users from health hazards including liver injury.
A recent review of Nigerian anti-diabetic herbal remedies suggested hypoglycemic effect of over 100 plants. One-third of them have been studied for their mechanism of action, while isolation of the bioactive constituent(s) has been accomplished for 23 plants. Several plants showed specific organ toxicity, mostly nephrotoxic or hepatotoxic, with direct effects on the levels of some liver function enzymes. Twenty-eight plants have been identified as in vitro modulators of P-glycoprotein and/or one or more of the cytochrome P450 enzymes, while eleven plants altered the levels of phase 2 metabolic enzymes, chiefly glutathione, with the potential to alter the pharmacokinetics of co-administered drugs
US authors published a case of a 44-year-old female who developed subacute liver injury demonstrated on a CT scan and liver biopsy within a month of using black cohosh to resolve her hot flashes. Since the patient was not taking any other drugs, they concluded that the acute liver injury was caused by the use of black cohosh. The authors concluded: we agree with the United States Pharmacopeia recommendations that a cautionary warning about hepatotoxicity should be labeled on the drug package.
Hong Kong toxicologists recently reported five cases of poisoning occurring as a result of inappropriate use of herbs in recipes or general herbal formulae acquired from books. Aconite poisoning due to overdose or inadequate processing accounted for three cases. The other two cases involved the use of herbs containing Strychnos alkaloids and Sophora alkaloids. These cases demonstrated that inappropriate use of Chinese medicine can result in major morbidity, and herbal formulae and recipes containing herbs available in general publications are not always safe.
Finally, Australian emergency doctors just published this case-report: A woman aged 34 years presented to hospital with a history of progressive shortness of breath, palpitations, decreased exercise tolerance and generalised arthralgia over the previous month. A full blood count revealed normochromic normocytic anaemia and a haemoglobin level of 66 g/L. The blood film showed basophilic stippling, prompting measurement of lead levels. Her blood lead level (BLL) was 105 µg/dL. Mercury and arsenic levels were also detected at very low levels. On further questioning, the patient reported that in the past 6 months she had ingested multiple herbal preparations supplied by an overseas Ayurvedic practitioner for enhancement of fertility. She was taking up to 12 different tablets and various pastes and powders daily. Her case was reported to public health authorities and the herbal preparations were sent for analytical testing. Analysis confirmed high levels of lead (4% w/w), mercury (12% w/w), arsenic and chromium. The lead levels were 4000 times the maximum allowable lead level in medications sold or produced in Australia. Following cessation of the herbal preparations, the patient was commenced on oral chelation therapy, iron supplementation and contraception. A 3-week course of oral DMSA (2,3-dimercaptosuccinic acid) was well tolerated; BLL was reduced to 13 µg/dL and haemoglobin increased to 99 g/L. Her symptoms improved over the subsequent 3 months and she remains hopeful about becoming pregnant.
So, how safe are herbal medicines? Unfortunately, the question is unanswerable. Some herbal medicines are quite safe, others are not. But always remember: whenever you administer a treatment you should ask yourself one absolutely crucial question: do the documented benefits outweigh the risks? There are several thousand different herbal medicines, and for less than a dozen of them can the honest answer to this question be YES.
One alternative therapy that I have so far almost entirely neglected is Ayurveda. It is said to be one of the fastest growing system within this sector. Ayurvedic healing includes herbs, nutrition, panchakarma cleansing, acupressure massage, Yoga, Sanskrit, and Jyotish (Vedic astrology). The website of the ‘Choppra Center’ explains: Recognizing that human beings are part of nature, Ayurveda describes three fundamental energies that govern our inner and outer environments: movement, transformation, and structure. Known in Sanskrit as Vata (Wind), Pitta (Fire), and Kapha (Earth), these primary forces are responsible for the characteristics of our mind and body. Each of us has a unique proportion of these three forces that shapes our nature. If Vata is dominant in our system, we tend to be thin, light, enthusiastic, energetic, and changeable. If Pitta predominates in our nature, we tend to be intense, intelligent, and goal-oriented and we have a strong appetite for life. When Kapha prevails, we tend to be easy-going, methodical, and nurturing. Although each of us has all three forces, most people have one or two elements that predominate.
However, the evidence for its effectiveness is not overwhelming. In 2007, we published a systematic review of Ayurvedic treatments for rheumatoid arthritis (RA). Seven studies met our inclusion criteria. Trials tested either Ayurvedic medicine against placebo or other Ayurvedic medicines. Of 3 placebo-controlled RCTs, one high-quality trial did not show benefit of the active treatment against placebo, while another incompletely reported study indicated beneficial effects of an Ayurvedic medicine. A further incompletely reported study showed no significant difference. The remaining 4 trials were difficult to interpret because they tested an Ayurvedic medicine against other Ayurvedic medicines whose effects were not proven. We concluded that there is a paucity of RCTs of Ayurvedic medicines for RA. The existing RCTs fail to show convincingly that such treatments are effective therapeutic options for RA.
Because of this paucity of reliable evidence, any new assessments are welcome.
The aim of this article was to review and meta-analyze the effectiveness and safety of different Ayurvedic interventions in patients with osteoarthritis (OA). 138 electronic databases were searched through August 2013. Randomized controlled trials, randomized crossover studies, cluster-randomized trials, and non-randomized controlled clinical trials were eligible. Adults with pre-diagnosed OA were included as participants.
Interventions were included as Ayurvedic, if they were explicitly labeled as such. The main outcome measures were pain, physical function, and global improvement. Risk of bias was assessed using the Cochrane risk of bias tool.
19 randomized and 14 non-randomized controlled trials on 12 different drugs and 3 non-pharmaceutical interventions with a total of 2,952 patients were included. For the compound preparation, Rumalaya, large and apparently unbiased effects beyond placebo were found for pain (standardized mean difference [SMD] -3.73; 95 % confidence interval [CI] -4.97, -2.50; P < 0.01) and global improvement (risk ratio 12.20; 95 % CI 5.83, 25.54; P < 0.01).
There was also some evidence that effects of the herbal compound preparation Shunti-Guduchi are comparable to those of glucosamine for pain (SMD 0.08; 95 % CI -0.20, 0.36; P = 0.56) and function (SMD 0.15; 95 % CI -0.12, 0.36; P = 0.41).
Based on single trials, positive effects were found for the compound preparations RA-11, Reosto, and Siriraj Wattana. For Boswellia serrata, Lepidium Sativum, a Boswellia serrata containing multicomponent formulation and the compounds Nirgundi Taila, Panchatikta Ghrita Guggulu, and Rhumayog, and for non-pharmacological interventions like Ayurvedic massage, steam therapy, and enema, no evidence for significant effects against potential methodological bias was found.
No severe adverse events were observed in any of the trials.
The authors concluded that the drugs Rumalaya and Shunti-Guduchi seem to be safe and effective drugs for treatment of OA-patients, based on these data. However, several limitations relate to clinical research on Ayurveda. Well-planned, well-conducted and well-published trials are warranted to improve the evidence for Ayurvedic interventions.
I am, of course, pleased that other too have noticed the paucity of good evidence and recommend more and better research into this area. There are, however, several things that worry me about this systematic review:
- How can there be a total absence of adverse effects? Even placebos would generate some.
- The conclusion that Rumalaya and Shunti-Guduchi are safe does not seem justified on the basis of just a few trials.
- My own review found quite encouraging effects for Boswellia serrate.
- 138 electronic databases? I did not even know that so many existed!
- I am also concerned by the way the treatments found to be ‘safe and effective’ are being promoted on the internet:
Rumalaya is a phytopharmaceutical formulation that relieves joint and bone ache associated with various orthopedic ailments. Its natural ingredients possess potent anti-inflammatory properties that alleviate pain. As an immunomodulator, Rumalaya modulates both the humoral and cell-mediated immune response to aches and pain. The medicine has strong anti-arthritic properties that work to combat arthritis.
- Rheumatic arthritis
- Rheumatoid arthritis
- Cervical and lumbar spondylosis
- Frozen shoulder
- Traumatic inflammatory conditions like fibrositis, bursitis, synovitis, capsulitis, tenosynovitis, myositis and sciatica.
I fail to see good evidence to support most of these claims.
Lastly, I find that the authors fail to warn the public in sufficiently strong terms of some of the drawbacks of Ayurvedic medicines. Many of them seem not to be safe. One of several problems is that they have been shown to be often contaminated/adulterated with toxic substances such as heavy metals.
My conclusion about the value of Ayurvedic medicines is therefore not so optimistic: EFFICACY IS USUALLY MORE THAN DOUBTFUL, WHILE RISKS ARE WELL-DOCUMENTED.
‘Red ginseng’ is an herbal medicine prepared by steaming raw ginseng. This process is believed to increase its pharmacological activity. Further conversion through fermentation is thought to increase its intestinal absorption and bioactivity to diminish its toxicity.
Red ginseng (RG) is traditionally used for diabetes. Our own systematic review of 4 RCTs concluded that the evidence for the effectiveness of RG in controlling glucose in type 2 diabetes is not convincing. Few included studies with various treatment regimens prohibit definitive conclusions. More rigorous studies are needed to clarify the effects of RG on this condition.
Now a new RCT has become available. This study was conducted to investigate the effects of daily supplementation with fermented red ginseng (FRG) on blood sugar levels in subjects with impaired fasting glucose or type 2 diabetes. It was a four-week long, randomized, double-blind, placebo-controlled trial. Forty-two subjects with impaired fasting glucose or type 2 diabetes were randomly allocated to two groups assigned to consume either placebo or FRG three times per day for 4 weeks. Fasting and postprandial glucose profiles during meal tolerance tests were assessed before and after the intervention.
Compared to the placebo, FRG supplementation led to a significant reduction in postprandial glucose levels and to an increase in postprandial insulin levels. There also was a significant improvement in the area under the curve (AUC) in the FRG group. However, fasting glucose, insulin, and lipid profiles did not differ from the placebo group.
The authors of this trial concluded that daily supplementation with FRG lowered postprandial glucose levels in subjects with impaired fasting glucose or type 2 diabetes.
What should we make of these findings? Do they indicate that FRG might be an alternative to conventional anti-diabetic drugs? I would caution that we have tons of data for the latter, while we know far too little about FRG to recommend it for routine use.
On the contrary, the findings could suggest that diabetic patients who are well-controlled with diet or anti-diabetic medication should be avoiding ginseng products. If they actually work, they might significantly interfere with their metabolic control which, in turn, could even endanger their lives.
On this blog, I have repeatedly stressed that there is reasonably good evidence to show that some herbal medicines are effective. The one that is probably supported with better evidence than any other is St. John’s wort (SJW). The first systematic review of SJW was published in 1995 and concluded that SJW is an effective symptomatic treatment for various forms of depressions. Meanwhile, many more trials have become available, and the current Cochrane review concludes that the available evidence suggests that the hypericum extracts tested in the included trials a) are superior to placebo in patients with major depression; b) are similarly effective as standard antidepressants; c) and have fewer side effects than standard antidepressants.
This must be good news for many patients; particularly the fact that SJW is much safer than synthetic antidepressants seems attractive. But don’t be fooled – SJW may still cause harm. If taken on its own, it is almost as safe as placebo, but when it is combined with other drugs, it can powerfully interact and significantly lower the plasma level of a wide range of prescription medicines.
Some proponents of alternative medicine have suggested that this caution is alar@BocktheRobber mist, and they insist that, actually, the danger is minimal. Are they correct? We need data, I think, not opinion.
A new article provides new insights.
The objective of this study was to assess how often SJW is prescribed with medications that may interact dangerously with it. The researchers conducted a retrospective analysis of nationally representative data from the National Ambulatory Medical Care Survey. The study setting was U.S. non-federal outpatient physician offices. Patients who were prescribed SJW between 1993 and 2010 were the subjects. The outcome measures were medications co-prescribed with SJW.
Twenty-eight percent of SJW visits involved a drug that has potentially dangerous interaction with SJW. These included selective serotonin reuptake inhibitors, benzodiazepines, warfarin, statins, verapamil, digoxin, and oral contraceptives.
The authors concluded that SJW is frequently used in potentially dangerous combinations. Physicians should be aware of these common interactions and warn patients appropriately.
There is little to add – perhaps just this: the awareness of physicians is undoubtedly desirable, but it is not enough; as SJW and other herbal medicines are usually self-prescribed, consumers’ awareness of the risks associated with herbal medicines is at least as important, I think.