Most diabetics need life-long medication. Understandably, this makes many fed-up, and some think that perhaps natural remedies might be a less harmful, less intrusive way to control their condition. They don’t have to look far to find an impressively large choice.
This article in the Canadian Journal of Diabetes was aimed at reviewing CAM, including natural health products (NHP) and others, such as yoga, acupuncture, tai chi and reflexology, that have been studied for the prevention and treatment of diabetes and its complications. It claims that, in adults with type 2 diabetes, the following NHP have been shown to lower glycated hemoglobin (A1C) by at least 0.5% in randomized controlled trials lasting at least 3 months:
Ayurveda polyherbal formulation
Ginger (Zingiber officinale)
Lichen genus Cladonia BAFS “Yagel-Detox”
Marine collagen peptides
Nettle (Urtica dioica)
Oral aloe vera
Pterocarpus marsupium (vijayasar)
Scoparia dulcis porridge
Soybean-derived pinitol extract
Touchi soybean extract
Traditional Chinese medicine herbs:
Gegen Qinlian Decoction (GQD)
Jianyutangkang (JYTK) with metformin
Jinlida with metformin
Shen-Qi-Formula (SQF) with insulin
Xiaoke (contains glyburide)
Trigonella foenum-graecum (fenugreek)
Even though the authors caution that these remedies should not be recommended for routine use, I fear that such lists do motivate diabetics to give them a try. If they do, the outcome could be that:
- Nothing at all happens other than the patient wasting some money on useless remedies. The clinical trials on which the above list is based are usually so flimsy that their findings are next to meaningless and quite possibly false-positive.
- The patient might, if the remedy does affect blood sugar levels, develop hypoglycaemia. If severe, this could be life-threatening.
- The patient might trust in a natural remedy and thus discontinue the prescribed anti-diabetic medication. In this case, she could develop hyperglycaemia. If severe, this could be life-threatening.
It seems obvious that none of the possible outcomes are in the patients’ interest. I fear that it is dangerous to tempt diabetics with the possibility that a natural remedy. Even if such treatments did work, they are not well-researched, unreliable and do not have sufficiently large effects (a 0.5% decrease of glycated haemoglobin is hardly impressive) to represent realistic options.
An article in yesterday’ Times makes the surprising claim that ‘doctors turn to herbal cures when the drugs don’t work’. As the subject is undoubtedly relevant to this blog and as the Times is a highly respected newspaper, I think this might be important and will therefore comment (in normal print) on the full text of the article (in bold print):
GPs are increasingly dissatisfied with doling out pills that do not work for illnesses with social and emotional roots, and a surprising number of them end up turning to alternative medicine.
What a sentence! I would have thought that GPs have always been ‘dissatisfied’ with treatments that are ineffective. But who says they turn to alternative medicine in ‘surprising numbers’ (our own survey does not confirm the notion)? And what is a ‘surprising number’ anyway (zero would be surprising, in my view)?
Charlotte Mendes da Costa is unusual in being both an NHS GP and a registered homeopath. Her frustration with the conventional approach of matching a medicine to a symptom is growing as doctors increasingly see the limits, and the risks, of such a tactic.
Do we get the impression that THE TIMES does not know that homeopathy is not herbal medicine? Do they know that ‘matching a medicine to a symptom’ is what homeopaths believe they are doing? Real doctors try to find the cause of a symptom and, whenever possible, treat it.
She asks patients with sore throats questions that few other GPs pose: “What side is it? Is it easier to swallow solids or liquids? What time of day is it worst?” Dr Mendes da Costa is trying to find out which homeopathic remedy to prescribe. But when NHS guidance for sore throats aims mainly to convince patients that they will get better on their own, her questions are just as important as her prescription.
This section makes no sense. Sore throats do get better on their own, that’s a fact. And empathy is not a monopoly of homeopaths. But Dr Mendes Da Costa might be somewhat detached from reality; she once promoted the nonsensical notion that “up to the end of 2010, 156 randomised controlled trials (RCTs) in homeopathy had been carried out with 41% reporting positive effects, whereas only 7% have been negative. The remainder were non-conclusive.” (see more on this particular issue here)
“It’s very difficult to disentangle the effect of listening to someone properly, in a non-judgmental way, and taking a real rather than a superficial interest,” she says. “With a sore throat [I was trained] really only to be interested in, ‘Do they need antibiotics or not?’ ”
In this case, she should ask her money back; her medical school seems to have been rubbish in training her adequately.
This week a Lancet series on back pain said that millions of patients were getting treatments that did them no good. A government review is looking into how one in 11 people has come to be on potentially addictive drugs such as tranquillisers, opioid painkillers and antidepressants.
Yes, and how is that an argument for homeopathy? It isn’t! It seems to come from the textbook of fallacies.
And this week a BMJ Open study found that GPs with alternative training prescribed a fifth fewer antibiotics.
That study was akin to showing that butchers sell less vegetables than green-grocers. It provided no argument at all for implying that homeopathy is a valuable therapy.
Doctors seem receptive to alternative approaches: in a poll on its website 70 per cent agreed that doctors should recommend acupuncture to patients in pain. The Faculty of Homeopathy now counts 400 doctors among its 700 healthcare professional members.
Wow! Does the Times journalist know that the ‘Faculty of Homeopathy’ is primarily an organisation for doctor homeopaths? If so, why are these figures anything to write home about? And does the author appreciate that the pole was open not just to doctors but to to anyone (particularly those who were motivated, like acupuncturists)?
This horrifies many academics, who say that there is almost no evidence that complementary therapies work.
It horrifies nobody, I’d say. It puzzles some people, and not just academics. And their claim of a lack of sound evidence is evidence-based.
“It’s a false battle”, says Michael Dixon, a GP who chairs the College of Medicine, which is trying to broaden the focus on treatment to patients’ whole lives. “GPs are practical. If a patient gets better that’s all that matters.”
Dr Dixon says there are enormous areas of illness ranging from chronic pain to irritable bowels where few conventional treatments have been shown to be particularly effective, so why not try alternatives with fewer side effects?
Unable to diagnose and treat adequately, let’s all do the next worst thing and apply some outright quackery?!? Logic does not seem to be Dixon’s strong point, does it?
He recommends herbal remedies such as pelargonium — “like a geranium, quite a pretty little flower” — acupressure, and techniques such as self-hypnosis. To those who say these are placebos he replies: so what?
So what indeed! There are over 200 species of pelargonium; only 2 or 3 of them are used in herbal medicine. I don’t suppose Dr Dixon wants to poison us?
“Aromatherapy does work, but only if you believe in it, that’s the way you have to look at it, like a mother kissing knees better.” He continues: “We are healers. That’s what we do as doctors. You can call it theatrical or you can call it a relationship. A lot of patients come in with a metaphor — a headache is actually unhappiness — and the treatment is symbolic.”
It frightens me to know that there are doctors out there who think like this!
What if a patient is seriously ill?
A cancer is a metaphor for what exactly?
As doctors, we have the ethical duty to apply BOTH the science and the art of medicine, BOTH efficacious, evidence-based therapies AND compassion. Can I be so bold as to recommend our book about the ethics of alternative medicine to Dixon?
Such talk makes conventional doctors very nervous. Yet acupuncture illustrates their dilemma. It used to be recommended by the NHS for back pain because patients did improve. Now it is not, after further evidence suggested that patients given placebo “sham acupuncture” did just as well.
No, acupuncture used to be recommended by NICE because there was some evidence; when subsequently more rigorous trials emerged showing that it does NOT work, NICE stopped recommending it. Real medicine develops – it’s only alternative medicine and its proponents that seem to be stuck in the past and resist progress.
Martin Underwood, of the University of Warwick, asks: “So are you going to say, ‘Well, patients get better than they would do otherwise’? Or say it’s all theatrical placebo because it shows no benefit over sham treatment? That’s the question for society.”
Society has long answered it! The answer is called evidence-based medicine. We are not content using quackery for its placebo response; we know that effective treatments do that too, and we want to make progress and improve healthcare of tomorrow.
Although many doctors agree that they need to look at patients more broadly, they insist they do not need to turn to unproven treatments. The magic ingredient, they say, is not an alternative remedy, but time. Helen Stokes-Lampard, chairwoman of the Royal College of GPs, said: “Practices which offer alternative therapies tend to spend longer with patients . . . allowing for more in-depth conversations.”
I am sorry, if this post turned into a bit of a lengthy rant. But it was needed, I think: if there ever was a poorly written, ill focussed, badly researched and badly argued article on alternative medicine, it must be this one.
Did I call the Times a highly respected paper?
I take it back.
At least this is what the authors of this new study want us to believe.
But are they right?
This RCT is entitled ‘Efficacy and tolerability of a complex homeopathic drug in children suffering from dry cough-A double-blind, placebo- controlled, clinical trial’. It recruited children suffering from acute dry cough to assess the efficacy and tolerability of a complex homeopathic remedy in liquid form (Drosera, Coccus cacti, Cuprum Sulfuricum, Ipecacuanha = Monapax syrup, short: verum).
The authors stated that “preparations of Drosera, Coccus cacti, Cuprum sulfuricum, and Ipecacuanha are well-known antitussives in homeopathic medicine. Each of them is connected with special subtypes of cough. Drosera is intended for inflammations of the respiratory tract, especially for whooping cough. Coccus cacti is intended for inflammations of the nasopharyngeal space and the respiratory tract. Cuprum sulfuricum is intended for spasmodic coughing at night. Ipecacuanha is intended for bronchitis, bronchial asthma, and whooping cough. The complex homeopathic drug explored in this trial consists of all four of these active substances.”
According to the authors of the paper, “the primary objective of the trial was to demonstrate the superiority of verum compared to the placebo”.
A total of 89 children, enrolled in the Ukraine between 15/04/2008 and 26/05/2008 in 9 trial centres, received verum and 91 received placebo daily for 7 days (age groups 0.5–3, 4–7 and 8–12 years). The trial was conducted using an adaptive 3-stage group sequential design with possible sample size adjustments after the two planned interim analyses. The inverse normal method of combining the p-values from all three stages was used for confirmatory hypothesis testing at the interim analyses as well as at the final analysis. The primary efficacy variable was the improvement of the Cough Assessment Score. Tolerability and compliance were also assessed. A confirmatory statistical analysis was performed for the primary efficacy variable and a descriptive analysis for the secondary parameters.
A total of 180 patients (89 in the verum and 91 in the placebo group) evaluable according to the intention-to-treat principle were included in the trial. The Cough Assessment Score showed an improvement of 5.2 ± 2.6 points for children treated with verum and 3.2 ± 2.6 points in the placebo group (p < 0.0001). The difference of the least square means of the improvements was 1.9 ± 0.4. The effect size of Cohen´s d was d = 0.77. In all secondary parameters the patients in the verum group showed higher rates of improvement and remission than those in the placebo group. In 15 patients (verum: n = 6; placebo: n = 9) 18 adverse drug reactions of mild or moderate intensity were observed.
The authors concluded that the administering verum resulted in a statistically significantly greater improvement of the Cough Assessment Score than the placebo. The tolerability was good and not inferior to that of the placebo.
This study seems fairly rigorous. What is more, it has been published in a mainstream journal of reasonably high standing. So, how can its results be positive? We all know that homeopathy does not work, don’t we?
Are we perhaps mistaken?
Are highly diluted homeopathic remedies effective after all?
I don’t think so.
Let me explain to you a few points that raise my suspicions about this study:
- It was conducted 10 years ago; why did it take that long to get it published?
- I don’t think highly of a study with “the primary objective … to demonstrate the superiority” of the experimental interventions. Scientists use RCTs for testing efficacy and pseudo-scientist use it for demonstrating it, I think.
- The study was conducted in the Ukraine in 9 centres, yet no Ukrainian is an author of the paper, and there is not even an acknowledgement of these primary investigators.
- The ‘adaptive 3-stage group sequential design with possible sample size adjustments’ sounds very odd to me, but I may be wrong; I am not a statistician.
- We learn that 180 patients were evaluated, but not how many were entered into the trial?
- The Cough Assessment Score is not a validated outcome measure.
- Was the verum distinguishable from the placebo? It would be easy to test whether the patients/parents were truly blinded. Yet no such results were included.
- The trial was funded by the manufacturer of the homeopathic remedy.
- The paper has three authors 1)Hans W. Voß has no conflict of interest to declare. 2) Rainer Brünjes is employed at Cassella-med, the marketing authorisation holder of the study product. 3) Andreas Michalsen has consulted for Cassella-med and participated in advisory boards.
I know, homeopathy fans will think I am nit-picking; and perhaps they are correct. So, let me tell you why I really do strongly reject the notion that this study shows or even suggests that highly diluted homeopathic remedies are more than placebos.
The remedy used in this study is composed of Drosera 0,02 g, Hedera helix Ø 0,04 g, China D1 0,02 g, Coccus cacti D1 0,04 g, Cuprum sulfuricum D4 2,0 g, Ipecacuanha D4 2,0 g, Hyoscyamus D4 2,0 g.
In case you don’t know what ‘Ø’ stands for (I don’t blame you, hardly anyone outside the world of homeopathy does), it signifies a ‘mother tincture’, i. e. an undiluted herbal extract; and ‘D1’ signifies diluted 1:10. This means that the remedy may be homeopathic from a regulatory point of view, but for all intents and purposes it is a herbal medicine. It contains an uncounted amount of active compounds, and it is therefore hardly surprising that it might have pharmacological effects. In turn, this means that this trial does by no means overturn the fact that highly diluted homeopathic remedies are pure placebos.
It’s a pity, I find, that the authors of the paper fail to explain this simple fact in full detail – might one think that they intentionally aimed at misleading us?
“In my medical practice, writes Sheila Patel, M.D. on the website of Deepak Chopra, I always take into consideration the underlying dosha of a patient, or what their main imbalance is, when choosing treatments out of the many options available. For example, if I see someone who has the symptoms of hypertension as well as a Kapha imbalance, I may prescribe a diuretic, since excess water is more likely to be a contributing factor. I would also encourage more exercise or physical activity, since lack of movement is often a causative factor for these individuals. However, in a Vata-type person with hypertension, a diuretic may actually cause harm, as the Vata system tends to have too much dryness (air and space). I’ve observed that Vatas often have more side effects and electrolyte imbalances due to the diuretic medication. For these individuals, a beta-blocker may be a better choice, as this “slows” down the excitatory pathways in the body. In addition, I recommend meditation and calming activities to settle the excess energy as an adjunct to (or at times, instead of) the medicine. Alternatively, for someone with hypertension who is predominantly a Pitta type or who has a Pitta imbalance, I may choose a calcium-channel blocker, as this medication may be more beneficial in regulating the process of “energy exchange” in the body, which is represented by the fire element of Pitta. This is just one example of the way in which we can tailor our choice of medication to best suit the individual.
“In contrast with conventional medicine, which until very recently has assumed that a given disorder or disease is the same in all people, Ayurveda places great importance on recognizing the unique qualities of individual human beings. Ayurveda’s understanding of constitutional types or doshas offers us a remarkably accurate way to pinpoint what is happening inside each individual, allowing us to customize treatment and offer specific lifestyle recommendations to prevent disease and promote health and longevity. Keeping the doshas balanced is one of the most important factors in keeping the whole mind-body system in balance. When our mind-body system is in balance and we are connecting to our inner wisdom and intelligence, then we are most able to realize our full human potential and achieve our optimal state of being…”
END OF QUOTE
From such texts, some might conclude that Ayurvedic medicine is gentle and kind (personally, I am much more inclined to feel that Ayurvedic medicine is full of BS). This may be true or not, but Ayurvedic medicines are certainly anything but gentle and kind. In fact, they can be positively dangerous. I have repeatedly blogged about their risks, in particular the risk of heavy metal poisoning (see here, here, and here, for instance).
My 2002 systematic review summarised the evidence available at the time and concluded that heavy metals, particularly lead, have been a regular constituent of traditional Indian remedies. This has repeatedly caused serious harm to patients taking such remedies. The incidence of heavy metal contamination is not known, but one study shows that 64% of samples collected in India contained significant amounts of lead (64% mercury, 41% arsenic and 9% cadmium). These findings should alert us to the possibility of heavy metal content in traditional Indian remedies and motivate us to consider means of protecting consumers from such risks.
Meanwhile, new data have emerged and a new article with important information has recently been published by authors from the Department of Occupational and Environmental Health , College of Public Health, The University of Iowa and the State Hygienic Laboratory at the University of Iowa, USA. They present an analysis based on reports of toxic metals content of Ayurvedic products obtained during an investigation of lead poisoning among users of Ayurvedic medicine. Samples of Ayurvedic formulations were analysed for metals and metalloids following established US. Environmental Protection Agency methods. Lead was found in 65% of 252 Ayurvedic medicine samples with mercury and arsenic found in 38 and 32% of samples, respectively. Almost half of samples containing mercury, 36% of samples containing lead, and 39% of samples containing arsenic had concentrations of those metals per pill that exceeded, up to several thousand times, the recommended daily intake values for pharmaceutical impurities.
The authors concluded that lack of regulations regarding manufacturing and content or purity of Ayurvedic and other herbal formulations poses a significant global public health problem.
I could not have said it better myself!
Newsweek recently reported that a herbalist has been charged with the death of a 13-year-old diabetic boy. Allegedly, the therapist replaced the boy’s insulin with herbal remedies. Tim Morrow, 83, was charged with
- child abuse causing death
- and with practicing medicine without a license.
Morrow stated that god had guided him to use herbs rather than conventional medicine and that he successfully treated treat his own prostate cancer in this way. Marrow can be seen on multiple YouTube videos from his ‘University of Common Sense’ promoting his bizarre ideas of health and disease.
Perhaps god also guided Marrow to make lots of money? He runs regular seminars and a thriving herbal on-line business, the ‘Common Sense Herbal Products‘. There are few ailments, for which ‘Common Sense Herbal Products’ do not seem to offer a herbal cure.
One of the remedies, ‘Pancreas Reg‘, for instance, claims to “act as natural insulin”. The 270 Tablets tub of this product costs US $74.22. It is easy to see, I find, how bold claims attract gullible customers depriving them not just of their money but also of their health.
Morrow started treating the boy suffering from Type 1 diabetes after he met his mother at one of his seminars. When the boy subsequently became semi-comatose, Morrow told his parents to treat their son with his herbal remedies rather than insulin which had been prescribed by qualified medical doctors. The boy, Edgar L., died only hours later. There is little doubt that he would have survived, if he had undergone conventional treatment, the medical examiner concluded.
“The allegations in this case underscore the serious health and safety risks of taking medical advice from someone who lacks a license and the proper training that goes with it,” the medical examiner said in a statement. “No family should have to suffer the tragedy of losing a child because of irresponsible, un-credentialed medical advice.”
On this blog, during lectures etc., I often stress that by far the biggest danger of seemingly harmless alternative therapies is that they are used to replace effective treatments for serious conditions. Diabetes is such a condition, and there are numerous instances where the advice of incompetent practitioners has endangered the lives of diabetics.
Three examples will have to suffice as examples of the plethora of such unethical neglect:
- “In homeopathy, diabetes is seen as a reflection of the body’s inability to function optimally. There is an imbalance that results in the body’s incapacity to effectively utilize the insulin that it produces, or to produce sufficient insulin for its needs. While symptoms often disappear after conventional treatment, the vital force does not. Homoeopathy can be used effectively in the treatment of diabetes. Here we mainly concentrate on functioning of the pancreas in efficient insulin production. The metabolic condition of a patient suffering from diabetes requires both therapeutic and nutritional measures to correct the illness. Homeopathy can regulate sugar metabolism while helping to resolve the metabolic disturbances that lead to diabetes. Furthermore, homeopathy helps stimulate the body’s self-healing powers in order to prevent complications such as open leg sores and other dysfunctions of the blood vessel, loss of vision, kidney failure. Homeopathic treatment does not target one illness, an organ, a body part or a symptom. Remedies are prescribed based on an assembly of presenting symptoms, their stresses in life.”
- “Management of Blood sugar. The commonly used remedies are Uranium Nitricum, Phosphoric Acid, Syzygium Jambolanum, Cephalandra Indica etc. These are classical Homeopathic remedies. These are used in physiologically active doses such as Mother tincture, 3x etc. depending up on the level of the blood sugar and the requirement of the patient. Several pharmaceutical companies have also brought in propriety medicines with a combination of the few Homeopathic medicines. Biochemic remedies which is a part of Homeopathy advocates Biocombination No 7 as a specific for Diabetes. Another Biochemic medicine Natrum Phos 3x is widely used with a reasonable success in controlling the blood sugar. Scientific studies on the impact of homeopathic medicines in bringing down blood sugar are limited, but many of the above remedies have some positive effects either as a stand-alone remedy or as an adjunct along with other medications.”
- “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.”
But these are very rare instances!!!
That’s what apologists usually respond.
Yet, the truth is that NOBODY knows how often such harm occurs.
There is no monitoring system anywhere that would provide such information.
Sipjeondaebo-tang is an East Asian herbal supplement containing Angelica root (Angelicae Gigantis Radix), the rhizome of Cnidium officinale Makino (Cnidii Rhizoma), Radix Paeoniae, Rehmannia glutinosa root (Rehmanniae Radix Preparata), Ginseng root (Ginseng Radix Alba), Atractylodes lancea root (Atractylodis Rhizoma Alba), the dried sclerotia of Poria cocos (Poria cocos Sclerotium), Licorice root (Glycyrrhizae Radix), Astragalus root (Astragali Radix), and the dried bark of Cinnamomum verum (Cinnamomi Cortex).
But does this herbal mixture actually work? Korean researchers wanted to find out.
The purpose of their study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests.
The results showed that anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group.
From this, the authors of the study concluded that sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy.
Well, isn’t this just great? Faced with a squarely negative result, one simply ignores it and draws a positive conclusion!
As we all know – and as trialists certainly must know – controlled trials are designed to compare the outcomes of two groups. Changes within one of the groups can be caused by several factors unrelated to the therapy and are therefore largely irrelevant. This means that “no significant difference between changes of Sipjeondaebo-tang group and placebo group” indicates that the herbal mixture had no effect. In turn this means that a conclusion stating that “sipjeondaebo-tang appears to have potential benefit for anorexia” is just fraudulent.
This level of scientific misconduct is remarkable, even for the notoriously poor Evid Based Complement Alternat Med.
I strongly suggest that:
- The journal is de-listed from Medline because similarly misleading nonsense has been coming out of this rag for some time.
- The paper is withdrawn because it can only mislead vulnerable patients.
Some say that Chinese herbal medicine offers a solution.
This Chinese multi-centre RCT included 588 mothers considering breastfeeding. The intervention group received the Chinese herbal mixture Zengru Gao, while the control group received no therapy. The primary outcomes were the percentages of fully and partially breastfeeding mothers, and a secondary outcome was baby’s daily formula intake.
At day 3 and 7 after delivery, significant differences were found in favour of Zengru Gao group on the percentage of full/ partial breastfeeding. At day 7, the percentage of full/ partial breastfeeding of the active group increased to 71.48%/20.70% versus 58.67%/30.26% in the control group, the differences remained significant. No statistically significant differences were detected on primary measures at day. While intake of formula differed between groups at day 1 and 3, this difference did not achieve statistical significance, but this difference was apparent by day 7.
The authors concluded that the Chinese Herbal medicine Zengru Gao enhanced breastfeeding success during one week postpartum. The approach is acceptable to participants and merits further evaluation.
To the naïve observer, this study might look rigorous, but it is a seriously flawed RCT. Here are just some of its most obvious limitations:
- All we get in the methods section is this explanation: Participants were randomly allocated to the blank control group or the intervention group: Zengru Gao, orally, 30 g a time and 3 times a day. This seems to indicate that the control group got no treatment at all which means there was no blinding nor placebo control. The authors even comment on this point in the discussion section of their paper stating that because we included new mothers who received no treatment as a control group, we were able to prove that the improvement in breastfeeding was not due to the placebo effect. However, this is a totally nonsensical argument.
- The experimental treatment is not reproducible. The authors state: Zengru Gao, a Chinese herbal formula, which is composed of 8 herbs: Semen Vaccariae, Medulla Tetrapanacis, Radix Rehmanniae Praeparata, Radix Angelicae Sinensis, Radix Paeoniae Alba,Rhizoma Chuanxiong, Herba Leonuri, Radix Trichosanthis. This is not enough information to replicate the study outside China where the mixture is not commercially available.
- The primary outcome was the percentage of fully, and partially breastfeeding mothers. Breastfeeding was defined as mother’s milk given by direct breast feeding. Full breastfeeding meant that no other types of milk or solids were given. Partially breastfeeding meant that sustained latch with deep rhythmic sucking through the length of the feed, with some pause, on either/ or both breasts. We are not being told how the endpoint was quantified. Presumably women kept diaries. We cannot guess how accurate this process was.
- As far as I can see, there was no correction for multiple testing for statistical significance. This means that some or all of the significant results might be false-positive.
- There is insufficient data to show that the herbal mixture is safe for the mothers and the babies. At the very minimum, the researchers should have measured essential safety parameters. This omission is a gross violation of research ethics.
- Towards the end of the paper, we find the following statement: The authors would like to thank the Research and Development Department of Zhangzhou Pien Tze Huang Pharmaceutical co., Ltd. … The authors declare that they have no competing interests. And the 1st and 3rd authors are “affiliated with” Guangzhou Hipower Pharmaceutical Technology Co., Ltd, Guangzhou, China, i. e. work for the manufacturer of the mixture. This does clearly not make any sense whatsoever.
I have seen too many flawed studies of alternative medicine to be shocked or even surprised by this level of incompetence and nonsense. Yet, I still find it lamentable. But, in my view, the worst is that supposedly peer-reviewed journals such as ‘BMC Complement Altern Med’ publish such overt rubbish.
It would be easy to shrug one’s shoulder and bin the paper. But the effect of such fatally flawed research is too serious for that. In our recent book MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE, we discuss that such flawed science amounts to a violation of medical ethics: CAM journals allocate peer review tasks to a narrow range of CAM enthusiasts who often have been chosen by the authors of the article in question. The raison d’être of CAM journals and CAM researchers is inextricably tied to a belief in CAM, resulting in a self-referential situation which is permissive to the acceptance of weak or ﬂawed reports of clinical effectiveness… Defective research—whether at the design, execution, analysis, or reporting stage—corrupts the repository of reliable medical knowledge. Ultimately, this leads to suboptimal and erroneous treatment decisions…
Rapidly rising in popularity, kratom is hailed by some as a readily available pain remedy that is safer than traditional opioids, an effective addiction withdrawal aid and a pleasurable recreational tonic. But kratom also is assailed as a dangerous and unregulated drug that can be purchased on the Internet, a habit-forming substance that authorities say can result in opioid-like abuse and death.
Last week, the Food and Drug Administration announced that the herbal supplement kratom possesses the properties of an opioid, thus escalating the government’s effort to slow usage of this alternative pain reliever. The FDA states that the number of deaths associated with kratom use has increased to a total of 44, up from a total of 36 since the FDA’s November 2017 report. In the majority of deaths that FDA attributes to kratom, subjects ingested multiple substances with known risks, including alcohol. The presence of multiple drugs makes it difficult to determine the role any one of them played.
So, what is kratom, and why might it be dangerous?
A recent review explains that the leaves of Mitragyna speciosa (commonly known as kratom), a tree endogenous to parts of Southeast Asia, have been used traditionally for their stimulant, mood-elevating, and analgesic effects. The plant’s active constituents, mitragynine and 7-hydroxymitragynine, have been shown to modulate opioid receptors, acting as partial agonists at mu-opioid receptors and competitive antagonists at kappa- and delta-opioid receptors. Both alkaloids are G protein-biased agonists of the mu-opioid receptor and therefore, may induce less respiratory depression than classical opioid agonists. The Mitragyna alkaloids also appear to exert diverse activities at other brain receptors (including adrenergic, serotonergic, and dopaminergic receptors), which may explain the complex pharmacological profile of raw kratom extracts. Kratom exposure alone has not been causally associated with human fatalities to date. However, further research is needed to clarify the complex mechanism of action of the Mitragyna alkaloids and unlock their full therapeutic potential.
Another review adds that, by the early 2000s, kratom was increasingly used in the US as a natural remedy to improve mood and quality of life and as substitutes for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There has been no documented threat to public health that would appear to warrant emergency scheduling of the products and placement in Schedule I of the CSA carries risks of creating serious public health problems. Banning kratom, risks creating public health problems that do not presently exist.
A third review explains that there are no published human pharmacologic, pharmacokinetic, or drug interaction studies on kratom or mitragynine, making it virtually impossible to fully understand kratom‘s therapeutic potential and risks and the populations most likely to benefit or experience harm from its use. Kratom has been used to ameliorate opioid withdrawal symptoms but also induces withdrawal. Human pharmacologic, pharmacokinetic and clinical data are of low quality precluding any firm conclusions regarding safety and efficacy. Kratom does cause a host of adverse effects without clear guidance for how they should be treated. There are numerous assessments where people have been unable to stop using kratom therapy and withdrawal signs and symptoms are problematic. Kratom does not appear in normal drug screens and, when taken with other substances of abuse, may not be recognized.
A systematic review evaluated all studies on kratom use and mental health published between January 1960 and July 2017. Its findings indicate kratom‘s potential as a harm reduction tool, most notably as a substitute for opioids among people who are addicted. Kratom also enhances mood and relieves anxiety among many users. For many, kratom‘s negative mental health effects – primarily withdrawal symptoms – appear to be mild relative to those of opioids. For some users, however, withdrawal is highly uncomfortable and maintaining abstinence becomes difficult.
In Europe, as of 2011, kratom has become a controlled drug in Denmark, Latvia, Lithuania, Poland, Romania and Sweden. In the UK, since 2016, the sale, import, and export of kratom are prohibited.
On balance, my conclusion is that we urgently need more data and meanwhile should avoid this ‘herbal drug’.
You might remember: I have been badly misquoted in an article in THE DAILY TELEGRAPH. Based on a newly published scientific paper, the Telegraph article was about herbal medicines and their potential to interact with synthetic drugs. Towards its end, it cited me stating this:
Emeritus Professor Edzard Ernst, Britain’s first professor of complementary medicine at Exeter University said that doctors should make it clear to patients that they could not be taking herbal remedies alongside drugs.
Prof Ernst said there was no good evidence that they work and that doctors were ‘contributing to disinformation’ by turning a blind eye to the practice.
Not only did this not make any sense (I felt, it made me look like an idiot), but crucially I had never stated this nor had I even commented to a Telegraph journalist about this scientific paper. This was (27/1) when I wrote my blog-post about it.
Several friends persuaded me to file an official complaint – which I somewhat reluctantly did. Subsequently, I received an email from the paper’s ‘editorial compliance executive’ asking me to supply more details about my grievances. I complied with the request by pointing out that:
The following things are wrong with this passage:
1) I never said this.
2) I have not even been interviewed by your journalist and do not know where this quote is supposed to come from.
3) As far as I am aware, I also never stated anything like this anywhere else.
4) It is not and never has been my view that there is no good evidence that herbal remedies can never be combined with drugs.
5) It is not and never has been my opinion that there is no good evidence to suggest that herbal remedies work.
6) It is not and never has been my view that doctors were contributing to disinformation by turning a blind eye to the use of herbal remedies.
The response came swiftly:
The quoted words were recorded at a briefing at the SMC to launch your new book, More Harm than Good? The Moral Maze of Complementary and Alternative Medicine on 17th January 2018.
We are aware that you have had correspondence with our Science Editor, Sarah Knapton who has since amended the online article to make this clear.
We do however accept that one sentence was mistakenly attributed to you. We have therefore amended the online article and added a footnote to explain what has been updated.
This was most bizarre, I thought, because I did NOT have a correspondence with Sarah Knapton, the author of the Telegraph article. On the plus-side, the Telegraph had indeed changed the passage in question; it now read (and did so until yesterday):
Emeritus Professor Edzard Ernst, Britain’s first professor of complementary medicine at Exeter University said there was a ‘potential for harm’.
“It’s a lazy way out of the problem,” he said at a briefing to launch his new book More Harm than Good? The Moral Maze of Complementary and Alternative Medicine. “In medicine you give treatment for a reason and if there is no reason for the homeopathic remedy why should you support it for the placebo treatment.
“As a good doctor you should be able to transmit a placebo effect any case. I just don’t see a reason, I see the potential for harm.”
The research was published in the British Journal of Clinical Pharmacology.
CORRECTION: This article originally stated that Professor Edzard Ernst said there was no good evidence that herbal remedies work and that doctors were ‘contributing to disinformation’ by turning a blind eye to their usage. In fact, this was not said by Professor Ernst. The article has been amended.
I felt that this was a correction of one mistake by another mistake and pointed out that the briefing had been about homeopathy and NOT about herbal medicine or herb/drug interactions. Therefore I replied to the ‘editorial compliance executive’ insisting on further corrections and pointing out that such an utterly nonsensical comment might harm my reputation as an expert. I also posted a comment under the Telegraph article explainig that homeopathy is not herbal medicine.
Sadly, nothing happened.
So, a few days later, I sent a reminder to the ‘editorial compliance executive’.
And again nothing happened.
… until yesterday.
I had almost given up and was contemplating what to do next, when I received an email. It was not from the ‘editorial compliance executive’, but from THE TELEGRAPH’s ‘Head of Editorial Compliance’. He wrote that he had listened to the tapes of the original briefing and realised that my comments were indeed made in a different context. Therefore, they had now erased all of the nonsensical stuff and replaced it with this text:
CORRECTION: This article originally stated that Professor Edzard Ernst, professor of complementary medicine at Exeter University, had said there was ‘potential for harm’ in herbal remedies and that doctors were ‘contributing to disinformation’ by turning a blind eye to this. These comments did not in fact relate to interactions between herbal remedies and prescribed medication, and they have been removed. We apologise to the Professor for the error.
I am pleased!
And I gratefully accept the apology.
This might be a long, convoluted and somewhat boring story, but I think it has at least two important elements to it:
- It may seem petty to complain, and complain, and send reminders when the complaint seems to be getting ignored (I certainly did not feel sure that I was doing the right thing). But occasionally, it is worth the effort – not because of the personal satisfaction (nice but not essential), but because the truth has a high value which should be respected.
- Wondering how all this mess came about, I am asking myself: Does the author of the Telegraph article perhaps genuinely not know the difference between herbal and homeopathic remedies? Obviously, I don’t know the answer to this question, but it would explain the mess she got herself (and me) into. And it would also suggest that it might be necessary to educate journalists about alternative medicine in general and homeopathy in particular (In case there is any interest, I offer to give a few informative lectures with opportunities to ask questions to London-based health writers and science journalists).
Many hard-nosed sceptics might claim that there is no herbal treatment for upper respiratory infections that makes the slightest difference difference. But is this assumption really correct?
According to my own research of 2004, it is not. Here is the abstract of our systematic review:
Acute respiratory infections represent a significant cause of over-prescription of antibiotics and are one of the major reasons for absence from work. The leaves of Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) are used as a medicinal herb in the treatment of infectious diseases. Systematic literature searches were conducted in six computerised databases and the reference lists of all papers located were checked for further relevant publications. Information was also requested from manufacturers, the spontaneous reporting schemes of the World Health Organisation and national drug safety bodies. No language restrictions were imposed. Seven double-blind, controlled trials (n = 896) met the inclusion criteria for evaluation of efficacy. All trials scored at least three, out of a maximum of five, for methodological quality on the Jadad scale. Collectively, the data suggest that A. paniculata is superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect. Adverse events reported following administration of A. paniculata were generally mild and infrequent. There were few spontaneous reports of adverse events. A. paniculata may be a safe and efficacious treatment for the relief of symptoms of uncomplicated upper respiratory tract infection; more research is warranted.
A. Paniculata (Burm.f.) Wall ex Nees (Acanthaceae family), also known as nemone chinensi, Chuān Xīn Lián, has traditionally been used in Indian and Chinese herbal medicine mostly as an antipyretic for relieving and reducing the severity and duration of symptoms of common colds and alleviating fever, cough and sore throats, or as a tonic to aid convalescence after uncomplicated respiratory tract infections. The active constituents of A. paniculata include the diterpene, lactones commonly known as the andrographolides which have shown anti-inflammatory, antiviral, anti-allergic, and immune-stimulatory activities. A. Paniculata has also been shown, in vitro, to be effective against avian influenza A (H9N2 and H5N1) and human influenza A H1N1 viruses, possibly through blocking the binding of viral hemagglutinin to cells, or by inhibiting H1N1 virus-induced cell death.
But our systematic review was published 14 years ago!
We need more up-to-date information!
And I am pleased to report that a recent paper provided exactly that.
This systematic review included published and unpublished RCTs. Quasi-RCTs, crossover trials, controlled before and after studies, interrupted time series (ITS) studies, and non-experimental studies were not included due to their potential high risk of bias.
Thirty-three trials involving 7175 patients with ARTIs were included. Their methodological quality was restricted as randomisation was not well documented; 73% of the trials included were not blinded; where ITT analysis were performed, loss to follow-up data were counted as no effect; and most trials were published without a protocol available.
Findings suggested limited but consistent evidence that A. Paniculata improved cough and sore throat when compared with placebo. A. Paniculata (alone or plus usual care) had a statistically significant effect in improving overall symptoms of ARTIs when compared to placebo, usual care, and other herbal therapies. A. Paniculata in pillule tended to be more effective in improving overall symptoms over A. Paniculata in tablet. Evidence also suggested that A. Paniculata (alone or plus usual care) shortens the duration of cough, sore throat and sick leave/time to resolution when compared versus usual care. Reduction in antibiotic usage was seldom evaluated in the included trials.
The authors concluded that A. Paniculata appears beneficial and safe for relieving ARTI symptoms and shortening time to symptom resolution. However, these findings should be interpreted cautiously owing to poor study quality and heterogeneity. Well-designed trials evaluating the effectiveness and potential to reduce antibiotic use of A. Paniculata are warranted.
In case you wonder about conflicts of interest: there were none with my 2004 paper, and the authors of the new review state that this paper presents independent research funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR). The views expressed are those of the author(s) and not necessarily those of the NIHR, the NHS or the Department of Health.
Yes, the RCTs are not all of top quality.
And yes, the effect size is not huge.
But maybe – just maybe – we do have here an alternative therapy that does help against a condition for which conventional drugs are fairly useless!?!