Monthly Archives: April 2017
“Millions of people have adverse drug reactions to prescribed medicine; it is ranked as the third leading causes of death. In the US, health-care spending reached $1.6 trillion in 2003. Considering this enormous expenditure, we should have the best medicine in the world. But we don’t. Bottom line, people are suffering. The public is calling out for a reform in mainstream medicine.” These seem to be the conclusions of a new film about homeopathy entitled JUST ONE DROP. It was shown recently for the first time in London, and we already have a fascinating comment about it.
“This professional, eight-year effort attempted to be quite even-handed, while featuring many compelling and documented success stories”, states “The World’s No. 1 Authority on Intention, Spirituality and the New Science”, Lynne Mc Taggart. An ‘even-handed’ effort is worth pursuing, I thought, and so I read on.
When I reached the point where Lynne writes “The greatest revelation had to do with the dirty pool employed by the Australian government’s National Health and Medical Research Council (NHMRC), when it decided to assess the effectiveness of homeopathy by reviewing all research that had been done to date”, I got a little suspicious. We discussed the NHMRC report here and here and I had an entirely different impression of it.
Lynne also elaborated at length on the infamous ‘Swiss report’: “The Swiss team had comprehensively reviewed all the major evidence for homeopathy, everything from preclinical research to double-blind, placebo-controlled studies and meta-analyses. After assessing all the available data, the Swiss team concluded that the high-quality investigations of preclinical basic research proved that homeopathic high-potency remedies induce “regulative and specific changes in cells or living organisms”. Of the systematic reviews of human research, said the report, 20 out of 22 detected “at least a trend in favor of homeopathy”, and five showed “clear evidence for homeopathic therapy”. The report found particularly strong evidence for the use of homeopathy for upper respiratory tract infections and allergic reactions. Perhaps most significantly, the report concluded that the effectiveness of homeopathy “can be supported by clinical evidence” and “regarded as safe”.(Forsch Komple-mentmed, 2006; 13 Suppl 2: 19–29).”
This report has been evaluated by many experts (see for instance here). One expert even called it ‘research misconduct’ and concluded that “…the authors of this report adopted a very unusual strategy in what should have been an impartial evidence appraisal. It appears that their goal was not to provide an independent assessment but to choose criteria that would lead to their chosen conclusion that homeopathy is effective. To this end, they chose to adopt a highly questionable criterion of “real-world” effectiveness, ignore negative findings concerning homeopathy in favour of implausible reinterpretation of results, and attack RCTs. This use of a unique and suspect methodology in an appraisal designed to assess healthcare objectively gives cause for particular concern; one imagines that the Swiss government wanted homeopathy to be judged against existing standards rather than new ones created specially for the evaluation. In doing so the authors have distorted the evidence and misled the public; these actions, combined with their conflicts of interest, strongly suggest that they are guilty of research misconduct. It is extremely unfortunate that the Swiss government lent legitimacy to this report by attaching its name to it, and also unfair that the English-language text is not available free of charge to the public when it is being widely misrepresented all over the world as proof of the efficacy of homeopathy. It remains possible that homeopathy is effective, but the authors of this report do the practice a grave disservice.”
Could it be that Lynne does not know all this?
Or is she not interested in an ‘even-handed’ approach?
For me, the last drop arrived when Lynne started writing about my friend “Simon Singh, the self-appointed attack dog on all things alternative”, as she calls him. This is where I began to feel nauseous, so much so that I had to reach for my Nux Vomica C30. Alas, it did not help – Lynne’s writing was too overpoweringly sickening, particularly when she tried to motivate her readers to defend charities that endanger public health by promoting bogus treatments for life-threatening conditions: “If you value alternative medicine, here’s what to write the CC before the deadline: Tell them to read the Swiss report on homeopathy, the most contentious of alternative therapies, which shows very good evidence for it. Demand a level playing field. If they are going to challenge charities for alternative medicine based on scientific evidence, then they need to evaluate Cancer Research UK, Arthritis Research UK and every other charity partly or wholly funded by pharmaceutical companies, an estimated 75 percent of whose research is massaged, manipulated or fabricated.”
My only hope now is that the film JUST ONE DROP is less bonkers than Lynne’s comment about it!
Tui Na is a massage technique that is based on the Taoist principles of TCM. It involves a range of manipulations usually performed by an operator’s finger, hand, elbow, knee, or foot applied to muscle or soft tissue at specific parts of the body. According to one website of TCM-proponents “Tui Na makes use of various hand techniques in combination with acupuncture and other manipulation techniques. To enhance the healing process, the practitioner may recommend the use of Chinese herbs. Many of the techniques used in this massage resemble that of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing and shaking. In Tui Na massage, the muscles and tendons are massaged with the help of hands, and an acupressure technique is applied to directly affect the flow of Qi at different acupressure points of the body, thus facilitating the healing process. It removes the blockages and keeps the energy moving through the meridians as well as the muscles. A typical session of Tui Na massage may vary from thirty minutes to an hour. The session timings may vary depending on the patient’s needs and condition. The best part of the therapy is that it relaxes as well as energizes the person. The main benefit of Tui Na massage is that it focuses on the specific problem, whether it is an acute or a chronic pain associated with the joints, muscles or a skeletal system. This technique is very beneficial in reducing the pain of neck, shoulders, hips, back, arms, highs, legs and ankle disorders. It is a very effective therapy for arthritis, pain, sciatica and muscle spasms. Other benefits of this massage therapy include alleviation of the stress related disorders like insomnia, constipation, headaches and other disorders related to digestive, respiratory and reproductive systems. The greatest advantage of Tui Na is that it focuses on maintaining overall balance with both physical and mental health. Any one who wants to avoid the side effects of drugs or a chemical based treatment can adopt this effective massage technique to alleviate their pain. Tui Na massage therapy is now becoming a more common therapy method due to its focus on specific problems rather than providing a general treatment.”
This clearly begs the question IS IT EFFECTIVE?
This systematic review assessed the evidence of Tui Na for cervical radiculopathy. Seven databases were searched. Randomised controlled trials (RCTs) incorporating Tui Na alone or Tui Na combined with conventional treatment were included. Five studies involving 448 patients were found. The pooled analysis from the 3 trials indicated that Tui Na alone showed a significant lowering immediate effects on pain score with moderate heterogeneity compared to cervical traction. The meta-analysis from 2 trials revealed significant immediate effects of Tui Na plus cervical traction in improving pain score with no heterogeneity compared to cervical traction alone. None of the RCTs mentioned adverse effects. There was very low quality or low quality evidence to support the results.
The authors concluded that “Tui Na alone or Tui Na plus cervical traction may be helpful to cervical radiculopathy patients, but supportive evidence seems generally weak. Future clinical studies with low risk of bias and adequate follow-up design are recommended.”
In my view, this is a misleading conclusion. A correct one would have been: THE CURRENT EVIDENCE IS INSUFFICIENT TO DRAW ANY CONCLUSIONS ABOUT THE EFFECTIVENESS OF TUI NA.
Why?
Here are some of the most obvious reasons:
- there are far too few studies for a firm conclusion,
- the included RCTs lack scientific rigour,
- all trials originate from China where reliability seems to be a serious problem,
- traction is not a useful therapy for radiculopathy,
- the primary studies violate research ethics by not reporting adverse effects.
Personally, I am getting very tired of conclusions stating ‘…XY MAY BE EFFECTIVE/HELPFUL/USEFUL/WORTH A TRY…’ It is obvious that the therapy in question MAY be effective, otherwise one would surely not conduct a systematic review. If a review fails to produce good evidence, it is the authors’ ethical, moral and scientific obligation to state this clearly. If they don’t, they simply misuse science for promotion and mislead the public. Strictly speaking, this amounts to scientific misconduct.
Drug and alcohol dependencies are notoriously difficult to treat effectively. Patients and their families are often desperate and willing to try anything. This seems like an ideal ground for acupuncturists who are, in my experience, experts in putting up smokescreens hiding the true value of their treatment.
The best way to determine the value of any intervention is probably conducting a systematic review of the evidence from rigorous clinical trials. Today we are in the fortunate position to have not just one of those articles; but do they really tell us the truth?
This brand-new systematic review investigated the effects of acupuncture on alcohol-related symptoms and behaviors in patients with this disorder. The PubMed database was searched until 23 August 2016, and reference lists from review studies were also reviewed. The inclusion criteria were the following: (1) being published in a peer-reviewed English-language journal, (2) use of randomized controlled trials (RCTs), (3) assessing the effects of acupuncture on psychological variables in individuals with a primary alcohol problem, and (4) reporting statistics that could be converted to effect sizes.
Seventeen studies were identified for a full-text inspection, and seven (243 patients) of these met our inclusion criteria. The outcomes assessed at the last post-treatment point and any available follow-up data were extracted from each of the studies. Five studies treated patients by inserting a needle into several acupoints in each ear. Two studies stimulated body points with or without ear stimulation. Four studies treated control patients with a placebo needle or under a completely different type of intervention, such as relaxation or transdermal stimulation, whereas the remaining studies inserted needles into nonspecific points. The patients were treated for 2 weeks to 3 months, and the treatment duration per session was 15–45 min. The results of the meta-analysis demonstrated that an acupuncture intervention had a stronger effect on reducing alcohol-related symptoms and behaviours than did the control intervention. A beneficial but weak effect of acupuncture treatment was also found in the follow-up data.
The authors concluded that although our analysis showed a significant difference between acupuncture and the control intervention in patients with alcohol use disorder, this meta-analysis is limited by the small number of studies included. Thus, a larger cohort study is required to provide a firm conclusion.
I am used to reading poor research papers, but this one is like a new dimension. Here are just the most obvious flaws:
- by searching just one database, the likelihood of missing studies is huge,
- by excluding non-English papers, the review automatically becomes non-systematic,
- the included studies differed vastly in many respects and can therefore not be pooled.
As it happens, a further meta-analysis has just been published. Here is its abstract:
Acupuncture has been widely used as a treatment for alcohol dependence. An updated and rigorously conducted systematic review is needed to establish the extent and quality of the evidence on the effectiveness of acupuncture as an intervention for reducing alcohol dependence. This review aimed to ascertain the effectiveness of acupuncture for reducing alcohol dependence as assessed by changes in either craving or withdrawal symptoms.
Methods
In this systematic review, a search strategy was designed to identify randomised controlled trials (RCTs) published in either the English or Chinese literature, with a priori eligibility criteria. The following English language databases were searched from inception until June 2015: AMED, Cochrane Library, EMBASE, MEDLINE, PsycINFO, and PubMed; and the following Chinese language databases were similarly searched: CNKI, Sino-med, VIP, and WanFang. Methodological quality of identified RCTs was assessed using the Jadad Scale and the Cochrane Risk of Bias tool.
Results
Fifteen RCTs were included in this review, comprising 1378 participants. The majority of the RCTs were rated as having poor methodological rigour. A statistically significant effect was found in the two primary analyses: acupuncture reduced alcohol craving compared with all controls (SMD = −1.24, 95% CI = −1.96 to −0.51); and acupuncture reduced alcohol withdrawal symptoms compared with all controls (SMD = −0.50, 95% CI = −0.83 to −0.17). In secondary analyses: acupuncture reduced craving compared with sham acupuncture (SMD = −1.00, 95% CI = −1.79 to −0.21); acupuncture reduced craving compared with controls in RCTs conducted in Western countries (SMD = −1.15, 95% CI = −2.12 to −0.18); and acupuncture reduced craving compared with controls in RCTs with only male participants (SMD = −1.68, 95% CI = −2.62 to −0.75).
Conclusion
This study showed that acupuncture was potentially effective in reducing alcohol craving and withdrawal symptoms and could be considered as an additional treatment choice and/or referral option within national healthcare systems.
This Meta-analysis is only a little better than the first, I am afraid. What its conclusions do not sufficiently reflect, in my view, is the fact that the quality of the primary studies was mostly very poor – too poor to draw conclusions from (other than ‘acupuncture research is usually lousy’; see figure below). Therefore, I fail to see how the authors could draw the relatively firm and positive conclusions cited above. In my view, they should have stated something like this: DUE TO THE RISK OF BIAS IN MANY TRIALS, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.
The authors of the first meta-analysis open the discussion by proudly declaring that “the present study is the first meta-analysis to examine the effect of acupuncture treatment on patients with alcohol use disorder and to provide data on the magnitude of this effect on alcohol-related clinical symptoms and behaviours.” They discretely overlook this meta-analysis from 2009 (and several others which even their rudimentary search would have identified):
Nineteen electronic databases, including English, Korean, Japanese, and Chinese databases, were systematically searched for RCTs of acupuncture for alcohol dependence up to June 2008 with no language restrictions. The methodological qualities of eligible studies were assessed using the criteria described in the Cochrane Handbook.
Eleven studies, which comprised a total of 1,110 individual cases, were systematically reviewed. Only 2 of 11 trials reported satisfactorily all quality criteria. Four trials comparing acupuncture treatment and sham treatments reported data for alcohol craving. Three studies reported that there were no significant differences. Among 4 trials comparing acupuncture and no acupuncture with conventional therapies, 3 reported significant reductions. No differences between acupuncture and sham treatments were found for completion rates (Risk Ratio = 1.07, 95% confidence interval, CI = 0.91 to 1.25) or acupuncture and no acupuncture (Risk Ratio = 1.15, 95% CI = 0.79 to 1.67). Only 3 RCTs reported acupuncture-related adverse events, which were mostly minimal.
The results of the included studies were equivocal, and the poor methodological quality and the limited number of the trials do not allow any conclusion about the efficacy of acupuncture for treatment of alcohol dependence. More research and well-designed, rigorous, and large clinical trials are necessary to address these issues.
One does not need to be an expert in interpreting meta-analyses, I think, to see that this paper is more rigorous than the new ones (which incidentally were published in the very dubious journals). And this is why I trust the conclusions of this last-named meta-analysis more than those of the new one: the efficacy of acupuncture remains unproven. And this means that we should not employ or promote it for routine care.
The world of homeopathy is getting very excited: HOMEOPATHY AWARENESS WEEK is approaching (it’s starting 10 April). An ideal occasion, I think, for making a celebratory offer to all homeopaths:
I am suggesting to give a free lecture on any homeopathy-related subject of your choosing. This, I hope, might increase homeopaths’ awareness of the science, research and evidence for or against homeopathy.
Which professional organisation could possibly say no to such a generous offer?
None with an interest in evidence, surely!
Homeopathy has been the number one subject on this blog from its very beginnings. It regularly attracts lively discussions, and I am confident that I could generate an even better dialogue, if you let me present the evidence. I think I am almost uniquely qualified to give such a lecture, not least because I have the following types of expertise:
- I have given about 800 lectures on alternative medicine and therefore know what to do,
- I have a sound knowledge of evidence-based medicine,
- I possess the ability to tell good from poor science,
- I have experience as a patient treated by a homeopath,
- I have research experience in homeopathy (clinical trials, systematic reviews, etc.),
- I have published many scientific papers on the subject,
- I possess many years of clinical experience,
- I have been trained in homeopathy and used it as a clinician,
- I can think critically,
- I regularly review the emerging literature,
- finally, I have recently published a book entitled HOMEOPATHY, THE UNDILUTED FACTS.
The specifics of my offer are as follows:
- I will give a 45-min lecture to your organisation.
- I will then answer questions for up to 30 min.
- This can be scheduled at a location and a time of day that suits you.
- I will not charge a lecture fee.
- You will cover my travel cost from my home in Suffolk to your venue.
- Depending on the location of the venue and timing of the lecture, I might need to stay overnight and would hope you can foot the bill for that.
- There will be no other costs involved.
- My offer is limited to a time-window during which I plan to be in the UK. The best time for me would be July and August.
I am convinced that we all might profit from such lectures:
- You might learn about science, the evidence, the need for thinking critically, etc.
- And I might learn a bit more about the views and concerns of homeopaths.
Therefore, I hope that my offer will find plenty of takers. If you are interested, please contact me via this blog.
How Jackfruit Kills Cancer… This title hardly left any doubt that jackfruit (Artocarpus heterophyllus Lam) is effective in curing cancer. The website [url disabled by admin because of suspected phishing site] continued in this vein:
“Jackfruit contains phytonutrients like lignans, saponins, and isoflavones, which have anticancer, antihypertensive, anti-ulcer, antioxidant, and anti-aging properties (2).
Isoflavones are also beneficial phytoestrogens that have been proven to reduce the risk of breast, endometrial, and prostate cancers (4,5).
Saponins, on the other hand, kill cancer cells by directly binding to cells as well as boosting white blood cell activity and preventing cell differentiation and proliferation (6,7).
Lastly, the cancer-preventing abilities of the fruit are due in part to dietary TF-binding lectins (8). The pulp has the ability to reduce the mutagenicity of carcinogens and combat the proliferation of cancer cells (9).
In addition, the fruit contains carotenoids, flavonoids, and polyphenols that lower blood pressure, fight stomach ulcers, boost metabolism, support nerve function, and play a role in hormone synthesis. They also contain polysaccharides that boost immunity by interacting with white blood cells, including T cells, monocytes, macrophages, and polymorphonuclear lymphocytes (10).
Each part of the fruit and tree can be used: the flowers help stop bleeding in open wounds, prevent ringworm infestations, and heal cracks in dry feet while the root is used to treat skin diseases, asthma, and diarrhea. Additionally, the wood has a sedative and abortifacient effect…”
END OF QUOTE
To many desperate cancer patients, this would sound convincing, not least because the references provided by the author look sophisticated and seem to back up most of the claims made.
But where are the references to clinical trials showing that jackfruit does cure this or that type of cancer? Where is the evidence that it does “lower blood pressure, fight stomach ulcers, boost metabolism, support nerve function, and play a role in hormone synthesis”? Where are the data to prove that it does “boost immunity”?
I did conduct a ‘rough and ready’ Medline search and found precisely nothing; not a single clinical trial that would confirm the multiple claims made above.
You are not surprised?
Neither am I!
But what about the desperate cancer patients?
How many fell for the scam? How many gave up their conventional cancer treatments and used jackfruit instead? How many consumers know that it is not unusual for plants to contain lignans, saponins, isoflavones and many other ingredients that have amazing effects in vitro? How many know that this rarely translates into meaningful health effects in human patients?
We will never know.
One thing we do know, however, is that articles like this one can cost lives, and that alternative cancer cures are and always will be a myth.
Is spinal manipulative therapy (SMT) dangerous? This question has kept us on this blog busy for quite some time now. To me, there is little doubt that SMT can cause adverse effects some of which are serious. But many chiropractors seem totally unconvinced. Perhaps this new overview of reviews might help to clarify the issue. Its aim was to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.
The authors searched five electronic databases from inception to December 8, 2015 and included reviews on any type of studies, patients, and SMT technique. The primary outcome was SAEs. The quality of the included reviews was assessed using a measurement tool to assess systematic reviews (AMSTAR). Since there were insufficient data for calculating incidence rates of SAEs, they used an alternative approach; the conclusions regarding safety of SMT were extracted for each review, and the communicated opinion were judged by two reviewers independently as safe, harmful, or neutral/unclear. Risk ratios (RRs) of a review communicating that SMT is safe and meeting the requirements for each AMSTAR item, were calculated.
A total of 283 eligible reviews were identified, but only 118 provided data for synthesis. The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT is safe, 15 (13%) expressed that SMT is harmful, and 49 reviews (42%) were neutral or unclear. Thirteen reviews reported incidence estimates for SAEs, roughly ranging from 1 in 20,000 to 1 in 250,000,000 manipulations. Low methodological quality was present, with a median of 4 of 11 AMSTAR items met (interquartile range, 3 to 6). Reviews meeting the requirements for each of the AMSTAR items (i.e. good internal validity) had a higher chance of expressing that SMT is safe.
The authors concluded that it is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.
This article is valuable, if only for the wealth of information one can extract from it. There are, however, numerous problems. One is that the overview included mostly reviews of the effectiveness of SMT for various conditions. We know that studies of SMT often do not even mention AEs. If such studies are then pooled in a review, they inevitably generate an impression of safety. But this would, of course, be a false-positive result!
The authors of the overview are aware of this problem and address it in the following paragraph: “When only considering the subset of reviews, where the objective was to investigate AEs (37 reviews), then 8 reviews (22%) expressed that SMT is safe, 13 reviews (35%) expressed that SMT is harmful and 16 reviews (43%) were neutral or unclear regarding the safety of SMT. Hence, there is a tendency that a bigger proportion of these reviews are expressing that SMT is harmful compared to the full sample of reviews…”
To my surprise, I found several of my own reviews in the ‘neutral or unclear’ category. Here are the verbatim conclusions of three of them:
- It is concluded that serious cerebrovascular complications of spinal manipulation continue to be reported.
- The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome.
- These data indicate that mild and transient adverse events seem to be frequent. Serious adverse events are probably rare but their incidence can only be estimated at present.
I find it puzzling how this could be classified as neutral or unclear. The solution of the puzzle might lie in the methodology used: “we appraised the communicated opinions of each review concerning the safety of SMT based on their conclusions regarding the AEs and SAEs. This was done by two reviewers independently (SMN, LK), who judged the communicated opinions as either ‘safe’, ‘neutral/unclear’ or ‘harmful’, based on the qualitative impression the reviewers had when reading the conclusions. The reviewers had no opinion about the safety/harmfulness of SMT before commencing the judgements. Cohen’s weighted Kappa was calculated for the agreement between the reviewers, with a value of 0.40–0.59 indicating ‘fair agreement’, 0.60–0.74 indicating ‘good agreement’ and ≥0.75 indicating ‘excellent agreement’. Disagreements were resolved by a third reviewer (MH).”
In other words, the categorisation was done on the basis of subjective judgements of two researchers. It seems obvious that, if their attitude was favourable towards SMT, their judgements would be influenced. The three examples from my own work cited above indicates to me that their verdicts were indeed far from objective.
So what is the main message here? In my view, it can be summarized in the following quote from the overview: “a bigger proportion of these reviews are expressing that SMT is harmful …”
Yes, yes, yes – I know that, if you are a chiropractor (or other practitioner using mostly SMT), you are unlikely to agree with this!
Perhaps you can agree with this statement then:
As long as there is reasonable doubt about the safety of SMT, and as long as we cannot be sure that SMT generates more good than harm, we should be very cautious using it for routine healthcare and do rigorous research to determine the truth (it’s called the precautionary principle and applies to all types of healthcare).
Several months ago, the Gibraltar Homeopathic Council (GHC) had called for an emergency meeting to discuss the future of Gibraltar. At that meeting, members voiced grave concern over Brexit; the main problem, they predicted, would be that Spain might use the general confusion during the early days of the negotiations to claim back their homeland. It was then that they decided to meet with their patron, Prince Charles. A secret meeting was thus held at High Grove in the presence of leading UK homeopaths, and a cunning plan was devised.
Back in Gibraltar, a team of researchers went to work to develop and test ‘Rock C30’. This novel and innovative remedy is produced by potentising Gibraltar rock according to the ‘like cures like’ principle. Pilot studies were hurriedly arranged, and their results indicated that Rock C30 was indeed a powerful remedy that neutralised all ambitions of individuals wanting to take possession of Gibraltar. Its mechanism of action is as yet unclear, but homeopaths believe it works holistically via stimulating the vital force. The study concluded that Rock C30 added to the water supplies of a small group of Spanish chauvinists proved to totally abolish their desire to consider annexing Gibraltar. The remedy caused no adverse effects and is therefore ready for routine application on a large scale.
The report which has been leaked to the Daily Mail also stated that the development of the new remedy was inspired by the research done on ‘Berlin Wall’, an equally effective solution to potentially difficult situations. Well-informed circles close to the GHC indicate that large supplies of Rock C30 have already been smuggled into Spain and are about to be dropped into the water supplies of its capital.
The president of the GHC apparently stated that ” this is an exciting development which will guarantee the future of Gibraltar as an integral part of the UK.” The patron of the GHC, Prince Charles, is said to have mumbled: “I am pleased not just for the sake of Gibraltar, but also for the sake of homeopathy. Even my cows in Cornwall have been more clever than those despicable homeopathy-deniers; my cows always knew it works.”
