medical ethics
Stable angina is a symptom of coronary heart disease which, in turn, is amongst the most frequent causes of death in developed countries. It is an alarm bell to any responsible clinician and requires causal, often life-saving treatments of which we today have several options. The last thing a patient needs in this condition is ACUPUNCTURE, I would say.
Yet acupuncture is precisely the therapy such patients might be tempted to employ.
Why?
Because irresponsible or criminally naïve acupuncturists advertise it!
Take this website, for instance; it informs us that a meta-analysis of eight clinical trials conducted between 2000 and 2014 demonstrates the efficacy of acupuncture for the treatment of stable angina. In all eight clinical trials, patients treated with acupuncture experienced a greater rate of angina relief than those in the control group treated with conventional drug therapies (90.1% vs 75.7%)….
I imagine that this sounds very convincing to patients and I fear that many might opt for acupuncture instead of potentially invasive/unpleasant but life-saving intervention. The original meta-analysis to which the above promotion referred to is equally optimistic. Here is its abstract:
Angina pectoris is a common symptom imperiling patients’ life quality. The aim of this study is to evaluate the efficacy and safety of acupuncture for stable angina pectoris. Clinical randomized-controlled trials (RCTs) comparing the efficacy of acupuncture to conventional drugs in patients with stable angina pectoris were searched using the following database of PubMed, Medline, Wanfang and CNKI. Overall odds ratio (ORs) and weighted mean difference (MD) with their 95% confidence intervals (CI) were calculated by using fixed- or random-effect models depending on the heterogeneity of the included trials. Total 8 RCTs, including 640 angina pectoris cases with 372 patients received acupuncture therapy and 268 patients received conventional drugs, were included. Overall, our result showed that acupuncture significantly increased the clinical curative effects in the relief of angina symptoms (OR=2.89, 95% CI=1.87-4.47, P<0.00001) and improved the electrocardiography (OR=1.83, 95% CI=1.23-2.71, P=0.003), indicating that acupuncture therapy was superior to conventional drugs. Although there was no significant difference in overall effective rate relating reduction of nitroglycerin between two groups (OR=2.13, 95% CI=0.90-5.07, P=0.09), a significant reduction on nitroglycerin consumption in acupuncture group was found (MD=-0.44, 95% CI=-0.64, -0.24, P<0.0001). Furthermore, the time to onset of angina relief was longer for acupuncture therapy than for traditional medicines (MD=2.44, 95% CI=1.64-3.24, P<0.00001, min). No adverse effects associated with acupuncture therapy were found. Acupuncture may be an effective therapy for stable angina pectoris. More clinical trials are needed to systematically assess the role of acupuncture in angina pectoris.
In the discussion section of the full paper, the authors explain that their analysis has several weaknesses:
Several limitations were presented in this meta-analysis. Firstly, conventional drugs in control group were different, this may bring some deviation. Secondly, for outcome of the time to onset of angina relief with acupuncture, only one trial included. Thirdly, the result of some outcomes presented in different expression method such as nitroglycerin consumption. Fourthly, acupuncture combined with traditional medicines or other factors may play a role in angina pectoris.
However, this does not deter them to conclude on a positive note:
In conclusion, we found that acupuncture therapy was superior to the conventional drugs in increasing the clinical curative effects of angina relief, improving the electrocardiography, and reducing the nitroglycerin consumption, indicating that acupuncture therapy may be effective and safe for treating stable angina pectoris. However, further clinical trials are needed to systematically and comprehensively evaluate acupuncture therapy in angina pectoris.
So, why do I find this irresponsibly and dangerously misleading?
Here a just a few reasons why this meta-analysis should not be trusted:
- There was no systematic attempt to evaluate the methodological rigor of the primary studies; any meta-analysis MUST include such an assessment, or else it is not worth the paper it was printed on.
- The primary studies all look extremely weak; this means they are likely to be false-positive.
- They often assessed not acupuncture alone but in combination with other treatments; consequently the findings cannot be attributed to acupuncture.
- All the primary studies originate from China; we have seen previously (see here and here) that Chinese acupuncture trials deliver nothing but positive results which means that their results cannot be trusted: they are false-positive.
My conclusion: the authors, editors and reviewers responsible for this article should be ashamed; they committed or allowed scientific misconduct, mislead the public and endangered patients’ lives.
I am so sorry we all missed this conference on ‘HOMEOPROPHYLAXIS’ ![Link disabled by Admin because of suspected malware]
The three-day meeting has ended yesterday.
It could have been a real eye-opener.
This is how it has been advertised:
This is THE conference for medical professionals, parents, and natural-minded healthcare providers to learn more about the evidence supporting the 200 year old practice of Homeoprophylaxis (HP), an immune boosting method that is safe and natural.
Homeoprophylaxis is internationally popular and proven method of protection against infectious disease. It is safe, natural, and does no harm. There are no toxins, preservatives, chemicals, or pathological particles. It works by naturally educating your child’s immune system to recognize and combat disease. Learn from our international panelists of doctors and researchers from across many field and schools of medicine at the upcoming HP Conference. Internationally recognized, our speakers have conducted research across the globe on HP immunization, and will be providing you with answers on their safety, effectiveness, and proven success.
You have to admit that this is eye-opening. If anyone ever doubted that (some) homeopaths were deluded to the point of being dangerous, they now have to see that they were mistaken.
- HP does not convey ‘natural immunity’.
- HP does not boost anything.
- HP is not safe; in fact it has the potential to kill millions through non-immunisation.
- HP is not natural.
- HP is luckily not popular; it is pursued merely by some extreme loons.
- HP is not proven.
- HP does not protect from infectious diseases.
- HP goes absolutely nothing to the immune system or any other organ function.
- HP does not combat disease.
- HP is certainly not ‘internationally recognised’ for anything but a criminally dangerous replacement of proper immunisation.
- HP is not of ‘proven success’.
All that HP truly provides is an indication as to how recklessly unethical and dangerously misleading homeopaths can be. As I wrote previously on this blog: I cannot think of anything in the realm of homeopathy that is more irresponsible than the promotion of HP.
A new nationally representative study from the US analysed ∼9000 children from the Child Complementary and Alternative Medicine File of the 2012 National Health Interview Survey. Adjusting for health services use factors, it examined influenza vaccination odds by ever using major CAM domains: (1) alternative medical systems (AMS; eg, acupuncture); (2) biologically-based therapies, excluding multivitamins/multiminerals (eg, herbal supplements); (3) multivitamins/multiminerals; (4) manipulative and body-based therapies (MBBT; eg, chiropractic manipulation); and (5) mind–body therapies (eg, yoga).
Influenza vaccination uptake was lower among children ever (versus never) using AMS (33% vs 43%; P = .008) or MBBT (35% vs 43%; P = .002) but higher by using multivitamins/multiminerals (45% vs 39%; P < .001). In multivariate analyses, multivitamin/multimineral use lost significance, but children ever (versus never) using any AMS or MBBT had lower uptake (respective odds ratios: 0.61 [95% confidence interval: 0.44–0.85]; and 0.74 [0.58–0.94]).
The authors concluded that children who have ever used certain CAM domains that may require contact with vaccine-hesitant CAM practitioners are vulnerable to lower annual uptake of influenza vaccination. Opportunity exists for US public health, policy, and medical professionals to improve child health by better engaging parents of children using particular domains of CAM and CAM practitioners advising them.
The fact that chiropractors, homeopaths and naturopaths tend to advise against immunisations is fairly well-documented. Unfortunately, this does not just happen in the US but it seems to be a global problem. The results presented here reflect this phenomenon very clearly. I have always categorised it as an indirect risk of alternative medicine and often stated that EVEN IF ALTERNATIVE THERAPIES WERE TOTALLY DEVOID OF RISKS, THE ALTERNATIVE PRACTITIONERS ARE NOT.
I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:
Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.
Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.
In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.
The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
END OF QUOTE
Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:
A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.
“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”
Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.
According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.
And what should we conclude from all this?
I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.
Bogus claims of alternative therapists are legion, particularly in homeopathy. But bogus claims are neither ethical nor legal. Homeopathy works for no human condition, and therefore any medical claim made for homeopathy is unethical, false, misleading and illegal.
This is not just my view (after studying the subject for more than two decades) but also that of the UK regulators. In case you doubt it, please read the full notice which the UK ‘Advertising Standards Authority’ has just published (dated 29/9/2016):
This week, our sister organisation, the Committee of Advertising Practice (CAP) Compliance team has written to homeopaths across the UK to remind them of the rules that govern what they can and can’t say in their marketing materials, including on their websites.
Homeopathy is based on the principle of treating like with like; in other words a substance which causes certain symptoms can also help remove those symptoms when it is diluted heavily in water before being consumed. Practitioners believe that this stimulates the body to heal itself. However, to date, despite having considered a body of evidence, neither us nor CAP has seen robust evidence that homeopathy works. Practitioners should therefore avoid making direct or implied claims that homeopathy can treat medical conditions.
We have no intention of restricting the ability of practitioners to advertise legitimate and legal services, nor do we seek to restrict the right of individuals to choose treatment. However, when advertisers make claims about these products or services, in all sectors, they must hold appropriate evidence to back up those claims. If they do not, then we have a responsibility to intervene to protect consumers by ensuring that those ads are amended or withdrawn.
If you are a practicing homeopath, please ensure that you carefully read CAP’s advice and guidance. It includes a non-exhaustive list of the types of claims you can and can’t make. You will then need to make changes, as necessary, to your marketing materials, including on your website, if you have one.
Further guidance can be found on the Society of Homeopaths’ website. We have worked closely with the Society over the course of the last year, to help them produce detailed guidance to support their members.
If you are a homeopath but have not received a letter from us, please download a copy here, together with supporting FAQs about Advertising Regulation.
I think this notice speaks for itself. All I want to add at this stage is my hope that UK homeopaths comply asap to avoid getting penalised and – much more importantly – to avoid continuing to mislead consumers.
Some osteopaths – similar to their chiropractic, naturopathic, homeopathic, etc. colleagues – claim they can treat almost any condition under the sun. Even gynaecological ones? Sure! But is the claim true? Let’s find out.
The aim of this recent review was to evaluate the effects of the osteopathic manipulative treatment (OMT) on women with gynaecological and obstetric disorders. An extensive search from inception to April 2014 was conducted on MEDLINE, Embase, the Cochrane library using MeSH and free terms. Clinical studies investigating the effect of OMT in gynaecologic and obstetric conditions were included as well as unpublished works. Reviews and personal contributions were excluded. Studies were screened for population, outcome, results and adverse effects by two independent reviewers using an ad-hoc data extraction form. The high heterogeneity of the studies led to a narrative review.
In total, 24 studies were included. They addressed the following conditions: back pain and low back functioning in pregnancy, pain and drug use during labor and delivery, infertility and subfertility, dysmenorrhea, symptoms of (peri)menopause and pelvic pain. Overall, OMT was considered to be effective for pregnancy related back pain. For all other gynaecological and obstetrical conditions the evidence was considered to be uncertain. Only three studies mentioned adverse events after OMT.
The authors concluded that, although positive effects were found, the heterogeneity of study designs, the low number of studies and the high risk of bias of included trials prevented any indication on the effect of osteopathic care. Further investigation with more pragmatic methodology, better and detailed description of interventions and systematic reporting of adverse events are recommended in order to obtain solid and generalizable results.
Given the fact that the lead authors of this review come from the “Accademia Italiana Osteopatia Tradizionale, Pescara, Italy, we can probably answer the question in the title of this blog with a straight NO. I see no reason why OMT should work for gynaecological conditions, and I am not in the least surprised to read that there is no clinical evidence for this notion. Sadly, this is unlikely to stop osteopaths to claim otherwise and continue to prey on the desperate and the gullible.
One might thus say that this review is totally unremarkable – but I would beg to differ: it highlights yet again one very important finding, namely the fact that trials of alternative therapies far too often fail to report adverse effects. I have stated this often already, but I will say it again: THIS OMISSION IS A VIOLATION OF RESEARCH ETHICS WHICH GIVES US A FALSE POSITIVE OVERALL PICTURE OF THE RISKS ASSOCIATED WITH ALTERNATIVE MEDICINE.
We have become used to bogus claims made by homeopaths – far too much so, I would argue. Therefore, we let the vast majority of their bogus claims pass without serious objections. Yet exposing bogus claims would be an important task, particularly when they relate to serious conditions. Doing this might even save lives!
According to the website of the ‘HOMEOPATHIC DOCTOR’, homeopathy is mild in nature and tends to modify the body’s natural immunity. It is the responsibility of the immune system of the body to protect it from all sorts of damage, whether from bacteria or viruses or from any other disease. It also helps in repairing any damage that may occur at any time. Homeopathic medicines help strengthen the natural immunity of the body so that it can perform its natural functions in a more efficient manner.
5 Best Homeopathic remedies for Ulcerative Colitis
In my experience, homeopathic medicines like Merc Sol, Baptisia, Nux Vomica, Arsenic Album and Phosphorus have been found to be quite effective in the treatment of Ulcerative Colitis…
Merc Sol- One of the best homeopathic medicines for ulcerative colitis with blood and tenesmus
When there is too much bleeding with tenesmus and other symptoms, Merc Sol is one of the best homeopathic medicines for ulcerative colitis. There are frequent stools with blood being discharged almost every time. The patient is a sweaty sort of patient who keeps on sweating most of the time. Creeping sort of chilliness may be felt in the back.
Nux Vomica- One of the best homeopathic remedies for ulcerative colitis due to high life
When the problem has occurred from living a high life, Nux Vomica is one of the best homeopathic remedies for ulcerative colitis. Excess of alcohol, stimulants like tea and coffee, late night partying and other habits incident to modern lifestyle can contribute to such a problem. The patient is usually a chilly sort of patient who cannot tolerate cold. He is unusually angry and that too at trifles.
Arsenic Album – One of the best homeopathic medicines for ulcerative colitis with anxiety and restlesness
When the predominant symptoms are the mental symptoms of anxiety and restlessness, Arsenic Album is one of the best homeopathic medicines for ulcerative colitis. The patient gets anxious, worried and restless for no rhyme or reason. There may be weakness which may be disproportionately more than the problem. There is increased thirst for water, though the patient takes a small quantity or a sip at a time.
Baptisia – One of the best homeopathic remedy for ulcerative colitis with low grade fever
When there is low grade fever present along with other symptoms, Baptisia is one of the best homeopathic remedy for ulcerative colitis. The patient has great muscular soreness all over the body as if bruised and beaten. Appetite is reduced or next to nil. At the same time, there is constant desire for water. Stools are very offensive, thin and watery.
Phosphorus – One of the best homeopathic medicine for ulcerative colitis with increased thirst for cold water
When there is intense thirst for cold water, Phosphorus is one of the best homeopathic medicine for ulcerative colitis. The patient is usually tall and thin. The diarrhoea is copious. Stool is watery and profuse bleeding may be present. Patient feels too weak and more so after passing a stool.
The ‘HOMEOPATHIC DOCTOR’s first statement was ‘in my experience…’? Unfortunately most patients will not understand what this expression truly means when written by a homeopath. It means THERE IS NOT A JOT OF EVIDENCE FOR ANY OF THIS. Had he stated this clearly, it would probably have been the only correct sentence in the whole article.
People who understand medicine a bit might laugh at such deluded clinicians and their weird, unethical recommendations. However, patients who are chronically ill and therefore desperate might take them seriously and follow their advice. Patients who suffer from potentially life-threatening diseases like ulcerative colitis might then cause serious damage to themselves or even die.
And this is precisely the reason why I will continue to expose these charlatans for what they are: irresponsible, unethical, uninformed, dangerous quacks
This is your occasion to meet some of the most influential and progressive people in health care today! An occasion too good to be missed! The future of medicine is integrated – we all know that, of course. Here you can learn some of the key messages and techniques from the horses’ mouths. Book now before the last places have gone; at £300, this is a bargain!!!
The COLLEGE OF MEDICINE announced the event with the following words:
This two-day course led by Professor David Peters and Dr Michael Dixon will provide an introduction to integrated health and care. It is open to all clinicians but should be particularly helpful for GPs and nurses, who are interested in looking beyond the conventional biomedical box.
The course will include sessions on lifestyle approaches, social prescribing, mind/body therapies and cover most mainstream complementary therapies.
The aim of the course will be to demonstrate our healing potential beyond prescribing and referral, to provide information that will be useful in discussing non-conventional treatment options with patients and to teach some basic skills that can be used in clinical practice. The latter will include breathing techniques, basic manipulation and acupuncture, mind/body therapies including self-hypnosis and a limited range of herbal remedies. There will also be an opportunity to discuss how those attending might begin to integrate their everyday clinical practice.
The course will qualify for Continuing Professional Development hours and can provide a first stage towards a Fellowship of the College.
Both Dixon and Peters have been featured on this blog before. I have also commented regularly on the wonders of integrated (or was it integrative?) medicine. And I have even blogged about the College of Medicine and what it stands for. So readers of this blog know about the players as well as the issues for this event. Now it surely must be time to learn more from those who are much better placed than I to teach about bogus claims, phoney theories and unethical practices.
What are you waiting for? Book now – they would love to have a few rationalists in the audience, I am sure.
This recent report is worth a mention, I think:
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) is aware that some chiropractors are advertising and attempting to turn breech babies in utero using the “Webster Technique”.
On 7 March 2016, the Chiropractic Board of Australia released the following statement in relation to chiropractic care of pregnant women and their unborn child:
“Care of pregnant patients
Chiropractors are not trained to apply any direct treatment to an unborn child and should not deliver any treatment to the unborn child. Chiropractic care must not be represented or provided as treatment to the unborn child as an obstetric breech correction technique.
RANZCOG supports the Chiropractic Board of Australia in its clear position that chiropractic care must not be represented or provided as a treatment to the unborn child as an obstetric breech correction technique. Chiropractors should not be using the “Webster Technique” or any other inappropriate breech correction technique to facilitate breech version as there is insufficient scientific evidence to support this practice.
In addition, RANZCOG does not support chiropractors treating pregnant women to reduce their risk of caesarean delivery. There is insufficient evidence to make any claims to consumers regarding the benefits of chiropractic treatment to reduce the risk of caesarean delivery. We commend the Chiropractic Board on their statement that:
“Advertisers must ensure that any statements and claims made in relation to chiropractic care are not false, misleading or deceptive or create an unreasonable expectation of beneficial treatment.”1
Recommendations for the management of a breech baby at term are outlined in the RANZCOG statement, Management of breech presentation at term
External Cephalic Version (ECV) is a procedure where a care provider puts his or her hands on the outside of the mother’s belly and attempts to turn the baby from breech to cephalic presentation. It is recommended that women with a breech presentation at or near term should be informed about external cephalic version (ECV) and offered it if clinically appropriate. Attempting cephalic version at term reduces the chance of non-cephalic presentation at birth, vaginal cephalic birth not achieved and caesarean section. There is not enough evidence from randomised trials to assess complications of ECV at term. Large observational studies suggest that complications are rare. ECV should only be performed by suitably trained health professionals where there is facility for emergency caesarean section. Each institution should have its own documented protocol for offering and performing ECVs.
This communiqué highlights the need for patients to be adequately informed when making health care choices.
END OF QUOTE
These are clear and badly needed words. As we have discussed often on this blog, chiropractors make all sorts of bogus claims. Those directed at children and unborn babies are perhaps the most nonsensical of them all. I applaud the College for their clear statements and hope that other institutions follow this example.
WARNING: THIS MIGHT MAKE YOU LAUGH OUT LOUDLY AND UNCONTROLLABLY.
Deepak Chopra rarely publishes in medical journals (I suppose, he has better things to do). I was therefore intrigued when I saw a recent article of which he is a co-author.
The ‘study‘ in question allegedly examined the effects of a comprehensive residential mind–body program on well-being. The authors describe it as “a quasi-randomized trial comparing the effects of participation in a 6-day Ayurvedic system of medicine-based comprehensive residential program with a 6-day residential vacation at the same retreat location.” They included 69 healthy women and men who received the Ayurvedic intervention addressing physical and emotional well-being through group meditation and yoga, massage, diet, adaptogenic herbs, lectures, and journaling. Key components of the program include physical cleansing through ingestion of herbs, fiber, and oils that support the body’s natural detoxification pathways and facilitate healthy elimination; two Ayurvedic meals daily (breakfast and lunch) that provide a light plant-based diet; daily Ayurvedic oil massage treatments; and heating treatments through the use of sauna and/or steam. The program includes lectures on Ayurvedic principles and lifestyle as well as lectures on meditation and yoga philosophy. The study group also participated in twice-daily group meditation and daily yoga and practiced breathing exercises (pranayama) as well as emotional expression through a process of journaling and emotional support. During the program, participants received a 1-hour integrative medical consultation with a physician and follow-up with an Ayurvedic health educator.
The control group simply had a vacation without any of the above therapies in the same resort. They were asked to do what they would normally do on a resort vacation with the additional following restrictions: they were asked not to engage in more exercise than they would in their normal lifestyle and to refrain from using La Costa Resort spa services. They were also asked not to drink ginger tea or take Gingko biloba during the 2 days before and during the study week.
Recruitment was via email announcements on the University of California San Diego faculty and staff and Chopra Center for Wellbeing list-servers. Study flyers stated that the week-long Self-Directed Biological Transformation Initiative (SBTI) study would be conducted at the Chopra Center for Wellbeing, located at the La Costa Resort in Carlsbad, California, in order to learn more about the psychosocial and physiologic effects of the 6-day Perfect Health (PH) Program compared with a 6-day stay at the La Costa Resort. The study participants were not blinded, and site investigators and study personnel knew to which group participants were assigned.
Participants in the Ayurvedic program showed significant and sustained increases in ratings of spirituality and gratitude compared with the vacation group, which showed no change. The Ayurvedic participants also showed increased ratings for self-compassion as well as less anxiety at the 1-month follow-up.
The authors arrived at the following conclusion: Findings suggest that a short-term intensive program providing holistic instruction and experience in mind–body healing practices can lead to significant and sustained increases in perceived well-being and that relaxation alone is not enough to improve certain aspects of well-being.
This ‘study’ had ethical approval from the University of California San Diego and was supported by the Fred Foundation, the MCJ Amelior Foundation, the National Philanthropic Trust, the Walton Family Foundation, and the Chopra Foundation. The paper’s first author is director of research at the Chopra Foundation. Deepak Chopra is the co-founder of The Chopra Center for Wellbeing.
Did I promise too much?
Isn’t this paper hilarious?
Just for the record, let me formulate a short conclusion that actually fits the data from this ‘study’: Lots of TLC, attention and empathy does make some people feel better.
This is hardly something one needs to write home about; and certainly nothing to do a study on!
But which journal would publish such unadulterated advertising?
On this blog, I have mentioned the JACM several times before. Recently, I wrote about the new man in charge of it. I concluded stating WATCH THIS SPACE.
I think the wait is now over – this paper is from the latest issue of the JACM, and I am sure we all agree that the new editor has just shown us of what he is made and where he wants to take his journal.
Just as I thought that this cannot get any better, it did! It did so in the form of a second paper which is evidently reporting from the same ‘study’. Here is its abstract unaltered in its full beauty:
The effects of integrative medicine practices such as meditation and Ayurveda on human physiology are not fully understood. The aim of this study was to identify altered metabolomic profiles following an Ayurveda-based intervention. In the experimental group, 65 healthy male and female subjects participated in a 6-day Panchakarma-based Ayurvedic intervention which included herbs, vegetarian diet, meditation, yoga, and massage. A set of 12 plasma phosphatidylcholines decreased (adjusted p < 0.01) post-intervention in the experimental (n = 65) compared to control group (n = 54) after Bonferroni correction for multiple testing; within these compounds, the phosphatidylcholine with the greatest decrease in abundance was PC ae C36:4 (delta = -0.34). Application of a 10% FDR revealed an additional 57 metabolites that were differentially abundant between groups. Pathway analysis suggests that the intervention results in changes in metabolites across many pathways such as phospholipid biosynthesis, choline metabolism, and lipoprotein metabolism. The observed plasma metabolomic alterations may reflect a Panchakarma-induced modulation of metabotypes. Panchakarma promoted statistically significant changes in plasma levels of phosphatidylcholines, sphingomyelins and others in just 6 days. Forthcoming studies that integrate metabolomics with genomic, microbiome and physiological parameters may facilitate a broader systems-level understanding and mechanistic insights into these integrative practices that are employed to promote health and well-being.
Now that I managed to stop laughing about the first paper, I am not just amused but also puzzled by the amount of contradictions the second article seems to cause. Were there 65 or 69 individuals in the experimental group? Was the study randomised, quasi-randomised or not randomised? All of these versions are implied at different parts of the articles. It turns out that they randomised some patients, while allocating others without randomisation – and this clearly means the study was NOT randomised. Was the aim of the study ‘to identify altered metabolomic profiles following an Ayurveda-based intervention’ or ‘to examine the effects of a comprehensive residential mind–body program on well-being’?
I am sure that others will find further contradictions and implausibilites, if they look hard enough.
The funniest inconsistency, in my opinion, is that Deepak Chopra does not even seem to be sure to which university department he belongs. Is it the ‘Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.’ as indicated in the 1st paper or is it the ‘Department of Family and Preventive Medicine, University of California San Diego, La Jolla, California, USA’ as listed in the 2nd article?
Does he know from which planet he is?
