Monthly Archives: July 2017
The current Cochrane review of acupuncture for polycystic ovary syndrome (PCOS) included 5 RCTs and concluded that thus far, only a limited number of RCTs have been reported. At present, there is insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS.
A new study was aimed at assessing whether active acupuncture, either alone or combined with clomiphene, increases the likelihood of live births among women with PCOS. A double-blind (clomiphene vs placebo), single-blind (active vs control acupuncture) factorial trial was conducted at 27 hospitals in mainland China between July 6, 2012, and November 18, 2014, with 10 months of pregnancy follow-up until October 7, 2015. Chinese women with polycystic ovary syndrome were randomized in a 1:1:1:1 ratio to 4 groups. Active or control acupuncture administered twice a week for 30 minutes per treatment and clomiphene or placebo administered for 5 days per cycle, for up to 4 cycles. The active acupuncture group received deep needle insertion with combined manual and low-frequency electrical stimulation; the control acupuncture group received superficial needle insertion, no manual stimulation, and mock electricity. The primary outcome was live birth.
Among the 1000 randomized women, 250 were randomized to each group, and 926 women completed the trial. Live births occurred in
- 69 of 235 women (29.4%) in the active acupuncture plus clomiphene group,
- 66 of 236 (28.0%) in the control acupuncture plus clomiphene group,
- 31 of 223 (13.9%) in the active acupuncture plus placebo group,
- 39 of 232 (16.8%) in the control acupuncture plus placebo group.
There was no significant interaction between active acupuncture and clomiphene, so main effects were evaluated. The live birth rate was significantly higher in the women treated with clomiphene than with placebo and not significantly different between women treated with active vs control acupuncture.
The authors concluded that among Chinese women with polycystic ovary syndrome, the use of acupuncture with or without clomiphene, compared with control acupuncture and placebo, did not increase live births. This finding does not support acupuncture as an infertility treatment in such women.
There is much evidence to show that nearly 100% of all acupuncture trials originating from China report positive findings regardless of the condition treated. This led to the assumption by myself and several other experts that such studies are best ignored.
This study is from China and does not report positive results. What is more, it is well-designed and well-reported. This trial therefore is a most laudable exception, and I applaud the authors for their courage and good science.
Does this mean that in future we can trust all Chinese acupuncture trials?
One swallow does not make a summer. And I will remain very sceptical. But perhaps this new study is a sign indicating that things are beginning to change. Perhaps Chinese acupuncture researchers are starting to join the 21st century?
This new RCT by researchers from the National Institute of Complementary Medicine in Sydney, Australia was aimed at ‘examining the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea’. It had four arms:
- low frequency manual acupuncture (LF-MA),
- high frequency manual acupuncture (HF-MA),
- low frequency electro acupuncture (LF-EA)
- and high frequency electro acupuncture (HF-EA).
A total of 74 women were given 12 treatments over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry.
During the treatment period and 9 month follow-up all groups showed statistically significant reductions in peak and average menstrual pain compared to baseline. However, there were no differences between groups. Health related quality of life increased significantly in 6 domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups. HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups.
The authors concluded that acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.
If I were not used to reading rubbish research of alternative medicine in general and acupuncture in particular, this RCT would amaze me – not so much because of its design, execution, or write-up, but primarily because of its conclusion (why, oh why, I ask myself, did PLOS ONE publish this paper?). They are, I think, utterly barmy.
Let me explain:
- “acupuncture treatment reduced menstrual pain intensity” – oh no, it didn’t; at least this is not what the study proves; the fact that pain was perceived as less could be due to a host of factors, for instance regression towards the mean, or social desirability; as there was no proper control group, nobody can tell;
- the lack of difference between treatments “may be due to a lack of power”. Yes, but more likely it is due to the fact that all versions of a placebo therapy generate similar outcomes.
- “acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials”. Why? Because the authors have a quasi-religious belief in acupuncture? And if they have, why did they not design their study ‘appropriately’?
The best conclusion I can suggest for this daft trial is this: IN THIS STUDY, THE PRIMARY ENDPOINT SHOWED NO DIFFERENCE BETWEEN THE 4 TREATMENT GROUPS. THE RESULTS ARE THEREFORE FULLY COMPATIBLE WITH THE NOTION THAT ACUPUNCTURE IS A PLACEBO THERAPY.
Something along these lines would, in my view, have been honest and scientific. Sadly, in acupuncture research, we very rarely get such honest science and the ‘National Institute of Complementary Medicine in Sydney, Australia’ has no track record of being the laudable exception to this rule.
An article by Rabbi Yair Hoffman for the Five Towns Jewish Times caught my eye. Here are a few excerpts:
“I am sorry, Mrs. Ploni, but the muscle testing we performed on you indicates that your compatibility with your spouse is a 1 out of a possible 10 on the scale.”
“Your son being around his father is bad for his energy levels. You should seek to minimize it.”
“Your husband was born normal, but something happened to his energy levels on account of the vaccinations he received as a child. It is not really his fault, but he is not good for you.”
Welcome to the world of Applied Kinesiology (AK) or health Kinesiology… Incredibly, there are people who now base most of their life decisions on something called “muscle testing.” Practitioners believe or state that the body’s energy levels can reveal remarkable information, from when a bride should get married to whether the next Kinesiology appointment should be in one week or two weeks. Prices for a 45 minute appointment can range from $125 to $250 a session. One doctor who is familiar with people who engage in such pursuits remarked, “You have no idea how many inroads this craziness has made in our community.”
… AK (applied kinesiology) is system that evaluates structural, chemical, and mental aspects of health by using “manual muscle testing (MMT)” along with other conventional diagnostic methods. The belief of AK adherents is that every organ dysfunction is accompanied by a weakness in a specific corresponding muscle… Treatments include joint manipulation and mobilization, myofascial, cranial and meridian therapies, clinical nutrition, and dietary counselling. A manual muscle test is conducted by having the patient resist using the target muscle or muscle group while the practitioner applies force the other way. A smooth response is called a “strong muscle” and a response that was not appropriate is called a “weak response.” Like some Ouiji board out of the 1970’s, Applied Kinesiology is used to ask “Yes or No” questions about issues ranging from what type of Parnassa courses one should be taking, to what Torah music tapes one should listen to, to whether a therapist is worthwhile to see or not.
“They take everything with such seriousness – they look at it as if it is Torah from Sinai,” remarked one person familiar with such patients. One spouse of an AK patient was shocked to hear that a diagnosis was made concerning himself through the muscle testing of his wife – without the practitioner having ever met him… And the lines at the office of the AK practitioner are long. One husband holds a crying baby for three hours, while his wife attends a 45 minute session. Why so long? The AK practitioner let other patients ahead – because of emergency needs…
END OF EXCERPTS
The article is a reminder how much nonsense happens in the name of alternative medicine. AK is one of the modalities that is exemplary:
- it is utterly implausible;
- there is no good evidence that it works.
The only systematic review of AK was published in 2008 by a team known to be strongly in favour of alternative medicine. It included 22 relevant studies. Their methodology was poor. The authors concluded that there is insufficient evidence for diagnostic accuracy within kinesiology, the validity of muscle response and the effectiveness of kinesiology for any condition.
Some AK fans might now say: absence of evidence is not evidence of absence!!! There is no evidence that AK does not work, and therefore we should give it the benefit of the doubt and use it.
This, of course, is absolute BS! Firstly, the onus is on those who claim that AK works to prove their assumption. Secondly, in responsible healthcare, we are obliged to employ those modalities for which the evidence is positive, while avoiding those for which the evidence fails to be positive.
The Daily Star reported that 9 children have died in Tripura Para of Sitakunda during the last week. At least 46 other children in the remote hilly area are suffering from the same unidentified disease which has not yet been identified. The children aged between one and 12 suffer from fever and other symptoms include body rash, breathing problems, vomiting and blood in stool.
None of the fatalities was taken to a hospital, and two of them were treated homeopathically. The three-year-old Rupali had fever and a rash all over her body for three days. “We took her to a man who practices homeopathy. He lives some two kilometres away. He had given Rupali some medicines”, said her uncle. Asked why they did not take the child to a hospital, Pradip said the next health complex was 15 kilometres away from their home. Besides, they did not have money to buy medicines which would have been prescribed by doctors.
Shimal Tripura was also among the children who died. His father Biman Tripura said the two-year-old boy had been suffering from fever for six days. Shimal was also taken to a local man who practices homeopathy.
“The disease could not be identified immediately,” said a spokesperson. Asked whether the disease could be transmitted by mosquitoes, he said, “It does not seem so. If it was, then why only children were being affected?” A medical team from the Institute of Epidemiology, Disease Control and Research in Dhaka was dispatched for Sitakunda, he said, adding that the local primary school was shut down to prevent the spread of the disease.
I have often pointed out that homeopathy can be deadly – not usually via its remedies (highly diluted homeopathic have no effects whatsoever) but via homeopaths who do not know what they are doing. It seems that here we have yet further tragic cases to confirm this point. Nine children were reported to have died. Two of them received homeopathic remedies and 7 seemed to have had no treatment at all. This looks like a very sad statistic indicating that homeopathy is as bad as no treatment at all.
It used to be called ‘good bedside manners’. The term is an umbrella for a range of attitudes and behaviours including compassion, empathy and conveying positive messages. What could be more obvious than the assumption that good bedside manners are better than bad ones?
But as sceptics, we need to doubt obvious assumptions! Where is the evidence? we need to ask. So, where is the evidence that positive messages have any clinical effects? A meta-analysis has tackled the issue, and the results are noteworthy.
The researchers aimed to estimate the efficacy of positive messages for pain reduction. They included RCTs of the effects of positive messages. Their primary outcome measures were differences in patient- or observer reported pain between groups who were given positive messages and those who were not. Of the 16 RCTs (1703 patients) that met the inclusion criteria, 12 trials had sufficient data for meta-analysis. The pooled standardized effect size was −0.31 (95% CI −0.61 to −0.01, P = 0.04, I² = 82%). The effect size remained positive but not statistically significant after we excluded studies considered to have a high risk of bias (standard effect size −0.17, 95% CI −0.54 to 0.19, P = 0.36, I² = 84%). The authors concluded that care of patients with chronic or acute pain may be enhanced when clinicians deliver positive messages about possible clinical outcomes. However, we have identified several limitations of the present study that suggest caution when interpreting the results. We recommend further high quality studies to confirm (or falsify) our result.
The 1st author of this paper published a comment in which he stated that our recent mega-study with 12 randomized trials confirmed that doctors who use positive language reduce patient pain by a similar amount to drugs. Other trials show that positive messages can:
• help Parkinson’s patients move their hands faster,
• increase ‘peak flow’ (a measure of how much air is breathed) in asthma patients,
• improve the diameter of arteries in heart surgery patients, and
• reduce the amount of pain medication patients use.
The way a positive message seems to help is biological. When a patient anticipates a good thing happening (for example that their pain will go away), this activates parts of the brain that help the body make its own drugs like endorphins. A positive doctor may also help a patient relax which can also improve health.
I am not sure that this is entirely correct. When the authors excluded the methodologically weak and therefore unreliable studies, the effect was no longer significant. That is to say, it was likely due to chance.
And what about the other papers cited above? I am not sure about them either. Firstly, they do not necessarily show that positive messages are effective. Secondly, there is just one study for each claim, and one swallow does not make a summer; we would need independent replications.
So, am I saying that being positive as a clinician is ineffective? No! I am saying that the evidence is too flimsy to be sure. And possibly, this means that the effect of positive messages is smaller than we all thought.
The last time I reported about Kate Birch, I ended my post stating that I became so angry that I was about to write something that I might later regret. Let’s see whether I can restrain myself again.
Kate published another book: The Solution Homeoprophylaxis: The Vaccine Alternative. Here is the press release for her new rant:
Modern parents and even medical practitioners often pose the question of whether the benefits of reducing the incidence of acute diseases through vaccinations is worth the risks of the increased incidence of immune system imbalanceas a result of those same vaccines. This often leads many into questioning if vaccinations for children are indeed safe.
Despite the fact that most medical practitioners refute the possibility that vaccines can cause harm to the immune system, and that their purpose and efficacy have been instilled in people’s minds for the last 200 years, many parents still are looking for possible alternative ways of preventing and treating infants from the so many forms of infectious, contagious acute diseases.
Certified classical homeopaths and authors Kate Birch and Cilla Whatcott want the world to know that there is an alternative path to the use of vaccination which is a more effective and less expensive method of helping to build immunity towards infectious disease. The Solution ~ Homeoprophylaxis: The Vaccine Alternative offers parents a wealth of useful information on the effective prevention of infectious diseases through homeoprophylaxis. The book introduces the basic principles of HP, and an overview of the immune system and how it iacs intended to work with infectious disease, what vaccines actually do in the immune system and a clinical overview of the homeopathic treatment of childhood eruptive diseases, febrile illnesses, and tropical diseases.
This book is written in simple language to help parents navigate the question of immune system development, infectious disease prevention with homeoprophylaxis and if vaccines are really doing what they are intended to do. The authors clearly explain and differentiate important terminology such as immunology, vaccination, and immunization. What is amazing with this book is that Birch and Whatcott offer the world a different view on disease prevention and the use of HP as an immune system educator, and cite multiple references to clinical research and real time applications of the use of HP for disease prevention.
The Solution is a must-read for every parent, health care provider, and any concerned citizen who has questions about the current day vaccine paradigm. As adverse reactions and associated health problems are becoming more and more prevalent in children after receiving vaccinations The Solution offers another way.
END OF QUOTE
- conventional vaccinations are dangerous
- conventional vaccinations are ineffective
- the public is being conned by BIG PHARMA
- homeopathy works like vaccination
- highly diluted homeopathic nosodes stimulate the immune system
- highly diluted homeopathic nosodes are effective for the prevention of infectious diseases
- they are much safer than conventional vaccinations
None of this is true!
- highly diluted nosodes do nothing whatsoever
- they cause to quantifiable effects on the immune system
- they do not prevent any disease
- to claim otherwise is irresponsible, unethical, and perhaps even criminal
- the epidemiological ‘evidence’ homeopaths cite for HP is misleading.
The concept of HP lives off the herd immunity we have via conventional vaccinations and, at the same time, endangers this very immunity. It is a danger for both the public and the individual who might believe in it. In my view, promoting HP is unethical, irresponsible and possibly even criminal.
To a significant extend, this blog has always exposed untruths in the realm of alternative medicine – not just one or two, but hundreds. Obviously, some of them are more clear-cut than others. If, for instance, someone claims that acupuncture has been proven to be effective for a given condition, this many seem like a lie or untruth to you, like a misinterpretation of the evidence to someone else, or like the truth to a third person.
But there are some statements which are demonstrably false. These are often the most irritating lies, frequently forwarded by people who should know better and who nevertheless insist on not being truthful. Below I have listed a few, randomly-chosen examples upon which I have previously commented. For clarity, I have copied the quotes in question, linked them to my original posts, named the authors in brackets, and added a brief comment by myself in bold print.
I was at Exeter when Ernst took over what was already a successful Chair in CAM. (anonymous reviewer of my book at Amazon)
Anyone can check this fairly easily, for instance, in my memoir ‘A SCIENTIST IN WONDERLAND’, there was no pre-existing chair at Exeter.
Ernst’s leak of the Smallwood report (also front page lead in The Times, August 2005), (Dr Peter Fisher, homeopath of the Queen)
This was painfully investigated during a 13 (!) months inquiry which found that I did not leak this report. Again you find the full details in my memoir.
As far as this statement implies that homeopathy is effective for treating intoxications, this is not only a lie but a very dangerous nonsense.
If this is to suggest that homeopathy is of proven effectiveness in treating diseases of animals, this is a lie.
Homeoprophylaxis, the homeopathic vaccine alternative, prevents disease through nosodes. (Lisa is the mastermind behind All Natural Ideas)
Homeoprophylaxis has never been proven to prevent any disease; this lie could kill millions.
There are essentially two categories of critics. The first category consists of individuals who are totally ignorant of homeopathy and just repeating propaganda they’ve been exposed to. The second category is people who know that homeopathy works, but have a vested financial interest in destroying it. (Alan Schmukler, US homeopathy)
This lie is quite funny in its transparent defamation of the truth, I think.
Homeopathy works like a vaccine. (Dr Batra, Indian homeopath)
Homeopathy does not even remotely work like a vaccine; in fact, it works like a placebo, if at all.
…UK invests 0% of its research budget on CAM… (Dr Michael Dixon, GP and advisor to Prince Charles)
There has always been a sizable budget for CAM-research in the UK.
Even cancer viruses have, on record, been put into vaccinations. There is no actual vaccine for cancer. The only reason to put cancer viruses in the mix is to create more cases of cancer. In this day and age, one of the most dangerous things you can do for your health is to get vaccinated… (US homeopath)
In this short quote, there are more lies than I care to comment on. The paranoia of the anti-vaccination brigade is astounding and endangers many lives.
A lie is a statement used intentionally for the purpose of deception. In alternative medicine, we encounter so many lies that one would need to continually publish volume after volume to expose just the most harmful untruths. The danger of these lies is that some people might believe them. This could seriously harm their health. Another danger is that we might get used to them, trivialise them, or – like Trump and co – start thinking of them as ‘alternative facts’.
I will continue to do my best to prevent any of this from happening.
Isn’t it wonderful when your long-held views are confirmed by someone with influence?
This, of course, is a rhetorical question – I can tell you: it is wonderful!
The multibillion-dollar market for “natural” health products has flourished under lax government regulations. These regulations have enabled manufacturers to exploit the public’s difficulty in distinguishing nonprescription drugs, with scientifically proven therapeutic benefits, from herbal or homeopathic preparations and supplements that often make similar health claims with little or no evidence and are frequently grounded in unscientific belief systems about health and disease…
In pharmacies, supermarkets and convenience stores, natural health products are displayed side by side with nonprescription drugs. Both tout their approval by Health Canada as an implicit endorsement of efficacy and safety on package labels that make similar health claims. However, although nonprescription drugs and their therapeutic claims require scientific evidence that is carefully scrutinized by Health Canada, natural health products have a separate regulatory system that typically imposes such minimal requirements that it is effectively a rubber stamp. Unlike nonprescription drugs, if a problem arises with a natural health product, Health Canada has little or no authority to compel any changes to its manufacture, labelling or sale.
…Risk is often difficult to perceive accurately without direct evidence. For example, under the proposed framework, Health Canada would continue to classify most homeopathic preparations as low-risk products and, thus, exempt from scientific review. Recently, a homeopathic product sold in the United States that claimed to relieve teething pain in infants and supposedly contained a very dilute extract from the belladonna plant was associated with several deaths of infants who manifested classic signs of anticholinergic poisoning…
…If consumers are unable to separate products with no scientific proof behind them from products supported by evidence, then we need to separate them in stores. Natural health products should be pulled from the shelves where they are mixed with nonprescription drug products and confined to their own separate section, away from any signage implying a therapeutic use.
The double standard perpetuated by both regulators and retailers that enables the deception of unsuspecting Canadians must end. Alternative medicines with claims based on alternative facts do not deserve an alternative, easy regulatory road to market — at the very least, they need to be moved to an alternative shelf.
END OF QUOTES
This, of course, is Canada. But elsewhere progress is also being made.The Australian reported about plans in Australia whereby pharmacies would be banned from selling useless and possibly dangerous homoeopathic remedies. The Australian last year revealed a review of pharmacy regulation, headed by Stephen King from the Productivity Commission, identified a potential conflict of interest in pharmacists selling vitamins, for example, that may not have a significant evidence base, alongside more stringently regulated and government-subsidised medicines. In its interim report, the review panel was “concerned that the sale of complementary medicines alongside other medicines may mislead consumers”. It therefore concludes that “complementary medicines should be held in a separate area within community pharmacies, where customers can easily access a pharmacist for appropriate advice.”
“To avoid potential harm, or the confusion between the efficacies of different types of medicines, pharmacists need to be easily accessible to give needed advice when consumers choose a complementary or pharmacy-only medicine,” the review panel said. It was scathing of homoeopathy and the perception of legitimacy given to those so-called remedies sold in pharmacies. “The only defence put to the panel regarding homoeopathy was that it was harmless and able to be used as a placebo in certain circumstances,” the review panel noted. “The panel does not believe that this argument is sufficient to justify the continued sale of these products in pharmacies …”
AUSTRALIAN JOURNAL OF PHARMACY (AJP) noted that the interim report of the Review of Pharmacy Remuneration and Regulation states that “there are unacceptable risks where community pharmacies are allowed to sell homeopathic products”.
In 2015 Pharmaceutical Society of Australia (PSA) said it did not support the sale of homeopathy in pharmacy. “Our position is that pharmacists must use their professional judgement to prevent the supply of products with evidence of no effect,” PSA president Joe Demarte said at the time. Ian Carr, of Saxby’s Pharmacy in Taree, NSW, and Friends of Science in Medicine member, told the AJP that “in terms of homeopathic products being recommended not to be sold by PBS-approved pharmacies, I one hundred per cent heartily agree with that finding. “I love saying that I believe homeopathy works. But it has never been shown to work better than placebo. There are many things that will work as well as placebo, but it’s not ethical to be selling them as a cure or treatment for something. I would have a bit more time for it if there was a plausible theory behind it, but its basis is entirely implausible – it pushes all the buttons for being a pseudoscience, so I agree it has no place in Australian pharmacy. However, I am at a bit of a loss to understand why they haven’t carried some of that logic over into the comments on complementary medicines generally.”
Mr Carr also told the AJP that “If one conceives of complementary medicines as being vitamins and minerals, that’s one thing. But the marketing of those items has become so diffuse and so wide that on most of these CM shelves we have traditional medicines, we’ve got herbal medicines, we’ve got items that are basically just marketing formulas for certain conditions. The evidence behind most of these things is very very slim, and we still have the possibility of health fraudsters just marching in and taking advantage of the lack of regulation in the industry.”
So, Canada and Australia are making progress in protecting consumers from bogus healthcare products and from pharmacists selling them.
When, I ask myself, are the UK, the US and other countries following suit?
This recently published report provides updated clinical practice guidelines from the Society for Integrative Oncology on the use of integrative therapies for specific clinical indications during and after breast cancer treatment, including anxiety/stress, depression/mood disorders, fatigue, quality of life/physical functioning, chemotherapy-induced nausea and vomiting, lymphedema, chemotherapy-induced peripheral neuropathy, pain, and sleep disturbance.
The practice guidelines are based on a systematic literature review from 1990 through 2015. The recommendations are as follows:
- Music therapy, meditation, stress management, and yoga are recommended for anxiety/stress reduction.
- Meditation, relaxation, yoga, massage, and music therapy are recommended for depression/mood disorders.
- Meditation and yoga are recommended to improve quality of life.
- Acupressure and acupuncture are recommended for reducing chemotherapy-induced nausea and vomiting.
- Acetyl-L-carnitine is not recommended to prevent chemotherapy-induced peripheral neuropathy due to a possibility of harm.
- No strong evidence supports the use of ingested dietary supplements to manage breast cancer treatment-related side effects.
The authors conclude that there is a growing body of evidence supporting the use of integrative therapies, especially mind-body therapies, as effective supportive care strategies during breast cancer treatment. Many integrative practices, however, remain understudied, with insufficient evidence to be definitively recommended or avoided.
I have to admit that I am puzzled by this paper.
The first obvious point to make is that these treatments are not ‘integrative therapies’; they are alternative or complementary and I fail to see what is integrative about them.
The second point is that the positive recommendations are based on often poor-quality studies which did not control for placebo effects.
The third point is that the negative recommendations are woefully incomplete. There are many more alternative therapies for which there is no strong evidence.
The forth point is the conclusion implying that treatment supported by insufficient evidence should be avoided. I would not claim that any of the mentioned treatments is backed by SUFFICIENT evidence. Therefore, we should avoid them all, one might argue.
But these concerns are perhaps relatively trivial or far-fetched. More important is the fact that a very similar article been published in 2014. Here is the abstract:
The majority of breast cancer patients use complementary and/or integrative therapies during and beyond cancer treatment to manage symptoms, prevent toxicities, and improve quality of life. Practice guidelines are needed to inform clinicians and patients about safe and effective therapies.
Following the Institute of Medicine’s guideline development process, a systematic review identified randomized controlled trials testing the use of integrative therapies for supportive care in patients receiving breast cancer treatment. Trials were included if the majority of participants had breast cancer and/or breast cancer patient results were reported separately, and outcomes were clinically relevant. Recommendations were organized by outcome and graded based upon a modified version of the US Preventive Services Task Force grading system.
The search (January 1, 1990–December 31, 2013) identified 4900 articles, of which 203 were eligible for analysis. Meditation, yoga, and relaxation with imagery are recommended for routine use for common conditions, including anxiety and mood disorders (Grade A). Stress management, yoga, massage, music therapy, energy conservation, and meditation are recommended for stress reduction, anxiety, depression, fatigue, and quality of life (Grade B). Many interventions (n = 32) had weaker evidence of benefit (Grade C). Some interventions (n = 7) were deemed unlikely to provide any benefit (Grade D). Notably, only one intervention, acetyl-l-carnitine for the prevention of taxane-induced neuropathy, was identified as likely harmful (Grade H) as it was found to increase neuropathy. The majority of intervention/modality combinations (n = 138) did not have sufficient evidence to form specific recommendations (Grade I).
Specific integrative therapies can be recommended as evidence-based supportive care options during breast cancer treatment. Most integrative therapies require further investigation via well-designed controlled trials with meaningful outcomes.
I have harshly criticised this review on this blog in 2016. For instance, I voiced concern about the authors declaration of conflicts of interest and stated:
I know none of the authors (Heather Greenlee, Lynda G. Balneaves, Linda E. Carlson, Misha Cohen, Gary Deng, Dawn Hershman, Matthew Mumber, Jane Perlmutter, Dugald Seely, Ananda Sen, Suzanna M. Zick, Debu Tripathy) of the document personally. They made the following collective statement about their conflicts of interest: “There are no financial conflicts of interest to disclose. We note that some authors have conducted/authored some of the studies included in the review.” I am a little puzzled to hear that they have no financial conflicts of interest (do not most of them earn their living by practising integrative medicine? Yes they do! The article informs us that: “A multidisciplinary panel of experts in oncology and integrative medicine was assembled to prepare these clinical practice guidelines. Panel members have expertise in medical oncology, radiation oncology, nursing, psychology, naturopathic medicine, traditional Chinese medicine, acupuncture, epidemiology, biostatistics, and patient advocacy.”). I also suspect they have other, potentially much stronger conflicts of interest. They belong to a group of people who seem to religiously believe in the largely nonsensical concept of integrative medicine…
The just-published update has a different statement about conflicts of interest:
DISCLOSURES: Linda E. Carlson reports book royalties from New Harbinger and the American Psychological Association. Misha R. Cohen reports royalties from Health Concerns Inc., outside the submitted work. Matthew Mumber owns stock in I Thrive. All remaining authors report no conflicts of interest.
Is this much better than the previous statement? Was the previous statement therefore false?
What do you think?
I have repeatedly cautioned about the often poor quality of research into alternative medicine. This seems particularly necessary with studies of acupuncture, and especially true for such research carried out in China. I have also frequently noted that certain ‘CAM journals’ are notoriously prone to publishing rubbish. So, what can we expect from a paper that:
- is on alternative medicine,
- focusses on acupuncture,
- is authored by Chinese researchers,
- was published in the Journal of Alternative and Complementary Medicine (JACM)?
The answer is PROBABLY NOT A LOT!
As if for confirming my prediction, The JACM just published this systematic review. It reports pairwise and network meta-analyses to determine the effectiveness of acupuncture and acupuncture-related techniques for the treatment of psoriasis. A total of 13 RCTs were included. The methodological quality of these studies was ‘not rigorous’ according to the authors – in fact, it was lousy. Acupoint stimulation seemed to be more effective than non-acupoint stimulation. The short-term treatment effect was superior to the long-term effect (as one would expect with placebo). Network meta-analysis suggested that acupressure or acupoint catgut embedding generate superior effects compared to medications. It was noted that acupressure was the most effective treatment of all the acupuncture-like therapies.
The authors concluded that acupuncture-related techniques could be considered as an alternative or adjuvant therapy for psoriasis in short term, especially of acupressure and acupoint catgut embedding. This study recommends further well-designed, methodologically rigorous, and more head-to-head randomized trials to explore the effects of acupuncture-related techniques for treating psoriasis.
And what is wrong with that?
- The review is of very poor quality.
- The primary studies are even worse.
- The English language is defective to the point of being not understandable.
- The conclusions are misleading.
Correct conclusions should read something like this: Due to the paucity and the poor quality of the clinical trials, this review could not determine whether acupuncture and similar therapies are effective for psoriasis.
And then there is, of course, the question about plausibility. How plausible is the assumption that acupuncture might affect a genetic autoimmune disease like psoriasis. The answer, I think, is that the assumption is highly unlikely.
In the above review, most of the 13 primary RCTs were from China. One of the few studies not conducted in China is this one:
56 patients suffering from long-standing plaque psoriasis were randomized to receive either active treatment (electrostimulation by needles placed intramuscularly, plus ear-acupuncture) or placebo (sham, ‘minimal acupuncture‘) twice weekly for 10 weeks. The severity of the skin lesions was scored (PASI) before, during, and 3 months after therapy. After 10 weeks of treatment the PASI mean value had decreased from 9.6 to 8.3 in the ‘active’ group and from 9.2 to 6.9 in the placebo group (p < 0.05 for both groups). These effects are less than the usual placebo effect of about 30%. There were no statistically significant differences between the outcomes in the two groups during or 3 months after therapy. The patient’s own opinion about the results showed no preference for ‘active’ therapy. It was also clear from the answers that the blinded nature of the study had not been discovered by the patients. In conclusion, classical acupuncture is not superior to sham (placebo) ‘minimal acupuncture‘ in the treatment of psoriasis.
Somehow, I trust these conclusions more than the ones from the review!
And somehow, I get very tired of journal editors failing to do their job of rejecting papers that evidently are embarrassing, unethical rubbish.