MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

risk/benefit

THE FIRST WORLDWIDE MANIFESTO AGAINST PSEUDOSCIENCE

2750 signatories from 44 countries have signed it [I was number 11] and today is its official launch. I am delighted to present to you the full text of the English version:

 

Let’s be clear: pseudoscience kills. And they are being used with total impunity thanks to European
laws that protect them.
They kill thousands of people, with names and families. People such as Francesco Bonifaz, a 7-yearold boy whose doctor prescribed homeopathy instead of antibiotics. He died in Italy [1]. People like Mario Rodríguez, who was 21 years old and was told to use vitamins to treat his cancer. He died in Spain [2]. People like Jacqueline Alderslade, a 55-year-old woman whose homeopath told her to stop taking her asthma medication. She died in Ireland [3]. People like Cameron Ayres, a 6-month-old baby, whose parents did not want to give their child “scientific medicine”. He died in England [4]. People like Victoria Waymouth, a 57-year-old woman who was prescribed a homeopathic medication to treat her heart problem. She died in France [5]. People like Sofia Balyaykina, a 25-year-old woman, who had a cancer that was curable with chemotherapy but was recommended an “alternative treatment”, a mosquito bite treatment. She died in Russia [6]. People like Erling Møllehave, a 71-year-old man whose acupuncturist pierced and damaged his lung with a needle. He died in Denmark [7]. People like Michaela Jakubczyk-Eckert, a 40-year-old-woman whose therapist recommended the German NewMedicine to treat her breast cancer. She died in Germany [8]. People like Sylvia Millecam, a 45-year-old woman whose New Age healer promised to cure her cancer. She died in the Netherlands [9].

European directive 2001/83/CE has made –and still makes— possible the daily deception of thousands of hundreds of European citizens [10]. Influential lobbyists have been given the opportunity to redefine what a medicine is, and now they are selling sugar to sick people and making them believe it can cure them or improve their health. This has caused deaths and will continue to do so until Europe admits an undeniable truth: scientific knowledge cannot yield to economic interests, especially when it means deceiving patients and violating their rights.

Europe is facing very serious problems regarding public health. Overmedication, multi-resistant bacteria and the financial issues of the public systems are already grave enough, without the additional problem of gurus, fake doctors or even qualified doctors claiming they can cure any disease by manipulating chakras, making people eat sugar or using “quantic frequencies”. Europe must not only stop the promotion of homeopathy but also actively fight to eradicate public health scams. More than 150 pseudo-therapies have been identified as being in use throughout Europe. Thousands of citizens lives depend on this being prevented. In fact, according to a recent research, 25.9 % of Europeans have used pseudo-therapies last year. In other words, 192 million patients have been deceived [11].

Some believe there is a conflict between freedom of choice for a treatment and the removal of pseudo-therapies, but this is not true. According to article 25 of the Universal Declaration of Human Rights, every person has a right to medical care. Lying to patients in order to sell them useless products that could kill them breaks their right to correct information about their health. This way, even if a citizen has a right to refuse medical treatment when he or she is properly informed, it is also true that nobody has the right to lie to obtain profit at the expense of someone else’s life. Only in a world in which lying to a sick person would be considered ethical, could homeopathy —or any other pseudo-therapy— be allowed to continue to be sold to citizens.

Effective treatments being replaced by false ones is not the only danger of pseudo-therapies. Obvious delays in therapeutic care occur when a person gets false products instead of medication at the early stages of a disease. Many times, it is then too late by the time they get treated with proper medicine. Moreover, several of these practices have serious effects on their own and may cause damage or even death because of their side effects.

Many pseudo-therapists argue that “the other medicine” comes with side effects as well, which is indeed true. However, the difference resides in that pseudo-therapies cannot cure a disease or improve your health, and because of that patients assume risks in exchange of promises that are a scam, according to the full weight of the scientific evidence available. Lying to a sick person is not another type of medicine, it is simply lying to a sick person.
Every country has to face the pseudo-therapies issue in its own ways. Yet it is not acceptable that European laws protect the distortion of scientific facts so that thousands of citizens can be deceived or even lead to their deaths.

We, the signatories of this manifest, therefore declare that:

1. Scientific knowledge is incompatible with what pseudo-therapies postulate, as in the case
of homeopathy.
2. European laws that protect homeopathy are not acceptable in a scientific and technological
society that respects the right of the patients not to be deceived.
3. Homeopathy is the best known pseudo-therapy, but it is not the only one nor the most
dangerous one. Others, such as acupuncture, reiki, German New Medicine, iridology,
biomagnetism, orthomolecular therapy and many more, are gaining ground and causing
victims.
4. Measures must be taken to stop pseudo-therapies, since they are harmful and result in
thousands of people being adversely affected.
5. Europe needs to work towards creating legislation that will help stop this problem.

Europe being concerned about the misinformation phenomena but at the same time protecting one the most dangerous types of it, health misinformation, is just not coherent. This is why the people signing this manifesto urge the governments of European countries to end a problem in which the name of science is being used falsely and which has already cost too many lives.

 

[1] Homeopathy boy died of encephalitis. Redazione ANSA, 2017.
http://www.ansa.it/english/news/general_news/2017/05/29/homeopathy-boy-died-of-encephalitis-3_13e02493-
4e62-4787-9162-12d831121ef6.html
[2] Grieving dad sues over ‘cure cancer with vitamins’ therapy, The local. Emma Anderson, 2016.
https://www.thelocal.es/20160412/grieving-father-sues-naturopath-over-son-cure-cancer-vitamins-leukaemia
[3] Asthmatic ‘told to give up drugs’. The Irish News, 2001.
https://www.independent.ie/irish-news/asthmatic-told-to-give-up-drugs-26063764.html
[4] Homeopaths warn of further tragèdies. BBC News, 2000.
http://news.bbc.co.uk/2/hi/health/702699.stm
[5] Alternative cure doctor suspended. BBC News, 2007.
http://news.bbc.co.uk/2/hi/uk_news/england/london/6255356.stm
[6] Футболист рассказал трагичную историю жены. Она умерла от рака в 25 лет. Sport24, 2018.
https://sport24.ru/news/football/2018-08-28-futbolist-rasskazal-tragichnuyu-istoriyu-zheny-ona-umerla-ot-raka-v-25-let
[7] Mand døde efter akupunktur – enke vil nu lægge sag an mod behandleren, TV2, 2018.
http://nyheder.tv2.dk/samfund/2018-01-23-mand-doede-efter-akupunktur-enke-vil-nu-laegge-sag-an-modbehandleren

[8] The price of refusing science-based medical and surgical therapy in breast càncer, Science Blogs, 2012.
https://scienceblogs.com/insolence/2012/08/30/the-price-of-refusing-science-based-medical-and-surgical-therapy-inbreast-cancer
[9] Psychic ‘misled actress to hopeless cancer death’. Expatica. 2004.
http://web.archive.org/web/20070208144309/http://www.expatica.com/actual/article.asp?subchannel_i
d=19&story_id=4821
[10] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
[11] Use of complementary and alternative medicine in Europe: Health-related and sociodemographic
determinants. Scandinavian Journal of Public Health. Laura M. Kemppainen et al. 2018.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5989251/

Prof. Shailendra Ramchandra Vishampayan is the 1st author of the paper we discussed yesterday. He was kind enough to repeatedly join us in the comments section, and I was therefore keen to learn more about him. On his website, he says about himself that he is a renowned academician and famous homeopath, enriched with decades of ideal experiences and quality services. He is registered medical practitioner (M.D), performs all the duties of registered medical practitioner following the law of land in India. Globally he is considered as homeopath and known as “Dr.V”. He is a registered member of Society of Homeopaths (overseas).

Dr. V, is a practicing homeopath with clinical experience of over 20 years. In course of his years of practice he had successfully helped more than 250 happy families globally, with various kinds of cases like thyroid, immune compromised, epilepsy, endocrine disorders, paediatric, gynaecological disorders addictions, psychiatric disorder, children with special needs, pets and plants.

He is famous for his path breaking concept and novel idea of creating an organization called ‘Folk Homeopathy ‘, which is dedicated to professional enrichment of homeopathic practitioners helping them to improve their clinical acumen with spot on prescription.

His practical approach in solving cases has earned him accolades and fame throughout the globe.

Dr. V is the author of ‘Kinder Garten Materia Medica’ a reference book for beginners widely used by homeopathic students in India. It is a book with unique combination of pictorial and pneumonic.

He is a Professor (PG) at D.Y.Patil Homeopathy Medical College (Pune). He has a teaching experience of over 16 years in teaching UG and PG. He has drawn large number of followers through webinars which is accessible throughout the globe. He has given more than 50 international seminar ,workshops and webinars in countries like USA, Ireland, Malaysia, with presentations on Homeopathic approach to female hormonal imbalance cases at OMICS Conference of Alternative Medicine, presentation on Psychiatric cases at Asian Homeopathic League. And various presentation at University of Cyberjaya, Malaysia, California Homeopathic Medical society, San Diego and also at Corte Madera, 98th FOH Congress, Liverpool and Kinvara Co Galway, Ireland.

And on the same site, we also learn that ‘Dr V’ is particularly adept at treating diabetes:

India is now considered as the diabetes capital of the world. Approximately 8.7 percent of Indians between the age of 20 to 70 years are diabetic. This translates to approximately 62.5 million diabetics living in India, according to estimates by the World Health Organisation (W.H.O.) The economic burden of managing this disease is also substantial since this is a combination of cost of treatment and loss of productivity in such a high number of diabetics. Diabetes can affect multiple organ systems resulting in a wide range of serious issues in patients. Many of these complications in a diabetic do not have any specific treatment with conventional medicines. However, an indication of the popularity of homeopathy amongst diabetics is that the doctors at our clinic treat approximately two hundred cases of diabetes or diabetes related issues every day. We have, in fact, developed specific diabetes management protocols for patients based on the experience of thousands of cases we have seen over four decades.

This is interesting, I thought, and conducted a few Medline searches to see whether there is any evidence to show that homeopathy is an effective therapy for diabetes. I am afraid, I found no papers of ‘Dr V’ to suggest such an effect. But what I did find was certainly fascinating.

Last year, Italian diabetologists published an review entitled ‘Alternative treatment or alternative to treatment? A systematic review of randomized trials on homeopathic preparations for diabetes and obesity‘. Here is what they reported:

The searches failed to retrieve any trial comparing homeopathic remedies with placebo or any active drug for the treatment of either diabetes or obesity.

These authors commented that

… if homeopathy is used as an alternative to available and effective treatments, the consequences can be catastrophic, particularly in some conditions such as insulin-requiring diabetes. In conclusion, there is no scientific evidence on efficacy and no demonstration of safety of homeopathy in diabetes and obesity…

I agree with my Italian colleagues and I have previously expressed this view bluntly; I even entitled one of my posts ‘This is how homeopathy could kill millions‘.

‘Dr V’ will probably point out that he is a fully qualified doctor and uses homeopathy merely as an adjunct to conventional anti-diabetic treatments; thus he kills nobody.

I certainly hope this is so! But, even in this case, I must still ask: WHERE IS THE EVIDENCE THAT HOMEOPATHY IS AN EFFECTIVE ADJUNCT TO CONVENTIONAL MEDICINE?

Manual therapy is a commonly recommended treatment of low back pain (LBP), yet few studies have directly compared the effectiveness of thrust (spinal manipulation) vs non-thrust (spinal mobilization) techniques. This study evaluated the comparative effectiveness of spinal manipulation and spinal mobilization at reducing pain and disability compared with a placebo control group (sham cold laser) in a cohort of young adults with chronic LBP.

This single-blinded (investigator-blinded), placebo-controlled randomized clinical trial with 3 treatment groups was conducted at the Ohio Musculoskeletal and Neurological Institute at Ohio University from June 1, 2013, to August 31, 2017. Of 4903 adult patients assessed for eligibility, 4741 did not meet inclusion criteria, and 162 patients with chronic LBP qualified for randomization to 1 of 3 treatment groups. Participants received 6 treatment sessions of (1) spinal manipulation, (2) spinal mobilization, or (3) sham cold laser therapy (placebo) during a 3-week period. Licensed clinicians (either a doctor of osteopathic medicine or physical therapist), with at least 3 years of clinical experience using manipulative therapies provided all treatments.

Primary outcome measures were the change from baseline in Numerical Pain Rating Scale (NPRS) score over the last 7 days and the change in disability assessed with the Roland-Morris Disability Questionnaire (scores range from 0 to 24, with higher scores indicating greater disability) 48 to 72 hours after completion of the 6 treatments.

A total of 162 participants (mean [SD] age, 25.0 [6.2] years; 92 women [57%]) with chronic LBP (mean [SD] NPRS score, 4.3 [2.6] on a 1-10 scale, with higher scores indicating greater pain) were randomized.

  • 54 participants were randomized to the spinal manipulation group,
  • 54 to the spinal mobilization group,
  • 54 to the placebo group.

There were no significant group differences for sex, age, body mass index, duration of LBP symptoms, depression, fear avoidance, current pain, average pain over the last 7 days, and self-reported disability. At the primary end point, there was no significant difference in change in pain scores between spinal manipulation and spinal mobilization (0.24 [95% CI, -0.38 to 0.86]; P = .45), spinal manipulation and placebo (-0.03 [95% CI, -0.65 to 0.59]; P = .92), or spinal mobilization and placebo (-0.26 [95% CI, -0.38 to 0.85]; P = .39). There was no significant difference in change in self-reported disability scores between spinal manipulation and spinal mobilization (-1.00 [95% CI, -2.27 to 0.36]; P = .14), spinal manipulation and placebo (-0.07 [95% CI, -1.43 to 1.29]; P = .92) or spinal mobilization and placebo (0.93 [95% CI, -0.41 to 2.29]; P = .17). A comparison of treatment credibility and expectancy ratings across groups was not statistically significant (F2,151 = 1.70, P = .19), indicating that, on average, participants in each group had similar expectations regarding the likely benefit of their assigned treatment.

The authors concluded that in this randomized clinical trial, neither spinal manipulation nor spinal mobilization appeared to be effective treatments for mild to moderate chronic LBP.

This is an exceptionally well-reported study. Yet, one might raise a few points of criticism:

  1. The comparison of two active treatments makes this an equivalence study, and much larger sample sizes are required or such trials (this does not mean that the comparisons are not valid, however).
  2. The patients had rather mild symptoms; one could argue that patients with severe pain might respond differently.
  3. Chiropractors could argue that the therapists were not as expert at spinal manipulation as they are; had they employed chiropractic therapists, the results might have been different.
  4. A placebo control group makes more sense, if it allows patients to be blinded; this was not possible in this instance, and a better placebo might have produced different findings.

Despite these limitations, this study certainly is a valuable addition to the evidence. It casts more doubt on spinal manipulation and mobilisation as an effective therapy for LBP and confirms my often-voiced view that these treatments are not the best we can offer to LBP-patients.

 

Black salve is a paste for external use made from a variable mixture of herbal and non-herbal ingredients. It usually contains bloodroot and/or chaparral and/or zinc chloride which are all ingredients that render the products corrosive. This means black salve destroys living cells that come in contact with it.

Black salve is said to originate from native American tribes who used the paste as a treatment for various conditions. It was adopted by conventional medicine during the Victorian era as a treatment for a range of skin problems, including skin cancers. When effective treatments became available, it became obsolete.

Black salve was recently re-discovered by some practitioners of so-called alternative medicine (SCAM) who now recommend it as a natural treatment for various skin conditions, including cancer. Black salve is readily available, for instance, via the Internet. Several national regulators have issued warnings to consumers not to use it. Consumers have little means of telling what is the nature, quality or strength of the black salve they might be purchasing.

No compelling evidence exists that black salve is efficacious for any condition, especially not for any type of skin cancer. Rigorous clinical trials testing its efficacy are not available. A recent review[1] of the published evidence concluded as follows: Black salve is not a natural therapy. It contains significant concentrations of synthetic chemicals. Black salve does not appear to possess tumour specificity with in vitro and in vivo evidence indicating normal cell toxicity. Black salve does appear to cure some skin cancers, although the cure rate for this therapy is currently unknown. The use of black salve should be restricted to clinical research in low risk malignancies located at low risk sites until a better understanding of its efficacy and toxicity is developed. Where a therapy capable of harm is already being used by patients, it is ethically irresponsible not to study and analyse its effects. Although cautionary tales are valuable, black salve research needs to move beyond the case study and into the carefully designed clinical trial arena. Only then can patients be properly informed of its true benefits and hazards.

Due to its erosive nature, black salve burns away the tissue with which it comes into contact. Numerous case reports of the resulting deformations have been published.[2],[3] Many horrendous pictures of patients maimed by their use of black salve are available on the Internet and give a dramatic impression of the harm caused. Black salve is unquestionably a treatment that can cause considerable damage and should be regarded as unsafe. One paper concluded that it is vital that members of the public are aware of the potential effects and toxicity of commercial salve products.[4]

In conclusion, black salve is not of proven efficacy as a treatment of any condition. It is well documented to cause much harm. Its use should be discouraged. Practitioners who employ or recommend it are, in my view, irresponsible to the extreme.

References:

[1] Croaker A, King GJ, Pyne JH, Anoopkumar-Dukie S, Liu L. A Review of Black Salve: Cancer Specificity, Cure, and Cosmesis. Evid Based Complement Alternat Med. 2017;2017:9184034. doi:10.1155/2017/9184034

[2] Ong NC, Sham E, Adams BM. Use of unlicensed black salve for cutaneous malignancy. Med J Aust. 2014;200(6):314. doi:10.5694/mja14.00041

[3] Saltzberg F, Barron G, Fenske N. Deforming self-treatment with herbal “black salve”. Dermatol Surg. 2009;35(7):1152-1154. doi:10.1111/j.1524-4725.2009.01206.x

[4] Lim A. Black salve treatment of skin cancer: a review. J Dermatolog Treat. 2018;29(4):388-392. doi:10.1080/09546634.2017.1395795

During the last decades, the sales-figures for so-called alternative medicine (SCAM) have been increasing steadily and substantially. A recent report predicts this trend to continue:

… The global market for alternative and complementary medicines is projected to experience substantial growth in the next few years. The rising expenditure of the healthcare facilities is considered as the major factor that is likely to encourage the growth of the overall market in the coming years. In addition, the increasing number of initiatives being taken by Governments across the globe to promote alternative and complementary medicines is projected to accelerate the market’s growth. Thanks to these factors, the global alternative and complementary medicine market is likely to exhibit a promising growth rate in the near future.

A significant rise in the number of initiatives by NGOs and government organizations to encourage the use of alternative and complementary medicines is estimated to bolster global market in the near future. In addition to this, technological advancements in this field and the rising inclination of consumers towards these medicines and practices are likely to offer lucrative growth opportunities for the leading players operating in the alternative and complementary medicine market across the globe. However, the lack of scientific results is expected to hamper the overall growth of the market in the next few years…

From a regional perspective, Europe is considered as one of the leading segment, thanks to the significant revenue contribution in the last few years. This region is expected to account for a large share of the global alternative and complementary medicine market with the rising use of botanicals. In addition to this, the increasing awareness among consumers regarding the availability of effective alternative and complementary medicines and the benefits they offers are expected to encourage the growth of the Europe market in the coming years.

Furthermore, with the rising popularity of medical tourism, the alternative and complementary medicine market in Asia Pacific is projected to witness a steady growth in the next few years. Moreover, the presence of a large number of new players operating in this region is likely to offer promising growth opportunities over the forecast period. The Middle East and Africa segment is anticipated to experience a healthy growth in the alternative and complementary medicine market in the near future.

The global market for alternative and complementary medicines is presently at a highly competitive stage and is predicted to experience an intense level of competition among the leading players in the coming years. The prominent players in the market are focusing on the expansion of the product portfolio so as to attract a large number of consumers across the globe. This is likely to help them in creating a brand name and acquiring a leading position in the global market. Some of the leading players operating in the alternative and complementary medicine market across the globe are Herb Pharm, Yoga Tree, Quantum Touch Inc., Helio USA Inc., Pure encapsulations, Inc., Pacific Nutritional Inc., Deepure Plus, Herbal Hills, Iyengar Yoga Institute, The Healing Company, and Nordic Naturals.

Yes, I know, this is little more than hot air mixed with platitudes and advertisements to purchase the full report. I used to buy such documents for my department and research but was invariably disappointed. They provide are expensive and of very little of value.

Yet, one thing has been confirmed over the years: the prediction of steady growth of the SCAM-industry is rarely wrong (certain sections, such as homeopathy, have been shrinking in some regions, but the industry as a whole is financially healthy). The scientific evidence seems to get less and less convincing, yet consumers buy more and more of these products. They may do little good and have the potential to cause quite a bit of harm, but consumers continue to waste their money on them.

The question is: why?

There are, of course, many reasons. An important one is that the gullible public wants to believe in SCAM, and the SCAM-industry is highly skilled in misleading us. What is worse: many governments, instead of limiting the damage, are mildly or even overtly supportive of the SCAM-industry.

Whenever I contemplate this depressing state of affairs, I realise that my blog is important. It is only a drop in the ocean, I know, but still…

 

 

 

On this blog, I have discussed the adverse events (AEs) of spinal manipulative therapy (SMT) with some regularity, and we have seen that ~ 50% of patients who receive SMT from a chiropractor experience some kind of AE. In addition there are many serious complications. In my book, I discuss, apart from the better-known vascular accidents followed by a stroke or death, the following:

  • atlantoaxial dislocation,
  • cauda equina syndrome,
  • cervical radiculopathy,
  • diaphragmatic paralysis,
  • disrupted fracture healing,
  • dural sleeve injury,
  • haematoma,
  • haematothorax,
  • haemorrhagic cysts,
  • muscle abscess,
  • muscle abscess,
  • myelopathy,
  • neurologic compromise,
  • oesophageal rupture
  • pneumothorax,
  • pseudoaneurysm,
  • soft tissue trauma,
  • spinal cord injury,
  • vertebral disc herniation,
  • vertebral fracture,
  • central retinal artery occlusion,
  • nystagmus,
  • Wallenberg syndrome,
  • ptosis,
  • loss of vision,
  • ophthalmoplegia,
  • diplopia,
  • Horner’s syndrome.

Considering this long list, we currently have far too little reliable information. A recent publication offers further information on this important topic.

The aim of this study was to identify beliefs, perceptions and practices of chiropractors and patients regarding benign AEs post-SMT and potential strategies to mitigate them. Clinicians and patients from two chiropractic teaching clinics were invited to respond to an 11-question survey exploring their beliefs, perceptions and practices regarding benign AEs post-SMT and strategies to mitigate them.

A total of 39 clinicians (67% response rate) and 203 patients (82.9% response rate) completed the survey. The results show that:

  • 97% of the chiropractors believed benign AEs occur.
  • 82% reported their own patients have experienced an AE.
  • 55% of the patients reported experiencing benign AEs post-SMT, with the most common symptoms being pain/soreness, headache and stiffness.
  • 61.5% of the chiropractors reported trying a mitigation strategy with their patients.
  • Yet only 21.2% of patients perceived their clinicians had tried any mitigation strategy.
  • Chiropractors perceived that patient education is most likely to mitigate benign AEs, followed by soft tissue therapy and/or icing after SMT.
  • Patients perceived stretching was most likely to mitigate benign AEs, followed by education and/or massage

 

The authors concluded that this is the first study comparing beliefs, perceptions and practices from clinicians and patients regarding benign AEs post-SMT and strategies to mitigate them. This study provides an important step towards identifying the best strategies to improve patient safety and improve quality of care.

The question that I have often asked before, and I am bound to ask again after seeing such results, is this:

If there were a drug that causes temporary pain/soreness, headache and stiffness in 55% of all patients (plus an unknown frequency of a long list of serious complications), while being of uncertain benefit, do you think it would still be on the market?

 

Much of so-called alternative medicine (SCAM) is used in the management of osteoarthritis pain. Yet few of us ever seem to ask whether SCAMs are more or less effective and safe than conventional treatments.

This review determined how many patients with chronic osteoarthritis pain respond to various non-surgical treatments. Published systematic reviews of randomized controlled trials (RCTs) that included meta-analysis of responder outcomes for at least 1 of the following interventions were included: acetaminophen, oral nonsteroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, cannabinoids, counselling, exercise, platelet-rich plasma, viscosupplementation (intra-articular injections usually with hyaluronic acid ), glucosamine, chondroitin, intra-articular corticosteroids, rubefacients, or opioids.

In total, 235 systematic reviews were included. Owing to limited reporting of responder meta-analyses, a post hoc decision was made to evaluate individual RCTs with responder analysis within the included systematic reviews. New meta-analyses were performed where possible. A total of 155 RCTs were included. Interventions that led to more patients attaining meaningful pain relief compared with control included:

  • exercise (risk ratio [RR] of 2.36; 95% CI 1.79 to 3.12),
  • intra-articular corticosteroids (RR = 1.74; 95% CI 1.15 to 2.62),
  • SNRIs (RR = 1.53; 95% CI 1.25 to 1.87),
  • oral NSAIDs (RR = 1.44; 95% CI 1.36 to 1.52),
  • glucosamine (RR = 1.33; 95% CI 1.02 to 1.74),
  • topical NSAIDs (RR = 1.27; 95% CI 1.16 to 1.38),
  • chondroitin (RR = 1.26; 95% CI 1.13 to 1.41),
  • viscosupplementation (RR = 1.22; 95% CI 1.12 to 1.33),
  • opioids (RR = 1.16; 95% CI 1.02 to 1.32).

Pre-planned subgroup analysis demonstrated no effect with glucosamine, chondroitin, or viscosupplementation in studies that were only publicly funded. When trials longer than 4 weeks were analysed, the benefits of opioids were not statistically significant.

The authors concluded that interventions that provide meaningful relief for chronic osteoarthritis pain might include exercise, intra-articular corticosteroids, SNRIs, oral and topical NSAIDs, glucosamine, chondroitin, viscosupplementation, and opioids. However, funding of studies and length of treatment are important considerations in interpreting these data.

Exercise clearly is an effective intervention for chronic osteoarthritis pain. It has consistently been recommended by international guideline groups as the first-line treatment in osteoarthritis management. The type of exercise is likely not important.

Pharmacotherapies such as NSAIDs and duloxetine demonstrate smaller but statistically significant benefit that continues beyond 12 weeks. Opioids appear to have short-term benefits that attenuate after 4 weeks, and intra-articular steroids after 12 weeks. Limited data (based on 2 RCTs) suggest that acetaminophen is not helpful. These findings are consistent with recent Osteoarthritis Research Society International guideline recommendations that no longer recommend acetaminophen for osteoarthritis pain management and strongly recommend against the use of opioids.

Limited benefit was observed with other interventions including glucosamine, chondroitin, and viscosupplementation. When only publicly funded trials were examined for these interventions, the results were no longer statistically significant.

Adverse events were inconsistently reported. However, withdrawal due to adverse events was consistently reported and found to be greater in patients using opioids, SNRIs, topical NSAIDs, and viscosupplementation.

Few of the interventions assessed fall under the umbrella of so-called alternative medicine (SCAM):

  • some forms of exercise,
  • cannabinoids,
  • counselling,
  • chondroitin,
  • glucosamine.

It is unclear why the authors did not include SCAMs such as chiropractic, osteopathy, massage therapy, acupuncture, herbal medicines, neural therapy, etc. in their review. All of these SCAMs are frequently used for osteoarthritis pain. If they had included these treatments, how do you think they would have fared?

My new book has just been published. Allow me to try and whet your appetite by showing you the book’s introduction:

“There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.” These words of Fontanarosa and Lundberg were published 22 years ago.[1] Today, they are as relevant as ever, particularly to the type of healthcare I often call ‘so-called alternative medicine’ (SCAM)[2], and they certainly are relevant to chiropractic.

Invented more than 120 years ago by the magnetic healer DD Palmer, chiropractic has had a colourful history. It has now grown into one of the most popular of all SCAMs. Its general acceptance might give the impression that chiropractic, the art of adjusting by hand all subluxations of the three hundred articulations of the human skeletal frame[3], is solidly based on evidence. It is therefore easy to forget that a plethora of fundamental questions about chiropractic remain unanswered.

I wrote this book because I feel that the amount of misinformation on chiropractic is scandalous and demands a critical evaluation of the evidence. The book deals with many questions that consumers often ask:

  • How well-established is chiropractic?
  • What treatments do chiropractors use?
  • What conditions do they treat?
  • What claims do they make?
  • Are their assumptions reasonable?
  • Are chiropractic spinal manipulations effective?
  • Are these manipulations safe?
  • Do chiropractors behave professionally and ethically?

Am I up to this task, and can you trust my assessments? These are justified questions; let me try to answer them by giving you a brief summary of my professional background.

I grew up in Germany where SCAM is hugely popular. I studied medicine and, as a young doctor, was enthusiastic about SCAM. After several years in basic research, I returned to clinical medicine, became professor of rehabilitation medicine first in Hanover, Germany, and then in Vienna, Austria. In 1993, I was appointed as Chair in Complementary Medicine at the University of Exeter. In this capacity, I built up a multidisciplinary team of scientists conducting research into all sorts of SCAM with one focus on chiropractic. I retired in 2012 and am now an emeritus professor. I have published many peer-reviewed articles on the subject, and I have no conflicts of interest. If my long career has taught me anything, it is this: in the best interest of consumers and patients, we must insist on sound evidence; not opinion, not wishful thinking; evidence.

In critically assessing the issues related to chiropractic, I am guided by the most reliable and up-to-date scientific evidence. The conclusions I reach often suggest that chiropractic is not what it is often cracked up to be. Hundreds of books have been published that disagree. If you are in doubt who to trust, the promoter or the critic of chiropractic, I suggest you ask yourself a simple question: who is more likely to provide impartial information, the chiropractor who makes a living by his trade, or the academic who has researched the subject for the last 30 years?

This book offers an easy to understand, concise and dependable evaluation of chiropractic. It enables you to make up your own mind. I want you to take therapeutic decisions that are reasonable and based on solid evidence. My book should empower you to do just that.

[1] https://pubmed.ncbi.nlm.nih.gov/9820267

[2] https://www.amazon.co.uk/SCAM-So-Called-Alternative-Medicine-Societas/dp/1845409701/ref=pd_rhf_dp_p_img_2?_encoding=UTF8&psc=1&refRID=449PJJDXNTY60Y418S5J

[3] https://www.amazon.co.uk/Text-Book-Philosophy-Chiropractic-Chiropractors-Adjuster/dp/1635617243/ref=sr_1_1?keywords=DD+Palmer&qid=1581002156&sr=8-1

About one in three individuals have elevated blood pressure. This is bad news because hypertension is one of the most important risk factors for cardiovascular events like strokes and heart attacks. Luckily, there are many highly effective approaches for treating elevated blood pressure (diet, life-style, medication, etc.), and the drug management of hypertension has improved over the last few decades.

But unfortunately all anti-hypertensive drugs have side-effects and some patients look towards so-called alternative medicine (SCAM) to normalise their blood pressure. Therefore, we have to ask: are SCAMs effective treatments for hypertension? Because of the prevalence of hypertension, this is a question of great importance for public health.

In 2005, I addressed the issue by publishing a review entitled ‘Complementary/alternative medicine for hypertension: a mini-review‘. Here is its abstract:

Many hypertensive patients try complementary/alternative medicine for blood pressure control. Based on extensive electronic literature searches, the evidence from clinical trials is summarised. Numerous herbal remedies, non-herbal remedies and other approaches have been tested and some seem to have antihypertensive effects. The effect size is usually modest, and independent replications are frequently missing. The most encouraging data pertain to garlic, autogenic training, biofeedback and yoga. More research is required before firm recommendations can be offered.

Since the publication of this paper, more systematic reviews have become available. In order to get an overview of this evidence, I conducted a few simple Medline searches for systematic reviews (SRs) of SCAM published between 2005 and today. I included only SRs that were focussed on just one specific therapy as a treatment of just one specific condition, namely hypertension (omitting SRs with titles such as ‘Alternative treatments for cardiovascular conditions’). Reviews on prevention were also excluded. Here is what I found (the conclusions of each SR is quoted verbatim):

  1. A 2020 SR of auricular acupressure including 18 RCTs: The results demonstrated a favorable effect of auricular acupressure to reduce blood pressure and improve sleep in patients with hypertension and insomnia. Further studies to better understand the acupoints and intervention times of auricular acupressure are warranted.
  2. A 2020 SR of Chinese herbal medicines (CHM) including 30 studies: CHM combined with conventional Western medicine may be effective in lowering blood pressure and improving vascular endothelial function in patients with hypertension.
  3. A 2020 SR of Tai chi including 28 RCTs: Tai Chi could be recommended as an adjuvant treatment for hypertension, especially for patients less than 50 years old.
  4. A 2020 SR of Tai chi including 13 trials: Tai chi is an effective physical exercise in treating essential hypertension compared with control interventions.
  5. A 2020 SR of Tai chi including 31 controlled clinical trials: Tai Ji Quan is a viable antihypertensive lifestyle therapy that produces clinically meaningful BP reductions (i.e., 10.4 mmHg and 4.0 mmHg of SBP and DBP reductions, respectively) among individuals with hypertension.
  6. A 2020 SR of pycnogenol including 7 trials:  the present meta-analysis does not suggest any significant effect of pycnogenol on BP.
  7. A 2019 SR of Policosanol including 19 studies: Policosanol could lower SBP and DBP significantly; future long term studies are required to confirm these findings in the general population.
  8. A 2019 SR of dietary phosphorus including 14 studies: We found no consistent association between total dietary phosphorus intake and BP in adults in the published literature nor any randomized trials designed to examine this association.
  9. A 2019 SR of ginger including 6 RCTs: ginger supplementation has favorable effects on BP.
  10. A 2019 SR of corn silk tea (CST) including 5 RCTs: limited evidence showed that CST plus antihypertensive drugs might be more effective in lowering blood pressure compared with antihypertensive drugs alone.
  11. A 2019 SR of blood letting including 7 RCTs: no definite conclusions regarding the efficacy and safety of BLT as complementary and alternative approach for treatment of hypertension could be drew due to the generally poor methodological design, significant heterogeneity, and insufficient clinical data.
  12. A 2019 SR of Xiao Yao San (XYS) including 17 trials: XYS adjuvant to antihypertensive drugs maybe beneficial for hypertensive patients in lowering BP, improving depression, regulating blood lipids, and inhibiting inflammation.
  13. A 2019 SR of Chinese herbal medicines including 9 RCTs: Chinese herbal medicine as complementary therapy maybe beneficial for postmenopausal hypertension.
  14. A 2019 Cochrane review of guided imagery including 2 trials: There is insufficient evidence to inform practice about the use of guided imagery for hypertension in pregnancy.
  15. A 2019 Cochrane review of acupuncture including 22 RCTs: At present, there is no evidence for the sustained BP lowering effect of acupuncture that is required for the management of chronically elevated BP.
  16. A 2019 SR of wet cupping including 7 RCTs: no firm conclusions can be drawn and no clinical recommendations made.
  17. A 2019 SR of transcendental meditation (TM) including 9 studies: TM was associated with within-group (but not between-groups) improvements in BP.
  18. A 2019 SR of yoga including 49 trials: yoga is a viable antihypertensive lifestyle therapy that produces the greatest BP benefits when breathing techniques and meditation/mental relaxation are included.
  19. A 2018 SR of mindfulness-based stress reduction (MBSR) including 5 studies: The MBSR program is a promising behavioral complementary therapy to help people with hypertension lower their blood pressure
  20. A 2018 SR of beetroot juice (BRJ) including 11 studies: BRJ supplementation should be promoted as a key component of a healthy lifestyle to control blood pressure in healthy and hypertensive individuals.
  21. A 2018 SR of taurine including 7 studies: ingestion of taurine at the stated doses and supplementation periods can reduce blood pressure to a clinically relevant magnitude, without any adverse side effects.
  22. A 2018 SR of acupuncture including 30 RCTs: there is inadequate high quality evidence that acupuncture therapy is useful in treating hypertension.
  23. A 2018 SR of co-enzyme Q10 including 17 RCTs: CoQ10 supplementation may result in reduction in SBP levels, but did not affect DBP levels among patients with metabolic diseases.
  24. A 2018 SR of a traditional Chinese formula Longdanxiegan decoction (LDXGD) including 9 trials: Due to poor methodological quality of the included trials, as well as potential reporting bias, our review found no conclusive evidence for the effectiveness of LDXGD in treating hypertension.
  25. A 2018 SR of viscous fibre including 22 RCTs: Viscous soluble fiber has an overall lowering effect on SBP and DBP.
  26. A 2017 SR of yoga breathing exercise (pranayama) including 13 studies: The pranayama’s effect on BP were not robust against selection bias due to the low quality of studies. But, the lowering BP effect of pranayama is encouraging.
  27. A 2017 SR of dietary nitrate supplementation including 13 trials: Positive effects of medium-term dietary nitrate supplementation on BP were only observed in clinical settings, which were not corroborated by more accurate methods such as 24-h ambulatory and daily home monitorings.
  28. A 2017 SR of Vitamin D supplementation including 8 RCTs: vitamin D is not an antihypertensive agent although it has a moderate SBP lowering effect.
  29. A 2017 SR of pomegranate including 8 RCTs: The limited evidence from clinical trials to date fails to convincingly show a beneficial effect of pomegranate on blood pressure
  30. A 2017 SR of ‘forest bathing’ including 20 trials:  This systematic review shows a significant effect of Shinrin-yoku on reduction of blood pressure.
  31. A 2017 SR of Niuhuang Jiangya Preparation (NHJYP) including 12 RCTs: Our review indicated that NHJYP has some beneficial effects in EH patients with liver-yang hyperactivity and abundant phlegm-heat syndrome.
  32. A 2017 SR of Chinese medicines (CM) including 24 studies: CM might be a promising approach for the elderly with isolated systolic hypertension, while the evidence for CM employed alone was insufficient.
  33. A 2017 SR of beetroot juice including 22 RCTs: Our results demonstrate the blood pressure-lowering effects of beetroot juice and highlight its potential NO3-independent effects.
  34. A 2017 SR of blueberry including 6 RCTs: the results from this meta-analysis do not favor any clinical efficacy of blueberry supplementation in improving BP
  35. A 2016 Cochrane review of co-enzyme Q10 including 3 RCTs: This review provides moderate-quality evidence that coenzyme Q10 does not have a clinically significant effect on blood pressure.
  36. A 2016 SR of Nigella sativa including 11 RCTs: short-term treatment with N. sativa powder can significantly reduce SBP and DBP levels.
  37. A 2016 SR of vitamin D3 supplementation including 30 RCTs: Supplementation may be beneficial at daily doses >800 IU/day for <6 months in subjects ≥50 years old.
  38. A 2016 SR of anthocyanin supplementation including 6 studies: results from this meta-analysis do not favor any clinical efficacy of supplementation with anthocyanins in improving blood pressure.
  39. A 2016 SR of flaxseed including 15 trials: This meta-analysis of RCTs showed significant reductions in both SBP and DBP following supplementation with various flaxseed products.
  40. A 2016 SR of massage therapy including 9 RCTs: This systematic review found a medium effect of massage on SBP and a small effect on DBP in patients with hypertension or prehypertension.
  41. A 2015 SR of massage therapy including 24 studies: There is some encouraging evidence of massage for essential hypertension.
  42. A 2015 SR of transcendental meditation (TM) including 12 studies: an approximate reduction of systolic and diastolic BP of -4.26 mm Hg (95% CI=-6.06, -2.23) and -2.33 mm Hg (95% CI=-3.70, -0.97), respectively, in TM groups compared with control groups.
  43. A 2015 SR of Zhen Wu Decoction (ZWD) including 7 trials: This systematic review revealed no definite conclusion about the application of ZWD for hypertension due to the poor methodological quality, high risk of bias, and inadequate reporting on clinical data.
  44. A 2015 SR of acupuncture including 23 RCTs: Our review provided evidence of acupuncture as an adjunctive therapy to medication for treating hypertension, while the evidence for acupuncture alone lowing BP is insufficient.
  45. A 2015 SR of xuefu zhuyu decoction (XZD) including 15 studies: This meta-analysis provides evidence that XZD is beneficial for hypertension.
  46. A 2015 SR of Shenqi pill including 4 RCTs: This systematic review firstly provided no definite evidence for the efficacy and safety of Shenqi pill for hypertension based on the insufficient data.
  47. A 2015 SR of Jian Ling Decoction (JLD) including 10 trials: Owing to insufficient clinical data, it is difficult to draw a definite conclusion regarding the effectiveness and safety of JLD for essential hypertension.
  48. A 2015 SR of Chinese herbal medicines (CHM) including 5 trials: No definite conclusions about the effectiveness and safety of CHM for resistant hypertension could be drawn.
  49. A 2015 SR of Chinese medicines (CM) including 27 RCTs: When combined with Western medines, CM as a complementary treatment approach has certain effects for the control of hypertension and protection of target organs.
  50. A 2015 SR of berberine including 17 RCTs: This study indicates that berberine has comparable therapeutic effect on type 2 DM, hyperlipidemia and hypertension with no serious side effect.
  51. A 2015 SR of garlic including 9 double-blind trials: Although evidence from this review suggests that garlic preparations may lower BP in hypertensive individuals, the evidence is not strong.
  52. A 2015 SR of chlorogenic acids (CGAs) including 5 studies: CGA intake causes statistically significant reductions in systolic and diastolic blood pressures.
  53. A 2014 SR of omega-3 fatty acid supplementation including 70 RCTs:  provision of EPA+DHA reduces systolic blood pressure, while provision of ≥2 grams reduces diastolic blood pressure.
  54. A 2014 SR of green tea including 20 RCTs: Green tea intake results in significant reductions in systolic blood pressure
  55. A 2014 SR of probiotics including 9 studies: consuming probiotics may improve BP by a modest degree, with a potentially greater effect when baseline BP is elevated, multiple species of probiotics are consumed, the duration of intervention is ≥8 weeks, or daily consumption dose is ≥10(11) colony-forming units.
  56. A 2014 SR of yoga including 17 trials: The evidence for the effectiveness of yoga as a treatment of hypertension is encouraging but inconclusive.
  57. A 2014 SR of yoga including 7 RCTs: very low-quality evidence was found for effects of yoga on systolic and diastolic blood pressure.
  58. A 2014 SR of yoga including 120 studies: yoga is an effective adjunct therapy for HPT and worthy of inclusion in clinical guidelines.
  59. A 2014 SR of moxibustion:  a beneficial effect of using moxibustion interventions on KI 1 to lower blood pressure compared to antihypertensive drugs.
  60. A 2014 SR of acupuncture including 4 sham-controlled RCTs: acupuncture significantly lowers blood pressure in patients taking antihypertensive medications.
  61. A 2014 SR of Tuina including 7 RCTs: The findings from our review suggest that Tuina might be a beneficial adjuvant for patients with EH
  62. A 2014 SR of ‘kidney tonifying’ (KT) Chinese herbal mixture including 6 studies: Compared with antihypertensive drugs alone, KT formula combined with antihypertensive drugs may provide more benefits for patients with SH.
  63. A 2014 SR of Tongxinluo capsule including 25 studies : There is some but weak evidence about the effectiveness of TXL in treating patients with hypertension.
  64. A 2014 SR of moxibustion including 5 RCTs: no confirm conclusion about the effectiveness and safety of moxibustion as adjunctive treatment for essential hypertension could be made
  65. A 2013 SR of Qi Ju Di Huang Wan (QJDHW) including 10 RCTs: QJDHW combined with antihypertensive drugs might be an effective treatment for lowering blood pressure and improving symptoms in patients with essential hypertension.
  66. A 2013 SR of yoga including 17 studies: Yoga can be preliminarily recommended as an effective intervention for reducing blood pressure.
  67. A 2013 SR of Tianma Gouteng Yin (TGY) including 22 RCTs: No confirmed conclusion about the effectiveness and safety of TGY as adjunctive treatment for essential hypertension … could be made.
  68. A 2013 SR of Zhen Gan Xi Feng Decoction (ZGXFD) including 6 RCTs: ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH
  69. A 2013 SR of Tianmagouteng decoction including 9 RCTs: Tianmagouteng decoction can decrease both systolic and diastolic blood pressure.
  70. A 2013 SR of fish oil including 17 RCTs: The small but statistically significant effects of fish-oil supplements in hypertensive participants in this review have important implications for population health and lowering the risk of stroke and ischaemic heart disease.
  71. A 2013 SR of acupuncture including 35 RCTs: While there are some evidences that suggest potential effectiveness of acupuncture for hypertension, the results were limited by the methodological flaws of the studies.
  72. A 2013 SR of yoga including 6 studies: There is some encouraging evidence of yoga for lowering SBP and DBP.
  73. A 2012 SR of spinal manipulation therapy (SMT) including 10 studies: There is currently a lack of low bias evidence to support the use of SMT as a therapy for the treatment of
  74. A 2012 SR of vitamin C including 29 trials: In short-term trials, vitamin C supplementation reduced SBP and DBP.
  75. A 2012 SR of magnesium supplementation including 22 trials: magnesium supplementation appears to achieve a small but clinically significant reduction in BP, an effect worthy of future prospective large randomised trials using solid methodology.
  76. A 2012 SR of Banxia Baizhu Tianma Decoction (BBTD) including 16 RCTs: There is encouraging evidence of BBTD for lowering SBP, but evidence remains weak.
  77. A 2012 SR of Liu Wei Di Huang Wan (LWDHW) including 6 RCTs: LWDHW combined with antihypertensive drugs appears to be effective in improving blood pressure and symptoms in patients with essential hypertension.
  78. A 2012 SR of aromatherapy including 5 studies: The existing trial evidence does not show convincingly that aromatherapy is effective for hypertension.
  79. A 2012 empty Cochrane review: As no trials could be identified, no conclusions can be made about the role of TGYF in the treatment of primary hypertension.
  80. A 2012 SR of yoga including 10 studies: Not only does yoga reduce high BP but it has also been demonstrated to effectively reduce blood glucose level, cholesterol level, and body weight, major problems affecting the American society.
  81. A 2011 SR of L-arginine including 11 RCTs: This meta-analysis provides further evidence that oral L-arginine supplementation significantly lowers both systolic and diastolic BP.
  82. A 2011 SR of soy isoflavones including 14 RCTs: Soy isoflavone extracts significantly decreased SBP but not DBP in adult humans, and no dose-response relationship was observed.
  83. A 2010 SR of moxibustion including 4 RCTs: There is insufficient evidence to suggest that moxibustion is an effective treatment for hypertension.
  84. A 2010 SR of acupunctures including 20 studies: Because of the paucity of rigorous trials and the mixed results, these findings result in limited conclusions. More rigorously designed and powered studies are needed.
  85. A 2010 SR of cupping including 3 trials: the evidence is not significantly convincing to suggest cupping is effective for treating hypertension.
  86. A 2010 empty Cochrane review: There is insufficient evidence to support the benefit of Roselle for either controlling or lowering blood pressure in patients with hypertension.
  87. A 2009 SR of acupuncture including 11 RCTs: the notion that acupuncture may lower high BP is inconclusive.
  88. A 2008 SR of transcendental meditation including 9 studies: The regular practice of Transcendental Meditation may have the potential to reduce systolic and diastolic blood pressure by approximately 4.7 and 3.2 mm Hg, respectively.
  89. A 2008 SR of relaxation therapies including 25 trials:  the evidence in favour of a causal association between relaxation and blood pressure reduction is weak.
  90. A 2007 SR of qigong including 12 RCTs: There is some encouraging evidence of qigong for lowering SBP, but the conclusiveness of these findings is limited.
  91. A 2007 SR of co-enzyme Q10 including 12 trials: coenzyme Q10 has the potential in hypertensive patients to lower systolic blood pressure by up to 17 mm Hg and diastolic blood pressure by up to 10 mm Hg without significant side effects.
  92. A 2007 SR of stress reduction programs including 106 studies: Available evidence indicates that among stress reduction approaches, the Transcendental Meditation program is associated with significant reductions in BP.
  93. A 2006 Cochrance review of magnesium supplementation including 12 RCTs:  the evidence in favour of a causal association between magnesium supplementation and blood pressure reduction is weak and is probably due to bias.
  94. A 2006 Cochrane review of calcium supplementation including 13 RCTs: evidence in favour of causal association between calcium supplementation and blood pressure reduction is weak and is probably due to bias.

ALMOST 100 NEW SRs!

To be honest, if I had known the volume of the material, I would probably not have tackled this task. Since the publication of my mini-review in 2005, there has been an explosion of similar papers:

  • 1 in 2005
  • 2 in 2006
  • 3 in 2007
  • 2 in 2008
  • 1 in 2009
  • 4 in 2010
  • 2 in 2011
  • 8 in 2012
  • 8 in 2013
  • 12 in 2014
  • 12 in 2015
  • 6 in 2016
  • 9 in 2017
  • 7 in 2018
  • 12 in 2019

As this is based on very simple Medline searches, the list is certainly not complete. Despite this fact, several conclusions seem to emerge:

  1. There is no shortage of SCAMs that have been tested for hypertension.
  2. Most seem to have positive effects; in many cases, they seem too good to be true.
  3. Many of the SRs are of poor methodological quality, based on poor quality primary studies, published in less than reputable journals. Some SRs, for instance, include studies without a control group which is likely to lead to false-positive overall conclusions about the effectiveness of the SCAM in question.
  4. In recent years, there are more and more SRs by Chinese authors focussed on Chinese herbal mixtures that are unknown and unobtainable outside China. These SRs are invariably based on studies published in Chinese language in journals that are inaccessible. This means it is almost impossible for the reader, reviewer or editor to check their accuracy. The reliability of the conclusions of these SRs must therefore be doubted.
  5. Most of the primary studies included in the SRs lack long-term data. Thus the usefulness of the SCAM in question is questionable.
  6. With several of the SCAMs, the dose of the treatment and treatment schedule is less than clear. For instance, one might ask how frequently a patient should have acupuncture to control her hypertension.
  7. Some of the SCAMs assessed in these SRs seem of doubtful practicality. For instance, it might not be feasible nor economical for patients to receive regular acupuncture to manage their blood pressure.
  8. Several contradictions emerge from some of the SRs of the same modality. This is particularly confusing because SRs are supposed to be the most reliable type of evidence. In most instances, however, the explanation can easily be found by looking at the quality of the SRs. If SRs are based on uncontrolled studies, or if they fail to critically evaluate the reliability of the included primary trials, they are likely to arrive at conclusions that are too positive. Examples for such confusion are the multiple SRs of co-enzyme Q10 or the three yoga SRs of 2014.
  9. Because of this confusion, SCAM advocates are able to select false-positive SRs to support their opinion that SCAM is effective.
  10. Despite a substantial amount of positive evidence, none of the SCAMs have become part of the routine in the management of hypertension. A 2013 statement by the American Heart Association entitled Beyond medications and diet: alternative approaches to lowering blood pressure: a scientific statement from the american heart association concluded that it is reasonable for all individuals with blood pressure levels >120/80 mm Hg to consider trials of alternative approaches as adjuvant methods to help lower blood pressure when clinically appropriate. A suggested management algorithm is provided, along with recommendations for prioritizing the use of the individual approaches in clinical practice based on their level of evidence for blood pressure lowering, risk-to-benefit ratio, potential ancillary health benefits, and practicality in a real-world setting. 

What lessons might this brief overview of SRs teach us? I think the following points are worth considering:

  • Systematic reviews are the best type of evidence we have for estimating the effectiveness of treatments. But it is essential that they include a strong element of CRITICAL evaluation of the primary studies. Without it, a SR is incomplete and potentially counter-productive.
  • The primary studies of SCAM are far too often of poor quality. This means that researchers should thrive to improve the rigour of their investigations.
  • Both poor-quality primary studies and uncritically conducted SRs are prone to yielding findings that are too good to be true.
  • Editors and reviewers have a responsibility to prevent the publication of trials and SRs that are of poor quality and thus likely to mislead us.
  • Those SCAMs that have shown promising effects on hypertension (for instance Tai chi) should now be submitted to further independent scrutiny to find out whether their efficacy and usefulness can be confirmed, for instance, by 24-h ambulatory and daily home blood pressure monitoring and studies testing their acceptability in real life settings. Subsequently, we ought to determine whether the SCAM in question can be reasonably integrated in routine blood pressure management.
  • The adjunctive use of a SCAM that has been proven to be effective and practical seems a reasonable approach. Yet, it requires proper scientific scrutiny.
  • There is a paucity of cost-effectiveness studies and investigations of the risks of SCAM which needs to be addressed before any SCAM is considered for routine care.

Mindfulness is one of the 150 so-called alternative medicines (SCAMs) that I have evaluated in my recent book ‘Alternative Medicine: A Critical Assessment of 150 Modalities‘. Here is an excerpt from my text:

Mindfulness is a form of meditation which involves bringing one’s attention to experiences occurring in the present moment while sitting silently and paying attention to thoughts, sounds, the sensations of breathing or parts of the body.

    1. Many experts do not consider mindfulness to be an alternative therapy but see it as a set of psychological methods that have long become well-accepted, conventional treatments.
    2. There are several forms of mindfulness meditation; one of the best-known and most thoroughly researched is Mindfulness-Based Stress Reduction developed by Jon Kabat-Zinn (1944- ). It uses a combination of mindfulness meditation, body awareness, and yoga to help people become more mindful.
    3. Mindfulness programs are currently popular and have been widely adopted in schools, hospitals, and other settings. They are also being applied to initiatives such as for healthy aging, weight management, athletic performance enhancement, for children with special needs, and as a help during the perinatal period.
    4. Novices are advised to start with short periods of about 10 minutes of meditation practice per day. With regular practice, it becomes easier to keep the attention focused and the length of time spent practising can be extended.
    5. There has been much research interest in mindfulness, and many studies are now available. However, the quality of these trials is often poor which is one reason why the evidence is less clear than one would hope.
    6. Several systematic reviews have assessed mindfulness for various medical conditions, e. g.:Image result for mindfulness meditation
    • A systematic review of mindfulness for chronic headaches concluded that, due to the low number, small scale and often high or unclear risk of bias of included randomized controlled trials, the results are imprecise; this may be consistent with either an important or negligible effect. Therefore, more rigorous trials with larger sample sizes are needed.[1]
    • A systematic review of mindfulness for addictions found support for the effectiveness of the mindfulness-based interventions.[2]
    • An overview included 26 reviews and found a substantially consistent picture… Improvements in depressive disorders, particularly recurrent major depression, were strongly supported. Evidence for other psychological conditions was limited by lack of data. In populations with physical conditions, the evidence for significant improvements in psychological well-being was clear, regardless of population or specific mindfulness intervention. Changes in physical health measures were inconclusive; however, pain acceptance and coping were improved.[3]
    1. Some reports have linked mindfulness to increasing fear and anxiety panic or “meltdowns” after treatments. However, these seem to be rare events; in general, mindfulness is considered to be a safe therapy.

[1] https://www.ncbi.nlm.nih.gov/pubmed/29863407

[2] https://www.ncbi.nlm.nih.gov/pubmed/29651257

[3] https://www.ncbi.nlm.nih.gov/pubmed/29306938

Now there is new evidence regarding the safety of Mindfulness, including an estimate of the incidence of adverse effects. An article in the NEW SCIENTIST warned that about one in 12 people who try meditation experience an unwanted negative effect, usually a worsening in depression or anxiety, or even the onset of these conditions for the first time, according to the first systematic review of the evidence. “For most people it works fine but it has undoubtedly been overhyped and it’s not universally benevolent,” says Miguel Farias at Coventry University in the UK, one of the researchers behind a paper which as yet is not available on-line.

Farias’s team combed through medical journals and found 55 relevant studies. Once the researchers had excluded those that had deliberately set out to find negative effects, they worked out the prevalence of people who experienced harms within each study and then calculated the average, adjusted for the study size, a common method in this kind of analysis. They found that about 8 per cent people who try meditation experience an unwanted effect. “People have experienced anything from an increase in anxiety up to panic attacks,” says Farias. They also found instances of psychosis or thoughts of suicide.

I will add a link to the original paper, once it has been published

 

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