We have repeatedly discussed the fact that alternative medicine (AM) is by no means free of risks. I find it helpful to divide them into two broad categories:
- direct risks of the intervention (such as stroke due to neck manipulation, or cardiac tamponade caused by acupuncture, or liver damage due to a herbal remedy) and
- indirect risks usually due to the advice given by AM practitioners.
The latter category is often more important than the former. It includes delay of effective treatment due to treatment with an ineffective or less effective form of AM. It is clear that this will cause patients to suffer unnecessarily.
Several investigations have recently highlighted this important problem, including this study from Singapore which assessed the predictors of AM-use in patients with early inflammatory arthritis (EIA), and its impact on delay to initiation of disease-modifying anti-rheumatic drugs (DMARD). Data were collected prospectively from EIA patients aged ≥ 21 years. Current or prior AM-use was ascertained by face-to-face interviews. Predictors of AM-use and its effect on time to DMARD initiation were determined by multivariate logistic regression and Cox proportional hazards, respectively.
One hundred and eighty patients were included: 83.9% had rheumatoid arthritis, 57% were seropositive. Median (IQR). Chinese race, being non-English speaking, smoking and high DAS28 were independent predictors of AM-use. AM-users initiated DMARD later (median [IQR] 21.5 [13.1-30.4] vs. 15.6 [9.4-22.7] weeks in non-users, P = 0.005). AM-use and higher DAS28 were associated with a longer delay to DMARD initiation. Race, education level, being non-English speaking, smoking and sero-positivity were not associated.
The authors concluded that healthcare professionals should be aware of the unique challenges in treating patients with EIA in Asia. Healthcare beliefs regarding AM may need to be addressed to reduce treatment delay.
These findings are not dissimilar to results previously discussed, for instance:
- AM-use delays cancer diagnosis.
- The advice of non-medically qualified practitioners may delay cancer therapy.
- Chiropractic care may delay referral to effective treatment.
- Consultations with homeopaths can delay effective therapy.
The only solution to the problem I can think of would be to educate AM practitioners and the public such that they are aware of the issue and do everything possible to prevent such problems. But this is, of course, easier said than done, and it seems more than just optimistic to hope that such endeavours might be successful. The public is currently bombarded with misleading information and outright lies about AM (many of my previous post have addressed this problem). And practitioners would have to operate against their own financial interest to prevent these problems from occurring.
This means that treatment delays caused by AM-use and advice from AM practitioners are inevitable…
unless you have a better idea.
If so, please let me know.
On this blog, we have often discussed the risks of spinal manipulation. As I see it, the information we have at present suggests that
- mild to moderate adverse effects are extremely frequent and occur in about half of all patients;
- serious adverse effects are being reported regularly;
- the occur usually with chiropractic manipulations of the neck (which are not of proven efficacy for any condition) and often relate to vascular accidents;
- the consequences can be permanent neurological deficits and even deaths;
- under-reporting of such cases might be considerable and therefore precise incidence figures are not available;
- there is no system to accurately monitor the risks;
- chiropractors are in denial of these problems.
Considering the seriousness of these issues, it is important to do more rigorous research. Therefore, any new paper published on this subject is welcome. A recent article might shed new light on the topic.
The objective of this systematic review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. A systematic searches were performed in 6 electronic databases up to December 2014. Of the initial 1043 articles thus located, 144 were included, containing 227 cases. 117 cases described male patients with a mean age of 45 and a mean age of 39 for females. Most patients were treated by chiropractors (66%). Manipulation was reported in 95% of the cases, and neck pain was the most frequent indication for the treatment. Cervical arterial dissection (CAD) was reported in 57% of the cases and 45.8% had immediate onset symptoms. The overall distribution of gender for CAD was 55% for female. Patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted, except that women seemed more at risk for CAD. The authors of this review concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.
This article provides little new information; but it does confirm what I have been saying since many years: NECK MANIPULATIONS ARE ASSOCIATED WITH SERIOUS RISKS AND SHOULD THEREFORE BE AVOIDED.
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.
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.
In the US, some right-wing politicians might answer this question in the affirmative, having suggested that American citizens don’t really need healthcare, if only they believed stronger in God. Here in the UK, some right-wing MPs are not that far from such an attitude, it seems.
A 2012 article in the ‘Plymouth Harald’ revealed that the Tory MP for South West Devon, Gary Streeter , has challenged the UK Advertising Standards Authority (ASA) for banning claims that ‘God can heal’. Mr Streeter was reported to have written to the ASA demanding it produce “indisputable scientific evidence” to prove that prayer does not work – otherwise they will raise the issue in Parliament, he threatened. Mr Streeter also accused the ASA of “poor judgement” after it banned a Christian group from using leaflets stating: “Need healing? God can heal today!… We believe that God loves you and can heal you from any sickness.”
The ASA said such claims were misleading and could discourage people from seeking essential medical treatment.
The letter to ASA was written on behalf of the all-party Christians in Parliament group, which Mr Streeter chairs. Here are a few quotes from this bizarre document:
“We write to express our concern at this decision and to enquire about the basis on which it has been made… It appears to cut across two thousand years of Christian tradition and the very clear teaching in the Bible. Many of us have seen and experienced physical healing ourselves in our own families and churches and wonder why you have decided that this is not possible. On what scientific research or empirical evidence have you based this decision?… You might be interested to know that I (Gary Streeter) received divine healing myself at a church meeting in 1983 on my right hand, which was in pain for many years. After prayer at that meeting, my hand was immediately free from pain and has been ever since. What does the ASA say about that? I would be the first to accept that prayed for people do not always get healed, but sometimes they do… It is interesting to note that since the traumatic collapse of the footballer Fabrice Muamba the whole nation appears to be praying for a physical healing for him. I enclose some media extracts. Are they wrong also and will you seek to intervene? … We invite your detailed response to this letter and unless you can persuade us that you have reached your ruling on the basis of indisputable scientific evidence, we intend to raise this matter in Parliament.”
Mr Streeter displays, of course, a profound and embarrassing ignorance of science, healthcare and common sense:
- ‘Indisputable’ evidence that something is ineffective is usually not obtainable in science.
- In healthcare it is also not relevant, because we try to employ treatments that are proven to work and avoid those for which this is not the case.
- It is common sense that those who make a claim must also prove it to be true; those who doubt it need not prove that it is untrue.
- Chronic pain disappearing spontaneously is not uncommon.
- The plural of anecdote is anecdotes, not evidence!
Personally, I find it worrying that a man with such views sits in parliament and exerts influence over me and our country.
Systematic reviews are aimed at summarising and critically evaluating the evidence on a specific research question. They are the highest level of evidence and are more reliable than anything else we have. Therefore, they represent a most useful tool for both clinicians and researchers.
But there are, of course, exceptions. Take, for instance, this recent systematic review by researchers from the
- Texas Chiropractic College, Pasadena, the Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport,
- Department of Planning, Policy and Design, University of California, Irvine,
- VA Puget Sound Health Care System, Tacoma,
- New York Chiropractic College, Seneca Falls,
- Logan University College of Chiropractic, Chesterfield,
- University of Western States, Portland.
Dr Gabriella Day is a GP in England who describes herself and her beliefs as follows: “I began training in homeopathy as it is clear that for many conditions conventional treatment options are not effective and can have unwanted side effects. It seemed to me that there must be another way to help people suffering from symptoms such as these… I believe in whole person medicine. No illness exists in isolation. The human body is immensely sophisticated and complicated and we do not understand it fully. Therefore the illness cannot be separated from the person suffering the disease. This may be as simple as stress impairing the immune system to far more complex interactions. Homeopathic treatment seeks to match the underlying disturbance in the system and stimulate the body to correct itself.”
I do not know Dr Day, but she caught my attention recently when she published an article in THE HIPPOCRATIC POST (I had never heard of this publication before!). It is, I think, sufficiently noteworthy to show you some excerpts (the references [in square brackets] were added by me, and they refer to my comments below):
START OF QUOTES
…Homeopathy can be helpful for pretty much any condition , whether as the main treatment , as a complement to a conventional treatment  to speed up the healing process , or to lessen the side-effects of a pharmacological medication . It can be helpful in the treatment of emotional problems , physical problems  and for multi-morbidity patients . I find it an invaluable tool in my GP’s toolbox and regularly see the benefits of homeopathy in the patients I treat …
There are many conditions for which I have found homeopathy to be effective … There are, however, a multitude of symptomatic treatments available to suppress symptoms, both on prescription and over-the-counter. Most symptoms experienced by patients in this context result from the body’s attempt to eliminate the infection. Our immune systems have spent thousands of years refining this response; therefore it seems counter-intuitive to suppress it .
For these types of acute conditions homeopathy can work with the body to support it . For instance, homeopathic Arsenicum album (arsenic) is a classic remedy for diarrhoea and vomiting that can be taken alongside essential oral rehydration . And in influenza I’ve found Eupatorium perfoliatum (ague or feverwort) to be very helpful if the patient is suffering with bony pain .
…Unless it is clinically imperative for a pharmacological intervention, I will always consider homeopathy first  and have successfully prescribed the homeopathic remedy Nux vomica (strychnine) for women suffering from morning sickness . Problems associated with breastfeeding such as mastitis have also responded well to the classic remedies Belladonna (deadly nightshade) and Phytolacca (pokeweed), while I have found Urtica urens (dog nettle) effective in switching off the milk supply to prevent engorgement when the mother stops breastfeeding .
…“heart sink” patients are clearly suffering from pain and discomfort, which is blighting their lives. This is understandably frustrating for them, for they know full well something is awry but there is no medical evidence for this… Homeopathy affords me another approach in trying to help these patients [1,3]. It doesn’t work for them all, but I’m frequently surprised at how many it does help .
The beauty of homeopathy is that it combines mental and emotional symptoms with physical symptoms . When the right remedy is found it appears to stimulate the body to recognise how it is being dysfunctional and corrects this, with no suppression, just a correction of the underlying disturbance . Thus homeopathy not only eliminates unwanted symptoms , it dramatically improves a patient’s overall well-being .
…homeopathy… enables me to reduce the number of painkillers and other drugs I’m prescribing [1,3]. This is particularly true for older multi-morbidity, polypharmacy patients  who are often taking huge amounts of medication.
Contrary to what most homeopaths will tell you, I believe homeopathic treatment does have side-effects – positive side-effects!  It fosters an enhanced doctor patient relationship . The process of eliciting the relevant information to select a remedy enables me to better understand the patient’s condition and helps me to get to know them better . And the patient, seeing that the doctor is interested in the idiosyncrasies and detail of their disease, finds themselves heard and understood . In short, since training in homeopathy I enjoy my job as a GP and my relationship with patients so much more .
Dr Gabriella Day BSc, MBBS, MRCP, DCH, MRCGP, MFHom
END OF QUOTES
- statement without good evidence,
- Hahnemann was vehemently against combining homeopathy with other treatments and called clinicians who disregarded this ‘traitors’,
- statement of belief,
- wrong assumption,
- questionable ethics.
I have recently attempted to slip into the brain of lay-homeopaths and shown how illogical, misguided and wrong the arguments of such enthusiasts really are. Surely, the logic of a doctor homeopath must be better, I then thought. Once you have studied medicine, you have learnt an awful lot of things about the body, disease, therapy, etc., etc., I felt.
Judging from the above article, I might have been wrong.
Olivia Newton-John is postponing her June U.S. and Canadian concert tour dates, as the back pain that initially caused her to postpone the first half of her concert tour, has been diagnosed as bone metastases form her earlier breast cancer. She now intends to complete a short course of photon radiation therapy along with alternative therapies for improving her quality of life. “I decided on my direction of therapies after consultation with my doctors and natural therapists and the medical team at my Olivia Newton-John Cancer Wellness and Research Centre in Melbourne”, Newton-John said. The actress had been diagnosed with breast cancer in 1992. At that time, she underwent chemotherapy after initially trying alternative treatments like acupuncture and homeopathy.
Olivia Newton-John’s daughter Chloe Lattanzi has said her mum would use cannabis oil to aid in her fight against cancer, while long-time friend John Farnham has thrown his support behind the singer. Lattanzi owns a legal marijuana farm in Oregon and said that her mum would also use other natural healing remedies plus modern medicine in addition to cannabis oil to help her battle the deadly disease for the second time.
The Olivia Newton-John Cancer Wellness & Research Centre is a treatment centre of Austin Health, an Australian public hospital. They say that “anyone with a referral from their doctor can be treated here, regardless of the stage of their treatment or insurance status. At the ONJ Centre your care is built around your individual needs. This includes your physical, psychological and emotional health. Every patient is surrounded by a multidisciplinary team of cancer specialists, allied health and wellbeing therapists. Your dedicated treatment team work together to guide you through your optimal treatment pathway. Learn more about the cancer treatments we deliver at the ONJ Centre, how we support you through your care, and find answers to commonly asked questions.”
Their therapies include acupuncture and several other alternatives used for palliation, but the site seems refreshingly free of false claims and quackery. On their website, they say that “palliative care assists patients who have a life limiting illness to be as symptom free as possible. We work with you to meet your emotional, spiritual and practical needs in a holistic way. Our support is also extended to your family and carers.”
Altogether, this seems like a fairly reasonable approach. Olivia might have learnt a lesson the hard way when her initial breast cancer did not respond to homeopathy. Let’s hope she does get her metastases under control with cutting edge cancer care and is able to keep her spirits up with the additional help of a little complementary medicine.
This study tested chondroitin sulfate 800 mg/day (CS) pharmaceutical-grade in the management of symptomatic knee osteoarthritis. It was designed as a prospective, randomised, 6-month, 3-arm, double-blind, double-dummy, placebo and celecoxib (200 mg/day)-controlled trial. The primary endpoints were changes in pain on a Visual Analogue Scale (VAS) and in the Lequesne Index (LI). Minimal-Clinically Important Improvement (MCII), Patient-Acceptable Symptoms State (PASS) were used as secondary endpoints.
A total of 604 patients, diagnosed according to American College of Rheumalogy (ACR) criteria, were recruited in five European countries and followed for 182 days. CS and celecoxib showed a greater significant reduction in pain and LI than placebo. In the intention-to-treat (ITT) population, pain reduction in VAS at day 182 in the CS group (−42.6 mm) and in celecoxib group (−39.5 mm) was significantly greater than the placebo group (−33.3 mm) (p=0.001 for CS and p=0.009 for celecoxib). No difference observed between CS and celecoxib. Similar trend for the LI, as reduction in this metric in the CS group (−4.7) and celecoxib group (−4.6) was significantly greater than the placebo group (−3.7) (p=0.023 for CS and p=0.015 for celecoxib). Again, no difference was observed between CS and celecoxib. Both secondary endpoints (MCII and PASS) at day 182 improved significantly in the CS and celecoxib groups. All treatments demonstrated excellent safety profiles.
The authors concluded that a 800 mg/day pharmaceutical-grade CS is superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee osteoarthritis (OA) patients. This formulation of CS should be considered a first-line treatment in the medical management of knee OA.
In my view, this is a good study with clear and useful results: CS seems to be efficacious and safe. Another recent study confirmed the superiority of CS over celecoxib at reducing cartilage volume loss in knee OA patients.
The current Cochrane review does not yet account for the new data; it concluded cautiously positive: A review of randomized trials of mostly low quality reveals that chondroitin (alone or in combination with glucosamine) was better than placebo in improving pain in participants with osteoarthritis in short-term studies. The benefit was small to moderate with an 8 point greater improvement in pain (range 0 to 100) and a 2 point greater improvement in Lequesne’s index (range 0 to 24), both seeming clinically meaningful. These differences persisted in some sensitivity analyses and not others. Chondroitin had a lower risk of serious adverse events compared with control. More high-quality studies are needed to explore the role of chondroitin in the treatment of osteoarthritis. The combination of some efficacy and low risk associated with chondroitin may explain its popularity among patients as an over-the-counter supplement.
The call for more high quality trials was justified but has now been answered. In my view, CS can be considered an evidence-based option in the management of OA.
A recent post discussed a ‘STATE OF THE ART REVIEW’ from the BMJ. When I wrote it, I did not know that there was more to come. It seems that the BMJ is planning an entire series on the state of the art of BS! The new paper certainly looks like it:
Headaches, including primary headaches such as migraine and tension-type headache, are a common clinical problem. Complementary and integrative medicine (CIM), formerly known as complementary and alternative medicine (CAM), uses evidence informed modalities to assist in the health and healing of patients. CIM commonly includes the use of nutrition, movement practices, manual therapy, traditional Chinese medicine, and mind-body strategies. This review summarizes the literature on the use of CIM for primary headache and is based on five meta-analyses, seven systematic reviews, and 34 randomized controlled trials (RCTs). The overall quality of the evidence for CIM in headache management is generally low and occasionally moderate. Available evidence suggests that traditional Chinese medicine including acupuncture, massage, yoga, biofeedback, and meditation have a positive effect on migraine and tension headaches. Spinal manipulation, chiropractic care, some supplements and botanicals, diet alteration, and hydrotherapy may also be beneficial in migraine headache. CIM has not been studied or it is not effective for cluster headache. Further research is needed to determine the most effective role for CIM in patients with headache.
My BS-detector struggled with the following statements:
- integrative medicine (CIM), formerly known as complementary and alternative medicine (CAM) – the fact that CIM is a nonsensical new term has been already mentioned in the previous post;
- evidence informed modalities – another new term! evidence-BASED would be too much? because it would require using standards that do not apply to CIM? double standards promoted by the BMJ, what next?
- CIM commonly includes the use of nutrition – yes, so does any healthcare or indeed life!
- the overall quality of the evidence for CIM in headache management is generally low and occasionally moderate – in this case, no conclusions should be drawn from it (see below);
- evidence suggests that traditional Chinese medicine including acupuncture, massage, yoga, biofeedback, and meditation have a positive effect on migraine and tension headaches – no, it doesn’t (see above)!
- further research is needed to determine the most effective role for CIM in patients with headache – this sentence does not even make the slightest sense to me; have the reviewers of this article been asleep?
And this is just the abstract!
The full text provides enough BS to fertilise many acres of farmland!
Moreover, the article is badly researched, cherry-picked, poorly constructed, devoid of critical input, and poorly written. Is there anything good about it? You tell me – I did not find much!
My BS-detector finally broke when we came to the conclusions:
The use of CIM therapies has the potential to empower patients and help them take an active role in their care. Many CIM modalities, including mind-body therapies, are both self selected and self administered after an education period. This, coupled with patients’ increased desire to incorporate integrative medicine, should prompt healthcare providers to consider and discuss its inclusion in the overall management strategy. Low to moderate quality evidence exists for the effectiveness of some CIM therapies in the management of primary headache. The evidence for and use of CIM is continuously changing so healthcare professionals should direct their patients to reliable and updated resources, such as NCCIH.
WHAT IS HAPPENING TO THE BMJ?
IT USED TO BE A GOOD JOURNAL!