systematic review
It seems that some people are pushing the notion that Boiron’s homeopathic product
Oscillococcinum®
might be helpful for the prevention and/or treatment of the Corona virus infection. To get an idea how implausible this assumption is, read my previous post on the subject.
The website of Boiron, the producer of the product, seems undeterred by plausibility and states the following:
Clinical studies show Boiron Oscillococcinum (Oscillo®) reduces the duration and severity of flu-like symptoms when taken at the onset of symptoms.1-2 Oscillo does not cause drowsiness and has no known or reported drug interactions.
Uses*
- Temporarily relieves flu-like symptoms such as body aches, headache, fever, chills and fatigue
- Non-drowsy; no drug interactions
- Easy-to-take, quick-dissolving pellets
- For everyone 2 years of age and older
- Make sure your patients always have Oscillococcinum on hand—it works best when taken at the first sign of symptoms. Help your patients feel better before they feel worse.
While this text does not state that Oscillococcinum works for the coronavirus, one could easily read it as implying it, particularly if one also considers this tweet:
Oscillococcinum USA
@OscilloUSA
Getting sick when travelling can ruin the best of vacations. Take non-drowsy Oscillococcinum the moment you feel body aches, headache, fever, chills or fatigue coming on. http://bit.ly/2BGCmCz
________________________________________________________________________________
On the Internet we find many much more direct claims. Take this website, for instance:
The commonly indicated Homeopathic remedies for Coronavirus are: –
• OSCILLOCOCCINUM
• Arsenic Album
• INFLUENZINUM
**However, for best results contact a Qualified Homeopathic doctor so that correct medicines can be prescribed.
And even some politicians promote such irresponsible nonsense.
________________________________________________________________________________
All the claims about Oscillococcinum have one thing in common: they are not evidence based! Any notion that it might work against the coronavirus is pure fantasy. And the above statement by Boiron is based on two cherry-picked studies. The totality of the evidence, however, does not show that Oscillococcinum is effective. The current Cochrane review says about its effectiveness: There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum(®) in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum(®) could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum(®).
The reason, I guess, why this conclusion is not more forthright stating THERE IS NO GOOD EVIDENCE THAT OSCILLOCOCCINUM HAS ANY EFFECT can be found in the list of conflicts of interest of the paper’s authors:
All three review authors are research‐active in the field of homeopathy. They were members of the International Scientific Committee for Homeopathic Investigations (ISCHI), whose membership also included two employees of Boiron (the manufacturers of Oscillococcinum®), and whose committee activities ceased in July 2013. Progress with the Cochrane Review on Oscillococcinum® was presented briefly at ISCHI meetings in 2010 and 2011. The drafting of this Cochrane Review was carried out independently of those communications and of the authors’ other ongoing research activity. ISCHI has not run or sponsored any research on Oscillococcinum®.
Robert T Mathie: Dr Mathie is Research Development Adviser, British Homeopathic Association. He was a member of the International Scientific Committee on Homeopathic Investigations, which ceased its committee activities in July 2013. Joyce Frye: Part of Dr Frye’s salary was supported by a research grant from the Standard Homeopathic Company, paid to her employer, the Center for Integrative Medicine, Department of Family Medicine, University of Maryland, USA. Support ended in June 2013 when Dr Frye resigned from the University of Maryland. Standard Homeopathic Company does not manufacture Oscillococcinum or any similar product, and had no interest in the outcome of the review. Dr Frye received honoraria from the International Scientific Committee on Homeopathic Investigations, which was dissolved in July 2013. Peter Fisher: I am Expert Adviser on Complementary and Alternative Medicine to the National Institute for Health and Clinical Excellence (NICE), which may take an interest in the evidence in this review. I am Editor in Chief of an international, peer‐reviewed journal dedicated to homeopathy. All payments and reimbursements for lectures have been from universities or professional or learned societies. None of these lectures has been dedicated to the subject of this review. Some meetings have been supported by grants from commercial interests, including the manufacturer of the product that is the subject of the review.
So, to be clear: oscillococcinum does not help against the corona or any other virus. Those who claim otherwise are either mistaken, or have a commercial interest, or both.
A team of chiropractic researchers conducted a review of the safety of spinal manipulative therapy (SMT) in children under 10 years. They aimed to:
1) describe adverse events;
2) report the incidence of adverse events;
3) determine whether SMT increases the risk of adverse events compared to other interventions.
They searched MEDLINE, CINAHL, and Index to Chiropractic Literature from January 1, 1990 to August 1, 2019. Eligible studies were case reports/series, cohort studies and randomized controlled trials. Studies of high and acceptable methodological quality were included.
Most adverse events are mild (e.g., increased crying, soreness). One case report describes a severe adverse event (rib fracture in a 21-day-old) and another an indirect harm in a 4-month-old. The incidence of mild adverse events ranges from 0.3% (95% CI: 0.06, 1.82) to 22.22% (95% CI: 6.32, 54.74). Whether SMT increases the risk of adverse events in children is unknown.
The authors concluded that the risk of moderate and severe adverse events is unknown in children treated with SMT. It is unclear whether SMT increases the risk of adverse events in children < 10 years.
Thanks to their ingenious methodology, the authors managed to miss 11 of the 13 studies included in the review by Vohra et al which reported 9 serious adverse events and 20 cases of delayed diagnosis associated with SMT. Another review reported 15 serious adverse events and 775 mild to moderate adverse events following manual therapy. As far as I can see, the authors of the new review make just one reasonable point:
We recommend the implementation of a population-based active surveillance program to measure the incidence of severe and serious adverse events following SMT treatment in this population.
In the absence of such a surveillance system, any incidence figures are not just guess-work but also a depiction of the tip of a much bigger iceberg. So, why do the authors of this review not make this point clearly and powerfully? Why does the review read mostly like an attempt to white-wash a thorny subject? Why do they not provide a breakdown of the adverse events according to profession? The answer to these questions can be found at the very end of the paper:
This study was supported by the College of Chiropractors of British Columbia to Ontario Tech University. The College of Chiropractors of British Columbia was not involved in the design, conduct or interpretation of the research that informed the research. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Pierre Côté who holds the Canada Research Chair in Disability Prevention and Rehabilitation at Ontario Tech University, and from the Canadian Chiropractic Research Foundation to Carol Cancelliere who holds a Research Chair in Knowledge Translation in the Faculty of Health Sciences at Ontario Tech University.
This study was supported by the College of Chiropractors of British Columbia to Ontario Tech University. The College of Chiropractors of British Columbia was not involved in the design, conduct or interpretation of the research that informed the research. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Pierre Côté who holds the Canada Research Chair in Disability Prevention and Rehabilitation at Ontario Tech University, and funding from the Canadian Chiropractic Research Foundation to Carol Cancelliere who holds a Research Chair in Knowledge Translation in the Faculty of Health Sciences at Ontario Tech University.
I have often felt that chiropractic is similar to a cult. An investigation by cult members into the dealings of a cult is not the most productive of concepts, I guess.
Many chiropractors claim that spinal manipulation (SM) has an effect on the pain threshold even in asymptomatic subjects, but SM has never been compared in studies to a validated sham procedure. Now a chiropractic research team has published a study investigating the effect of SM on the pressure pain threshold (PPT) when measured in
i) the area of intervention, 
ii) an area remote from the intervention.
In addition, the researchers measured the size and duration of the effect.
In this randomized cross-over trial, 50 asymptomatic chiropractic students had their PPT measured at baseline, immediately after and every 12 min after intervention, over a period of 45 min, comparing values after SM and a previously validated sham. The trial was conducted during two sessions, separated by 48 h. PPT was measured both regionally and remotely from the ‘treated’ thoracic segment. Blinding of study subjects was tested with a post-intervention questionnaire.
The results show that the study subjects had been successfully blinded. No statistically significant differences were found between SM and sham estimates, at any time or anatomical location.
The authors concluded that, when compared to a valid sham procedure and with successfully blinded subjects, there is no regional or remote effect of spinal manipulation of the thoracic spine on the pressure pain threshold in a young pain-free population.
Reduced pain sensitivity following SM (often also called ‘manipulation-induced hypoalgesia’ (MIH)) turns out to be little more than a myth promoted by chiropractors for the obvious reason of boosting their business (6 further myths are summarised in the over-optimistic chiropractic advertisement above).
A recent review of the evidence found that systemic MIH (for pressure pain threshold) does occur in musculoskeletal pain populations, though there was low quality evidence of no significant difference compared to sham manipulation. Future research should focus on the clinical relevance of MIH, and different types of quantitative sensory tests.
An enthusiast of homeopathy recently posted an overview of systematic reviews of homeopathy concluding that the data we do have point towards homeopathy as having an effect greater than that of placebo:
In recent decades, homeopathy has been examined via a number of clinical trials, the number of which now allow meta-analysis. As we can see from the study findings, the type of homeopathy research (ie, individualized vs non-individualized, placebo-controlled vs non-placebo-controlled) can have a strong influence on the results, although trial quality also has a strong effect.
All meta-analyses performed in at least a somewhat open and rigorous manner have found statistically significant effects. This suggests that homeopathy has a greater-than-placebo effect, or at least a strong trend in that direction, when using data from the totality of homeopathy research, or from individualized, placebo-controlled trials. The meta-analyses with questionable methodology, one of which is undergoing government investigation for academic irregularities, have produced negative results, which have been demonstrated to be a direct result of their exclusion of vast swathes of the homeopathic clinical trial literature (based on arbitrary and unexplained criteria), as well as of their failure to differentiate – as Mathie has done – different types of homeopathic research.
The clinical data are flawed. Issues with methodology used in homeopathy RCTs, combined with a lack of research funding, have produced a lack of high-quality trials and data. However, the data we do have point towards homeopathy as having an effect greater than that of placebo.
There can be no argument with this conclusion, aside from possible new data emerging. Anyone who disputes this is going against the existing set of the highest-quality evidence on homeopathy.
His overview is based on the following publications:
| Kleijnen, 19911 | All types of homeopathy (eg, single remedy vs combination). Methodological quality assessed; 105 trials. Results: Positive trend, regardless of type of homeopathy; 81 trials were positive, 24 showed no effect. |
| Linde, 19972 | All types of homeopathy. Out of 185 trials, 119 met inclusion criteria; 89 of these had extractable data. Results: OR = 2.45 (95% CI 2.05-2.93). |
| Ernst, 19983 | Individualized homeopathy; 5 trials determined to be high-quality. Results: OR = 0. |
| Linde, 19985 | Individualized homeopathy; 32 trials, 19 of which had extractable data. Results: OR = 1.62 for all trials (95% CI 1.17-2.23). Only high-quality trials produced no significant trend. |
| Cucherat, 20009 | All types of homeopathy; 118 trials, 16 of which met inclusion criteria. Used unusual method of combining p values. Results: All trials = p< 0.000036. Less than 10% dropouts: p<0.084; less than 5% dropouts (higher standards than most trials considered reliable): p<0.08 (non-significant). |
| Shang, 200511 | All types of homeopathy; only 8 trials selected from 21 high-quality trials of 110 selected with unusual criteria. Results: OR = 0.88 (0.65-1.19). Result strongly disputed by statisticians. |
| Mathie, 201413 | Individualized homeopathy; of the analysis pooled data from 22 higher-quality, individualized, double-blind RCTs. Results: OR = 1.53 (1.22-1.91) for all trials pooled; OR = 1.93 (1.16-3.38) for the 3 reliable trials. |
| NHMRC, 201516 | Out of 176 studies, 171 were excluded, leaving only 5 for the study. Investigators used unprecedented methods, did not combine data, and are currently under investigation for outcome shopping. Results: Negative results. |
| Mathie, 201720 | Non-individualized homeopathy; very few higher-quality trials. Results: For 54 trials with extractable data, SMD = -0.33 (-0.44, -0.21). When these were adjusted for publication bias, SMD = -0.16 (-0.46,-0.09). The 3 high-quality trials had non-significant results: SMD = -0.18 (-0.46, +0.09). |
| Mathie, 201821 | Individualized, other-than-placebo-controlled trials; 11 trials found, 8 with extractable data. Results: 4 heterogeneous comparative trials showed a non-significant difference. One trial in this group was positive. Three heterogeneous trials with additive homeopathy showed a statistically significant SMD. No definitive conclusion possible due to trial heterogeneity, poor quality, and low number of trials. |
| Mathie, 201922 | Non-individualized, other-than-placebo-controlled trials; 17 RCTs found, 14 with high risk of bias. Results: Significant heterogeneity prevented much comparison; 3 comparable trials showed a non-significant SMD. |
Apart from getting the wrong end of the stick when interpreting the results of these papers (see for instance here, and here), there are other rather embarrassing flaws in this overview:
- Many older systematic reviews were omitted (including about 10 of my own papers). This is relevant because the author of the above review went beck until 1991 to find the reviews he included.
- Several new papers were missing as well. This is relevant because the author evidently included reviews up to 2019. Here are the key passages from the conclusions of some of them:
… homoeopathy as a whole may be considered as a placebo treatment.
We found no evidence to support the efficacy of homeopathic medicinal products
I am, of course, not saying that this overview amounts to anything like a systematic review. It merely gives you a flavour how trustworthy proponents of homeopathy are when they pretend to provide us with an objective evaluation of the best available evidence.
Neurolinguistic programming (NLP) was developed in the mid-seventies. It is a so-called alternative therapy (SCAM) that is not easy to define. Those who started it and those involved in it use such vague language that NLP means different things to different people. One metaphor keeps recurring: NLP claims to help people change by teaching them to program their brains. We were given brains, we are told, without an instruction manual, and NLP offers a user-manual for the brain. Consciously or unconsciously, NLP is based on the assumptions that:
- the unconscious mind constantly influences our conscious thoughts and actions;
- Freud’s theories are correct;
- hypnotherapy is effective.
Wikipedia is more outspoken about it: Neuro-linguistic programming (NLP) is a pseudoscientific approach to communication, personal development, and psychotherapy…
Despite the fact that NLP is unproven (to say the least), the COLLEGE OF MEDICINE AND INTEGRATED HEALTH (COMAIH) is sufficiently impressed by NLP to offer a course for GPs and SCAM practitioners. Here is their announcement:
Neurolinguistic Healthcare in association with the College of Medicine brings you a 2-day Introduction to Hypnosis, Neurolinguistic Programming (NLP) and Neurolinguistic Healthcare (NLH). Dr Wong and Dr Akhtar who lead the course are Trainers in NLP and Hypnosis and GPs who apply their skills in daily practice within the 10-minute consultation. The course is suitable for both medical professionals and complementary therapists. This is a limited training event offered by them to share their years of knowledge and skills with you.
You will learn:
-
- A basic overview of NLP and the most useful aspects to use it to begin making effective changes in how you and the people you treat think and behave
- An understanding of the NLH model of the mind so that you understand the concepts of therapy using this mixed hypnosis/ NLP approach in relation to health.
- The ability to Hypnotise effectively in a very short period of time with practical experience – the ability to go through all the stages of hypnosis – the induction, deepening, therapy, and emergence, including rapid hypnosis techniques. (Hypnosis courses which are less practical often charge in excess of £2000 for this)
- Learn at least 3 therapeutic techniques, including the NLP therapeutic techniques which work much better in trance, so using and applying the skills you will learn in hypnosis
- Access to an online mentorship programme with Dr Akhtar or Dr Wong for 6 months and who will provide 3x30mins group webinar meetings after the course to ensure any remaining questions get answered and that you are actually going forth to apply these skills. (worth another £600 in value)
- Access to an online learning membership site with educational videos and other content like pain relief techniques, papers with therapeutic scripts, etc
This is an opportunity to learn a different way of helping people from doctors who target the 10-minute consultation with fast, effective formal hypnosis techniques and sleight-of-mouth. It is possible to make change happen in 10-minutes.
Note that attending this course will not make you a certified hypnotherapist, but confer you the skills you will learn to use personally and in the context of guided meditations and relaxations that are commonplace now.
And what evidence do I have for stating that NLP is unproven?
Is there an up-to-date and sound systematic review of NLP?
The answer is yes.
This systematic review of NLP included 10 experimental studies. Five studies were RCTs and five were uncontrolled pre-post studies. Targeted health conditions were anxiety disorders, weight maintenance, morning sickness, substance misuse, and claustrophobia during MRI scanning. NLP interventions were mainly delivered across 4-20 sessions although three were single session. Eighteen outcomes were reported and the RCT sample sizes ranged from 22 to 106. Four RCTs reported no significant between group differences with the fifth finding in favour of NLP. Three RCTs and five pre-post studies reported within group improvements. Risk of bias across all studies was high or uncertain.
The authors concluded that there is little evidence that NLP interventions improve health-related outcomes. This conclusion reflects the limited quantity and quality of NLP research, rather than robust evidence of no effect. There is currently insufficient evidence to support the allocation of NHS resources to NLP activities outside of research purposes.
Surprised?
I am not!
I did not expect the COMAIH to allow critical thinking to get in the way of quackery-promotion.
Yesterday, we discussed a paper concluding (amongst other things) that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for cancer‐related pain. Today, we are looking at one that overtly contradicts this verdict.
This systematic review (published in JAMA Oncology) evaluated the existing randomized clinical trials (RCTs) for evidence of the association of acupuncture and acupressure with reduction in cancer pain. Randomized clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care for managing cancer pain were included. The primary outcome was pain intensity measured by the Brief Pain Inventory, Numerical Rating Scale, Visual Analog Scale, or Verbal Rating Scale.
A total of 17 RCTs (with 1111 patients) were included, and data from 14 RCTs (with 920 patients) were used in the meta-analysis. Seven sham-controlled RCTs (35%) were notable for their high quality, being judged to have a low risk of bias for all of their domains, and showed that real (compared with sham) acupuncture was associated with reduced pain intensity. A favourable association was also seen when acupuncture and acupressure were combined with analgesic therapy in 6 RCTs for reducing pain intensity and in 2 RCTs for reducing opioid dose. The evidence grade was moderate because of the substantial heterogeneity among studies.
The authors concluded that this systematic review and meta-analysis found that acupuncture and/or acupressure was significantly associated with reduced cancer pain and decreased use of analgesics, although the evidence level was moderate. This finding suggests that more rigorous trials are needed to identify the association of acupuncture and acupressure with specific types of cancer pain and to integrate such evidence into clinical care to reduce opioid use.
So, which of the two conclusions should we trust?
Personally, I find the JAMA paper unimpressive to the point of being suspect. Here are some of my reasons:
- About half of the primary studies are Chinese; and we have seen repeatedly that they are unreliable and report only positive results.
- Many of the trials are published in Chinese and can thus not be checked by non-Chinese readers (nor, presumably, by the experts who acted as peer-reviewers for JAMA Oncology).
- I have my doubts about the rigor of the peer-review of some of the journals that published the primary studies included in the review.
- One paper included in the review is even a mere doctoral thesis which usually is not peer-reviewed in the usual sense.
- The authors state that they included only clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care. However, this is evidently not true; many of the studies had the infamous A+B versus B design comparing acupuncture plus a conventional therapy against the conventional therapy. As we have discussed ad nauseam on this blog, such trials cannot produce a negative finding even if ‘A’ is a placebo.
- Contrary to what the authors claim, the quality of most of the included studies was extremely poor, as far as I can see.
- One included paper which I cannot access is entitled ‘Clinical observation on 30 cases of moderate and severe cancer pain of bone metastasis treated by auricular acupressure‘. Are the review authors seriously claiming that this is an RCT?
The more I study the details of the JAMA Oncology paper, the more I feel it might be worth a complaint to the editor with a view of initiating a thorough investigation and a possible retraction.
Are you hungover today? you will be pleased to hear that so-called alternative medicine (SCAM) has a lot to offer – at least this is what its enthusiasts think.
Homeopaths swear by Nux Vomica as the first remedy to think of with hangover headaches, but it is also excellent for headaches from overwork, indigestion headaches and headaches accompanying constipation. Use it when your headache is worse when you cough or bend down, and headaches that aggravate when you move your eyes. If you have overeaten and drunk too much alcohol, you may also feel nauseous and want to vomit to make yourself feel better but find you cannot. If this describes your symptoms then Nux Vomica is the remedy for you.
When I worked as a homeopath, I and others often tried this treatment – it never worked. More importantly, there is not a jot of evidence that it does.
Some people recommend artichoke extract. I say: forget it. Here is why:
BACKGROUND:
Extract of globe artichoke (Cynara scolymus) is promoted as a possible preventive or cure for alcohol-induced hangover symptoms. However, few rigorous clinical trials have assessed the effects of artichoke extract, and none has examined the effects in relation to hangovers. We undertook this study to test whether artichoke extract is effective in preventing the signs and symptoms of alcohol-induced hangover.
METHODS:
We recruited healthy adult volunteers between 18 and 65 years of age to participate in a randomized double-blind crossover trial. Participants received either 3 capsules of commercially available standardized artichoke extract or indistinguishable, inert placebo capsules immediately before and after alcohol exposure. After a 1-week washout period the volunteers received the opposite treatment. Participants predefined the type and amount of alcoholic beverage that would give them a hangover and ate the same meal before commencing alcohol consumption on the 2 study days. The primary outcome measure was the difference in hangover severity scores between the artichoke extract and placebo interventions. Secondary outcome measures were differences between the interventions in scores using a mood profile questionnaire and cognitive performance tests administered 1 hour before and 10 hours after alcohol exposure.
RESULTS:
Fifteen volunteers participated in the study. The mean number (and standard deviation) of alcohol units (each unit being 7.9 g, or 10 mL, of ethanol) consumed during treatment with artichoke extract and placebo was 10.7 (3.1) and 10.5 (2.4) respectively, equivalent to 1.2 (0.3) and 1.2 (0.2) g of alcohol per kilogram body weight. The volume of nonalcoholic drink consumed and the duration of sleep were similar during the artichoke extract and placebo interventions. None of the outcome measures differed significantly between interventions. Adverse events were rare and were mild and transient.
INTERPRETATION:
Our results suggest that artichoke extract is not effective in preventing the signs and symptoms of alcohol-induced hangover. Larger studies are required to confirm these findings.
Is there anything else you might want to try? I am afraid the answer is NO. Here is our systematic review on the subject:
OBJECTIVE:
To assess the clinical evidence on the effectiveness of any medical intervention for preventing or treating alcohol hangover.
DATA SOURCES:
Systematic searches on Medline, Embase, Amed, Cochrane Central, the National Research Register (UK), and ClincalTrials.gov (USA); hand searches of conference proceedings and bibliographies; contact with experts and manufacturers of commercial preparations. Language of publication was not restricted.
STUDY SELECTION AND DATA EXTRACTION:
All randomised controlled trials of any medical intervention for preventing or treating alcohol hangover were included. Trials were considered if they were placebo controlled or controlled against a comparator intervention. Titles and abstracts of identified articles were read and hard copies were obtained. The selection of studies, data extraction, and validation were done independently by two reviewers. The Jadad score was used to evaluate methodological quality.
RESULTS:
Fifteen potentially relevant trials were identified. Seven publications failed to meet all inclusion criteria. Eight randomised controlled trials assessing eight different interventions were reviewed. The agents tested were propranolol, tropisetron, tolfenamic acid, fructose or glucose, and the dietary supplements Borago officinalis (borage), Cynara scolymus (artichoke), Opuntia ficus-indica (prickly pear), and a yeast based preparation. All studies were double blind. Significant intergroup differences for overall symptom scores and individual symptoms were reported only for tolfenamic acid, gamma linolenic acid from B officinalis, and a yeast based preparation.
CONCLUSION:
No compelling evidence exists to suggest that any conventional or complementary intervention is effective for preventing or treating alcohol hangover. The most effective way to avoid the symptoms of alcohol induced hangover is to practise abstinence or moderation.
Yes, it’s true, the only sound advice is moderation!
The current Cochrane review of clinical trials testing the effectiveness of manipulation/mobilisation for neck pain concluded as follows:
Although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices.
Such a critical assessment must be tough for chiropractors who gain a substantial part of their income from treating such patients. What is the solution? Simple, convene a panel of chiros and issue recommendations that are more prone to stimulate their cash flow!
Exactly that seems to have just happened.
The purpose of the researchers was to develop best-practice recommendations for chiropractic management of adults with neck pain.
A steering committee of experts in chiropractic practice, education, and research drafted a set of recommendations based on the most current relevant clinical practice guidelines. Additional supportive literature was identified through targeted searches conducted by a health sciences librarian. A national panel of chiropractors representing expertise in practice, research, and teaching rated the recommendations using a modified Delphi process. The consensus process was conducted from August to November 2018. Fifty-six panelists rated the 50 statements and concepts and reached consensus on all statements within 3 rounds.
The statements and concepts covered aspects of the clinical encounter, ranging from informed consent through diagnosis, assessment, treatment planning and implementation, and concurrent management and referral for patients presenting with neck pain.
The authors concluded that these best-practice recommendations for chiropractic management of adults with neck pain are based on the best available scientific evidence. For uncomplicated neck pain, including neck pain with headache or radicular symptoms, chiropractic manipulation and multimodal care are recommended.
Let’s be clear what this amounts to: a panel of highly selected chiropractors (sponsored by a chiropractic organisation) has reached a consensus (and published it in a chiropractic) which allows them to continue to treat patients with neck pain.
Isn’t that just great?
Now let’s think ahead – what next?
I suggest the following:
- A panel of homeopaths recommending homeopathy.
- A panel of faith healers recommending faith healing.
- A panel of crystal healers recommending crystal healing.
- A panel of colon therapists recommending colonic irrigation.
- A panel of supplement manufacturers recommending to buy supplements.
- …
- …
- …
I am sure you get the gist.
This post is dedicated to all who claim that I never discuss anything positive about so-called alternative medicine (SCAM).
Autogenic training is a therapy developed in the 1920s by the German psychiatrist Johannes Heinrich Schultz (1884 – 1970). It is an auto-hypnotic relaxation technique popular in Germany but less so other countries. (The lack of international appreciation of autogenic training might be related to Schultz’ well-documented Nazi past. In 1935, he published an essay which supported compulsory sterilization of men to eliminate hereditary illnesses. Later he was appointed deputy director of the Göring Institute in Berlin. Through this institute, he had an active role in the extermination of mentally handicapped individuals in the framework of the ‘Aktion T4’, the Nazi’s infamous euthanasia programme.)
Autogenic training consists of mental exercises using instructions directed at different parts of the body to control bodily perceptions, such as ‘my right foot feels warm’ or ‘my left arm feels heavy’. Patients tend to report an intense sense of relaxation during and after autogenic training. Autogenic training is taught in a series of lessons by a qualified instructor.
Autogenic training should be practised regularly and does not require further supervision. It is thus an inexpensive therapy. The technique is claimed to help for a range of (mostly stress-related) conditions. However, the evidence from clinical trials is scarce and, not least due to methodological problems, less than convincing.
This systematic review was conducted to evaluate the effectiveness of autogenic training on stress responses. A total 11 studies were included in a meta-analysis. They showed that autogenic training decreased anxiety and depression, and increased the high frequency of heart rate variability as well as a reduction of anxiety score by 1.37 points (n=85, SMD=-1.37: 95% CI -2.07 to -0.67), in the studies on short-term intervention targeting healthy adults.For depression, a reduction was noted of the symptom score by 0.29 point (n=327, SMD=-0.29: 95% CI -0.50 to -0.07) in the studies on long term intervention targeting the patient group.
The authors concluded that autogenic training is effective for adults’ stress management, and nurses will be able to effectively perform autogenic training programs for workers’ stress relief at the workplace.
I cannot access the full article because it was published in Korean. Nevertheless, I feel that the conclusions are probably correct.
Why?
Because I know (most of) the primary studies and three of the RCTs are my own.
(Yet, some of my critics continue to claim that I never conducted any positive studies of SCAM)
I have to admit, I only read the DAILY MAIL, if I have to (and certainly not today). This is probably why I missed this article announcing the 1st traditional Chinese medicine to be licensed in the UK.
The plant Sigesbeckia, which has an unpleasant smell, is renowned for its ability to treat aches and pains – including those caused by arthritis. It is the active ingredient in Phynova Joint and Muscle Relief Tablets, which have just been licensed by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency.
The directive also made it more difficult for medicines to get a licence as it demanded they had to have been in use for 30 years, of which at least 15 years had to be in the EU. Some Western herbal medicines have managed to gain licences in a process costing thousands of pounds to verify their ingredients. But the Phynova tablets are the first traditional Chinese medicine to be approved.
Robert Miller, chief executive of Oxford-based Phynova, said he was ‘extremely proud’, adding: ‘This has come from years of working with our Chinese colleagues. ‘Britain can now benefit from having access to high quality, regulated Chinese medicines.’ He also said that the company is planning to apply for a licence for a second traditional Chinese medicine, a cold and flu remedy.
Dr Chris Etheridge, a medical herbalist and adviser to Potter’s Herbals, celebrated the ‘good news’, adding that Sigesbeckia, which is not commonly used in the West, ‘offers an alternative to those who prefer not to take non-steroidal anti-inflammatory drugs for muscle and joint pain’.
But Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, warned that the new product demonstrates the difficulties the EU rules created for supplying herbal products safely to the public. He said it is ‘almost impossible to satisfy the licensing conditions’. He added that some people have therefore turned to the internet to buy unlicensed products, but this means they have ‘no idea whether they are safe or effective’.
How exciting!
Exciting enough to do a quick search for the evidence. Are there any clinical trials to show or suggest that this herbal remedy does anything other than filling the bank account of the manufacturer? Sadly, the answer seems to be NO! At least, I could not find a single such study (if anyone knows more, I’d be pleased to stand corrected).
Frustrated I looked at the website of the manufacturer. Here I found this:
Exclusively containing Sigesbeckia extract, Phynova Joint and Muscle Relief Tablets is a traditional herbal medicinal product used for the relief of backache, rheumatic, joint and muscle pain as well as minor sports injuries. Sigesbeckia has been used for thousands of years around the world to relieve painful joints and muscles.
Benefits
– Relief from joint & muscle pain
– Gentle on the stomach
– No known side effects
– No known drug indications or contraindications
– Can be taken with or without food
And this:
What can Sigesbeckia be used to treat?
Traditionally used for arthritic pain, rheumatic pain, back pain and sciatica. Today, Sigesbeckia can be used for;
Backache
Back pain can occur through a sprain or strain, spasms, nerve compression, herniated discs and other problems in your lower, middle and upper back.
Poor posture, lifting and stretching, sudden movements placing strain on your lower back and sports injuries, are amongst the main culprits for causing back pain.
Minor sports injuries
Minor sports injuries can be caused by an accident such as a fall or blow, not warming up properly before exercise, pushing yourself too hard and not using the appropriate equipment or perhaps poor technique.
Rheumatic and muscular pain
Common causes of rheumatic and muscle pain can be due to; tension and stress, lack of minerals, certain medication, dehydration, sprains and strains, sleep deficiency, too much physical activity and sometimes other underlying health conditions and diseases.
General aches and pains in muscles and joints
Overexertion due to a new exercise routine or from a sprain or strain can cause general aches and pains in muscles and joints. But so too can modern day busy life. The impact on our bodies can trigger aches and pains in your muscles and joints and lower your resistance to illness and disease.
The Benefit of Sigesbeckia extract
One of the benefits of Sigesbeckia extract, as used in approved licensed products, is that it has no known side effects or interactions with other medications according to the Summary of Product Characteristics (SmPC). Always check that the product you purchase is an approved Traditional Herbal Medicine Product in the UK.
In summary: Look after your joints and muscles with Sigesbeckia
Our bodies are all different, and our approach and tolerances will vary. Used for over a thousand years and known for its anti-inflammatory and mobility benefits alongside being used for joint and muscle pain; Sigesbeckia is a herbal medicine that works best when used over time.
Looking for a traditional remedy for joint and muscle relief? Why not try Sigesbeckia?
But again no sign of a clinical trial to back up this plethora of therapeutic claims. How can this be? The answer lies in the directive mentioned in the Mail article. To obtain a licence that enables the manufacturer to make therapeutic claims, a herbal remedy merely needs to demonstrate that it has been in use for 30 years, of which at least 15 years had to be in the EU.
I think I understand the intention of the directive. But I would nevertheless have thought that, 4 years after obtaining a license, the manufacturer could have conducted a study to test whether the product works. In my view this should be a moral and ethical, if not legal obligation. The ‘test of time’ is woefully insufficient and unreliable and no basis for generating progress or securing the best interests of patients.
Considering the total lack of efficacy and safety data, do you agree that the above comment by Michael McIntyre are ironic to the extreme? And do you agree that manufacturers who manage to obtain such a license should be obliged to deliver a proof of efficacy within a reasonable period of time?
