About 85% of German children are treated with herbal remedies. Yet, little is known about the effects of such interventions. A new study might tell us more.
This analysis accessed 2063 datasets from the paediatric population in the PhytoVIS data base, screening for information on indication, gender, treatment, co-medication and tolerability. The results suggest that the majority of patients was treated with herbal medicine for the following conditions:
- common cold,
- digestive complaints,
- skin diseases,
- sleep disturbances
The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events.
The authors concluded that the results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.
If you are a fan of herbal medicine, you will be jubilant. If, on the other hand, you are a critical thinker or a responsible healthcare professional, you might wonder what this database is, why it was set up and how exactly these findings were produced. Here are some details:
The data were collected by means of a retrospective, anonymous, one-off survey consisting of 20 questions on the user’s experience with herbal remedies. The questions included complaints/ disease, information on drug use, concomitant factors/diseases as well as basic patient data. Trained interviewers performed the interviews in pharmacies and doctor’s offices. Data were collected in the Western Part of Germany between April 2014 and December 2016. The only inclusion criterion was the intake of herbal drugs in the last 8 weeks before the individual interview. The primary endpoint was the effect and tolerability of the products according to the user.
And who participated in this survey? If I understand it correctly, the survey is based on a convenience sample of parents using herbal remedies. This means that those parents who had a positive experience tended to volunteer, while those with a negative experience were absent or tended to refuse. (Thus the survey is not far from the scenario I often use where people in a hamburger restaurant are questioned whether they like hamburgers.)
So, there are two very obvious factors other than the effectiveness of herbal remedies determining the results:
- selection bias,
- lack of objective outcome measure.
This means that conclusions about the clinical effects of herbal remedies in paediatric patients are quite simply not possible on the basis of this survey. So, why do the authors nevertheless draw such conclusions (without a critical discussion of the limitations of their survey)?
Could it have something to do with the sponsor of the research?
The PhytoVIS study was funded by the Kooperation Phytopharmaka GbR Bonn, Germany.
Or could it have something to do with the affiliations of the paper’s authors:
1 Institute of Pharmacy, University of Leipzig, Brüderstr. 34, 04103, Leipzig, Germny. email@example.com.
2 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 573, Bonn, Germany. firstname.lastname@example.org.
3 Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.
4 ClinNovis GmbH, Genter Str. 7, 50672, Cologne, Germany.
5 Bayer Consumer Health, Research & Development, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295, Darmstadt, Germany.
6 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 53173, Bonn, Germany.
7 Institute of Pharmaceutical Biology, Goethe University Frankfurt, Max-von-Laue-Str. 9, 60438, Frankfurt, Germany.
8 Chair of Naturopathy, University Medicine Rostock, Ernst-Heydemann Str. 6, 18057, Rostock, Germany.
WHAT DO YOU THINK?
‘HOMEOPATHY360’ are fiercely decided to defend homeopathy, no matter what. They state that we promise to stand by your side always to fight against the critical attacks on Homeopathy… Therefore, I was not really surprised when, a couple of days ago, I received an email by them urging me to support US homeopaths against the threat by the FDA. Here is part of this correspondence:
… If you want to know more about the FDA’s proposed new rules for homeopathic medicines, here’s a summary of the most important points:
- The new rules, if adopted, will allow the FDA to withdraw even properly manufactured and labeled homeopathic medicines from the marketplace. This is puzzling because these have never posed any sort of safety concern according to an initial review of public FDA records by Americans for Homeopathy Choice.
- It is clear that the FDA intends to use this authority and has even mentioned specific medicines such as Belladonna, Nux vomica and Lachesis muta in its public statements regarding enforcement.
- The authority for this kind of assault on homeopathy will result from the declaration by the FDA that all homeopathic medicines are “new drugs.” We all know this is nonsense. Homeopathic medicines have been around for 200 years.
- But this nonsense declaration means that under U.S. law all homeopathic remedies will become technically “illegal” and subject to withdrawal from the marketplace. If the FDA just thinks there is a problem with a homeopathic medicine, it can withdraw it forever without conducting any sort of investigation.
- Since the agency has already said that it thinks that Belladonna, Nux vomica, Lachesis muta and several other remedies are dangerous, we can anticipate that it will try to remove them from the marketplace as soon as its new rules are adopted.
- But, it won’t be possible for Americans to get remedies that are banned sent to them from abroad. The FDA will simply stop these remedies at the border.
I could tell you more, but what I’ve told you so far should convince you that we ought to help the American homeopathy community defeat these unreasonable and misinformed rules. The rules simply do not reflect the realities of homeopathic medicines, namely, that they are nontoxic, mild, effective and have few, if any, side-effects. And, homeopaths use them in ways that individualize treatment. That this is the best way to treat patients was discovered by Samuel Hahnemann 200 years ago.
The enemies of homeopathy are everywhere and they appear to be stepping up their attacks. That’s why the world homeopathy community must work together to stand up to them…
I have reported about the FDA initiatives on homeopathy before. In 2015, they started it with a public hearing. Since then, the FDA also issued several warnings to manufacturers who were putting consumers at risk (see, for instance, here, here, and here).
What the FDA seem to be trying to do is nothing else but meeting their ethical, moral and legal responsibility vis a vis consumer safety. Homeopathy has had a free ride for far too long. It is high time that this sector joins the 21st century.
The above quote, with its bonanza of bogus claims and falsehoods, shows the urgency of this task. The defenders of homeopathy seem to live on a different planet where rationality, facts and evidence can easily be over-ruled by creed, dogma and wishful thinking. If homeopaths want their trade to join the realm of real medicine they need, at the very minimum, to show with sound evidence:
- that their remedies generate more good than harm,
- that they adhere to acceptable quality standards.
Failing this – and so far, homeopaths not only failed at this task but continue bombarding us with an incessant flow of bogus and dangerous claims – homeopathics cannot be considered to be medicines, and homeopaths cannot be called responsible healthcare professionals. It is high time to stop turning a blind eye to the double standards that have been applied for 200 years.
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.
At the heart of this story is Joseph Mercola, a dietary supplement entrepreneur and osteopath.
His website states that:
EVERYONE can benefit from Dr Mercola’s unparalleled knowledge. For expertise in alternative healthcare and high quality supplemental medicine, it’s hard to beat visionary Dr Joseph Mercola. The Chicago-based health wizard has his own website, Mercola.com (‘Take Control of Your Health’), but you can find so many of his health support products right here at Evolution Organics. Our customers swear by them. They love the diversity of the range, and that the products are priced affordably, meaning that everyone can benefit from Dr Mercola’s vast experience and unmatched know-how. And it’s not just men, women and children who can feel better ‘the Dr Mercola way’ – his brand includes health support products for pets, too.
However, an article in the Washington Post tells a different story; allow me to quote a few excerpts:
The National Vaccine Information Center was founded in 1982 by Barbara Loe Fisher, who has said that her son was injured by a vaccine. The group claimed credit this year for helping to defeat legislation in a dozen states that would have made it harder for parents to opt out of vaccinating their children. At the beginning of last year’s flu season, Fisher and Mercola appeared in a YouTube video urging people to be skeptical about flu shots. Mercola claimed that vaccines have been associated with “deaths and permanent neurological complications,” and he said vitamin D supplements were among “far more effective, less expensive and less risky alternatives.” … Fisher said in an interview that Mercola has asked for nothing in exchange for his donations and that the National Vaccine Information Center does not sell or advertise Mercola’s products on its site. “I do not take funding for a quid pro quo,” she said. “When [Mercola] called me, he said, ‘I admire your work. I’d like to help you.’ ” The center’s homepage, which the group says was visited more than 1.2 million times last year, displays Mercola.com’s logo. An affiliated website run by Fisher’s group refers numerous times to Mercola.com as one of the most popular health and wellness websites…
In recent years, the center has been at the forefront of a movement that has led some parents to forgo or delay immunizing their children against vaccine-preventable diseases such as measles… The Northern Virginia-based National Vaccine Information Center lists Mercola.com as a partner on its homepage and links to the website, where readers can learn about and purchase Mercola’s merchandise…Asked if his companies benefit from his donations to the anti-vaccine group, Mercola said in an email that “being an adversary to powerful industries is not a positive for a business like mine.” …
On this blog, I have repeatedly warned that many so-called alternative medicine (SCAM) practitioners recommend against vaccinations. Specifically implicated are:
- Physicians practising integrative medicine
- Doctors of anthroposophical medicine
We knew about the ‘ideology’ and the misinformation pushing SCAM-related anti-vaccination sentiments. The article in the Washington Post is a stark reminder of the financial interests behind all this. As a result, SCAM-use is associated with low vaccination-uptake (as we have discussed ad nauseam – see for instance here, here, here and here). Anyone who needs more information will find it by searching this blog. Anyone claiming that this is all my exaggeration might look at papers which have nothing to do with me (there are plenty more for those who are willing to conduct a Medline search):
- Lehrke P, Nuebling M, Hofmann F, Stoessel U. Attitudes of homeopathic physicians towards vaccination. Vaccine. 2001;19:4859–4864. doi: 10.1016/S0264-410X(01)00180-3. [PubMed]
- Halper J, Berger LR. Naturopaths and childhood immunizations: Heterodoxy among the unorthodox. Pediatrics. 1981;68:407–410. [PubMed]
- Colley F, Haas M. Attitudes on immunization: A survey of American chiropractors. Journal of Manipulative and Physiological Therapeutics. 1994;17:584–590. [PubMed]
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’.
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.
– 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
What can Sigesbeckia be used to treat?
Traditionally used for arthritic pain, rheumatic pain, back pain and sciatica. Today, Sigesbeckia can be used for;
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?
Many patients with chronic pain (CP) are prescribed opioids, a situation which has led to the much-discussed opioid crisis. Integrative medicine (IM), which combines pharmacological and so-called alternative medicine (SCAM), has been proposed as a solution. Yet, the role of SCAM therapies in reducing opioid use remains unclear.
This systematic review explored the effectiveness of the IM approach or any of the SCAM therapies to reduce or cease opioid use in CP patients. Electronic searches yielded 5,200 citations. Twenty-three studies were selected. Eight studies were randomized controlled trials, seven were retrospective studies, four studies were prospective observational, three were cross-sectional, and one was quasi-experimental. The majority of the studies showed that opioid use was reduced significantly after using IM/SCAM. Cannabinoids were among the most commonly investigated approaches in reducing opioid use, followed by multidisciplinary approaches, cognitive-behavioral therapy, and acupuncture. The majority of the studies had limitations related to sample size, duration, and study design.
The authors concluded that there is a small but defined body of literature demonstrating positive preliminary evidence that the IM approach including SCAM therapies can help in reducing opioid use. As the opioid crisis continues to grow, it is vital that clinicians and patients be adequately informed regarding the evidence and opportunities for IM/SCAM therapies for CP.
I am unimpressed by this review.
And here is why:
- Because of their design, most of the included studies do not allow any conclusions about cause and effect.
- The 8 RCTs that would allow such conclusions are mostly of poor quality.
- Some of the 8 RCTs are not even what the review authors claim to be. Here is just one example:
Background: Current levels and dangers of opioid use in the U.S. warrant the investigation of harm-reducing treatment alternatives.
Purpose: A preliminary, historical, cohort study was used to examine the association between enrollment in the New Mexico Medical Cannabis Program (MCP) and opioid prescription use.
Methods: Thirty-seven habitual opioid using, chronic pain patients (mean age = 54 years; 54% male; 86% chronic back pain) enrolled in the MCP between 4/1/2010 and 10/3/2015 were compared to 29 non-enrolled patients (mean age = 60 years; 69% male; 100% chronic back pain). We used Prescription Monitoring Program opioid records over a 21 month period (first three months prior to enrollment for the MCP patients) to measure cessation (defined as the absence of opioid prescriptions activity during the last three months of observation) and reduction (calculated in average daily intravenous [IV] morphine dosages). MCP patient-reported benefits and side effects of using cannabis one year after enrollment were also collected.
Results: By the end of the 21 month observation period, MCP enrollment was associated with 17.27 higher age- and gender-adjusted odds of ceasing opioid prescriptions (CI 1.89 to 157.36, p = 0.012), 5.12 higher odds of reducing daily prescription opioid dosages (CI 1.56 to 16.88, p = 0.007), and a 47 percentage point reduction in daily opioid dosages relative to a mean change of positive 10.4 percentage points in the comparison group (CI -90.68 to -3.59, p = 0.034). The monthly trend in opioid prescriptions over time was negative among MCP patients (-0.64mg IV morphine, CI -1.10 to -0.18, p = 0.008), but not statistically different from zero in the comparison group (0.18mg IV morphine, CI -0.02 to 0.39, p = 0.081). Survey responses indicated improvements in pain reduction, quality of life, social life, activity levels, and concentration, and few side effects from using cannabis one year after enrollment in the MCP (ps<0.001).
Conclusions: The clinically and statistically significant evidence of an association between MCP enrollment and opioid prescription cessation and reductions and improved quality of life warrants further investigations on cannabis as a potential alternative to prescription opioids for treating chronic pain.
This study is evidently NOT an RCT!
Most of the 8 RCTs investigate whether SCAM is useful for weaning opioid-dependent patients off their drug. To equate this with the question whether IM/SCAM can reduce or cease opioid use in CP patients is, I think, wrong. The way to reduce opioid use in CP patients is to prescribe less opioids. And for prescribing less opioids, we need no SCAM but we need to remember what we learned in medical school: opioids are not for routine treatment of CP!
So, why do the authors of this review try to mislead us?
Could it have something to do with some of their affiliations and the bias that goes with it?
- Canadian College of Naturopathic Medicine, North York, Ontario, Canada.
- Australian Research Centre in Complementary and Integrative Medicine, University of Technology Sydney, Ultimo, Australia.
- Pacific College of Oriental Medicine, San Diego, California, USA.
What do you think?
Maintenance Care is an approach whereby patients have chiropractic manipulations even when symptom-free. Thus, it is an ideal method to keep chiropractors in clover. Previous reviews concluded that evidence behind this strategy is lacking. Since then, more data have emerged. It was therefore timely to review the evidence.
Fourteen original research articles were included in the review. Maintenance Care was defined as a secondary or tertiary preventive approach, recommended to patients with previous pain episodes, who respond well to chiropractic care. Maintenance Care is applied to approximately 30% of Scandinavian chiropractic patients. Both chiropractors and patients believe in the efficacy of Maintenance Care. Four studies investigating the effect of chiropractic Maintenance Care were identified, with disparate results on pain and disability of neck and back pain. However, only one of these studies utilized all the existing evidence when selecting study subjects and found that Maintenance Care patients experienced fewer days with low back pain compared to patients invited to contact their chiropractor ‘when needed’. No studies were found on the cost-effectiveness of Maintenance Care.
The authors concluded that knowledge of chiropractic Maintenance Care has advanced. There is reasonable consensus among chiropractors on what Maintenance Care is, how it should be used, and its indications. Presently, Maintenance Care can be considered an evidence-based method to perform secondary or tertiary prevention in patients with previous episodes of low back pain, who report a good outcome from the initial treatments. However, these results should not be interpreted as an indication for Maintenance Care on all patients, who receive chiropractic treatment.
I have to admit, I have problems with these conclusions.
- Maintenance Care is not normally defined as secondary or tertitary prevention. It also includes primary prevention, which means that chiropractors recommend it for just about anyone. By definition it is long term care, that is not therapeutically necessary, but performed at regular intervals to help prevent injury and enhance quality of life. This form of care is provided after maximal therapeutic benefit is achieved, without a trial of treatment withdrawal, to prevent symptoms from returning or for those without symptoms to promote health or prevent future problems.
- I am not convinced that the evidence would be positive, even if we confined it to secondary and tertiary prevention.
To explain my last point, let’s have a look at the 4 RCT and check whether they really warrant such a relatively positive conclusion.
FIRST STUDY For individuals with recurrent or persistent non-specific low back pain (LBP), exercise and exercise combined with education have been shown to be effective in preventing new episodes or in reducing the impact of the condition. Chiropractors have traditionally used Maintenance Care (MC), as secondary and tertiary prevention strategies. The aim of this trial was to investigate the effectiveness of MC on pain trajectories for patients with recurrent or persistent LBP.
This pragmatic, investigator-blinded, two arm randomized controlled trial included consecutive patients (18–65 years old) with non-specific LBP, who had an early favorable response to chiropractic care. After an initial course of treatment, eligible subjects were randomized to either MC or control (symptom-guided treatment). The primary outcome was total number of days with bothersome LBP during 52 weeks collected weekly with text-messages (SMS) and estimated by a GEE model.
Three hundred and twenty-eight subjects were randomly allocated to one of the two treatment groups. MC resulted in a reduction in the total number of days per week with bothersome LBP compared with symptom-guided treatment. During the 12 month study period, the MC group (n = 163, 3 dropouts) reported 12.8 (95% CI = 10.1, 15.5; p = <0.001) fewer days in total with bothersome LBP compared to the control group (n = 158, 4 dropouts) and received 1.7 (95% CI = 1.8, 2.1; p = <0.001) more treatments. Numbers presented are means. No serious adverse events were recorded.
MC was more effective than symptom-guided treatment in reducing the total number of days over 52 weeks with bothersome non-specific LBP but it resulted in a higher number of treatments. For selected patients with recurrent or persistent non-specific LBP who respond well to an initial course of chiropractic care, MC should be considered an option for tertiary prevention.
SECOND STUDY Back and neck pain are associated with disability and loss of independence in older adults. Whether long‐term management using commonly recommended treatments is superior to shorter‐term treatment is unknown. This randomized clinical trial compared short‐term treatment (12 weeks) versus long‐term management (36 weeks) of back‐ and neck‐related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).
Eligible participants were ages ≥65 years with back and neck disability for ≥12 weeks. Coprimary outcomes were changes in Oswestry Disability Index (ODI) and Neck Disability Index (NDI) scores after 36 weeks. An intent‐to‐treat approach used linear mixed‐model analysis to detect between‐group differences. Secondary analyses included other self‐reported outcomes, adverse events, and objective functional measures.
THIRD STUDY A prospective single blinded placebo controlled study was conducted. To assess the effectiveness of spinal manipulation therapy (SMT) for the management of chronic nonspecific low back pain (LBP) and to determine the effectiveness of maintenance SMT in long-term reduction of pain and disability levels associated with chronic low back conditions after an initial phase of treatments. SMT is a common treatment option for LBP. Numerous clinical trials have attempted to evaluate its effectiveness for different subgroups of acute and chronic LBP but the efficacy of maintenance SMT in chronic nonspecific LBP has not been studied. Sixty patients, with chronic, nonspecific LBP lasting at least 6 months, were randomized to receive either (1) 12 treatments of sham SMT over a 1-month period, (2) 12 treatments, consisting of SMT over a 1-month period, but no treatments for the subsequent 9 months, or (3) 12 treatments over a 1-month period, along with “maintenance spinal manipulation” every 2 weeks for the following 9 months. To determine any difference among therapies, we measured pain and disability scores, generic health status, and back-specific patient satisfaction at baseline and at 1-, 4-, 7-, and 10-month intervals. Patients in second and third groups experienced significantly lower pain and disability scores than first group at the end of 1-month period (P = 0.0027 and 0.0029, respectively). However, only the third group that was given spinal manipulations (SM) during the follow-up period showed more improvement in pain and disability scores at the 10-month evaluation. In the nonmaintained SMT group, however, the mean pain and disability scores returned back near to their pretreatment level.SMT is effective for the treatment of chronic nonspecific LBP. To obtain long-term benefit, this study suggests maintenance SM after the initial intensive manipulative therapy.
FORTH STUDY Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP). The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT) compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program.Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29), a SMT group (n = 36) or a SMT + exercise group (n = 33). The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group), 1 monthly SMT session (SMT group) or 1 monthly SMT session combined with a home exercise program (SMT + exercise group). The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS), active cervical ranges of motion (cROM), the neck disability index (NDI) and the Bournemouth questionnaire (BQ). Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ) and the SF-12 Questionnaire. Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL) was associated with the preventive phase. This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the preventive phase of the trial. This hypothesis was not supported by the study results. Lack of a treatment specific effect is discussed in relation to the placebo and patient provider interactions in manual therapies. Further research is needed to delineate the specific and non-specific effects of treatment modalities to prevent unnecessary disability and to minimise morbidity related to NCNP. Additional investigation is also required to identify the best strategies for secondary and tertiary prevention of NCNP.
I honestly do not think that the findings from these 4 small trials justify the far-reaching conclusion that Maintenance Care can be considered an evidence-based method… For that statement to be evidence-based, one would need to see more and better studies. Therefore, the honest conclusion, I think, is that maintenance care is not supported by sound evidence for effectiveness; as chiropractic manipulations are costly and not risk-free, its risk/benefit balance fails to be positive. Therefore, this approach cannot be recommended.
Tiger Balm (TB) ointments are Chinese topical remedies, often used for pain relief available as over-the-counter medications. TB is clearly popular, but does it work? The aim of this systematic review was to find out by assessing the efficacy, safety and tolerability of TB ointments.
A total of 12 studies were included (five on TB ointments efficacy, whereas seven on their safety and tolerability). Two cases of dermatitis and one of cheilitis likely ascribable to the use of TB ointments have been reported. Based on available studies, it might be estimated that around 4% [95% CI, 3%-5%] of patients with history of contact skin allergy could be positive if patch tested with TB ointments, therefore caution is recommended in the use of TB among these subjects.
The authors concluded that, according to retrieved evidence, TB ointments might be useful for the management of pain due to tension headache, and they seem capable of increasing leg blood flow if combined with massage. Considering available evidence on topical products with camphor, TB ointments shouldn’t be used in children, as well as in pregnant or lactating women. Chronic use, large amounts of balm, and the application on damaged skin must be avoided too. Further studies are recommended.
I had to laugh out loud when reading these conclusions:
- That TB MIGHT be useful is hardly worth writing home about. A systematic review should tell us whether there is any good evidence THAT it is useful.
- That TB seems capable of increasing leg blood flow is also nonsense. Firstly, anything increases blood flow IF COMBINED WITH MASSAGE. Secondly, why would anyone want to increase leg blood flow? Ahh of course: if you have leg ischaemia, e. g. in intermittent claudication. But then increasing blood flow of the skin of the leg is likely to be counter-productive, as this would shunt blood away from the already oxygen-starved muscles.
So, what evidence is there that TB might be effective? It turns out that there is all of ONE small randomised clinical trial that is over 20 years old which delivers a positive result. In view of this, I find it hard to resist re-writing the conclusions as follows:
TB IS A CHINESE REMEDY THAT CAN CAUSE ADVERSE EFFECTS AND FOR WHICH THERE IS NO GOOD EVIDENCE OF EFFICACY. ITS RISK/BENEFIT BALANCE IS THEREFORE NOT DEMONSTRABLY POSITIVE.
On 6 November the Guardian published an article in which acupuncture and its risks were briefly mentioned. It prompted a complaint by the British Acupuncture Council which, I think, is sufficiently interesting to merit a discussion. The British Acupuncture Council (BAcC) has a membership of around 3,000 professionally qualified acupuncturists. It is the UK’s largest professional/ self-regulatory body for the practice of traditional acupuncture. Here is their complaint in full:
Re: Guardian article ‘Doctors call for tighter regulation of traditional Chinese medicine’, published 6 November 2019. We wish to respond to the article referenced above, specifically with regards to the two sentences relating to the safety of acupuncture. We request you correct the misleading comments made in the article and publish this letter online.
1. ‘And acupuncture, they will say, “is not necessarily harmless.”’
Yes, of course it may not be harmless: it involves piercing the skin with a sharp object. Hence the need for proper training of acupuncturists, together with evidenced guidelines, a robust code of safe practice and regulatory teeth. These components are all in place for members of the British Acupuncture Council (BAcC). Acupuncture has not been taken into state control in the UK precisely because it has been found to be so safe; instead, the BAcC is entrusted with self-regulation and is an accredited member of the Professional Standards Authority. Statements about the safety of acupuncture commonly conclude: ‘Acupuncture seems, in skilled hands, one of the safer forms of medical intervention’ (White 2001).
2. ‘…A review in 2017 found many injuries, infections and adverse reactions.’
That first part of your acupuncture safety comment was a direct quote from the FEAM/EASAC statement, which was the focus of the article, but it then departs from the script to manufacture the colourful soundbite above. You refer to the same acupuncture safety overview paper (Chan et al 2017) that FEAM/EASAC drew on, but then substantially misrepresent its content and messages. It is neither a quote from the FEAM/EASAC statement, nor from the overview paper. In fact, the latter sums up the findings of the 17 included reviews thus: ‘However, all the reviews have suggested that adverse events are rare and often minor.’ Your statement about many injuries, infections and adverse reactions gives a very different message to the paper’s authors.
The Guardian article appears to have been written with little understanding of the science involved in investigating medical adverse events. In particular, it is impossible to establish the significance of the numbers of adverse events reported without knowing how many treatments they came from. Chan et al (2017) noted that incidence rates could not be calculated ‘because many adverse events came from case reports and many of the reviews did not include full details about the number of participants in their included studies’. The 17 reviews between them covered literature from 1950 to 2014 and countries across the globe, so potentially millions and millions of treatments. No wonder they turned up plenty of incidents!
One of the ‘gold standard’ acupuncture safety reviews (Xu et al 2013), which was included in Chan’s overview, provides the following information on this issue:
‘Incidence rates for major AEs [adverse events] of acupuncture are best estimated from large prospective surveys of practitioners. Four recent surveys of acupuncture safety among regulated, qualified practitioners, two conducted in Germany (Melchart 2004; Witt 2009), and two in the United Kingdom (MacPherson 2001; White 2001), confirm that serious adverse events after acupuncture are uncommon. Indeed, of these surveys, covering more than 3 million acupuncture treatments all together, there were no deaths or permanent disabilities, and all those with AEs fully recovered (Witt 2011). Thus, it can be concluded that acupuncture has a very low rate of AEs, when conducted among licensed, qualified practitioners in the West.’
The overview authors also raised this concern: ‘A major limitation of the presented information was that no causality could be determined’. In other words there is often no evidence to link acupuncture to the reported event: it is implicated just because it was around at the time. Adverse events only become adverse reactions (your words) if there is a substantiated link.
Your article (and indeed the FEAM/EASAC statement) completely omits perhaps the most important consideration: how does acupuncture compare to other available treatment options? It is most often used by people for chronic pain. The evidence base for this is good (Vickers 2018) and supports acupuncture’s effectiveness compared to conventional treatments (Trinh 2019). The potential harms of opioids and non-steroidal anti-inflammatory drugs are well known and acupuncture is associated with fewer adverse events than medications in controlled trials across a wide range of conditions (Cao 2018; Xu 2018; Lu 2016). It was estimated that one in 1,200 people taking NSAIDS for at least two months will die of gastrointestinal complications (Tramer 2000). Six percent of hospitalisations in developed countries are due to adverse drug reactions (Angamo 2016).
On safety grounds there is no comparison: no serious adverse events were reported in a survey covering 34,407 acupuncture treatments given by BAcC members (Macpherson 2001). Of the mild transient reactions reported, the most frequent were ‘feeling relaxed’, and ‘feeling energised’. This is not to downplay the potential harms, for they can be serious, but as with any medical intervention there should be a proper assessment of how likely this is, which the Guardian article signally failed to do.
Mark Bovey Research Manager British Acupuncture Council
I had no involvement in the Guardian article; I nevertheless feel that several things need to be pointed out about this bizarre complaint:
- The quote attributed to White A is, in fact, by White, Hayhoe, Hart and Ernst (yes, petty point), and our investigation showed (not petty point) that there were 43 significant minor adverse events reported, a rate of 14 per 10,000, of which 13 (30%) interfered with daily activities. One patient suffered a seizure (probably reflex anoxic) during acupuncture, but no adverse event was classified as serious. Avoidable events included forgotten patients, needles left in patients, cellulitis and moxa burns. This, I think, entirely justifies the words -is not necessarily harmless – published by the Guardian.
- The complaint states that there is often no evidence to link acupuncture to the reported event: it is implicated just because it was around at the time. Adverse events only become adverse reactions (your words) if there is a substantiated link. What this seems to imply is this: the BAcC claim that causality of adverse effects remains speculative, while having failed to establish a surveillance system that could establish their causality more firmly. Perhaps the BAcC should file a complaint about themselves?
- The BAcC claim that the author of the Guardian article lacks understanding of the science of adverse effect reporting. However, I get the impression that the lack of understanding is embarrassingly evident on the side of the BAcC.
- The BAcC then highlight the most important consideration: how does acupuncture compare to other available treatment options? This is more than a little odd. Firstly, such comparisons hardly were the aim of the Guardian article. Secondly, such comparisons only make sense with options that have a comparable risk/benefit profile. As the benefits of acupuncture for most conditions are still debatable, and since its risks are finite, its risk/benefit balance might not be clearly positive. Therefore, such comparisons are of doubtful value and could easily turn out to generate unfavourable evidence against acupuncture.
- Comparisons to opioids or NSAIDS are evidently nonsensical for the reason just mentioned.
- The Guardian article’s comments on acupuncture risks were of a general nature and were unelated to any specific issues about BAcC members. There are many non-medically trained acupuncturists – both in the UK and abroad – who might represent a substantially higher risk. Therefore the Guardian should not be criticised but praised for publishing words of caution.
The BAcC state that this is not to downplay the potential harms, yet I fear that this is precisely what they are trying to do. Until there is a post-marketing surveillance system, it would be honest and ethical to admit that the risks of acupuncture are essentially not known.
In my view, the complaint has no reasonable basis, tells us more about the BAcC than the Guardian, and should not be acted upon by the Guardian.
RE: Review of chiropractic spinal care for children under 12 years
The Australian Medical Association (AMA Victoria) appreciates the opportunity to respond to the Safer Care Victoria (SCV) consultation on chiropractic manipulation of children under 12 years.
The AMA is pleased that SCV has decided to review this practice which is manifestly unsafe and unwarranted.
Chiropractic spinal manipulation on children has received recent media attention and prompted community concerns about its safety, appropriateness and the professional duties of those undertaking it. Most notably, in February this year medical experts and the Victorian Government condemned the controversial practice of infant spine manipulation after footage emerged of a Melbourne chiropractor treating a two-week old baby on the chiropractor’s own site.
Treatment of infants and very young children
We are aware that chiropractors are treating children for problems such as “infantile colic” by manipulative therapies. There is no credible evidence for this, it is a dangerous practice in itself and it potentially impedes the proper assessment and management of an infant. Additionally, it preys on often tired parents by the promise of a frequently false unequivocal diagnosis and false “quick fix”. This is plainly unconscionable and dangerous behaviour.
In preparing our response, we engaged with doctors across many specialities who have offered valuable insights into the matters being considered as part of this review. It is our very firm view that the risk of undertaking spinal manipulation on small infants is of no benefit and is potentially extremely dangerous. Newborn babies are extremely fragile and AMA Victoria warns that damage done to a baby or infant may not be immediately obvious to parents, and may not manifest until many years later. This is supported by a study conducted by the American Academy of Pediatrics  which found serious adverse events may be associated with paediatric spinal manipulation.1
Another critical issue is that it is very unlikely that parents are providing informed consent to such procedures. For parents to provide informed consent, they would need to be fully advised of the risks including, for example:
• the diagnosis of “infant colic” is a catch all for a range of symptoms with different aetiologies;
• the potential drastic short and long term consequences of spinal manipulation on their baby;
• there are no scientific safety and efficacy studies undertaken; and
• there is no credible scientific evidence for manipulation.
Chiropractors should also be directing parents to general practitioners for the proper holistic assessment and care of the child and family.
Additionally, infants and very young children cannot provide assent for a procedure for which there is no evidence they require and which may leave them with long term consequences. Consideration of whether such potentially dangerous therapies, which are not underpinned by a strong evidence-base, should be supported by private health insurance rebates is also warranted.
Treatment of children under 12 years of age
Although there is limited evidence that some musculoskeletal treatments are effective in adults, there is no credible scientific evidence that manipulation, mobilisation or any applied spinal therapy in children under 12 years of age is warranted or safe.
AMA Victoria does not support clinical interventions unless there is scientific evidence that such treatments are useful in treating the illness. AMA Victoria also supports patients being fully informed on the illness and the risks and benefits to any treatment. When the risks are to be borne by a non-assenting child, the requirement of evidence and consent is especially important.
AMA Victoria strongly advocates that chiropractic (and other health professionals) spinal care for children under 12 years of age is dangerous, unwarranted and must cease immediately.
If you would like to discuss any aspect of our response, please contact Ms Nada Martinovic, Senior Policy Advisor on (03) 9280 8773 or email@example.com.
Associate Professor Julian Rait OAM AMA VICTORIA PRESIDENT
1 Sunita, V., et al., Adverse Events Associated with Pediatric Spinal Manipulation: A Systemic Review, Pediatrics, 2007: 119; 275-283.
I am truly delighted that the AMA Victoria agrees with many points I have tried to make previously (see for instance here, here and here). The statement is unsurpassed in its directness and strength. My congratulations to Prof Raith – very well done!
Let’s hope that professional bodies of other regions and counties will swiftly follow suit with equal clarity.