Mercury is a highly toxic chemical that threatens the health of humans and the environment. When it is released into the environment, it enters the food chain where it accumulates, particularly in fish. Exposure to high levels of mercury can cause harm to the brain, lungs, kidneys and the immune system. For these reasons, dental amalgam fillings which contain mercury have long been criticized. This is particularly true in the realm of so-called alternative medicine (SCAM) where, as discussed repeatedly, amalgam has long been a subject of both concern and misinformation, e.g.:
- Is removal of dental amalgam a good idea?
- Dental Amalgam
- Three Trends In “Alternative Dentistry” Part 3: Amalgam Removal and Avoidance
- Three Trends In “Alternative Dentistry” Part 1: The Concept of Projections—Of Meridians and Temporo-Mandibular Joint Dysfunction (TMJD)
- Holistic dentistry?
In the EU, dental amalgam might soon be merely of historical interest.
It has been announced that the EU Parliament and Council reached a provisional political agreement on the Commission’s proposal to address the remaining uses of mercury in products in the EU in line with commitments set out in the EU’s Zero Pollution Ambition.
In spite of viable mercury-free alternatives, around 40 tonnes of mercury are still used in the EU annually for dental amalgam as current rules only forbid the use of dental amalgam for treating teeth in children under 15 years old as well as pregnant and breastfeeding women.
Negotiators agreed to phase out the use of dental amalgam in the EU by 1 January 2025 except if deemed strictly necessary by the dental practitioner based on the duly justified specific medical needs of the patient.
EU countries that have not yet adjusted their reimbursement system to cover alternatives, may postpone the phase-out up until 30 June 2026, to avoid negative repercussions for low-income individuals that would otherwise be socio-economically disproportionally affected by the phase-out.
The export of dental amalgam will also be prohibited from 1 January 2025, whereas the manufacturing and import into the EU will be banned from 1 July 2026.
After the agreement, rapporteur Marlene Mortler (EPP, Germany) said: “After an intensive week of negotiations, we were able to reach an agreement today to ban dental amalgam containing mercury. This is an important step towards a mercury-free future. I am very pleased with the result – because we have ensured that such dental amalgam may only be used in medically necessary cases. Some Member States have been granted an exemption in order to mitigate the socio-economic consequences of the amalgam phase-out. After all, the ban on dental amalgam must not mean that low-income EU citizens can no longer afford adequate dental treatment in these countries. Another key point of this agreement is the decision that lamps containing mercury may only be exported to countries outside the EU until 30 June 2026. This will ensure that products that are already banned in the EU are not sold to third countries and have environmentally harmful consequences there.”
The deal still has to be adopted by the EU Parliament and Council, after which the new law will be published in the EU Official Journal and enter into force 20 days later.
We have discussed dental amalgam and its risks to human health before. Finally, there is new legislation in sight. The European Commission has revised the EU Mercury Regulation to protect EU citizens and the environment from toxic mercury. Among other things, this will completely ban the use of dental amalgam, for which 40 tons of mercury are currently consumed annually in the EU. The revised mercury ordinance provides for the following:
– No more use of dental amalgam from January 1, 2025; viable mercury-free alternatives are available.
– Ban on the manufacture and export of dental amalgam from the EU from January 1, 2025;
– Ban on the manufacture and export of six mercury-containing lamps from January 1, 2026 and January 1, 2028 (depending on lamp type).
The delegated act adopted under the Mercury Regulation transposes into EU law the decisions taken at the fourth Conference of the Parties (2022) to the Minamata Convention by introducing a ban on the production, import, and export of eight additional mercury-containing products, including mercury-containing lamps and non-electrical equipment.
The Minamata Convention is the main international legal framework for the protection of human health and the environment from anthropogenic emissions and releases of mercury to air, water, and soil. Like the Mercury Regulation, it addresses the entire life cycle of mercury, from primary mercury mining to mercury waste management.
The revised Mercury Regulation must now be approved by the European Parliament and the Council under the ordinary legislative procedure. The delegated act will be sent to the European Parliament and the Council for consideration.
Mercury is a highly toxic chemical that poses a threat to both human health and the environment. When released into the environment, it enters the food chain where it accumulates (mainly in fish). High mercury exposure can damage the brain, lungs, kidneys, and immune system.
Historically, mercury has been used in a wide range of applications, including gold mining, batteries, fluorescent tubes, thermometers, and barometers. Over the last twenty years, the EU has developed a comprehensive body of legislation, in particular the Mercury Regulation, which protects human health and the environment from anthropogenic emissions and releases of mercury, taking into account the entire life cycle of mercury from primary mercury mining to final disposal of mercury waste. It also includes measures on trade in mercury-containing products and mercury pollution.
The Minamata Convention entered into force on August 16, 2017, and has so far been ratified by the European Union and 143 countries, including all EU Member States. The fifth session of the Conference of the Parties to the Minamata Convention on Mercury (COP-5) will be held in Geneva, Switzerland, from October 30 to November 3, 2023.
I found this acupuncture study from the Department of Oral and Maxillofacial Sciences, “Sapienza” University of Rome, Rome, Italy. As this seems to be a respectable institution, I had a look. What I found was remarkable! Let me show you the abstract in its full beauty:
Background: Pain related to Temporomandibular Disorders (TMD) is severe, negatively affecting patients’ quality of life, and often resistant to conventional treatments. Abdominal Acupuncture (AA) is known to be particularly effective for pain, especially chronic and musculoskeletal pain, but it is still poorly studied and never investigated in TMD patients. Objectives: To analyze the efficacy of AA for the treatment of patients with subacute and chronic pain related to TMD and non-responding to previous conventional therapies (occlusal splint, medications, physical therapy).
Methods: Twenty-eight patients, 24 F and four M (mean age 49.36 years), were recruited from January 2019-February 2021. All patients underwent AA treatment: two sessions per week for four weeks, for a total of eight sessions. At the beginning of therapy (T0) and at the end of the cycle (T1) the following data were evaluated: maximum mouth opening (MMO); cranio-facial pain related to TMD (verbal numeric scale, VNS); pain interference with normal activities and quality of life of patients (Brief Pain Inventory, BPI); oral functioning (Oral Behavior Checklist, OBC); impression of treatment effectiveness (Patients’ Global Impression of Improvement, PGI-I Scale). Statistical comparison of data before and after the AA treatment was performed by Wilcoxon’s signed-rank test (significance level p < 0.05).
Results: The MMO values were significantly improved after one cycle of AA (p = 0.0002). In addition, TMD-related pain had a statistically significant decline following AA treatment (all p < 0.001). Patients’ general activity and quality of life (BPI) were described as improved following a course of AA, with statistically significant values for all aspects considered (all p < 0.05).
Conclusion: Abdominal acupuncture resulted in effective treatment of subacute/chronic resistant pain related to TMD, capable of improving mandibular function and facial pain, and reduced the interference of pain affecting patients’ quality of life.
This study did not include a control group. Such uncontrolled studies are not necessarily useless. In areas where there is no prior evidence, they can be a reasonable starting point for further research. In the case of TMD/acupuncture, however, this does not imply. Here we already have about a dozen controlled trials. This means an uncontrolled study cannot possibly contribute to our knowledge. This means that the present study is useless. And that, in turn, means it is unethical.
But even if we ignore all this, the study is very misleading. It concludes that acupuncture improved TMD. This, however, can be doubted!
- What about placebo?
- What about regression toward the mean?
- What about the natural history of the condition?
Bad science is regrettable and dangerous, as it
- wastes resources,
- misleads vulnerable patients,
- violates ethics,
- and undermines trust in science.
I fear that the Italian group has just provided us with a prime example of these points.
Third molar extraction is a painful treatment and thus is often used to investigate the effects of analgesics on pain. Hypnotherapy is said to help to reduce pain and to decrease the intake of postoperative systemic analgesics. Therefore, it seems reasonable to study the effects of hypnotherapy on the pain caused by third molar extraction.
In this study, the effectiveness of a brief hypnotic induction for patients undergoing third molar extractions was investigated. Data were collected from 33 patients with third molar extractions on the right and left sides. Patients received two different types of interventions in this monocentric randomized crossover trial. Third molar extraction was conducted on one side with reduced preoperative local anesthetics and an additional brief hypnotic induction (Dave Elman technique). The other side was conducted with regular preoperative local anesthetics without a brief hypnotic induction (standard care). Intake of postoperative systemic analgesics was allowed in both treatments.
Patients’ expectations about hypnosis were assessed at baseline. The primary outcome was the area under the curve with respect to ground of pain intensity after the treatment. Secondary outcomes were the amount of postoperative analgesics consumed and the preferred treatment.
There was no evidence that the area under the curve with respect to ground of pain differed between the two interventions (controlling for gender). There was, however, evidence to show that the patients’ expectations affected the effectiveness of the brief hypnotic induction. This means that patients with high expectations about hypnosis benefit more from treatment with reduced preoperative local anesthetics and additional brief hypnotic induction.
The authors concluded that, in this study, additional a brief hypnotic induction with reduced preoperative local anesthetic use did not generally reduce posttreatment pain after third molar extraction more than regular local anesthetics. The expectation of the patients about the effectiveness of hypnosis affected the effectiveness of the brief hypnotic induction so that patients with high expectations had a larger benefit from a brief hypnotic induction than patients with low expectations.
The most interesting findings here are, in my view, that:
- Hypnotherapy is not as effective as many enthusiasts claim.
- Expectation influences the outcome of hypnotherapy.
Expectation is, of course, a determinant of the size of the placebo response. Thus, this finding is interesting but far from unexpected. I would go as far as postulating that similar results would be obtained with most treatments regardless of whether they are alternative or conventional. The difference is that, in the case of alternative therapies, the expectation is a major (if not the only) determinant of the outcome, while it merely somewhat improves the outcome of an effective treatment. To put it differently, so-called alternative medicine (SCAM) relies entirely/mostly on expectation, while conventional medicine does not.
When I first saw this, I was expecting something like If Homeopathy Beats Science (Mitchell and Webb) – YouTube : videos (reddit.com). But no, “Acute Care Homeopathy for Medical Professionals” is not a masterpiece by gifted satirists. It is much better; it is for real! In fact, it is a collaboration between the “Academy of Homeopathy Education” (AHE) and the American Institute of Homeopathy (AIH). Together, they published the following announcement:
AHE and AIH are pleased to present a customized educational program designed for busy medical professionals interested in enhancing their practice and expanding the treatment tools available with Homeopathy. Grounded in the original theory and philosophy of Homeopathy, AHE’s quality curriculum empowers practitioners and the material’s inspirational delivery encourages further study towards the mastery of Homeopathy for chronic care.
This course is open to all licensed healthcare providers— medical, osteopathic, naturopathic, dentists, chiropractors, veterinarians, nurse practitioners, nurses, physician assistants, pharmacologists and pharmacists.
Acute-care homeopathy addresses the challenges of 21st-century medical practice.
Among many things, you’ll learn safe and effective ways to manage pain and mitigate antibiotic overuse with FDA-regulated and approved Homeopathic remedies. AHE delivers an integrated learning experience that combines online real-time classroom experiences culminating in a telehealth based clinical internship allowing participants to study from anywhere in the world.
AHE’s team of Homeopathy experts have taught thousands of students around the globe and are known for unparalleled academic rigor, comprehensive clinical training, and robust research initiatives. AHE ensures that every graduate develops the necessary critical thinking skills in homeopathy case taking, analysis, and prescribing to succeed in practice with confidence and competence.
- Smart and savvy tech support team helps to on-board and train even the most reticent digital participants
- Academic support professionals provide an educational safety-net
- Stellar faculty to inspire confidence and encourage students to achieve their best work
- “Fireside Chats,” forums, and social gatherings build community
- Tried and true administrative systems keep things running smoothly so you can focus on learning Homeopathy.
All AHE students receive Radar Opus, the leading software package used by professional homeopaths worldwide.
Upon completion of the didactic program, practitioners begin an Acute Care Internship through AHE and the Homeopathy Help Network’s Acute Care Telehealth Clinic “Homeopathy Help Now” (HHN) which sees thousands of cases each year. Upon successful completion of the internship, practitioners will be invited to participate in ongoing supervised practice through HHN.
AHE is part of a larger vision to shape the future of Homeopathy: HOHM Foundation and the Homeopathy Help NetworkAll clinical services are delivered in an education and research-driven model. HOHM’s Office of Research has multiple peer-reviewed publications focused on education, practice, and clinical outcomes. HOHM is committed to funding Homeopathy study and research at every level.
The Academy of Homeopathy Education (AHE) operates in conjunction with HOHM Foundation, a 501c3 initiative committed to education, advocacy, and access. The Homeopathy Help Network is a telehealth clinic providing fee-for-service chronic care as well as donation-based acute care through Homeopathy Help Now.
I suspect you simply cannot wait to enroll. To learn more about “Acute Care Homeopathy for Medical Professionals” please fill out the form.
… and don’t forget to pay the fee of US$ 5 500.
No, it’s not expensive, if you think about it. After all, acute-care homeopathy addresses the challenges of 21st-century medical practice.
There are many patients in general practice with health complaints that cannot be medically explained. Some of these patients attribute their problems to dental amalgam.
This study examined the cost-effectiveness of the removal of amalgam fillings in patients with medically unexplained physical symptoms (MUPS) attributed to amalgam compared to usual care, based on a prospective cohort study in Norway.
Costs were determined using a micro-costing approach at the individual level. Health outcomes were documented at baseline and approximately two years later for both the intervention and the usual care using EQ-5D-5L. Quality-adjusted life year (QALY) was used as the main outcome measure. A decision analytical model was developed to estimate the incremental cost-effectiveness of the intervention. Both probabilistic and one-way sensitivity analyses were conducted to assess the impact of uncertainty on costs and effectiveness.
In patients who attributed health complaints to dental amalgam and fulfilled the inclusion and exclusion criteria, amalgam removal was associated with a modest increase in costs at the societal level as well as improved health outcomes. In the base-case analysis, the mean incremental cost per patient in the amalgam group was NOK 19 416 compared to the MUPS group, while the mean incremental QALY was 0.119 with a time horizon of two years. Thus, the incremental costs per QALY of the intervention were NOK 162 680, which is usually considered to be cost-effective in Norway. The estimated incremental cost per QALY decreased with increasing time horizons, and amalgam removal was found to be cost-saving over both 5 and 10 years.
The authors concluded that this study provides insight into the costs and health outcomes associated with the removal of amalgam restorations in patients who attribute health complaints to dental amalgam fillings, which are appropriate instruments to inform health care priorities.
The group sizes were 32 and 28 respectively. This study was thus almost laughably small and therefore cannot lead to firm conclusions of any type. In this contest, a recent systematic review might be relevant; it concluded as follows:
On the basis of the available RCTs, amalgam restorations, if compared with resin-based fillings, do not show an increased risk for systemic diseases. There is still insufficient evidence to exclude or demonstrate any direct influence on general health. The removal of old amalgam restorations and their substitution with more modern adhesive restorations should be performed only when clinically necessary and not just for material concerns. In order to better evaluate the safety of dental amalgam compared to other more modern restorative materials, further RCTs that consider important parameters such as long and uniform follow up periods, number of restorations per patient, and sample populations representative of chronic or degenerative diseases are needed.
Similarly, a review of the evidence might be informative:
Since more than 100 years amalgam is successfully used for the functional restoration of decayed teeth. During the early 1990s the use of amalgam has been discredited by a not very objective discussion about small amounts of quicksilver that can evaporate from the material. Recent studies and reviews, however, found little to no correlation between systemic or local diseases and amalgam restorations in man. Allergic reactions are extremely rare. Most quicksilver evaporates during placement and removal of amalgam restorations. Hence it is not recommended to make extensive rehabilitations with amalgam in pregnant or nursing women. To date, there is no dental material, which can fully substitute amalgam as a restorative material. According to present scientific evidence the use of amalgam is not a health hazard.
Furthermore, there is evidence that the removal of amalgam fillings is not such a good idea. One study, for instance, showed that the mercury released by the physical action of the drill, the replacement material and especially the final destination of the amalgam waste can increase contamination levels that can be a risk for human and environment health.
As dental amalgam removal does not seem risk-free, it is perhaps unwise to remove these fillings at all. Patients who are convinced that their amalgam fillings make them ill might simply benefit from assurance. After all, we also do not re-lay electric cables because some people feel they are the cause of their ill-health.
I was alerted to this announcement by the Faculty of Homeopathy:
Faculty of Homeopathy Accredited Education
The role of Dentistry in Integrative Medicine and Homeopathy
Dentistry appears to be the Cinderella of healthcare and the importance of good oral health is hugely underestimated. The mouth is the portal into the rest of our bodies. There is increasing evidence proving that health of the oral cavity has strong links with the health of the rest of the body especially increasing risk of heart disease, low birth weight babies and type 2 diabetes. The aim of this webinar is to highlight the vital importance of dentistry and oral health in integrative medicine and why healthcare professionals need to work closely with dentists. It will also cover how, as homeopaths, we can appreciate symptoms in the mouth as indications of general health or disease and manage dental conditions.
THE TICKETS FOR THIS WEBINAR ARE LIMITED THEREFORE, PLEASE REGISTER NOW TO ENSURE ACCESS.
Some splendid platitudes there:
- the Cinderella of healthcare
- The mouth is the portal into the rest of our bodies
- health of the oral cavity has strong links with the health of the rest of the body…
But what about the importance of dentistry in integrative medicine? The importance of dentistry in medicine is fairly clear to me. However, what is the importance of dentistry in integrative medicine?
Even more puzzling seems the ‘role of dentistry in homeopathy’? What on earth do they mean by that? Perhaps they meant the ‘role of homeopathy in dentistry’?
And what is the role of homeopathy in dentistry? The British Homeopathic Dental Association should know, shouldn’t they? On their website, they explain that they are a group of dentists and dental care professionals that have an interest in using homeopathy alongside our dentistry.
On the basis of what evidence, you ask? They kindly provide an answer to that question:
In dentistry there is limited research though studies have shown improved bone healing around implants with Symphytum and reduced discomfort and improved healing time with ulcers and beneficial in oral lichen planus. These studies have small numbers and are not generally acepted as stong evidence.
Are they trying to tell us that there is no good evidence? Looks like it, doesn’t it? In this case, the above Webinar seems rather superfluous.
For those of you who want to save the money for the tickets, here is a full and evidence-based summary of all the conditions where homeopathy might be helpful in dentistry:
The objective of this review (entitled ‘Systematic Review on the Use of Homeopathy in Dentistry:
Critical Analysis of Clinical Trials‘) was to map the literature on homeopathy in dentistry and to evaluate the effectiveness of using homeopathy in dental practice through the critical analysis of clinical studies.
The search for scientific articles in any language, year, and place of publication was made in the databases of Public Medline (PUBMED), Web of Science, Cochrane, and Virtual Health Library; the articles selected were later classified according to the type of study. Gray literature was accessed through Google Scholar. Clinical trials were analyzed for methodological quality. Two trained reviewers accomplished the entire process independently.
Of the 281 studies retrieved by means of the search, 44 met the eligibility criteria. The included papers were:
- literature reviews (56.8%),
- clinical trials (34.1%),
- cross-sectional studies (6.8%),
- laboratory research (6.8%),
- longitudinal observational studies (4.5%).
The clinical trials were published from 1965 to 2019, using homeopathy in several dental specialties:
- Orofacial Pain,
- Pediatric Dentistry,
- dental anxiety.
Qualitative failures, in all criteria investigated, and positive influences of the individual prescriptions on the results of treatments reported were observed.
The authors concluded that there is still a scarcity of studies about homeopathy and dentistry. The clinical trials selected showed positive effects on oral health; however, when they were critically evaluated, it was possible to recognize qualitative failures, mainly relative to double-blinding. It is necessary to encourage research on the subject, using standardized methodological procedures, to obtain better evaluation of the clinical applicability.
According to the authors, their review adhered to the PRISMA guideline of systematic reviews. This is, however, not the case. The authors correctly point out that the primary studies had many flaws: methodological failures were observed in the clinical trials, mainly related to double-blinding (66.7%). Significant failures were also observed in similarity (61.1%), randomization (27.8%), description of losses and exclusions (27.8%), and exclusion criteria (27.8%). They do not seem to realize that flaws of this nature and frequency should prevent positive conclusions.
So, what does this paper actually demonstrate? In my view, it shows that:
- the peer-review process at the JACM continues to be a joke;
- poor quality trials run by enthusiasts tend to produce false-positive results;
- in so-called alternative medicine (SCAM), people get away with publishing even the most obvious falsehoods.
Bach-Flower Remedies (BFRs) are often confused with homeopathics. Like them, they contain no active molecule; unlike them, they are not potentised nor used according to the ‘like cures like’ assumption. Both have in common that they are as popular as implausible.
Few studies have tested BFRs; my own systematic review of controlled clinical trials was published in 2010:
Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.
Now a new study has emerged. This trial from the Department of Pedodontics and Preventive Dentistry, DY Patil University – School of Dentistry, Navi Mumbai, Maharashtra, India, compared the effects of Bach Flower Therapy (BFT) and music therapy (MT) on the dental anxiety in paediatric patients. A total of 120 children (aged 4-6 years) were selected and randomly allocated to one of three groups:
- BFT group: Children from this group were administered orally four drops of “rescue remedy” diluted in 40 mL of water 15 min before the treatment. Children were asked to wear headphones without playing any music during the dental treatment
- MT group: Children from this group were provided with a headphone, and Indian classical instrumental music (Raag Sohni played by Pandit Shiv Kumar Sharma on santoor) was played during the scheduled dental treatment. Children were also given 40 mL plain water to drink 15 min before the treatment
- Control group: Children from this group were given 40 mL plain water 15 min before the treatment. During the treatment, children were asked to wear the headphone without playing any music.
All children received oral prophylaxis and fluoride treatment (no further details provided). Dental anxiety was evaluated using
- North Carolina Behavior Rating Scale (NCBRS), the primary outcome measure,
- Facial Image Scale (FIS),
- and physiological parameters.
Significantly better behaviour was seen in children from the BFT group as compared to the control group (P = 0.014). FIS scores measured postoperatively did not show significant differences among the groups.
Children from the BFT and MT groups showed a significant decrease in the pulse rates intraoperatively from the preoperative period. Intraoperative systolic blood pressure in children from the MT group was significantly lower than both the BFT and the control groups. Diastolic blood pressure significantly increased in the control group intra-operatively, whereas other groups showed a decrease.
The authors concluded that the results of this study demonstrate significant effects of both single dose of BFT and exposure to MT, on reduction of dental anxiety in children aged between 4 and 6 years.
I find these findings most puzzling (like all BFRs, Rescue Remedies do not contain a single active molecule that could explain them) and strongly recommend that we wait until we have an independent replication before accepting these results as trustworthy.
Hurray, homeopaths have a new study to be jubilant about!
But how far can we trust its findings?
Let’s have a look.
The aim of this study was to evaluate the effects of homeopathy (H) as an adjunct to non-surgical periodontal therapy (NSPT) in individuals with type 2 diabetes (DMII) and chronic periodontitis (CP). Eighty individuals with CP and DM II participated in this randomized, double-blind, placebo-controlled study. They were randomly divided into two groups: control group (CG) and the test group (TG), and both groups received the NSPT. TG also received homeopathic therapy, including Berberis, Mercurius solubilis/Belladonna/Hepar sulphur and Pyrogenium, while CG received placebo, while the TG received placebos. Clinical and laboratorial examinations were evaluated at baseline and after 1, 6 and 12 months of treatment.
Both groups showed significant improvement throughout the study for most of the parameters studied, but TG presented a significative gain of clinical attachment at 1 and 12 months compared to CG. Mean glucose and glycated haemoglobin significantly decreased in both groups after 6 and 12 months. However, there was a significant further reduction of these parameters in TG, as compared to CG.
The authors concluded that homeopathy as supplement of NSPT may further improve health condition, including glycemic control, in DMII patients with CP.
Over the years, I have learnt how to ‘sniff out’ studies that are odd. This is one of them, I fear; it smells strangely ‘fishy’.
Here are some of the reasons why I remain sceptical:
- There does not seem to be an approval by an ethics committee.
- I also could also not find any mention of informed consent.
- There is no mention of conflicts of interest
- Neither is the source of funding disclosed.
- There were zero drop-outs which I find hard to believe.
- The trial started in 2013, but was published only recently.
- The treatment with homeopathy lacks biological plausibility.
- The authors conducted > 50 tests for statistical significance without correcting for multiple testing.
- The clinical relevance of the findings is unclear.
Even if we accepted the results of this study, we would require at least one independent replication before we allow them to influence our clinical practice.