diabetes
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM) that can cause annoying symptoms. To address this condition, several treatment approaches have been proposed, including static magnetic field (SMF) therapy, which has shown promise in treating neurological conditions. Therefore, this study aimed to investigate the effects of SMF therapy on symptomatic DPN and the quality of life (QoL) in patients with type 2 diabetes.
A double-blind, randomized, placebo-controlled trial was conducted from April to October 2021. Sixty-four DPN patients (20 males, 44 females) were recruited for the study via invitation. The participants were divided into two groups: the magnet group, which used magnetic ankle bracelets (155 mT) for 12 weeks, and the sham group, which used non-magnetic ankle bracelets for the same duration. Neuropathy Symptom Score (NSS), Neuropathic Disability Score (NDS), and Visual Analogue Scale (VAS) were used to assess neuropathy symptoms and pain. In addition, the Neuropathy Specific Quality of Life Questionnaire (Neuro-QoL) tool was used to measure the patients’ quality of life.
Before treatment, there were no significant differences between the magnet and sham groups in terms of the NSS scores (P = 0.50), NDS scores (P = 0.74), VAS scores (P = 0.17), and Neuro-QoL scores (P = 0.82). However, after 12 weeks of treatment, the SMF exposure group showed a significant reduction in NSS scores (P < 0.001), NDS scores (P < 0.001), VAS scores (P < 0.001), and Neuro-QoL scores (P < 0.001) compared to the baseline. The changes in the sham group, on the other hand, were not significant.
The authors concluded that according to obtained data, SMF therapy is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL in diabetic type-2 patients.
Our own study and systematic review of the effects of magnetic bracelets and similar devices suggested that the effects of such treatments are due to placebo responses. Therefore, I find the findings of this new study most surprising. Not only that, to be honest, I also find them suspect. Apart from the fact that the treatment has no biological plausibility, I have three main reasons for my skepticism.
- The authors stated that there was no distinguishable difference between the sham and SMF devices in terms of their appearance, weight, or texture, which helped to ensure that the study was double-blinded. This is nonsense, I am afraid! The verum device is magnetic and the sham device is not. It is hardly conceivable that patients who handle such devices for any length of time do not discover this simple fact and thus de-blind themselves. In turn, this means that a placebo effect can easily explain the outcomes.
- Authors who feel that their tiny study of a highly implausible therapy lends itself to concluding that their therapy ‘is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL’ can, in my view, not be taken seriously.
- Something that always makes me suspicious of clinical trials is a lack of a placebo response where one would normally expect one. In this study, the control group exhibits hardly any placebo response. Wearing a strap around your ankle that allegedly emits therapeutic radiation would result in quite a strong placebo effect, according to our own findings.
So, forgive me if I do not trust this study any further than I can throw it! And pardon me if I still think that our previous conclusion is correct: The evidence does not support the use of static magnets for pain relief, and therefore magnets cannot be recommended as an effective treatment.
The ‘keto diet’ is a currently popular high-fat, low-carbohydrate diet; it limits the intake of glucose which results in the production of ketones by the liver and their uptake as an alternative energy source by the brain. It is said to be an effective treatment for intractable epilepsy. In addition, it is being promoted as a so-called alternative medicine (SCAM) for a wide range of conditions, including:
- weight loss,
- cognitive and memory enhancement,
- type II diabetes,
- cancer,
- neurological and psychiatric disorders.
Now, it has been reported that the ‘keto diet’ may be linked to higher levels of cholesterol and double the risk of cardiovascular events. In the study, researchers defined a low-carb, high-fat (LCHF) diet as 45% of total daily calories coming from fat and 25% coming from carbohydrates. The study, which has so far not been peer-reviewed, was presented Sunday at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology.
“Our study rationale came from the fact that we would see patients in our cardiovascular prevention clinic with severe hypercholesterolemia following this diet,” said Dr. Iulia Iatan from the Healthy Heart Program Prevention Clinic, St. Paul’s Hospital, and University of British Columbia’s Centre for Heart Lung Innovation in Vancouver, Canada, during a presentation at the session. “This led us to wonder about the relationship between these low-carb, high-fat diets, lipid levels, and cardiovascular disease. And so, despite this, there’s limited data on this relationship.”
The researchers compared the diets of 305 people eating an LCHF diet with about 1,200 people eating a standard diet, using health information from the United Kingdom database UK Biobank, which followed people for at least a decade. They found that people on the LCHF diet had higher levels of low-density lipoprotein and apolipoprotein B. Apolipoprotein B is a protein that coats LDL cholesterol proteins and can predict heart disease better than elevated levels of LDL cholesterol can. The researchers also noticed that the LCHF diet participants’ total fat intake was higher in saturated fat and had double the consumption of animal sources (33%) compared to those in the control group (16%). “After an average of 11.8 years of follow-up – and after adjustment for other risk factors for heart disease, such as diabetes, high blood pressure, obesity, and smoking – people on an LCHF diet had more than two times higher risk of having several major cardiovascular events, such as blockages in the arteries that needed to be opened with stenting procedures, heart attack, stroke, and peripheral arterial disease.” Their press release also cautioned that their study “can only show an association between the diet and an increased risk for major cardiac events, not a causal relationship,” because it was an observational study, but their findings are worth further investigation, “especially when approximately 1 in 5 Americans report being on a low-carb, keto-like or full keto diet.”
I have to say that I find these findings not in the slightest bit surprising and would fully expect the relationship to be causal. The current craze for this diet is concerning and we need to warn consumers that they might be doing themselves considerable harm.
Other authors have recently pointed out that, within the first 6-12 months of initiating the keto diet, transient decreases in blood pressure, triglycerides, and glycosylated hemoglobin, as well as increases in HDL and weight loss may be observed. However, the aforementioned effects are generally not seen after 12 months of therapy. Despite the diet’s favorable effect on HDL-C, the concomitant increases in LDL-C and very-low-density lipoproteins (VLDL) may lead to increased cardiovascular risks. And another team of researchers has warned that “given often-temporary improvements, unfavorable effects on dietary intake, and inadequate data demonstrating long-term safety, for most individuals, the risks of ketogenic diets may outweigh the benefits.”
The concept of ultra-processed food (UPF) was initially developed and the term coined by the Brazilian nutrition researcher Carlos Monteiro, with his team at the Center for Epidemiological Research in Nutrition and Health (NUPENS) at the University of São Paulo, Brazil. They argue that “the issue is not food, nor nutrients, so much as processing,” and “from the point of view of human health, at present, the most salient division of food and drinks is in terms of their type, degree, and purpose of processing.”
Examples of UPF include:
- Carbonated soft drinks,
- Sweet, fatty or salty packaged snacks,
- Candies (confectionery),
- Mass-produced packaged breads and buns,
- Cookies (biscuits),
- Pastries,
- Cakes and cake mixes,
- Margarine and other spreads,
- Sweetened breakfast cereals,
- Sweetened fruit yoghurt and energy drinks,
- Powdered and packaged instant soups, noodles, and desserts,
- Pre-prepared meat, cheese, pasta and pizza dishes,
- Poultry and fish nuggets and sticks,
- Sausages, burgers, hot dogs, and other reconstituted meat products,
Ultra-processed food is bad for our health! This message is clear and has been voiced so many times – not least by proponents of so-called alternative medicine (SCAM) – that most people should now understand it.
But how bad?
And what diseases does UPF promote?
How strong is the evidence?
I did a quick Medline search and was overwhelmed by the amount of research on this subject. In 2022 alone, there were more than 2000 publications! Here are the conclusions from just a few recent studies on the subject:
- Higher intake of UPFs was associated with higher incidence of Crohn’s disease, but not ulcerative colitis. In individuals with a pre-existing diagnosis of inflammatory bowel disease, consumption of UPFs was significantly higher compared to controls, and was associated with an increased need for IBD-related surgery. Further studies are needed to address the impact of UPF intake on disease pathogenesis, and outcomes.
- In this prospective cohort study, higher consumption of UPF was associated with higher risk of dementia, while substituting unpr2ocessed or minimally processed foods for UPF was associated lower risk of dementia.
- In almost all countries and age groups, increases in the dietary share of ultraprocessed foods were associated with increases in energy density and free sugars and decreases in fiber, suggesting that ultraprocessed food consumption is a potential determinant of obesity in children and adolescents.
- Higher ultraprocessed foods consumption was independently associated with a higher risk of incident chronic kidney disease in a general population.
- These data suggest that a consistent intake of ultra-processed foods over time is needed to impact nutritional status and body composition of children and adolescents.
- This meta-analysis suggests that high consumption of UPF, sugar-sweetened beverages, artificially sweetened beverages, processed meat, and processed red meat might increase all-cause mortality, while breakfast cereals might decrease it.
- The consumption of ultraprocessed foods represents a significant cause of premature death in Brazil.
- Available evidence suggests that UPFs may increase cancer risk via their obesogenic properties as well as through exposure to potentially carcinogenic compounds such as certain food additives and neoformed processing contaminants.
- The high consumption of UPF, almost more than 10% of the diet proportion, could increase the risk of developing type 2 diabetes in adult individuals.
Don’t get me wrong: this is not a systematic review of the subject. I am merely trying to give a rough impression of the research that is emerging. A few thoughts seem nonetheless appropriate.
- The research on this subject is intense.
- Even though most studies disclose associations and not causal links, there is in my view no question that UPF aggravates many diseases.
- The findings of the current research are highly consistent and point to harm done to most organs.
- Even though this is a subject on which advocates of SCAM are exceedingly keen, none of the research I saw was conducted by SCAM researchers.
- The view of many SCAM proponents that conventional medicine does not care about nutrition is clearly not correct.
- Considering how unhealthy UPF is, there seems to be a lack of effective education and action aimed at preventing the harm UPF does to us.
It has been reported that a father accused of withholding insulin from his eight-year-old diabetic daughter and relying on the healing power of God has been committed to stand trial for her alleged murder.
Jason Richard Struhs, his wife Kerrie, and 12 others from a fringe religious group have been charged over the death of type 1 diabetic Elizabeth Rose Struhs. Police alleged she had gone days without insulin and then died. The police prosecutor detailed statements from witnesses and experts, including pediatric consultant Dr. Catherine Skellern, who said Elizabeth’s death “would have been painful and was over a prolonged period of days”.
“There is [also] body-worn camera footage at the scene … where Jason Struhs has recounted the events of the week leading up to the death of Elizabeth,” said the prosecutor. “This details the decision that Jason Struhs has made to stop the administration of insulin, and he stated that he knew the consequences, and he stated in that recording that he will ‘probably go to jail like they put Kerrie in jail’.”
During the hearing, Struhs, who appeared from jail by videolink, mainly sat with his head bowed and hands clasped against his forehead as magistrate Clare Kelly described the evidence against him. “It is said that Mr. Struhs, his wife Kerrie Struhs, and their children, including Elizabeth, were members of a religious community… The religious beliefs held by the members of the community include the healing power of God and the shunning of medical intervention in human life.” She also described a statement from Skellern suggesting Elizabeth would have spent her final days suffering from “insatiable thirst, weakness and lethargy, abdominal pain, incontinence, and the onset of impaired levels of consciousness”. The evidence read into court was an attempt by prosecutors to firm up an additional charge of torture. She said a post-mortem found Elizabeth’s cause of death was diabetic ketoacidosis, caused by a lack of insulin. “It is a life-threatening condition, which requires urgent medical treatment,” Kelly said.
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Cases like these are tragic, all the more so because they might have been preventable with more information and critical thinking. They make me desperately sad, of course, but they also convince me that my work with this blog should continue.
Even though most people do not think about it in this way, tea is a herbal remedy. We know that it is pleasant, but is it also effective?
This study explored the associations between tea drinking and the incident risk of type 2 diabetes mellitus(T2 DM). A dynamic prospective cohort study among a total of 27 841 diabetes-free permanent adult residents randomly selected from 2, 6, and 7 rural communities between 2006-2008, 2011-2012, and 2013-2014, respectively. Questionnaire survey, physical examination, and laboratory test were carried out among the participants. In 2018, the researchers conducted a follow-up through the electronic health records of residents. Cox regression models were applied to explore the association between tea drinking and the incident risk of T2 DM and estimate the hazard ratio(HR), and its 95%CI.
Among the 27 841 rural community residents in Deqing County, 10 726(39%) were tea drinkers, 8215 (77%) of which were green tea drinkers. A total of 883 new T2 DM incidents were identified until December 31, 2018, and the incidence density was 4.43 per 1000 person-years (PYs). The incidence density was 4.07/1000 PYs in those with tea drinking habits and 4.71/1000 PYs in those without tea drinking habits. The incidence density was 3.79/1000 PYs in those with green tea drinking habits. After controlling for sex, age, education, farming, smoking, alcohol consumption, dietary preference, body mass index, hypertension, impaired fasting glucose, and family history of diabetes, the risk of T2 DM among rural residents with tea drinking habits was 0.79 times higher than that among residents without tea drinking habits(HR=0.79, 95%CI 0.65-0.96), and the risk of T2 DM among residents with green tea drinking habits was 0.72 times higher than that among residents without tea drinking habits(HR=0.72, 95%CI 0.58-0.89). No significant associations were found between other kinds of tea and the risk of T2 DM, nor the amount of green tea-drinking.
The authors concluded that drinking green tea may reduce the risk of T2 DM among adult population in rural China.
Epidemiological studies of this nature resemble big fishing expeditions that can bring up all sorts of rubbish and – if lucky – also some fish. The question thus is whether this study identified an interesting association or just some odd rubbish.
A quick look into Medline seems to suggest great caution. Here are the conclusions from a few further case-control studies:
- In Chinese adults, daily green tea consumption was associated with a lower risk of incident T2D and a lower risk of all-cause mortality in patients with diabetes, but the associations for other types of tea were less clear. In addition, daily tea consumption was associated with a lower risk of diabetic microvascular complications, but not macrovascular complications.
- Green tea drinking was associated with an increased risk of T2D in Chinese adults. The mechanisms underlying the association need to be elucidated.
- Tea consumers had reduced risks of all-cause mortality and partial cause-specific mortality, but not for the risk of death from cancer. On the contrary, daily tea drinkers with smoking habits and excessive alcohol drinking had an increased risk of death from cancer.
Thus the question of whether tea drinking might prevent diabetes remains open, in my view.
Yet, the paper might teach us two important lessons:
- Case-control studies must be taken with a pinch of salt.
- Correlation is not the same as causation.
Should Acupuncture-Related Therapies be Considered in Prediabetes Control?
No!
If you are pre-diabetic, consult a doctor and follow his/her advice. Do NOT do what acupuncturists or other self-appointed experts tell you. Do NOT become a victim of quackery.
But the authors of a new paper disagree with my view.
So, let’s have a look at the evidence.
Their systematic review was aimed at evaluating the effects and safety of acupuncture-related therapy (AT) interventions on glycemic control for prediabetes. The Chinese researchers searched 14 databases and 5 clinical registry platforms from inception to December 2020. Randomized controlled trials involving AT interventions for managing prediabetes were included.
Of the 855 identified trials, 34 articles were included for qualitative synthesis, 31 of which were included in the final meta-analysis. Compared with usual care, sham intervention, or conventional medicine, AT treatments yielded greater reductions in the primary outcomes, including fasting plasma glucose (FPG) (standard mean difference [SMD] = -0.83; 95% confidence interval [CI], -1.06, -0.61; P < .00001), 2-hour plasma glucose (2hPG) (SMD = -0.88; 95% CI, -1.20, -0.57; P < .00001), and glycated hemoglobin (HbA1c) levels (SMD = -0.91; 95% CI, -1.31, -0.51; P < .00001), as well as a greater decline in the secondary outcome, which is the incidence of prediabetes (RR = 1.43; 95% CI, 1.26, 1.63; P < .00001).
The authors concluded that AT is a potential strategy that can contribute to better glycemic control in the management of prediabetes. Because of the substantial clinical heterogeneity, the effect estimates should be interpreted with caution. More research is required for different ethnic groups and long-term effectiveness.
But this is clearly a positive result!
Why do I not believe it?
There are several reasons:
- There is no conceivable mechanism by which AT prevents diabetes.
- The findings heavily rely on Chinese RCTs which are known to be of poor quality and often even fabricated. To trust such research would be a dangerous mistake.
- Many of the primary studies were designed such that they failed to control for non-specific effects of AT. This means that a causal link between AT and the outcome is doubtful.
- The review was published in a 3rd class journal of no impact. Its peer-review system evidently failed.
So, let’s just forget about this rubbish paper?
If only it were so easy!
Journalists always have a keen interest in exotic treatments that contradict established wisdom. Predictably, they have been reporting about the new review thus confusing or misleading the public. One journalist, for instance, stated:
Acupuncture has been used for thousands of years to treat a variety of illnesses — and now it could also help fight one of the 21st century’s biggest health challenges.
New research from Edith Cowan University has found acupuncture therapy may be a useful tool in avoiding type 2 diabetes.
The team of scientists investigated dozens of studies covering the effects of acupuncture on more than 3600 people with prediabetes. This is a condition marked by higher-than-normal blood glucose levels without being high enough to be diagnosed as diabetes.
According to the findings, acupuncture therapy significantly improved key markers, such as fasting plasma glucose, two-hour plasma glucose, and glycated hemoglobin. Additionally, acupuncture therapy resulted in a greater decline in the incidence of prediabetes.
The review can thus serve as a prime example for demonstrating how irresponsible research has the power to mislead millions. This is why I have often said that poor research is a danger to public health.
And what can be done about this more and more prevalent problem?
The answer is easy: people need to behave more responsibly; this includes:
- trialists,
- review authors,
- editors,
- peer-reviewers,
- journalists.
Yes, the answer is easy in theory – but the practice is far from it!
This systematic review and meta-analysis of clinical trials were performed to summarize the evidence of the effects of Urtica dioica (UD) consumption on metabolic profiles in patients with type 2 diabetes mellitus (T2DM).
Eligible studies were retrieved from searches of PubMed, Embase, Scopus, Web of Science, Cochrane Library, and Google Scholar databases until December 2019. Cochran (Q) and I-square statistics were used to examine heterogeneity across included clinical trials. Data were pooled using a fixed-effect or random-effects model and expressed as weighted mean difference (WMD) and 95% confidence interval (CI).
Among 1485 citations, thirteen clinical trials were found to be eligible for the current metaanalysis. UD consumption significantly decreased levels of fasting blood glucose (FBG) (WMD = – 17.17 mg/dl, 95% CI: -26.60, -7.73, I2 = 93.2%), hemoglobin A1c (HbA1c) (WMD = -0.93, 95% CI: – 1.66, -0.17, I2 = 75.0%), C-reactive protein (CRP) (WMD = -1.09 mg/dl, 95% CI: -1.64, -0.53, I2 = 0.0%), triglycerides (WMD = -26.94 mg/dl, 95 % CI = [-52.07, -1.82], P = 0.03, I2 = 90.0%), systolic blood pressure (SBP) (WMD = -5.03 mmHg, 95% CI = -8.15, -1.91, I2 = 0.0%) in comparison to the control groups. UD consumption did not significantly change serum levels of insulin (WMD = 1.07 μU/ml, 95% CI: -1.59, 3.73, I2 = 63.5%), total-cholesterol (WMD = -6.39 mg/dl, 95% CI: -13.84, 1.05, I2 = 0.0%), LDL-cholesterol (LDL-C) (WMD = -1.30 mg/dl, 95% CI: -9.95, 7.35, I2 = 66.1%), HDL-cholesterol (HDL-C) (WMD = 6.95 mg/dl, 95% CI: -0.14, 14.03, I2 = 95.4%), body max index (BMI) (WMD = -0.16 kg/m2, 95% CI: -1.77, 1.44, I2 = 0.0%), and diastolic blood pressure (DBP) (WMD = -1.35 mmHg, 95% CI: -2.86, 0.17, I2= 0.0%) among patients with T2DM.
The authors concluded that UD consumption may result in an improvement in levels of FBS, HbA1c, CRP, triglycerides, and SBP, but did not affect levels of insulin, total-, LDL-, and HDL-cholesterol, BMI, and DBP in patients with T2DM.
Several plants have been reported to affect the parameters of diabetes. Whenever I read such results, I cannot stop wondering whether this is a good or a bad thing. It seems to be positive at first glance, yet I can imagine at least two scenarios where such effects might be detrimental:
- A patient reads about the antidiabetic effects and decides to swap his medication for the herbal remedy which is far less effective. Consequently, the patient’s metabolic control is insufficient.
- A patient adds the herbal remedy to his therapy. Consequently, his blood sugar drops too far and he suffers a hypoglycemic episode.
My advice to diabetics is therefore this: if you want to try herbal antidiabetic treatments, please think twice. And if you persist, do it only under the close supervision of your doctor.
Diabetic polyneuropathy is a prevalent, potentially disabling condition. Evidence-based treatments include specific anticonvulsants and antidepressants for pain management. All current guidelines advise a personalized approach with a low-dose start that is tailored to the maximum response having the least side effects or adverse events. Homeopathy has not been shown to be effective, but it is nevertheless promoted by many homeopaths as an effective therapy.
This study assessed the efficacy of individualized homeopathic medicines in the management of diabetic polyneuropathy. A multi-centric double-blind, placebo-controlled, randomized clinical trial was conducted by the Indian Central Council for Research in Homoeopathy at six centers with a sample size of 84. Based on earlier observational studies and repertorial anamnesis of DDSP symptoms 15 homeopathic medicines were shortlisted and validated scales were used for evaluating the outcomes post-intervention. The primary outcome measure was a change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. Secondary outcomes included changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) score at 12 months.
Data of 68 enrolled cases were considered for data analysis. A statistically significant difference (p<0.014) was found in NTSS-6 post-intervention in the Verum group. A positive trend was noted for the Verum group as per the graph plotted for DNE score and assessment done for NCS. No significant difference was found between the groups for WHOQOL-Bref. Out of 15 pre-identified homeopathic medicines, 11 medicines were prescribed in potencies in ascending order from 6C to 1M.
The authors refrain from drawing conclusions about the efficacy of their homeopathic treatment (which is more than a little odd, as their stated aim was to assess the efficacy of individualized homeopathic medicines in the management of diabetic polyneuropathy). So, please allow me to do it for them:
The findings of this study confirm that homeopathy is a useless treatment.
In my last post, I reported that there are no rigorous studies of homeopathy for diabetes. This was only partly true: there are no such trials to test homeopathy’s effects on the disease itself, but I did find a study of homeopathy for diabetic complications.
It comes from India and seems to be based on proper preliminary ground-work:
A prospective multi-centric clinical observational study was published in 2013 in the journal ‘HOMEOPATHY’. It was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) at its five institutes/units. Its authors were Patients suffering from diabetes mellitus (DM) and presenting with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were evaluated by the diabetic distal symmetric polyneuropathy symptom score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months.
Of 336 patients (167 males and 169 females) enrolled in the study, 247 patients (123 males and 124 females) were analysed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis.). A statistically significant improvement in DDSPSS total score (p = 0.0001) was found at 12 months from baseline. Most objective measures did not show significant improvement. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the medicines most frequently prescribed. Adverse event of hypoglycaemia was observed in one patient only.
The authors concluded that this study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the quality of life (QOL) assessment.
As good as their word, they then conducted a more rigorous trial which was published this year:
This study (authored in 2020 by and published in ‘EXPLORE’, an even worse journal than ‘HOMEOPATHY’, in my view) assessed the efficacy of individualized homoeopathic medicines in management of diabetic distal symmetric polyneuropathy (DDSP). It was designed as a multi-centric double-blind, placebo controlled, randomised clinical trial and conducted by the Central Council for Research in Homoeopathy at 6 centres with a sample size of 84. Based on earlier observational studies and repertorial anamnesis of DDSP symptoms 15 homoeopathic medicines were shortlisted and validated scales were used for evaluating the outcomes post-intervention.
The primary outcome measure was change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. Secondary outcomes included changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) Score at 12 months.
The data of 68 enrolled cases was considered for data analysis. Statistically significant difference (p<0.014) was found in NTSS-6 post intervention in the Verum group. Positive trend was noted for Verum group as per the graph plotted for DNE score and assessment done for NCS. No significant difference was found between the groups for WHOQOL-Bref. Out of 15 pre-identified homoeopathic medicines 11 medicines were prescribed in potencies in ascending order from 6C to 1M.
The authors concluded that further studies must be taken up with larger sample size and defined parameters for NCS to assess the effectiveness of homoeopathy.
This looks to me as though the trial failed to produce a positive result on inter-group comparisons. The abstract is unfortunately not very clear, and I have no access to the full text (in case someone has, please send it to me). Judging from the abstract, the study has several important flaws. For instance, it was small and we don’t know why only 68 of 84 patients were considered for analysis. Normally, an intention to treat analysis would be needed for analysis of all 84 patients.
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So, does homeopathy have anything to offer to patients with diabetes?
As far as I can see, the answer is NO!
I’d be happy to change my mind, provided someone shows me convincing evidence.
Prof. Shailendra Ramchandra Vishampayan is the 1st author of the paper we discussed yesterday. He was kind enough to repeatedly join us in the comments section, and I was therefore keen to learn more about him. On his website, he says about himself that he is a renowned academician and famous homeopath, enriched with decades of ideal experiences and quality services. He is registered medical practitioner (M.D), performs all the duties of registered medical practitioner following the law of land in India. Globally he is considered as homeopath and known as “Dr.V”. He is a registered member of Society of Homeopaths (overseas).
Dr. V, is a practicing homeopath with clinical experience of over 20 years. In course of his years of practice he had successfully helped more than 250 happy families globally, with various kinds of cases like thyroid, immune compromised, epilepsy, endocrine disorders, paediatric, gynaecological disorders addictions, psychiatric disorder, children with special needs, pets and plants.
He is famous for his path breaking concept and novel idea of creating an organization called ‘Folk Homeopathy ‘, which is dedicated to professional enrichment of homeopathic practitioners helping them to improve their clinical acumen with spot on prescription.
His practical approach in solving cases has earned him accolades and fame throughout the globe.
Dr. V is the author of ‘Kinder Garten Materia Medica’ a reference book for beginners widely used by homeopathic students in India. It is a book with unique combination of pictorial and pneumonic.
He is a Professor (PG) at D.Y.Patil Homeopathy Medical College (Pune). He has a teaching experience of over 16 years in teaching UG and PG. He has drawn large number of followers through webinars which is accessible throughout the globe. He has given more than 50 international seminar ,workshops and webinars in countries like USA, Ireland, Malaysia, with presentations on Homeopathic approach to female hormonal imbalance cases at OMICS Conference of Alternative Medicine, presentation on Psychiatric cases at Asian Homeopathic League. And various presentation at University of Cyberjaya, Malaysia, California Homeopathic Medical society, San Diego and also at Corte Madera, 98th FOH Congress, Liverpool and Kinvara Co Galway, Ireland.
And on the same site, we also learn that ‘Dr V’ is particularly adept at treating diabetes:
India is now considered as the diabetes capital of the world. Approximately 8.7 percent of Indians between the age of 20 to 70 years are diabetic. This translates to approximately 62.5 million diabetics living in India, according to estimates by the World Health Organisation (W.H.O.) The economic burden of managing this disease is also substantial since this is a combination of cost of treatment and loss of productivity in such a high number of diabetics. Diabetes can affect multiple organ systems resulting in a wide range of serious issues in patients. Many of these complications in a diabetic do not have any specific treatment with conventional medicines. However, an indication of the popularity of homeopathy amongst diabetics is that the doctors at our clinic treat approximately two hundred cases of diabetes or diabetes related issues every day. We have, in fact, developed specific diabetes management protocols for patients based on the experience of thousands of cases we have seen over four decades.
This is interesting, I thought, and conducted a few Medline searches to see whether there is any evidence to show that homeopathy is an effective therapy for diabetes. I am afraid, I found no papers of ‘Dr V’ to suggest such an effect. But what I did find was certainly fascinating.
Last year, Italian diabetologists published an review entitled ‘Alternative treatment or alternative to treatment? A systematic review of randomized trials on homeopathic preparations for diabetes and obesity‘. Here is what they reported:
The searches failed to retrieve any trial comparing homeopathic remedies with placebo or any active drug for the treatment of either diabetes or obesity.
These authors commented that
… if homeopathy is used as an alternative to available and effective treatments, the consequences can be catastrophic, particularly in some conditions such as insulin-requiring diabetes. In conclusion, there is no scientific evidence on efficacy and no demonstration of safety of homeopathy in diabetes and obesity…
I agree with my Italian colleagues and I have previously expressed this view bluntly; I even entitled one of my posts ‘This is how homeopathy could kill millions‘.
‘Dr V’ will probably point out that he is a fully qualified doctor and uses homeopathy merely as an adjunct to conventional anti-diabetic treatments; thus he kills nobody.
I certainly hope this is so! But, even in this case, I must still ask: WHERE IS THE EVIDENCE THAT HOMEOPATHY IS AN EFFECTIVE ADJUNCT TO CONVENTIONAL MEDICINE?
