Edzard Ernst

MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

Prof Ernst is far too critical about homeopathy!

He is biased against it!

He cherry-picks the evidence!

He does not understand homeopathy!

If you are one of the many who believe such notions, please read on.

The website of the NHS England has a fairly detailed account of homeopathy. Here is the section entitled ‘What can we conclude from the evidence?‘ – but I recommend reading the full text:

There have been several reviews of the scientific evidence on the effectiveness of homeopathy.

The House of Commons Science and Technology Committee said there’s no evidence that homeopathy is effective as a treatment for any health condition.

There’s no evidence behind the idea that substances that cause certain symptoms can also help treat them.

Nor is there any evidence behind the idea that diluting and shaking substances in water can turn those substances into medicines.

The ideas that underpin homeopathy aren’t accepted by mainstream science, and aren’t consistent with long-accepted principles on the way the physical world works.

The Committee’s 2010 report on homeopathy said the “like cures like” principle is “theoretically weak”, and that this is the “settled view of medical science”.

For example, many homeopathic remedies are diluted to such an extent that it’s unlikely there’s a single molecule of the original substance remaining in the final remedy. In cases like these, homeopathic remedies consist of nothing but water.

Some homeopaths believe that, as a result of the succussion process, the original substance leaves an “imprint” of itself on the water. But there’s no known mechanism by which this can occur.

The 2010 report said: “We consider the notion that ultra-dilutions can maintain an imprint of substances previously dissolved in them to be scientifically implausible.”

Some people who use homeopathy may see an improvement in their health condition as the result of a phenomenon known as the placebo effect.

If you choose health treatments that provide only a placebo effect, you may miss out on other treatments that have been proven to be more effective.

__________________________________

Since 1948, homeopathy had been part of the NHS, there were 5 homeopathic NHS hospitals, and the costs for homeopathy were covered. Why would the NHS decision makers suddenly turn against it? They must have loved homeopathy for at least 4 reasons:

      1. It is inexpensive.
      2. It has support in high places.
      3. It did not cause any direct harm.
      4. It had many supporters who fought tooth and nail for it.

It is therefore hardly reasonable to assume that the NHS is biased against homeopathy. But, why do they now say that it is

  • implausible,
  • not effective beyond placebo,
  • and can cause harm by making people miss out on effective therapies?

 

The answer is simple: BECAUSE THESE STATEMENTS ARE IN ACCORDANCE WITH THE OVERWHELMING MAJORITY OF THE BEST EVIDENCE AVAILABLE TO DATE.

So, here you are: the NHS now confirms what I (and many other experts) have been saying since years. And we all insist on the fact that this not because we are biased, stupid, uninformed, paid by BIG PHARMA, or want to deprive anyone of anything. We do it for one reason only:

BECAUSE IT’S THE TRUTH!

Alcohol-related hangover symptoms such as nausea, headache, stress and anxiety cause a considerable amount of harm and economic loss. Several so-called alternative medicines (SCAMs) are being recommended to alleviate hangovers. But, according to our systematic review, none has been shown to be convincingly effective:

Objective: To assess the clinical evidence on the effectiveness of any medical intervention for preventing or treating alcohol hangover.

Data sources: Systematic searches on Medline, Embase, Amed, Cochrane Central, the National Research Register (UK), and ClincalTrials.gov (USA); hand searches of conference proceedings and bibliographies; contact with experts and manufacturers of commercial preparations. Language of publication was not restricted.

Study selection and data extraction: All randomised controlled trials of any medical intervention for preventing or treating alcohol hangover were included. Trials were considered if they were placebo controlled or controlled against a comparator intervention. Titles and abstracts of identified articles were read and hard copies were obtained. The selection of studies, data extraction, and validation were done independently by two reviewers. The Jadad score was used to evaluate methodological quality.

Results: Fifteen potentially relevant trials were identified. Seven publications failed to meet all inclusion criteria. Eight randomised controlled trials assessing eight different interventions were reviewed. The agents tested were propranolol, tropisetron, tolfenamic acid, fructose or glucose, and the dietary supplements Borago officinalis (borage), Cynara scolymus (artichoke), Opuntia ficus-indica (prickly pear), and a yeast based preparation. All studies were double blind. Significant intergroup differences for overall symptom scores and individual symptoms were reported only for tolfenamic acid, gamma linolenic acid from B officinalis, and a yeast based preparation.

Conclusion: No compelling evidence exists to suggest that any conventional or complementary intervention is effective for preventing or treating alcohol hangover. The most effective way to avoid the symptoms of alcohol induced hangover is to practise abstinence or moderation.

However, now we have new data; do they change our conclusion?

The aim of this study is to investigate the effect of the amino acid L-cysteine (an amino acid that is contained in most high-protein foods) on the alcohol/acetaldehyde related aftereffects. Voluntary healthy participants were recruited through advertisements. Volunteers had to have experience of hangover and/or headache. The hangover study was randomized, double-blind and placebo-controlled. Nineteen males randomly swallowed placebo and two differently dosed L-cysteine tablets. The alcohol dose was 1.5 g/kg, which was consumed during 3 h. The study involved 6 drinking sessions on subsequent Friday evenings which all started around 7pm and finished at 10pm.

The primary results based on correlational analysis showed that L-cysteine prevents or alleviates hangover, nausea, headache, stress and anxiety. For hangover, nausea and headache the results were apparent with the L-cysteine dose of 1200 mg and for stress and anxiety already with the dose of 600 mg.

Men taking L-cysteine also had lower scores for nausea

Men who took the L-cysteine pills (plotted in blue) suffered fewer headaches the morning after drinking. The red plots are the placebo and purple are a mix of L-cysteine and placebo

 

The authors concluded that L-cysteine would reduce the need of drinking the next day with no or less hangover symptoms: nausea, headache, stress and anxiety. Altogether, these effects of L-cysteine are unique and seem to have a future in preventing or alleviating these harmful symptoms as well as reducing the risk of alcohol addiction.

The study was conducted in Finland where excessive drinking is apparently not a rarity. According to the study protocol, an 80kg man would have to drink 15 units of alcohol at 6 weekly occasions. This is an impressive amount, and one might wonder about the ethical implications of such a study.

More crucially, one might wonder whether the sample size was sufficiently large to draw such definitive conclusions. Looking at the graphs, it is easy to see that the average effects were determined by just a few data points. Personally, I would therefore feel uncomfortable with these conclusions and insist on further research before issuing far-reaching recommendations.

My discomfort would increase significantly considering that the sponsor of the study was the manufacturer of the L-cysteine supplement being tested, Catapult Cat Oy.

Acute radiation-induced proctitis (ARP) is a common side effect following radiotherapy for malignant pelvic disease. It occurs in about 75% of patients and often proves difficult to treat thus causing much pain and suffering. Aloe vera has been advocated for the prevention of ARP, but does it work?

This study evaluated the efficacy of Aloe vera ointment in prevention of ARP. Forty-two patients receiving external-beam radiotherapy (RT) for pelvic malignancies were randomized to receive either Aloe vera 3% or placebo topical ointment during radiotherapy for 6 weeks. Participants applied ointments especially manufactured for the study rectally via applicator, from the first day of starting radiotherapy for 6 weeks, 1 g twice daily. They were evaluated based on the severity (grade 0-4) of the following symptoms weekly: rectal bleeding, abdominal/rectal pain, diarrhoea, or faecal urgency. RTOG acute toxicity criteria and psychosocial status of the patients were also recorded weekly. Lifestyle impact of the symptoms, and quantitative measurement of C-reactive protein (CRP), an indicator of systemic inflammation, were also measured.

The results demonstrated a significant preventive effect for Aloe vera in occurrence of symptom index for diarrhoea (p < 0.001), rectal bleeding (p < 0.001), and faecal urgency (p = 0.001). The median lifestyle score improved significantly with Aloe vera during RT (p < 0.001). Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).

The authors concluded that Aloe vera topical ointment was effective in prevention of symptoms of ARP in patients undergoing RT for pelvic cancers.

This is by no means the first study of its kind. A previous trial had concluded that a substantial number of patients with radiation proctitis seem to benefit from therapy with Aloe vera 3% ointment. And another study has shown that the prophylactic use of Aloe vera reduces the intensity of radiation-induced dermatitis.

The new trial seems to be methodologically the best so far. Yet it is not perfect, for instance, its sample size is small. Therefore, it would probably be wise to insist on more compelling evidence before this approach can be recommended in oncological routine care.

When chiropractors try to play medical doctors, their patients are in danger. When they try to play epidemiologists, we might all be in danger. Already in April 2020, the Australian ‘Patrons of Chiropractic Science’ issued a press release on COVID 19 stating:

Good function of the body’s joints, particularly within the spine, may improve neurological function, which is important for an effective natural immune system. Treatment by a qualified and experienced chiropractor offers one of the most effective methods to improve and maintain good spinal joint function. The chiropractic profession attends to many patients, and like all other health workers, the profession truly cares for the welfare of every individual.

Now they have gone further. Their press release of 18/8/2020 states amongst other things:

  • Approximately 1.5% of those infected with SARS-CoV-2 may die; all people with a compromised immune system, that being the aged or those suffering a co-morbidity;
  • 98.5% of those infected with the COVID-19 virus suffer either no symptoms, mild symptoms or treatable symptoms no worse than seasonal influenza;
  • COVID-19 positive test numbers are largely irrelevant, as 98.5% of those testing positive will simply develop natural immunity and recover as the virus moves through the population. Recent studies by the UK based Centre for Evidence Based Medicine confirms increased COVID testing is the primary reason for increased case numbers, which have little relationship to mortality. The focus on case numbers is again designed to engender public fear and compliance;

Patrons of Chiropractic Science demands that the Victorian Government and its senior health officials cease distorting facts, stop blaming Victorian non-compliance for the increased positive testing numbers, and assume full responsibility for the aged care deaths and the current economic damage.

Simple facts: it is critical and more effective to isolate and protect the high-risk groups, effectively quarantine return travellers, but cease the illogical isolation of the vast majority of the population who are not at risk as the virus naturally circulates, and allow them to recommence working to save many businesses and initiate economic recovery.

________________________________

Implying that regular chiropractic manipulations improve immunity or protect people from the corona virus is bad enough. But the new press release is worse:

  1. It is not true that only people with impaired immune systems, of old age, or affected by other diseases die of COVID 19.
  2. It is not true that all of the 98.5% who do not die have treatable symptoms not worse than a flu; an undefined percentage of the survivors suffer from very severe and sometimes long-lasting conditions.
  3. It is not true that 98.5% of those testing positive will simply develop natural immunity and recover; many will not recover completely, and the question whether mildly affected individuals develop immunity and for how long is as yet unanswered.
  4. It is not true that COVID testing results are unrelated to mortality; the figures need, of course, careful interpretation; the percentage of positive tests per number of tests done, for instance, should be independent of the frequency of testing.
  5. It is not true that the vast majority of the population are not at risk, if the virus were to circulate naturally.

All this looks to me as though the ‘Patrons of Chiropractic Science’ are in urgent need of learning some science. Meanwhile, it would be most helpful, if they could keep quiet.

For many years, ‘HOMEOPATHY‘ (the ‘flag-ship’ journal of homeopathy which started its life in 1911 as THE BRITISH JOURNAL OF HOMOEOPATHY) was edited by Peter Fisher. When Peter fired me from its editorial board, it arguably lost its only expert who was critical of homeopathy. Then the journal was transferred from Elsevier to Thieme. When Peter tragically died, the journal lost its editor who, despite everything, had at least tried to keep the most dangerous loons within the homeopathy cult at bay.

Now, under the new editor, this seems no longer possible. The current issue of HOMEOPATHY holds several papers about the role of homeopathy in the present pandemic:

First paper entitled ‘The COVID-19 Pandemic: A View from New York City’

This article provides a view of homeopathic clinical practice in the New York City area in the first few months of 2020 as the coronavirus disease 2019 (COVID-19) pandemic began to evolve in the United States. Key symptoms used to generate a short list of potentially curative remedies are given, and the pandemic syndrome is viewed as appearing in stages or as having various clinical manifestations each with its own main remedy. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is briefly described, as are the preliminary presenting signs and symptoms of COVID-19 infection. Several clinical examples are given, some with positive laboratory confirmation.

Second paper entitled The Hydra-Headed Coronaviruses: Implications of COVID-19 for Homeopathy

Successful homeopathic prescriptions are based on careful individualization of symptoms, either for an individual patient or collectively in the case of epidemic outbreaks. The ongoing COVID-19 pandemic was initially represented as a severe acute respiratory illness, with eventual dramatic complications. However, over time it revealed to be a complex systemic disease with manifestations derived from viral-induced inflammation and hypercoagulability, thus liable to affect any body organ or system. As a result, clinical presentation is variable, in addition to variations associated with several individual and collective risk factors. Given the extreme variability of pathology and clinical manifestations, a single, or a few, universal homeopathic preventive Do not split medicine(s) do not seem feasible. Yet homeopathy may have a relevant role to play, inasmuch as the vast majority of patients only exhibit the mild form of disease and are indicated to self-care at home, without standard monitoring, follow-up, or treatment. For future pandemics, homeopathy agencies should prepare by establishing rapid-response teams and efficacious lines of communication.

Third paper entitled The Experience of an Italian Public Homeopathy Clinic during the COVID-19 Epidemic, March-May 2020

During the COVID-19 epidemic in Italy, hospital outpatient clinics progressively decreased their activities; in March 2020 they were closed except for emergencies. During this period, the activities of the public Homeopathy Outpatient Clinic of Lucca aimed at guaranteeing therapeutic continuity to patients by means of telephone or video consultations, and searching for homeopathic medicines that best responded to early COVID-19 symptoms. In March 2020, the Complementary Medicine Working Group participated in the organization of a mission of COVID-19 Chinese experts for the online training of professionals working in the Tuscan Healthcare System. The medical staff of the Lucca Clinic also cooperated in telephone health surveillance of infected patients at home, seroprevalence investigations using the capillary blood rapid test, and the implementation of the CLIFICOL (Clinical Files Collection) project.

Why is this a regrettable development?

In my mind, there is little doubt that homeopathy has no role to play in the current pandemic. To state or imply otherwise is not just false but dangerous. It endangers the lives of millions.

Others might see it differently and argue that it is not a bad thing at all. By coming out on the side of the loons within homeopathy, the ‘flag-ship’ journal of homeopathy has done a favour to rational healthcare: it has demonstrated beyond reasonable doubt that HOMEOPATHY (both the journal and the cult) cannot be taken seriously and can therefore be safely discarded to the waste-basket of medical history.

Mindfulness is one of the 150 so-called alternative medicines (SCAMs) that I have evaluated in my recent book ‘Alternative Medicine: A Critical Assessment of 150 Modalities‘. Here is an excerpt from my text:

Mindfulness is a form of meditation which involves bringing one’s attention to experiences occurring in the present moment while sitting silently and paying attention to thoughts, sounds, the sensations of breathing or parts of the body.

    1. Many experts do not consider mindfulness to be an alternative therapy but see it as a set of psychological methods that have long become well-accepted, conventional treatments.
    2. There are several forms of mindfulness meditation; one of the best-known and most thoroughly researched is Mindfulness-Based Stress Reduction developed by Jon Kabat-Zinn (1944- ). It uses a combination of mindfulness meditation, body awareness, and yoga to help people become more mindful.
    3. Mindfulness programs are currently popular and have been widely adopted in schools, hospitals, and other settings. They are also being applied to initiatives such as for healthy aging, weight management, athletic performance enhancement, for children with special needs, and as a help during the perinatal period.
    4. Novices are advised to start with short periods of about 10 minutes of meditation practice per day. With regular practice, it becomes easier to keep the attention focused and the length of time spent practising can be extended.
    5. There has been much research interest in mindfulness, and many studies are now available. However, the quality of these trials is often poor which is one reason why the evidence is less clear than one would hope.
    6. Several systematic reviews have assessed mindfulness for various medical conditions, e. g.:Image result for mindfulness meditation
    • A systematic review of mindfulness for chronic headaches concluded that, due to the low number, small scale and often high or unclear risk of bias of included randomized controlled trials, the results are imprecise; this may be consistent with either an important or negligible effect. Therefore, more rigorous trials with larger sample sizes are needed.[1]
    • A systematic review of mindfulness for addictions found support for the effectiveness of the mindfulness-based interventions.[2]
    • An overview included 26 reviews and found a substantially consistent picture… Improvements in depressive disorders, particularly recurrent major depression, were strongly supported. Evidence for other psychological conditions was limited by lack of data. In populations with physical conditions, the evidence for significant improvements in psychological well-being was clear, regardless of population or specific mindfulness intervention. Changes in physical health measures were inconclusive; however, pain acceptance and coping were improved.[3]
    1. Some reports have linked mindfulness to increasing fear and anxiety panic or “meltdowns” after treatments. However, these seem to be rare events; in general, mindfulness is considered to be a safe therapy.

[1] https://www.ncbi.nlm.nih.gov/pubmed/29863407

[2] https://www.ncbi.nlm.nih.gov/pubmed/29651257

[3] https://www.ncbi.nlm.nih.gov/pubmed/29306938

Now there is new evidence regarding the safety of Mindfulness, including an estimate of the incidence of adverse effects. An article in the NEW SCIENTIST warned that about one in 12 people who try meditation experience an unwanted negative effect, usually a worsening in depression or anxiety, or even the onset of these conditions for the first time, according to the first systematic review of the evidence. “For most people it works fine but it has undoubtedly been overhyped and it’s not universally benevolent,” says Miguel Farias at Coventry University in the UK, one of the researchers behind a paper which as yet is not available on-line.

Farias’s team combed through medical journals and found 55 relevant studies. Once the researchers had excluded those that had deliberately set out to find negative effects, they worked out the prevalence of people who experienced harms within each study and then calculated the average, adjusted for the study size, a common method in this kind of analysis. They found that about 8 per cent people who try meditation experience an unwanted effect. “People have experienced anything from an increase in anxiety up to panic attacks,” says Farias. They also found instances of psychosis or thoughts of suicide.

I will add a link to the original paper, once it has been published

 

At present, we see a wave of promotion of Traditional Chinese Medicine (TCM) as a treatment of corona-virus infections. In this context, we should perhaps bear in mind that much of the Chinese data seem to be less than reliable. Moreover, I find it important to alert people to a stern warning recently published by two Australian experts. Here is the crucial passage from their paper:

We wish to highlight significant concerns regarding the association between traditional herbal medicines and severe, non-infective interstitial pneumonitis and other aggressive pulmonary syndromes, such as diffuse alveolar haemorrhage and ARDS which have emerged from Chinese and Japanese studies particularly during the period 2017−2019. Initially the association between traditional herbal therapies and pneumonitis was based on isolated case reports. These included hypersensitivity pneumonitis associated with the use of traditional Chinese or Japanese medicines such as Sai-rei-to, Oren-gedoku-to, Seisin-renshi-in and Otsu-ji-to (9 references in supplemental file). Larger cohorts and greater numbers now support this crucial relationship. In a Japanese cohort of 73 patients, pneumonitis development occurred within 3 months of commencing traditional medicine in the majority of patients [], while a large report from the Japanese Ministry of Health, Labor and Welfare, described more than 1000 cases of lung injury secondary to traditional medications, the overwhelming majority of which (852 reports) were described as ‘interstitial lung disease [].

Currently the constituent of traditional herbal medicines which is considered most likely to underlie causation of lung disease is Scutellariae Radix also known as Skullcap or ou-gon, which has been implicated through immunological evidence of hypersensitivity as well as circumstantial evidence, being present in all of those medicines outlined above []. Notably, skullcap is a constituent of QPD as used and described in the paper by Ren et al. relating to COVID-19 []. Scutellariae Radix-induced ARDS and COVID-19 disease share the same characteristic chest CT changes such as ground-glass opacities and airspace consolidation, therefore distinguishing between lung injury due to SARS-CoV-2 and that secondary to TCM may be very challenging. The potential for iatrogenic lung injury with TCM needs to be acknowledged []…

Morbidity and mortality from COVID-19 are almost entirely related to lung pathology []. Factors which impose a burden on lung function such as chronic lung disease and smoking are associated with increased risk for a poor outcome. Severe COVID-19 may be associated with a hypersensitivity pneumonitis component responsive to corticosteroid therapy []. Against this background the use of agents with little or no evidence of clinical efficacy and which have been significantly implicated in causing interstitial pneumonitis that could complicate SARS-CoV-2 infection, should be considered with extreme caution.

In conclusion, the benefits of TCM in the treatment of COVID-19 remain unproven and may be potentially deleterious. We recognise that there is currently insufficient evidence to prove the role of TCM in the causation of interstitial pneumonitis, however the circumstantial data is powerful and it would seem prudent to avoid these therapies in patients with known or suspected SARS-CoV-2 infection, until the evidence supports their use.

Declaration of Competing Interest: There are no conflicts to declare.

I have to admit that the ‘Asian Journal of Pharmaceutical Research and Development‘ did not formerly belong to my reading list. This will have to change, I guess, because any journal capable of publishing such a hilarious spoof ought to be read regularly.

The article in question is entitled ‘An Integrative Medicine Is Prudential Hope for Covid-19 Therapeutics‘ and is authored by Mayank dimri, Rajendra Singh Pawar, Virbal Singh Rajwar, Luv Kush from the SBS University Balawala, Dehradun- Uttarakhand, India. The paper is so unique that I simply could not resist showing you an excerpt. I hope  you have as much fun reading it as I had when I was alerted to this masterpiece.

Antiviral Astrological Rationality The viral infectivity is governed by Saturn, Rahu and Ketu. COVID-19 is geminian virus, ruled by mercury. It rules lungs / respiratory system and also health/ nutrition house (6th). Antiviral astrological advices are: Stay away from crowds, maintain maximum cleanness and personal hygiene, dietary regimens should be enriched by vitamins, vegetables, nuts and fruits. The foods and drinking water should be warm. The cold and unhealthy environment may be avoided.

The complimentary / alternative integrative medicine conceptualized ethical use of traditional re- medies with
self-responsibility. The concept of herd immunity (epidemological) relates to population. The orthomolecular
medicine10prescribe nutritional supplements for restoration of antiviral immunity. Both have antiviral benefits for fighting global pandemic of COVID-19.

The desirable antiviral activities are anti-replicating to block viral replication, anti-inflammatory for preventing
viral inflammation. Immune stimulatory for strengthening innate immunity and anti-mutagenic for curbing viral mutations.

The ayurvedic herbs have antiviral phytochemicals. Some of them are listed here: Ursolic acid, Apigenin, Rosmarinic acid, Oleanolic acid, Elenoic acid, Hypercin,Liquiritigenin, Acetoside, Glycyrrhizin etc. They have anti RSV activity and possibly prevent viral entry to host cells. The plant extract of Plantago asiatica and Clerodendrum trichotomum proved to be effective antiviral. Fifatrol is an ayurvedic prized medicine against viruses. It is useful in treatment of viral upper respiratory infections and relief from nasal congestion. It is a supportive therapy against COVID-19 virus.

The synergism of vitamins (A, C, D, E) acts as revitaler for fighting against COVID-19. Vitamin C has great potential
as antiviral for respiratory infections. It prevents cytokine induced lung damage and natural immune booster.

Eucalyptus oil has multiple benefits.It is supporter of respiratory system, immune booster and anti-inflammatory. Aromadendrene is an aroma therapeutical, present in oil and moderate antiviral….

I know that the last few months have not been easy for many of us. Therefore, we should be all the more thankful for those who lighten our spirits with some comic relief…

 

 

… or did they actually mean what they wrote?

Intravenous (IV) vitamin C seems to be recommended more and more, particularly by practitioners of so-called alternative medicine (SCAM). At least this is what this survey suggests:

We surveyed attendees at annual CAM Conferences in 2006 and 2008, and determined sales of intravenous vitamin C by major U.S. manufacturers/distributors. We also queried practitioners for side effects, compiled published cases, and analyzed FDA’s Adverse Events Database. Of 199 survey respondents (out of 550), 172 practitioners administered IV vitamin C to 11,233 patients in 2006 and 8876 patients in 2008. Average dose was 28 grams every 4 days, with 22 total treatments per patient. Estimated yearly doses used (as 25g/50ml vials) were 318,539 in 2006 and 354,647 in 2008. Manufacturers’ yearly sales were 750,000 and 855,000 vials, respectively. Common reasons for treatment included infection, cancer, and fatigue.

Yet, the potential harm associated with the use of IV vitamin C has not been systematically assessed. An international team of researchers aimed to fill this gap by reviewing the available evidence on harm related to such treatment. They included studies in adult populations that reported harm related to IV high-dose vitamin C which they defined as greater than or equal to 6 g/d, greater than or equal to 75 mg/kg/d, or greater than or equal to 3 g/m/d.

They identified 8,149 reports, of which 650 full text were assessed for eligibility, leaving 74 eligible studies. In these studies, 2,801 participants received high-dose vitamin C at a median (interquartile range) dose of 22.5 g/d (8.25-63.75 g/d), 455 mg/kg/d (260-925 mg/kg/d), or 70 g/m/d (50-90 g/m/d); and 932 or more adverse events were reported. Among nine double-blind randomized controlled trials (2,310 patients), adverse events were reported in three studies with an event rate per patient for high-dose vitamin C identical to placebo group in one study (0.1 [1/10] vs 0.1 [1/10]), numerically lower in one study (0.80 [672/839] vs 0.82 [709/869]), and numerically higher in one study (0.33 [24/73] vs 0.23 [17/74]). Six double-blind randomized controlled trials reported no adverse event in either group. Five cases of oxalate nephropathy, five cases of hypernatremia, three cases of hemolysis in glucose-6-phosphate dehydrogenase deficiency patients, two cases of glucometer error, and one case of kidney stones were also reported overall.

The authors concluded that there is no consistent evidence that IV high-dose vitamin C therapy is more harmful than placebo in double-blind randomized controlled trials. However, reports of oxalate nephropathy, hypernatremia, glucometer error, and hemolysis in glucose-6-phosphate dehydrogenase deficiency patients warrant specific monitoring.

So, is IV vitamin C safe or not?

I would interpret these findings as follows:

  • Clinical trials are often very poor yard-sticks for estimating safety; they are too small and often neglect to mention adverse effects.
  • When it come to evaluating the safety of therapeutic interventions, we must therefore often rely on case-reports, case series and other uncontrolled data.
  • Such data show that IV vitamin C has been associated with adverse effects, some of which are serious.
  • The incidence of such event remains unclear.

The aim of this paper was to systematically review the available clinical evidence of homeopathy in urological conditions. Relevant trials published between Jan 1, 1981 and Dec 31, 2017 were identified through a comprehensive search. Internal validity of the randomized trials and observational studies was assessed by The Cochrane Collaboration’s tool and methodological index for non-randomized studies (MINORS) criteria respectively, homeopathic model validity by Mathie’s six judgmental domains, and quality of homeopathic individualization by Saha’s criteria.

Four controlled (three randomized and one sequentially allocated controlled study) trials and 14 observational studies were included. Major focus areas were benign prostatic hypertrophy and kidney stones.

All the observational studies generated positive findings. One of the four controlled trials had ‘adequate’ model validity, but suffered from ‘high’ risk of bias. None of the non-randomized studies was of good methodological quality. Nine observational studies had ‘adequate’ model validity and quality criteria of individualization. The evidence from the controlled trials of individualized was inconclusive.

The authors concluded that, although observational studies appeared to produce encouraging effects, lack of adequate quality data from randomized trials hindered to arrive at any conclusion regarding the efficacy or effectiveness of homeopathy in urological disorders. The findings from the RCTs remained scarce, underpowered and heterogeneous, had low reliability overall due to high or uncertain risk of bias and sub-standard model validity. Well-designed trials are warranted with improved methodological robustness.

This new systematic review of homeopathy offers a number of surprises:

  1. When evaluating the effectiveness/efficacy of a therapy, observational studies are not informative and should therefore not be included in the analyses.
  2. The paper is badly written (what was the editor thinking?).
  3. The review is of poor methodological quality (what were the reviewers thinking?).
  4. The literature searches are now almost three years old; this means the review is outdated before it was published.
  5. The conclusion of the review is confusing; essentially, the authors admit that there is no good evidence for homeopathy as a treatment of urological conditions. Yet they seem to be bending over backwards to hide this message the best they can.
  6. The journal in which the paper was published is the ‘Journal of Complementary & Integrative Medicine‘; suffice to say that it is not a publication many people would want to read.
  7. The article was authored by an international team with impressive affiliations:
  • Homoeopathy University, Jaipur, Rajasthan, India.
  • Former Director General, Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India, New Delhi, India.
  • Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India, New Delhi, India.
  • Secretary, Information and Communication, Liga Medicorum Homoeopathica Internationalis, Izmir, Turkey.
  • Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India, Izmir, India.
  • Department of Neuro-Urology, Swiss Paraplegic Centre, Nottwil, Switzerland.
  • Department of Urology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • State National Homoeopathic Medical College, Lucknow, Govt. of Uttar Pradesh, India.
  • Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, India.
  • Independent Researcher, Champsara, Baidyabati, Hooghly, West Bengal, India.
  • Homoeopathic Drug Research Institute, Lucknow, under Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of New Delhi, New Delhi, India.

I am pleased with my last point: at least one feature that is impressive about this new review.

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