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

risk/benefit

1 2 3 18

In 2012, we evaluated the efficacy/effectiveness of lavender for the reduction of stress/anxiety.

Our systematic review included 15 RCTs. Two trials scored 4 points on the 5-point Jadad scale, the remaining 13 scored two or less. Results from seven trials appeared to favour lavender over controls for at least one relevant outcome. We concluded that methodological issues limit the extent to which any conclusions can be drawn regarding the efficacy/effectiveness of lavender. The best evidence suggests that oral lavender supplements may have some therapeutic effects. However, further independent replications are needed before firm conclusions can be drawn.

Since 2012, more evidence has emerged. The latest study on the subject aimed to investigate the effects of lavender oil on sleep and quality of life of menopausal women through steam inhalation. It was quasi-experimental with pre-test/post-test placebo control groups. It was conducted with 57 women, 27 of whom were subject to aromatherapy and 30 to a placebo. Data were collected using the Questionnaire Form, the Pittsburgh Sleep Quality Index (PSQI) and the Menopause-Specific Quality of Life Questionnaire (MENQOL).

For the intervention group, the PSQI median scores after the administration of aromatherapy were found to be significantly lower than those before the administration (p < 0.001) and those of the placebo group (p < 0.001). Similarly, for the intervention group, the total median MENQOL scores after the administration of the aromatherapy were found to be significantly lower than the scores prior to the administration (p < 0.001) as well as the scores of the placebo group (p < 0.001). See the source image

The authors of the new study concluded that that aromatherapy involving lavender-scented steam inhalation increased sleep quality and quality of life in women with sleep deprivation problems during menopause.

Hurray, this seems to be a decent trial with a positive result for SCAM!

And why not? It is not at all implausible that lavender has hypnotic effects. There are now quite a few reasonably sound trials that suggest it works. Moreover, it is safe and not very expensive (or even free, if you can grow it yourself).

I for one am more than happy to report a positive finding for a SCAM and merely regret that I cannot do so more often.

The objective of this study was to identify adverse drug reactions (ADR) associated with the use of so-called alternative medicine (SCAM) in Malaysia and to define factors which are associated with the more serious reactions. For this purpose, all ADR associated with the use of SCAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR.

From a total of 74 997 reports in the database, 930 (1.2%) involved SCAM products. From a total of 930 reports, 242 (26%) were serious ADR with 36 deaths. Six people died as a result of taking the SCAM, while another 30 cases were possibly associated with the SCAM products. Among the 36 mortality cases, adulterants were detected in 30% of cases. Examples of adulterants were dexamethasone, avanafil, nortadalafil and banned drugs such as phenylbutazone and sibutramine

About a third of the reports involved used SCAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the SCAM products were used for chronic illnesses (odds ratio [OR] 1.99, confidence interval [CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02).

The authors concluded that the prevalence of serious ADR associated with SCAM products is high. Factors identified with serious ADR included ethnicity, SCAM users with pre-existing diseases, use of SCAM for chronic illnesses and concomitant use of SCAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of SCAM products.

The authors also point out that underreporting of ADRs remains a major ongoing issue in pharmacovigilance. Many SCAM consumers may not be vigilant or may be unaware of ADR they experience due to misconceptions on the
safety of SCAM products. Most doctors rarely ask their patients about the use of SCAM.

To this, I would add that SCAM providers do their utmost to give the impression that their products are natural and therefore safe. Furthermore the press is far too often perpetuating the myth, and the regulators tend to turn a blind eye.

I expect that some readers of this post will now point out that the rate of SCAM-related ADRs is very small compared to that of conventional drugs. They would be correct, of course. But they would also miss the point that the value of a treatment is not determined by its risk alone. It is determined by the risk/benefit balance. Where there is no effectiveness, this balance is negative, even if the risk is tiny.

So, now let me challenge the defenders of SCAM to name a few SCAMs that are demonstrably associated with a positive risk/benefit balance.

 

By guest blogger Loretta Marron

Although assumed to be traditional, what we know today as ‘Traditional Chinese Medicine’ (TCM) was invented in the 1950s for political reasons by then Chairman Mao. It has since been proclaimed by Xi Jinping, now life-President of the People’s Republic of China, as the “jewel” in the millennia of Chinese civilization.

In May this year, Xi “announced plans to criminalise criticism of traditional Chinese medicine”. Speaking out against TCM could land you years in prison, prosecuted for “picking fights to disturb public order” and “defaming” the practice.

With the industry expected to earn $420 billion by the end of 2020, covid-19 has provided Xi with a platform to promote unproven, potentially harmful TCM. To keep these profits filling Chinese coffers, the World Health Organization (WHO) remains silent and those challenging TCM are silenced.

In January, the late Dr Li Wenliang was arrested and gaoled for warning China about covid-19. Li was one of up to nine people who were disciplined for spreading rumours about it. As the virus silently spread around the world, Beijing told the WHO that there was ‘no clear evidence’ of spread between humans.

As their death toll passed 1,000, Beijing’s response was to remove senior officials and to sack hundreds over their handling of the outbreak. With the support of the WHO, claims continue to be made that TCM “has been proved effective in improving the cure rate”, denying the simple fact that “patients would have recovered even if they hadn’t taken the Chinese medicine”.

With cases now heading for 8 million, and over four hundred thousand people confirmed dead world-wide and with economies in free-fall, Beijing continues, “to protect its interests and people overseas; to gain leadership of international governance”,for financial gain, to aggressively use its national power. Under the guise of ‘International Aid’, during the pandemic, Beijing promoted treatments based on unproven traditional medicine, sending TCM practitioners to countries including Italy, France and Iran.

Countries challenging Beijing can expect claims of racism and financial retaliation.

Back in 2016, the Chinese State Council released a “Strategic Development Plan for Chinese Medicine (2016-2030)”, seeking to spread ‘knowledge’ into campuses, homes and abroad.

In July 2017, a law promising equal status for TCM and western medicine came into effect. Provisions included encouragement to China’s hospitals to set up TCM centres. “The new law on traditional Chinese medicine will improve global TCM influence, and give a boost to China’s soft power”.

In 2019, after strong lobbying by the Chinese Communist Party (CCP), WHO added a chapter on TCM to their official International Classification of Diseases (ICD-11).  In China, doctors are now instructed to prescribe traditional medicine to most patients.

While Chinese herbs might have exotic names, they are, once translated, often the same as western herbs, many of which might have significant interactions. WHO fails to acknowledge any drug interactions.

In 1967, Mao launched Project 523 to find a cure for chloroquine-resistant malaria. Over 240,000 compounds had already been tested and none had worked. Trained in pharmacology and modern western methods, Tu Youyou used the scientific method to test sweet wormwood, a herb traditionally used in China for fever, where she developed a useful artemisinin derivative for resistant malaria. The drug has saved millions of lives. In 2015 she won the Nobel Prize for her work. However, Tu’s work is not a blanket endorsement of TCM: without the years of research, she would not have been successful.

TCM is commercially driven. Criticism of remedies is often blocked on the Internet in China, and critics have been jailed.  The majority of TCM’s are not tested for efficacy in randomized clinical trials. Clinical trials are usually of poor quality and serious side effects are underreported.   China has even rolled back regulations as Beijing forcefully promotes TCM’s as an alternative to proven western medicine. An increasing number of prestigious research hospitals now prescribe and dispense herbs that may cause drug interactions alongside western medicine for major illness patients.

TCM’s are not safe. Most systematic reviews suggest that there is no good or consistent evidence for effectiveness, negative results aren’t published, research data are fabricated and TCM-exports are of dubious quality.

If the benefits of herbal remedies are to be realised, good clinical studies must be encouraged.

TCM is not medicine. It’s little more than a philosophy or a set of traditional beliefs, about various concoctions and interventions and their alleged effect on health and diseases.

To stop misleading the world with what Mao himself saw as nonsense, and to mitigate future pandemics, WHO can and should remove all mention of TCM other than to state that it is unproven and could be dangerous.

Someone alerted me to a short article (2008) of mine that I had forgotten about. In it, I mention the 32 Cochrane reviews of acupuncture available at the time and the fact that they showed very little in favour of acupuncture. This made me wonder to what extent the situation might have changed in the last 12 years. So, I made a renewed attempt at evaluating this evidence. The entire exercise comes in three parts:

  1. My original paper from 2008
  2. The current evidence from Cochrane reviews
  3. Comments on the new evidence

PART 1

Acupuncture has a long history of ups and downs. Its latest renaissance started in 1971, when a journalist in President Nixon’s press corps experienced symptomatic relief after being treated for postoperative abdominal distension. He reported this experience in The New York Times, which triggered a flurry of interest and research. In turn, it was discovered that needling might release endorphins in the brain or act via the gate control mechanism. Thus, plausible modes of action seemed to have been found, and the credibility of acupuncture increased significantly. Numerous clinical trials were initiated, and their results often suggested that acupuncture is clinically effective for a surprisingly wide range of conditions. Both a World Health Organization report and a National Institutes of Health consensus conference provided long lists of indications for which acupuncture allegedly was of proven benefit.

Many of the clinical studies, however, lacked scientific rigor. Most experts therefore remained unconvinced about the true value of acupuncture, particularly as a treatment for all ills. Some investigators began to suspect that the results were largely due to patient expectation. Others showed that the Chinese literature, a rich source of acupuncture trials, does not contain a single negative study of acupuncture, thus questioning the reliability of this body of evidence.

A major methodological challenge was the adequate control for placebo effects in clinical trials of acupuncture. Shallow needling or needling at non-acupuncture points had been used extensively for this purpose. Whenever the results of such trials did not show what acupuncture enthusiasts had hoped, they tended to claim that these types of placebos also generated significant therapeutic effects. Therefore, a negative result still would be consistent with acupuncture being effective. The development of non-penetrating needles was aimed at avoiding such problems. These “stage dagger”-like devices are physiologically inert and patients cannot tell them from real acupuncture. Thus, they fulfil the criteria for a reasonably good placebo.

The seemingly difficult question of whether acupuncture works had become complex—what type of acupuncture, for what condition, compared with no treatment, standard therapy, or to placebo, and what type of placebo? Meanwhile, hundreds of controlled clinical trials had become available, and their results were far from uniform. In this situation, systematic reviews might be helpful in establishing the truth, particularly Cochrane reviews, which tend to be more rigorous, transparent, independent, and up-to-date than other reviews. The traditional Chinese concept of acupuncture as a panacea is reflected in the fact that 32 Cochrane reviews are currently (January 2008) available, and a further 35 protocols have been registered. The notion of acupuncture as a “heal all” is not supported by the conclusions of these articles. After discarding reviews that are based on only 3 or fewer primary studies, only 2 evidence-based indications emerge: nausea/vomiting and headache. Even this evidence has to be interpreted with caution; recent trials using the above-mentioned “stage-dagger” devices as placebos suggest that acupuncture has no specific effects in either of these conditions.

Further support for the hypothesis that acupuncture is largely devoid of specific therapeutic effects comes from a series of 8 large randomized controlled trials (RCTs) initiated by German health insurers (Figure). These studies had a similar, 3-parallel-group design: pain patients were randomized to receive either real acupuncture, shallow needling as a placebo control, or no acupuncture. Even though not entirely uniform, the results of these studies tend to demonstrate no or only small differences in terms of analgesic effects between real and placebo acupuncture. Yet, considerable differences were observed between the groups receiving either type of acupuncture and the group that had no acupuncture at all.

The most recent, as-yet-unpublished trial also seems to confirm the “placebo hypothesis.” This National Institutes of Health-sponsored RCT included 640 patients with chronic back pain. They received either individualized acupuncture according to the principles of traditional Chinese medicine, or a standardized form of acupuncture, or sham acupuncture. The results demonstrate that acupuncture added to usual care was superior to usual care alone, individualized acupuncture was not more effective than standardized acupuncture, and neither type of real acupuncture was more effective than sham acupuncture.

Figure

Schematic representation of the recent acupuncture trials all following a similar 3-group design. These 8 randomized controlled trials related to chronic back pain, migraine, tension headache, and knee osteoarthritis (2 trials for each indication). Their total sample size was in excess of 5000. Patients in the “no acupuncture” group received either standard care or were put on a waiting list. Sham acupuncture consisted of shallow needling at non-acupuncture points. Real acupuncture was semi-standardized. The differences between the effects of both types of acupuncture and no acupuncture were highly significant in each study. The differences between sham and real acupuncture were, with the exception of osteoarthritis, not statistically significant.

Enthusiasts employ such findings to argue that, in a pragmatic sense, acupuncture is demonstrably useful: it is clearly better than no acupuncture at all. Even if it were merely a placebo, what really matters is to alleviate pain of suffering patients, never mind the mechanism of action. Others are not so sure and point out that all well-administrated treatments, even those that generate effects beyond placebo, will induce a placebo response. A treatment that generates only non-specific effects (for conditions that are amenable to specific treatments) cannot be categorized as truly effective or useful, they insist.

So, after 3 decades of intensive research, is the end of acupuncture nigh? Given its many supporters, acupuncture is bound to survive the current wave of negative evidence, as it has survived previous threats. What has changed, however, is that, for the first time in its long history, acupuncture has been submitted to rigorous science—and conclusively failed the test.

[references in the original paper]

Part 2 will be posted tomorrow.

“Unless positive evidence emerges, the risk/benefit balance of ozone therapy for any condition fails to be positive.”  This is the conclusion I recently drew after assessing the evidence for or against this therapy. Now a new review has just been published. Does it change my verdict?

This review evaluated the available literature on the application of oxygen-ozone therapy (OOT) in the treatment of knee osteoarthritis (KOA) to understand its therapeutic potential and to compare it with other conservative treatment options.

Eleven studies involving 858 patients met the inclusion criteria. Patients in the control groups received different treatments:

  • placebo in 1 trial;
  • hyaluronic acid in 2 studies;
  • hyaluronic acid and PRP in 1 trial;
  • corticosteroids in 4;
  • hypertonic dextrose, radiofrequency, or celecoxib + glucosamine in the remaining 3 trials.

The quality of these studies was poor; none of the studies included reached “good quality” standard, 2 were ranked as “fair,” and the rest were considered “poor.” No major complications or serious adverse events were reported following intra-articular OOT, which provided encouraging pain relief at short term. On the basis of the available data, no clear indication emerged from the comparison of OOT with other established treatments for KOA.

The authors concluded that the analysis of the available RCTs on OOT for KOA revealed poor methodologic quality, with most studies flawed by relevant bias, thus severely limiting the possibility of drawing conclusions on the efficacy of OOT compared with other treatments. On the basis of the data available, OOT has, however, proven to be a safe approach with encouraging effects in pain control and functional recovery in the short-middle term.

The use of ozone for treatment of KOA is highly controversial. The mechanism of action of ozone therapy for the treatment of KOA is unclear. Some studies have suggested that ozone injections results in pain relief, reduction of oedema, and improved mobility. The above review might be valuable in summarising the evidence, however, I fing its conclusion odd:

  • The authors write that they cannot arrive at a verdict about efficacy because of the poor quality of the primary studies. I think the conclusion is very clear and should have been expressed bluntly. THE AVAILABLE DATA FAIL TO SHOW EFFICACY; THE THERAPY IS THUS UNPROVEN AND SHOULD THEREFORE NOT BE USED. Simple!
  • I also disagree that OOT was proven to be safe. No treatment can be proven to be safe on the basis of just a few studies. This would require a much, much greater sample size.

This leaves us with the following situation:

  1. OOT is not plausible.
  2. OOT is unproven.
  3. The risks of OOT are unknown.

To me this means that we should stop using it (and I don’t need to change my above-quotes verdict).

People who use so-called alternative medicines (SCAM) tend to be more vaccine hesitant. One possible conclusion that can be drawn from this is that trusting SCAM results in people becoming more vaccine hesitant. An alternative possibility is that vaccine hesitancy and use of SCAM are both consequences of a distrust in conventional treatments. an International team of researchers conducted analyses designed to disentangle these two possibilities.

They measured vaccine hesitancy and SCAM use in a representative sample of Spanish residents (N = 5200). They also quantified their trust in three CCAM interventions;     

  1. acupuncture,
  2. reiki,
  3. homeopathy                                                                  

and in two conventional medical interventions:

  1. chemotherapy,
  2. antidepressants.

Vaccine hesitancy turned out to be strongly associated with (dis)trust in conventional medicine, and this relationship was particularly strong among SCAM users. In contrast, trust in SCAM was a relatively weak predictor of vaccine hesitancy, and the relationship was equally weak regardless of whether or not participants themselves had a history of using SCAM.

According to the authors of this paper, the implication for practitioners and policy makers is that SCAM is not necessarily a major obstacle to people’s willingness to vaccinate, and that the more proximal obstacle is people’s mistrust of conventional treatments.

This is an interesting study. Yet, it begs a few questions:

  1.  Is it possible to reliably establish trust in SCAM by asking about just 3 specific therapies?
  2. Is it possible to reliably establish trust in conventional medicine by asking about just 2 treatments?
  3. Why those therapies out of hundreds of options?
  4. Could it be that here are national differences (in other countries distrust in conventional medicine is not a strong determinant of SCAM use)?
  5. Is trust in SCAM and distrust in conventional medicine perhaps the common expression of an anti-science attitude or cultist tendencies?

As mentioned before, the US ‘Agency for Healthcare Research and Quality (AHRQ) have published a most comprehensive review update entitled ‘Noninvasive Nonpharmacological Treatment for Chronic Pain‘. It followed the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness. The conditions included were:

  • Chronic low back pain
  • Chronic neck pain
  • Osteoarthritis (knee, hip, hand)
  • Fibromyalgia
  • Chronic tension headache

 

Here are the main findings related to spinal manipulation:

LOW BACK PAIN

  • Spinal manipulation was associated with small improvements compared with sham manipulation, usual care, an attention control, or a placebo intervention in short-term (3 trials) and intermediate-term (3 trials) function (strength of evidence : low). There was no difference between spinal manipulation versus sham manipulation, usual care, an attention control, or a placebo intervention in short-term pain (3 trials), but manipulation was associated with a small improvement compared with controls on intermediate-term pain (3 trials) (SOE: low for short term, moderate for intermediate term).

CHRONIC TENSION HEADACHE

  • Spinal manipulation therapy was associated with small improvements in function and moderate improvements in pain compared with usual care over the short term in one trial (: low). Approximately a quarter of the patients had comorbid migraine.

HARMS

It was noted that many trails failed to report on adverse effects (AEs). Non- serious AEs reported included mild to moderate increase in pain, local discomfort and tiredness (2 RCTs).

___________________

Hardly impressive, is it?

Yet, some chiropractors treating chronic pain claim they practice Evidence-based medicine. This review seems to disclose this claim as bogus. What chiropractors do practice on virtually all patients is spinal manipulation which generates more harm than it produces benefit.

Please note yet again that:

  • many chiro trials fail to mention AEs (thus violating research ethics),
  • clinical trials are always too small to give a reliable impression about safety,
  • no post-marketing surveillance exists in chiropractic,
  • we thus have to rely mostly on case reports and similar articles,
  • and the collective evidence from such reports shows quite clearly that spinal manipulations are not safe,
  • chiropractors tend to deny all of the above,
  • this is because they have a monumental conflict of interest.

The WHO have issued the following press-release:

The World Health Organization (WHO) welcomes innovations around the world including repurposing drugs, traditional medicines and developing new therapies in the search for potential treatments for COVID-19.

WHO recognizes that traditional, complementary and alternative medicine has many benefits and Africa has a long history of traditional medicine and practitioners that play an important role in providing care to populations. Medicinal plants such as Artemisia annua are being considered as possible treatments for COVID-19 and should be tested for efficacy and adverse side effects. Africans deserve to use medicines tested to the same standards as people in the rest of the world. Even if therapies are derived from traditional practice and natural, establishing their efficacy and safety through rigorous clinical trials is critical.

African governments through their Ministers of Health adopted a resolution urging Member States to produce evidence on the safety, efficacy and quality of traditional medicine at the Fiftieth Session of the WHO Regional Committee for Africa in 2000. Countries also agreed to undertake relevant research and require national medicines regulatory agencies to approve medicines in line with international standards, which include the product following a strict research protocol and undergoing tests and clinical trials. These studies normally involve hundreds of people under the monitoring of the national regulatory authorities and may take quite a few months in an expedited process.

WHO is working with research institutions to select traditional medicine products which can be investigated for clinical efficacy and safety for COVID-19 treatment. In addition, the Organization will continue to support countries as they explore the role of traditional health practitioners in prevention, control, and early detection of the virus as well as case referral to health facilities.

Over the past two decades, WHO has been working with countries to ensure safe and effective traditional medicine development in Africa by providing financial resources and technical support. WHO has supported clinical trials, leading 14 countries to issue marketing authorization for 89 traditional medicine products which have met international and national requirements for registration. Of these, 43 have been included in national essential medicines lists. These products are now part of the arsenal to treat patients with a wide range of diseases including malaria, opportunistic infections related to HIV, diabetes, sickle cell disease and hypertension. Almost all countries in the WHO African region have national traditional medicine policies, following support from WHO.

As efforts are under way to find treatment for COVID-19, caution must be taken against misinformation, especially on social media, about the effectiveness of certain remedies. Many plants and substances are being proposed without the minimum requirements and evidence of quality, safety and efficacy. The use of products to treat COVID-19, which have not been robustly investigated can put people in danger, giving a false sense of security and distracting them from hand washing and physical distancing which are cardinal in COVID-19 prevention, and may also increase self-medication and the risk to patient safety.

WHO welcomes every opportunity to collaborate with countries and researchers to develop new therapies and encourages such collaboration for the development of effective and safe therapies for Africa and the world.

________________________________

While this message – mostly directed towards Africa – seems very clear and reasonable, it is, at the same time, prone to be misunderstood. Here is an excerpt from an Ghana newspaper article commenting on the WHO initiative which demonstrates my point:

In the view of this newspaper, it stands to reason that, since the virus, was transmitted from animals, the best form of cure, is to use herbs.

We have abundance of the plant Madagascar is using to develop the cure. Medical doctors should stop seeing those practicing alternative medicine, as competitors.

The open hatred, and disdain by medical doctors, towards practitioners of alternative medicine, must be a cause for concern by all.

In the considered opinion of this newspaper, the government must bring the two together to work to avert any calamity.

The number of cases recorded so far, is a ticking time bomb. We cannot continue to treat it as business as usual, where traditional medicine practitioners, will claim to make a discovery, which will not be accepted by their counterpart who practice orthodox medicine.

If any country in Africa, should have been the first to announce a discovery of cure for coronavirus, using herbal remedy it should have been Ghana.

We can do a lot, if the two come together, instead of working at cross purpose.

This is how easily the crucial WHO message ‘the use of products to treat COVID-19, which have not been robustly investigated can put people in danger’ can be forgotten.

FIRST TEST

MAKE SURE IT WORKS

MAKE SURE IT’S REASONABLY SAFE

THEN USE IN ROUTINE CARE

Everything else is not going to be helpful!

Dr. Dhanunjaya Lakkireddy, a cardiologist at the Kansas City Heart Rhythm Institute in the US, has started a trial of prayer for corona-virus infection. The study will involve  1000 patients with COVID-19 infections severe enough to require intensive care. The four-month study will investigate “the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 patients,” according to a description provided to the National Institutes of Health.

Inclusion Criteria:

  • Male or female greater than 18 years of age
  • Confirmed positive for COVID-19
  • Patient admitted to Intensive Care Unit

Exclusion Criteria:

  • Patients admitted to ICU for diagnosis that is not COVID-19 positive

(Not giving informed consent is not listed as an exclusion criterion!)

Half of the patients, randomly chosen, will receive a “universal” prayer offered in five denominational forms, via:

  • Buddhism,
  • Christianity,
  • Hinduism,
  • Islam,
  • Judaism.

The other 500 patients in the control group will not be prayed for by the prayer group. All the patients will receive the standard care prescribed by their medical providers. “We all believe in science, and we also believe in faith,” Lakkireddy claims. “If there is a supernatural power, which a lot of us believe, would that power of prayer and divine intervention change the outcomes in a concerted fashion? That was our question.”

The outcome measures in the trial are

  • the time patients remain on ventilators,
  • the number of patients who suffer from organ failure,
  • the time patients have to stay in intensive care,
  • the mortality rate.

On this blog, we have seen many other ‘corona-quacks’ come forward with their weird ideas. I ask myself why we give them not the opportunity to test their concepts as well? Why do we not spend our resources testing:

In my recent book, I included a short review of the literature on prayer as a medical intervention. This is what I wrote:

  1. Prayer can be defined as the solemn request or thanksgiving to God or other object of worship.
  2. Intercessory prayer is practised by people of all faiths and involves a person or group setting aside time for petitioning god on behalf of another person who is in need. Intercessory prayer is organised, regular, and committed. Those who practise it usually do not ask for payments because they hold a committed belief.
  3. The mechanisms by which prayer might work therapeutically are unknown, and hypotheses about its mode of action will depend to a large extent on the religious beliefs in question. People who believe in the possibility that prayers might improve their health assume that god could intervene on their behalf by blessing them with healing energy.
  4. These assumptions lack scientific plausibility.
  5. Numerous clinical trials have been conducted. Most of them fail to adequately control for bias, and their findings are not uniform.
  6. A systematic review of all these studies is available. It included 10 trials with a total of 7646 patients. The authors concluded that the findings are equivocal and, although some of the results of individual studies suggest a positive effect of intercessory prayer, the majority do not and the evidence does not support a recommendation either in favour or against the use of intercessory prayer. We are not convinced that further trials of this intervention should be undertaken and would prefer to see any resources available for such a trial used to investigate other questions in health care.[1]

[1] https://www.ncbi.nlm.nih.gov/pubmed/19370557

Lakkireddy says he has no idea what he will find. “But it’s not like we’re putting anyone at risk,” he says. “A miracle could happen. There’s always hope, right?”

Personally, I have a pretty good idea what he will find. I also find Lakkireddy not all that honest and think his assumptions are deeply mistaken:

  • Lakkireddy cites an extensive list of references; however, the Cochrane review (usually the most reliable and independent source of evidence) that arrived to the conclusions I quoted above, he somehow ‘forgot’ to mention.
  • As the review-authors tried to indicate, further trials of prayer are a waste of resources.
  • There are many much more promising interventions to be tested, and by conducting this study, he is diverting research funds that are badly needed elsewhere.
  • The study seems to have several ethical problems, e.g. informed consent.
  • Contrary to Lakkireddy’s belief, he will harm in more than one way; apart from wasting resources, his study undermines rational thought and public trust in clinical research.

PERSONALLY, I FIND THIS PROJECT DESPICABLE!

Guest post by Christian Lehmann

It’s the end of February. We see the first death, in the Oise department, near Paris, of a French citizen who has not recently travelled abroad. For doctors concerned about what is happening in China, this is the red alert. In spite of of the little notices posted by the health minister, Agnes Buzyn, at airports, the coronavirus has made it onto French soil. Nobody knows at that point how it will spread. Almost nobody, apart from those responsible for it, yet knows that France has completely run down its stocks of masks. Doctors themselves do know that the health service has only held out, for as long as it has, on the backs of its care personnel. Some are assessing the scale of what is to come.

The announcement by Didier Raoult about the spectacular effectiveness of a synthetic antimalarial, chloroquine, has brought enormous relief, followed immediately for many of us health professionals by growing doubts about an accumulation of errors: Raoult denies any toxicity, urges people to “fall upon” a medication requiring sensitive handling. When we locate the Chinese article on which Didier Raoult is basing his crisis communication, we are stupefied. No need for specialised knowledge in statistical methodology to understand that there is something seriously wrong. No numerical data. Nobody knows what dosage has been given, to what type of patient, nor how many have been treated. The article has not been “peer reviewed”, that is to say reviewed by professional equals; decoded, it has the effect of a simple announcement. So of course at this chaotic time we tell ourselves that, given a revelation of such importance, the Chinese wanted to act as quickly as possible, to inform the whole world. And Didier Raoult, who routinely advises, as he explains with delicious modesty, the Chinese, « the world’s best virologists », has probably been entitled to the first fruits of this revelation.

On Youtube, on 28 February, he posts a weird interview, “Why would the Chinese be mistaken?”, in which he repeatedly takes up his interviewer with obvious irritation. “No, that’s not the question that you should be asking me. You should be asking me….” An informal group of doctors and tweeters pass around the link. We are rubbing our eyes in disbelief. What Didier Raoult is passing off as an interview is nothing more then an audience accorded to one of his media aides. We advise him, sarcastically, to make a professional cut of the video before broadcasting it. An hour later the video disappears and returns in a more professional form which could create the illusion of a genuine interview. And rapidly, in the Press which is beginning to turn its microphones towards the Professor from Marseille, he modifies his stance, without ever acknowledging the radical changes.

Chloroquine, spectacular and miraculous only yesterday, disappears as if by magic, replaced from one day to the next by hydroxychloroquine (Plaquenil), a different medicine, less common. Though its chemical structure is close to that of the antimalarial medication, hydroxychloroquine is used primarily in rheumatic conditions such as rheumatoid polyarthritis, or immune conditions such as lupus. So at least it isn’t lying around in large quantities in medicine cabinets. And its cardiac toxicity, very real, is slightly lower then that of chloroquine. Didier Raoult puts forward HCQ as an immense discovery, continuing in his usual manner to ridicule his detractors. “The doctors who criticise me are neither in my field nor up to my weight”. He flays the inaction of embittered petty health officials, only fit to follow the diktats of the authorities, who, bogged down in their catastrophic crisis management, dare not intervene. And his posturing as a refractory Gaul, a loudmouth taking on the system, gains sympathy, from those to whom he gives hope, from those who understand that the State does not tell them everything, and from those looking for a hero to fit in with their stereotypes: the man on his own against the establishment, the White Knight taking on Big Pharma, the Hippocratic colossus besieged by hordes of soulless ants.

No one among those who hold out their microphones to him, not one asks him the question which we are all asking, GPs, cardiologists, pharmaceutical specialists, emergency specialists, resuscitation specialists – by what sleight of hand has Didier Raoult exchanged his miracle medicine, in 48 hours, openly and publicly? And how is it that no one has noticed the sleight-of-hand? Has this man who makes such a big deal of his image on social networks suddenly become aware of the risk of being confronted about chloroquine with a justifiable public outcry and with deaths by self-medication?

While the World Health Organisation is sounding alarm bells, in the context of overall mistrust with regard to scientific opinion, of confrontation with regard to government, of growing awareness ( belated and sometimes disproportionate) of the influence of Big Pharma, and as the initial fear gives way to real panic for some with the registration of each new case, Didier Raoult piles up Facebook likes, fans, sites to his glory. And for us, fearful, begins the long registration of flagrant mistruths delivered as revealed truths, which this professor will never have the honestly to set right.

For Didier Raoult, a minimum of intellectual integrity would demand that he admits having changed horses in midstream. That he admits that the concern of his despised detractors was well founded, with respect to chloroquine to which many have access without knowing its dangers ( Nivaquine is very often used in suicides). And, because Didier Raoult withdraws nothing, he continues to stash away all the profits of his media coverage. Every supporter of the Wise Man of Marseille piles in with testimony. Their brother, sister, uncle, the father-in-law of their hairdresser has been taking the Professor’s medicine ( Which one? ) for eight years in Africa and has never had a problem, so that’s the real proof that his detractors are just jealous, or, even worse, backed by “the lobbies”.

And untiringly we repeat the fundamental truths:

  • Yes chloroquine has existed for years
  • Yes it is widely used
  • But for a different treatment, the prevention of malaria
  • And in dosages 5 to 10 times smaller
  • And in large dosages it causes cardiac arrest
  • And it has never been effective in fighting a virus
  • Not this virus nor any other
  • And the same is true for hydroxychloroquine
  • In fact it’s rather the opposite

In fact what is being patiently stated by the upholders of the scientific method is very counter-intuitive, almost inaudible, because they are telling worried and disorientated people, who have put their trust and their hope in one man, that in his assertions………nothing makes sense.

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