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

alternative medicine

Two recent reviews have evaluated the evidence for acupuncture as a means of preventing migraine attacks.

The first review assessed the efficacy and safety of acupuncture for the prophylaxis of episodic or chronic migraine in adult patients compared to pharmacological treatment.

The authors included randomized controlled trials published in western languages that compared any treatment involving needle insertion (with or without manual or electrical stimulation) at acupuncture points, pain points or trigger points, with any pharmacological prophylaxis in adult (≥18 years) with chronic or episodic migraine with or without aura according to the criteria of the International Headache Society.

Nine randomized trials were included encompassing 1,484 patients. At the end of the intervention, a small reduction was found in favor of acupuncture for the number of days with migraine per month: (SMD: -0.37; 95% CI -1.64 to -0.11), and for response rate (RR: 1.46; 95% CI 1.16-1.84). A moderate effect emerged in the reduction of pain intensity in favor of acupuncture (SMD: -0.36; 95% CI -0.60 to -0.13), and a large reduction in favor of acupuncture in both the dropout rate due to any reason (RR 0.39; 95% CI 0.18 to 0.84) and the dropout rate due to adverse event (RR 0.26; 95% CI 0.09 to 0.74). The quality of the evidence was moderate for all these primary outcomes. Results at longest follow-up confirmed these effects.

The authors concluded that, based on moderate certainty of evidence, we conclude that acupuncture is mildly more effective and much safer than medication for the prophylaxis of migraine.

 

The second review aimed to perform a network meta-analysis to compare the effectiveness and acceptability between topiramate, acupuncture, and Botulinum neurotoxin A (BoNT-A).

The authors searched OVID Medline, Embase, the Cochrane register of controlled trials (CENTRAL), the Chinese Clinical Trial Register, and clinicaltrials.gov for randomized controlled trials (RCTs) that compared topiramate, acupuncture, and BoNT-A with any of them or placebo in the preventive treatment of chronic migraine. A network meta-analysis was performed by using a frequentist approach and a random-effects model. The primary outcomes were the reduction in monthly headache days and monthly migraine days at week 12. Acceptability was defined as the number of dropouts owing to adverse events.

A total of 15 RCTs (n = 2545) could be included. Eleven RCTs were at low risk of bias. The network meta-analyses (n = 2061) showed that acupuncture (2061 participants; standardized mean difference [SMD] -1.61, 95% CI: -2.35 to -0.87) and topiramate (582 participants; SMD -0.4, 95% CI: -0.75 to -0.04) ranked the most effective in the reduction of monthly headache days and migraine days, respectively; but they were not significantly superior over BoNT-A. Topiramate caused the most treatment-related adverse events and the highest rate of dropouts owing to adverse events.

The authors concluded that Topiramate and acupuncture were not superior over BoNT-A; BoNT-A was still the primary preventive treatment of chronic migraine. Large-scale RCTs with direct comparison of these three treatments are warranted to verify the findings.

Unquestionably, these are interesting findings. How reliable are they? Acupuncture trials are in several ways notoriously tricky, and many of the primary studies were of poor quality. This means the results are not as reliable as one would hope. Yet, it seems to me that migraine prevention is one of the indications where the evidence for acupuncture is strongest.

A second question might be practicability. How realistic is it for a patient to receive regular acupuncture sessions for migraine prevention? And finally, we might ask how cost-effective acupuncture is for that purpose and how its cost-effectiveness compares to other options.

The objective of this survey was to determine the prevalence of Osteopathic Manipulative Treatment (OMT) use, barriers to its use, and factors that correlate with increased use.

The American Osteopathic Association (AOA) distributed its triannual survey on professional practices and preferences of osteopathic physicians, including questions on OMT, to a random sample of 10,000 osteopathic physicians in August 2018 through Survey Monkey (San Mateo, CA). Follow-up efforts included a paper survey mailed to nonrespondents one month after initial distribution and three subsequent email reminders. The survey was available from August 15, 2018, to November 5, 2018. The OMT questions focused on the frequency of OMT use, perceived barriers, and basic demographic information of osteopathic physician respondents. Statistical analysis (including a one-sample test of proportion, chi-square, and Spearman’s rho) was performed to identify significant factors influencing OMT use.

Of 10,000 surveyed osteopathic physicians, 1,683 (16.83%) responded. Of those respondents, 1,308 (77.74%) reported using OMT on less than 5% of their patients, while 958 (56.95%) did not use OMT on any of their patients. Impactful barriers to OMT use included lack of time, lack of reimbursement, lack of institutional/practice support, and lack of confidence/proficiency. Factors positively correlated with OMT use included female gender, being full owner of a practice, and practicing in an office-based setting.

The authors concluded that OMT use among osteopathic physicians in the US continues to decline. Barriers to its use appear to be related to the difficulty that most physicians have with successfully integrating OMT into the country’s insurance-based system of healthcare delivery. Follow-up investigations on this subject in subsequent years will be imperative in the ongoing effort to monitor and preserve the distinctiveness of the osteopathic profession.

What can one conclude from a three-year-old survey with a 17% response rate?

The answer is almost nothing!

Yet, it seems fair to say that OMT-use by US osteopaths is not huge. It might even be fair to speculate that, in reality, it is smaller than 17%. It stands to reason that the non-responders in this survey were the ones who could not care less about OMT. I would argue that this would be a good thing!

On 20 February 2021, I published on my blog a comment on a new study of an Ayurvedic remedy for COVID-19. The study was in my view suspect, and I expressed this as follows:

I have the following concerns or questions about this trial:

  • Why do the authors call it a pilot study? A pilot study is merely for testing the feasibility of a trial design and is not meant to yield definitive efficacy results.
  • The authors state that the patients were asymptomatic yet in the discussion they claim they were asymptomatic or mildly symptomatic.
  • Some of the effect sizes reported here are extraordinary and seem almost too good to be true.
  • The claim of no adverse effect is implausible; even placebos would cause perceived adverse effects in a percentage of patients.
  • If the study is solid and withstands the scrutiny of the raw data, it is of huge relevance for public health. So, why did the authors publish it in PHYTOMEDICINE, a relatively minor and little-known journal?

An article in The Economic Times’ reported this:

Patanjali Ayurved released what it called the first “evidence-based” medicine for Covid-19 on Friday. It claimed it has been “recognised by the WHO (World Health Organization) as an ayurvedic medicine for corona”. Patanjali promoter, yoga guru Baba Ramdev, released a scientific research paper in this regard at the launch, presided over by Union health minister Harsh Vardhan and transport minister Nitin Gadkari. The Ayurveda products maker said it has received a certification from the Ayush ministry. “Coronil has received the Certificate of Pharmaceutical Product (CoPP) from the Ayush section of Central Drugs Standard Control Organisation (CDSCO) as per the WHO certification scheme,” it said in a statement. Under the CoPP, Coronil can be exported to 158 countries, the company said, adding that based on the presented data, the ministry has recognised Coronil as medicine for “supporting measure in Covid-19”.

Am I the only one who fears that something is not entirely kosher about the study? (This is an honest question, and I would be pleased to receive answers from my readers)

What happened next is most puzzling. After putting it on Facebook several times, I got banned for 72 hours from posting this article or anything else on Facebook. When this period had elapsed, I put the article in question again on Facebook. Subsequently, I was banned again but this time for 7 days. Facebook gave the following explanation:

You can’t post or comment for 7 days

This is because your previous posts didn’t follow our Community Standards.

No one else can see these posts.

1 Mar

Your post goes against our Community Standards on misinformation that could cause physical harm

We usually offer the chance to request a review, and follow up if we’ve gotten decisions wrong.

We have fewer reviewers available at the moment because of the coronavirus (COVID-19) outbreak. We’re trying hard to prioritise reviewing content with the most potential for harm.

This means that we may not be able to follow up with you, though your feedback helps us do better in the future.

Thank you for understanding.

On Twitter, the hype had begun even before its text was available. Priti Gandhi, for instance, tweeted:

Yet another feather in India’s cap!! 1st evidence-based, CoPP-WHO GMP certified medicine for Covid-19 released today. Congratulations to @yogrishiramdev ji, @Ach_Balkrishna ji & the team of scie…

EDZARDERNST.COM An RCT on the efficacy of ayurvedic treatment on asymptomatic COVID-19 patients

________________________________

As I did not feel I had broken any rules, I protested against the bans each time. When the 2nd ban was over, I posted my article yet again and, sure enough, yesterday I got banned again, this time for 30 days. Here is how they let me know:

You can’t post or comment for 30 days

This is because you previously posted something that didn’t follow our Community Standards.

This post goes against our standards on misinformation that could cause physical harm, so only you can see it.

Learn more about updates to our standards. On Twitter, the hype had begun even before its text was available. Priti Gandhi, for instance, tweeted: Yet another feather in India’s cap!! 1st evidence-based, CoPP-WHO GMP certified medicine for Covid-19 released today. Congratulations to @yogrishiramdev ji, @Ach_Balkrishna ji & the team of scie…

EDZARDERNST.COM An RCT on the efficacy of ayurvedic treatment on asymptomatic COVID-19 patients

____________________________

As the reason for the ban always seems to be the Ayurvedic study, I suspect that some party interested in the product is behind the complaints that lead to the bans. I find it extraordinary that I can be banned repeatedly without having done anything wrong and without my objections ever being considered.

Has anyone else experienced similar things?
Can anyone shed more light on this mysterious story?
Is there anything I can do, except for objecting, which I have now done thrice?

This recent article is truly remarkable:

There is a faction within the chiropractic profession passionately advocating against the routine use of X-rays in the diagnosis, treatment and management of patients with spinal disorders (aka subluxation). These activists reiterate common false statements such as “there is no evidence” for biomechanical spine assessment by X-ray, “there are no guidelines” supporting routine imaging, and also promulgate the reiterating narrative that “X-rays are dangerous.” These arguments come in the form of recycled allopathic “red flag only” medical guidelines for spine care, opinion pieces and consensus statements. Herein, we review these common arguments and present compelling data refuting such claims. It quickly becomes evident that these statements are false. They are based on cherry-picked medical references and, most importantly, expansive evidence against this narrative continues to be ignored. Factually, there is considerable evidential support for routine use of radiological imaging in chiropractic and manual therapies for 3 main purposes: 1. To assess spinopelvic biomechanical parameters; 2. To screen for relative and absolute contraindications; 3. To reassess a patient’s progress from some forms of spine altering treatments. Finally, and most importantly, we summarize why the long-held notion of carcinogenicity from X-rays is not a valid argument.

Not only is low dose radiation not detrimental, but it also protects us from cancer, according to the authors:

Exposures to low-dose radiation incites multiple and multi-hierarchical biopositive mechanisms that prevent, repair or remove damage caused mostly by endogenous reactive oxygen species (ROS) and H2O2 from aerobic metabolism. Indeed, non-radiogenic (i.e. naturally occurring) molecular damage occurs daily at rates many orders of magnitude greater than the rate of damage caused by low-dose radiation such as diagnostic X-rays. It is estimated that the endogenous genetic damage caused on a daily basis from simply breathing air is about one million times the damage initially resulting from an X-ray. We concur that “it is factually preposterous to have radiophobic cancer concerns from medical X-rays after considering the daily burden of endogenous DNA damage.”

And, of course, radiological imaging makes sense in cases of non-specific back pain due to ‘malalignment’ of the spine:

Pressures to restrict the use of “repeat” (i.e. follow-up) X-rays for assessing patient response to treatment shows a complete disregard for the evidence discussed that definitively illustrates how modern spine rehabilitation techniques and practices successfully re-align the spine and pelvis for a wide variety of presenting subluxation/deformity patterns. The continued anti-X-ray sentiment from “consensus” and opinion within chiropractic needs to stop; it is antithetical to scientific reality and to the practice of contemporary chiropractic practice. We reiterate a quote from the late Michael A. Persinger: “what is happening in recent years is that facts are being defined by consensus. If a group of people think that something is correct, therefore it’s true, and that’s contradictory to science.”

Thus, the authors feel entitled to conclude:

Routine and repeat X-rays in the nonsurgical treatment of patients with spine disorders is an evidence-based clinical practice that is warranted by those that practice spine-altering methods. The evidence supporting such practices is based on definitive evidence supporting the rationale to assess a patient’s spinopelvic parameters for biomechanical diagnosis, to screen for relative and absolute contraindications for specific spine care methods, and to re-assess the spine and postural response to treatment.

The traditional and underlying presumption of the carcinogenicity from X-rays is not a valid notion because the LNT is not valid for low-dose exposures. The ALARA radiation protection principle is obsolete, the threshold for harm is high, low-dose exposures prevent cancers by stimulating and upregulating the body’s innate adaptive protection mechanisms, the TCD concept in invalid, and aged cohort studies assumed to show cancers resulting from previous X-rays are not generalizable to the wider population because they represent populations predisposed to cancers.

Red flags, or suspected serious underlying disease is a valid consideration warranting screening imaging by all spine care providers. We contend, however, that as long as the treating physician or rehabilitation therapist is practicing evidence-based methods, proven to improve spine and postural parameters in order to provide relief for the myriad of spinal disorders, spinal X-rays are unequivocally justified. Non-surgical spine care guidelines need to account for proven and evolving non-surgical methods that are radiographically guided, patient-centered, and competently practiced by those specialty trained in such methods. This is over and above so-called “red flag only” guidelines. The efforts to universally dissuade chiropractors from routine and repeat X-ray imaging is neither scientifically justified nor ethical.

There seems to be just one problem here: the broad consensus is against almost anything these authors claim.

Oh, I almost forgot: this paper was authored and sponsored by CBP NonProfit.

“The mission of Chiropractic BioPhysics® (CBP®) Non-Profit is to provide a research based response to these changing times that is clinically, technically, and philosophically sound. By joining together, we can participate in the redefinition and updating of the chiropractic profession through state of the art spine research efforts. This journey, all of us must take as a Chiropractic health care profession to become the best we can be for the sake of the betterment of patient care. CBP Non-Profit’s efforts focus on corrective Chiropractic care through structural rehabilitation of the spine and posture. Further, CBP Non-Profit, Inc. has in its purpose to fund Chiropractic student scholarships where appropriate as well as donate needed chiropractic equipment to chiropractic colleges; always trying to support chiropractic advancement and education.”

 This study aimed to evaluate the effect of Traditional Chinese Medicine (TCM) on patients with gastric cancer following surgery and adjuvant chemotherapy in Taiwan. The cohort sampling data set was obtained from the Registry of Catastrophic Illness Patient Database, a research database of patients with severe illnesses from the National Health Insurance Research Database, Taiwan. Patients who had received a new diagnosis of gastric cancer and had undergone surgery were enrolled. the researchers matched TCM users and nonusers at a ratio of 1 : 3 based on the propensity score, and TCM users were also grouped into short-term and long-term users.

The number of TCM users and nonusers was 1701 and 5103 after applying the propensity score at a ratio of 1 : 3. Short-term users and long-term TCM users were independently associated with a decreased risk of death with HRs of 0.59 (95% confidence interval (CI), 0.55-0.65) and 0.41 (95% CI, 0.36-0.47), respectively, compared with TCM nonusers. The researchers also obtained similar results when they adjusted for covariates in the main model, as well as each of the additional listed covariates. They also observed similar HR trends in short-term users and long-term TCM users among men and women aged <65 years and ≥65 years. The most commonly prescribed single herb and herbal formula in our cohort were Hwang-Chyi (Radix Hedysari; 11.8%) and Xiang-Sha-Liu-Jun-Zi-Tang (15.5%), respectively.

The authors concluded that TCM use was associated with higher survival in patients with gastric cancer after surgery and adjuvant chemotherapy. TCM could be used as a complementary and alternative therapy in patients with gastric cancer after surgery and adjuvant chemotherapy.

This is an interesting study which seems well-done – except for one fatal mistake: even in the title, the authors imply a causal relationship between TCM and survival. Their conclusion has two sentences; the first one speaks correctly of an association. The second, however, not only implies causality but goes much further in suggesting that TCM should be used to prolong the life of patients. Yet, there are, of course, dozens of factors that could interfere with the findings or be the true cause of the observed outcome.

Anyone with a minimum of critical thinking ability should know that CORRELATION IS NOT CAUSATION; sadly, the authors of this study seem to be the exception.

Scientists from Israel and Iceland recently suggested that an extract of spirulina algae has the potential to reduce the chances of COVID-19 patients developing a serious case of the disease. Here is the abstract of their paper:

An array of infections, including the novel coronavirus (SARS-CoV-2), trigger macrophage activation syndrome (MAS) and subsequently hypercytokinemia, commonly referred to as a cytokine storm (CS). It is postulated that CS is mainly responsible for critical COVID-19 cases, including acute respiratory distress syndrome (ARDS). Recognizing the therapeutic potential of Spirulina blue-green algae (Arthrospira platensis), in this in vitro stimulation study, LPS-activated macrophages and monocytes were treated with aqueous extracts of Spirulina, cultivated in either natural or controlled light conditions. We report that an extract of photosynthetically controlled Spirulina (LED Spirulina), at a concentration of 0.1 µg/mL, decreases macrophage and monocyte-induced TNF-α secretion levels by over 70% and 40%, respectively. We propose prompt in vivo studies in animal models and human subjects to determine the putative effectiveness of a natural, algae-based treatment for viral CS and ARDS, and explore the potential of a novel anti-TNF-α therapy.

The Jerusalem Post reported that the research was conducted in a MIGAL laboratory in northern Israel with algae grown and cultivated by the Israeli company VAXA, which is located in Iceland. VAXA received funding from the European Union to explore and develop natural treatments for coronavirus. Iceland’s MATIS Research Institute also participated in the study.

In a small percentage of patients, infection with the coronavirus causes the immune system to release an excessive number of TNF-a cytokines, resulting in what is known as a cytokine storm. The storm causes acute respiratory distress syndrome and damage to other organs, the leading cause of death in COVID-19 patients. “If you control or are able to mitigate the excessive release of TNF-a, you can eventually reduce mortality,” said Asaf Tzachor, a researcher from the IDC Herzliya School of Sustainability and the lead author of the study. During cultivation, growth conditions were adjusted to control the algae’s metabolomic profile and bioactive molecules. The result is what Tzachor refers to as “enhanced” algae.

Tzachor said that despite the special growth mechanism, the algae are a completely natural substance and should not produce any side effects. Spirulina is approved by the US Food and Drug Administration as a dietary substance. It is administrated orally in liquid drops. “This is natural, so it is unlikely that we would see an adverse or harmful response in patients as you sometimes see in patients that are treated with chemical or synthetic drugs,” he said. The algae have been shown to reduce inflammation. Tzachor said that if proven effective, spirulina could also be used against other coronaviruses and influenza. “If we succeed in the next steps,” said Dr. Dorit Avni, director of the laboratory at MIGAL, “there is a range of diseases that can be treated using this innovative solution – as a preventative treatment or a supportive treatment.”

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This is undoubtedly interesting, and one can only hope that their research is successful. However, it is a far cry from what some journalists are already making of the news. One headline read: “Scientists Discover ‘All-Natural’ COVID Treatment That Can Prevent ‘Cytokine Storm’ In Severe Patients.”

 

 

 

Several previously published clinical trials have suggested that both acupuncture and sham acupuncture exert significant, non-specific effects on treatment outcomes when compared to no-treatment controls. A recently developed framework (mechanisms in orthodox and complementary and alternative medicine-MOCAM) suggests that the non-specific effects of acupuncture originate from multiple domains (e.g. patient characteristics, acupuncturist skill/technique, the patient-acupuncturist relationship, and the acupuncture environment). However, it remains to be determined precisely how these domains influence the non-specific effects of treatment among patients receiving acupuncture and sham acupuncture in clinical trials.

To address this issue, researchers conducted a systematic review to synthesize existing qualitative evidence on how trial participants randomized to acupuncture and sham acupuncture groups experience non-specific effects, regardless of the types of medical conditions investigated.

This systematic review included primary qualitative studies embedded in randomized controlled trials designed to investigate acupuncture or sham acupuncture interventions. Eligible studies published in English were derived from a search of five international databases. The methodological quality of included studies was evaluated using the Critical Appraisal Skills Programme (CASP) tool. Using a framework synthesis approach, the identified MOCAM framework was adapted based on the synthesis of the available qualitative evidence.

A total of 20 studies of high methodological quality were included. The proposed model indicated that the effects of acupuncture may be increased by:

  • maintaining a professional status,
  • applying a holistic treatment approach,
  • practicing empathy,
  • providing patients with an appropriate explanation of the theory behind acupuncture and sham acupuncture.

From the patient’s perspective, the efficacy of treatment can be increased by:

  • following the lifestyle modification advice provided by acupuncturists,
  • maintaining a positive attitude toward treatment efficacy,
  • actively engaging with acupuncturists during the consultation,
  • making behavioral changes based on experience gained during the trial.

The authors concluded that the results of this study may provide a basis for improving and standardizing key components of non-specific effects in acupuncture treatment, and for improving the isolation of specific effects in future clinical trials involving acupuncture and sham acupuncture.

The authors also state that having a positive attitude and high expectations regarding treatment efficacy can lead to positive health outcomes, along with a sense of curiosity and altruistic desire to join clinical trials. Indeed, previous clinical trials have reported that higher expectations regarding treatment effects may help to reduce fatigue and alleviate osteoarthritis in both acupuncture and sham acupuncture groups. Similar benefits of positive expectations have also been observed among patients with irritable bowel syndrome in sham acupuncture trials. 

SO CLOSE AND YET SO FAR!

So close to admitting that these findings indicate quite strongly that acupuncture is but a theatrical placebo.

For some time now, I have been using the umbrella term ‘so-called alternative medicine’ (SCAM). As I explain below, I think it is relatively well-suited. But this is not to say that it is the only name for it. Many other umbrella terms have been used in the past.

Is there perhaps one that you prefer?

  • Fringe medicine is rarely used today. It denotes the fact that the treatments under this umbrella are not in the mainstream of healthcare. Some advocates seem to find the word derogatory, and therefore it is now all but abandoned.
  • Unorthodox medicine is a fairly neutral term describing the fact that medical orthodoxy tends to shun most of the treatments in question. Strictly speaking, the word is also incorrect; the correct term would be ‘heterodox medicine’.
  • Unconventional is also a neutral term but it is open to misunderstandings: any new innovation in medicine might initially be called unconventional. It is therefore less than ideal.
  • Traditional medicine describes the fact that most of the modalities in question have been around for centuries and thus have a long tradition of usage. However, as the term is sometimes also used for conventional medicine, it is confusing and far from ideal.
  • Alternative medicine is the term everyone seems to know and which is most commonly employed in non-scientific contexts. In the late 1980s, some experts pointed out that the word could give the wrong impression: most of the treatments in question are not used as a replacement but as an adjunct to conventional medicine.
  • Complementary medicine became subsequently popular based on the above consideration. It accounts for the fact that the treatments tend to be used by patients in parallel with conventional medicine.
  • Complementary and alternative medicine (CAM) describes the phenomenon that many of the treatments can be employed either as a replacement of or as an adjunct to conventional medicine.
  • Holistic medicine denotes the fact that practitioners often pride themselves to look after the whole patient – body, mind, and spirit. This could lead to the erroneous impression that conventional clinicians do not aim to practice holistically. As I have tried to explain repeatedly, any good healthcare always has been holistic. Therefore, the term is misleading, in my view.
  • Natural medicine describes the notion that many of the methods in question are natural. The term seems attractive and is therefore good for business. However, any critical analysis will show that many of the treatments in question are not truly natural. Therefore this term too is misleading.
  • Integrated medicine is currently popular and much used by Prince Charles and other enthusiasts. As we have discussed repeatedly on this blog, the term is nevertheless highly problematic.
  • Integrative medicine is the word used in the US for integrated medicine.
  • CAIM (complementary/alternative/integrative medicine) is a term that some US authors recently invented. I find this attempt to catch all the various terms in one just silly.
  • So-called alternative medicine (SCAM) is the term I tend to use. It accounts for two important facts: 1) if a treatment does not work, it cannot possibly serve as an adequate alternative; 2) if a therapy does work, it should be part of conventional medicine. Thus, there cannot be an ‘alternative medicine’, as much as there cannot be an alternative chemistry or an alternative physics.

Yet,some advocates find ‘SCAM’ derogatory. Intriguingly, my decision to use this term was inspired by Prince Charles, arguably the world’s greatest champion of this sector of healthcare. In his book ‘HARMONY’, he repeatedly speaks of ‘so-called alternative treatments’.

You don’t believe me?

Fair enough!

In this case – and in order to save you the expense of buying Charles’ book for checking – let me provide you with a direct quote: “Some so-called alternative treatments seek to work with these functions to aid recovery…” (page 225).

And who would argue that Charles is dismissive about alternative medicine?

 

 

 

As we have often discussed, proponents of so-called alternative medicine (SCAM), have an unfortunate tendency to mislead the public about vitamins and other supplements. Consequently, there is much uncertainty in many people’s minds. It is, therefore, all the more important to highlight new information that might counter this phenomenon.

This study tested whether high-dose zinc and/or high-dose ascorbic acid reduce the severity or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2 infection. It was designed as a multicenter, single health system randomized clinical factorial open-label trial and enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and Florida. The trial was conducted from April 27, 2020, to October 14, 2020.

Patients were randomized in a 1:1:1:1 allocation ratio to receive either:

  1. zinc gluconate (50 mg),
  2. ascorbic acid (8000 mg),
  3. both of these agents,
  4. standard care only.

The treatments lasted 10 days.

The primary endpoint was the number of days required to reach a 50% reduction in symptoms, including the severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom). Secondary endpoints included days required to reach a total symptom severity score of 0, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements.

A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women. The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary endpoint. Patients who received usual care without supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5 (3.4) days for the group receiving both (overall P = .45). There was no significant difference in secondary outcomes among the treatment groups.

The authors concluded that, in this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care.

This study has several limitations (and its authors are laudably frank about them):

  • Its sample size is small.
  • It has no placebo control group.
  • It is open-label.
  • Patients were not masked to which therapy they received.

The trial nevertheless adds important information about the value of using zinc or vitamin C or both in the management of COVID patients.

On Twitter, the hype had begun even before its text was available. Priti Gandhi, for instance, tweeted:

Yet another feather in India’s cap!! 1st evidence-based, CoPP-WHO GMP certified medicine for Covid-19 released today. Congratulations to @yogrishiramdev ji, @Ach_Balkrishna ji & the team of scientists at Patanjali Research Institute. Your efforts have been successful!! #Ayurveda

So, what is it all about? This study included 100 patients and was designed to evaluate the impact of traditional Indian Ayurvedic treatment on asymptomatic patients with COVID-19 infection. It is a placebo-controlled randomized double-blind pilot clinical trial that was conducted at the Department of Medicine in the National Institute of Medical Sciences and Research, Jaipur, India.

The verum treatment consisted of:
  • 1 g of Giloy Ghanvati (Tinospora cordifolia)
  • 2 g of Swasari Ras (traditional herbo-mineral formulation)
  • 0.5 g of Ashwagandha (Withania somnifera)
  • 0.5 g of Tulsi Ghanvati (Ocimum sanctum)

The treatment was given orally to the patients in the treatment group twice per day for 7 days. Medicines were given in the form of tablets and each tablet weighed 500 mg. While Swasari Ras was administered in powdered form, 30 min before breakfasts and dinners, rest were scheduled for 30 min post-meals. Patients in the treatment group also received 4 drops of Anu taila (traditional nasal drop) in each nostril every day 1 h before breakfast. Patients in the placebo group received identical-looking tablets and drops, post-randomization, and double-blinded assortments. The RT-qPCR test was used for the detection of viral load in the nasopharyngeal and oropharyngeal swab samples of study participants during the study. Chemiluminescent immunometric assay was used to quantify serum levels of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and high sensitivity C-reactive protein (hs-CRP) on day 1 and day 7 of the study. Patient testing negative for SARS-CoV-2 in the RT-PCR analysis was the primary outcome of this study.

By day three, 71.1 % and 50.0 % of patients recovered in the treatment and placebo groups, respectively. The treatment group witnessed 100 % recovery by day 7, while it was 60.0 % in the placebo group. Average fold changes in serum levels of hs-CRP, IL-6, and TNF-α in the treatment group were respectively, 12.4, 2.5 and 20 times lesser than those in the placebo group at day 7. There was a 40 % absolute reduction in the risk of delayed recovery from infection in the treatment group.

The authors concluded that Ayurvedic treatment can expedite virological clearance, help in faster recovery and concomitantly reduce the risk of viral dissemination. Reduced inflammation markers suggested less severity of SARS-CoV-2 infection in the treatment group. Moreover, there was no adverse effect observed to be associated with this treatment.

I have the following concerns or questions about this trial:

  • Why do the authors call it a pilot study? A pilot study is merely for testing the feasibility of a trial design and is not meant to yield definitive efficacy results.
  • The authors state that the patients were asymptomatic yet in the discussion they claim they were asymptomatic or mildly symptomatic.
  • Some of the effect sizes reported here are extraordinary and seem almost too good to be true.
  • The claim of no adverse effect is implausible; even placebos would cause perceived adverse effects in a percentage of patients.
  • If the study is solid and withstands the scrutiny of the raw data, it is of huge relevance for public health. So, why did the authors publish it in PHYTOMEDICINE, a relatively minor and little-known journal?

An article in The Economic Times’ reported this:

Patanjali Ayurved released what it called the first “evidence-based” medicine for Covid-19 on Friday. It claimed it has been “recognised by the WHO (World Health Organization) as an ayurvedic medicine for corona”.

Patanjali promoter, yoga guru Baba Ramdev, released a scientific research paper in this regard at the launch, presided over by Union health minister Harsh Vardhan and transport minister Nitin Gadkari.

The Ayurveda products maker said it has received a certification from the Ayush ministry. “Coronil has received the Certificate of Pharmaceutical Product (CoPP) from the Ayush section of Central Drugs Standard Control Organisation (CDSCO) as per the WHO certification scheme,” it said in a statement.

Under the CoPP, Coronil can be exported to 158 countries, the company said, adding that based on the presented data, the ministry has recognised Coronil as medicine for “supporting measure in Covid-19”.

Am I the only one who fears that something is not entirely kosher about the study? (This is an honest question, and I would be pleased to receive answers from my readers)

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