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

study design

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Energy healing is an umbrella term for a range of paranormal healing practices. Their common denominator is the belief in a mystical ‘energy’ that can be used for therapeutic purposes. Forms of energy healing have existed in many ancient cultures. The ‘New Age’ movement has brought about a revival of these ideas, and today energy healing systems are amongst the most popular alternative therapies in the US as well as in many other countries.

Energy healing relies on the esoteric belief in some form of ‘energy’ which is distinct from the concept of energy understood in physics and refers to some life force such as chi in Traditional Chinese Medicine, or prana in Ayurvedic medicine. Some proponents employ terminology from quantum physics and other ‘cutting-edge’ science to give their treatments a scientific flair which, upon closer scrutiny, turns out to be but a veneer of pseudo-science. The ‘energy’ that energy healers refer to is not measurable and lacks biological plausibility.

The purpose of this study was to evaluate the effects of energy healing (EH) therapy prior to and following posterior surgical correction for adolescent idiopathic scoliosis (AIS) compared to controls.

Patients were prospectively randomized to one of two groups: standard operative care for surgery (controls) vs. standard care with the addition of three EH sessions. The outcomes included visual analog scales (VAS) for pain and anxiety (0-10), days until conversion to oral pain medication, and length of hospital stay. For the experimental group, VAS was assessed pre- and post-EH session.

Fifty patients were enrolled-28 controls and 22 EH patients. The controls had a median of 12 levels fused vs. 11 in the EH group (p = 0.04). Pre-operative thoracic and lumbar curve magnitudes were similar (p > 0.05). Overall VAS pain scores increased from pre- to post-operative (p < 0.001), whereas the VAS anxiety scores decreased immediately post-operative (p < 0.001). The control and pre-EH assessments were statistically similar. Significant decreases in VAS pain and anxiety scores from pre to post-EH assessments were noted for the EH group. Both groups transitioned to oral pain medication a median of 2 days post-operative (p = 0.11). The median days to discharge were four in the controls and three in the EH group (p = 0.07).

The authors concluded that EH therapy resulted in a decrease in patient’s pre-operative anxiety. Offering this CAM modality may enhance the wellbeing of the patient and their overall recovery when undergoing posterior surgical correction for AIS.

I am getting tired of explaining that this trial design tells us as good as nothing about the effects of the tested therapy per se. As we have discussed ad nauseam on this blog, A+B is always more than B alone. Such trials appear to be rigorous and fool many people, but they are unable to control for context effects, like placebo or attention. Therefore, I need to re-write the conclusions:

The placebo effect and the extra attention associated with EH therapy resulted in a decrease in patients’ pre-operative anxiety. EH itself is most likely bar any effect. Further studies in this area are not required.

The aim of this paper was to synthesize the most recent evidence investigating the effectiveness and safety of therapeutic touch as a complementary therapy in clinical health applications.
A rapid evidence assessment (REA) approach was used to review recent TT research adopting PRISMA 2009 guidelines. CINAHL, PubMed, MEDLINE, Cochrane databases, Web of Science, PsychINFO and Google Scholar were screened between January 2009–March 2020 for studies exploring TT therapies as an intervention. The main outcome measures were for pain, anxiety, sleep, nausea and functional improvement.
Twenty‐one studies covering a range of clinical issues were identified, including 15 randomized trials, four quasi‐experimental studies, one chart review study, and one mixed-methods study including 1,302 patients. Eighteen of the studies reported positive outcomes. Only four exhibited a low risk of bias. All others had serious methodological flaws, bias issues, were statistically underpowered, and scored as low‐quality studies. No high‐quality evidence was found for any of the benefits claimed.

 The authors offer the following conclusions:

After 45 years of study, scientific evidence of the value of TT as a complementary intervention in the management of any condition still remains immature and inconclusive:

  • Given the mixed result, lack of replication, overall research quality, and significant issues of bias identified, there currently exists no good-quality evidence that supports the implementation of TT as an evidence‐based clinical intervention in any context.
  • Research over the past decade exhibits the same issues as earlier work, with highly diverse poor quality unreplicated studies mainly published in alternative health media.
  • As the nature of human biofield energy remains undemonstrated, and that no quality scientific work has established any clinically significant effect, more plausible explanations of the reported benefits are from wishful thinking and use of an elaborate theatrical placebo.

These are clear and much-needed words addressed at nurses (the paper was published in a nursing journal). Nurses have been oddly fond of TT. Therefore, it seems important to send evidence-based information in their direction. In my recent book, I arrived at similar conclusions about TT:

  1. The assumptions that form the basis for TT are not biologically plausible.
  2. Several trials and reviews of TT have emerged. However, many of them are by ardent proponents of TT, seriously flawed, and thus less than reliable. e.g.[1],[2]
  3. One rigorous pre-clinical study, co-designed by a 9-year-old girl, found that experienced TT practitioners were unable to detect the investigator’s “energy field.” Their failure to substantiate TT’s most fundamental claim is unrefuted evidence that the claims of TT are groundless and that further professional use is unjustified. [3]
  4. There are no reasons to assume that TT causes direct harm. One could, however, argue that, like all forms of paranormal healing, it undermines rational thinking.

[1] https://www.ncbi.nlm.nih.gov/pubmed/19299529

[2] https://www.ncbi.nlm.nih.gov/pubmed/27194823

[3] https://www.ncbi.nlm.nih.gov/pubmed/?term=rosa+e%2C+therapeutic+touch%2C+jama

In the world of homeopathy, Prof Michael Frass is a famous man. He is the First Chairman of the Scientific Society for Homeopathy (WissHom), the president of the Umbrella organization of Austrian Doctors for Holistic Medicine, and the Vicepresident of the Doctors Association for Classical Homeopathy. Frass has featured on this blog before, not least because he has published numerous studies of homeopathy, none of which has ever failed to produce a positive result

This is not just remarkable, in my view, it defies logic and the laws of nature. Even if homeopathy were a supremely effective therapy – a very broad consensus holds that it is not! – one would occasionally expect some negative results. No treatment works under all circumstances

… that is no treatment except homeopathy, according to Frass.

Recently Frass amazed even the world of oncology by publishing a study suggesting that homeopathy can prolong the survival of lung cancer patients. Every oncologist I know was flabbergasted.

Can this be true? This is the question, many people have been asking for some time in relation to Frass’s research.

In my quest to shine more light on it, I was recently alerted to an article by the formidable Austrian investigative journalist, Alwin Schönberger. In 2015, he came across a press release announcing that “HOMEOPATHY HAD BEEN PROVEN TO WORK AFTER ALL” (strikingly similar to one issued in 2018). It came from Austria’s leading manufacturer who was giving an award to an apparently outstanding thesis supervised by Frass. Even today, this piece of research has not been published in the peer-reviewed literature.

Yet, after some difficulties, Schönberger managed to obtain a copy. What he found was surprising, and he thus published his findings in the respected Austrian journal ‘Profil’ (2. Mai 2015 • profil 22).

Frass’s student had been given the task to systematically review all the homeopathy trials published between 2008 and 2012. Contrary to the hype of the press release, the meta-analysis merely suggested a very small effect. When digging deeper, Schönberger found several inconsistencies and mistakes in the analysis. They all were such that they produced a false-positive picture for homeopathy. Upon their correction, homeopathy turned out to be no longer significantly superior to placebo. Frass was then interviewed about it and claimed that the inconsistencies were only ‘errors’ but insisted that homeopathy is not a placebo therapy.

Yes, of course, errors happen in research. But if they all go in one direction and if that direction coincides with the interests of the researchers, we have the right, perhaps even the duty, to be suspicious. The questions that arise from this story are, I think, as follows:

  • Have the errors been corrected?
  • Are there perhaps other errors in Frass’s research?
  • Can we trust anything that Frass says?
  • Is it time to consider an official investigation into Frass’s studies of homeopathy?

 

 

There are plenty of people who find it hard to accept that highly diluted homeopathic remedies are placebos. They religiously believe in the notion that homeopathy works and studiously ignore the overwhelming evidence (plus a few laws of nature). Yet, they pretend to staunchly believe in science and keep on conducting (pseudo?) scientific studies of homeopathy. To me, this seems oddly schizophrenic because, on the one hand, they seem to accept science by conducting trials, while, on the other hand, they reject science by negating the scientific consensus.

The objective of this recent study was to evaluate the quality of life (QoL) of women treated with homeopathy within the Public Health System of Belo Horizonte, Brazil.

The study was designed as a prospective randomized controlled pragmatic trial. The patients were divided into two independent groups, one group underwent homeopathic treatment during a 6-month period, while the other did not receive any homeopathic treatment. In both randomized groups, patients maintained their conventional medical treatment as necessary. The World Health Organization Quality of Life abbreviated questionnaire (WHOQOL-BREF) was used for QoL analysis prior to treatment and 6 months later.

Randomization was successful in that it resulted in similar baseline results in three domains of QoL analysis for both groups. After 6 months’ treatment, the investigators noted a statistically significant difference between groups in the physical domain of WHOQOL-BREF: the average score improved to 63.6 ± (SD) 15.8 in the homeopathy group, compared with 53.1 ± (SD) 16.7 in the control group.

The authors concluded that homeopathic treatment showed a positive impact at 6 months on the QoL of women with chronic diseases. Further studies should be performed to determine the long-term effects of homeopathic treatment on QoL and its determinant factors.

I would not be surprised if the world of homeopathy were to celebrate this trial as yet another proof that homeopathy is effective. I am afraid, however, that I might have to put a damper on their excitement:

THIS STUDY DOES NOT SHOW WHAT YOU THINK IT DOES.

Why not?

Regular readers of this blog will have already guessed it: the trail follows the infamous ‘A+B versus B’ design. Some people will think that I am obsessed with this theme – but I am not; it’s just that, in SCAM, it comes up with such depressing regularity. And as this blog is mainly about commenting on newly published research, I am unable to avoid the subject.

So, let me explain it again.

Think of it in monetary terms: you have an amount X, your friend has the same amount X plus an extra sum Y. Who do you think has more money? You don’t need to be a genius to guess, do you?

The same happens in the above ‘A+B versus B’ trial:

  • the patients in group 1 received homeopathy (A) plus usual care (B);
  • the patients in group 2 received usual care (B) and nothing else.

You don’t need to be a genius to guess who might have the better outcomes.

Because of homeopathy?

No! Because of the patients’ expectation, the placebo effect, and the extra attention of the homeopaths. They call this trial design ‘pragmatic’. I feel it is an attempt to mislead the public.

So, allow me to re-write the authors’ conclusion as follows:

The effect of a homeopathic consultation and the administration of a placebo generated a positive impact at 6 months on the QoL of women with chronic diseases. This was entirely predictable and totally unrelated to homeopathy. Further studies to determine the long-term effects of homeopathic treatment on QoL and its determinant factors are not needed.

 

This study was aimed at determining the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors.

The Personalized Electroacupuncture vs Auricular Acupuncture Comparativeness Effectiveness (PEACE) trial is a randomized clinical trial that was conducted from March 2017 to October 2019 (follow-up completed April 2020) across an urban academic cancer center and 5 suburban sites in New York and New Jersey. Study statisticians were blinded to treatment assignments. The 360 adults included in the study had a prior cancer diagnosis but no current evidence of disease, reported musculoskeletal pain for at least 3 months, and self-reported pain intensity on the Brief Pain Inventory (BPI) ranging from 0 (no pain) to 10 (worst pain imaginable).

Patients were randomized 2:2:1 to:

  1. electroacupuncture (n = 145),
  2. auricular acupuncture (n = 143),
  3. or usual care (n = 72).

Intervention groups received 10 weekly sessions of electroacupuncture or auricular acupuncture. Ten acupuncture sessions were offered to the usual care group from weeks 12 through 24.

The primary outcome was a change in the average pain severity score on the BPI from baseline to week 12. Using a gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture were compared with usual care using a linear mixed model. Noninferiority of auricular acupuncture to electroacupuncture was tested if both interventions were superior to usual care.

Among 360 cancer survivors (mean [SD] age, 62.1 [12.7] years; mean [SD] baseline BPI score, 5.2 [1.7] points; 251 [69.7%] women; and 88 [24.4%] non-White), 340 (94.4%) completed the primary end point. Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12. Noninferiority of auricular acupuncture to electroacupuncture was not demonstrated. Adverse events were mild; 15 of 143 (10.5%) patients receiving auricular acupuncture and 1 of 145 (0.7%) patients receiving electroacupuncture discontinued treatments due to adverse events (P < .001).

The authors of this study concluded that, in this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture and auricular acupuncture produced greater pain reduction than usual care. However, auricular acupuncture did not demonstrate noninferiority to electroacupuncture, and patients receiving it had more adverse events.

I think the authors made a mistake in formulating their conclusions. Perhaps they allow me to correct it:

In this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture plus usual care and auricular acupuncture plus usual care produced greater pain reduction than usual care alone.

I know, I must sound like a broken record, but – because it followed the often-discussed ‘A+B versus B’ design – this study does simply not show what the authors conclude. In fact, it tells us very little about any effects caused by the two acupuncture versions per se. The study does not control for placebo effects and therefore its results are consistent with acupuncture itself having no effect at all.

Here is an attempt at explaining the ‘A+B versus B’ study design I posted previously:

As regularly mentioned on this blog, there are several ways to design a study such that the risk of producing a negative result is minimal. The most popular one in SCAM research is the ‘A+B versus B’ design…

Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual alone, and the former is therefore more than likely to produce a better result. This will be true, even if acupuncture is a pure placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.

Imagine the two interventions had been a verbal encouragement or pat on the shoulder or a pat on the right shoulder for group 1 and one on the left for group 2. The findings could well have been very similar. To provide evidence that acupuncture PRODUCES PAIN REDUCTION, we need proper tests of the hypothesis. And to ‘determine the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors’, we need a different methodology.

This is, of course, all very elementary. Nothing elaborate or complicated! Scientists know it; editors know it; reviewers know it. Or at least they should know it. Therefore, I am at a loss trying to understand why even journals of high standing publish IMPROPER tests, better known as pseudo-science.

It is hard not to conclude that they deliberately try to mislead us.

Osteopathic manipulative treatment (OMT) is popular, but does it work? On this blog, we have often discussed that there are good reasons to doubt it.

This study compared the efficacy of standard OMT vs sham OMT for reducing low back pain (LBP)-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP. It was designed as a prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial. 400 patients with nonspecific subacute or chronic LBP were recruited from a tertiary care center in France starting and randomly allocated to interventions in a 1:1 ratio.

Six sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by osteopathic practitioners. For both
experimental and control groups, each session lasted 45 minutes and consisted of 3 periods: (1) interview focusing on pain location, (2) full osteopathic examination, and (3) intervention consisting of standard or sham OMT. In both groups, practitioners assessed 7 anatomical regions for dysfunction (lumbar spine, root of mesentery, diaphragm, and atlantooccipital, sacroiliac, temporomandibular, and talocrural joints) and applied sham OMT to all areas or standard OMT to those that were considered dysfunctional.

The primary endpoint was the mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index. Secondary outcomes were the mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leave, as well as the number of LBP episodes at 12 months, and the consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months.

A total of 200 participants were randomly allocated to standard OMT and 200 to sham OMT, with 197 analyzed in each group; the median (range) age at inclusion was 49.8 (40.7-55.8) years, 235 of 394 (59.6%) participants were women, and 359 of 393 (91.3%) were currently working. The mean (SD) duration of the current LBP episode had been 7.5 (14.2) months. Overall, 164 (83.2%) patients in the standard OMT group and 159 (80.7%) patients in the sham OMT group had the primary outcome data available at 3 months.

The mean (SD) Quebec Back Pain Disability Index scores were:

  • 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months in the OMT-group,
  • 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months in the sham group.

The mean reduction in LBP-specific activity limitations at 3 months was -4.7 (95% CI, -6.6 to -2.8) and -1.3 (95% CI, -3.3 to 0.6) for the standard OMT and sham OMT groups, respectively (mean difference, -3.4; 95% CI, -6.0 to -0.7; P = .01). At 12 months, the mean difference in mean reduction in LBP-specific activity limitations was -4.3 (95% CI, -7.6 to -1.0; P = .01), and at 3 and 12 months, the mean difference in mean reduction in pain was -1.0 (95% CI, -5.5 to 3.5; P = .66) and -2.0 (95% CI, -7.2 to 3.3; P = .47), respectively. There were no statistically significant differences in other secondary outcomes. Four and 8 serious adverse events were self-reported in the standard OMT and sham OMT groups, respectively, though none was considered related to OMT.

The authors concluded that standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable.

This study was funded the French Ministry of Health and sponsored by the Département de la Recherche Clinique et du Développement de l’Assistance Publique-Hôpitaux de Paris. It is of exceptionally good quality. Its findings are important, particularly in France, where osteopaths have become as numerous as their therapeutic claims irresponsible.

In view of what we have been repeatedly discussing on this blog, the findings of the new trial are unsurprising. Osteopathy is far less well supported by sound evidence than osteopaths want us to believe. This is true, of course, for the plethora of non-spinal claims, but also for LBP. The French authors cite previously published evidence that is in line with their findings: In a systematic review, Rubinstein and colleagues compared the efficacy of manipulative treatment to sham manipulative treatment on LBP-specific activity limitations and did not find evidence of differences at 3 and 12 months (3 RCTs with 573 total participants and 1 RCT with 63 total participants). Evidence was considered low to very low quality. When merging the present results with these findings, we found similar standardized mean difference values at 3months (−0.11 [95% CI, −0.24 to 0.02]) and 12 months (−0.11 [95% CI, −0.33 to 0.11]) (4 RCTs with 896 total participants and 2 RCTs with 320 total participants).

So, what should LBP patients do?

The answer is, as I have often mentioned, simple: exercise!

And what will the osteopaths do?

The answer to this question is even simpler: they will find/invent reasons why the evidence is not valid, ignore the science, and carry on making unsupported therapeutic claims about OMT.

The author of this study introduces the subject by stating that Reiki is a biofield energy therapy that focuses on optimizing the body’s natural healing abilities balancing the life force energy or qi/chi. Reiki has been shown to reduce stress, pain levels, help with depression/anxiety, increase relaxation, improve fatigue, and quality of life.

Despite the fact that the author seems to have no doubt about the effectiveness of Reiki, she decided single-handedly to conduct a study of it – well, not a real study but a ‘pilot study’:

In this pilot randomized, double-blinded, and placebo-controlled study, the effects of Reiki on heart rate, diastolic and systolic blood pressure, body temperature, and stress levels were explored in an effort to gain objective outcome measures and to understand the underlying physiological mechanisms of how Reiki may be having these therapeutic effects on subjective measures of stress, pain, relaxation, and depression/anxiety.

Forty-eight subjects were block-randomized into three groups (Reiki treatment, sham treatment, and no treatment). The changes in pre-and post-treatment measurements for each outcome measure were analyzed through analysis of variance (ANOVA) post hoc multiple comparison test, which found no statistically significant difference between any of the groups. The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone.

The author concluded that a second study with a larger sample size is warranted to investigate this finding further and perhaps with additional outcome measures to look at other possible physiological mechanisms that may underlie the therapeutic effects of Reiki.

I have a few questions about this paper:

  • If a researcher already knows that a treatment works, why do a study?
  • If she nevertheless does a study, why a pilot that is not meant for evaluating effects but for testing the feasibility?
  • Why does the author calculate effects instead of evaluating the feasibility of his project?
  • Why does the author try to interpret a negative outcome as though it signifies an almost positive effect?
  • Why did someone who knows how to do research at the Ohio Wesleyan University (the author’s affiliation) not give her some guidance?
  • Why did the reviewers of this paper let it pass?
  • Why does any journal publish such rubbish?

Oh, the embarrassment!

It’s a journal for which I once (a long time ago) served on the editorial board.

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!

 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.

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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