scientific misconduct
Muscular dystrophies are a rare, severe, and genetically inherited disorders characterized by progressive loss of muscle fibers, leading to muscle weakness. The current treatment includes the use of steroids to slow muscle deterioration by dampening the inflammatory response. Chinese herbal medicine (CHM) has been offered as adjunctive therapy in Taiwan’s medical healthcare plan, making it possible to track CHM usage in patients with muscular dystrophies. This investigation explored the long-term effects of CHM use on the overall mortality of patients with muscular dystrophies.
A total of 581 patients with muscular dystrophies were identified from the database of Registry for Catastrophic Illness Patients in Taiwan. Among them, 80 and 201 patients were CHM users and non-CHM users, respectively. Compared to non-CHM users, there were more female patients, more comorbidities, including chronic pulmonary disease and peptic ulcer disease in the CHM user group. After adjusting for age, sex, use of CHM, and comorbidities, patients with prednisolone usage exhibited a lower risk of overall mortality than those who did not use prednisolone. CHM users showed a lower risk of overall mortality after adjusting for age, sex, prednisolone use, and comorbidities. The cumulative incidence of the overall survival was significantly higher in CHM users. One main CHM cluster was commonly used to treat patients with muscular dystrophies; it included Yin-Qiao-San, Ban-Xia-Bai-Zhu-Tian-Ma-Tang, Zhi-Ke (Citrus aurantium L.), Yu-Xing-Cao (Houttuynia cordata Thunb.), Che-Qian-Zi (Plantago asiatica L.), and Da-Huang (Rheum palmatum L.).
The authors concluded that the data suggest that adjunctive therapy with CHM may help to reduce the overall mortality among patients with muscular dystrophies. The identification of the CHM cluster allows us to narrow down the key active compounds and may enable future therapeutic developments and clinical trial designs to improve overall survival in these patients.
I disagree!
What the authors have shown is a CORRELATION, and from that, they draw conclusions implying CAUSATION. This is such a fundamental error that one has to wonder why a respected journal let it go past.
A likely causative explanation of the findings is that the CHM group of patients differed in respect to features that the statistical evaluations could not control for. Statisticians can never control for factors that have not been measured and are thus unknown. A possibility in the present case is that these patients had adopted a different lifestyle together with employing CHM which, in turn, resulted in a longer survival.
Exploring preventive therapeutic measures has been among the biggest challenges during the coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A team of Indian and US researchers explored the feasibility and methods of recruitment, retention, and potential signal of efficacy, of selected homeopathic medicines as a preventive measure for developing COVID-19 in a multi-group study.
A six-group, randomized, double-blind, placebo-controlled prophylaxis study was conducted in a COVID-19 exposed population in a quarantine facility in Mumbai, India. Each group received one of the following:
- Arsenicum album 30c,
- Bryonia alba 30c,
- Arsenicum album 30c, Bryonia alba 30c, Gelsemium sempervirens 30c, and Influenzinum 30c
- coronavirus nosode CVN01 30c,
- Camphora 1M,
- placebo.
Six pills twice a day were administered for 3 days. The primary outcome measure used was testing recruitment and retention in this quarantined setting. Secondary outcomes were numbers testing positive for COVID-19 after developing symptoms of illness, the number of subjects hospitalized, and days to recovery.
Good rates of recruitment and retention were achieved. Of 4,497 quarantined individuals, 2,343 sought enrollment, with 2,294 enrolled and 2,233 completing the trial (49.7% recruitment, 97.3% retention). Subjects who were randomized to either Bryonia alba (group 2) or to the CVN01 nosode (group 4) signaled a numerically lower incidence of laboratory-confirmed COVID-19 and a shorter period of illness, with evidence of fewer hospitalizations than those taking placebo. The three other groups did not show signals of efficacy.
The authors concluded that this pilot study supports the feasibility of a larger randomized, double-blind, placebo-controlled trial. Bryonia alba 30c and CVN01 30c should both be explored in disease prevention or shortening the course of disease symptomatology in a COVID-19-exposed population.
Signals of efficacy?
Are they kidding us?
The results failed to be statistically significant!
Hence the conclusions should be rewritten as follows:
This pilot study supports the feasibility of a larger trial in India where people have been told by an irresponsible government to believe in homeopathy. None of the 5 homeopathic treatments generated encouraging findings and none should be explored further. Studies of this nature must be discouraged firstly because homeopaths would not accept the findings of a trial of non-individualized homeopathy, and secondly because such trials will further confuse the public who might think that homeopathy is worth trying.
This shocking paper presents 5 cases of patients with moderate to severe COVID-19 infections, 2 of them hospitalized in the intensive care unit, who were successfully treated with homeopathy. All 5 patients responded to homeopathic treatment in an unexpectedly short time span (in fact, it took up to 8 days), improving both physically and mentally.
The authors concluded that the present case series emphasizes the rapidity of response among moderate to severely ill patients to homeopathic treatment, when conventional medical options have been unable to relieve or shorten the disease. The observations described should encourage use of homeopathy in treating patients with COVID-19 during the acute phase of the disease.
If I hear about patients suffering from a cold, or tennis elbow, or otitis, or back pain, or allergy who responded to homeopathic treatment in an unexpectedly short time span, I tend to giggle and usually consider it a waste of time to explain that the observed outcome most likely is not a RESPONSE to homeopathic treatment but a non-causally related by-product. Correlation is not causation! What caused the outcome was, in fact, the natural history of the condition which would have improved even without homeopathy. To make this even clearer, I sometimes ask the homeopath: HOW DO YOU KNOW THAT THE PATIENT WOULD NOT HAVE IMPROVED EVEN FASTER IF YOU HAD NOT GIVEN HIM THE HOMEOPATHIC REMEDY? This question sometimes (sadly not always) leads to the realization that homeopathy may not have caused the outcome.
But when, in the middle of a pandemic during which millions of people died and continue to die, someone writes in a medical journal that 5 COVID patients responded to homeopathic treatment in an unexpectedly short time span, I feel compelled to disclose the statement as pure, unethical, irresponsible, and dangerous quackery.
The 5 patients with COVID-19 were hospitalized at a tertiary medical center in Jerusalem for moderate to severe
COVID-19-related symptoms. Each of them requested homeopathic treatment in addition to conventional therapy from the hospital’s ‘Center for Integrative Complementary Medicine’. All 5 patients were over 18 years old and had confirmed COVID-19 infection at the time of admission. They received their homeopathic medications as small round pills (globules); no further information about the homeopathic treatment was provided. Similarly, we also do not learn whether some patients who did not receive homeopathy recovered just as quickly (I am sure that worldwide thousands did), or whether some patients who did get homeopathic remedies failed to recover.
To make matters worse, the authors of this paper state this:
Several conclusions are evident from the cases presented:
1 homeopathy’s effect may be expected within minutes or, at most, hours;
2 contrary to classical homeopathic consultations, which may extend over an hour, correct medications for patients with acute COVID-19 symptoms may be determined in minutes;
3 there were no observable adverse effects to homeopathic treatment of COVID-19;
4 therapy can be administered via telehealth services, increasing safety of treating patients with active infection;
5 patient satisfaction was high; scoring their experience of homeopathic therapy on a 7-point scale, ranging
from “It greatly improved my condition” to “It greatly aggravated my condition,” all 5 patients indicated it
had greatly improved their condition.
The possibility that the outcomes are not causally related to the homeopathic treatment seems to have escaped the authors. The harm that can be done by such an article seems obvious: fans of homeopathy might be misled into assuming that homeopathy is an effective therapy for COVID infections and other serious conditions. It is not hard to imagine that this error would cost many lives.
The authors state in their article that, to the best of their knowledge, this is the first time that a tertiary medical center has permitted homeopathic therapy of patients under treatment for COVID-19-related illness.
I sincerely hope that it is also the last time!
This study aimed to assess the feasibility of a future definitive trial, with a preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in the treatment of cutaneous warts.
A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of the Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebos (n = 30). The primary outcome measures were numbers and sizes of warts; the secondary outcome measure was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample.
Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater in the IH group than in the placebo group. Inter-group differences were statistically non-significant (all p > 0.05, Mann-Whitney U tests) with small effect sizes, both in the primary outcomes (number of warts after 3 months: IH median [interquartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%), and Sulphur (8.3%) were the most frequently prescribed medicines. No homeopathic aggravations or serious adverse events were reported.
The authors concluded that, as regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted.
Partly the same group of authors recently published another trial of homeopathy with similar findings. At the time, I commented as follows:
We have come across this terminology before; homeopaths seem to like it. It prevents them from calling a negative trial by its proper name: A NEGATIVE TRIAL. In their view
- a positive trial is a study where homeopathy yields better results than placebo,
- a negative trial is a study where placebo yields better results than homeopathy,
- an inconclusive trial is a study where homeopathy yields results that are not significantly different from placebo.
Is this silly?
Yes, it is completely bonkers!
Is it dishonest?
Yes, in my view, it is.
Why is it done nonetheless?
Perhaps a glance at the affiliations of the authors provides an answer. And here is the list of the affiliations of the trialists of the present cutaneous wart study:
- 1Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India.
- 2D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India.
- 3Department of Organon of Medicine and Homoeopathic Philosophy, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 4Department of Practice of Medicine, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 5Department of Repertory, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India.
- 6Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India.
- 7Department of Pediatrics, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India.
- 8Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, Lucknow, Uttar Pradesh.
- 9Independent Researcher; Champsara, Baidyabati, Hooghly, West Bengal, India.
- 10Independent Researcher, Shibpur, Howrah, West Bengal, India.
And, as before, this paper also contains this statement:
Conflict of interest statement
None declared.
Pre-hypertension, or stage 1 hypertension as it is also called, is usually defined as a systolic pressure reading between 120 mmHg and 139 mmHg, or a diastolic reading between 80 mmHg and 89 mmHg. It remains a significant public health challenge and appropriate intervention is required to stop its progression to hypertension and cardiovascular diseases.
This double-blind, randomized, two parallel arms, placebo-controlled study tested the effects of individualized homeopathic medicines (IH) against placebo in intervening with the progression of pre-hypertension to hypertension.
Ninety-two patients with pre-hypertension were randomized to receive either IH (n = 46) or identical-looking placebo (n = 46). Both IH or placebo were applied in the mutual context of lifestyle modification (LSM) advice including dietary approaches to stop hypertension (DASH) and brisk exercises.
The primary endpoints were systolic and diastolic blood pressures (SBP and DBP); secondary endpoints were Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2) scores. All endpoints were measured at baseline, and every month, up to 3 months.
After 3 months of intervention, the number of patients having progression from pre-hypertension to hypertension between groups was similar without any significant differences in between the groups. Reduction in BP and MYMOP-2 scores were also not significantly different. Lycopodium clavatum, Thuja occidentalis and Natrum muriaticum were the most frequently prescribed medicines. No serious adverse events were reported from either group.
The authors concluded that there was a small, but non-significant direction of effect favoring homeopathy, which ultimately rendered the trial as inconclusive.
We have come across this terminology before; homeopaths seem to like it. It prevents them from calling a negative trial by its proper name: A NEGATIVE TRIAL. In their view
- a positive trial is a study where homeopathy yields better results than placebo,
- a negative trial is a study where placebo yields better results than homeopathy,
- an inconclusive trial is a study where homeopathy yields results that are not significantly different from placebo.
Is this silly?
Yes, it is completely bonkers!
Is it dishonest?
Yes, in my view, it is.
Why is it done nonetheless?
Perhaps a glance at the affiliations of the authors provides an answer:
- 1Dept. of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India. Electronic address: [email protected].
- 2Dept. of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.
- 3Principal and Administrator D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.
- 4Dept. of Practice of Medicine, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.
- 5Dept. of Practice of Medicine, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, Govt. of West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.
- 6Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India; affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.
- 7Dept. of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, Lucknow, Govt. of Uttar Pradesh, affiliated to Dr. Bhimrao Ramji Ambedkar University, Agra, Govt. of Uttar Pradesh), India.
- 8Dept. of Repertory, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.
Despite these multiple conflicts of interest, the article carries this note:
“Declaration of Competing Interest: None declared.”
In their 2019 systematic review of spinal manipulative therapy (SMT) for chronic back pain, Rubinstein et al included 7 studies comparing the effect of SMT with sham SMT.
They defined SMT as any hands-on treatment of the spine, including both mobilization and manipulation. Mobilizations use low-grade velocity, small or large amplitude passive movement techniques within the patient’s range of motion and control. Manipulation uses a high-velocity impulse or thrust applied to a synovial joint over a short amplitude near or at the end of the passive or physiological range of motion. Even though there is overlap, it seems fair to say that mobilization is the domain of osteopaths, while manipulation is that of chiropractors.
The researchers found:
- low-quality evidence suggesting that SMT does not result in a statistically better effect than sham SMT at one month,
- very low-quality evidence suggesting that SMT does not result in a statistically better effect than sham SMT at six and 12 months.
- low-quality evidence suggesting that, in terms of function, SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Exclusion of an extreme outlier accounted for a large percentage of the statistical heterogeneity for this outcome at this time interval (SMD −0.27, 95% confidence interval −0.52 to −0.02; participants=698; studies=7; I2=39%), resulting in a small, clinically better effect in favor of SMT.
- very low-quality evidence suggesting that, in terms of function, SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.
This means that SMT has effects that are very similar to placebo (the uncertain effects on function could be interpreted as the result of residual de-blinding due to a lack of an optimal placebo or sham intervention). In turn, this means that the effects patients experience are largely or completely due to a placebo response and that SMT has no or only a negligibly small specific effect on back pain. Considering the facts that SMT is by no means risk-free and that less risky treatments exist, the inescapable conclusion is that SMT cannot be recommended as a treatment of chronic back pain.
Guest post by Norbert Aust and Viktor Weisshäupl
Imagine you recently published an excellent and rigorous trial providing solid evidence that a certain therapy is able to help patients suffering from some inevitably fatal condition. You proved that your therapy is able to significantly prolong the patients’ lifetime, much longer than with the current state-of-the-art therapeutic approach. But the patients not only live considerably longer, but they also do so with a much better quality of life (QoL) and subjective well-being. In short: this therapy marks some progress that would otherwise take years or decades of scientific effort.
And then someone comes forward and points out your data apparently were manipulated. Essential parameters of this trial were modified sometime after data collection was completed, with the patients’ outcome and first analyses available. Thus the results were biased in a certain direction and the critics show that the results as published in your study show characteristics that such manipulations would evoke. After all, this holds an implication of scientific misconduct that could, if verified, ruin your academic reputation more or less completely.
What would you do?
Ignore the preposterous concerns because you know your methods and performance were rigorous and solid? After all, anytime some real academic criticism arises you are ready to prove your findings are well-founded results of accepted scientific methods. Or would you publish data or documents that your critics were too ignorant to find or to understand, and thus to stop such rumours once and for all? Maybe you could even clarify some of the issues raised by those critics, maybe add some follow-up information or data to ensure no more misunderstandings occur. Or would you try to find some clues for a libel lawsuit?
Well, we thought some of the above would happen after we contacted the authors of the recent study on adjunct homeopathy in non-small cell lung cancer. On that date, we forwarded our detailed analysis to the lead author and all the co-authors.
Of course, we even considered the possibility, not very likely though, that we would receive some explanation for the numerous exclusion criteria while other serious conditions that coincide with advanced age did not preclude enrollment. Or an updated CONSORT diagram accounting for the patients excluded. Or some explanation just why the numerous amendments to the protocol were necessary but not important enough to mention them in the published paper.
But nothing of this happened as yet (July 2021). Instead on June 14 and 16, 2021, not two weeks after our messages to the authors, the registration data at ClinicalTrials were updated once again and a new version of the protocol was uploaded [3]. And this update looks pretty much like it is meant to cover up and blur the former data that we based our analysis on. Of course, these data and the former version of the protocol are available still – just one layer further down, and you have to scroll to the bottom of the page to find the small link “history of changes”. Maybe not many visitors will do that.
In contrast to the versions before, now the uploaded data are in line with the study as published, namely, they include a full list of the exclusion criteria and the reduced observation time for QoL, which was the primary outcome. Note: throughout the trial until the end of data assessment those parameters were set with pregnancy as the only exclusion criterion and two years follow up time, only to be amended in the protocol uploaded two months after data collection was complete and analysis presumably was well underway.
In addition, there is a new version of the study protocol, this one dated Feb. 6, 2014. Of course, this protocol is fairly new, in spite of the date it carries. Why would the older version allegedly from January 2011 be uploaded to the register in September 2019, if this more actual version already had existed and was available?
Contrary to the prior version all the clues are removed that would indicate that this document was finished at a much later point in time than given in its date: References to some future software versions that were released years after the protocol was allegedly compiled are dropped. And this strange literature reference “25” that corresponds to the reference list in the final study as published but is pointless in the protocol without any reference list, is removed too. And of course, again contrary to the prior version, the exclusion criteria are identical with the final study as is the shortened follow-up time for QoL.
New to the protocol is a section “Bringing in the patient’s voice”, where the authors disclose how they want to “systematically research the ethical, legal, socio-political, and science theoretical dimensions of homeopathy as in the case of lung cancer (non-small-cell lung carcinoma) exemplified” in some “integral social scientific study”, where some “focus groups” of 4 to 10 participants together with their relatives, friends and caregivers included should be used to study “interactions between individuals, collectively shared and uncontested assumptions, and the emergence of collective meaning”.
But from all of this more or less meaningless but very sciency sounding socio-speak, not a single word found its way into the study. Nothing. So it is pointless to try to figure out what the content of this part of the investigation is all about.
Why then was this chapter added? This “integral social scientific study” was to start after the “third or fourth homeopathic treatment” (But why should patients not be included in this “research” from the very first beginning?). Is it perhaps to give some rationale why the follow-up time for QoL was to end after the third homeopathic treatment?
So what we see, when we look up the study at ClinicalTrials now, is a perfectly matching set of data and a protocol that corresponds to the study as published and looks as if it was published at a time where the trial was underway and the patients were still blinded. If you do not look very closely everything now appears to be perfect.
And here we would like to forward some critique to the register: The purpose of the study register is to prevent not only publication bias but misleading manipulation from happening as well. They do quite a good job in preserving former versions of data and documents and keeping them available to the public. Many national study registers do not offer this service. But you must be of a suspicious mind and of some persistence to actively search and find and check the history of modifications. Thus, a cover-up like the one we are witnessing here might well prove successful. We, therefore, propose to improve the presentation of the registration: If vital amendments occurred that may affect the outcomes – such as protocol changes, extensions of exclusion criteria, modifications of follow-up time – this should be indicated upfront in the study’s record instead of some small hint to “history of changes” at the very bottom of the page.
In conclusion, there appears to be no proof that the results of the study were produced using rigorous scientific methods. And the issues we raised in our report to the authors remain unresolved.
On FACEBOOK I recently found this advertisement posted by ‘LifeCell Health’
Guys, weight loss starts at our gut. The reishi mushroom targets this key area of the body and promotes weight loss in a unique way, by changing our gut bacteria to digest food in a manner that improves weight loss and can even prevent weight gain. By combining 3 of the most researched mycological species on the planet, LifeCell Myco+ delivers a blend of weight loss mushrooms like no other: Improve gut health, speed up weight loss, enhance immune function, natural energy and more with our blend of Reishi, Turkey Tail, and Shiitake mushrooms. Each mushroom has been the subject of several in-vivo studies proving their efficacy when it comes to weight loss.
Why Mushrooms Work.
Reishi: Prevents weight gain by altering bacteria inside the digestive system
Shiitake: Helps the body develop less fat by nourishing good gut bacteria.
Turkey Tail: Reduces inflammation and helps prevent weight gain.
That sounded interesting, I thought, and I investigated a bit further. On the website of the firm, I found this text:
By combining 3 of the most researched mycological species on the planet, LifeCell Myco+ delivers an organic wellness formula unlike any other. Improve gut health, speed up weight loss, enhance immune function, natural energy and more with our blend of Reishi, Turkey Tail, and Shiitake mushrooms.
Keeping a healthy balance of beneficial bacteria in your gut is critical for maintaining a strong immune system. Your gut bacteria interact with immune cells and directly impact your immune response. Turkey tail mushrooms contain prebiotics, which help nourish these helpful bacteria. An 8-week study in 24 healthy people found that consuming 3,600 mg of PSP extracted from turkey tail mushrooms per day led to beneficial changes in gut bacteria and suppressed the growth of the possibly problematic E. coli and Shigella bacteria.
Next, I conducted a few Medline searches but was unable to find any trial data suggesting that any of the three mushrooms or their combination might reduce body weight. So, I wrote to the company:
Dear Madam/Sir
I am intrigued by your product MYCO +. Would you be kind enough to send me the studies showing that it can reduce body weight?
Many thanks
Edzard Ernst
What followed was a bizarre correspondence with several layers of administrators in the firm. They all said that I should discuss this with the next higher person. So, I asked myself up the hierarchy of LiveCell. The last email I received was this one:
Good morning Edzark,
Thank you for your email and I hope you are enjoying your day.
It is great to hear that you are interested in our LifeCell Myco. I have forwarded your request for additional information and once received I will be sure to forward the information to you.
What do I conclude from this experience?
Apart from being unable to get my name right, the people responsible at ‘LifeCell Health’ seem also not able to send me the evidence I asked for. This, I fear, means that there is no such evidence which means the claims are unsubstantiated. Scientifically, this might amount to misconduct; legally, it could be fraudulent.
But I am, of course, no lawyer and therefore leave it to others to address the legal issues.
PS
If anyone happens to know of some evidence, please let me know and I will correct my post accordingly.
Chinese researchers evaluated the effect of Chinese medicine (CM) on survival time and quality of life (QoL) in patients with small-cell lung cancer (SCLC). They conducted an exploratory and prospective clinical observation. Patients diagnosed with SCLC receiving CM treatment as an add-on to conventional cancer therapies were included and followed up every 3 months. The primary outcome was overall survival (OS), and the secondary outcomes were progression-free survival (PFS) and QoL.
A total of 136 patients including 65 limited-stage SCLC (LS-SCLC) patients and 71 extensive-stage SCLC (ES-SCLC) patients were analyzed. The median OS of ES-SCLC patients was 17.27 months, and the median OS of LS-SCLC was 40.07 months. The survival time was 16.27 months for SCLC patients with brain metastasis, 9.83 months for liver metastasis, 13.43 months for bone metastasis, and 18.13 months for lung metastasis. Advanced age, pleural fluid, liver, and brain metastasis were risk factors, while longer CM treatment duration was a protective factor. QoL assessment indicated that after 6 months of CM treatment, scores increased in function domains and decreased in symptom domains.
The authors concluded that CM treatment might help prolong OS of SCLC patients. Moreover, CM treatment brought the trend of symptom amelioration and QoL improvement. These results provide preliminary evidence for applying CM in SCLC multi-disciplinary treatment.
Sorry, but these results provide NO evidence for applying CM in SCLC multi-disciplinary treatment! Even if the findings were a bit better than those reported for SCLC in the literature – and I am not sure they are – it is simply not possible to say with any degree of certainty what effect the CM had. For that, we would obviously need a proper control group.
The study was supported by the National Natural Science Foundation of China (No. 81673797), and Beijing Municipal Natural Science Foundation (No. 7182142). In my view, this paper is an example for showing how the relentless promotion of dubious Traditional Chinese Medicine by Chinese officials might cost lives.
I feel that it is time to do something about it.
But what precisely?
Any ideas anyone?
Prof Harald Walach has had a few rough weeks. First, he published his paper suggesting that Covid vaccinations do more harm than good which was subsequently retracted as flawed, if not fraudulent. Next, he published a paper showing that children are put in danger when wearing face masks suggesting that “decision-makers weigh the hard evidence produced by these experimental measurements accordingly, which suggest that children should not be forced to wear face masks.” Now, the journal put out the following announcement about it:
The Research Letter, “Experimental Assessment of Carbon Dioxide Content in Inhaled Air With or Without Face Masks in Healthy Children: A Randomized Clinical Trial,” by Harald Walach, PhD, and colleagues published online in JAMA Pediatrics on June 30, 2021,1 is hereby retracted.
Following publication, numerous scientific issues were raised regarding the study methodology, including concerns about the applicability of the device used for assessment of carbon dioxide levels in this study setting, and whether the measurements obtained accurately represented carbon dioxide content in inhaled air, as well as issues related to the validity of the study conclusions. In their invited responses to these and other concerns, the authors did not provide sufficiently convincing evidence to resolve these issues, as determined by editorial evaluation and additional scientific review. Given fundamental concerns about the study methodology, uncertainty regarding the validity of the findings and conclusions, and the potential public health implications, the editors have retracted this Research Letter.
To make things even worse, Walach’s University fired him because of his fraudulent anti-vax research. Poznan University of Medical Sciences tweeted on 6 July:
We wish to emphasize that the claims included in dr Harald Walach’s recent article in @Vaccines_MDPI do not represent the position of @PUMS_tweets . We find that the article lacked scientific diligence and proper methodology. Dr. Walach’s affiliation with PUMS was now terminated. Throughout the pandemic PUMS has actively promoted vaccination programs, offering scientific expertise in the media, broadcasting seminars, and reported on progress of the vaccination program. We consider vaccinations as the paramount tool in the global fight against the pandemic. We consider vaccinations as the paramount tool in the global fight against the #pandemic. Over 85% of our own academic community has already been vaccinated with support and encouragement from the University.
As I said, this is truly unlucky …
.. or perhaps not?
Come to think of it, it is lucky when pseudo-science and fraud are called out. It means that the self-cleaning mechanisms of science are working and we are protected from the harm done by charlatans.
