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

clinical trial

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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.

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)

My ‘ALTERNATIVE MEDICINE HALL OF FAME’ is filling up nicely. But I noticed that so far we have nobody from Spain. That can be rectified ever so easily. I think I found the ideal candidate to join this group of illustrious experts who never bring themselves to publish a negative conclusion: JORGE VAS.

Jorge Vas works at the ‘Pain Treatment Unit, Doña Mercedes Primary Health Care Center, Dos Hermanas’ in Spain. I have long noticed his research which is focused on ACUPUNCTURE. From memory, I had the impression that his findings are always positive.

But is this true? To find out, I did a Medline search and found 11 clinical trials of acupuncture in his name, published between 2006 and 2019. Here are the conclusions:

  1. After 2 weeks of treatment, ear acupuncture applied by midwives and associated with standard obstetric care significantly reduces lumbar and pelvic pain in pregnant women, improves quality of life and reduces functional disability.
  2. Individualised acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualised acupuncture in patients with fibromyalgia is recommended.
  3. The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services.
  4. …all 3 modalities of acupuncture were better than conventional treatment alone…
  5. Moxibustion treatment applied at acupuncture point BL67 can avoid the need for caesarean section and achieve cost savings for the healthcare system in comparison with conventional treatment.
  6. The application of auriculopressure in patients with non-specific spinal pain in primary healthcare is effective and safe, and therefore should be considered for inclusion in the portfolio of primary healthcare services.
  7. The degree of pain relief experienced by patients from acupuncture justifies a more rigorous study.
  8. Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus.
  9. Single-point acupuncture in association with physiotherapy improves shoulder function and alleviates pain, compared with physiotherapy as the sole treatment. This improvement is accompanied by a reduction in the consumption of analgesic medicaments.
  10. Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic treatment of osteoarthritis of the knee.
  11. In the treatment of the intensity of chronic neck pain, acupuncture is more effective than the placebo treatment and presents a safety profile making it suitable for routine use in clinical practice.

Eleven of 11 trials with a positive conclusion!

That surely is a rare feast.

Actually, I cheated a tiny bit. The unabridged sentence from the conclusion of paper N4 was: In the analysis adjusted for the total sample (true acupuncture relative risk 5.04, 95% confidence interval 2.24-11.32; sham acupuncture relative risk 5.02, 95% confidence interval 2.26-11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21-5.46), as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were better than conventional treatment alone, but there was no difference among the 3 acupuncture modalities, which implies that true acupuncture is not better than sham or placebo acupuncture. Thus this (multicentre) study was negative with just a touch of positivity.

But still, look at the range of conditions that respond positively to acupuncture in Vas’ hands. Is there anyone who doubts that Jorge Vas does not deserve to join all these other geniuses in THE ALTERNATIVE MEDICINE HALL OF FAME?

I am sure that Vas has more than merited to join them.

WELCOME JORGE VAS!

Tuina is a massage therapy that originates from Traditional Chinese Medicine. Many of the techniques used in tuina resemble those of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing, and shaking. Tuina involves a range of manipulations usually performed by the therapist’s finger, hand, elbow, knee, or foot. They are applied to muscle or soft tissue at specific locations of the body.

The aim of Tuina is to enhance the flow of the ‘vital energy’ or ‘chi’, that is alleged to control our health. Proponents of the therapy recommend Tuina for a range of conditions, including paediatric ones. Paediatric Tuina has been widely used in children with acute diarrhea in China. However, due to a lack of high-quality clinical evidence, the benefit of Tuina is not clear.

This study aimed to assess the effect of paediatric Tuina compared with sham Tuina as add-on therapy in addition to usual care for 0-6-year-old children with acute diarrhea.

Eighty-six participants aged 0-6 years with acute diarrhea were randomized to receive Tuina plus usual care (n = 43) or sham Tuina plus usual care (n = 43). The primary outcomes were days of diarrhea from baseline and times of diarrhea on day 3. Secondary outcomes included a global change rating (GCR) and the number of days when the stool characteristics returned to normal. Adverse events were assessed.

Tuina treatment in the intervention group was performed on the surface of the children’s body using moderate pressure (Fig. 1a). Tuina treatment in the control group was different: the therapist used one hand to hold the child’s hand or put one hand on the child’s body, while the other hand performed manipulations on the therapist’s own hand instead of the child’s hand or body (Fig. ​(Fig.11b).

Tuina was associated with a reduction in times of diarrhea on day 3 compared with sham Tuina in both ITT and per-protocol analyses. However, the results were not significant when adjusted for social-demographic and clinical characteristics. No significant difference was found between groups in days of diarrhea, global change rating, or number of days when the stool characteristics returned to normal.

The authors concluded that in children aged 0-6 years with acute diarrhea, pediatric Tuina showed significant effects in terms of reducing times of diarrhea compared with sham Tuina. Studies with larger sample sizes and adjusted trial designs are warranted to further evaluate the effect of pediatric Tuina therapy.

This study was well-reported and has interesting features, such as the attempt to use a placebo control and blinding (whether blinding was successful is a different matter and was not tested in the trial). It is, therefore, all the more surprising that the essentially negative result is turned into a positive one. After adjustment, the differences disappear (a fact which the authors hardly mention in the paper), which means they are not due to the treatment but to group differences and confounding. This, in turn, means that the study shows not the effectiveness but the ineffectiveness of Tuina.

It’s sad but true: not everyone likes THE ALTERNATIVE MEDICINE HALL OF FAME. Take this recent comment, for instance:

It is pathetic to see that Edzard only engages in the systematic harassment of his former colleagues or people who in most cases ignore him. Perhaps because he knows that his battle against homeopathy was totally lost in Germany, Switzerland and Brazil, as could be seen in the imminent failure of the “Questao Da Ciencia Institute”…  Edzard acts as a real bully against Dr. Jacobs by including her in a “hall of fame” to humiliate her before the hoolingans who applaud her, who are always the four guardian trolls who never contribute or benefit to the discussion… 

But then there are others who do appreciate it and recognize that it serves an important purpose: to alert the public to the fact that there is something deeply wrong with much of the published research in so-called alternative medicine (SCAM). Incidentally, this was also the theme of my last post on acupuncture and is the topic of many of my recent articles. Thus the aim of my HALL OF FAME is not to humiliate anyone; it is merely one of many of my attempts to protect the public from misleading information that has the potential to do much harm.

And therefore, I am not likely to close the HALL OF FAME any time soon.

Someone who has been waiting for ages to get admitted is the prolific psychologist Professor Harald Walach. He has in the past changed employment frequently.  After building up a research group in SCAM at the University Hospital in Freiburg he held a research professorship with the University of Northampton, UK from 2005-2009 where he directed the MSc Program of Transpersonal Psychology and Consciousness Studies. From 2010 to 2016, he worked at the European University Viadrina in Frankfurt (Oder), where he headed a postgraduate Master program training doctors in SCAM and cultural sciences. Currently, Walach is affiliated with three institutions:

  • Department of Pediatric Gastroenterology, Medical University Poznan, Poznan, Poland.
  • Department of Psychology, University Witten-Herdecke, Witten, Germany.
  • Change Health Science Institute, Berlin, Germany

In 2012, Walach was elected pseudoscientist of the year, a fact that should almost automatically unlock the HALL’s door for him. But let’s not be hasty; let’s have a look at his publications. My Medline search for ‘Walach H, clinical trial’ generated 40 hits of which 19 related to clinical studies of so-called alternative medicine (SCAM). Here are their conclusions:

  1. Both physiotherapy and PPT improve subacute low back pain significantly. PPT is likely more effective and should be studied further.
  2. One treatment session of enhanced MMT physiotherapy or RegentK can lead to nearly full function and thus recovery of a ruptured ACL after 1 year.
  3. MBSR did not produce cardiac autonomic benefits or changes in daily activity in FM. Furthermore, the lack of an association between patient-experienced clinical improvement and objective physiological measures suggests that subjective changes in the wellbeing of FM patients over time are not related to alterations in the cardiorespiratory autonomic function or activity levels.
  4. Mindfulness therapy may prevent disability pension and it may have a potential to significantly reduce societal costs and increase the effectiveness of care. Accumulated weeks of unemployment and sickness benefit are possible risk factors for BDS.
  5. Mindfulness therapy is a feasible and acceptable treatment. The study showed that mindfulness therapy was comparable to enhanced treatment as usual in improving quality of life and symptoms.
  6. In conclusion, primary outcome analyses did not support the efficacy of MBSR in fibromyalgia, although patients in the MBSR arm appeared to benefit most.
  7. Homeopathic remedies produce different symptoms than placebo.
  8. We, therefore, conclude that homeopathic remedies produce more symptoms typical for a remedy than non-typical symptoms. The results furthermore suggest a somewhat non-classical pattern because symptoms of one remedy appear to be mimicked in the other trial arm. This might be indicative of entanglement in homeopathic systems.
  9. In patients with CFS, distant healing appears to have no statistically significant effect on mental and physical health but the expectation of improvement did improve outcome.
  10. Treatments with QUANTEC may be accompanied by beneficial health effects.
  11. The results showed that both remedies ‘produced’ significantly more symptoms than placebo. With regard to the specificity, the Calendula officinalis group displayed more remedy-specific symptoms than placebo. However, in the Ferrum muriaticum group more Calendula symptoms than placebo were also recorded.
  12. Homeopathic proving symptoms appear to be specific to the medicine and do not seem to be due to a local process.
  13. We conclude that in an unselected sample of headache patients some may indeed be susceptible to the low intensity type of electromagnetic radiation exemplified by sferics pulses.
  14. We conclude that Bach-flower remedies are an effective placebo for test anxiety and do not have a specific effect.
  15. Approximately 30% of patients in homeopathic treatment will benefit after 1 y of treatment. There is no indication of a specific, or of a delayed effect of homeopathy.
  16. There is no indication that belladonna 30CH produces symptoms different from placebo or from no intervention. Symptoms of a homeopathic pathogenetic trial (HPT) are most likely chance fluctuations.
  17. Chronically ill patients who want to be treated by distant healing and know that they are treated improve in quality of life.
  18. Mind machines do not have a specific effect on general well-being and physiological relaxation, although they may produce unusual psychological experiences; people with psychiatric illnesses should not use such devices.
  19.  Group evaluation showed no clearcut differences. The claim that homoeopathic potencies can produce symptoms other than placebo in healthy subjects should be put to further scrutiny.

So, as we see, Prof Walach has published many clinical trials on numerous SCAMs . Their majority arrived at positive conclusions. His TI is therefore sky-high. But he has also published studies that were dramatically negative, even some of homeopathy!

The main criterion for admission to THE ALTERNATIVE MEDICINE HALL OF FAME is to have published SCAM research that hardly ever concludes negatively. Does Walach fulfill it? Should he be allowed to join this illustrious group of people?

I have to admit, the decision was not easy in this case. However, after considering all the evidence, I have decided in favour of admission.

WELCOME PROF WALACH!

 

The state of acupuncture research has long puzzled me. The first thing that would strike who looks at it is its phenomenal increase:

  • Until around the year 2000, Medline listed about 200 papers per year on the subject.
  • From 2005, there was a steep, near-linear increase.
  • It peaked in 2020 when we had a record-breaking 20515 acupuncture papers currently listed in Medline.

Which this amount of research, one would expect to get somewhere. In particular, one would hope to slowly know whether acupuncture works and, if so, for which conditions. But this is not the case.

On the contrary, the acupuncture literature is a complete mess in which it gets more and more difficult to differentiate the reliable from the unreliable, the useful from the redundant, and the truth from the lies. Because of this profound confusion, acupuncture fans are able to claim that their pet-therapy is demonstrably effective for a wide range of conditions, while skeptics insist it is a theatrical placebo. The consumer might listen in bewilderment.

Yesterday (18/1/2021), I had a quick (actually, it was not that quick after all) look into what Medline currently lists in terms of new acupuncture research published in 2021 and found a few other things that are remarkable:

  1. There were already 100 papers dated 2021 (today, there were even 118); that corresponds to about 5 new articles per day and makes acupuncture one of the most research-active areas of so-called alternative medicine (SCAM).
  2. Of these 100 papers, only 7 were clinical trials (CTs). In my view, clinical trials would be more important than any other type of research on acupuncture. To see that they amount to just 7% of the total is therefore disappointing.
  3. Twelve papers were systematic reviews (SRs). It is odd, I find, to see almost twice the amount of SRs than CTs.
  4. Eighteen papers referred to protocols of studies of SRs. In particular protocols of SRs are useless in my view. It seems to me that the explanation for this plethora of published protocols might be the fact that Chinese researchers are extremely keen to get papers into Western journals; it is an essential boost to their careers.
  5. Seven papers were surveys. This multitude of survey research is typical for all types of SCAM.
  6. Twenty-four articles were on basic research. I find basic research into an ancient therapy of questionable clinical use more than a bit strange.
  7. The rest of the articles were other types of publications and a few were misclassified.
  8. The vast majority (n = 81) of the 100 papers were authored exclusively by Chinese researchers (and a few Korean). In view of the fact that it has been shown repeatedly that practically all acupuncture studies from China report positive results and that data fabrication seems rife in China, this dominance of China could be concerning indeed.

Yes, I find all this quite concerning. I feel that we are swamped with plenty of pseudo-research on acupuncture that is of doubtful (in many cases very doubtful) reliability. Eventually, this will create an overall picture for the public that is misleading to the extreme (to check the validity of the original research is a monster task and way beyond what even an interested layperson can do).

And what might be the solution? I am not sure I have one. But for starters, I think, that journal editors should get a lot more discerning when it comes to article submissions from (Chinese) acupuncture researchers. My advice to them and everyone else:

if it sounds too good to be true, it probably is!

The aim of this study was to evaluate the effect of reflexology and homeopathy as adjunctive therapies in asthma. In a single centre, randomised, investigator blinded, controlled study, 86 asthma patients were enrolled. They were assigned to one of three study groups:

  1. conventional treatment alone,
  2. conventional treatment with homeopathy
  3. conventional treatment with reflexology

All patients received their asthma treatment during the study and were followed as usual by their general practitioner. The clinical assessors were blinded to group allocations. The primary outcome was the change in the asthma quality of life questionnaire (AQLQ) scores after 26 weeks. Secondary outcomes included asthma control questionnaire, EuroQol, forced expiratory volume in 1 sec, morning and evening peak expiratory flow, asthma symptoms, rescue medication use, and total medication score.

Minor improvements in the AQLQ score were observed in all three groups. However, no statistically significant changes in AQLQ scores were seen within or between groups. Likewise, secondary outcomes did not differ between groups.

The authors concluded that, in this study, the addition of homeopathy or reflexology to conventional treatment did not result in improved quality of life in asthma.

This study has several flaws. For instance, its sample size is too small to allow firm conclusions and it follows the ‘A+B versus B’ design. Therefore, we need to ask whether the findings are perhaps not reliable. The best answer to this question might be found by looking up the current Cochrane review. It concludes that there is not enough evidence to reliably assess the possible role of homeopathy in asthma. In other (and clearer) words, there is no good reason to assume that homeopathy is effective for asthma; in the present study, it did not even convey a placebo effect. This, I think, suggests that the conclusion of this new trial might be correct:

HOMEOPATHY DOES NOTHING FOR ASTHMA PATIENTS.

Professor Andreas Michalsen is the clinical director of the department of naturopathy in a Berlin hospital. He seems most keen to represent the scientific side of so-called alternative medicine in Germany. He has published several (fairly uncritical) books on SCAM and numerous papers in the medical literature. I had a look at those papers and hope you agree that Michalsen should join the other extraordinary experts in THE ALTERNATIVE MEDICINE HALL OF FAME:

My Medline search on 10/1/2021 for ‘Michalsen A, clinical trial’, generated 69 hits. Below I list the key conclusions of the 47 SCAM studies that were published in English by Andreas Michalsen et al:

  1. In this explorative pilot trial, an increase of HRV (more parasympathetic dominance and overall higher HRV) after ten weeks of yoga in school in comparison to regular school sports was demonstrated, showing an improved self-regulation of the autonomic nervous system. (pilot)
  2.  Results showed a contrast between the high agreement of the consented final diagnosis and disagreement on certain diagnostic details.
  3. A single session of leech therapy is more effective over the short term in lowering the intensity of pain over the short term and in improving physical function and quality of life over the intermediate term.
  4. Short term fasting during chemotherapy is well tolerated and appears to improve QOL and fatigue during chemotherapy. Larger studies should prove the effect of STF as an adjunct to chemotherapy. (pilot)
  5. Administering verum (a complex homeopathic drug) resulted in a statistically significantly greater improvement of the Cough Assessment Score than the placebo. The tolerability was good and not inferior to that of the placebo.
  6. Ayurvedic treatment is beneficial in reducing knee OA symptoms.
  7. We did not find any clinically relevant differences between groups in this controlled clinical pilot trial of 8 wk of intermittent fasting in healthy volunteers.
  8. We found positive effects for both groups, which however were more pronounced in the Ayurvedic group. The conversational and counseling techniques in the Ayurvedic group offered more opportunities for problem description by patients as well as patient-centered practice and resource-oriented recommendations by the physician.
  9. Results of this study suggest that prolonged fasting is feasible and might have beneficial clinical effects. (pilot)
  10. This clinical trial indicates comparable efficacy of the herbal combination and antibiotic, although non-inferiority was not proved. However, the results and lessons learned are important for the planning of future trials.
  11. Thus, cycles of a 5-day fasting-mimiking diet are safe, feasible, and effective in reducing markers/risk factors for aging and age-related diseases.
  12. Ayurvedic external treatment is effective for pain-relief in chronic low back pain in the short term.
  13. Focused meditation and self-care exercise lead to comparable, symptomatic improvements in patients with chronic low back pain.
  14. This randomized trial found no effects of yoga on health-related quality of life in patients with colorectal cancer. Given the high attrition rate and low intervention adherence, no definite conclusions can be drawn from this trial.
  15. The Alexander Technique was not superior to local heat application in treating chronic non-specific neck pain.
  16.  In conclusion, meditation may support chronic pain patients in pain reduction and pain coping. 
  17. The herbal preparation of myrrh, chamomile extract and coffee charcoal is well tolerated and shows a good safety profile. We found first evidence for a potential efficacy non-inferior to the gold standard therapy mesalazine, which merits further study of its clinical usefulness in maintenance therapy of patients with ulcerative colitis.
  18. Yoga was more effective in relieving chronic nonspecific neck pain than a home-based exercise program. Yoga reduced neck pain intensity and disability and improved health-related quality of life. Moreover, yoga seems to influence the functional status of neck muscles, as indicated by improvement of physiological measures of neck pain.
  19. In this preliminary trial, yoga appears to be an effective treatment in chronic neck pain with possible additional effects on psychological well-being and QOL.  (pilot)
  20. These results suggest that Gua Sha may be an effective treatment for patients with chronic neck and low back pain.
  21. The data indicate that during needle insertion high dose acupuncture stimulation leads to a higher increase of sympathetic nerve activity than low dose stimulation independent of personality. After needle insertion subjects who tend to augment incoming stimuli might show a lack of psychological relaxation when receiving high dose stimulation.
  22. In patients with METS, phlebotomy, with consecutive reduction of body iron stores, lowered BP and resulted in improvements in markers of cardiovascular risk and glycemic control.
  23. The present study gives preliminary evidence that healing clay jojoba oil facial masks can be effective treatment for lesioned skin and mild acne vulgaris.
  24. In a laboratory setting, an electroacupuncture procedure was as effective as a single dose of an orally administered opiate in reducing experimentally induced ischaemic pain.
  25. In the presence of modern treatments, complementary prescription of comprehensive lifestyle modification has no impact on coronary artery calcium progression but sustainable benefit for blood pressure, heart rate and the need of anti-ischemic medication is demonstrated. 
  26. A single course of leech therapy was effective in relieving pain in the short-term and improved disability in intermediate-term. Leeches might be considered as an additional option in the therapeutic approach to lateral epicondylitis.
  27. Gua sha has beneficial short-term effects on pain and functional status in patients with chronic neck pain.
  28. Alterations in short-chain fatty acids were found in terms of significant changes to increased acetate levels in the fasting group.
  29. In this first study on the efficacy of cantharidin blisters, a clinically relevant pain-relieving short-term effect on lumbar spinal stenosis was observed.
  30. We conclude that cupping therapy may be effective in relieving the pain and other symptoms related to CTS.
  31.  A single course of leech therapy is effective in relieving pain, improving disability and QoL for at least 2 months.
  32. The high effect sizes indicate that repeated rhythmic embrocation with Solum Oil may improve mood, pain perception (sensory PPS), and the ability to cope with pain (affective PPS) in patients with chronic low back pain.
  33. The data indicate, that verum acupuncture and sham acupuncture might have a beneficial influence on the autonomic nervous system in migraineurs with a reduction of the LF power of HRV related to the clinical effect. This might be due to a reduction of sympathetic nerve activity. VA and SA induce different effects on the high-frequency component of HRV, which seem, however, not to be relevant for the clinical outcome in migraine.
  34. Gua Sha increases microcirculation local to a treated area, and that increase in circulation may play a role in local and distal decrease in myalgia. Decrease in myalgia at sites distal to a treated area is not due to distal increase in microcirculation. There is an unidentified pain-relieving biomechanism associated with Gua Sha.
  35. These results are consistent with possible short-term benefits of a comprehensive lifestyle modification program on some aspects of quality-of-life and emotional well-being, but no effects were discernable 12 months after completion of therapy.
  36. In the presence of modern treatments, comprehensive lifestyle modification provides no additional benefits on progression of atherosclerosis but improves autonomic function, angina, and QOL with concomitant reduced need of medication. These responses are more pronounced in GNB3*825T allele carriers.
  37. Neither Mediterranean diet nor fasting treatments affect the microbiologically assessed intestinal flora and sIgA levels in patients with RA and FM.
  38. Women suffering from mental distress participating in a 3-month Iyengar yoga class show significant improvements on measures of stress and psychological outcomes.
  39. Adoption of a Mediterranean diet by patients with medically treated CAD has no effect on markers of inflammation and metabolic risk factors.
  40. A comprehensive lifestyle modification and stress management program did not improve psychological outcomes in medically stable CAD patients. The program did appear to confer psychological benefits for women but not men. Further trials should investigate gender-related differences in coronary patient responses to behavioral interventions.
  41. Mind-body therapy may improve quality of life in patients with UC in remission, while no effects of therapy on clinical or physiological parameters were found, which may at least in part be related to selective patient recruitment.
  42. Leech therapy helps relieve symptoms in patients with osteoarthritis of the knee.
  43. A home-based hydrotherapeutic thermal treatment program improves quality of life, heart-failure-related symptoms and heart rate response to exercise in patients with mild chronic heart failure. The results of this investigation suggest a beneficial adaptive response to repeated brief cold stimuli in addition to enhanced peripheral perfusion due to thermal hydrotherapy in patients with chronic heart failure.
  44. This open pilot study demonstrates that along with a decrease in sleep arousals a 1-week fasting period promotes the quality of sleep and daytime performance in non-obese subjects.
  45. Periarticular application of 4 leeches led to rapid relief of pain with sustained improvement after 4 weeks in the absence of major complications.
  46. Short-term fasting in inpatients with pain and stress syndromes is safe and well tolerated, concomitant mineral supplements have no additive benefit.
  47. The results suggest that the cardiovascular response during whole-body infrared-A irradiation is accompanied by significant changes in autonomic cardiac regulation: A significant decrease of low-frequency power corresponding to depressed vagal activity results in an increase of Iow/high-frequency ratio. During serial hyperthermias the acute response is diminished suggesting an adaption of the autonomic response to hyperthermia.

This list is impressive in several ways: very few SCAM researchers managed to publish 47 Medline-listed clinical studies, and nobody I know has ever conducted clinical trials of so many different SCAMs in so many different medical conditions. They include:

  • Acupuncture
  • Alexander technique
  • Ayrurvedic medicine
  • Blood letting
  • Cupping
  • Diet
  • Embrocation
  • Fasting
  • Gua cha
  • Herbal medicine
  • Homeopathy
  • Hydrotherapy
  • Hyperthermia
  • Meditation
  • Mind/body therapies
  • Leeching
  • Life style modification
  • Yoga

While this is astounding, another fact is even more baffling: with just 2 or 3 exceptions, all these studies yield postive results. Whatever Michalsen touches turns to gold! And if it doesn’t, he spins the findings such that the conclusions are at least partly positive; see for instance No 14, 33, 36, 40 or 41 in the above list.

WELCOME TO THE ALTERNATIVE MEDICINE HALL OF FAME PROFESSOR MICHALSEN!

Turmeric is certainly a plant with fascinating properties; we have therefore discussed it before. Reseach into turmeric continues to be active, and I will continue to report about new studies.

This study was aimed at estimating the effect of turmeric supplementation on quality of life (QoL) and haematological parameters in breast cancer patients who were on Paclitaxel chemotherapy. In this case series with 60 participants, QoL was assessed using a standard questionnaire and haematological parameters were recorded from the patients’ hospital records.

Turmeric supplementation for 21 days resulted in clinically relevant and statistically significant improvement in global health status, symptom scores (fatigue, nausea, vomiting, pain, appetite loss, insomnia), and haematological parameters.

The authors concluded that turmeric supplementation improved QoL, brought about symptom palliation and increased hematological parameters in breast cancer patients.

Really?

The way the conclusions are phrased, they clearly imply that turmeric caused the observed outcomes. How certain can we be that this is true?

On a scale of 0 -10, I would say 0.

Why?

Because there are important other determinants of the outcomes:

  • placebo,
  • concommittant treatments,
  • natural history,
  • etc., etc.

Why does this matter?

  • Because such unwarranted conclusions mislead patients, healthcare professionals and carers.
  • Because such bad science gives a bad name to clinical research.
  • Because this type of nonsense might deter meaningful research into a promising subject.
  • Because no ‘scientific’ journal should be permitted to publish such nonsense.
  • Because it is unethical of ‘scientists’ to make false claims.

But maybe the Indian authors are just a few well-meaning and naive practitioners who merely were doing their unexperienced best? Sadly not! The authors of this paper give the following affiliations:

  • Clinical Pharmacology, Pfizer Healthcare Private Limited, Chennai, Tamil Nadu, India.
  • Department of Radiation Oncology, Faculty of Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, India.
  • Process Development, HCL Technologies, Chennai, Tamil Nadu, India.
  • Department of Pharmacognosy, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, India.

Yes, they really should know better!

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