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

clinical trial

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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?

 

Myofascial release (also known as myofascial therapy or myofascial trigger point therapy) is a type of low-load stretch therapy that is said to release tightness and pain throughout the body caused by the myofascial pain syndrome, a chronic muscle pain that is worse in certain areas known as trigger points. Various types of health professionals provide myofascial release, e.g. osteopaths, chiropractors, physical or occupational therapists, massage therapists, or sports medicine/injury specialists. The treatment is usually applied repeatedly, but there is also a belief that a single session of myofascial release is effective. This study was a crossover clinical trial aimed to test whether a single session of a specific myofascial release technique reduces pain and disability in subjects with chronic low back pain (CLBP).

A total of 41 participants were randomly enrolled into 3 situations in a balanced and crossover manner:

  • experimental,
  • placebo,
  • control.

The subjects underwent a single session of myofascial release on thoracolumbar fascia and the results were compared with the control and placebo groups. A single trained and experienced therapist applied the technique.

For the control treatment, the subjects were instructed to remain in the supine position for 5 minutes. For the muscle release session, the subjects were in a sitting position with feet supported and the thoracolumbar region properly undressed. The trunk flexion goniometry of each participant was performed and the value of 30° was marked with a barrier to limit the necessary movement during the technique. The trained researcher positioned their hands on all participants without sliding over the skin or forcing the tissue, with the cranial hand close to the last rib and at the T12–L1 level on the right side of the individual’s body and the caudal hand on the ipsilateral side between the iliac crest and the sacrum. Then, the researcher caused slight traction in the tissues by moving their hands away from each other in a longitudinal direction. Then, the participant was instructed to perform five repetitions of active trunk flexion-extension (30°), while the researcher followed the movement with both hands simultaneously positioned, without losing the initial tissue traction and position. The same technique and the same number of repetitions of active trunk flexion-extension were repeated with the researcher’s hands positioned on the opposite sides. This technique lasted approximately five minutes.

For the placebo treatment, the subjects were not submitted to the technique of manual thoracolumbar fascia release, but they slowly performed ten repetitions of active trunk flexion-extension (30°) in the same position as the experimental situation. Due to the fact that touch can provide not only well-recognized discriminative input to the brain, but also an affective input, there was no touch from the researcher at this stage.

The outcomes, pain, and functionality, were evaluated using the numerical pain rating scale (NPRS), pressure pain threshold (PPT), and Oswestry Disability Index (ODI).

The results showed no effects between-tests, within-tests, nor for interaction of all the outcomes, i.e., NPRS (η 2 = 0.32, F = 0.48, p = 0.61), PPT (η2 = 0.73, F = 2.80, p = 0.06), ODI (η2 = 0.02, F = 0.02, p = 0.97).

The authors concluded that a single trial of a thoracolumbar myofascial release technique was not enough to reduce pain intensity and disability in subjects with CLBP.

Surprised?

I’m not!

Recently, I received this comment from a reader:

Edzard-‘I see you do not understand much of trial design’ is true BUT I wager that you are in the same boat when it comes to a design of a trial for LBP treatment: not only you but many other therapists. There are too many variables in the treatment relationship that would allow genuine , valid criticism of any design. If I have to pick one book of the several listed elsewhere I choose Gregory Grieve’s ‘Common Vertebral Joint Problems’. Get it, read it, think about it and with sufficient luck you may come to realize that your warranted prejudices against many unconventional ‘medical’ treatments should not be of the same strength when it comes to judging the physical therapy of some spinal problems as described in the book.

And a chiro added:

EE: I see that you do not understand much of trial design

Perhaps it’s Ernst who doesnt understand how to research back pain.

“The identification of patient subgroups that respond best to specific interventions has been set as a key priority in LBP research for the past 2 decades.2,7 In parallel, surveys of clinicians managing LBP show that there are strong views against generic treatment and an expectation that treatment should be individualized to the patient.6,22.”

Journal of Orthopaedic & Sports Physical Therapy
Published Online:January 31, 2017Volume47Issue2Pages44-48

Do I need to explain why the Grieve book (yes, I have it and yes, I read it) is not a substitute for evidence that an intervention or technique is effective? No, I didn’t think so. This needs to come from a decent clinical trial.

And how would one design a trial of LBP (low back pain) that would be a meaningful first step and account for the “many variables in the treatment relationship”?

How about proceeding as follows (the steps are not necessarily in that order):

  • Study the previously published literature.
  • Talk to other experts.
  • Recruit a research team that covers all the expertise you need (and don’t have yourself).
  • Formulate your research question. Mine would be IS THERAPY XY MORE EFFECTIVE THAN USUAL CARE FOR CHRONIC LBP? I know LBP is but a vague symptom. This does, however, not necessarily matter (see below).
  • Define primary and secondary outcome measures, e.g. pain, QoL, function, as well as the validated methods with which they will be quantified.
  • Clarify the method you employ for monitoring adverse effects.
  • Do a small pilot study.
  • Involve a statistician.
  • Calculate the required sample size of your study.
  • Consider going multi-center with your trial if you are short of patients.
  • Define chronic LBP as closely as you can. If there is evidence that a certain type of patient responds better to the therapy xy than others, that might be considered in the definition of the type of LBP.
  • List all inclusion and exclusion criteria.
  • Make sure you include randomization in the design.
  • Randomization should be to groups A and B. Group A receives treatment xy, while group B receives usual care.
  • Write down what A and B should and should not entail.
  • Make sure you include blinding of the outcome assessors and data evaluators.
  • Define how frequently the treatments should be administered and for how long.
  • Make sure all therapists employed in the study are of a high standard and define the criteria of this standard.
  • Train all therapists of both groups such that they provide treatments that are as uniform as possible.
  • Work out a reasonable statistical plan for evaluating the results.
  • Write all this down in a protocol.

Such a trial design does not need patient or therapist blinding nor does it require a placebo. The information it would provide is, of course, limited in several ways. Yet it would be a rigorous test of the research question.

If the results of the study are positive, one might consider thinking of an adequate sham treatment to match therapy xy and of other ways of firming up the evidence.

As LBP is not a disease but a symptom, the study does not aim to include patients that all are equal in all aspects of their condition. If some patients turn out to respond better than others, one can later check whether they have identifiable characteristics. Subsequently, one would need to do a trial to test whether the assumption is true.

Therapy xy is complex and needs to be tailored to the characteristics of each patient? That is not necessarily an unsolvable problem. Within limits, it is possible to allow each therapist the freedom to chose the approach he/she thinks is optimal. If the freedom needed is considerable, this might change the research question to something like ‘IS THAT TYPE OF THERAPIST MORE EFFECTIVE THAN THOSE EMPLOYING USUAL CARE FOR CHRONIC LBP?’

My trial would obviously not answer all the open questions. Yet it would be a reasonable start for evaluating a therapy that has not yet been submitted to clinical trials. Subsequent trials could build on its results.

I am sure that I have forgotten lots of details. If they come up in discussion, I can try to incorporate them into the study design.

 

 

Acupuncture is a veritable panacea; it cures everything! At least this is what many of its advocates want us to believe. Does it also have a role in supportive cancer care?

Let’s find out.

This systematic review evaluated the effects of acupuncture in women with breast cancer (BC), focusing on patient-reported outcomes (PROs).

A comprehensive literature search was carried out for randomized controlled trials (RCTs) reporting PROs in BC patients with treatment-related symptoms after undergoing acupuncture for at least four weeks. Literature screening, data extraction, and risk bias assessment were independently carried out by two researchers. The authors stated that they followed the ‘Preferred Reporting Items for Systematic Review and Meta-Analyses’ (PRISMA) guidelines.

Out of the 2, 524 identified studies, 29 studies representing 33 articles were included in this meta-analysis. The RCTs employed various acupuncture techniques with a needle, such as hand-acupuncture and electroacupuncture. Sham/placebo acupuncture, pharmacotherapy, no intervention, or usual care were the control interventions. About half of the studies lacked adequate blinding.

At the end of treatment (EOT), the acupuncture patients’ quality of life (QoL) was measured by the QLQ-C30 QoL subscale, the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), the Functional Assessment of Cancer Therapy–General/Breast (FACT-G/B), and the Menopause-Specific Quality of Life Questionnaire (MENQOL), which depicted a significant improvement. The use of acupuncture in BC patients lead to a considerable reduction in the scores of all subscales of the Brief Pain Inventory-Short Form (BPI-SF) and Visual Analog Scale (VAS) measuring pain. Moreover, patients treated with acupuncture were more likely to experience improvements in hot flashes scores, fatigue, sleep disturbance, and anxiety compared to those in the control group, while the improvements in depression were comparable across both groups. Long-term follow-up results were similar to the EOT results. Eleven RCTs did not report any information on adverse effects.

The authors concluded that current evidence suggests that acupuncture might improve BC treatment-related symptoms measured with PROs including QoL, pain, fatigue, hot flashes, sleep disturbance and anxiety. However, a number of included studies report limited amounts of certain subgroup settings, thus more rigorous, well-designed and larger RCTs are needed to confirm our results.

This review looks rigorous on the surface but has many weaknesses if one digs only a little deeper. To start with, it has no precise research question: is any type of acupuncture better than any type of control? This is not a research question that anyone can answer with just a few studies of mostly poor quality. The authors claim to follow the PRISMA guidelines, yet (as a co-author of these guidelines) I can assure you that this is not true. Many of the included studies are small and lacked blinding. The results are confusing, contradictory and not clearly reported. Many trials fail to mention adverse effects and thus violate research ethics, etc., etc.

The conclusion that acupuncture might improve BC treatment-related symptoms could be true. But does this paper convince me that acupuncture DOES improve these symptoms?

No!

Withania somnifera, commonly known as Ashwagandha, is a plant belonging to the family of Solanaceae. It is widely used in Ayurvedic medicine. The plant is promoted as an immunomodulator, anti-inflammatory, anti-stress, anti-Parkinson, anti-Alzheimer, cardioprotective, neural and physical health enhancer, neuro-defensive, anti-diabetic, aphrodisiac, memory-boosting, and ant-cancer remedy. It contains diverse phytoconstituents including alkaloids, steroids, flavonoids, phenolics, nitrogen-containing compounds, and trace elements.

But how much of the hype is supported by evidence? Unsurprisingly, there is a shortage of good clinical trials. Yet, during the last few years, a surprising number of reviews of the accumulating evidence have emerged:

  • One review suggested that pre-clinical, as well as clinical studies, suggest the effectiveness of Withania somnifera (L.) against neurodegenerative disease.
  • A further review suggested a potential role of W. somnifera in managing diabetes.
  • A systematic review of 5 clinical trials found that W. somnifera extract improved performance on cognitive tasks, executive function, attention, and reaction time. It also appears to be well tolerated, with good adherence and minimal side effects.
  • Another systematic review included 4 clinical trials and reported significant improvements in serum hormonal profile, oxidative biomarkers, and antioxidant vitamins in seminal plasma. No adverse effects were reported in infertile men taking W. somnifera treatment.
  • Another review concluded that the root of the Ayurvedic drug W. somnifera (Aswagandha) appears to be a promising safe and effective traditional medicine for management of schizophrenia, chronic stress, insomnia, anxiety, memory/cognitive enhancement, obsessive-compulsive disorder, rheumatoid arthritis, type-2 diabetes and male infertility, and bears fertility promotion activity in females adaptogenic, growth promoter activity in children and as adjuvant for reduction of fatigue and improvement in quality of life among cancer patients undergoing chemotherapy.
  • A systematic review of 13 RCTs found that Ashwagandha supplementation was more efficacious than placebo for improving variables related to physical performance in healthy men and women.
  • Another systematic review concluded that Ashwagandha supplementation might improve the VO2max in athletes and non-athletes.

Impressed?

This certainly looks as though that this plant is worthy of further study. But I can never help feeling a bit skeptical when I hear of such a multitude of benefits without evidence for adverse effects (other than minor upset stomach, nausea, and drowsiness).

While working on yesterday’s post, I discovered another recent and remarkable article co-authored by Prof Harald Walach. It would surely be unforgivable not to show you the abstract:

The aim of this study is to explore experiences and perceived effects of the Rosary on issues around health and well-being, as well as on spirituality and religiosity. A qualitative study was conducted interviewing ten Roman Catholic German adults who regularly practiced the Rosary prayer. As a result of using a tangible prayer cord and from the rhythmic repetition of prayers, the participants described experiencing stability, peace and a contemplative connection with the Divine, with Mary as a guide and mediator before God. Praying the Rosary was described as helpful in coping with critical life events and in fostering an attitude of acceptance, humbleness and devotion.

The article impressed me so much that it prompted me to design a virtual study for which I borrowed Walach’s abstract. Here it is:

The aim of this study is to explore experiences and perceived effects of train-spotting on issues around health and well-being, as well as on spirituality. A qualitative study was conducted interviewing ten British adults who regularly practiced the art of train-spotting. As a result of using a tangible train-spotter diary and from the rhythmic repetition of the passing trains, the participants described experiencing stability, peace, and a contemplative connection with the Divine, with Mary as a guide and mediator before the almighty train-spotter in the sky. Train-spotting was described as helpful in coping with critical life events and in fostering an attitude of acceptance, humbleness, and devotion.

These virtual results are encouraging and encourage me to propose the hypothesis that Rosary use and train-spotting might be combined to create a new wellness program generating a maximum holistic effect. We are grateful to Walach et al for the inspiration and are currently applying for research funds to test our hypothesis in a controlled clinical trial.

 

Homeopathy is sometimes claimed to be effective for primary dysmenorrhoea (PD), but the claim is not supported by sound evidence. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IH) against placebo in the treatment of PD.

A double-blind, randomized, placebo-controlled trial was conducted at the gynecology outpatient department of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IH (n=64) or identical-looking placebo (n=64). Primary and secondary outcome measures were 0-10 numeric rating scales (NRS) measuring the intensity of pain of dysmenorrhea and verbal multidimensional scoring system (VMSS) respectively, all measured at baseline, and every month, up to 3 months.

The two groups were comparable at baseline. The attrition rate was 10.9% (IH: 7, placebo: 7). Differences between groups in both pain NRS and VMSS favored IH over placebo at all time points with medium to large effect sizes. Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines. No harms, serious adverse events, or intercurrent illnesses were recorded in either group.

The authors concluded that homeopathic medicines acted significantly better than placebo in the treatment of PD. Independent replication is warranted.

A previously published RCT could not show any significant effect of homeopathy on primary dysmenorrhea in comparison with placebo. The authors of the new study claim that the discrepant findings might be due to the fact that IH requires great skill. In other words, negative studies are according to this explanation negative not because homeopathy does not work but because the prescribers are not up to it. Such notions have often been voiced on this blog and elsewhere and are used as a veritable ‘get-out clause’ for homeopathy: ONLY THE POSITIVE RESULTS ARE VALID! Consequently, systematic reviews of the evidence must only consider positive trials. And this, of course, means that the findings are invariable positive.

I find this more than a little naive and would much prefer to wait for an independent replication where ‘independent’ means that the trial is run by experts who are not advocates of homeopathy (as in the present trial).

 

According to one website, electromagnetic fields (EMFs) are “the new smoking“:

For decades, a group of cigarette companies referred to as ‘Big Tobacco’ financed bogus scientific studies claiming smoking was perfectly safe. This tricked doctors, scientists, politicians, and smokers into a false sense of security. There were early warning signs that smoking was dangerous, but it took 50 years for the government to finally take action. Today we’re facing an even bigger health threat… EMFs. Even if many doctors, politicians and Big Wireless still claim that EMFs are perfectly safe, the early warning signs could not be clearer:

  • Many leading EMF scientists say EMFs should be classified as a “Class 1” definite carcinogen (just like smoking and asbestos)
  • The best functional medicine doctors like Dr. Dietrich Klinghardt, MD, PhD have observed that EMFs are at the very root cause of “Mystery” symptoms including insomnia, fatigue, depression, and digestive issues.
  • New technologies like the “5G” (fifth generation) networks are being rolled out at a frantic pace, while exactly ZERO biological studies prove their safety.
  • EMF “safety” standards haven’t been updated since 1996, and are based on short-term exposure to ONE device.

The Atox Bio Computer is one of many devices marketed as the solution. It is a little device that supposedly protects any person who is gullible enough to buy it from electrosmog and other EMFs. It was developed by the Russian physicist, Alexander Tarasov. Worn around the neck, the device allegedly acts by “converting negative information into positive”. Alarmingly, the Atox is also promoted as protection against ionizing radiation. Pseudo-scientific explanations are given for the mode of action, in which there is talk of an ominous “energy-information component” of radiation:

“The revolutionary insight of Dr. Tarasov is that any electromagnetic radiation of any origin consists of two components, the physical and the energy-information component. Whereby the energy-information component precedes the physical vibration and primarily affects the human organism or its bioenergetic field.”

Sounds weird? Yes, I agree! But it must be true because it is supported by a real professor from a leading medical school. In 2007, it was reported in a press release that Prof. Dr. Michael FRASS examined the ATOX Bio Computer and found that 90% of people with too low and 100% with too high initial values achieved normalization of their vegetative performance. Altogether, 92.9% of the persons benefited by wearing the ATOX biocomputer.

With regard to the ratio of sympathetic to parasympathetic impulses, 100% of the people with too low and 82.3% with too high initial values normalize their range of the total autonomic power. Overall, 84.2% of the treated individuals showed a positive course under the influence of ATOX biocomputer. According to Frass, this means that people with a high stress factor have a very high probability of returning to normal values of the autonomic system with the help of the ATOX biocomputer.

Considering the fact that such findings, if true, would necessitate to re-write large parts of the textbooks of physics and medicine, it is surprising that Frass does not include them in his CV. Perhaps he is a deeply modest scientist? Or maybe he does not want to spoil his chances for a Nobel?

Prof. Frass has, of course, featured on this blog before. For instance, because his many studies of homeopathy are invariably positive, or because his results have been shown to contain a few (pro-homeopathy) ‘errors’, or (most recently) because he published a trial of homeopathy that claimed lung cancer patients live longer if they are treated with homeopathy. The latter study is now under investigation for fraud.

Had such an investigation been initiated in back 2007 when Frass came out with his ATOX Bio Computer study (which incidentally was never properly published [at least I could not find it on Medline]), we would now not need to worry whether some desperate cancer patients did take Frass’ ‘science’ seriously.

Bach flower remedies were invented in the 1920s by Dr. Edward Bach (1886-1936), a doctor homeopath who had previously worked in the London Homeopathic Hospital. They have since become very popular in Europe and beyond. Bach flower remedies are clearly inspired by homeopathy; however, they are not the same because they do not follow the ‘like cures like’ principle and are they potentized. They are manufactured by placing freshly picked specific flowers or parts of plants in water which is subsequently mixed with alcohol, bottled, and sold. Like most homeopathic remedies, they are highly dilute and thus do not contain therapeutic amounts of the plant printed on the bottle.

The aim of this new randomized, double-blind, placebo-controlled trial was to compare the efficacy of flower therapy for the treatment of anxiety in overweight or obese adults with that of a placebo. The authors examined improvement in sleep patterns, reduction in binge eating, and change in resting heart rate (RHR).

The study included 40 participants in the placebo group and 41 in the intervention group. Participants were of both genders, from 20 to 59 years of age, overweight or obese, with moderate to high anxiety. They were randomized into two groups:

  1. one group was treated with Bach flower remedies (BFR) (bottles containing 30 mL of 30% hydro-brandy solution with two drops each of Impatiens, White Chestnut, Cherry Plum, Chicory, Crab Apple, and Pine), purchased from Healing® Flower Essences (São Paulo, Brazil)
  2. the other group was given a placebo (same solution without BFR).

All patients were instructed to orally ingest the solutions by placing four drops directly in the mouth four times a day for 4 weeks.

The primary outcome was anxiety (State-Trait Anxiety Inventory [STAI]). Secondary outcomes were sleep (Pittsburgh Sleep Quality Index [PSQI]), binge eating (Binge Eating Scale [BES]), and RHR (electrocardiogram).

Multivariate analysis showed significant reductions in scores for the following variables in the intervention group when compared with the placebo group: STAI (β = −0.190; p < 0.001), PSQI (β = −0.160; p = 0.027), BES (β = −0.226; p = 0.001), and RHR (β = −0.07; p = 0.003).

The authors concluded that anxiety symptoms, binge eating, and RHRs of the individuals treated with flower therapy decreased, and their sleep patterns improved when compared with those treated with the placebo.

Did the alcohol in the verum preparation had a relaxing effect? No, I was teasing. The amount would have been too small and the effect would have been the same in both groups. But what could have caused the observed outcome? I have to admit that I have no idea.

I read the study several times and could not find a major flaw. Hence it must have been the flower remedy that caused the positive outcome? No, I am teasing again. I find this impossible to imagine. These remedies contain nothing that might explain the results and all previous systematic reviews of all the available trials have all reached a negative conclusion. Before I seriously consider the option that flower remedies are more than placebos, I would like to see an independent replication.

Ever since I published a post about the irresponsible and aggressive advertising campaign of LYMA (“the world’s 1st super-supplement”), I am pursued by them with emails informing me about the wonders of this supplement. Here is one I received recently:

Here at LYMA we are firm believers that optimal productivity depends on good quality sleep and your day is only as good as the previous night.

Suffering from bad sleep is debilitating whether it’s ourselves or we’re watching someone we love suffer, the search for good rest is something we’re all united in.

Energy levels, positive mindset and strong cognitive function all come from sleep, which is why we spent so long formulating the LYMA supplement. Our patented KSM-66® Ashwagandha is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world. The hefty combination of purity and potency make it unrivalled in its ability to reduce inflammation, neutralise anxiety and promote deep, restful sleep, night after night.

Thousands of customers have told us that after years of bad sleep, they’re finally getting the rest they need and feeling transformed as a result. In fact, it’s one of the very first benefits most people notice. We’re happy to hear it.

And the knock-on effects of a good night’s sleep in how we feel, how we perform and our overall health are far reaching. Which is why we are so delighted to welcome Michael Grandner, world-renowned sleep expert and Director of the Behavioural Sleep Medicine Clinic, Arizona to the LYMA team.

Michael is one of the most cited sleep experts in the world and has himself published over 175 articles on issues relating to sleep and health. We plan on tapping into every area of his expertise to understand our own sleep habits and how we can all become the best at rest.

To introduce Michael to the LYMA community we’re hosting a seminar dedicated to understanding sleep on Tuesday 22nd June…

I was tempted to discard all this as rather pathetic advertising hype. But then I had second thoughts. This text does after all make several medical claims, and the question is: ARE THEY SUPPORTED BY EVIDENCE?

It claims that KSM-66® Ashwagandha:

  1. is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world.
  2. That the hefty combination of purity and potency makes it unrivalled in its ability to reduce inflammation.
  3. That the product neutralises anxiety.
  4. That it promotes deep, restful sleep, night after night.

I ran a few searches to find out whether there is any sound evidence for any of these claims.

  1. There seem to be several supplements that contain,KSM-66® Ashwagandha’. The impression that LYMA is the only one is thus wrong. Zero toxicity must also be wrong; not even water has zero toxicity. In fact, epigastric pain/discomfort and loose stools were reported as most common (>5%); and giddiness, drowsiness, hallucinogenic, vertigo, nasal congestion (rhinitis), cough, cold, decreased appetite, nausea, constipation, dry mouth, hyperactivity, nocturnal cramps, blurring of vision, hyperacidity, skin rash and weight gain have all been associated with the herbal remedy. Moreover, if it is true that Ashwagandha stimulates the immune system, it might cause problems for people with autoimmune diseases.
  2. I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha reduces inflammatory conditions in humans.
  3. I found a study concluding that Ashwagandha given as an adjunct offered some potential advantages as a safe and effective adjunctive therapy to SSRIs in GAD. Yet, I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha as a single supplement reduces anxiety in otherwise healthy individuals.
  4. A 2021 study suggested that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Yet the authors cautioned that additional clinical trials are required to generalize the outcome.

So, what does that tell us?

It could mean that:

  1. My searches were not sufficiently thorough and that I have missed compelling evidence. If so, I would appreciate, if the LYMA promoters would show me their evidence so that I can assess it.
  2. The LYMA people are irresponsible and mislead the public with untenable claims.

I am looking forward to their response.

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