Boris Johnson has recently bent over backward in order to please the Indian PM, Narendra Mondi. Some even say that a trade agreement between the two countries was achieved at the cost of letting the Delta variant into the UK. Now it seems that political considerations are at the heart of the decision to lend official support to Indian traditional medicine in the UK. The ‘2030 Roadmap for India-UK future relations‘ is a policy document of the UK government. In it, we find that the UK government intends to:
- Explore cooperation on research into Ayurveda and promote yoga in the UK.
- Increase opportunities for generic medicine supply from India to the UK by seeking access for Indian pharma products to the NHS and recognition of Indian generic and Ayurvedic medicines that meet UK regulatory standards.
This clearly begs the question, are these plans good or bad for UK public health?
Ayurveda is a system of healthcare developed in India around the mid-first millennium BCE. Ayurvedic medicine involves a range of techniques, including meditation, physical exercises, nutrition, relaxation, massage, and medication. Ayurvedic medicine thrives for balance and claims that the suppression of natural urges leads to illness. Emphasis is placed on moderation. Ayurvedic medicines are extremely varied. They usually are mixtures of multiple ingredients and can consist of plants, animal products, and minerals. They often also contain toxic substances, such as heavy metals which are deliberately added in the ancient belief that they can have positive health effects. The truth, however, is that they can cause serious adverse effects.
Relatively few studies of Ayurvedic remedies exist and most are methodologically weak. A Cochrane review, for instance, concluded that” although there were significant glucose-lowering effects with the use of some herbal mixtures, due to methodological deficiencies and small sample sizes we are unable to draw any definite conclusions regarding their efficacy. Though no significant adverse events were reported, there is insufficient evidence at present to recommend the use of these interventions in routine clinical practice and further studies are needed.”
The efficacy of Ayurvedic remedies obviously depends on the exact nature of the ingredients. Generalizations are therefore problematic. Promising findings exist for a relatively small number of ingredients, including Boswellia, Frankincense, Andrographis paniculata.
Yoga has been defined in several different ways in the various Indian philosophical and religious traditions. From the perspective of alternative medicine, it is a practice of gentle stretching exercises, breathing control, meditation, and lifestyles. The aim is to strengthen prana, the vital force as understood in traditional Indian medicine. Thus, it is claimed to be helpful for most conditions affecting mankind. Most people who practice yoga in the West practise ‘Hatha yoga’, which includes postural exercises (asanas), breath control (pranayama), and meditation (dhyana). It is claimed that these techniques bring an individual to a state of perfect health, stillness, and heightened awareness. Other alleged benefits of regular yoga practice include suppleness, muscular strength, feelings of well-being, reduction of sympathetic drive, pain control, and longevity. Yogic breathing exercises are said to reduce muscular spasms, expand available lung capacity and thus alleviate the symptoms of asthma and other respiratory conditions.
There have been numerous clinical trials of various yoga techniques. They tend to suffer from poor study design and incomplete reporting. Their results are therefore not always reliable. Several systematic reviews have summarised the findings of these studies. An overview included 21 systematic reviews relating to a wide range of conditions. Nine systematic reviews arrived at positive conclusions, but many were associated with a high risk of bias. Unanimously positive evidence emerged only for depression and cardiovascular risk reduction (Ernst E, Lee MS: Focus on Alternative and Complementary Therapies Volume 15(4) December 2010 274–27).
Yoga is generally considered to be safe. However, the only large-scale survey specifically addressing the question of adverse effects found that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases.
So, should we be pleased about the UK government’s plan to promote Ayurveda and yoga? In view of the mixed and inconclusive evidence, I feel that a cautious approach would be wise. Research into these subjects could be a good idea, particularly if it were aimed at finding out what the exact risks are. Whole-sale integration does, however, not seem prudent at this stage. In other words, let’s find out what generates more good than harm for which conditions and subsequently consider adopting those elements that fulfill this vital criterium.
Prince Charles has claimed that people struggling to return to full health after having the coronavirus should practice yoga. This is what the GUARDIAN reported about it on Friday:
In a video statement on Friday to the virtual yoga and healthcare symposium Wellness After Covid, the heir apparent said doctors should work together with “complementary healthcare specialists” to “build a roadmap to hope and healing” after Covid. “This pandemic has emphasised the importance of preparedness, resilience and the need for an approach which addresses the health and welfare of the whole person as part of society, and which does not merely focus on the symptoms alone,” Charles said. “As part of that approach, therapeutic, evidenced-informed yoga can contribute to health and healing. By its very nature, yoga is an accessible practice which provides practitioners with ways to manage stress, build resilience and promote healing…”
… Charles, who has previously espoused the benefits of yoga, is not the only fan in the royal family. His wife, the Duchess of Cornwall, has said “it makes you less stiff” and “more supple”, while Prince William has also been pictured doing yogic poses. In 2019, the Prince of Wales said yoga had “proven beneficial effects on both body and mind”, and delivered “tremendous social benefits” that help build “discipline, self-reliance and self-care”.
END OF QUOTE
Yoga is a complex subject because it entails a host of different techniques, attitudes, and life-styles. There have been numerous clinical trials of various yoga techniques. They tend to suffer from poor study design as well as incomplete reporting and are thus no always reliable. Several systematic reviews have summarised the findings of these studies. A 2010 overview included 21 systematic reviews relating to a wide range of conditions. Nine systematic reviews arrived at positive conclusions, but many were associated with a high risk of bias. Unanimously positive evidence emerged only for depression and cardiovascular risk reduction. There is no evidence that yoga speeds the recovery after COVID-19 or any other severe infectious disease, as Charles suggested.
Yoga is generally considered to be safe. However, a large-scale survey found that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that patients with chronic diseases were more likely to experience adverse events. It, therefore, seems unlikely that yoga is suited for many patients recovering from a COVID-19 infection.
The warning by the Vatican’s chief exorcist that yoga leads to ‘demonic possession’ might not be taken seriously by rational thinkers. Yet, experts have long warned that many yoga teachers try to recruit their clients into the more cult-like aspects of yoga.
Perhaps the most remarkable expression in Charles’ quotes is the term ‘EVIDENCE-INFORMED‘. It crops up regularly when Charles (or his advisor Dr. Michael Dixon) speaks or writes about so-called alternative medicine (SCAM). It is a clever term that sounds almost like ‘evidence-based’ but means something entirely different. If a SCAM is not evidence-based, it can still be legitimately put under the umbrella of ‘evidence-informed’: we know the evidence is not positive, we were well-informed of this fact, we nevertheless conclude that yoga (or any other SCAM) might be a good idea!
In my view, the regular use of the term ‘evidence-informed’ in the realm of SCAM discloses a lack of clarity that suits all snake-oil salesmen very well.
 Ernst E, Lee MS: Focus on Alternative and Complementary Therapies Volume 15(4) December 2010 274–27
 Matsushita T, Oka T. A large-scale survey of adverse events experienced in yoga classes. Biopsychosoc Med. 2015 Mar 18;9:9. doi: 10.1186/s13030-015-0037-1. PMID: 25844090; PMCID: PMC4384376.
This amazing announcement reached me via Twitter. It seems that the people in the AYUSH ministry are highly delusional. According to Wikipedia, the Ministry of Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy (abbreviated as AYUSH) is purposed with developing education, research and propagation of indigenous alternative medicine systems in India. As per a recent notification published in the Gazette of India on 13 April 2021, the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy), will now be known as the Ministry of Ayush.
India is suffering from a very severe health crisis, and the ministry should stop its propaganda for useless solutions.
- Homeopathy (considered to be indigenous in India),
- Sowa-Rigpa (the traditional medicine of Tibet)
have in common that they can offer very little help to patients infected by COVID-19. In view of this fact, the announcement is ununderstandable and irresponsible, in my view.
A new study evaluated the effects of yoga and eurythmy therapy compared to conventional physiotherapy exercises in patients with chronic low back pain.
In this three-armed, multicentre, randomized trial, patients with chronic low back pain were treated for 8 weeks in group sessions (75 minutes once per week). They received either:
- Yoga exercises
The primary outcome was patients’ physical disability (measured by RMDQ) from baseline to week 8. Secondary outcome variables were pain intensity and pain-related bothersomeness (VAS), health-related quality of life (SF-12), and life satisfaction (BMLSS). Outcomes were assessed at baseline, after the intervention at 8 weeks, and at a 16-week follow-up. Data of 274 participants were used for statistical analyses.
The results showed no significant differences between the three groups for the primary and secondary outcomes. In all groups, RMDQ decreased comparably at 8 weeks but did not reach clinical meaningfulness. Pain intensity and pain-related bothersomeness decreased, while the quality of life increased in all 3 groups. In explorative general linear models for the SF-12’s mental health component, participants in the eurythmy arm benefitted significantly more compared to physiotherapy and yoga. Furthermore, within-group analyses showed improvements of SF-12 mental score for yoga and eurythmy therapy only. All interventions were safe.
Everyone knows what physiotherapy or yoga is, I suppose. But what is eurythmy?
It is an exercise therapy that is part of anthroposophic medicine. It consists of a set of specific movements that were developed by Rudolf Steiner (1861–1925), the inventor of anthroposophic medicine, in conjunction with Marie von Sievers (1867-1948), his second wife.
Steiner stated in 1923 that eurythmy has grown out of the soil of the Anthroposophical Movement, and the history of its origin makes it almost appear to be a gift of the forces of destiny. Steiner also wrote that it is the task of the Anthroposophical Movement to reveal to our present age that spiritual impulse that is suited to it. He claimed that, within the Anthroposophical Movement, there is a firm conviction that a spiritual impulse of this kind must enter once more into human evolution. And this spiritual impulse must perforce, among its other means of expression, embody itself in a new form of art. It will increasingly be realized that this particular form of art has been given to the world in Eurythmy.
Consumers learning eurythmy are taught exercises that allegedly integrate cognitive, emotional, and volitional elements. Eurythmy exercises are based on speech and direct the patient’s attention to their own perceived intentionality. Proponents of Eurythmy believe that, through this treatment, a connection between internal and external activity can be experienced. They also make many diffuse health claims for this therapy ranging from stress management to pain control.
There is hardly any reliable evidence for eurythmy, and therefore the present study is exceptional and noteworthy. One review concluded that “eurythmy seems to be a beneficial add-on in a therapeutic context that can improve the health conditions of affected persons. More methodologically sound studies are needed to substantiate this positive impression.” This positive conclusion is, however, of doubtful validity. The authors of the review are from an anthroposophical university in Germany. They included studies in their review that were methodologically too weak to allow any conclusions.
So, does the new study provide the reliable evidence that was so far missing? I am afraid not!
The study compared three different exercise therapies. Its results imply that all three were roughly equal. Yet, we cannot tell whether they were equally effective or equally ineffective. The trial was essentially an equivalence study, and I suspect that much larger sample sizes would have been required in order to identify any true differences if they at all exist. Lastly, the study (like the above-mentioned review) was conducted by proponents of anthroposophical medicine affiliated with institutions of anthroposophical medicine. I fear that more independent research would be needed to convince me of the value of eurythmy.
The purpose of this survey (the authors call it a ‘study’) was to evaluate the patient-perceived benefit of yoga for symptoms commonly experienced by breast cancer survivors.
A total of 1,049 breast cancer survivors who had self-reported use of yoga on a follow-up survey, in an ongoing prospective Mayo Clinic Breast Disease Registry (MCBDR), received an additional mailed yoga-focused survey asking about the impact of yoga on a variety of symptoms. Differences between pre-and post- scores were assessed using Wilcoxon Signed Rank Test.
802/1,049 (76%) of women who were approached to participate, consented and returned the survey. 507/802 (63%) reported use of yoga during and/or after their cancer diagnosis. The vast majority of respondents (89.4%) reported some symptomatic benefit from yoga. The most common symptoms that prompted the use of yoga were breast/chest wall pain, lymphedema, and anxiety. Only 9% of patients reported that they had been referred to yoga by a medical professional. While the greatest symptom improvement was reported with breast/chest wall pain and anxiety, significant improvement was also perceived in joint pain, muscle pain, fatigue, headache, quality of life, hot flashes, nausea/vomiting, depression, insomnia, lymphedema, and peripheral neuropathy, (all p-values <0.004).
The authors concluded that data supporting the use of yoga for symptom management after cancer are limited and typically focus on mental health. In this study, users of yoga often reported physical benefits as well as mental health benefits. Further prospective studies investigating the efficacy of yoga in survivorship are warranted.
I have little doubt that yoga is helpful during palliative and supportive cancer care (but all the more doubts that this new paper will further the reputation of research in this area). In fact, contrary to what the conclusions state, there is quite good evidence for this assumption:
- A 2009 systematic review included 10 clinical trials. Its authors concluded that although some positive results were noted, variability across studies and methodological drawbacks limit the extent to which yoga can be deemed effective for managing cancer-related symptoms.
- A 2017 systematic review with 25 clinical trials concluded that among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology.
- A 2017 Cochrane review included 24 studies and found that moderate-quality evidence supports the recommendation of yoga as a supportive intervention for improving health-related quality of life and reducing fatigue and sleep disturbances when compared with no therapy, as well as for reducing depression, anxiety and fatigue, when compared with psychosocial/educational interventions. Very low-quality evidence suggests that yoga might be as effective as other exercise interventions and might be used as an alternative to other exercise programmes.
So, why publish a paper like the one above?
To be able to add one more publication to the authors’ lists?
And why would the journal editor go along with this nonsense?
Search me again!
No, hold on: Global Advances in Health and Medicine, the journal that carried the survey, is published in association with Academic Consortium for Integrative Medicine & Health.
Yes, that explains a lot.
As I have pointed out several times before, surveys of this nature are like going into a Mac Donald’s and asking the customers whether they like Hamburgers. You might then also find that “the vast majority of respondents (89.4%) reported”… blah, blah, blah.
The title of the paper is ‘Real-World Experiences With Yoga on Cancer-Related Symptoms in Women With Breast Cancer‘.
NOTE TO MYSELF: never touch a paper with ‘real-world experience’ in the title.
I have to admit that the ‘Asian Journal of Pharmaceutical Research and Development‘ did not formerly belong to my reading list. This will have to change, I guess, because any journal capable of publishing such a hilarious spoof ought to be read regularly.
The article in question is entitled ‘An Integrative Medicine Is Prudential Hope for Covid-19 Therapeutics‘ and is authored by Mayank dimri, Rajendra Singh Pawar, Virbal Singh Rajwar, Luv Kush from the SBS University Balawala, Dehradun- Uttarakhand, India. The paper is so unique that I simply could not resist showing you an excerpt. I hope you have as much fun reading it as I had when I was alerted to this masterpiece.
Antiviral Astrological Rationality The viral infectivity is governed by Saturn, Rahu and Ketu. COVID-19 is geminian virus, ruled by mercury. It rules lungs / respiratory system and also health/ nutrition house (6th). Antiviral astrological advices are: Stay away from crowds, maintain maximum cleanness and personal hygiene, dietary regimens should be enriched by vitamins, vegetables, nuts and fruits. The foods and drinking water should be warm. The cold and unhealthy environment may be avoided.
The complimentary / alternative integrative medicine conceptualized ethical use of traditional re- medies with
self-responsibility. The concept of herd immunity (epidemological) relates to population. The orthomolecular
medicine10prescribe nutritional supplements for restoration of antiviral immunity. Both have antiviral benefits for fighting global pandemic of COVID-19.
The desirable antiviral activities are anti-replicating to block viral replication, anti-inflammatory for preventing
viral inflammation. Immune stimulatory for strengthening innate immunity and anti-mutagenic for curbing viral mutations.
The ayurvedic herbs have antiviral phytochemicals. Some of them are listed here: Ursolic acid, Apigenin, Rosmarinic acid, Oleanolic acid, Elenoic acid, Hypercin,Liquiritigenin, Acetoside, Glycyrrhizin etc. They have anti RSV activity and possibly prevent viral entry to host cells. The plant extract of Plantago asiatica and Clerodendrum trichotomum proved to be effective antiviral. Fifatrol is an ayurvedic prized medicine against viruses. It is useful in treatment of viral upper respiratory infections and relief from nasal congestion. It is a supportive therapy against COVID-19 virus.
The synergism of vitamins (A, C, D, E) acts as revitaler for fighting against COVID-19. Vitamin C has great potential
as antiviral for respiratory infections. It prevents cytokine induced lung damage and natural immune booster.
Eucalyptus oil has multiple benefits.It is supporter of respiratory system, immune booster and anti-inflammatory. Aromadendrene is an aroma therapeutical, present in oil and moderate antiviral….
I know that the last few months have not been easy for many of us. Therefore, we should be all the more thankful for those who lighten our spirits with some comic relief…
… or did they actually mean what they wrote?
While many of us are wondering what SCAM will be promoted next for the corona pandemic, the editor of the infamous JCAM thought it wise to publish this note along with an article advertising the wonders of Ayurvedic medicine and yoga for the corona-virus entitled: ‘Public Health Approach of Ayurveda and Yoga for COVID-19 Prophylaxis‘.
Here are John Weeks’ remarks:
National governments are deeply divided over whether traditional, complementary and integrative practices have value for human beings relative to COVID-19. We witness a double standard. Medical doctors explore off-label uses of pharmaceutical agents that may have some suggestive research while evidence that indicates potential utility of natural products, practices and practitioners is often dismissed. In this Invited Commentary, a long-time JACM Editorial Board member Bhushan Patwardhan, PhD, from the AYUSH Center of Excellence, Center for Complementary and Integrative Health at the Savitribai Phule Pune University, India and colleagues from multiple institutions make a case for the potential roles of Ayurvedic medicine and Yoga as supportive measures in self-care and treatment. Patwardhan is a warrior for enhancing scientific standards in traditional medicine in India. Patwardhan was recently appointed by the Ministry of AYUSH, Government of India, as Chairman of an 18 member expert group known as “Interdisciplinary AYUSH Research and Development Taskforce” for initiating, coordinating and monitoring efforts against COVID-19. He was last seen here in an invited commentary entitled “Contesting Predators: Cleaning Up Trash in Science” (JACM, October 2019). We are pleased to have this opportunity to share the recommended approaches, the science, and the historic references as part of the global effort to leave no stone unturned in best preparing our populations to withstand COVID-19 and future viral threats. – John Weeks, Editor-in-Chief, JACM
His remarks are, I think, worthy of four very brief comments:
- As far as I can see, national governments and their advisors struggle to make sense of the rapidly changing situation. In all the confusion, they are, however, very clear about one thing: traditional, complementary and integrative practices have no real value for human beings relative to COVID-19.
- The double standards Weeks bemoans do not exist. There are dozens of studies currently on their way testing virtually any therapeutic option that shows even the smallest shimmer of hope. Testing implausible options only because some quacks feel neglected would be the last thing the world needs in the present situation.
- Weeks claims that ‘evidence that indicates potential utility of natural products, practices and practitioners is often dismissed’. What evidence? The article published alongside his remarks is free of what anyone with a thinking brain might call ‘evidence’. If there is evidence, Weeks or anyone else should approach the experts responsible for conducting the current trials; I am sure that they would listen and be only too happy to consider any reasonable option.
- The Indian Ministry of AYUSH has indeed been promoting all sorts of quackery for the corona-virus. This behaviour is likely to cause many fatalities in India. It should be squarely condemned and not promoted as Weeks seem to think.
Today is Valentine’s Day, a good moment to take a critical look at some of the libido-boosters so-called alternative medicine (SCAM) has to offer. The Internet offers plenty; this website, for instance, advertises over 20 different natural (mostly botanical) products. But such sites are typically thin on evidence.
A quick Medline search locates plenty of research. Much of it seems to be on rats which is not so relevant – unless, of course, your husband is a rat. In terms of clinical trials, Medline too is not all that informative. Here are some of the studies I found:
Eurycoma longifolia is reputed as an aphrodisiac and remedy for decreased male libido. A randomized, double-blind, placebo controlled, parallel group study was carried out to investigate the clinical evidence of E. longifolia in men. The 12-week study in 109 men between 30 and 55 years of age consisted of either treatment of 300 mg of water extract of E. longifolia (Physta) or placebo. Primary endpoints were the Quality of Life investigated by SF-36 questionnaire and Sexual Well-Being investigated by International Index of Erectile Function (IIEF) and Sexual Health Questionnaires (SHQ); Seminal Fluid Analysis (SFA), fat mass and safety profiles. Repeated measures ANOVA analysis was used to compare changes in the endpoints. The E. longifolia (EL) group significantly improved in the domain Physical Functioning of SF-36, from baseline to week 12 compared to placebo (P = 0.006) and in between group at week 12 (P = 0.028). The EL group showed higher scores in the overall Erectile Function domain in IIEF (P < 0.001), sexual libido (14% by week 12), SFA- with sperm motility at 44.4%, and semen volume at 18.2% at the end of treatment. Subjects with BMI ≥ 25 kg/m(2) significantly improved in fat mass lost (P = 0.008). All safety parameters were comparable to placebo.
Yoga is a popular form of complementary and alternative treatment. It is practiced both in developing and developed countries. Use of yoga for various bodily ailments is recommended in ancient ayvurvedic (ayus = life, veda = knowledge) texts and is being increasingly investigated scientifically. Many patients and yoga protagonists claim that it is useful in sexual disorders. We are interested in knowing if it works for patients with premature ejaculation (PE) and in comparing its efficacy with fluoxetine, a known treatment option for PE. Aim: To know if yoga could be tried as a treatment option in PE and to compare it with fluoxetine. Methods: A total of 68 patients (38 yoga group; 30 fluoxetine group) attending the outpatient department of psychiatry of a tertiary care hospital were enrolled in the present study. Both subjective and objective assessment tools were administered to evaluate the efficacy of the yoga and fluoxetine in PE. Three patients dropped out of the study citing their inability to cope up with the yoga schedule as the reason. Main outcome measure: Intravaginal ejaculatory latencies in yoga group and fluoxetine control groups. Results: We found that all 38 patients (25-65.7% = good, 13-34.2% = fair) belonging to yoga and 25 out of 30 of the fluoxetine group (82.3%) had statistically significant improvement in PE. Conclusions: Yoga appears to be a feasible, safe, effective and acceptable nonpharmacological option for PE. More studies involving larger patients could be carried out to establish its utility in this condition.
Antidepressants including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs) are known to cause secondary sexual dysfunction with prevalence rates as high as 50%-90%. Emerging research is establishing that acupuncture may be an effective treatment modality for sexual dysfunction including impotence, loss of libido, and an inability to orgasm. Objectives: The purpose of this study was to examine the potential benefits of acupuncture in the management of sexual dysfunction secondary to SSRIs and SNRIs. Subjects: Practitioners at the START Clinic referred participants experiencing adverse sexual events from their antidepressant medication for acupuncture treatment at the Mood and Anxiety Disorders, a tertiary care mood and anxiety disorder clinic in Toronto. Design: Participants received a Traditional Chinese Medicine assessment and followed an acupuncture protocol for 12 consecutive weeks. The acupuncture points used were Kidney 3, Governing Vessel 4, Urinary Bladder 23, with Heart 7 and Pericardium 6. Participants also completed a questionnaire package on a weekly basis. Outcomes measured: The questionnaire package consisted of self-report measures assessing symptoms of depression, anxiety, and various aspects of sexual function. Results: Significant improvement among male participants was noted in all areas of sexual functioning, as well as in both anxiety and depressive symptoms. Female participants reported a significant improvement in libido and lubrication and a nonsignificant trend toward improvement in several other areas of function. Conclusions: This study suggests a potential role for acupuncture in the treatment of the sexual side-effects of SSRIs and SNRIs as well for a potential benefit of integrating medical and complementary and alternative practitioners.
The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment. Participants and design: Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study. In the trial, an herbal medicine intervention of Bulgarian origin was used (Tribestan®, Sopharma AD). Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112.5mg). Each patient received orally 3×2 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, participants’ sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical parameters were also determined. The primary outcome measure was the change in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using maximum allowable% deviation) with an equal number of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allocation is not allowed; that is, all groups must have the same target sample size. Patients, investigational staff, and data collectors were blinded to treatment. All outcome assessors were also blinded to group allocation. Results: 86 patients in each group completed the study. The IIEF score improved significantly in the TT group compared with the placebo group (Р<0.0001). For intention-to-treat (ITT) there was a statistically significant difference in change from baseline of IIEF scores. The difference between TT and placebo was 2.70 (95% CI 1.40, 4.01) for the ITT population. A statistically significant difference between TT and placebo was found for Intercourse Satisfaction (p=0.0005), Orgasmic Function (p=0.0325), Sexual Desire (p=0.0038), Overall Satisfaction (p=0.0028) as well as in GEQ responses (p<0.0001), in favour of TT. There were no differences in the incidence of adverse events (AEs) between the two groups and the therapy was well tolerated. There were no drug-related serious AEs. Following the 12-week treatment period, significant improvement in sexual function was observed with TT compared with placebo in men with mild to moderate ED. TT was generally well tolerated for the treatment of ED.
What makes me suspicious about these trials is that:
- they are mostly on the flimsy side,
- there are as good as no independent replications,
- they all report positive outcomes. I was unable to find a single study where the authors concluded: SORRY, BUT THIS STUFF IS USELESS!
Disappointed with the quality and the content of the existing trials, I am now off to buy some oysters!
Some people seem to think that all so-called alternative medicine (SCAM) is ineffective, harmful or both. And some believe that I am hell-bent to make sure that this message gets out there. I recommend that these guys read my latest book or this 2008 article (sadly now out-dated) and find those (admittedly few) SCAMs that demonstrably generate more good than harm.
The truth, as far as this blog is concerned, is that I am constantly on the lookout to review research that shows or suggests that a therapy is effective or a diagnostic technique is valid (if you see such a paper that is sound and new, please let me know). And yesterday, I have been lucky:
This paper has just been presented at the ESC Congress in Paris.
Its authors are: A Pandey (1), N Huq (1), M Chapman (1), A Fongang (1), P Poirier (2)
(1) Cambridge Cardiac Care Centre – Cambridge – Canada
(2) Université Laval, Faculté de Pharmacie – Laval – Canada
Here is the abstract in full:
Yes, this study was small, too small to draw far-reaching conclusions. And no, we don’t know what precisely ‘yoga’ entailed (we need to wait for the full publication to get this information plus all the other details needed to evaluate the study properly). Yet, this is surely promising: yoga has few adverse effects, is liked by many consumers, and could potentially help millions to reduce their cardiovascular risk. What is more, there is at least some encouraging previous evidence.
But what I like most about this abstract is the fact that the authors are sufficiently cautious in their conclusions and even state ‘if these results are validated…’
SCAM-researchers, please take note!
A recent blog-post pointed out that the usefulness of yoga in primary care is doubtful. Now we have new data to shed some light on this issue.
The new paper reports a ‘prospective, longitudinal, quasi-experimental study‘. Yoga group (n= 49) underwent 24-weeks program of one-hour yoga sessions. The control group had no yoga.
Participation was voluntary and the enrolment strategy was based on invitations by health professionals and advertising in the community (e.g., local newspaper, health unit website and posters). Users willing to participate were invited to complete a registration form to verify eligibility criteria.
The endpoints of the study were:
- quality of life,
- psychological distress,
- satisfaction level,
- adherence rate.
The yoga routine consisted of breathing exercises, progressive articular and myofascial warming-up, followed by surya namascar (sun salutation sequence; adapted to the physical condition of each participant), alignment exercises, and postural awareness. Practice also included soft twists of the spine, reversed and balance postures, as well as concentration exercises. During the sessions, the instructor discussed some ethical guidelines of yoga, as for example, non-violence (ahimsa) and truthfulness (satya), to allow the participant to have a safer and integrated practice. In addition, the participants were encouraged to develop their awareness of the present moment and their body sensations, through a continuous process of self-consciousness, keeping a distance between body sensations and the emotional experience. The instructor emphasized the connection between breathing and movement. Each session ended with a guided deep relaxation (yoga nidra; 5–10 min), followed by a meditation practice (5–10 min).
The results of the study showed that the patients in the yoga group experienced a significant improvement in all domains of quality of life and a reduction of psychological distress. Linear regression analysis showed that yoga significantly improved psychological quality of life.
The authors concluded that yoga in primary care is feasible, safe and has a satisfactory adherence, as well as a positive effect on psychological quality of life of participants.
Are the authors’ conclusions correct?
I think not!
Here are some reasons for my judgement:
- The study was far to small to justify far-reaching conclusions about the safety and effectiveness of yoga.
- There were relatively high numbers of drop-outs, as seen in the graph above. Despite this fact, no intention to treat analysis was used.
- There was no randomisation, and therefore the two groups were probably not comparable.
- Participants of the experimental group chose to have yoga; their expectations thus influenced the outcomes.
- There was no attempt to control for placebo effects.
- The conclusion that yoga is safe would require a sample size that is several dimensions larger than 49.
In conclusion, this study fails to show that yoga has any value in primary care.
Oh, I almost forgot: and yoga is also satanic, of course (just like reading Harry Potter!).