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

herbal medicine

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Resveratrol is one of the most popular dietary supplements. It is an antioxidant found in red grape skin, Japanese knotweed, blueberries and other berries. Resveratrol is available as dietary supplements from red wine extracts, grape seed extracts, Japanese knotweed extracts and other plants. The amount and purity of resveratrol in supplements varies significantly; absorption in the gut is low.

While, for many supplements, there is no or very little research, this one has a huge amount. So, has reseveratrol any proven health effects demonstrated in clinical trials?

The answer is encouraging.

This abstract provides a useful summary:

Resveratrol is a polyphenolic nutraceutical that exhibits pleiotropic activities in human subjects. The efficacy, safety, and pharmacokinetics of resveratrol have been documented in over 244 clinical trials, with an additional 27 clinical trials currently ongoing. Resveretrol is reported to potentially improve the therapeutic outcome in patients suffering from diabetes mellitus, obesity, colorectal cancer, breast cancer, multiple myeloma, metabolic syndrome, hypertension, Alzheimer’s disease, stroke, cardiovascular diseases, kidney diseases, inflammatory diseases, and rhinopharyngitis. The polyphenol is reported to be safe at doses up to 5 g/d, when used either alone or as a combination therapy. The molecular basis for the pleiotropic activities of resveratrol are based on its ability to modulate multiple cell signaling molecules such as cytokines, caspases, matrix metalloproteinases, Wnt, nuclear factor-κB, Notch, 5′-AMP-activated protein kinase, intercellular adhesion molecule, vascular cell adhesion molecule, sirtuin type 1, peroxisome proliferator-activated receptor-γ coactivator 1α, insulin-like growth factor 1, insulin-like growth factor-binding protein 3, Ras association domain family 1α, pAkt, vascular endothelial growth factor, cyclooxygenase 2, nuclear factor erythroid 2 like 2, and Kelch-like ECH-associated protein 1. Although the clinical utility of resveratrol is well documented, the rapid metabolism and poor bioavailability have limited its therapeutic use. In this regard, the recently produced micronized resveratrol formulation called SRT501, shows promise. This review discusses the currently available clinical data on resveratrol in the prevention, management, and treatment of various diseases and disorders. Based on the current evidence, the potential utility of this molecule in the clinic is discussed.

This is a comprehensive review but it fails to critically assess the quality of the clinical trials. Once we do that, we are likely to get disappointed. Many studies are just not up to the mark.

And if we consult a Cochrane review, our enthusiasm for resveratrol disappears completely: Currently, research is insufficient for review authors to evaluate the safety and efficacy of resveratrol supplementation for treatment of adults with T2DM [type 2 diabetes mellitus]. The limited available research does not provide sufficient evidence to support any effect, beneficial or adverse, of four to five weeks of 10 mg to 1000 mg of resveratrol in adults with T2DM. Adequately powered RCTs reporting patient-relevant outcomes with long-term follow-up periods are needed to further evaluate the efficacy and safety of resveratrol supplementation in the treatment of T2DM.

So, for the time being, I might just continue to obtain my resveratrol in very small but regular doses from red wine, I think.

 

 

The ‘Corona-Virus Quackery Club’ (CVQC) is getting positively crowded. You may remember, its members include:

Today we are admitting the herbalists. The reason is obvious: many of them have jumped on the corona band-wagon by trying to improve their cash-flow on the back of the pandemic-related anxiety of consumers. If you go on the Internet you will find many examples, I am sure. I have chosen this website for explaining the situation.

Herbs That Can Stop Coronavirus Reproduction

CoV multiplies fast in the lungs and the stomach and intestines. The more virus, the sicker you get. The herbs are in their scientific names and common names.

    1. Cibotium barometz – golden chicken fern or woolly fern grows in China and Southeast Asia.

      Cibotium Barometz

    2. Gentiana scabra – known as Korean gentian or Japanese gentian seen in the United States and Japan.

      Japanese Gentian

    3. Dioscorea batatas or Chinese Yam grows in China and East Asia

      Chinese Yam

    4. Cassia tora or Foetid cassia, The Sickle Senna, Wild Senna – grows in India and Central America

      Cassia Tora

    5. Taxillus Chinensis – Mulberry Mistletoe

Lectin Plants that Have Anti Coronavirus Properties

Plant Lectins with Antiviral activity Against Coronavirus

From the table above, all have anti coronavirus activity except for garlic. One plant that is effective but not listed is Stinging nettle.

Yes, very nice pictures – but sadly utterly unreliable messages. My advice is that, in case you have concerns about corona (or any other health problem for that matter), please do not ask a herbalist.

WELCOME TO THE CVQC, HERBALISTS!

What Quacks Don’t Tell You is that ‘What Doctors Don’t Tell You‘ and ‘Get Well‘ magazines misinform the public in a scandalously dangerous fashion. If one ever needed evidence for this statement, it is provided by their latest action, explained on their website:

Lynne McTaggart and Bryan Hubbard, editors of What Doctors Don’t Tell You and Get Well magazines, are pleased to announce a series of four FREE weekly webinars, via Zoom, starting Thursday, April 2 designed to maximize your health and wellness in every way during these challenging times.

In these free hour-long sessions, Lynne and Bryan will interview a number of pioneering doctors and specialists, who will give you detailed advice about natural substances that kill viruses, the best supplements, foods and exercises to boost your immune system, and the best techniques to stay calm and centered during these challenging times.

Sign up to be sent the link for the live webinar where you can have the ability to ask your questions to these pioneers, get access to the recording of the webinars and receive a handout of helpful relevant tips to that webinar.

Part 1: Supercharging Yourself With Natural Virus Killers
Thursday, April 2, 2020
9 am PDST/12pm EDST/5 pm BST/6 pm CSTThis webinar will feature the best substances and supplements proven to prevent the spread of viruses. Joining Lynne and Bryan are noted pioneer Dr. Damien Downing, president of the Society for Environmental Medicine, who was part of a team of orthomolecular doctors who devised a special supplement preventative against the coronavirus; Dr. Sarah Myhill, a British integrative doctor noted expert on vitamin C and other natural virus killers; and Dr. Robert Verkerk PhD, the founder and president of the Alliance for Natural Health and an expert on food and health.
This hardly need a comment. Perhaps just this: there are no dietary supplements that have been shown to prevent the spread of the corona virus. Claiming otherwise might be commercially motivated or it might stem from a deep delusion. In any case, it risks the life of those consumers who believe in such bogus claims and, wrongly feel they are protected, and thus neglect effective measures of protection.

So far, our ‘Corona-Virus Quackery Club’ (CVQC) boasts the following membership:

It is time now, I think, to admit some supplement peddlers.

How come?

Many dietary supplement merchants seem to feel that the current pandemic is an excellent opportunity to flog their useless wares to the anxious public.

“COVID-19

In order to support increasing worldwide demand for the LYMA supplement, we would like to inform new and existing customers that we have sufficient stock in place to ensure uninterrupted supply.”

This was the text of an email I received recently. It linked to a website that informed me of the following:

We continue to work with our scientific network and global supply chain to bring you the latest scientific developments as they arise.

Dr. Paul Clayton, PhD – Director of Science, LYMA

“Covid-19 is causing an enormous amount of illness and disruption. This is due to its high transmission rates, long incubation period, and the substantial numbers of people – 15 to 20% of those infected – who become ill enough to require hospitalisation. This last aspect is concerning as no health care system in the world has sufficient resources to cope with such an influx of seriously ill patients.

At the time of writing there are no specific treatments available. The only advice given is to avoid crowds, wash the hands frequently, and not touch the face. Some authorities recommend face masks and gloves; and we are increasingly being recommended to shelter in place.

But there may be more we can do to protect ourselves. Dysnutrition is common, due to our over-consumption of ultra-processed foods with little nutritional value. Supplements have a role to play in improving general nutritional status and general immunity. But we can take that further.

LYMA. The ultimate supplement.

Chronic stress reduces immuno-competence and makes us more vulnerable to infection. Adaptogens such as KSM-66 Ashwagandha in LYMA have the ability to alleviate the damaging effects of stress and have been shown to improve immunity. So have the Wellmune 1-3, 1-6 beta glucans in LYMA, with many hundreds of studies showing that these natural compounds increase resistance to infection.

These are just two elements that may improve our chances in the difficult times ahead.”
Dr. Paul Clayton, PhD – Director of Science, LYMA

In case the name ‘LYMA’ rings a bell: yes, we have previously discussed the ‘the world’s first super supplement’ and the many claims made for it. We even had the pleasure of an interesting exchange with the above-pictured Dr Paul Clayton in the comments section of that post. Given the above, I am more than happy to welcome him, his LYMA team, and all other supplement peddlers who try to make a fast buck in the present crisis to the CVQC.

WELCOME GUYS!

A new appointment in the realm of so-called alternative medicine (SCAM) has just been announced:

Friends of Science in Medicine (FSM) President, Assoc Professor Ken Harvey MB BS (Melb), FRCPA, AM congratulates Professor Jon Wardle, nurse and naturopath, with postgraduate qualifications in public health, law and health economics, on being appointed to Southern Cross University’s (SCU) Maurice Blackmore Chair of Naturopathic Medicine in Lismore. Professor Wardle has also been appointed as Foundation Director of the National Centre for Naturopathic Medicine (NCNM) funded with $10 Million from the Blackmore Foundation set up to sponsor research into ‘complementary medicine’.

Vice Chancellor, Professor Adam Shoemaker BA (Hons), PhD (ANU), researcher in Indigenous literature and culture, said the benefits of basing the NCNM at Southern Cross were enormous, “Being in a region like the Northern Rivers of New South Wales means we have brilliant local networks in this field. We are also supported by a local community who, like the University, are really receptive to trying new things in order to create a healthier future”.

Professor Harvey comments, “Professor Wardle certainly has challenges ahead. The Northern Rivers region is the anti-vax capital of Australia and some naturopaths advise against vaccination. Degree courses in naturopathy such as the Torrens Bachelor of Health Science (Naturopathy) degree, include studies of homeopathy, iridology and flower essence therapy. None have scientific evidence of efficacy”.

FSM has long argued that health care should be based on scientifically sound research, published in peer-reviewed journals of accepted standing. FSM is equally concerned about medical practitioners offering unproven and often exploitative treatments as it is about complementary medicine practitioners. Professor Harvey said, “some naturopaths practicing in Lismore, associated with SCU, work at clinics that use unverified laboratory tests to make dubious diagnoses and recommend treatment programs that lack evidence of efficacy”.

Professor Harvey (and FSM) conclude that there is an urgent need for evidence-based science to be applied to naturopathy. They trust that Professor Wardle will emulate Professor Edzard Ernst, Foundation Professor of Complementary Medicine at Exeter University, by applying accepted scientific standards to the evaluation of naturopathic interventions.

The March 24 opening of the NCNM in Lismore will feature a panel discussion on the future of health care with guest speakers: Professor Kerryn Phelps AM, former President of the Australasian Integrative Medicine Association, Marcus Blackmore AM, naturopath and Executive Director of Blackmores Ltd, which markets vitamin and herbal products, and Professor Jon Wardle. FSM hopes that the panel will discuss some of the issues raised above.

Sounds exciting, but is Wardle up to the job?

Judging from his publication record, he is certainly a naturopath through and through. He has published lots of papers; as far as I can see most of them are surveys of some sort or another. Many leave me somewhat bewildered. Two examples must suffice:

No 1

Objectives: To explore the recommendations of naturopathic medicine for the management of endometriosis, dysmenorrhea, and menorrhagia, drawing on traditional and contemporary sources.

Design: Content analysis.

Setting: Australia, Canada, and the United States of America (USA).

Subjects: Contemporary sources were identified from reviewing naturopathic higher education institutions’ recommended texts, while traditional sources were identified from libraries which hold collections of naturopathic sources. Sources were included if they were published from 1800 to 2016, were in English, published in Australia, Canada, or the USA, and reported on the topic. Included sources were as follows: 37 traditional texts; 47 contemporary texts; and 83 articles from naturopathic periodicals.

Results: Across included sources, the most reported disciplines were herbal medicine, clinical nutrition, mineral medicines, homeopathy, hydrotherapy, and chemical-based medicines. Herbal medicines were extensively reported from all sources for the management of endometriosis, dysmenorrhea, and menorrhagia. Clinical nutrition was only recommended from contemporary sources for all three conditions. Mineral medicines were mentioned in both traditional and contemporary sources, but were only recommended for dysmenorrhea and menorrhagia. There were limited recommendations for homeopathy and hydrotherapy treatments in all conditions across all sources. Chemical-based medicines were only mentioned for dysmenorrhea and menorrhagia, and recommendations ceased after 1922. Recommendations for endometriosis were not present in any of the traditional sources, across all reported disciplines.

Conclusions: The findings of this article provide insights into the documented historical and contemporary treatments within naturopathic medicine for endometriosis, dysmenorrhea, and menorrhagia. While philosophical principles remain the core of naturopathic practice, the therapeutic armamentarium appears to have changed over time, and a number of the original naturopathic treatments appear to have been retained as key elements of treatment for these conditions. Such insights into naturopathic treatments will be of particular interest to clinicians providing care to women, educators designing and delivering naturopathic training, and researchers conducting clinical and health service naturopathic research.

No 2

Complementary and alternative medicine (CAM) is an increasingly prevalent part of contemporary health care. Whilst there have been some attempts to understand the dynamics of CAM integration in the health care system from the perspective of conventional care providers and patients, little research has examined the view of CAM practitioners. This study aims to identify the experiences of integration within a conventional healthcare system as perceived by naturopaths. Qualitative semi-structured interviews were conducted using a purposeful sample of 20 practising naturopaths in South East Queensland, Australia to discuss their experiences and perceptions of integrating with conventional medical providers. Analysis of the interviews revealed five broad challenges for the integration of CAM according to naturopaths: competing paradigms between CAM and conventional medicine; co-option of CAM by conventional medical practitioners; the preservation of separate CAM and conventional medical worlds by patients and providers due to lack of formalised relations; negative feedback and biases created through selective or limited experience or information with CAM; and indifferent, reactive and one-sided interaction between CAM and conventional medical providers. Naturopaths support the integration of health services and attempt to provide safe and appropriate care to their patients through collaborative approaches to practice. The challenges identified by naturopaths associated with integration of CAM with conventional providers may impact the quality of care of patients who choose to integrate CAM and conventional approaches to health. Given the significant role of naturopaths in contemporary health-care systems, these challenges require further research and policy attention.

So, is Jon Wardle up to the job?

The answer obviously depends on what the job is.

If it is about publishing 100 more surveys that show nothing of much value and are essentially SCAM-promotion, then he ought to be fine. If it is about rigorously testing which SCAMs generate more good than harm, then ‘Houston, we have a problem’!

It is not often that a top journal reports a trial of a (mostly) herbal remedy. For this reason alone, this Italian study (published in the Journal of the American Heart Association) is remarkable.

Sixty‐nine uncontrolled hypertension patients, aged 40 to 68 years, on antihypertensive medication were enrolled in 2 double‐blind studies. In the first study, 45 were randomized to placebo or a new nutraceutical combination named AkP05. Blood pressure (BP), endothelial function, and circulating nitric oxide were assessed before and at the end of 4 weeks of treatment. In the second study, 24 patients were randomized to diuretic or AkP05 for 4 weeks and underwent a cardiopulmonary exercise test to evaluate the effects of AkP05 on functional capacity of the cardiovascular, pulmonary, and muscular systems. Furthermore, vascular and molecular studies were undertaken on mice to characterize the action of the single compounds contained in the AkP05 nutraceutical combination.

AkP05 supplementation reduced BP, improved endothelial function, and increased nitric oxide release; cardiopulmonary exercise test revealed that AkP05 increased maximum O2 uptake, stress tolerance, and maximal power output. In mice, AkP05 reduced BP and improved endothelial function, evoking increased nitric oxide release through the PKCα/Akt/endothelial nitric oxide synthase pathway and reducing reactive oxygen species production via NADPH‐oxidase inhibition. These effects were mediated by synergism of the single compounds of AkP05.

The authors concluded that this is the first study reporting positive effects of a nutraceutical combination on the vasculature and exercise tolerance in treated hypertensive patients. Our findings suggest that AkP05 may be used as an adjunct for the improvement of cardiovascular protection and to better control BP in uncontrolled hypertension.

These are good studies, it seems. However, I am puzzled by the authors’ conclusions:

  1. I very much doubt that this is the first such study.
  2. The studies did not test AkP05 ‘as an adjunct’, so their findings cannot suggest that it should be used as such.

And now you are, of course, all dying to learn what this new wonder nutraceutical contains. It is a mixture of Bacopa monnieri, extract of Ginkgo biloba leaves, extract of green tea leaves, and phosphatidylserine and is manufactured by Damor Farmaceutici, Italy.

It has been reported that, in China, patients affected by the coronavirus are being treated with Traditional Chinese Medicine (TCM). Treatments in Wuhan hospitals combine TCM and western medicines, said Wang Hesheng, the new health commission head in Hubei, the province at the centre of the epidemy. He said TCM was applied on more than half of confirmed cases in Hubei. “Our efforts have shown some good result,” Wang said at a press conference on Saturday. Top TCM-experts have been sent to Hubei for “research and treatment,” he said. Some 2,200 TCM workers have been sent to Hubei, Wang said.

Another website confirmed that TCM has been applied to more than half of the confirmed patients of corona or COVID-19 infection in Hubei. It’s also used in the prevention and control of COVID-19 at the community level. “Since the beginning of the outbreak, the government has attached importance to both TCM and Western medicine by mobilizing the strongest scientific research and medical forces in both fields to treat the patients,” said Wang Hesheng. “By coordinating the resources of traditional Chinese and Western medicine, we strive to improve the cure rate and reduce fatalities by the greatest possible amount to effectively safeguard the safety and health of the people,” Wang noted.

China Daily added that many of the medical workers also have participated in the fight against the SARS outbreak in 2003, said Huang Luqi, president of China Academy of Chinese Medical Sciences. Three national-level TCM teams, organized by the National Administration of Traditional Chinese Medicine, also have been dispatched to Hubei, said Huang, head of the TCM team at Wuhan Jinyintan Hospital.

The TCM workers have treated 248 confirmed and suspected novel coronavirus patients, and 159 of them have shown improvement and 51 have been discharged from the hospital, Huang said at a daily news conference in Wuhan. More than 75 percent of novel coronavirus patients in Hubei, and more than 90 percent of patients in other regions of the country, have received TCM treatment, he said. “We hope that Hubei province and Wuhan city can increase the use of TCM in treating confirmed and suspected novel coronavirus patients,” Huang said. TCM can shorten the course of disease for patients with severe symptoms, reduce the possibility of mild infections becoming severe, help with patient recovery and disease prevention and offer psychological support to patients, he noted.

__________________________________________________________________

No information is available on the nature of the TCM treatments used. Moreover, the reported response rate (159 of 248) sounds far from encouraging to me. In fact, it could reflect merely the natural history of the disease or might even hide a detrimental effect of TCM on the infection. What we need are controlled studies, without them, reports like the ones above are mere useless and potentially harmful propaganda for boosting China’s TCM-trade.

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!

About 85% of German children are treated with herbal remedies. Yet, little is known about the effects of such interventions. A new study might tell us more.

This analysis accessed 2063 datasets from the paediatric population in the PhytoVIS data base, screening for information on indication, gender, treatment, co-medication and tolerability. The results suggest that the majority of patients was treated with herbal medicine for the following conditions:

  • common cold,
  • fever,
  • digestive complaints,
  • skin diseases,
  • sleep disturbances
  • anxiety.

The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events.

The authors concluded that the results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.

If you are a fan of herbal medicine, you will be jubilant. If, on the other hand, you are a critical thinker or a responsible healthcare professional, you might wonder what this database is, why it was set up and how exactly these findings were produced. Here are some details:

The data were collected by means of a retrospective, anonymous, one-off survey consisting of 20 questions on the user’s experience with herbal remedies. The questions included complaints/ disease, information on drug use, concomitant factors/diseases as well as basic patient data. Trained interviewers performed the interviews in pharmacies and doctor’s offices. Data were collected in the Western Part of Germany between April 2014 and December 2016. The only inclusion criterion was the intake of herbal drugs in the last 8 weeks before the individual interview. The primary endpoint was the effect and tolerability of the products according to the user.

And who participated in this survey? If I understand it correctly, the survey is based on a convenience sample of parents using herbal remedies. This means that those parents who had a positive experience tended to volunteer, while those with a negative experience were absent or tended to refuse. (Thus the survey is not far from the scenario I often use where people in a hamburger restaurant are questioned whether they like hamburgers.)

So, there are two very obvious factors other than the effectiveness of herbal remedies determining the results:

  1. selection bias,
  2. lack of objective outcome measure.

This means that conclusions about the clinical effects of herbal remedies in paediatric patients are quite simply not possible on the basis of this survey. So, why do the authors nevertheless draw such conclusions (without a critical discussion of the limitations of their survey)?

Could it have something to do with the sponsor of the research?

The PhytoVIS study was funded by the Kooperation Phytopharmaka GbR Bonn, Germany.

Or could it have something to do with the affiliations of the paper’s authors:

1 Institute of Pharmacy, University of Leipzig, Brüderstr. 34, 04103, Leipzig, Germny. [email protected]

2 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 573, Bonn, Germany. [email protected]

3 Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.

4 ClinNovis GmbH, Genter Str. 7, 50672, Cologne, Germany.

5 Bayer Consumer Health, Research & Development, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295, Darmstadt, Germany.

6 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 53173, Bonn, Germany.

7 Institute of Pharmaceutical Biology, Goethe University Frankfurt, Max-von-Laue-Str. 9, 60438, Frankfurt, Germany.

8 Chair of Naturopathy, University Medicine Rostock, Ernst-Heydemann Str. 6, 18057, Rostock, Germany.

WHAT DO YOU THINK?

If you, like many of us, have heavily ‘toxed’, you might now consider ‘detoxing’. What I mean is that we have probably all over-indulged a bit over the holidays. Unless you were the guest of someone, you had to pay dearly for it (Champagne is not cheap!). And now, a whole industry of ‘detox’ entrepreneurs tells you to pay again – this time, for detox.

As you payed ‘through your nose’ for the ‘tox’, you might as well use the same orifice for the ‘detox’. An Indian tradition called Nasiyam (or Nasyam? or Nasya? – I am confused!)  makes it possible. This website explains:

Nasal Instillation (Nasyam) is the practice of instilling medicated oils, fresh juices of leaves or flowers in the nostrils … Nasyam is specially directed towards the purification of various parts related to the head…

I don’t know about you, but I always felt that all my parts were related to my head! So, Nasyam is for purification of all my parts? The announcement below – I picked it up on Twitter – is much clearer: detox through the nasal doorway! Who would refuse such an offer after the festivities of late?

This sounds fascinating, I thought. Thus I ran a quick Medline search but only found this abstract:

BACKGROUND:

Ardita (facial paralysis) is a medical condition that disfigures or distorts the facial appearance of the sufferer causing facial asymmetry and malfunction. Ardita patients may benefit from considering alternative treatments such as Ayurveda, including Taila Nasya (nasal instillation of medicated oil).

OBJECTIVES:

To synthesize the best available evidence on the effectiveness of different Nasya oils in the treatment of Ardita.

INCLUSION CRITERIA TYPES OF PARTICIPANTS:

Studies conducted on adult sufferers (18-70 years) of Ardita (chronic or acute) in any setting were considered. Studies including participants who were pregnant or suffered allergic rhinitis, fever, intracranial tumor/hemorrhage and bilateral facial palsy were excluded.

INTERVENTION(S)/COMPARATOR(S):

Standalone treatment of Nasya (at all dosages and frequencies) compared to Nasya in combination with other Ayurvedic treatments was considered. Comparisons between different interventions including Taila Nasya alone, Taila Nasya in combination with other Ayurvedic interventions and Ayurvedic interventions that did not include Taila Nasya were also considered.

OUTCOMES AND MEASURES:

Changes in Ardita symptoms, including facial distortion, speech disorders and facial pain, were measured.

TYPES OF STUDIES:

All quantitative study designs (experimental, quasi-experimental and observational) were considered.

SEARCH STRATEGY:

Relevant studies were identified following a comprehensive literature search. References provided within these key studies identified additional resources. Indian universities were also contacted for results of Ardita studies undertaken in their institutions.A three-step search strategy aimed to find studies of published and unpublished studies was undertaken. Studies published in the English language were considered for inclusion, irrespective of publication date/year. Following an initial limited search of MEDLINE and CINAHL, the text words contained in the title and abstract, and of the index terms used to describe each articles were analyzed. From the identified keywords and index terms, searches were undertaken across all relevant databases such as PubMed, CINHAL, Cochrane (CENTRAL), Scopus, Centre for Review and Dissemination databases, Turning Research into Practice (TRIP), EMBASE, EBM Reviews, DHARA, Google Scholar, MedNar and ProQuest Dissertations. Finally, reference lists of identified theses and articles were searched for additional studies. Universities and website operators related to Ayurvedic research in India were contacted, including the National Institute of Ayurveda for relevant studies. Besides this, the University of Adelaide librarian was contacted to retrieve those studies identified in the reference lists of theses and articles.

METHODOLOGICAL QUALITY:

Studies were critically assessed by the review author and a secondary reviewer prior to inclusion in the review using the standardized critical appraisal instrument from the Joanna Briggs Institute.

DATA EXTRACTION:

Data was extracted by the primary reviewer using the standardized data extraction tool from the Joanna Briggs Institute.

DATA SYNTHESIS:

Different interventions and comparators across studies precluded meta-analysis. Narrative synthesis was performed.

RESULTS:

Only two pseudo randomized studies with a small number of participants met inclusion criteria and were included in the review. One study with 20 participants, divided equally into two groups compared the effectiveness of two nasal instillations in alleviating four Ardita symptoms. The second study of 15 participants each in two groups compared the effectiveness of nasal instillation with placement of medicated oil on the head on seven Ardita symptoms. Observational measurements of Ardita symptoms were graded as Mild, Moderate or Marked at baseline and after one month. The study conducted on 30 participants using Nasya intervention showed participants had better relief from the symptoms of facial pain, speech disorder and earache within the range of 78.2% to 90.9%, graded as Marked. Along with statistical data available in the studies, this review found low levels of evidence favoring Taila Nasya intervention. The review did not include any studies examining effectiveness of Nasya compared to conventional treatment for Ardita.

CONCLUSIONS:

This review presents extremely limited evidence from only two small experimental studies that administration of Nasya oil alone may provide some relief from Ardita symptoms of facial distortion, speech disorder, inability to shut eyelids/upward eye rolling and dribbling of saliva in adult patients. No strong conclusions may be drawn from the evidence included in the review due to the limited number of studies, limited number of participants and poor quality of studies.

IMPLICATIONS FOR PRACTICE:

Practitioners should advice Ardita patients that there is extremely limited evidence suggesting the potential effectiveness of Nasya oils alone or Nasya in conjunction with other Ayurvedic treatments in managing symptoms. However, given the absence of a strong evidence base, practitioners should be guided by clinical wisdom and patient preference.

IMPLICATIONS FOR RESEARCH:

Well controlled clinical trials comparing standalone Nasya therapy to other Ayurvedic treatments and/or conventional medicine for Ardita symptoms need to be conducted to examine the relative effectiveness of different Nasya oils in treating.

I think you agree, that’s nothing to write home about.

So, on second thought I might give Nasya (or whatever it is called) a miss. The same applies, by the way, to any other form of detox.

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