MD, PhD, FMedSci, FSB, FRCP, FRCPEd

herbal medicine

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Yes, the festive season is upon us and therefore it is high time to discuss detox (yet again). As many of us are filling their fridges to the brim, most of us prepare for some serious over-indulgence. Following alt med logic, this must prompt some counter-measures, called detox.

The range of treatments advocated by detox-fans is weird and wide (see also below):

  • various alternative diets,
  • herbal, vitamins, minerals and other ‘natural’ supplements,
  • various forms of chelation therapy,
  • electromagnetic devices,
  • colonic irrigation and enemas,
  • various forms of skin bruising,
  • cupping,
  • sauna and other means of inducing extensive sweating,
  • homeopathy,
  • ear candles,
  • foot-baths,
  • etc., etc.

I suppose it was to be expected that detox often goes with other crazy beliefs. This website, for instance, shows that it is even associated with anti-vaxx:

START OF QUOTE

Whether you believe vaccines to be harmful or not, one has to admit that all the ingredients added to vaccines cannot be good for anyone, especially children.

As David Wolfe has discussed, vaccines contain the following: sucrose, fructose, dextrose, potassium phosphate, aluminum potassium sulfate, peptone, bovine extract, formaldehyde, FD&C Yellow #6, aluminum lake dye, fetal bovine serum, sodium bicarbonate, monosodium glutamate, aluminum hydroxide, benzethonium chloride, lactose thimerosal, ammonium sulfate, formaldehyde, glutaraldehyde, bovine extract), calf serum, aluminum phosphate, aluminum hydroxyphosphate sulfate, and ethanol.

That is a long scary list and many of these things will not leave the body naturally. Thus, a gentle detox is necessary.

Detoxification Bath

Living Traditionally suggests a detoxification bath with both Zendocrine and epsom salt. Zendocrine is an essential oil mixture made up of tangerine, rosemary, geranium, juniper berry, and cilantro. Rosemary, juniper berry, and cilantro are good choices for detoxification and tangerine and geranium are purifiers.

Garlic

Garlic has been scientifically proven to treat heavy metal poisoning. Organic Lifestyle Magazine suggests consuming three cloves a day to help remove toxins.

Silica

Silica is also good for a heavy metal detox. Natural News states, “Aluminum (Al) is passed out through the urine when one supplements silica. It seems there’s little danger of taking too much, as long as adequate water is consumed and vitamin B1 and potassium levels are maintained.”

One of the best ways to get silica in your system is with the horsetail herb, rye, barley, oats, wheat, and alfalfa sprouts nuts.

Chlorella

Chlorella is one of the best detoxifying substances available. According to Dr. Mercola, “Chlorella is uniquely designed to not bind to the minerals your body naturally needs to function optimally. It does not bind to beneficial minerals like calcium, magnesium, or zinc. It’s almost as if chlorella knows which metals belong in your body and which chemicals need to be removed. Supplementing with chlorella is like unleashing a tiny army inside your body to fight the battle of removing toxins from your tissues and ushering them back outside your body where they belong.”
You can take it in supplement form or add a powdered version to your smoothie.

Probiotics

Probiotics are what is needed to put good bacteria system to rights when it has been thrown off by toxins. “They can provide assistance by decreasing the number of bad bacteria while helping to restore balance between good and bad bacteria in the gut and to keep your body functioning properly.” (LiveStrong)

Some probiotic foods include: organic yogurt, kefir, sauerkraut, kombucha, and fermented vegetables.

Omega-3

Omega 3 oils are especially good for cell repair and keeping your brain healthy. This is because of their high fat content is similar to the fats that are naturally part of cell and brain systems. (Daily Mail)

A teaspoon daily should be enough or you could take a supplement.

Cilantro

According to Natural Society, cilantro is a very gentle detoxification tool. It is also effective for removing heavy metals from the brain.
For 2-3 weeks, add a teaspoon of cilantro to your food, smoothie, or just eat it up. You can also substitute with 6-7 drops of cilantro essential oil by adding it to your bath.

END OF QUOTE

Don’t you just adore the sources quoted by the author as evidence for his/her statements?

As I said, the therapies recommended for detox are diverse. Yet, they have one important feature in co<span style=”color: #668a1d;”>mmon: they are not based on anything remotely resembling good evidence. As I stressed in my article of 2012:

The common characteristics of all of these approaches are that they are unproved. Even experts who are sympathetic to alternative medicine and AD admit: ‘while there are hundreds of randomized controlled trials on drug and alcohol detox, there are no such trials of detox programs focusing on environmental toxins … at present, “detox” is certainly more of a sales pitch than a science’. The ‘studies’ of AD that have been published are of such poor methodological quality that no conclusions can be drawn from them.

While there is a total absence of sound evidence for benefit, some of these treatments have been associated with risks which depend on the nature of the treatment and can be particularly serious with diets (malnutrition), supplements (hepatoxicity), chelation (electrolyte depletion) and colonic irrigation (perforation of the colon).

Yet detox is big business’. A recent survey, for instance, suggested that 92% of US naturopaths use some form of detox. To lay people, its principles seem to make sense and, in many of us, the desire to ‘purify’ ourselves is deep rooted. Thus detox-entrepreneurs (including Prince Charles who, several years ago, launched a ‘Detox-Tincture’ via his firm Duchy Originals) are able to exploit a gullible public.

Proponents of detox are keen to point out that ‘a modern science of ‘detoxicology’ seems to be emerging’. If there is such a thing, it should address the following, fundamental questions:

  • What are the toxins and toxicants?
  • What evidence exists that they damage our health?
  • How do we quantify them?
  • How do we diagnose that a patient requires detox?
  • Which treatments are effective in eliminating which toxins?

Currently, there is insufficient evidence to answer any of these questions. Until this situation changes, I do not think a ‘science of detox’ exists at all.

This meta-analysis was performed “to ascertain the effectiveness of oral aloe vera consumption on the reduction of fasting blood glucose (FBG) and hemoglobin A1c (HbA1c).”

PubMed, CINAHL, Natural Medicines Comprehensive Database, and Natural Standard databases were searched. The searches were limited to clinical trials or observational studies conducted in humans and published in English. Studies of aloe vera’s effect on FBG, HbA1c, homeostasis model assessment-estimated insulin resistance (HOMA-IR), fasting serum insulin, fructosamine, and oral glucose tolerance test (OGTT) in prediabetic and diabetic populations were examined.

Nine studies were included in the FBG parameter (n = 283); 5 of these studies included HbA1c data (n = 89). Aloe vera decreased FBG by 46.6 mg/dL (p < 0.0001) and HbA1c by 1.05% (p = 0.004). Significant reductions of both endpoints were maintained in all subgroup analyses. Additionally, the data suggested that patients with an FBG ≥200 mg/dL may see a greater benefit. A mean FBG reduction of 109.9 mg/dL was observed in this population (p ≤ 0.0001). There was evidence of publication bias with FBG but not with HbA1c.

The authors concluded that the results of this meta-analysis support the use of oral aloe vera for significantly reducing both FBG (46.6 mg/dL) and HbA1c (1.05%) in prediabetic and diabetic patients. However, given the current overall quality and relative scarcity of data, further clinical studies that are more robust and better controlled are warranted to confirm and further explore these findings.

Oh no, the results do not support the use of aloe vera at all!!

Why?

Because this ‘meta-analysis’ is of unacceptably poor quality. Here are just some of the flaws that render it totally useless, particularly for issuing advice such as above:

  • The authors included uncontrolled observational studies which make no attempt to control for non-specific effects.
  • In several studies, the use of concomitant anti-diabetic medications was allowed; therefore it is not possible to establish cause and effect by aloe vera.
  • The search strategy was woefully inadequate; for instance non-English publications were not considered.
  • There was no assessment of the scientific rigor of the included studies; this totally invalidates the reliably of the conclusions.
  • The included studies used preparations of widely different aloe vera preparations, and there is no way of knowing the does of the active ingredients.

Diabetes is a serious condition that affects millions worldwide. If some of these patients are sufficiently gullible to follow the conclusions of this paper, they might be dead within a matter of days. This makes this article one of the most dangerous papers that I have seen in the ‘peer-reviewed’ literature of alternative medicine.

Who publishes such utter and irresponsible rubbish?

You may well ask.

The journal has been discussed on this blog  before for the junk that regularly appears in its pages, and so has its editor in chief. The authors (and the reviewers) are not known to me, but one thing is for sure: they don’t know the first thing about conducting a decent systematic review/meta-analysis.

The boom of alternative medicine in the US – and consequently in the rest of the developed world – is intimately connected with a NHI centre now called NCCIH (National Center for Complementary and Integrative Health). It was founded in the early 1990s because some politicians were bent on promoting quackery. Initially the institution had modest funding but, after more political interference, it had ample cash to pursue all sorts of activities, including sponsoring research into alternative therapies at US universities. A most interesting video summarising the history of the NCCIH can be seen here.

No other institution in the world had more funds for research into alternative medicine than the NCCIH, and it soon became the envy of alt med researchers globally. I have been invited by the NCCHI on several occasions and invariably was impressed by their apparent affluence. While we Europeans usually had to do our research on a shoe-string, our American colleagues seemed to be ‘rolling in it’.

I was often far less impressed with the research they sponsored. Not only it was invariably eye-wateringly expensive, but also its quality seemed often dismal. Sometimes, I even got the impression that research was used as a means of mainstreaming quackery for the unsuspecting American – and consequently world-wide – public.

An example of this mainstreaming is an article in JAMA published yesterday. Here is a short but telling excerpt:

Researchers led by Richard L. Nahin, PhD, MPH, lead epidemiologist at the NIH’s National Center for Complementary and Integrative Health (NCCIH), examined efficacy and safety evidence in 105 randomized controlled trials (RCTs) conducted between January 1966 and March 2016. The review—geared toward primary care physicians as part of the journal’s Symposium on Pain Medicine—focused on popular complementary approaches to common pain conditions.

Unlike a typical systematic review that assigns quality values to the studies, the investigators conducted a narrative review, in which they simply looked at the number of positive and negative trials. “If there were more positives than negatives then we generally felt the approach had some value,” Nahin explained. “If there were more negatives, we generally felt the approach had less value.” Trials that were conducted outside of the United States were excluded from the review.

Based on a “preponderance” of positive vs negative trials, complementary approaches that may offer pain relief include acupuncture and yoga for back pain; acupuncture and tai chi for osteoarthritis of the knee; massage therapy for neck pain; and relaxation techniques for severe headaches and migraine. Several other techniques had weaker evidence, according to the qualitative assessments, for specific pain conditions (see “Selected Complementary Health Approaches for Pain”). The treatments were generally safe, with no serious adverse events reported.

To me, this looks that NCCIH has now managed to persuade even the editors of JAMA to white-wash their dodgy science. The review referred to here is a paper we discussed some time ago on this blog. I then stated about it the following:

Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:

  • the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
  • the authors talk about efficacy but seem to mean effectiveness;
  • the authors only included RCTs from the US which must result in a skewed and incomplete picture;
  • the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
  • not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
  • the discussion of the paper totally lacks any critical thinking;
  • there is no assessment of the quality of the trials included in this review.

My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.

I find it puzzling that the ‘lead epidemiologist at the NIH’s National Center for Complementary and Integrative Health’ would publish such dubious research. Why does he do it? If you have watched the video mentioned above, you are inclined to think that it might be because of political interference.

However, I suggest another, in a way much more damming reason or contributing factor: the NCCIH has so long indulged in such poor science that even its top people have forgotten what good science looks like. I know this is a bold hypothesis; so, let me try to support it with some data.

Several years ago, my team together with several other researches have looked at the NCCIH-sponsored research systematically according to 4 different subject areas. Here are the conclusions of our articles reporting the findings:

ACUPUNCTURE

Seven RCTs had a low risk of bias. Numerous methodological shortcomings were identified. Many NCCAM-funded RCTs of acupuncture have important limitations. These findings might improve future studies of acupuncture and could be considered in the ongoing debate regarding NCCAM-funding. [Focus on Alternative and Complementary Therapies Volume 17(1) March 2012 15–21]

HERBAL MEDICINE

This independent assessment revealed a plethora of serious concerns related to NCCAM studies of herbal medicine. [Perfusion 2011; 24: 89-102]

ENERGY MEDICINE

In conclusion, the NCCAM-funded RCTs of energy medicine are prime examples of misguided investments into research. In our opinion, NCCAM should not be funding poor-quality studies of implausible practices. The impact of any future studies of energy medicine would be negligible or even detrimental. [Focus on Alternative and Complementary Therapies Volume 16(2) June 2011 106–109 ]

CHIROPRACTIC

In conclusion, our review demonstrates that several RCTs of chiropractic have been funded by the NCCAM. It raises numerous concerns in relation to these studies; in particular, it suggests that many of these studies are seriously flawed. [https://www.ncbi.nlm.nih.gov/pubmed/21207089]

I think I can rest my case and urge you to watch the video mentioned above.

The Scotsman reported that David Tredinnick, the somewhat feeble-minded Tory MP for Bosworth, has been at it again. Apparently he said that many of his constituents are only alive today because they have been treated with alternative medicine.

Tredennick recently urged ministers to spend more NHS money on alternative therapies such as homeopathy and acupuncture to treat patients. It seems to me that, for him and other quackery promoters, evidence and science are issues beyond comprehension. Mr Tredinnick also disclosed the fact that he received acupuncture at a Chinese medical clinic just before the Commons debate on cancer strategy – a regular treatment he credits with keeping him healthy.

Tredennick told his fellow MPs: “I was talking there to practitioners about what they are able to do for cancer patients, and there is actually a very long list of types of cancer that can be treated using traditional Chinese herbal medicine.“ One, cervical cancer, two, non-Hodkins lymphoma, three, HIV, four, colon cancer, five… six, breast cancer, seven, prostate cancer. And so the list goes on. “I have in my constituency several constituents who I believe are alive today because they have used Chinese medicine.“ And the reason for that is what it does is it strengthens your system, and it strengthens the immune system, and it is very effective after cancer treatment. It deals with particular symptoms.”

This is by no means the first outburst of quackery-promotion by the Right Honourable Gentleman. I have a whole selection of quotes from him which I sometimes use for amusing my audience during public lectures. Because amusing he is; Tredennick seems to be utterly devoid of rational thought when it comes to the subject of alternative medicine, and often his statements make for comedy gold. This time, however, he might be sailing closer to the wind than he perhaps realizes: Under English law, it is an offence to claim that any treatment can cure cancer, I believe.

We all had to learn to laugh about unethical and dangerous nonsense the ‘Tredennicks of this world’ regularly claim about alternative medicine. Laughing is the only solution for coping with such idiocy, I am afrid. If we don’t laugh, we have to consider taking it seriously – and this is a truly frightening prospect, particularly considering that this guy actually sits in parliament and has the power to influence our lives.

Dietary and herbal supplements (DHS) are currently popular. They are being promoted as being natural and therefore safe – an assumption that is clearly wrong: some DHS can contain toxic substances or they might cause interactions with drugs or other DHS.

This study explored whether adverse events were actually associated with such interactions and examined specific characteristics among inpatient DHS users prone to such adverse events. It was designed as a cross-sectional survey of 947 patients hospitalized in 12 departments of a tertiary academic medical centre in Haifa, Israel. It evaluated the rate of DHS use among inpatients, the potential for interactions, and actual adverse events during hospitalization associated with DHS use. It also assessed whether DHS consumption was documented in patients’ medical files. Statistical analysis was used to delineate DHS users at risk for adverse events associated with interactions with conventional drugs or other DHS.

The results show that about half of all patients took DHS. In 17 (3.7%) of the 458 DHS users, an adverse event may have been caused by DHS-drug-DHS interactions. According to the Drug Interaction Probability Scale, 14 interactions “probably” caused the adverse events, and 11 “possibly” caused them. Interactions occurred more frequently in older patients (p = 0.025, 95% CI: 2.26-19.7), patients born outside Israel (p = 0.025, 95% CI: 0.03-0.42), those with ophthalmologic (p = 0.032, 95% CI: 0.02-0.37) or gastrointestinal (p = 0.008, 95% CI: 0.05-0.46) comorbidities, and those using higher numbers of DHS (p < 0.0001, 95% CI: 0.52-2.48) or drugs (p = 0.027, 95% CI: 0.23-3.77).

The authors concluded that approximately one in 55 hospitalizations in this study may have been caused by adverse events associated with DHS-drug-DHS interactions. To minimize the actual occurrence of adverse events, medical staff education regarding DHS should be improved.

This seems to be a good study and it generated interesting findings on an important topic.

Why do I have nevertheless a problem with it?

The answer is simple but not pleasant: very similar results have been published almost simultaneously in more than one journal. The link above is to an article in the BR J CLIN PHARMACOL of October this year. The following text is from the abstract of an article in INTERN EMERG MED also of October this year:

Of 927 patients who agreed to answer the questionnaire, 458 (49.4 %) reported the use of 89 different DHS. Potential DHS-DHS interactions were identified in 12.9 % of DHS users. Three interactions were associated with the actual occurrence of adverse events. Patients at risk of DHS-DHS interactions included females (p = 0.026) and patients with greater numbers of concomitant medications (p < 0.0001) and of consumed DHS (p < 0.0001). In 88.9 % of DHS users, DHS use was not reported in medical files and only 18 % of the DHS involved in interactions were documented. Potential DHS-DHS interactions are common in inpatients, and may lead to hospitalization or worsen existing medical conditions. The causal relationship between potential interactions and actual adverse events requires further study.

END OF QUOTE

And to my surprise, I also found a third article also from the October issue of INTERN EMERG MED reporting on this survey. Here is part of its abstract:

DHS users were determined via a questionnaire. The Natural Medicine database was used to search for potential DHS-drug interactions for identified DHS, and the clinical significance was evaluated using Lexi-interact online interaction analysis. Medical files were assessed for documentation of DHS use. Univariate and multivariate logistic regression analyses were used to characterize potential risk factors for DHS-drug interactions. Of 927 patients consenting to answer the questionnaire, 458 (49 %) reported DHS use. Of these, 215 (47 %) had at least one potential interaction during hospitalization (759 interactions). Of these interactions, 116 (15 %) were potentially clinically significant. Older age [OR = 1.02 (1.01-1.04), p = 0.002], males [OR = 2.11 (1.35-3.29), p = 0.001] and increased number of used DHS [OR = 4.28 (2.28-8.03), p < 0.001] or drugs [OR = 1.95 (1.17-3.26), p = 0.011] were associated with potential interactions in DHS users. Physicians documented only 16.5 % of DHS involved in these interactions in patients’ medical files. In conclusion, a substantial number of inpatients use DHS with potential interactions with concomitant medications. Medical staff should be aware of this, question patients on DHS usage and check for such interactions.

END OF QUOTE

What is the difference between the three articles? The first one in INTERN EMERG MED authored by Levy I, Attias S, Ben Arye E, Goldstein L, Schiff E evaluated “potential DHS-DHS interactions among inpatients”. The second one in INTERN EMERG MED also authored by Levy I, Attias S, Ben Arye E, Goldstein L, Schiff E evaluated “potentially dangerous interactions of DHS with prescribed medications among inpatients”. Finally the one in BR J CLIN PHARMACOL also authored by Levy I, Attias S, Ben-Arye E, Goldstein L, Schiff E  assessed in addition the interactions between DHS and prescription drugs.

Dual publications are usually considered to be a violation of research ethics. Publication of different aspects of one single data-set in multiple articles is called ‘salami-slicing’ and is often considered to be poor form.

My question to you, the reader of this post, is: What type of scientific misconduct do we have here?

Athletes tend to adopt a healthy life-style, and today this seems to include the regular intake of a range of dietary supplements. Supplements specifically marketed for sports-people promote good health and performance, we are constantly told – but is this true?

A 2010 review found that “there is good evidence that caffeine can improve single-sprint performance, while caffeine, creatine and sodium bicarbonate ingestion have all been demonstrated to improve multiple-sprint performance. The evidence is not so strong for the performance-enhancing benefits of β-alanine or colostrum. Current evidence does not support the ingestion of ribose, branched-chain amino acids or β-hydroxy-β-methylbutyrate, especially in well trained athletes.”

However, a 2011 paper was considerably more cautious: “For most supplements, the evidence is weak, or even completely absent. A few supplements, including caffeine, creatine, and bicarbonate, are supported by a strong research base. Difficulties arise when new evidence appears to support novel supplements: in recent years, β-alanine has become popular, and the use of nitrate and arginine is growing. Athletes seldom wait until there is convincing evidence of efficacy or of safety, but caution is necessary to minimize risk.”

The purpose of this new article was to collect the most recent data regarding the safety of well-known or emerging dietary supplements used by athletes.

The review suggests that about 90% of sports supplements contain estrogenic endocrine disruptors, and about 25% of them having a higher estrogenic activity than acceptable. About 50% of the supplements are contaminated by melamine, a source of non-protein nitrogen. Additional data accumulate toward the safety of nitrate ingestion. In the last 2 years, the safety of emerging supplements such as higenamine, potentially interesting to lose weight, creatine nitrate and guanidinoacetic acid has been evaluated but still needs further investigation.

The authors of this article claim that “the consumption of over-the-counter supplements is very popular in athletes. Although most supplements may be considered as safe when taking at the recommended doses, athletes should be aware of the potential risks linked to the consumption of supplements. In addition to the risks linked to overdosage and cross-effects when combining different supplements at the same time, inadvertent or deliberate contamination with stimulants, estrogenic compounds, diuretics or anabolic agents may occur.”

Despite these cautions, the market for supplements is growing and the myth that supplements are good for health continues. The truth is, however, more complex and far less encouraging:

  • It is impossible to generalise across the entire range of highly diverse supplements.
  • Some have positive effects.
  • The vast majority do nothing at all.
  • Most are quite harmless.
  • Some can have serious adverse effects.
  • All of them cause harm to your bank account.

This website tells us that ‘Stopain Migraine’ is the first topical product to effectively relieve migraine pain. It is a safe alternative to other migraine relief products that begins to work as soon as it’s applied. And the press release informs us that Troy Healthcare extended its Stopain line with a Stopain Migraine offering – a topical pain relieving gel that is massaged onto the back of the neck and behind each ear.

“Many of the women we shopped with told us they like that Stopain Migraine lacks systemic side effects and can be used in conjunction with other products – whether that’s natural remedies like peppermint essential oil, Epsom salts and ginger tea, or even prescription drugs or other over-the-counter products,” stated Anthony Cicini, VP Troy Healthcare.

Stopain Migraine begins to work as soon as it’s applied, can be reapplied after 30 minutes, and can be used up to four times daily, the company noted. It’s unique in that it can be used alone, or in addition to other ingestible migraine products to relieve migraine pain.

The homeopathic blend of ingredients follow the guidelines of The Homeopathic Pharmacopoeia of the United State and is recommended by both by primary care physicians and OBGYNs, the company stated.

In addition to providing effective relief quickly, Stopain Migraine offers peace of mind for migraine sufferers, knowing the product is free from aspirin, acetaminophen and caffeine, has no known drug interactions and contains no dyes or preservatives.

Consumers can now find Stopain Migraine nationwide for the suggested retail price of $11.99

END OF PRESS RELEASE

Any evidence, you’d probably ask. A quick Medline search located this abstract:

OBJECTIVE:

To determine whether topical menthol 6% gel will relieve a migraine attack.

MATERIALS AND METHODS:

A single-center, open-label pilot trial of 25 patients with at least 1 year of diagnosed episodic migraine and <15 headache days per month. Patients treated one migraine attack with STOPAIN topical menthol 6% gel to skull base within 2 h of headache onset. Headache pain severity was assessed prior to and after gel application.

RESULTS:

Thirty-two patients enrolled and 25 completed the study. Prior to treatment, 7 patients had mild pain, 13 moderate pain, and 5 severe pain. Two hours following gel application, 7 (28%) patients had no pain, 7 (28%) mild pain, 6 (25%) moderate pain, and 5 (20%) severe pain. The majority of patients had similar pain intensity (8; 32%) or improvement (13; 52%). At 24-h, only two non-rescued patients still had mild headache. Of the 25 completers, 2 patients took rescue medication prior to the 2-h period, and an additional 10 patients rescued between 2 and 24 h.

CONCLUSION:

Study results showed a significant improvement in headache intensity by 2 h after gel application. This pilot study shows STOPAIN gel may be effective in treating an acute migraine attack.

A pilot study! I thought pilots were for testing feasibility, not effectiveness!

No control group! The observed effect is therefore not attributable to ‘Stopain’ at all!

But there is more! Iranian researchers published this RCT:

OBJECTIVE:

To investigate the efficacy and safety of the cutaneous application of menthol 10% solution for the abortive treatment of migraine.

BACKGROUND:

Peppermint and its active ingredient menthol have long been used for the treatment of various pain conditions including headache.

METHODS:

This is a randomised, triple-blind, placebo-controlled, crossed-over study conducted in the neurology Clinic of Nemazee Hospital, affiliated with Shiraz University of Medical Sciences, Shiraz, southern Iran, from March 2007 to March 2008. The patients were recruited via local newspaper advertisements. Eligible patients were categorised into two groups and a 10% ethanol solution of menthol (as drug) and 0.5% ethanol solution of menthol (as placebo) were applied to the forehead and temporal area in a crossover design. Pain free, pain relief, sustained pain free and sustained pain relief end-points were measured by questionnaires using a visual analogue scale.

RESULTS:

The intent-to-treat population consisted of 35 patients (80% women, 20% men, mean age: 29.6 +/- 6.2) with 118 migraine attacks. In the intent-to-treat population, the menthol solution was statistically superior to the placebo on 2-h pain free (p = 0.001), 2-h pain relief (p = 0.000), sustained pain free and sustained pain relief end-points (p = 0.008). The menthol solution was also more efficacious in the alleviation of nausea and/or vomiting and phonophobia and/or photophobia (p = 0.02). In the per-protocol population, there was significantly higher number of patients who experienced at least one pain free/pain relief after the application of menthol rather than the placebo (p = 0.002). No significant difference was seen between the adverse effects of the drug and the placebo groups (p = 0.13).

CONCLUSION:

Menthol solution can be an efficacious, safe and tolerable therapeutic option for the abortive treatment of migraine.

Yes, you are quite right; this must be a different product. It contains just menthol and at a higher concentration than ‘Stopain’.

So what does ‘Stopain’ actually contain?  I must say that 6% menthol does not sound very homeopathic to me! The website of Troy Healthcare tells us that it has a total of 4 ingredients:

Mentholum 1X HPUS – 50.00%
Belladonna 3X HPUS – 1.33%
Iris Versicolor 6X HPUS – 1.33%
Sanguinaria Canadensis 6X HPUS – 1.33%

And what do the three homeopathically diluted ingredients do?

Is the term ‘homeopathic’ used here merely to attract a certain type of customer?

And why do they claim that ‘Stopain’ is effective when there is no evidence?

Or perhaps there is evidence and they haven’t published it?

And why do they claim that ‘Stopain’ is the first topical product?

Wasn’t a German topical menthol product marketed years ago?

Search me! I am not sure I know all the answers.

I hope someone from Troy Healthcare reads this and cares to explain.

I have blogged about the herbal antidepressant before; for instance about the fact that it can cause potentially dangerous herb-drug interactions. When taken alone, however, it seems to be both safe and efficacious in reducing the symptoms of depression. This notion has just been confirmed yet again.

A new systematic review evaluated St. John’s wort (SJW) for the treatment of Major Depressive Disorder (MDD). The objectives of this review were to (1) evaluate the efficacy and safety of SJW in adults with MDD compared to placebo and active comparator and (2) evaluate whether the effects vary by severity of MDD.

The authors searched 9 electronic databases and existing reviews to November 2014. Two independent reviewers screened the citations, abstracted the data, and assessed the risk of bias. They included randomized controlled trials (RCTs) examining the effect of at least a 4-week administration of SJW on depression outcomes against placebo or active comparator in adults with MDD. Risk of bias was assessed using the Cochrane Risk of Bias tool and USPSTF criteria. Quality of evidence (QoE) was assessed using the GRADE approach.

Thirty-five studies examining 6993 patients met inclusion criteria; 8 studies evaluated a SJW extract that combined 0.3 % hypericin and 1-4 % hyperforin. SJW was associated with more treatment responders than placebo (relative risk [RR] 1.53; 95 % confidence interval [CI] 1.19, 1.97; I(2) 79 %; 18 RCTs; N = 2922, moderate QoE; standardized mean differences [SMD] 0.49; CI 0.23, 0.74; 16 RCTs; I(2) 89 %, N = 2888, moderate QoE). Compared to antidepressants, SJW participants were less likely to experience adverse events (OR 0.67; CI 0.56, 0.81; 11 RCTs; moderate QoE) with no difference in treatment effectiveness (RR 1.01; CI 0.90, 1.14; 17 RCTs, I(2) 52 %, moderate QoE; SMD -0.03; CI -0.21, 0.15; 14 RCTs; I(2) 74 %; N = 2248, moderate QoE) in mild and moderate depression.

The authors concluded that SJW monotherapy for mild and moderate depression is superior to placebo in improving depression symptoms and not significantly different from antidepressant medication. However, evidence of heterogeneity and a lack of research on severe depression reduce the quality of the evidence. Adverse events reported in RCTs were comparable to placebo and fewer compared with antidepressants. However, assessments were limited due to poor reporting of adverse events and studies were not designed to assess rare events. Consequently, the findings should be interpreted with caution.

This is an excellent review from a reputable and independent team. The findings are therefore trustworthy.

Does that mean that we can now recommend SJW for patients suffering from depression?

Perhaps – but we need to keep an eye on the interaction issue. As a sole treatment, SJW is much safer than conventional antidepressants. But if a patient takes other medicines, we ought to be very careful.

Other currently unresolved issues are the questions of which extract and which dose. At present, there is not enough evidence to provide conclusive answers to either of these, and therefore the enthusiasm of many doctors for prescribing SJW is understandably limited.

Irrespective of these problems, I have to say that SJW is without question one of the biggest ‘success stories’ from the realm of alternative medicine. Pity that there are not more of them!

WARNING: THIS MIGHT MAKE YOU LAUGH OUT LOUDLY AND UNCONTROLLABLY.

Deepak Chopra rarely publishes in medical journals (I suppose, he has better things to do). I was therefore intrigued when I saw a recent article of which he is a co-author.

The ‘study‘ in question allegedly examined the effects of a comprehensive residential mind–body program on well-being. The authors describe it as “a quasi-randomized trial comparing the effects of participation in a 6-day Ayurvedic system of medicine-based comprehensive residential program with a 6-day residential vacation at the same retreat location.” They included 69 healthy women and men who received the Ayurvedic intervention addressing physical and emotional well-being through group meditation and yoga, massage, diet, adaptogenic herbs, lectures, and journaling. Key components of the program include physical cleansing through ingestion of herbs, fiber, and oils that support the body’s natural detoxification pathways and facilitate healthy elimination; two Ayurvedic meals daily (breakfast and lunch) that provide a light plant-based diet; daily Ayurvedic oil massage treatments; and heating treatments through the use of sauna and/or steam. The program includes lectures on Ayurvedic principles and lifestyle as well as lectures on meditation and yoga philosophy. The study group also participated in twice-daily group meditation and daily yoga and practiced breathing exercises (pranayama) as well as emotional expression through a process of journaling and emotional support. During the program, participants received a 1-hour integrative medical consultation with a physician and follow-up with an Ayurvedic health educator.

The control group simply had a vacation without any of the above therapies in the same resort. They were asked to do what they would normally do on a resort vacation with the additional following restrictions: they were asked not to engage in more exercise than they would in their normal lifestyle and to refrain from using La Costa Resort spa services. They were also asked not to drink ginger tea or take Gingko biloba during the 2 days before and during the study week.

Recruitment was via email announcements on the University of California San Diego faculty and staff and Chopra Center for Wellbeing list-servers. Study flyers stated that the week-long Self-Directed Biological Transformation Initiative (SBTI) study would be conducted at the Chopra Center for Wellbeing, located at the La Costa Resort in Carlsbad, California, in order to learn more about the psychosocial and physiologic effects of the 6-day Perfect Health (PH) Program compared with a 6-day stay at the La Costa Resort. The study participants were not blinded, and site investigators and study personnel knew to which group participants were assigned.

Participants in the Ayurvedic program showed significant and sustained increases in ratings of spirituality and gratitude compared with the vacation group, which showed no change. The Ayurvedic participants also showed increased ratings for self-compassion as well as less anxiety at the 1-month follow-up.

The authors arrived at the following conclusion: Findings suggest that a short-term intensive program providing holistic instruction and experience in mind–body healing practices can lead to significant and sustained increases in perceived well-being and that relaxation alone is not enough to improve certain aspects of well-being.

This ‘study’ had ethical approval from the University of California San Diego and was supported by the Fred Foundation, the MCJ Amelior Foundation, the National Philanthropic Trust, the Walton Family Foundation, and the Chopra Foundation. The paper’s first author is director of research at the Chopra Foundation. Deepak Chopra is the co-founder of The Chopra Center for Wellbeing.

Did I promise too much?

Isn’t this paper hilarious?

Just for the record, let me formulate a short conclusion that actually fits the data from this ‘study’: Lots of TLC, attention and empathy does make some people feel better.

This is hardly something one needs to write home about; and certainly nothing to do a study on!

But which journal would publish such unadulterated advertising?

On this blog, I have mentioned the JACM several times before. Recently, I wrote about the new man in charge of it. I concluded stating WATCH THIS SPACE.

I think the wait is now over – this paper is from the latest issue of the JACM, and I am sure we all agree that the new editor has just shown us of what he is made and where he wants to take his journal.

Just as I thought that this cannot get any better, it did! It did so in the form of a second paper which is evidently reporting from the same ‘study’. Here is its abstract unaltered in its full beauty:

The effects of integrative medicine practices such as meditation and Ayurveda on human physiology are not fully understood. The aim of this study was to identify altered metabolomic profiles following an Ayurveda-based intervention. In the experimental group, 65 healthy male and female subjects participated in a 6-day Panchakarma-based Ayurvedic intervention which included herbs, vegetarian diet, meditation, yoga, and massage. A set of 12 plasma phosphatidylcholines decreased (adjusted p < 0.01) post-intervention in the experimental (n = 65) compared to control group (n = 54) after Bonferroni correction for multiple testing; within these compounds, the phosphatidylcholine with the greatest decrease in abundance was PC ae C36:4 (delta = -0.34). Application of a 10% FDR revealed an additional 57 metabolites that were differentially abundant between groups. Pathway analysis suggests that the intervention results in changes in metabolites across many pathways such as phospholipid biosynthesis, choline metabolism, and lipoprotein metabolism. The observed plasma metabolomic alterations may reflect a Panchakarma-induced modulation of metabotypes. Panchakarma promoted statistically significant changes in plasma levels of phosphatidylcholines, sphingomyelins and others in just 6 days. Forthcoming studies that integrate metabolomics with genomic, microbiome and physiological parameters may facilitate a broader systems-level understanding and mechanistic insights into these integrative practices that are employed to promote health and well-being.

Now that I managed to stop laughing about the first paper, I am not just amused but also puzzled by the amount of contradictions the second article seems to cause. Were there 65 or 69 individuals in the experimental group? Was the study randomised, quasi-randomised or not randomised? All of these versions are implied at different parts of the articles. It turns out that they randomised some patients, while allocating others without randomisation – and this clearly means the study was NOT randomised. Was the aim of the study ‘to identify altered metabolomic profiles following an Ayurveda-based intervention’ or ‘to examine the effects of a comprehensive residential mind–body program on well-being’?

I am sure that others will find further contradictions and implausibilites, if they look hard enough.

The funniest inconsistency, in my opinion, is that Deepak Chopra does not even seem to be sure to which university department he belongs. Is it the ‘Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.’ as indicated in the 1st paper or is it the ‘Department of Family and Preventive Medicine, University of California San Diego, La Jolla, California, USA’ as listed in the 2nd article?

Does he know from which planet he is?

 

In alternative medicine, good evidence is like gold dust and good evidence showing that alternative therapies are efficacious is even rarer. Therefore, I was delighted to come across a brand-new article from an institution that should stand for reliable information: the NIH, no less.

According to its authors, this new article “examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.”

The results of this huge undertaking are complex, of course, but in a nutshell they are at least partly positive for alternative medicine. Specifically, the authors state that “based on a preponderance of positive trials vs negative trials, current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM, and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.”

This is excellent news! Finally, we have data from an authoritative source showing that some alternative treatments can be recommended for common pain conditions.

Hold on, not so fast! Yes, the NIH is a most respectable organisation, but we must not blindly accept anything of importance just because it appears to come form a reputable source. Let’s look a bit closer at the actual evidence provided by the authors of this paper.

Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:

  • the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
  • the authors talk about efficacy but seem to mean effectiveness;
  • the authors only included RCTs from the US which must result in a skewed and incomplete picture;
  • the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
  • not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
  • the discussion of the paper totally lacks any critical thinking;
  • there is no assessment of the quality of the trials included in this review.

My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.

Personally, I find it lamentable that such a potentially worthy exercise ended up employing such lousy methodology. Perhaps even more lamentable is the fact that the NIH (or one of its Centers) can descend that low; to mislead the public in this way borders on scientific misconduct and is, in my view, unethical and unacceptable.

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