clinical trial
Placentophagy is the act of eating the placenta after childbirth. It seems to be advocated widely. But why would anyone even think of doing such a weird thing?
According to Wikipedia, the placenta contains high levels of prostaglandin. Prostaglandin stimulates involution (an inward curvature or penetration, or, a shrinking or return to a former size) of the uterus. The placenta also contains small amounts of oxytocin which eases birth stress and causes the smooth muscles around the mammary cells to contract and eject milk.
Wiki also tells us that human placenta has also been an ingredient in some traditional Chinese medicines, including using dried human placenta, known as “Ziheche” (simplified Chinese: 紫河车; traditional Chinese: 紫河車; pinyin: Zǐhéchē), to treat wasting diseases, infertility, impotence and other conditions. Most recently, the Center for Disease Control published a report of a newborn infected with Group B Streptococcus (GBS) bacteria likely after the mother ingested placenta capsules. Consequently, the CDC said that placenta capsule ingestion should be avoided and to educate mothers interested in placenta encapsulation about the potential risks. A recent publication advised that physicians should discourage placentophagy because it is potentially harmful with no documented benefit.
The benefits of placentophagy are, according to many proponents of this therapy, considerable. This website, for instance, claims the following effects:
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BALANCE HORMONES
When a woman births the placenta, she loses the many useful hormones contained in it that were produced during pregnancy. It can take months for the body to balance these hormones again. Taking placenta pills helps reintroduce these hormones into the mother’s body in small doses, until her body resumes its natural hormonal balance.
DECREASE THE INCIDENCE OF POSTPARTUM DEPRESSION
Iron-deficiency in postpartum women can lead to fatigue, and may be a contributing factor to depressive symptoms. The placenta is extremely rich in natural iron and can be a valuable and natural resource to replenish the mother’s lost iron supply. It is also rich in naturally-produced B6 which is often used to combat depression. Many mothers find the combination of these substances in placenta encapsulation to be helpful in improving their post-birth emotional experience.
INCREASE ENERGY & FACILITATE FASTER HEALING
The placenta contains hormones and nutrients that have been found to increase energy and promote healing. It is also rich in naturally-produced iron and protein, which can help replenish the mother’s nutrients following childbirth.
LESSEN POSTPARTUM BLEEDING
Historically, midwives have utilized a small portion of the placenta to control postpartum bleeding during and after childbirth. Placenta pills contain these same hormones and can lessen bleeding and help promote uterine healing.
PROMOTE HEALTHY BREAST MILK PRODUCTION
The placenta contains Human Placental Lactogen and Prolactin, which help prepare the mammary glands and stimulate milk production. These are often beneficial in successful breastfeeding of a new infant.
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As we all know, bogus claims abound in alternative medicine; the question, as always is: are they true?
There have been no studies of whether placentophagy provides hormonal effects in humans, Wiki claims. But this last statement is no longer true. The first human trial of placentophagy has just been published. The objective of this study was to investigate whether salivary hormone concentrations of women ingesting their own encapsulated placenta during the early postpartum differed from those of women consuming a placebo.
Randomly assigned participants (N=27) were given a supplement containing either their dehydrated and homogenized placenta (n=12), or placebo (n=15). Saliva samples were collected during late pregnancy and early postpartum. Samples of participants’ processed placenta, and the encapsulated placebo, were also collected. Hormone analyses were conducted on all samples utilizing liquid chromatography-tandem mass spectrometry.
The results show that there were no significant differences in salivary hormone concentrations between the placenta and placebo groups post-supplementation that did not exist pre-supplementation. There were, however, significant dose-response relationships between the concentration of all 15 detected hormones in the placenta capsules and corresponding salivary hormone measures in placenta group participants not seen in the placebo group. The higher salivary concentrations of these hormones in the placenta group reflects the higher concentrations of these hormones in the placenta supplements, compared to the placebo.
In a second paper on the same trial, the authors assessed the maternal mood, bonding, and fatigue via validated scales across 4 time points during late pregnancy and early postpartum.
The results show no significant main effects related to maternal mood, bonding, or fatigue between placenta and placebo group participants. However, examination of individual time points suggested that some measures had specific time-related differences between placenta and placebo groups that may warrant future exploration. Though statistical significance should not be interpreted in these cases, the authors did find some evidence of a decrease in depressive symptoms within the placenta group but not the placebo group, and reduced fatigue in placenta group participants at the end of the study compared to the placebo group.
The authors concluded that no robust differences in postpartum maternal mood, bonding, or fatigue were detected between the placenta and placebo groups. This finding may be especially important for women considering maternal placentophagy as a ‘natural’ (i.e., non-pharmacological) means of preventing or treating blues/depression. Given the study limitations, these findings should be interpreted as preliminary. Small, time-related improvements in maternal mood and lower fatigue post-supplementation among placenta group participants may warrant further research.
Will this largely negative evidence stop enthusiasts of placentophagy making therapeutic claims?
I very much doubt it!
This is a blog about alternative medicine! A blog that promised to cover all major forms of alternative medicine. So, how could I have so far ignored the incredible health benefits of Apple Cider Vinegar (ACV)? Realising that this omission is quite frankly scandalous, I now quickly try to make amends by dedicating this entire post to ACV and its fantastic properties.
There is no shortage of information on the subject (almost 1.5 million websites!!!); this article entitled “13 Reasons Apple Cider Vinegar Is the Magic Potion You Need in Your Life”, for instance, tells us about the ’13 Real Benefits of vinegar’. As it was published in the top science journal ‘COSMOPOLITAN’, it must be reliable. The article makes the wonders of ACV very clear:
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1. It reduces bloating. Vinegar increases the acidity in the stomach, which allows it to digest the food you’ve eaten and helps propel it into the small intestine, according to Raphael Kellman, MD, founder of the Kellman Center for Integrative and Functional Medicine in New York City. Because slow digestion can cause acid reflux, a burning sensation that occurs when food in your stomach backs up all the way into your esophagus and triggers feelings of fullness, consuming vinegar to move things along can stop you from feeling like the Pillsbury Dough Boy.
2. It increases the benefits of the vitamins and minerals in your food. “When your stomach isn’t producing enough acid, this impairs the absorption of nutrients as well as B6, folate, calcium, and iron,” Dr. Kellman explains. Help your body by ingesting a bit more acid in the form of vinegar, and you’ll actually be able to use all the good stuff you consumed by ordering the side salad instead of fries.
3. It cancels out some of the carbs you eat. The acetic acid found in vinegar interferes with the enzymes in your stomach responsible for digesting starch so you can’t absorb the calories from carbs you’ve eaten.
4. It softens your energy crash after eating lots of sugar or carbs. Consuming vinegar before a meal can help by slowing the rush of sugar to your blood stream, so your blood sugar spike resembles a hill instead of a mountain and you don’t crash quite as hard.
5. It keeps you full longer. In a small but thorough study, researchers found that people who consumed vinegar before eating a breakfast of white bread felt more satisfied 90 minutes after eating compared to people who only ate the bread. (Worth noting: Two hours after eating, both groups were equally hungry. It just goes to show why white bread doesn’t make a stellar breakfast food — with or without vinegar.)
6. It can help your muscles produce energy more efficiently before a major push. Endurance athletes sometimes drink diluted vinegar before they carb-load the night before competing because acetic acid can helps the muscles turn carbs into energy to fuel intense exercise, according to well-regarded research conducted on animals.
7. It could lower your blood pressure. Animal studies suggest that drinking vinegar can lower your blood pressure by a few points. Researchers don’t understand exactly how this works or whether it is equally effective among humans, but Johnston is pretty confident it can make at least a modest difference.
8. It cleans fruits and veggies. The best way to clean produce, according to Johnston, is with diluted vinegar: Research suggests its antibacterial properties can significantly reduce pathogens such as Salmonella. Just fill an empty spray bottle with diluted vinegar and spritz your produce (salad stuff, fruits, etc.) then rinse in regular water before serving.
10. It deodorizes smelly feet. Just wipe down your clompers with a paper towel dipped in diluted vinegar. The antibacterial properties of vinegar will kill the smelly stuff.
11. It relieves jellyfish stings. In case you’re ever stung by a jellyfish and just so happen to have diluted vinegar on hand, you’ll be awfully lucky: Vinegar deactivates the jellyfish’s sting better than many other remedies — even though hot water still works best, according to a study that compared both techniques.
12. It balances your body’s pH levels, which could mean better bone health. Although vinegar is obviously acidic, it actually has a neutralizing effect once it’s inside of you. Meaning: It makes your body’s pH more basic (i.e., alkaline).
13. It alleviates heartburn — sometimes, according to Johnston, who just wrapped up a study on using vinegar to treat this condition. Vinegar’s effectiveness depends on the source of your heartburn: If you have erosive heartburn caused by lesions in your esophagus or stomach ulcers, a dose of vinegar will only aggravate the problem. But if your heartburn stems from something you ate, adding acetic acid to your stomach can help neutralize the acid in there and help fix the problem, providing you with at least a little bit of comfort.
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What, you are not impressed by these claims nor the references? I found another website that offers plenty more science:
- Katie J. Astell, Michael L. Mathai, Andrew J. McAinch, Christos G. Stathis, Xiao Q. Su. A pilot study investigating the effect of Caralluma fimbriata extract on the risk factors of metabolic syndrome in overweight and obese subjects: a randomised controlled clinical trial. Biomedical and Lifestyle Diseases (BioLED) Unit, College of Health and Biomedicine, Victoria University, Melbourne, Victoria 3021, Australia.
- Niedzielin, K., Kordecki, H.,
http://journals.lww.com/eurojgh/Abstract/2001/10000/A_controlled,_double_blind,_randomized_study_on.4.aspx - M. Million, et al. Obesity-associated gut microbiota is enriched in Lactobacillus reuteri and depleted in Bifidobacterium animalis and Methanobrevibacter smithii. International Journal of Obesity (2012) 36, 817–825; doi:10.1038/ijo.2011.153; published online 9 August 2011
- Rastmanesh R., et al. High polyphenol, low probiotic diet for weight loss because of intestinal microbiota interaction. Chemico-Biological InteractionsPublished 15 October 2010.
- Thielecke F, et al. Epigallocatechin-3-gallate and postprandial fat oxidation in overweight/obese male volunteers: a pilot study Eur J Clin Nutr. 2010 Jul;64(7):704-13. doi: 10.1038/ejcn.2010.47.
- Wang H., Effects of catechin enriched green tea on body composition. Obesity (Silver Spring). 2010 Apr;18(4):773-9. doi: 10.1038/oby.2009.256.
- Bitange Nipa Tochi, Zhang Wang, Shi – Ying Xu and Wenbin Zhang, 2008. Therapeutic Application of Pineapple Protease (Bromelain): A Review. Pakistan Journal of Nutrition, 7: 513-520.
- Date K, Satoh A, Iida K, Ogawa H. Pancreatic α-Amylase Controls Glucose Assimilation by Duodenal Retrieval through N-Glycan-specific Binding, Endocytosis, and Degradation. J Biol Chem. 2015 May 28. pii: jbc.M114.594937.
- Perano SJ,Couper JJ,Horowitz M, Martin AJ, Kritas S, Sullivan T, Rayner CK. Pancreatic enzyme supplementation improves the incretin hormone response and attenuates postprandial glycemia in adolescents with cystic fibrosis: a randomized crossover trial.J Clin Endocrinol Metab. 2014 Jul;99(7):2486-93. doi: 10.1210/jc.2013-4417. Epub 2014 Mar 26.
Ok, not plenty; and not very sound or relevant either.
So, let’s do a Medline search! This is sure to produce convincing clinical trials on human patients that back up all of the above claims.
Yes! Medline does indeed generate 58 hits for ACV (just to give you a comparison, searching for ‘atenolol’, a fairly ancient beta-blocker, for instance, generates 7877 hits and searching for ‘acupuncture’ provides more that 27 000 hits):
The first human study of ACV listed on Medline is from one of my favourite journals, the Altern Ther Health Med. It is not a clinical trial, but a case report:
A 32-y-old married woman was admitted with intense vaginal discharge with foul odor, itching, groin pain, and infertility for the past 5 y. Candida albicans was isolated from the culture of vaginal swab. The patient was diagnosed with chronic vaginal candida infection. She failed to respond to integrative medicine methods prescribed. Recovery was achieved with the application of apple cider vinegar. Alternative treatment methods can be employed in patients unresponsive to medical therapies. As being one of these methods, application of apple cider vinegar can cure vaginal candida infection.
But surely that cannot be all!
No, no, no! There is more; a pilot study has also been published. It included all of 10 patients and concluded that vinegar affects insulin-dependent diabetes mellitus patients with diabetic gastroparesis by reducing the gastric emptying rate even further, and this might be a disadvantage regarding to their glycaemic control.
That’s what I like! A bold statement, even though we are dealing with a tiny pilot. He who dares wins!
Anything else?
Afraid not! The rest of the 58 references are either animal studies, in vitro experiments or papers that were entirely irrelevant for the clinical effects of ACV.
But how can this be?
Does this mean that all the claims made by ‘COSMOPOLITAN’ and thousands of other publications are bogus?
I cannot imagine – no, it must mean that, yet again, science has simply not kept up with the incredible pace of alternative medicine.
A new acupuncture study puzzles me a great deal. It is a “randomized, double-blind, placebo-controlled pilot trial” evaluating acupuncture for cancer-related fatigue (CRF) in lung cancer patients. Twenty-eight patients presenting with CRF were randomly assigned to active acupuncture or placebo acupuncture groups to receive acupoint stimulation at LI-4, Ren-6, St-36, KI-3, and Sp-6 twice weekly for 4 weeks, followed by 2 weeks of follow-up. The primary outcome measure was the change in intensity of CFR based on the Chinese version of the Brief Fatigue Inventory (BFI-C). The secondary endpoint was the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS). Adverse events were monitored throughout the trial.
A significant reduction in the BFI-C score was observed at 2 weeks in the 14 participants who received active acupuncture compared with those receiving the placebo. At week 6, symptoms further improved. There were no significant differences in the incidence of adverse events of the two group.
The authors, researchers from Shanghai, concluded that fatigue is a common symptom experienced by lung cancer patients. Acupuncture may be a safe and feasible optional method for adjunctive treatment in cancer palliative care, and appropriately powered trials are warranted to evaluate the effects of acupuncture.
And why would this be puzzling?
There are several minor oddities here, I think:
- The first sentence of the conclusion is not based on the data presented.
- The notion that acupuncture ‘may be safe’ is not warranted from the study of 14 patients.
- The authors call their trial a ‘pilot study’ in the abstract, but refer to it as an ‘efficacy study’ in the text of the article.
But let’s not be nit-picking; these are minor concerns compared to the fact that, even in the title of the paper, the authors call their trial ‘double-blind’.
How can an acupuncture-trial be double-blind?
The authors used the non-penetrating Park needle, developed by my team, as a placebo. We have shown that, indeed, patients can be properly blinded, i. e. they don’t know whether they receive real or placebo acupuncture. But the acupuncturist clearly cannot be blinded. So, the study is clearly NOT double-blind!
As though this were not puzzling enough, there is something even more odd here. In the methods section of the paper the authors explain that they used our placebo-needle (without referencing our research on the needle development) which is depicted below.
Then they state that “the device is placed on the skin. The needle is then gently tapped to insert approximately 5 mm, and the guide tube is then removed to allow sufficient exposure of the handle for needle manipulation.” No further explanations are offered thereafter as to the procedure used.
Removing the guide tube while using our device is only possible in the real acupuncture arm. In the placebo arm, the needle telescopes thus giving the impression it has penetrated the skin; but in fact it does not penetrate at all. If one would remove the guide tube, the non-penetrating placebo needle would simply fall off. This means that, by removing the guide tube for ease of manipulation, the researchers disclose to their patients that they are in the real acupuncture group. And this, in turn, means that the trial was not even single-blind. Patients would have seen whether they received real or placebo acupuncture.
It follows that all the outcomes noted in this trial are most likely due to patient and therapist expectations, i. e. they were caused by a placebo effect.
Now that we have solved this question, here is the next one: IS THIS A MISUNDERSTANDING, CLUMSINESS, STUPIDITY, SCIENTIFIC MISCONDUCT OR FRAUD?
Malaria is an infection caused by protozoa usually transmitted via mosquito bites. Malaria is an important disease for homeopaths because of Hahnemann’s quinine experiment: it made him postulate his ‘like cures like’ theory. Today, many experts assume that Hahnemann misinterpreted the results of this experience. Yet most homeopaths are still convinced that potentised cinchona bark is an effective prophylaxis against malaria. Some homeopathic pharmacies still offer homeopathic immunisations against the infection. In several cases, this has caused people who believed to be protected fall ill with the infection.
Perhaps because of this long tradition, homeopaths seem to have difficulties giving up the idea that they hold the key to effective malaria prevention. An article published in THE INDIAN EXPRESS entitled ‘Research suggests hope for homoeopathic vaccine to treat malaria’ reminds us of this bizarre phenomenon:
…In a laboratory test set-up, an ultra-dilute homoeopathic preparation was prepared by extracting samples from Plasmodium falciparum, the parasite that causes malaria. The homoeopathic preparation was used in-vitro to check if it had anti-malarial activity… “Homoeopathy has been criticised for lack of scientific evidence. This lab-model test established that a medicine developed from an organism that causes malaria can be used to treat the infection,” said Dr Rajesh Shah, principal investigator in the research.
Following the tests, Shah is approaching the government in order to conduct a full-fledged clinical trial for the homoeopathic medicine. “We found that the homoeopathic medicine exhibited 65 per cent inhibition against malaria while chloroquine treatment has 54 per cent efficacy,” Shah claimed. The research was published in the International Journal of Medical and Health Research in July. It observed that the homoeopathic solution inhibited enzyme called hemozoin is known to have an anti-malarial effect…
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I thought this story was both remarkable and odd. So I looked up the original paper. Here is the abstract:
The inventor has developed malaria nosode and has subjected it for evaluation of antimalarial activity in vitro assay along with few other homeopathy preparations. The potential antimalarial activity of the Malaria nosode, Malaria officinalis and China officinalis was evaluated by β-Hematin Formation Assay. The hemozoin content was determined by measuring the absorbance at 400 nm. The results were recorded as % inhibition of heme crystallization compared to negative control (DMSO) Malaria nosode, Malaria officinalis and China officinalis exhibited inhibition of hemozoin and the inhibition was greater than the positive control Chloroquine diphosphate used in the study. The study has shown anti-disease activity of an ultra-dilute (potentized) homeopathic preparation. The Malaria nosode prepared by potentizing Plasmodium falciparum organisms has demonstrated antimalarial activity, which supports the basic principle behind homeopathy, the law of similar.
Now I am just as puzzled!
Why would any responsible scientist advocate running a ‘full-fledged clinical trial’ on the basis of such flimsy and implausible findings?
Would that not be highly unethical?
Would one not do further in-vitro tests?
Then perhaps some animal studies?
Followed by first studies in humans?
Followed perhaps by a small pilot study?
And, if all these have generated positive results, eventually a proper clinical trial?
The answers to all these questions is YES.
But not in homeopathy, it seems!
The ‘Dr Rath Foundation’ just published a truly wonderful (full of wonders) article about me. I want to publicly congratulate the author: he got my name right [but sadly not much more]. Here is the opening passage of the article which I encourage everyone to read in full [the numbers in square brackets refer to my comments below].
Professor Edzard Ernst: A Career Built On Discrediting Natural Health Science? [1]
Professor Edzard Ernst, a retired German [2] physician and academic, has recently [3] become a prominent advocate of plans that could potentially outlaw [4] the entire profession of naturopathic doctors [5] in Germany. Promoting the nonsensical idea that naturopathic medicine somehow poses a risk to public health, Ernst attacks its practitioners as supposedly having been educated in “nonsense” [6]. Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own [7], Ernst’s apparent attempts to discredit natural healthcare approaches are largely reliant instead on his analysis or review of handpicked negative studies carried out by others [8].
- When I was appointed at Exeter to research alternative medicine in 1993, I had already been a full professor at Hannover, Germany and subsequently at Vienna, Austria. If anything, coming to Exeter was a big step down in terms of ‘career’, salary, number of co-workers etc. (full details in my memoir)
- I am German-born, became an Austrian citizen in 1990, and since 2000 I am a British national.
- I have been critical about the German ‘Heilpraktiker’ for more than 20 years.
- This refers to the recent ‘Muensteraner Memorandum’ which is the work of an entire team of multidisciplinary experts and advocates reforming this profession.
- ‘Heilpraktiker’ are certainly not doctors; they have no academic or medical background.
- This is correct, and I stand by my statement that educating people in vitalism and other long-obsolete concepts is pure nonsense.
- Since I am researching alternative medicine, I have conducted and published about 40 ‘scientific trials’, and before that time (1993) I have published about the same number again in various other fields.
- This refers to systematic reviews which, by definition, include all the studies available on a defines research question, regardless of their conclusion (their aim is to minimise random and selection biases) .
I hope you agree that these are a lot of mistakes (or are these even lies?) in just a short paragraph.
Now you probably ask: who is Dr Rath?
Many reader of this blog will have heard of him. This is what the Guardian had to say about this man:
Matthias Rath, the vitamin campaigner accused of endangering thousands of lives in South Africa by promoting his pills while denouncing conventional medicines as toxic and dangerous, has dropped a year-long libel action against the Guardian and been ordered to pay costs.
A qualified doctor who is thought to have made millions selling nutritional supplements around the globe through his website empire, Rath claimed his pills could reverse the course of Aids and distributed them free in South Africa, where campaigners, who have won a hard-fought battle to persuade the government to roll out free Aids drugs to keep millions alive, believe Rath’s activities led to deaths.
The Dr Rath Foundation focuses its promotional activities on eight countries – the US, the UK, Germany, the Netherlands, South Africa, Spain, France and Russia – claiming that his micronutrient products will cure not just Aids, but cancer, heart disease, strokes and other illnesses…
I am sure you now understand why I am rather proud of being defamed by this source!
This randomized controlled trial was aimed to investigate the effect of aromatherapy massage on anxiety, depression, and physiologic parameters in older patients with acute coronary syndrome. It was conducted on 90 older women with acute coronary syndrome. The participants were randomly assigned into the intervention and control groups. The intervention group received reflexology with lavender essential oil plus routine care and the control group only received routine care. Physiologic parameters, the levels of anxiety and depression in the hospital were evaluated using a checklist and the Hospital’s Anxiety and Depression Scale, respectively, before and immediately after the intervention.
Significant differences in the levels of anxiety and depression were reported between the groups after the intervention. The analysis of physiological parameters revealed a statistically significant reduction in systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. However, no significant difference was observed in the respiratory rate.
The authors concluded that aromatherapy massage can be considered by clinical nurses an efficient therapy for alleviating psychological and physiological responses among older women suffering from acute coronary syndrome.
WRONG!
This trial does not show remotely what the authors think. It demonstrates that A+B is always more than B. We have discussed this phenomenon so often that I hesitate to mention it again. Any study with the ‘A+B versus B’ design can only produce a positive result. The danger that this result is false-positive is so high that it is best to forget about such investigations altogether.
Ethics committees should not accept such protocols.
Researchers should stop running such studies.
Reviewers should not pass them for publication.
Editors should not publish such trials.
THEY MISLEAD ALL OF US AND GIVE CLINICAL RESEARCH A BAD NAME.
Gastro-oesophageal reflux disease (GORD) is a common, benign condition. It can be treated by changing eating habits or drugs. Many alternative therapies are also on offer, for instance, acupuncture. But does it work? Let’s find out.
The objective of this meta-analysis was to explore the effectiveness of acupuncture for the treatment of gastro-oesophageal reflux disease (GORD). Four English and four Chinese databases were searched through June 2016. Randomised controlled trials investigating the effectiveness of manual acupuncture or electroacupuncture (MA/EA) for GORD versus or as an adjunct to Western medicine (WM) were selected.
A total of 12 trials involving 1235 patients were included. The results demonstrated that patients receiving MA/EA combined with WM had a superior global symptom improvement compared with those receiving WM alone with no significant heterogeneity. Recurrence rates of those receiving MA/EA alone were lower than those receiving WM with low heterogeneity, while global symptom improvement (six studies) and symptom scores (three studies) were similar. Descriptive analyses suggested that acupuncture also improves quality of life in patients with GORD.
The authors concluded that this meta-analysis suggests that acupuncture is an effective and safe treatment for GORD. However, due to the small sample size and poor methodological quality of the included trials, further studies are required to validate our conclusions.
I am glad the authors used the verb ‘suggest’ in their conclusions. In fact, even this cautious terminology is too strong, in my view. Here are 9 reasons why:
- The hypothesis that acupuncture is effective for GORD lacks plausibility.
- All the studies were of poor or very poor methodological quality.
- All but one were from China, and we know that all acupuncture trials from this country are positive, thus casting serious doubt on their validity.
- Six trials had the infamous ‘A+B versus B’ design which never generates a negative result.
- There was evidence of publication bias, i. e. negative trials had disappeared and were thus not included in the meta-analysis.
- None of the trials made an attempt to control for placebo effects by using a sham-control procedure.
- None used patient-blinding.
- The safety of a therapy cannot be assessed on the basis of 12 trials
- Seven studies failed to report adverse effects, thus violating research ethics.
Considering these facts, I think that a different conclusion would have been more appropriate: this meta-analysis provides no good evidence for the assumption that acupuncture is an effective and safe treatment for GORD.
Insomnia is a ‘gold standard’ indication for alternative therapies of all types. In fact, it is difficult to find a single of these treatments that are not being touted for this indication. Consequently, it has become a nice little earner for alternative therapists (hence ‘gold standard’).
But how good is the evidence suggesting that any alternative therapy is effective for insomnia?
Whenever I have discussed this issue on my blog, the conclusion was that the evidence is less than convincing or even negative. Similarly, whenever I conducted proper systematic reviews in this area, the evidence turned out to be weak or negative. Here are four of the conclusions we drew at the time:
- The evidence for acupuncture as a treatment of insomnia is plagued by important limitations, e.g. the poor quality of most primary studies and some systematic reviews. Those that are sensitive to such limitations, fail to arrive at a positive verdict about the effectiveness of acupuncture.
- We conclude that, because of the paucity and of the poor quality of the data, the evidence for the effectiveness of auricular acupuncture for the symptomatic treatment of insomnia is limited. Further, rigorously designed trials are warranted to confirm these results.
- The evidence for valerian as a treatment for insomnia is inconclusive.
- Evidence from RCTs does not show homeopathy to be an effective treatment for insomnia and sleep-related disorders. (FACT, 2011, 16:195-99)
“But this ERNST fellow cannot be trusted, he is not objective!”, I hear some of my detractors shout.
But is he really?
Would an independent, high-level panel of experts arrive at more positive conclusions?
Let’s find out!
This European guideline for the diagnosis and treatment of insomnia recently provided recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to grade the evidence and guide recommendations.
The findings and recommendations are as follows:
- Cognitive behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (strong recommendation, high-quality evidence).
- A pharmacological intervention can be offered if cognitive behavioural therapy for insomnia is not sufficiently effective or not available. Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4 weeks; weak recommendation, moderate-quality evidence). Antihistamines, antipsychotics, melatonin and phytotherapeutics are not recommended for insomnia treatment (strong to weak recommendations, low- to very-low-quality evidence).
- Light therapy and exercise need to be further evaluated to judge their usefulness in the treatment of insomnia (weak recommendation, low-quality evidence).
- Complementary and alternative treatments (e.g. homeopathy, acupuncture) are not recommended for insomnia treatment (weak recommendation, very-low-quality evidence).
I think, I can rest my case.
The claimed benefits of Shinrin-yoku are remarkable:
- Boosted immune system functioning, with an increase in the count of the body’s Natural Killer (NK) cells.
- Reduced blood pressure
- Reduced stress
- Improved mood
- Increased ability to focus, even in children with ADHD
- Accelerated recovery from surgery or illness
- Increased energy level
- Improved sleep
- Deeper and clearer intuition
- Increased flow of energy
- Increased capacity to communicate with the land and its species
- Increased flow of eros/life force
- Deepening of friendships
- Overall increase in sense of happiness
But is any of this really true?
The aim of this state-of-the-art review was to summarise empirical research conducted on the physiological and psychological effects of Shinrin-Yoku. Research published from 2007 to 2017 was considered. A total of 64 studies met the inclusion criteria. According to the authors, they show that health benefits associated with the immersion in nature continue to be currently researched. Longitudinal research, conducted worldwide, is needed to produce new evidence of the relationships associated with Shinrin-Yoku and clinical therapeutic effects. Nature therapy as a health-promotion method and potential universal health model is implicated for the reduction of reported modern-day “stress-state” and “technostress.”
Odd?
Yes!
A look at the primary studies reveals that they are usually small and of poor quality.
Perhaps a brand new review aimed more specifically at evaluating preventive or therapeutic effects of Shinrin-Yoku on blood pressure can tell us more. The authors considered all published, randomized, controlled trials, cohort studies, and comparative studies that evaluated the effects of the forest environment on changes in systolic blood pressure. Twenty trials involving 732 participants were reviewed. Systolic and diastolic blood pressure of patients submitted to the forest environment was significantly lower than that of controls. The authors concluded that this systematic review shows a significant effect of Shinrin-yoku on reduction of blood pressure.
I find this paper odd as well:
- it lacks important methodological detail;
- the authors included not just controlled clinical trials but all sorts of ‘studies’;
- there is no assessment of the methodological rigor of the primary trials (from what I could see, they were mostly too poor to draw any conclusions from them).
What does all of this mean?
I have no problems in assuming that relaxation in a forest is beneficial in many ways and a nice experience.
But why call this a therapy?
It is relaxation!
Why make so many unsubstantiated claims?
And why study it in such obviously flawed ways?
All this does, I fear, is giving science a bad name.
The UK ‘Faculty of Homeopathy’ (FoH) is the professional body of British doctors who specialise in homeopathy. As doctors, FoH members have been to medical school and should know about evidence, science etc., I had always thought. But perhaps I was mistaken?
The FoH has a website with an interesting new post entitled ‘Scientific evidence and Homeopathy’. Here I have copied the section on CLINICAL TRIALS OF HOMEOPATHY. I have read it several times and must admit: it is a masterpiece, in my view – not a masterpiece in accurate reporting, but a masterpiece in misleading the public. The first and most obvious thing that struck me is the fact that is cites not a single clinical trial. But read for yourself (the numbers in round brackets were inserted by me and refer to my comments below):
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By August 2017 1,138 clinical trials of homeopathy had been published (1). Details can be found on the CORE-HOM database also maintained by the Carstens Foundation and accessible without charge: http://archiv.carstens-stiftung.de/core-hom
Four (2) systematic review/meta-analyses of homeopathy for all conditions have been published.[26],[27],[28] Of these, three (3) reached a positive conclusion: that there is evidence that homeopathy is clinically effective (4). The exception is the review by Shang et al.46 This meta-analysis was controversial, particularly because its conclusions were based on only eight clinical trials whose identity was concealed until several months after the publication, precluding informed examination of its results (5) (6). The only undisputed conclusion (7) of this paper is that clinical trials of homeopathy are of higher quality than matched trials of conventional medicine: of 110 clinical trials each of homeopathy and conventional medicine, 21 trials of homeopathy but only 9 trials of conventional medicine were of ‘higher quality’.[29] [30]
A leading Swedish medical researcher (8) remarked: “To conclude that homeopathy lacks clinical effect, more than 90% of the available clinical trials had to be disregarded. Alternatively, flawed statistical methods had to be applied.”[31] Higher quality equates to less risk of bias, Mathie et al analysed randomized clinical trials of individualized homeopathy, showing that the highest quality trials yielded positive results (9).[32]
Systematic reviews of randomized controlled trials of homeopathy in specific clinical situations have also yielded positive results, including: allergies and upper respiratory tract infections (2 systematic reviews),[33],[34] (10) (11) Arnica in knee surgery,[35] (12) Childhood diarrhoea,[36] Post-operative ileus,[37] (13) Rheumatic diseases,[38] (14) Seasonal allergic rhinitis (hay fever) (2 systematic reviews),[39] [40] (15) (16) and vertigo.[41] (17)
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MY COMMENTS:
- This is a wild exaggeration which was made possible by counting all sorts of clinical reports as ‘clinical trials’. A clinical trial “follows a pre-defined plan or protocol to evaluate the effects of a medical or behavioral intervention on health outcomes.” This would exclude most observational studies, case series, case reports. However, the figure cited here includes such reports.
- The author cites only three!
- Does the author mean ‘two’?
- This is not quite true! I have dedicated an entire post to this issue.
- True, the Shang meta-analysis has been criticised – but exclusively by homeopaths who, for obvious reasons, were unable to accept its negative findings. In fact, it is a solid piece of research.
- Why does the author not mention the most recent systematic review of homeopathy? Perhaps because it concluded: Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
- Really? Undisputed? Even by the logic of the author’s last sentence, this would be disputed.
- The ‘leading researcher’ is Prof Hahn who has featured many times on my blog. He seems to be more than a little unhinged when it comes to the topic of homeopathy.
- The author forgot to mention that Mathie – who was sponsored by the British Homeopathic Association – included this little caveat in his conclusions: The low or unclear overall quality of the evidence prompts caution in interpreting the findings.
- Reference 33 is the infamous ‘Swiss report’ that has been shown to be fatally flawed over and over again.
- Reference 34 refers to a review that fails to adhere to almost all the criteria of a systematic review.
- This review concluded: In all three trials, patients receiving homeopathic arnica showed a trend towards less postoperative swelling compared to patients receiving placebo. However, a significant difference in favour of homeopathic arnica was only found in the CLR trial. Only a deluded homeopath can call this a ‘positive result’.
- This is a systematic review by my team. It showed that several flawed trials produced a false positive result, while the only large multicentre trial was negative. Our conclusions therefore include the statement that several caveats preclude a definitive judgment. Only a deluded homeopath can call this a ‘positive result’.
- This reference refers to the following abstract: Despite a growing interest in uncovering the basic mechanisms of arthritis, medical treatment remains symptomatic. Current medical treatments do not consistently halt the long-term progression of these diseases, and surgery may still be needed to restore mechanical function in large joints. Patients with rheumatic syndromes often seek alternative therapies, with homeopathy being one of the most frequent. Homeopathy is one of the most frequently used complementary therapies worldwide. Only a deluded homeopath can call this a ‘positive result’.
- The first reference refers to a paper where the author analysed three of his own studies.
- Reference 40 refers to a review that fails to adhere to almost all the criteria of a systematic review.
- This reference refers to a review of Vertigoheel@ that includes observational studies. One of its authors was an employee of the manufacturer of the product. Vertigoheel is not a homeopathic remedy (it does not adhere to the ‘like cures like’ principle) but a homotoxicologic product. Homotoxicology is a method inspired by homeopathy which was developed by Hans Heinrich Reckeweg (1905 – 1985). He believed that all or most illness is caused by an overload of toxins in the body. The toxins originate, according to Reckeweg, both from the environment and from the malfunction of physiological processes within the body. His treatment consists mainly in applying homeopathic remedies which usually consist of combinations of single remedies, because health cannot be achieved without ridding the body of toxins. The largest manufacturer and promoter of remedies used in homotoxicology is the German firm Heel. Our own systematic review of RCTs of homotoxicology included 7 trials which were mostly of a high methodological standard, according to the Jadad score. The trials tested the efficacy of seven different medicines for seven different indications. The results were positive in all but one study. Important flaws were found in all trials. These render the results of the primary studies less reliable than their high Jadad scores might suggest. Despite mostly positive findings and high ratings on the Jadad score, the placebo-controlled, randomised clinical trials of homotoxicology fail to demonstrate the efficacy of this therapeutic approach.
So!
What do we make of all this?
To say that it is disappointing would, I think, be an understatement. The FoH is not supposed to be a lobby group of amateurs ignorant of science and evidence; it is a recognised professional organisation who must behave ethically. Patients and consumers should be able to trust the FoH. The fact that the FoH publish misinformation on such a scale should, in my view, be a matter for the General Medical Council.
