MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

clinical trial

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This systematic review aimed to identify and explore published studies on the health, wellbeing and economic impact of retreat experiences. Three electronic databases were searched for residential retreat studies published in English. Studies were included, if they involved an intervention program in a residential setting of one or more nights, and included before-and-after data related to the health of participants.

A total of 23 studies including 8 randomised controlled trials, 6 non-randomised controlled trials and 9 longitudinal cohort studies met the inclusion criteria. These studies included a total of 2592 participants from diverse geographical and demographic populations and a great heterogeneity of outcome measures, with 7 studies examining objective outcomes such as blood pressure or biological makers of disease, and 16 studies examining subjective outcomes that mostly involved self-reported questionnaires on psychological and spiritual measures.

All studies reported post-retreat health benefits ranging from immediately after to five-years post-retreat. Study populations varied widely and most studies had small sample sizes, poorly described methodology and little follow-up data, and no studies reported on health economic outcomes or adverse effects, making it difficult to make definite conclusions about specific conditions, safety or return on investment.

The authors concluded that health retreat experiences appear to have health benefits that include benefits for people with chronic diseases such as multiple sclerosis, various cancers, HIV/AIDS, heart conditions and mental health. Future research with larger numbers of subjects and longer follow-up periods are needed to investigate the health impact of different retreat experiences and the clinical populations most likely to benefit. Further studies are also needed to determine the economic benefits of retreat experiences for individuals, as well as for businesses, health insurers and policy makers.

In the article, the authors also state that the findings from the reviewed studies suggest there are many positive health benefits from retreat experiences that includes improvements in both subjective and objective measures… The results from the most rigorous studies that used randomized controlled designs were consistent with less rigorous studies and suggest that retreat experiences can produce benefits that include positive changes in metabolic and neurological pathways, loss of weight, blood pressure and abdominal girth, reduction in health symptoms and improvements in quality of life and subjective wellbeing.

As it happens, we have discussed one of their ‘most rigorous’ RCTs on this blog. Here is what I wrote about it when it was first published:

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… 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… 

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The subject of health retreats could be relevant and important. Educating people and teaching them the essentials about healthy life-styles is potentially a good thing. It could well turn out that health retreats benefit many individuals, while saving money for society.

Yet, do we need all sorts of quackery for achieving this aim?

No, we don’t!

A rational programme would need to teach and motivate people about diet, weight control, smoking cessation, regular sleep, relaxation, exercise, etc. It could prevent disease and save funds. This approach has existed in Europe long before the US ‘New Agers’ with their flimflam jumped on this bandwagon. Health education is a good idea, but it does not require the use of alternative therapies or luxury retreats.

As it turns out, the new systematic review is a disappointment. It fails to stress that no firm conclusions can be drawn from flimsy data and degenerates into little more than an embarrassing advertisement for Deepak Chopra’s and similar entrepreneurs’ money-making retreats. It totally ignores the sizable body of Non-English literature on the subject, and is focussed on promoting fashionable retreats and wellness centres in the US and Australia.

To be fair to the authors, they almost admit as much when they state: “Competing interests: MC is a board member of the Global Wellness Summit and has previously been a paid presenter at the Gwinganna Health Retreat. RMIT University has received donations from Danubius Hotel Group, Lapinha, Sunswept Resorts, Sheenjoy and The Golden Door for ongoing retreat research.”

I rest my case.

Can conventional therapy (CT) be combined with herbal therapy (CT + H) in the management of Alzheimer’s disease (AD) to the benefit of patients? This was the question investigated by Chinese researchers in a recent retrospective cohort study funded by grants from China Ministry of Education, National Natural Science Foundation of China, Beijing Municipal Science and Technology Commission, and Beijing Municipal Commission of Health and Family Planning.

In total, 344 outpatients diagnosed as probable dementia due to AD were collected, who had received either CT + H or CT alone. The GRAPE formula was prescribed for AD patients after every visit according to TCM theory. It consisted mainly (what does ‘mainly’ mean as a description of a trial intervention?) of Ren shen (Panax ginseng, 10 g/d), Di huang (Rehmannia glutinosa, 30 g/d), Cang pu (Acorus tatarinowii, 10 g/d), Yuan zhi (Polygala tenuifolia, 10 g/d), Yin yanghuo (Epimedium brevicornu, 10 g/d), Shan zhuyu (Cornus officinalis, 10 g/d), Rou congrong (Cistanche deserticola, 10 g/d), Yu jin (Curcuma aromatica, 10 g/d), Dan shen (Salvia miltiorrhiza, 10 g/d), Dang gui (Angelica sinensis, 10 g/d), Tian ma (Gastrodia elata, 10 g/d), and Huang lian (Coptis chinensis, 10 g/d), supplied by Beijing Tcmages Pharmaceutical Co., LTD. Daily dose was taken twice and dissolved in 150 ml hot water each time. Cognitive function was quantified by the mini-mental state examination (MMSE) every 3 months for 24 months.

The results show that most of the patients were initially diagnosed with mild (MMSE = 21-26, n = 177) and moderate (MMSE = 10-20, n = 137) dementia. At 18 months, CT+ H patients scored on average 1.76 (P = 0.002) better than CT patients, and at 24 months, patients scored on average 2.52 (P < 0.001) better. At 24 months, the patients with improved cognitive function (△MMSE ≥ 0) in CT + H was more than CT alone (33.33% vs 7.69%, P = 0.020). Interestingly, patients with mild AD received the most robust benefit from CT + H therapy. The deterioration of the cognitive function was largely prevented at 24 months (ΔMMSE = -0.06), a significant improvement from CT alone (ΔMMSE = -2.66, P = 0.005).

 

The authors concluded that, compared to CT alone, CT + H significantly benefited AD patients. A symptomatic effect of CT + H was more pronounced with time. Cognitive decline was substantially decelerated in patients with moderate severity, while the cognitive function was largely stabilized in patients with mild severity over two years. These results imply that Chinese herbal medicines may provide an alternative and additive treatment for AD.

Conclusions like these render me speechless – well, almost speechless. This was nothing more than a retrospective chart analysis. It is not possible to draw causal conclusions from such data.

Why?

Because of a whole host of reasons. Most crucially, the CT+H patients were almost certainly a different and therefore non-comparable population to the CT patients. This flaw is so elementary that I need to ask, who are the reviewers letting such utter nonsense pass, and which journal would publish such rubbish? In fact, I can be used for teaching students why randomisation is essential, if we aim to find out about cause and effect.

Ahhh, it’s the ! I think the funders, editors, reviewers, and authors of this paper should all go and hide in shame.

The question whether chiropractic is a truly valuable option for people suffering from back pain has been addressed repeatedly on this blog. My answer was usually negative, but proponents of chiropractic tended to argue that I am biased. Therefore I find it constructive to see what an organisation that hardly can be accused of bias says on this topic. An article by ‘SHOW ME THE EVIDENCE’ has recently provided a comprehensive overview of treatments for back pain. This is what they wrote about chiropractic:

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Spinal manipulation, the cranking and tweaking on offer when you visit a traditional chiropractor, is among the most popular approaches to back pain. Practitioners lay their hands on the patient and move their joints to or beyond their range of motion — a technique that’s often accompanied by a pop or crack.

There is some evidence the approach can help people with chronic back pain — but not any more than over-the-counter painkillers or exercise, and you need to take precautions when seeking out a chiropractor.

First, a quick look at the evidence. There are two recent Cochrane reviews on spinal manipulation for low back pain: one focused on people with acute (again, episodic/short duration) pain and the other on chronic pain. The 2011 review on chronic low back pain found that spinal manipulation had small, short-term effects on reducing pain and improving the patient’s functional status — but this effect was about the same as other common therapies for chronic low back pain, such as exercise. That review was published in 2011; UpToDate reviewed the randomized trials that have come out since — and also found that spinal manipulation delivered modest, short-term benefits for chronic back pain sufferers.

The Cochrane review on acute pain found that spinal manipulation worked no better than placebo. So people with a short episode of back pain should probably not bother seeing a chiropractor.

“Based on the evidence,” University of Amsterdam assistant professor Sidney Rubinstein, who is the lead author on the Cochrane reviews, told me, “it would appear [spinal manipulation] works as well as other accepted conservative therapies for chronic low back pain, such as non-prescription medication or exercise, but less well for patients with acute low back pain.”

As a chiropractor himself, he had some advice for patients: They should avoid chiropractors who routinely make X-rays or do advanced diagnostics for low back pain because this adds nothing to the clinical picture, particularly in the case of nonspecific low back pain. Patients should also beware chiropractors who put them on extended programs of care.

“Patients who respond to chiropractic care traditionally respond rather quickly,” he said. “My advice is those patients who have not responded to a short course of chiropractic care or manipulation should consider another type of therapy.”

While the risks of serious side effects from spinal manipulation for back pain are rare — about one in 10 million — the risks associated with chiropractic therapy for neck pain tend to be slightly higher: 1.46 strokes for every million neck adjustments.

The issue is the vertebral artery, which travels from the neck down through the vertebrae. Manipulating the neck can put patients at a higher risk of arterial problems, including stroke or vertebral artery dissection, or the tearing of the vertebral artery (though Rubinstein noted that people in the initial stages of stroke or dissection may also seek out care for their symptoms, such as neck pain, which makes it difficult to untangle how many of health emergencies are brought on by the adjustments).

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This all seems fairly reasonable to me – except for the following not entirely unimportant points:

  • I am not sure where the evidence about risks of spinal manipulation comes from. In my view, it is not entirely correct: as there is no effective post-marketing surveillance, we cannot possibly name the incidence figures.
  • Neck manipulations are clearly more risky than manipulations lower down. But this does not necessarily mean that back patients are safer than those with neck pain. Chiropractors view the spine as a whole organ and will regularly manipulate the neck (if they sense ‘subluxations’ in this area), even if the patient comes with low back pain.
  • There are also indirect risks with consulting a chiropractor; for instance, they often give incompetent advice about healthcare. This can include discouraging immunisations or treating serious diseases, such as asthma, colic etc., with chiropractic.
  • I think the article should point out that exercise is not just as effective (or as ineffective) as chiropractic, but it is much safer and less expensive.
  • What Rubinstein says about responders is debatable, in my view. In particular, most chiropractors will convince their patients to continue treatment, even if they do not ‘respond’. And ‘responding’ might be simply the natural history of the condition and therefore totally unrelated to the therapy.

The bottom line: Chiropractic is not the best treatment for back pain!

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.

9. It kills bad breath. You might have heard that the antibacterial properties of vinegar can kill microorganisms responsible for bad breath — and in theory, this is true. However, Johnston warns, “it’s no more effective than any other antibacterial agents, and there are better products designed for this purpose.”

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:

  1. 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.
  2. Niedzielin, K., Kordecki, H.,
    http://journals.lww.com/eurojgh/Abstract/2001/10000/A_controlled,_double_blind,_randomized_study_on.4.aspx
  3. 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
  4. Rastmanesh R., et al. High polyphenol, low probiotic diet for weight loss because of intestinal microbiota interaction. Chemico-Biological InteractionsPublished 15 October 2010.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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 . 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.

Park Sham Device Set

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…

END OF QUOTE

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].

  1. 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)
  2. I am German-born, became an Austrian citizen in 1990, and since 2000 I am a British national.
  3. I have been critical about the German ‘Heilpraktiker’ for more than 20 years.
  4. This refers to the recent ‘Muensteraner Memorandum’ which is the work of an entire team of multidisciplinary experts and advocates reforming this profession.
  5. ‘Heilpraktiker’ are certainly not doctors; they have no academic or medical background.
  6. This is correct, and I stand by my statement that educating people in vitalism and other long-obsolete concepts is pure nonsense.
  7. 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.
  8. 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:

  1. The hypothesis that acupuncture is effective for GORD lacks plausibility.
  2. All the studies were of poor or very poor methodological quality.
  3. 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.
  4. Six trials had the infamous ‘A+B versus B’ design which never generates a negative result.
  5. There was evidence of publication bias, i. e. negative trials had disappeared and were thus not included in the meta-analysis.
  6. None of the trials made an attempt to control for placebo effects by using a sham-control procedure.
  7. None used patient-blinding.
  8. The safety of a therapy cannot be assessed on the basis of 12 trials
  9. 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.

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