Polanco and San Sebastian

The Choral Festival here has booked us in outreach concerts all around the area. Sadly two of these are somewhat far flung. Last afternoon we boarded the bus for a 2.5 hour ride to Polanco a little hillside town population 5500 almost directly west of here. On arrival we had a quick rehearsal. In the church where we were to perform originally a Roman temple now restored after a fire during

The other Kuta

Natalie39s in the shower and I39m checking my email when the alarm goes off. Kai and Netta knock while I39m checking the room for anything we39ve forgotten and we head to the ferry port. 10000R each for a ticket on the feryy to that39ll leave as soon as there39s 25 passengers. We wait two minutes.At Bangsal port we get jumped by taxi drivers and we have no idea where we are go

Paul and Janet Australia Vacation

Last night we saw a huge colony of bats in the botanic gardens. They are the size of large cats with a 3 foot wingspan....Paul says they are really the size of rats with a 1 foot wingspan......don39t listen to him. This morning we took the ferry to Taronga zoo. We were up close and personal with wallabies and wombats after this we went on a walkabout along the coast of the bay. The day was gorg

A town for photographers

I took a minibus from Vang Viang to Luang Prabang 6hrs through the mountains and valleys the scenery absolutely stunning. We stopped at the top of the mountains for lunch. Getting out of the minibus everyone was saying toilet toilet and showing you where. Then you go and they all say 2000 2000 Have to laugh. When we arrived in Luang Prabang the driver then said more money more money because h

Baie de Lan Ha magique

A quelques heures de la baie dHalong surpeuple de touristes chinois et occidentaux la baie de Lan Ha est tout aussi fabuleuse et nous y sommes pratiquement seuls Incroyable le spectacle qui soffre a nous Plongs dans une lgre brume des lots en forme de pain de sucre recouverts de vgtation mergent au hasard des flots vert meraude. Le dcor est splendide et la jonque en

Day 1 in Sydney

The flight in was good. Technically I drank and watched movies for 2 days straight since I crossed the international dateline. Lets just say I think I did some good damage to their Bacardi stash. My first day in Sydney was very interesting to say the least. First I found out that verizon wireless phones at least mine is not compatible with SIM cards. So I had to use the payphone to try and call

To Food or Not to Food that is the Question

Sitting around the house today we began discussing all the things we are going to miss about Seoul and South Korea in particular. Shauna and I have both agreed that most of what we miss about Calgary are all the great food locations we use to frequent like1. Peter39s Drivein for magnificent milkshakes2. Oriental Palace for amazing Chinese food in Parkdale3. La Vienna for traditional Ital

Bohol and the chocolate Hills

I took the 730 boat from Dumaguete to Tagbilaran on Bohol then after taking a habalhabal to the jeepney station I caught a jeepney to Nuts Huts. Not sure where I wanted to get off I was hoping the guy I paid would let me know but he fell asleep so after passing the sign I told the lady next to me and the bus stopped not too far down the road. It was then a 20 min walk from the road through the f

A taste of Chiang Mai

Norma and myself caught the bus from Ayutthaya to Chaing Mai during the day eventually and after the tuktuk driver took us to the train station instead of the bus station another 7km away even that wasnt simple. On the 10hr drive north with an amazing amount of leg room you could see where the floods had hit and there was some houses nearly completely submerged. But on arriving in Chaing Mai t

A normal weekend

Its the weekend Wow what it feels like to have a weekend. Saturday I caught up with Norma and we went to the Irish bar in town to watch the Rugby matches. First the Ireland game and after eating a delicious lunch of blueberry pancakes the England game. Gutted but they both lost. After dinner we watched The Three Muscateers at the cinema. A normal day for a change is so good when your travelling a

Friday evening celebrations and the Lao border

Friday evening Tou one of the Thai girls on the class organised for us all to go out for dinner. It was great We all went to River View restaurant Tou picked some of us up from the school in her pick up truck and we all crammed in the back of it Lida our instructor also came and the two of them ordered so much food for us all to share it was crazy and we all ordered a dish aswell. By the end

Amasya

Its been awhile now since I was in Amasya and so much has happened since that I was going to skip saying anything about it. But then I thought of the lovely little city with its mountains pockmarked by the tombs of ancient Pontic kings elbowing their way into the streets and I realized that it just wasnt fair. I liked Amaysa from the moment the bus pulled into the small otogar.

TSOMORIRI LAKE

TsomoririThe Tsomoriri Lake is a beautiful mountain bounded expanse of water around 240 Kms. from Leh. The lake is located at 14000 ft. near the small village of Korzok. Korzok is sparsely populated and is the only permanent settlement in Rupshu which is otherwise inhabited only by nomadic Changpa herdsmen. Though it is much smaller than the Pangong lake it is equally spectacular and is the b

October Long Weekend

Well Week Two is done and dusted and wasn39t it awesome to finish on a Thursday thanks Queenie. The week itself was just as busy as normal thoughon Monday night Beck and I went to SIK boxing on the marsh and my muscles waged war on me for the next 3 days at least. Wednesday night was mixed netball and Thursday night was volleyball and then the staff Halloween Party. I got to bed after midnig

NUBRA VALLEY

Nubra 39the valley of flowers39 is located in the north of Leh around 120 kms across Khardung La 18380ft the world39s highest motorable road. Nubra used to be an important trade center on the famous silk route leading from Leh to Kashgar through the two passes of Saser and Karakoram. The main attractions of this region are the Bactrian camels double humped camels KhardungLa Pass

Milk Thistle and Mushroom Poisoning

If you’ve been fortunate to live in the parts of the US that were soggier than usually as of late – or unfortunate enough to have had flooding from hurricanes and tropical storms – then you’ve be noticing a tremendous burst of mushrooms.

For mycologists – mushroom enthusiasts – there are two classic chestnuts: “There are old mushroom collectors and bold mushrooms collectors, but there are no old, bold mushroom collectors.”

Or, in a more concise Croatian proverb, “All mushrooms are edible, but some only once.”

As such, this is the time of year that emergency rooms and regional poison centers begin to see a burst in poisonings from mushroom ingestion, due primarily to amateur misidentification of the fruiting bodies.

Just this past week, Jason McClure at Medscape Oncology News (free reg req’d) wrote about the unusual bloom of mushrooms in the northeastern US and the concomitant bloom of mushroom poisonings this fall.

But “mushroom poisoning” is an imprecise diagnosis for the ER physician. The constellation of symptoms caused by toxic mushrooms is as diverse as the colors and shapes of these wonders of nature. From another Medscape article on emergency management of mushroom poisoning by Dr. Rania Habal from the Emergency Medicine department of NYU:

Mushrooms are best classified by the physiologic and clinical effects of their poisons. The traditional time-based classification of mushrooms into an early/low toxicity group and a delayed/high toxicity group may be inadequate. Additionally, many mushroom syndromes develop soon after ingestion. For example, most of the neurotoxic syndromes, the Coprinus syndrome (ie, concomitant ingestion of alcohol and coprine), the immunoallergic and immunohemolytic syndromes, and most of the GI intoxications occur within the first 6 hours after ingestion.

Ingestions most likely to require intensive medical care involve mushrooms that contain cytotoxic substances such as amatoxin, gyromitrin, and orellanine. Mushrooms that contain involutin may cause a life-threatening immune-mediated hemolysis with hemoglobinuria and renal failure. Inhalation of spores of Lycoperdon species may result in bronchoalveolitis and respiratory failure that requires mechanical ventilation.

Mushrooms that contain the GI irritants psilocybin, ibotenic acid, muscimol, and muscarine may cause critical illness in specific groups of people (eg, young persons, elderly persons). Hallucinogenic mushrooms may also result in major trauma and require care in an intensive care setting. Lastly, coprine-containing mushrooms cause severe illness only when combined with alcohol (ie, Coprinus syndrome).

Among the poisonous mushrooms, Amanita phalloides is perhaps the most deadly. If you’ve spent any time in a biochemical laboratory you will have learned of the primary toxin of the mushroom, α-amanitin. This potency of this toxin comes from its remarkably high affinity for RNA polymerase II, the primary RNA polymerase for making messages that are converted into proteins.

The challenge in treating α-amanitin poisoning is that it has a relatively long half-life in the body because it is conjugated with glucuronic acid in the liver and secreted in the bile. But then microbes that normally inhabit our gut cleave the glucuronide sugar molecule off the toxin, released the toxic α-amanitin.

Throughout the history of folk medicine in the Middle East and Europe, extracts of the seeds of milk thistle (Silybum marianum) were determined to have protective effects against liver toxins. I’m still not terribly pleased with understanding the history of how this came about but answering this question is one of my liberal arts pursuits. As an aside, I should make the disclosure that my laboratory and colleagues have been investigating the anticancer effects of compounds from milk thistle and still receive NIH funding to do so; however, I do not (yet) study how milk thistle compounds prevent liver toxicity.

Nevertheless, milk thistle products are quite popular in Europe and the US for the general prevention of liver toxicity from statins, acetaminophen, and alcohol. Several of my friends have joked that one could make create a successful market for an alcoholic product containing milk thistle extract.

But one of the primary roadblocks in using milk thistle extracts or pure compounds for any indication is that the compounds have rather poor bioavailability. The seven major flavonolignans and one flavonoid in the typical extracts are very avidly conjugated by glucuronidation. In studies by collabortors at the University of Colorado, we now know that it takes daily doses of approximately 10-13 grams of milk thistle extract to achieve plasma concentrations consistent with known anticancer effects in vitro. It can be done, but it means taking much more than the typical 180 mg capsules you can buy at your local health food store.

However, an intravenous preparation of milk thistle extract has been available in Europe for over 20 years: Legalon SIL. This GMP-manufactured product is common to emergency rooms in Germany, France, and Belgium for the treatment of mushroom poisoning. The preparation is comprised of silybin A and silybin B – known collectively as silibinin – as a hemisuccinate that both improves the solubility and bioavailability of the compounds.

Two cases in the US – one in 2007 and another just this past month – have seen emergency IND approval of this European product. In 2007, Legalon was used to save four of five family members who had ingested Amanita phalloides while on a New Year’s Day picnic outside of Santa Cruz, California. And just last month, a team led by Dr. Jacqueline Laurin at Georgetown Medical Center successfully treated two men for accidental ingestion of Amanita. Georgetown is now an approved referral center for this IV prep of Legalon and their efforts were greatly assisted by the Santa Cruz team who handled the 2007 cases.

Less satisfying to me is the mechanism by which silybin A and silybin B protect the liver from the effects of RNA polymerase II inhibition by α-amanitin. The literature to date seems to converge on the inhibition of toxin uptake into hepatocytes by silibinin. A German group led by Herbert de Groot in Essen, Germany, published a highly-cited 1996 paper proposing that inhibition of inflammatory mediator release from Kupffer cells (the macrophage of the liver) might partly account for the hepatoprotective effects of silibinin. More recent work continues to address the modulation of inflammation.

Regardless, we are now seeing legitimate use of a medicine from a herbal tradition being used in clinical situations where emergency IRB approval and IND status have been given to such a product. Certainly, these stories may be used by marketers to promote use of their oral milk thistle products. But, as I mentioned earlier, such effects required ingestion of large doses of capsules. Instead, I present this story to SBM readers to illustrate that amidst the wooful promotion of herbal therapies, a few gems exist and are most worthy of our scientific investigation.

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Please Don’t Define “Complementary and Alternative Health Practices”!

Since I have a master’s and doctoral degree in health education and since I’m a professor in a department of public health with an undergraduate curriculum that includes substantial attention to health education, I participate in the email discussion group of HEDIR, the Health Education Directory. On August 16th, I received a message to the discussion group from the American Association for Health Education inviting participants to complete an online survey from the Joint Committee on Health Education and Promotion Terminology with results to be analyzed at the Committee’s meeting in September 2011.

The survey items include various terms used by health educators, the currently approved terminology, and three choices followed by a type-in box:

  • This term should remain as defined
  • This term should remain in the report but modified in definition
  • This term is no longer commonly used in health education/health promotion literature

If modify, please provide the suggested wording and reference for that definition if you are citing it from a specific source.

For one of the terms, my preferred response would have be have been a fourth choice that was not offered: The term is commonly used in health education/health promotion and elsewhere, but it should not be used because its use only serves to distort our thought processes and promote quackery.

Here is the term along with the definition presented in the survey:

Complementary and Alternative Health Practices: These practices generally include natural substances, physical manipulations, and self-care modalities. These approaches often incorporate aspects of interventions derived from traditional practices. The approach in Western societies has been to select specific approaches from these systems and apply them to health maintenance, health enhancement, or disease management. Such approaches can be used to compliment[sic] conventional allopathic care (complementary therapy), or as an alternative to conventional approaches (alternative therapy). Many of these complementary and alternative approaches have not been validated through experiential research, but those that have, such as acupuncture for pain, are being integrated into conventional health practices (integrative medicine).

And here are my objections to the term and to the definition given:

“Complementary and alternative health practices” is marketing doublespeak that conceals how promoting (via advertising, publicity, direct selling, word-of-mouth, etc.) non-validated or invalidated practices is unethical. When a practice is science-based, it is simply part of good healthcare or health promotion. “Complementary and alternative” jargon is never necessary to describe validated practices in health promotion or health care delivery. Science-based uses of natural substances, physical manipulations, and self-care modalities are all part of regular medicine.

Science-based natural products medicine is called pharmacognosy. Labels like “complementary and alternative” are used to give the impression of legitimacy, not to pharmacognosy, but to superstitious and often ecologically destructive uses of natural products such as herbalism (particularly paraherbalism), gruesome extractions of bile from living bears, shark cartilage, and rhinoceros horns.

Physical manipulations with a rational basis such as many of those included in personal exercise programs and physical therapy do not require euphemistic labels such as “complementary” or “alternative.” However, the labels “complementary” or “alternative” are often applied to give the appearance of legitimacy to superstition-based or pseudoscience-based physical manipulation treatments such as those used in chiropractic. Many chiropractors falsely claim that the spine requires periodic maintenance “adjustments” of health compromising  “subluxations” that only chiropractors can supposedly detect. Such adjustments don’t complement anything else and they aren’t a viable alternative for health promotion or disease prevention.

Many of the manipulations promoted as “complementary” or “alternative” are actually non-physical; they are rooted in vitalism, which is defined as: “a doctrine that the functions of a living organism are due to a vital principle distinct from physicochemical forces” or “a doctrine that the processes of life are not explicable by the laws of physics and chemistry alone….” Different health cults have different names for the supposed vital principle. In anthroposophy, the names are the divine element in nature, astral body, formative force, or either body. In Ayurvedic medicine, it’s prana. In chiropractic, it’s innate intelligence. In Reichian psychotherapy, it’s orgone energy. In homeopathy, it’s vital energy. In naturopathy, it’s vis medicatrix naturae. In Traditional Chinese Medicine and acupuncture, it’s chi or qi or ki.

The vital principle was popularized in Star Wars as “the force.” But in the real universe, nothing like “the force” is reliably detectable and there are no Jedi-like masters who can manipulate anything akin to it for healing or any other purposes. In the movie Austin Powers: The Spy Who Shagged Me, the vital principle was called mojo. The idea that some people have skills as mojo detectors or mojo manipulators is as absurd as the movie, but “there are some ideas so absurd that only an intellectual could believe them.”

Self-care modalities have been promoted as “complementary” and “alternative,” but what useful distinction is there to be made between supposed “complementary” or “alternative” self-care modalities and those that don’t qualify and are therefore implicitly non-complementary or non-alternative? If the distinction is to be based on validation for safety and efficacy, why introduce euphemistic language like “complementary” or “alternative”? Categories such as validated, non-validated, and invalidated should suffice to give consumers useful information for deciding what modalities of self-care are worth trying out.

It’s true that many tradition-based practices are promoted as “complementary” or “alternative.”  Scholars who attempt to advance “complementary and alternative medicine” often like to emphasize traditional systems of care and ignore other practices marketed as “complementary and alternative.” Since it is often considered rude to be judgmental about traditions associated with particular cultures, fallacious appeals to traditional wisdom are useful in public relations. But numerous practices, products, and services marketed to consumers as “complementary” or “alternative” are promoted as “innovative,” “advanced,” “cutting edge,” “modern,” “scientific,” and the like, not as tradition-based. Examples include such so-called complementary and alternative medicine approaches (sCAMs) as metabolic therapy, chelation therapy, oxygenation treatments, insulin potentiation therapy, clinical ecology, anti-aging medicine, attachment therapy, various other mental health therapies, antineoplastons, cellular therapy, and syncrometers & zappers.

Referring to the selection of specific approaches from traditional systems in Western societies as “complementary” or “alternative” implies an East-West dichotomy that is simply false. Tradition-based systems and supposed whole-system care are not uniquely Eastern. Is it only in Western societies that approaches from traditional systems get used separately from whole-system care?

Medical anthropologists, medical sociologists, educated laypersons, health educators, and even physicians often make the mistake of describing standard medical practices of today and recent decades as “conventional allopathic care.” Allopathy is a term coined by Samuel Hahnemann (formulator of homeopathic treatment principles) as a label for medical practices of his day that were based upon ancient Greek humoral theory of disease such as bleeding and purging and blistering to manipulate the four so-called body humors: blood, phlegm, black bile, and yellow bile. As medicine became more science-based, it discarded treatment based upon the convention of manipulating body humors and progressed by developing healthcare consistent with progress in biological and physical sciences. Nevertheless, approaches to healthcare based upon humoral theory—what Hahnemann called allopathy—persist today in parts of India, Pakistan and elsewhere as Unani medicine, which, ironically, the World Health Organization recognizes as a type of “CAM.” Unani is an Arabic adjective meaning Greek.

Since modern medicine makes progress by relying on science, it is iconoclastic—the antithesis of conventional. By contrast, the real allopathy practiced today as Unani medicine is bound to its ancient conventions. Like much of what gets promoted as “complementary” and “alternative,” Unani medicine reflects conventional wisdom of healing traditions rather than the rigor of scientific testing and the iconoclasm of scientific discovery.

I have previously explained that calling an approach to healthcare “complementary” implies that it adds to the outcome when combined with some other treatment and that calling an approach to healthcare “alternative” implies that it can be successfully used in lieu of some other approach. However, this is misleading labeling. Simply calling an approach “complementary” doesn’t mean it actually complements anything else and calling an approach “alternative” doesn’t make it a viable alternative. The jargon “complementary and alternative” serves to distract attention away from questions of utility based upon scientific merit.

Professor Richard Dawkins has explained: “Either it is true that a medicine works or it isn’t. It cannot be false in the ordinary sense but true in some ‘alternative’ sense.”

Drs. John E. Dodes and Marvin Schissel put it this way: “Erythromycin is an alternative to penicillin, but a pogo stick is not an alternative to an automobile.”

Drs. Marcia Angell and Jerome Kassirer wrote: “There cannot be two kinds of medicine—conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work.”

Dr. George Lundberg explains it this way:

There is no “alternative medicine.” There is only medicine:

  • Medicine that has been tested and found to be safe and effective. Use it; pay for it.
  • And, medicine that has been tested and found to be unsafe or ineffective. Don’t use it; don’t pay for it.
  • And, medicine for which there is some plausible reason to believe that it might be safe and effective. Test it and then place it into one of the other two categories.

Although many people believe that acupuncture for pain is medicine that fits Dr. Lundberg’s first category,  the weight of evidence places it in the second category, especially considering the lack of a plausible rationale for acupuncture as a therapy. Few, if any, health practices that have been promoted as “complementary” and “alternative” also belong in Dr. Lundberg’s first category. More than ten years of research funding by the National Center for Complementary and Alternative Medicine has failed to contribute to medical progress.

The term integrative medicine is superfluous and should not be used by responsible health professionals. Palliative care and adjunctive care are meaningful and useful terms for efforts to provide rational modalities of humane care, comfort, and support addressing the diverse needs of patients. The term “integrative medicine” adds nothing to describe approaches strongly supported by scientific evidence, but serves as an income-generating mechanism for attracting patients to seemingly special modalities that typically lack support beyond cherry-picked evidence or tradition. The term “integrative medicine” is not needed to offer science-based psychological approaches for managing health problems, but it does help in marketing when you are offering modalities based on vitalism. “Integrative medicine” represents branding, not a meaningful medical specialty. It projects a misleading image of academic seriousness that serves only to obscure its hype and help secure funding for clinical research of dubious need.

Terms such as “alternative,” “complementary,” and “integrative” have become popular euphemisms for non-validated and invalidated approaches to health enhancement—especially approaches with farfetched rationales. The use of such euphemisms facilitates quackery: the promotion of health products, services, or practices of questionable safety, effectiveness, or validity for an intended purpose. Today quackery is a far less popular term than the euphemisms. In some circles, it is politically incorrect to refer to quackery. But if we cannot refer to quackery as quackery, we can expect it to persist as a neglected public health scandal. I suggest that there are better alternatives to using currently popular euphemisms of alt-speak.


William M. London is a professor in the Honors College and in the Department of Public Health in the College of Health and Human Services at California State University, Los Angeles. He co-authored the sixth, seventh, eighth, and ninth (in press) editions of the college textbook Consumer Health: A Guide to Intelligent Decisions. Since 2002, he has been associate editor of the free weekly e-newsletter Consumer Health Digest. Since 2005, he has been co-host of the Credential Watch web site. He tweets as @healthgadfly.

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Constipation Myths and Facts

When it comes to health issues, bowels are big business. Bowel movements are part of everyday life, and we notice immediately when our routine changes. Constipation, from the Latin word constipare (“to crowd together”) is something almost everyone has some experience with. In most cases, it’s an occasional annoyance that resolves quickly. For others, particularly the elderly, constipation can be a chronic condition, significantly affecting quality of life.  Depending on the question and the sample surveyed, prevalence seems to vary widely.  It’s estimate that there are 2.5 million physician visits per year in the USA, and the costs of management are estimated at about $7.5 billion annually. It’s not a trivial issue.

One of the biggest challenges in interpreting both individual patient situations, as well as the literature overall, is understanding what’s defined as “constipation”. One person’s regular routine may be another person’s constipation. From my dialogue with patients, personal definitions seem to vary. Some panic after a single missed bowel movement, while others may be unconcerned with daily (or even less frequent) movements. What’s the optimal frequency? It depends. Infants may be 3x/day. Older children may be once daily. Adults may be daily or less frequently.  The literature generally, though not consistently, defines constipation as a delay or difficulty in bowel movements ( usually less than 3 per week) lasting two weeks. Symptoms can include infrequent, painful bowel movements, straining, and lumpy or hard stools.  When these problems last for more than three months, it’s termed chronic constipation. When constipation is accompanied by other symptoms like bloating, diarrhea, and abdominal pain, it may be termed  irritable bowel syndrome (IBS).

There are multiple causes of constipation. It may be a consequence of other illnesses (e.g., high/low thyroid, diabetes, cancer, and neurological diseases like multiple sclerosis). Drugs, both prescription and over-they-counter, can also cause constipation.  Primary or idiopathic constipation is a diagnosis of exclusion, after other causes have been ruled out.  If there are no signs of a more serious underlying condition, treatments can be considered.

Many have firmly-held opinions about their colon and their bowel movements: what’s normal, and what’s not. And there are equally strong opinions about the causes of, and solutions to, constipation. But despite the ubiquity of constipation and the firmly-held opinions on treatments, there’s a sizable chasm between practice and evidence.  This is an area with crappy (sorry) data, and it’s hard to sort out what are true treatment effects. But an absence of evidence isn’t evidence of absence, so we’re challenged to make the best decisions possible, despite a disappointing evidence base. Here are some common statements I’ve encountered, and an evidence check on their veracity.

The colon is the root of all illness

Colonic dysfunction as constipation has been described as a cause of disease since at least the 16th Century BC. It’s been a recurring medical motif as long as medicine has existed, starting with ideas of internal putrefaction, and later, once germ theory arrived, became a worry about autointoxication. This theory proposed that unnamed “toxins” were being absorbed from the bowel and causing systemic disease.  Now discredited in science-based medicine, these ideas continue to manifest today, largely in the realm of CAM with its warnings to “detox”, irrigate our colon, and indulge in other ritualistic “cleansing” practices. So today the colon continues to be blamed for all manners of illness, including eczema, cancer, high blood pressure, allergies, and more. There’s no evidence  to substantiate these claims.

I need to have a bowel movement at least every “X” to avoid toxins/allergies/chronic disease/certain death

This argument is an extension of beliefs about the necessity of bowel movements to avoid systemic disease. Interestingly, over hundreds of years, there’s always been the idea that constipation is a modern disease, one of urbanization and civilization: dietary changes, the busy pace of life and a lack of exercise.  So if you don’t feel constipated, you aren’t. Bowel habits can be evaluated on their own merits. As long as they’re not painful or hard, there is no ideal frequency. In the absence of constipation, the flushing of the colon, or the use of laxatives or other purgatives is at best unnecessary, and at worst, potentially harmful.

A lack of fibre can cause constipation, and fibre supplements are effective constipation treatments

The granddaddy of fibre cereals, All Bran, appeared on the market in the 1900s as a treatment for the diagnosis of the day,  autointoxication of the colon. Since then, fibre has held a special place in the armamentarium of health professionals and CAM advocates alike: It’s not only natural, but nature’s little broom, right?

Fibre, from cereal or other foods, serves multiple purposes in the bowel. It adds bulk to the stool and can increase the frequency of bowel movements. But there is a lack of correlation between dietary fibre intake, and the risk of constipation. And in patients given fibre supplements, the response in patients with chronic constipation is erratic. Fibre, particularly bran and other insoluble fibres causes gas formation, which can limit acceptance. Soluble fibres, like psyllium (Metamucil) are better tolerated.

Studies suggest that that low fibre diets may be a a contributing factor to constipation in a subset of patients, who may  respond to higher fibre diets. Consequently, Fibre supplements may be useful in some patients with mild or occasional constipation. But in more severe cases of chronic constipation, fibre can actually aggravate symptoms,and does not appear to be an effective therapy.

Drinking more fluids can help reduce the risk of constipation

The idea that consuming more water will result in softer, easier to pass stools hasn’t been substantiated when studied in patients with chronic constipation. Studies in the elderly have also failed to reveal an association between increased fluid intake and constipation. Constipated children, randomized to consume different amounts of fluid, didn’t experience any changes in stool frequency, consistency, or ease of defecation. Unless there’s evidence of dehydration, consuming extra fluid on its own is unlikely to make any difference in cases of constipation.

Exercise can help constipation

In most patients with constipation, this statement is true. There’s an established relationship between our activity level and our bowel habits, giving us the luxury of sleeping several hours without interruption. There seems to be a relationship between exercise levels and incidence of constipation, though across several studies, it’s not clearly a causal relationship. And in cases of vigorous exercise (e.g., running) there is clearly evidence of a significant increase in activity. While it’s not possible to do a truly randomized, double-blind trial, the evidence available supports the use of  physical exercise can be helpful for modest constipation, but it does not seem to be effective for severe cases.

Stool softeners are effective
Stool softeners (e.g., docusate sodium (Colace)) are among the most popular products prescribed for the prevention or treatment of constipation. They’re often a reflex prescription that accompanies narcotic prescriptions, because constipation is a frequent side effect of narcotic drug use, mainly due to effects on transit time through the colon. Stool softeners are essentially soap, and the theory is that they make the stool easier to pass. Despite their widespread use, there’s no good evidence that docusate sodium or docusate calcium are effective for the treatment of constipation. I find it quite fascinating that docusate sodium is one of the active ingredients in Corexit, last seen being dumped in large quantities into the Gulf of Mexico to disperse the Deepwater Horizon oil spill. Presumably the evidence is better for that indication.

Natural or synthetic, the drugs don’t work

Before treating constipation, getting an understanding of symptoms, other medications, and other illnesses is important. In cases where reversible factors  have been ruled out, drug therapy may be warranted. Despite the lack of good evidence, dietary and lifestyle changes usually precede drug therapy. In cases that don’t respond or resolve on their own, medications are next. Broadly, categories of treatments include bulk-forming products, stool softeners, osmotic agents, and stimulant laxatives.  Products available are a mix of naturally-derived and synthetic products. Some of the most popular laxatives are naturally-derived. The strange smell of Senokot tablets gives a clue to its origin: They’re senna glycosides, a product of the senna plant. The naturally occuring glucosides it contains are colonic irritants, stimulating colon contraction. Metamucil is psyllium seed husks, which swell into a gelatinous mass in the stomach, carrying water and bulk to the colon. Most of the other fibre supplements are naturally-derived as well.

The other commonly used products are synthetically derived. Milk of magnesia, despite its natural sounding name, is a suspension of magnesium hydroxide.When consumed, most of the magnesium isn’t absorbed, and it pulls fluid with it (via osmotic pressure) when it’s shunted to the colon. Polyethylene glycol (PEG) works this way, as does lactulose, a non-digestible sugar. The cathartics taken before endoscopy are all osmotic agents, too.

Bisacodyl (Dulcolax) is another popular over-the-counter product. A stimulant laxative like senna, bisacodyl stimulates colon contraction.

Despite the number of products, and prevalence of constipation, the evidence base for drug treatments is weak. There’s little head-to-head evidence that has pitted on treatment against another. So we’re largely left to make inferences from poor studies on different populations. The best evidence (which is still pretty weak) exists for the osmotic agents like PEG. Some evidence exists for psyllium, but it’s underwhelming. There’s evidence for lactulose as a treatment, as well. An excellent systematic review from the Oregon Evidence-Based Practice Center summarizes the evidence base in greater detail.

Probiotics can be effective for constipation

Probiotics, covered in depth by Mark Crislip already, are live microorganisms administered with intent of a therapeutic effect. If you like yogurt that does double duty, you’ll probably see brands that include Bifidobacterium and Lactobacillus, and, depending on your national regulator, there may be vague health claims about intestinal “wellness” on the label. The idea of probiotics for constipation is at least plausible, as probiotics have the potential to disrupt the colon’s bacteria ecosystem – if only to a very limited extent, as Mark noted in his post.  For constipation, their effectiveness hasn’t been demonstrated though. A systematic review published in 2010 examined the data supporting their use in adults and children.  Five high quality trials were identified and the results were unimpressive:

Data published to date suggest that adults with constipation might benefit from ingestion of B. lactis DN-173?010, L. casei Shirota, and E. coli Nissle 1917, which were shown to increase defecation frequency and improve stool consistency. However, in some cases, even if there was a significant difference in results, their clinical relevance is unclear.

Their conclusion:

Until more data are available, we believe the use of probiotics for the treatment of constipation condition should be considered investigational.

Overall, not encouraging. And little reason to recommend their use. That’s the opinion of some regulators, too. The European Food Safety Authority has largely rejected general health claims for probiotics.

Taking laxatives continuously is dangerous and leads to tolerance and then dependence

This is a common myth, but not substantiated by fact. [PDF] As a pharmacist I see a lot of chronic laxative use – some appropriate, and some clearly inappropriate. Something that was planted in my head in pharmacy school was the warning that chronic use would lead to dependence, and a near-certain risk of constipation if their use was suddenly stopped.  The warning is primarily with the stimulant laxatives, which have been believed to affect nerve conduction and muscle damage, largely based on anecdotal evidence. Microsope examination of colon tissue in chronic laxative users reveal some differences from normal subjects. But whether these changes are caused by stimulant laxatives, or are a product of an underlying disorder, is unclear. The best evidence we have suggests that risks of of most  laxatives, when used to treat constipation, at recommended doses, is probably small.  Risks seem restricted to patients with severe symptoms on high doses of stimulant laxatives.  Notably, because laxatives are generally not even absorbed, there is no risk of them directly causing nervous system effects. Consequently, there’s no risk of a actual addiction, through there’s no question that they can be misused. Misuse beyond the treatment of constipation can be problematic, potentially leading to electrolyte disturbances.

Children are little adults

False. Constipation is children is common, and it causes distress to parents, too. I’ve spoken with parents of infants only weeks old, already set on giving their child a suppository because the “regular” bowel movement is hours late. In infants, parents often ask me about iron-free formulas, thinking the iron may be causing constipation. However iron-fortified formulas haven’t been shown to be more constipating that iron-containing formulas. So switching to an iron-free formula may have no effect, and introduce the challenge of ensuring adequate iron intake.

The most common cause of constipation in children is functional constipation – constipation without an intrinsic cause, usually caused by children deliberately delaying or avoiding bowel movements, usually due to a painful past movement. Delaying causes further constipation, and further pain with bowel movements. Functional constipation is the cause of almost all constipation in children. Constipation that’s accompanied by abdominal pain, nausea, anorexia, or vomiting needs a physician examination to rule out other causes.

Despite its frequency, constipation in children rarely lasts and generally doesn’t require medication. Which is good, because there’s little evidence to demonstrate that laxatives are effective in children. A systematic review published earlier this year summarized the evidence base. Like treatment for adults, the data are limited. Because of the lack of evidence, dietary changes, while also not well supported by evidence, should precede any drug therapy. Acute treatments should be followed with longer term strategies to prevent further episodes. While the effectiveness of fibre for the treatment of constipation in children hasn’t been demonstrated, encouraging fibre-rich fruits or vegetables as a first step may plausibly help, and have numerous other health benefits as well.

Conclusion

Constipation is is common condition, yet there’s little high quality evidence to guide our actions. Myths about constipation further complicate treatment strategies. In the absence of high quality evidence, it would seem most conservative to carefully evaluate each situation for potentially causal factors, and introduce the treatments backed by the best evidence only after core dietary and lifestyle factors have been implemented.

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Alpha Brain – What’s Wrong with the Supplement Industry

There is an endless stream of supplement products on the market that are of questionable value. They tend to follow a similar pattern: put an essentially random assortment of vitamins, minerals, perhaps herbs and nutritional elements into a pill and then make whatever pseudo-health claims you want. Usually the claim is implied in the name of the product itself – sleepwell, or brainboost. The popular product Airborne fits this mold. It is essentially a multivitamin with the unfounded claim that it will prevent infection by boosting the immune system.

In the US, regulations (under DSHEA) specifically allow “structure/function” claims without any requirement for evidence to back up the claims. In other words, as long as you don’t mention a disease by name, you can make pretty much whatever claim you want. This was supposed to be good for the consumer, when in fact it is springtime for industry at the expense of the consumer. If your claims are outrageous enough the FTC can still go after you, but they are playing a game of whack-a-mole and losing.

Another pattern that is common is for a supplement product to contain specific components that are claimed to have specific benefits. Often these claims are based upon evidence – just the wrong kind of evidence. Basic science evidence is used inappropriately to support clinical claims. This strategy is more insidious, as it gives the public the sense that the product is science-based when it isn’t.

Recently a product came to my attention which fits this mold perfectly – Alpha Brain. This is a supplement that claims to “enhance” mental function, sleep, creativity, and athletic performance. Their website includes a section called “The science behind alpha-brain.” I always find it amusing to following the links for promised evidence on such sites. What they never seem to contain is links or references to primary sources that actually demonstrate the claims they are making.

The site reviews all of the ingredients in Alpha-Brain explaining the science behind the claims – let’s look in detail at just one example, GPC choline, which is an essential nutrient and a precursor for the neurotransmitter acetylcholine. The site claims:

There is scientific evidence that proves that increased levels of acetylcholine in the body can dramatically increase memory and cognitive ability of men and women of all ages[1]

The reference given is not to a peer-reviewed study, but to another promotional site that simply makes more claims about the benefits of choline. The concept here is not implausible, but also cannot be assumed, and is very common in the supplement industry. The idea is that a precursor of an important molecule in the body will increase the availability and therefore function of that molecule. That could be true, if availability of the precursor is the rate-limiting-step in the production and function of the molecule. Specifically in this case, is the nutritional availability of choline limiting the production and function of acetylcholine?

Choline is an essential nutrient, so (as is true with all nutrients) in someone who is undernourished or with specific deficits in their diet, supplementing will help. But in someone with an adequate diet, there is no reason to assume that more will be better. Supplements treat deficiencies – but there is no reason to think that taking additional nutrients beyond the minimum necessary will have functional benefits.

They then report:

A study performed by Sangiorgi Barbagallo at the University of Palermo studied 2044 candidates who suffered from recent stroke or transient ischemic attack. The study concluded that administration of GPC choline confirmed its therapeutic role in improving cognitive ability in this group of study subjects.

They don’t give the reference, but I tracked in down. This is an excellent example of how a company can cite studies to make is seem as if their claims are evidence-based when they are not. The question is – how relevant is this study to Alpha-Brain? There are two major problems: The first is that the study (which was not blinded, but even if we take its results at face value) used 1000mg IM (intramuscular) for 28 days, followed by 400mg orally daily. Alpha-Brain contains 100mg of GPC choline. IM administration likely has a completely different bioavailability than an oral dose. And of course the dosing for 28 days was 10 times that in the supplement.

A bigger problem, however, is the study population – those recovering from a stroke or TIA. When the body is under physiological stress demand for nutrients are likely to become a limiting factor in the rate of recovery, even when those same nutrients are not a limiting factor in a healthy individual. You therefore cannot extrapolate from a disease population to a healthy population – just because a nutrient helps recovery does not mean it will enhance normal function.

The same is true for Alzheimer’s disease. There is evidence that choline supplements may improve the symptoms of dementia. But this does not mean they will enhance mental function in a healthy individual.

Conclusion

I am presenting just one illustrative example of the types of deceptive marketing practice by the supplement industry, specifically with their use of scientific evidence. They use the evidence as a marketing tool, not as a way to determine the net clinical effects of a product. Several types of deceptive use of evidence are common: using basic science studies to support clinical claims, using studies in ill subjects to make claims about enhancing normal function, referencing secondary sources or sources that do not support the claims being made, and making inappropriate comparisons to different doses and routes of administration.

The goal is to create the impression that the supplement being marketed has health benefits that are backed by science – but the devil is always in the details. What they never seem to provide is rigorous studies of their actual product published in the peer-reviewed literature showing the specific benefits they are claiming when used as directed.

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KA at U Minnesota and Michigan State

I’ll be giving a talk, “Homeopathy and Skepticism,” to skeptical students this Thursday, Oct 27, at the University of Minnesota (7:00 PM at MCB 3-120) and this Friday, Oct. 28, at Michigan State University (7:00 PM at Holmes Hall 106). Here is the abstract:

Homeopathy is an extraordinary popular delusion that has persisted for more than 200 years. It is now a mainstay of “complementary and alternative medicine” in spite of longstanding, definitive scientific refutations. It is of particular interest to skeptics because its history evokes fundamental concepts such as sympathetic magic, Ockham’s razor, and Hume’s Maxim, and major historical figures such as Oliver Wendell Holmes, Sr., and Hume himself.

Show up in Halloween costume if you like; I may do that myself.

KA

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