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Table of Contents
FDA Consumer magazine
The Healing Power of Placebos
by Tamar Nordenberg
One patient stands out in the memory of Stephen Straus, M.D., for her remarkable recovery, more than 10 years ago, from chronic fatigue syndrome. The woman, then in her 30s, was "very significantly impaired," says Straus, chief of the Laboratory of Clinical Investigation at the National Institute of Allergy and Infectious Diseases. "She had no energy, couldn't work, and spent most of her time at home." But her strength was restored during a study to test the effectiveness of an experimental chronic fatigue drug.
"She and her parents were so thrilled with her recovery that they were blessing me and my colleagues," recalls Straus, the principal investigator on that study.
Like many drug studies, the chronic fatigue medication trial was a "placebo-controlled" study, meaning that a portion of the patients took the experimental drug, while others took look-alike pills with no active ingredient, with neither researchers nor patients knowing which patients were getting which.
It's human nature, Straus explains, for patients and investigators alike to try and guess in each case: Is it the real drug or a dummy pill? But people shouldn't kid themselves, he says, that they can consistently tell the actual drug from the sham by seeking out tell-tale signs of improvement.
Turns out, the woman's quick turnaround from chronic fatigue occurred after taking placebo pills, not the experimental drug. Straus says, "She was amazed by the revelation that she'd gotten better on placebo."
Research has confirmed that a fake treatment, made from an inactive substance like sugar, distilled water, or saline solution, can have a "placebo effect"--that is, the sham medication can sometimes improve a patient's condition simply because the person has the expectation that it will be helpful. For a given medical condition, it's not unusual for one-third of patients to feel better in response to treatment with placebo.
"Expectation is a powerful thing," says Robert DeLap, M.D., head of one of the Food and Drug Administration's Offices of Drug Evaluation. "The more you believe you're going to benefit from a treatment, the more likely it is that you will experience a benefit."
The 1988 chronic fatigue syndrome (CFS) working case definition (Holmes, et al) did not effectively distinguish CFS from other types of unexplained fatigue. For this reason, it was decided during a 1993 meeting of CFS investigators to develop a logical revision of that definition. The core of the revised CFS case definition is a set of uniformly applicable guidelines for the clinical and research evaluation of CFS and the other forms of fatigue.
From the Center for Disease Control
CFS Home > About CFS > CFS Definition
The Revised Case Definition (abridged version)
In the revised definition, a consensus viewpoint from many of the leading CFS researchers and clinicians (including input from patient group representatives), chronic fatigue syndrome is treated as a subset of chronic fatigue, a broader category defined as unexplained fatigue of greater than or equal to six month's duration. Chronic fatigue in turn, is treated as a subset of prolonged fatigue, which is defined as fatigue lasting one or more months. The expectation is that scientists will devise epidemiologic studies of populations with prolonged fatigue and chronic fatigue, and search within those populations for illness patterns consistent with CFS.
Chronic fatigue syndrome researchers offer physical evidenceMain Category: Depression
Article Date: 24 Aug 2004 - 0:00 PST
A University of Alberta study has verified that there is physical evidence for those who suffer from chronic fatigue syndrome (CFS), giving new weight to the often stigmatized and misdiagnosed disorder. Research just published in the "International Journal of Psychophysiology" determined that, using independent criteria, CFS can be distinguished from depression--two disorders that share many of the same symptoms.
CFS is an often debilitating disorder, characterized by a constellation of symptoms including fever, sore throat, headache, muscle weakness, myalgias, post-external malaise, sleep and cognitive disturbances. The level of disability varies for people with CFS, but some individuals find they are unable to return to work or function normally on a day-to-day basis. Unfortunately, many of these symptoms are subjective in nature and are difficult to quantify or confirm, says Hannah Pazderka-Robinson, the lead author on the study. Not only does the stigma attached with the disorder play an emotional toll on the patient, but it has implications for insurance claims as well.
"There are a number of medical professionals who don't believe that CFS exists in the first place," said Pazderka-Robinson. "The problem is, both CFS and depression are characterized by very similar profiles. Imagine a patient who approaches a doctor and tells him they feel depressed and tired all the time.
"Since depression shows a high co-morbidity with CFS, some CFS patients are often given antidepressants--that don't work or work poorly, since they do not address the underlying condition. Again, when these medications don't work, physicians sometimes jump to the conclusion that there isn't really anything, physically, wrong. Obviously, both misdiagnosis and the tendency for doctors to treat these patients as if they're not really sick can be extremely distressing. It can also undermine the patient's trust in the doctor and make them less likely to seek treatment if the condition worsens."
Evidence for Chronic Fatigue Syndrome?Proteins in Spinal Fluid May Be Markers of Syndrome, Early Tests ShowBy Miranda HittiDec. 1, 2005 -- Scientists may have found biological evidence of chronic fatigue syndrome.
WebMD Medical News
Chronic fatigue syndrome involves severe, unexplained tiredness that lasts for at least six months and doesn't improve with rest.
Chronic fatigue syndrome often greatly interferes with patients' lives. But it hasn't been well understood from a scientific point of view, and its cause is unknown.
The new evidence lies in patients' spinal fluid. Tests show 16 proteins in the spinal fluid of people with chronic fatigue syndrome but not in healthy people, according to a study in BMC Neurology.
Chronic fatigue syndrome may be a legitimate neurological condition
Researchers might have found evidence that chronic fatigue syndrome is a real and legitimate neurological condition.
A pilot study published in the open access journal BMC Neurology reveals that patients with chronic fatigue syndrome (CFS) have a set of proteins in their spinal cord fluid that were not detected in healthy individuals. These proteins might give insight into the causes of CFS, and could be used as markers to diagnose patients with CFS.
Department of Rheumatology, The National Hospital Rikshospitalet, Forskningsvn. 2, Block B, 0027 Oslo, Norway. firstname.lastname@example.org
Fibromyalgia (FM) is a medically unexplained or functional somatic syndrome (FSS). The two classification criteria are chronic widespread pain (CWP) and the finding of 11/18 tender points (TP). FM overlaps and co-occurs with other FSSs, and auxiliary symptoms that are not included in the criteria may be clues to other FSSs. About ten FSSs include chronic fatigue syndrome, myofascial pain syndromes and irritable bowel syndrome. TP do not reflect demonstrable pathology, and are locations where everyone is generally more tender. In FM they are more tender than normal due to lowered pain threshold. High TP counts are associated with the extent of distress or unspecific somatic symptoms in the absence of chronic pain. TP lack validity and should be excluded. CWP and distress are outside the domain of rheumatology, and abnormal mechanisms in FM relate to the central nervous system, as compared to "peripheral" mechanisms studied in rheumatology. FM should not be considered as a rheumatologic condition but rather as part of a broader spectre of FSSs. Patients with FSSs should be considered and treated together across medical specialities by general physicians in primary health care.
PMID: 17641896 [PubMed - indexed for MEDLINE]
This delightful and underused word means "absence of knowledge." Most folks go with ignorance instead, but nescience avoids most of the pejorative associations of that word, while having an air of mystery about it by being so seldom seen or heard.
CHIROPRACTIC MANAGEMENT OF MIGRAINE WITHOUT AURA:
A Case Study
Objective: To assess the response of a patient with chronic migraines to a short program of chiropractic care (diversified technique).Method: The study was run over a 13 week period with chiropractic spinal manipulative therapy (CSMT) on a once weekly schedule for 5 weeks, followed by an 8 week re-evaluation.Outcome Measures: To measure the effect of treatment, a previously reported diary system was used which noted the intensity of a range of symptoms that are recorded following each migraine episode.Results: The results attained showed there was a marked improvement in the migraine symptoms following the chiropractic care. The patient reported an improvement in frequency, intensity, duration and use of medication. These findings appear to also confirm other evidence which documented similar changes following a large randomised controlled trial of chiropractic treatment of migraine.Discussion: The case is presented as further support for CSMT in the treatment of migraine. The outcome of this case is also discussed in relation to recent research that concludes that CSMT is a very effective treatment for some people with non-neuromusculoskeletal conditions.
Conclusion: It now appears clear that chiropractic care may be used to assist patients with migraine. Research is currently being undertaken to investigate the potential mechanisms of chiropractic in the treatment of migraine. This research should also assess what (if any) prognostic signs can be identified to assist practitioners making a more informed decision on the treatment of choice for migraine.
Atlas vertebra realignment and achievement of arterial pressure goal in hypertensive patients: a pilot study.
Department of Preventive Medicine, Rush University Hypertension Center, Chicago, IL, USA. email@example.com
Anatomical abnormalities of the cervical spine at the level of the Atlas vertebra are associated with relative ischaemia of the brainstem circulation and increased blood pressure (BP). Manual correction of this mal-alignment has been associated with reduced arterial pressure. This pilot study tests the hypothesis that correcting mal-alignment of the Atlas vertebra reduces and maintains a lower BP. Using a double blind, placebo-controlled design at a single center, 50 drug naïve (n=26) or washed out (n=24) patients with Stage 1 hypertension were randomized to receive a National Upper Cervical Chiropractic (NUCCA) procedure or a sham procedure. Patients received no antihypertensive meds during the 8-week study duration. The primary end point was changed in systolic and diastolic BP comparing baseline and week 8, with a 90% power to detect an 8/5 mm Hg difference at week 8 over the placebo group. The study cohort had a mean age 52.7+/-9.6 years, consisted of 70% males. At week 8, there were differences in systolic BP (-17+/-9 mm Hg, NUCCA versus -3+/-11 mm Hg, placebo; P<0.0001) p="0.002)." p="0.002).">P<0.0001) p="0.002)." p="0.002)."
We conclude that restoration of Atlas alignment is associated with marked and sustained reductions in BP similar to the use of two-drug combination therapy.
For contrary to the long-held assumption that brain power peaks between the ages of 18 and 26, new research indicates that it actually increases with age.
The ground-breaking report suggests that many preconceptions about ageing made by employers and policymakers need to be brushed aside.
The study - by psychologist Lars Larsen, of Denmark's University of Aarhus - looked at 4,300 U.S. servicemen who had undergone intelligence tests when they signed up aged around 20, and again 20 years later.
Comparing the two sets of results showed that mathematical skills among the servicemen - all Vietnam veterans - appeared to remain unchanged, rather than reducing with age, while their verbal skills actually improved considerably.
Scientists find how bacteria in cows milk may cause Crohn's disease
December 11, 2007 - Scientists at the University of Liverpool have found how a bacterium, known to cause illness in cattle, may cause Crohn's disease in humans.
The team found that a bacterium called Mycobacterium paratuberculosis releases a molecule that prevents a type of white blood cell from killing E.coli bacteria found in the body. E.coli is known to be present within Crohn’s disease tissue in increased numbers.
It is thought that the Mycobacteria make their way into the body’s system via cows’ milk and other dairy products. In cattle it can cause an illness called Johne's disease - a wasting, diarrhoeal condition. Until now, however, it has been unclear how this bacterium could trigger intestinal inflammation in humans.
Professor Jon Rhodes, from the University’s School of Clinical Sciences, explains: “Mycobacterium paratuberculosis has been found within Crohn’s disease tissue but there has been much controversy concerning its role in the disease. We have now shown that these Mycobacteria release a complex molecule containing a sugar, called mannose. This molecule prevents a type of white blood cells, called macrophages, from killing internalised E.Coli.”
Scientists have previously shown that people with Crohn’s disease have increased numbers of a ‘sticky’ type of E.coli and weakened ability to fight off intestinal bacteria. The suppressive effect of the Mycobacterial molecule on this type of white blood cell suggests it is a likely mechanism for weakening the body’s defence against the bacteria.
Professor Rhodes added: "We also found that this bacterium is a likely trigger for a circulating antibody protein (ASCA) that is found in about two thirds of patients with Crohn's disease, suggesting that these people may have been infected by the Mycobacterium."Science Daily
Treatment & diagnosis of Crohn's DiseaseIf you want to read a lot of evidence, read on.
From The Lancet
Is Crohn's disease caused by a mycobacterium?
The most plausible candidate is Mycobacterium avium subspecies paratuberculosis (MAP). Intriguingly, Koch's postulates may have been fulfilled for MAP and Crohn's disease, even though they still have not been met for Mycobacterium leprae and leprosy. In animals MAP causes Johne's disease, a chronic wasting intestinal diarrhoeal disease evocative of Crohn's disease. Johne's disease occurs in wild and domesticated animals, including dairy herds. Viable MAP is found in human and cow milk, and is not reliably killed by standard pasteurisation. MAP is ubiquitous in the environment including in potable water. Since cell-wall-deficient MAP usually cannot be identified by Ziehl-Neelsen staining, identification of MAP in human beings requires culture or detection of MAP DNA or RNA. If infectious in origin, Crohn's disease should be curable with appropriate antibiotics. Many studies that argue against a causative role for MAP in Crohn's disease have used antibiotics that are inactive against MAP. However, trials that include macrolide antibiotics indicate that a cure for Crohn's disease is possible.
by Michael Greger, MD
Updated January 2001
Paratuberculosis Awareness & Research Association (PARA) is an organization of Crohn's disease patients, their families and others who are concerned about the relationship between MAP (Mycobacterium avium subspecies paratuberculosis) and Crohn's disease.
Over 20 years of independent research links a common disease in humans characterized by chronic diarrhea and severe with sick cows and contaminated milk.
Paratuberculosis or Johne's disease is a chronic enteritis of the cattle and other small ruminant animals caused by Mycobacterium avium subsp. paratuberculosis. In Argentina, the strains were characterized in beef and dairy cattle and deer in different genetic patterns by molecular tools. M. avium subsp. paratuberculosis has been linked in men to a chronic inflammation of the intestine, named Crohn's disease. There is clinical and experimental evidence to link M. avium subsp. paratuberculosis with Crohn's disease by PCR, positive bacteriological culture from mother milk, blood and affected tissues by in situ hybridization. The milk and sub-products might be one of the possible infection sources and it has been suggested that M. avium subsp. paratuberculosis could resist pasteurization. Several works showed that this mycobacteria could be present in retail milk of countries such as United Kingdom, USA, Czech Republic, and recently in Argentina. M. avium subsp. paratuberculosis was associated with different dairy products and water for human consumption. Therefore, it is possible that these food sources may have a role for transmission.
[Mycobacterium paratuberculosis in the intestine of patients with Crohn's disease] PubMed
Mycobacterium paratuberculosis DNA in Crohn's disease tissue. PubMed
Common Food Additive Doubles Kids' Hyperactivity
Sodium benzoate seems to be much more than just a preservative...
by Richard Hollingham
Can food additives affect children’s behavior? A study published in the November 3 issue of the British medical journal The Lancet suggests they can.
A team from the University of Southampton in England measured levels of hyperactivity in 153 three-year-olds and 144 eight- and nine-year-olds. The children were put on a diet free of the additives used in the experiment. Then each day over a six-week period they were given one of two mixtures with artificial coloring and the preservative sodium benzoate, or a plain fruit juice placebo. All the drinks looked and tasted identical.
Researchers observed the children in the classroom and analyzed reports of their behavior from parents and teachers. The older kids were also given a computer-based attention test. The results from all these tests were scored to produce a measure of hyperactivity known as a global hyperactivity aggregate (GHA). The higher the GHA, the greater the hyperactivity.
On average, the children who drank the additive concoctions showed a near doubling of GHA scores compared to those on the placebo. This was true for the younger and older children. Investigators also reported differences in the way individual children responded to the additives, with some becoming much more hyperactive than others.
“The study shows that, on average, children have higher levels of hyperactivity when taking a drink with additives in it compared to their behavior when taking fruit juices alone,” says Jim Stevenson, head of the study.
Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial
We undertook a randomised, double-blinded, placebo-controlled, crossover trial to test whether intake of artificial food colour and additives (AFCA) affected childhood behaviour.Methods
153 3-year-old and 144 8/9-year-old children were included in the study. The challenge drink contained sodium benzoate and one of two AFCA mixes (A or B) or a placebo mix. The main outcome measure was a global hyperactivity aggregate (GHA), based on aggregated z-scores of observed behaviours and ratings by teachers and parents, plus, for 8/9-year-old children, a computerised test of attention. This clinical trial is registered with Current Controlled Trials (registration number ISRCTN74481308). Analysis was per protocol.Findings
16 3-year-old children and 14 8/9-year-old children did not complete the study, for reasons unrelated to childhood behaviour. Mix A had a significantly adverse effect compared with placebo in GHA for all 3-year-old children (effect size 0·20 [95% CI 0·01–0·39], p=0·044) but not mix B versus placebo. This result persisted when analysis was restricted to 3-year-old children who consumed more than 85% of juice and had no missing data (0·32 [0·05–0·60], p=0·02). 8/9-year-old children showed a significantly adverse effect when given mix A (0·12 [0·02–0·23], p=0·023) or mix B (0·17 [0·07–0·28], p=0·001) when analysis was restricted to those children consuming at least 85% of drinks with no missing data.Interpretation
Artificial colours or a sodium benzoate preservative (or both) in the diet result in increased hyperactivity in 3-year-old and 8/9-year-old children in the general population.
OBJECTIVES: To provide a brief overview of intravesical dimethly sulfoxide (DMSO) therapy for interstitial cystitis and offer a practical approach to patient treatment.
METHODS: A review of the literature and a summation of the experience with treatment of > 300 patients with DMSO at the Interstitial Cystitis Clinic, New England Medical Center.
RESULTS: DMSO is helpful in a significant number of patients and it has acceptable morbidity and an excellent safety profile. CONCLUSIONS: Intravesical DMSO (singly or in combination) is one of the mainstays in the pharmacologic treatment of interstitial cystitis.
Scientific evidence is evidence which serves to either support or counter a scientific theory or hypothesis. Such evidence is expected to be empirical and properly documented in accordance with scientific method such as is applicable to the particular field of inquiry. Standards for evidence may vary according to whether the field of inquiry is among the natural sciences or social sciences.Empirical, properly documented, applicable, all fine words, important words. Then we have standards, which vary.
Latin scientia, ('knowledge'), in the broadest sense, refers to any systematic knowledge or practice. In a more restricted sense, science refers to a system of acquiring knowledge based on the scientific method, as well as to the organized body of knowledge gained through such research.Systemic knowledge or practice. Of course the scientific method is the real issue. The focus of Evidence Based Science. You might think the scientific method is hard and fast. No weasel words allowed, no wiggle room. Looking at the current body of knowledge shows us this is not the case.