Western Medicine

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http://nephropal.blogspot.com/2010/05/halloween-comes-early.html

Am tired from travel. But this is worth looking into:

A new study by French and British researchers examined 72 new drug therapy studies to evaluate if there was a spin on the conclusions for the benefit of the drug.

“More than 40% of the reports had spin in at least 2 of these sections in the main text.”

Reuters link

Abstract:

Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes

Isabelle Boutron, MD, PhD; Susan Dutton, MSc; Philippe Ravaud, MD, PhD; Douglas G. Altman, DSc
JAMA. 2010;303(20):2058-2064.

Context Previous studies indicate that the interpretation of trial results can be distorted by authors of published reports.

Objective To identify the nature and frequency of distorted presentation or “spin” (ie, specific reporting strategies, whatever their motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes.

Data Sources March 2007 search of MEDLINE via PubMed using the Cochrane Highly Sensitive Search Strategy to identify reports of RCTs published in December 2006.
Study Selection Articles were included if they were parallel-group RCTs with a clearly identified primary outcome showing statistically nonsignificant results (ie, P .05).

Data Extraction Two readers appraised each selected article using a pretested, standardized data abstraction form developed in a pilot test.

Results From the 616 published reports of RCTs examined, 72 were eligible and appraised. The title was reported with spin in 13 articles (18.0%; 95% confidence interval [CI], 10.0%-28.9%). Spin was identified in the Results and Conclusions sections of the abstracts of 27 (37.5%; 95% CI, 26.4%-49.7%) and 42 (58.3%; 95% CI, 46.1%-69.8%) reports, respectively, with the conclusions of 17 (23.6%; 95% CI, 14.4%-35.1%) focusing only on treatment effectiveness. Spin was identified in the main-text Results, Discussion, and Conclusions sections of 21 (29.2%; 95% CI, 19.0%-41.1%), 31 (43.1%; 95% CI, 31.4%-55.3%), and 36 (50.0%; 95% CI, 38.0%-62.0%) reports, respectively. More than 40% of the reports had spin in at least 2 of these sections in the main text.

Conclusion In this representative sample of RCTs published in 2006 with statistically nonsignificant primary outcomes, the reporting and interpretation of findings was frequently inconsistent with the results

Statistical proof of what we’ve been saying all along.  We can make studies say what we want.

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This is… interesting.  I won’t comment, just link and quote… and highlight…

http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000258

Abstract

Background

In late spring 2009, concern was raised in Canada that prior vaccination with the 2008–09 trivalent inactivated influenza vaccine (TIV) was associated with increased risk of pandemic influenza A (H1N1) (pH1N1) illness. Several epidemiologic investigations were conducted through the summer to assess this putative association.

Methods and Findings

Studies included: (1) test-negative case-control design based on Canada’s sentinel vaccine effectiveness monitoring system in British Columbia, Alberta, Ontario, and Quebec; (2) conventional case-control design using population controls in Quebec; (3) test-negative case-control design in Ontario; and (4) prospective household transmission (cohort) study in Quebec. Logistic regression was used to estimate odds ratios for TIV effect on community- or hospital-based laboratory-confirmed seasonal or pH1N1 influenza cases compared to controls with restriction, stratification, and adjustment for covariates including combinations of age, sex, comorbidity, timeliness of medical visit, prior physician visits, and/or health care worker (HCW) status. For the prospective study risk ratios were computed. Based on the sentinel study of 672 cases and 857 controls, 2008–09 TIV was associated with statistically significant protection against seasonal influenza (odds ratio 0.44, 95% CI 0.33–0.59). In contrast, estimates from the sentinel and three other observational studies, involving a total of 1,226 laboratory-confirmed pH1N1 cases and 1,505 controls, indicated that prior receipt of 2008–09 TIV was associated with increased risk of medically attended pH1N1 illness during the spring–summer 2009, with estimated risk or odds ratios ranging from 1.4 to 2.5. Risk of pH1N1 hospitalization was not further increased among vaccinated people when comparing hospitalized to community cases.

Conclusions

Prior receipt of 2008–09 TIV was associated with increased risk of medically attended pH1N1 illness during the spring–summer 2009 in Canada. The occurrence of bias (selection, information) or confounding cannot be ruled out. Further experimental and epidemiological assessment is warranted. Possible biological mechanisms and immunoepidemiologic implications are considered.

 No...Comment.  Flu Vaccine linked with Swine Flu Incidence?

You'll never see a headline saying "Vaccination Spreads Disease"

Background

Every winter, millions of people catch influenza—a viral infection of the airways—and hundreds of thousands of people die as a result. These seasonal epidemics occur because small but frequent changes in the influenza virus mean that an immune response produced one year through infection or vaccination provides only partial protection against influenza the next year. Annual vaccination with killed influenza viruses of the major circulating strains can greatly reduce a person’s risk of catching influenza. Consequently, many countries run seasonal influenza vaccination programs. In most of Canada, vaccination with a mixture of three inactivated viruses (a trivalent inactivated vaccine or TIV) is provided free to children aged 6–23 months, to elderly people, to people with long-term conditions that increase their risk of influenza-related complications, and those who provide care for them; in Ontario, free vaccination is offered to everyone older than 6 months.

In addition, influenza viruses occasionally emerge that are very different and to which human populations have virtually no immunity. These viruses can start global epidemics (pandemics) that can kill millions of people. Experts have been warning for some time that an influenza pandemic is long overdue and, in March 2009, the first cases of influenza caused by a new virus called pandemic A/H1N1 2009 (pH1N1; swine flu) occurred in Mexico. The virus spread rapidly and on 11 June 2009, the World Health Organization declared that a global pandemic of pH1N1 influenza was underway. By the end of February 2010, more than 16,000 people around the world had died from pH1N1.

Why Was This Study Done?

During an investigation of a school outbreak of pH1N1 in the late spring 2009 in Canada, investigators noted that people with illness characterized by fever and coughing had been vaccinated against seasonal influenza more often than individuals without such illness. To assess whether this association between prior vaccination with seasonal 2008–09 TIV and subsequent pH1N1 illness was evident in other settings, researchers in Canada therefore conducted additional studies using different methods. In this paper, the researchers report the results of four additional studies conducted in Canada during the summer of 2009 to assess this possible association.

What Did the Researchers Do and Find?

The researchers conducted four epidemiologic studies. Epidemiology is the study of the causes, distribution, and control of diseases in populations.

Three of the four studies were case-control studies in which the researchers assessed the frequency of prior vaccination with the 2008–09 TIV in people with pH1N1 influenza compared to the frequency among healthy members of the general population or among individuals who had an influenza-like illness but no sign of infection with an influenza virus. The researchers also did a household transmission study in which they collected information about vaccination with TIV among the additional cases of influenza that were identified in 47 households in which a case of laboratory-confirmed pH1N1 influenza had occurred. The first of the case-control studies, which was based on Canada’s vaccine effectiveness monitoring system, showed that, as expected, the 2008–09 TIV provided protection against seasonal influenza. However, estimates from all four studies (which included about 1,200 laboratory-confirmed pH1N1 cases and 1,500 controls) showed that prior recipients of the 2008–09 TIV had approximately 1.4–2.5 times increased chances of developing pH1N1 illness that needed medical attention during the spring–summer of 2009 compared to people who had not received the TIV. Prior seasonal vaccination was not associated with an increase in the severity of pH1N1 illness, however. That is, it did not increase the risk of being hospitalized among those with pH1N1 illness.

What Do These Findings Mean?

Because all the investigations in this study are “observational,” the people who had been vaccinated might share another unknown characteristic that is actually responsible for increasing their risk of developing pH1N1 illness (“confounding”). Furthermore, the results reported in this study might have arisen by chance, although the consistency of results across the studies makes this unlikely. Thus, the finding of an association between prior receipt of 2008–09 TIV and an increased risk of pH1N1 illness is not conclusive and needs to be investigated further, particularly since some other observational studies conducted in other countries have reported that seasonal vaccination had no influence or may have been associated with reduced chances of pH1N1 illness. If the findings in the current study are real, however, they raise important questions about the biological interactions between seasonal and pandemic influenza strains and vaccines, and about the best way to prevent and control both types of influenza in future.

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Remember how I wrote about biased headlines? (http://qi-spot.com/2010/02/09/another-biased-headline/)  In that previous article, I had mentioned that one can subtly affect comprehension by careful(?) selection of words to use in a headline.  The headline in question then read “Researcher Warns on Herbal Medicines”.  Only when you read the article itself will you see that it actually warns against misuse of herbal medicines or potential side effects from mixing with western meds.  The typical reaction, however, is to just glance over the headline – giving one the impression that herbal medicines PER SE are something generally unsafe and thus there is a need to warn the public about it.

Compare that with this headline: “Mixing medicine with herbal remedies can be risky.” (http://news.medill.northwestern.edu/chicago/news.aspx?id=158237)  This is much better and not misleading at all.

A few quotes from the article proves the spirit of the writer’s intent.  Allow me to refresh you:

Dr. Arshad Jahangir, a cardiologist at the Mayo Clinic in Phoenix/Scottsdale Arizona, who wrote the review, said the main reason patients look to herbal remedies is because they want to preserve their health.
“They think it’s natural and probably safe to use,” he said. “We’re not saying anywhere in the review that people should not take these products. But they should, at the very least, consult with their doctors who can look at their other medications and identify the potential for harm.”Herbal medications readily found over-the-counter can adversely affect the way prescription drugs are absorbed by the body by either enhancing or reducing their effectiveness.” (emphasis mine)

Yes! The article fits the headline!  And for the record, I perfectly agree. Next we see that integration between “eastern” and “western” medicine is promoted.  (albeit in a method I don’t agree with 100%, but I’ll take what is given.)

Christina Ferrari-Noonan, an acupuncturist and herbalist at Ancient Healing Chicago downtown, said patients who want to take herbal remedies should consult their doctors first.

“Patients should definitely go by the physician’s recommendation and see what they’re comfortable with,” she said. “There are definitely a lot of over-the-counter herbs that can be considered dangerous.”

Ferrari-Noonan, who has a background in Eastern and Western medicine, said herbalists should work in conjunction with doctors “We’re diagnosticians in traditional medicine not in western medicine,” she said. “Patients need to go their doctor first to get diagnosed. That diagnosis needs to be in place, and then as herbalists, we can go from there. Blood tests are especially valuable as a starting point.”

What I don’t agree with is the last sentence.  At times, people present with discomforts that cannot be classified in western medicine (how do you translate “Spleen Qi deficiency leading to weakness of the four limbs” into western medicine?  It isn’t CFS, it isn’t a movement disorder, etc etc) or do not appear in blood tests.

Jahangir agreed that herbalists and physicians should work together. “We’re not at war with herbalists and they are not against what we do,” he said. “Our goals are common, which is to serve our patients and to give them medicine or products that will do the job it’s supposed to do without causing harm.”

Tell that to the skeptics who insist that only commercial pharmaceuticals are worthwhile.

Mary Helen Lee, an herbalist at Chicago’s White Moon Healing Center, said herbal supplements could be beneficial as a compliment to chemical-based drugs, if taken correctly. “It’s definitely possible to take herbs to reverse the toxic side effects and lessen the harm the chemicals medications can have on your body,” she said. (I do this a lot with cancer patients on chemotherapy – Phil)

Lee said incorrect dosage amounts could also cause problems. “Either people are taking too much or too little, which can have a major effect,” she said. “Obviously, there are some dangerous herbs out there and people should be cautious. Patients should see a professional and get the correct herb and the correct dose for their problem.”

Experts agree that the biggest mistake people make is to self-diagnose on the Internet and treat themselves with over-the-counter herbal remedies without consulting doctors first. (emphasis mine)

“The Internet can be very helpful in educating yourself about herbs and possible effects, but it can also be very dangerous,” Ferrari-Noonan said.

So there you have it – a more balanced view that can be summarized thus:

a) herbs can work if used properly

b) always tell any healthcare professional about everything you’re doing for your health.  If they become biased against you because of that, then it’s time to find another provider.

c) never self medicate – there ARE herbal scammers out there who are only out to sell you stuff.

d) physicians of all traditions CAN and SHOULD work together.

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I don’t normally just cut and paste blog entries here in my own blog, but this article is too good for me not to quote and is so self-explanatory that I can’t really comment on it further except to say, “yeah, that’s right.”  I’ll just highlight some goodies.

The Science of Traditional Chinese Medicine: How Does it Really Work? <http://www.cityweekend.com.cn/shanghai/articles/blogs-shanghai/cw-radar/the-science-of-traditional-chinese-medicine-how-does-it-all-really-work>  by Trista Baldwin, posted by Andrea Wong (yeah I’m a bit confused…) posted and accessed 11/19/2009

Relegated to the realm of alternative medicine in the West, TCM is often viewed as a system based more on ancient superstition than science. Trying to understand TCM from the viewpoint of 20th century science is akin to trying to decipher Old English without a modern translation. There is a methodical approach at work; it’s just difficult to understand.

Couched in the ancient language and philosophy of the time, with references to qi, the five elements and yin and yang, that approach is often misinterpreted as being overly philosophical. However, the applications are actually quite practical. Qi refers to a physiological process; yin and yang to balance. The five elements (wu xing) are in fact a system used to describe the interactions and relationships that connect the various systems in the body to each other and to the environment–the flow of energy or fluids, for example. These systems are further confused by the Western understanding of anatomy.

When a TCM doctor refers to the Lung, this is not the same as its anatomical counterpart. The Chinese organs are interrelated systems. “An organ has its own qi , and delivers that to another organic system which gets its energy from another system and so forth,” explains Doris Rathgeber, general manager of Body & Soul Medical Clinics. As such, “A cough might actually be related to a problem with the Kidney,” explains Dr. Shao Lei, head of the acupuncture department of Huashan Hospital Fudan University. “This is often hard for patients to understand.”

Western studies on TCM have focused particularly on the workings of acupuncture and herbology, although explanations are not easily forthcoming. Many of the world’s pharmaceuticals come from herbs, but “it’s still hard to measure why the combination of one herb with another herb works,” Rathgeber says. Herbal prescriptions alter according to changes in the patient’s constitution and environment, making herbal remedies harder to test in isolation.

The healing effects of acupuncture, though not fully explained, are strongly linked to the nervous system. Piercing the skin with a needle triggers the sensation of injury. The brain generates an immune response, stimulating the area and strengthening the immune system in one fell prick. “The nervous system is interconnected,” adds Shao. “One point affects another.”

Despite its strengths in preventative and palliative medicine, neither Shao nor Rathgeber believes TCM needs to be practiced in isolation. Acute conditions requiring antibiotics or other Western treatments should not be avoided if necessary. Neither doctor shies from using Western diagnostic tools such as X-rays, MRIs or lab tests to more clearly pin-point the exact cause of a perceived deficiency. “Western medicine is more concerned with exact measurements, whereas TCM focuses on the overall result,” says Shao.

“For me, it’s not important if TCM is proven scientifically,” states Rathgeber, “more that it’s proven to work for the patient.”

Okay, room for ONE comment.  For me, whether it works for my patients or not is most important, but it is also important to prove TCM scientifically.  By not doing so, we are discouraging more MDs from integrating TCM into conventional medicine and thus giving more benefit to patients.

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Library stacks 700px 300x201 Evidence Based Medicine

Evidence Based Medicine

This article (http://www.voxy.co.nz/national/urban-myth-evidence-based-medicine/5/27647) does a good job of presenting the proof that the argument that western medicine is “evidenced based” does not hold water.  Some excerpts:

Studies from 1991 estimated that only 15% of medical interventions practiced by doctors were supported by solid scientific evidence.

More recently it has been estimated decisions made by doctors using such science ranges widely from 11% to 70%. “Hardly ringing endorsement of medicine as science” says Dr Wayne Jonas, author of the AMA’s paper `Scientific Evidence and Medical Practice’. (download PDF here)

Basically, what Jonas is saying is that (and this is especially true for general practitioners or family doctors), physicians tend to rely more on personal experience:

Primary care physicians appear to value evidence types differently than taught in standard EBM and in a way more consistent with the CAM practitioners in the study by Tilburt and colleagues.  Gabbay and le May performed an in-depth observational study of how physicians and nurse practitioners use evidence in making clinical decisions. Rather than systematic evaluation of current evidence from RCTs or even the use of current guidelines, conventional primary care practitioners rely on what Gabbay and le May called “mindlines.” Mindlines involved using tacit, internal guidelines derived from physicians’ own experiences and the opinion of colleagues in “communities of practice.” Indeed, physicians often distrusted the results of RCTs as relevant for the patients they see and instead used opinions of trusted peers.

So how does this affect acupuncture an other so-called unscientific practices?  The article says:

Wrote the study’s high ranking nursing professor authors: “If orthodox medicine is practiced on the basis of scientific evidence, as is claimed by its practitioners, such variations defy explanation,” with them adding, “… in view of such admissions, it seems incredible that medical practitioners have been trying to undermine the practice of complementary therapists because of their lack of an appropriate evidence base.”

This lack of EBM has been a criticism long levelled at holistic or natural health practitioners. Yet just as it’s being revealed how little of modern medicine actually relies on solid science, the global popularity of holistic treatments is itself driving a body of evidence proving their effectiveness. (emphasis mine)

Typical bias – those against chinese medicine will ignore all the evidence proving it, while ignoring evidence against their own positions.

Sources:

“Urban Myth? Evidence-Based Medicine” voxy.co.nz 19 October 2009.  19 October 2009 <http://www.voxy.co.nz/national/urban-myth-evidence-based-medicine/5/27647>

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