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Drug Research

The 21st Century View on Antibiotics, aka Fleming Turning in His Grave

October 22, 2014 by James Bogash

There is a time and a place for everything in medicine.  Even, I would (very) begrudgingly admit, statins. But too often we are using meds without a full understand of the dark side of medicine.

And that dark side can be as devastating to your health as any diseases we’re trying to conquer with drugs.  Antibiotics are on this list.

When you would ask the average doctor what the principle danger of antibiotics is, it is almost assured that you will get antibiotic resistance as the answer.  And antibiotic resistance is a community issue.  As the prescribing physician, it’s easy to think that the risk of antibiotic resistance has little to do with the patient standing in front of you with an upper respiratory infection.  After all, antibiotic resistance is a community” thing, not an “individual” thing.

In other words, if there is little harm of antibiotic resistance from unneeded antibiotic use to the patient staring you in the face, the potential benefit, however small, is worth the risk.  So that prescription will be given on the off chance that it may help the upper respiratory infection.

The first peer reviewed published article on probiotics was published in 1908.  Now, 106 years later (as of the writing of this article) very few doctors grasp even the basics of the relationship between us and the bacteria in our gut.  This is despite literally thousands of studies documented the benefits of probiotics.

But even this concept is reversed.

It’s not about the benefits of probiotics.  Rather, it’s about the devastating health consequences of destroying the beneficial bacteria seeking refuge in your body:

  • Disrupted immune balance, leaving you susceptible to allergies, asthma and autoimmune conditions
  • Inability to fight off infections from disease-causing bacteria, viruses and parasites
  • Inability to detoxify toxic chemicals from the environment
  • Alteration of the hormone balance in the body, leading to depression, obesity and anxiety

The list is far longer, but I think you get the idea.

The group who does NOT get the idea, however, is the one continuing to write prescriptions for antibiotics in all but the most severe cases.  Ear infections.  H. pylori in the stomach.  Upper respiratory tract infections.  Pharyngitis (sore throat).  Before dental work.  After every surgery.  Sinus infections.  As a preventative just in case a bacterial infection MIGHT happen during a viral illness.  The list is quite long.  And all of this in spite of mounds of research screaming to NOT use antibiotics.

Until prescribing providers truly, deeply and passionately understand just how important it is to have a normal bacterial flora living and thriving within us, our society will be plagued with chronic diseases.

This particular article drives this home.  Even further, most of this entire Journal of Clinical Investigation is devoted to the topic of just how integrated bacterial populations are integrated into every part of our health.

The authors highlight the emerging viewpoint that we need to view ourselves and the bacteria within us as an ecological community.  One where wanton destruction of its inhabitants have long-term damaging consequences to our health.

It takes no convincing for society to look with horror on the killing of Siberian tigers for the pelts, elephants for their tusks, the overfishing of certain fish populations to near extinction or the loss of the rainforests killing the abundant life that lives within.

It is through this lens that we need to view the bacteria within us.  We need to focus our efforts on supporting solid growth and diversity in our newborns and infants through vaginal birth, breastfeeding and NO antibiotics in the first few years of life.  As we age we need to focus on diets that support the growth of bacteria rich in soluble fibers and without processed junk.  We need to do everything in our power to avoid drugs that block acid production in the stomach (unless a bleeding ulcer is present).  And we need to change the way we raise livestock in an antibiotic soup.

Until we can make these changes, both in understanding and in behaviors, the modern, antiseptic life is going to rob us of health.

 

Filed Under: Drug Research, Probiotic Tagged With: antibiotic overuse, antibiotic resistance, probiotics, side effects of antibiotics

Drugs and Medical Treatment: How Powerful is the Placebo Effect?

July 20, 2014 by James Bogash

placebo and nocebo response
Photo courtesy of https://flic.kr/ps/q5KAv

You have heard of the placebo response and have a general idea of how it works. The reality is that few of us know just how powerful it is.

This wouldn’t be a problem except that most drugs, when studied in clinical trials, are compared to placebo.  This means that patient beliefs during treatment may have much stronger effects than the drug itself.  Many drugs are studied under double-blind placebo controlled studies in the attempt to control for the placebo response.  In these studies, neither the reviewer (many times this is the treating physician) nor the patient knows who is taking the placebo and who is taking the active drug.  But if the patient even thinks he or she is on the active drug, it can completely throw off the results of the study.

In single-blind studies, the reviewer knows whether or not the patient is on the placebo or drug.  This requires the reviewer to maintain an absolutely neutral attitude towards the patient lest he or she gives a hint as to what arm of the study the patient is in.

In non-blinded studies, all bets are off.

Although I don’t have the reference I remember coming across a study on blood pressure medications.  The sneaky design of the study had participants believing that the study was designed to compare the drug to the placebo.  In the study, the placebo had a pretty powerful response and the drug response was only a little bit stronger.  However, when researchers teased apart those who were most compliant with taking the pills, whether drug or placebo, had the strongest blood pressure response.  From compliance, we can conjecture that those who took the pills as prescribed had a much deeper belief that it was going to help them.  This belief trumped all as far as a treatment response.

With that being said about the power of placebo, the opposite can also be true.  This is called the nocebo response and deals with patients who have negative expectations for treatment or side effects.  In other words, if you hear from your doctor that Drug A has some pretty nasty side effects, you are actually more likely to experience said side effects.

This particular study will completely destroy your faith in the ability to truly study the benefit of any drug in any study.

In it, researchers took 66 chronic migraine sufferers and followed them from an initial migraine attack through the next 6 attacks.  In each of the attacks (after the initial attack for which no treatment was given, which served as the control), participants were given either a placebo or Maxalt (10-mg rizatriptan) over the course of the next 459 attacks.

(Editor’s note: due to the nature of this article, I will not go into the correct approach to the management and elimination of migraines.  Feel free to check out my Migraines and Epilepsy eBook for that…)

What made this trial different was what was communicated to the migraine sufferer.  The treatment was given under three different information conditions:

  1. Negative—they were given and told they were given a placebo
  2. Neutral—they were given and told they were given Maxalt
  3. Positive—they were given placebo but told it was Maxalt.

Pretty clever (but sneaky) if you ask me.  Here’s what the researchers found out:

  • Response to Maxalt was stronger than placebo (not unexpected).
  • The placebo response was stronger than no treatment (not unexpected either).
  • The placebo, even when the patients were told it was a placebo, had a stronger response then no treatment (a wee bit of a surprise here…)
  • When participants were given placebo labeled as (i) placebo, (ii) Maxalt or placebo, and (iii) Maxalt, the overall placebo effect increased.
  • Maxalt had a similar progressive boost when labeled with these three labels.
  • The response to Maxalt labeled as a placebo and placebo labeled as Maxalt were similar.
  • Compared to no treatment, the placebo, under each information condition, resulted in more than 50% of the drug effect.

This is really interesting stuff.  Basically, the more “positive” information the patient got, the stronger the response, regardless of whether it was a drug or placebo. The reverse was also true—if the patients did not believe they were given the drug the response was not as strong.

This says a few things about society and can help me as a physician.  First, a note on society.  And it’s a sad note.  This study found that, even if patients were told they were given a placebo that we all know is “just a sugar pill” our programming that drugs “fix things” runs so incredibly deep that merely taking a pill has the potential to help EVEN when we know it can’t possibly help.

More importantly, I know that, as a physician, my beliefs and reassurances about the treatments I offer have a strong impact on the outcomes of these same treatments.  My assurance to a patient that a treatment for his or her condition can be very effective can be as powerful as the treatment itself.  Ironically, with experience and seeing thousands of patients over the years benefit, I become more confident in the treatment I provide.  This confidence can, in turn, improve the outcomes of my patients.  Pretty cool.

Filed Under: Drug Research Tagged With: drug research, nocebo, placebo, positive thinking

Stressed Out? Problems Sleeping? Taking These May Kill You

April 16, 2014 by James Bogash

sleep hynotics increase risk of death
Photo courtesy of https://www.flickr.com/photos/hopkinsii/

The typical answer for sleep problems or anxiety is medication. But in no way do these drugs actually fix anything.

Rather, the underlying brain damage that stress causes is allowed to run amok, unchecked. And make no mistake–stress destroys your brain. Shrinks it. Kills off healthy brain cells. Shortens memory. Accompanying the brain damage is damage to the rest of your body as well. Increased risks of obesity, diabetes, heart disease and cancer.

In summary, not good.

In my opinion, stress is the leading cause of sleep problems. How is your body supposed to sleep when all the cortisol-based alarms in your head are screaming that there is a saber-toothed pacing in the hallway. Managing stress is key to anxiety and sleep problems. Exercise and eating right for your body. Meditation, self-hypnosis or biofeedback for your brain.

Using medication to cover this up is a recipe for disaster and is associated with over a half MILLION deaths per year. I’ve written about this in a previous blog article that can be found by clicking here. So, with this in mind, is nothing new and just reinforces this dangerous association and puts the damaging effects of stress on your health into perspective.

Here are the details of this study looking at 34,727 patients 16 years of age and older who were prescribed anxiolytic or hypnotic drugs and followed for an average of 7.6 years:

• Most common drugs were benzodiazepines (think diazepam) and the “Z” drugs (zaleplon, zolpidem, and zopiclone – think Ambien).
• Those taking one of these drugs had a 346% higher risk of dying in the study period.
• The higher the dose, the greater the risk.
• To put in more plainly, there were about four excess deaths for every 100 patients using one of drugs.

If this was not the first study to find an association between the use of these 2 types of drugs (for anxiety and sleep problems) we could maybe blow off the results. But we can no longer ignore the fact that taking a drug in this class WILL increase your risk of dying. Period. Maybe it’s the stress or maybe some aspect of the drugs themselves. Either way, it doesn’t change the outcome. Dead is dead regardless of how it happened.

Filed Under: Anxiety, Drug Research Tagged With: Ambien, anxiety, diazepam, insomnia, sleep hypnotics, sleep problems

Zetia & Cholesterol: How to Tell if Your Doc Stays Up to Date

April 11, 2014 by James Bogash

cholesterol lowering drugs
Image credit: jgroup / 123RF Stock Photo

Ezetimibe, aka Zetia, hit the market in 2002 based on its ability to lower LDL cholesterol levels. Scripts skyrocketed 180 TIMES over the next 6 years.

In the US in 2002, 6 out of 100,000 people were given prescriptions for Zetia; by 2008, this number vaulted to 1082 per 100,000 persons. A mind blowing increase for a drug that had not yet been shown to save lives, just shown merely to lower LDL cholesterol. In Canada, over similar time frames, use jumped from 2 per 100,000 to 495, an even more massive increase of 247.5 TIMES as many prescriptions. Again–for a drug that really hadn’t been shown to do anything just yet.

And it is chiropractors who are sometimes accused of being unscientific.

This should have all changed in 2008 with the release of the data from the ENHANCE trial. In the ENHANCE trial, ezetimibe was added to a statin (the combination being called Vytorin) to further force cholesterol levels down, because that is really all that is important. Disappointingly, the trial showed no benefit from ezetimibe.

Just in case this wasn’t enough, in 2009 in the ARBITER 6–HALTS trial, the combination was actually shown to INCREASE plaguing in the carotid arteries of the neck. Not a good thing. Surely, by this point prescriptions for Zetia fell to nonexistent levels, right?

Not quite.

This particular study looked at how much the publication of the ENHANCE trail data affected physicians’ use of ezetimibe in both the US and Canada. In the US, after the publication of these two trials, prescriptions fell from the aforementioned 1082 per 100,000 people down to 572, a drop of 47.1%. In Canada, however, the increase in the number of prescriptions slowly and steadily moved up (from 2 to 495 per 100,000 people) even after the publication of the trials.

This is not the first example of mainstream medicine ignoring the evidence that is supposed to guide the practice of medicine. But this one seems particularly bothersome. This drug launched itself from zero to near superstar status on pretty much nothing but the ability to lower a single lab value 20%. And, I might add, this particular lab value is LDL cholesterol, which has now lost favor as a lab value that has any real ability to predict risk of heart disease.

The bottom line is that you should ONLY see a physician who keeps up with the medical literature. Maybe not to the DSM-V worthy level that some of us do, but at LEAST the basics. If you doctor has written you a prescription for either Zetia or Vytorin, he or she is not in this group.

Filed Under: Cholesterol, Drug Research, Heart Disease Tagged With: cholesterol, drug research, ezetimibe, heart disease, Vytorin, Zetia

Antibiotic Side Effects; You Thought Diarrhea was the Worst Concern

April 2, 2014 by James Bogash

The side effects of diarrhea are pretty well played known. Diarrhea and antibiotic resistance top the chart.

I have not exactly been silent about my position that the above two concerns are minor side effects and that the destruction of the normal, protective bacterial flora in the gut is of one of the most horrendous, underappreciated side effects of wanton antibiotic use. Nothing will destroy the delicate balance of the immune system like throwing the bacterial flora off kilter with antibiotics.

But this is a story for another time. This particular article raises a very, very disturbing concern that I had not been aware of until now.

Azithromycin (think Zithromax and the Z-pak) and levofloxacin (Levaquin) are very commonly used antibiotics for just about everything. While the aforementioned antibiotic-associated diarrhea still remains a concern, researchers in this article found a new side effect that occurred within the first 5 days of using one of these antibiotics.

Arrhythmias and fatal heart attacks. Now, maybe I’m overreacting, but to me, it seems like death as a side effect from taking antibiotics for a viral respiratory infection seems a little unbalanced.

To put this in perspective, one of the researchers noted that 50% of patients continue to receive antibiotics, especially broad-spectrum antibiotics, for illnesses such as “acute cough.” This means that, “if it is assumed that 50% of the 40 million outpatient prescriptions for azithromycin written in 2011 were unnecessary, then based on the data, it may be reasonable to estimate 4560 deaths were caused by antibiotic alone.”

Here are the specifics from the study:

• This study looked at 1.6 million antibiotic prescriptions among Veterans.
• Those who received azithromycin had a 48% higher risk of death.
• They also had a 77% higher risk of cardiac arrhythmias.
• This occurred in the first five days of treatment (but, since azithromycin is a short course, this is somewhat irrelevant).
• Those who received levofloxacin had a 149% higher risk of death and 143% higher risk of cardiac arrhythmia in the first five days.
• The risk were not as bad, but still present on days 6-10, at 95% and 75% higher, respectively.
• The risks were greater for those with existing prolonged QT interval, low blood levels of potassium or magnesium, those with bradycardia or those currently taking antiarrhythmic medications. Further, elderly patients and those already at high risk for heart disease were also at higher risk.

Lest you think that you are entirely safe, other macrolide antibiotics that are like azithromycin such as erythromycin and clarithromycin, have also been shown to up risk of QT-interval prolongation, torsades de points, and polymorphic ventricular tachycardia.

What does this mean? Overall, it really doesn’t change the story. Antibiotics, from my perspective, have always been a dangerous class of drugs to use except when absolutely necessary. However, this concern is largely due to the long term effects of destroying immune balance that will show up years later. This study makes long term side effects irrelevant if you happen to be dead from a heart attack.

Filed Under: Drug Research, Probiotic Tagged With: antibiotic side effects, antibiotics, probiotics

US prescription drug sales boosted by advertising – (10-30-00)

February 23, 2014 by James Bogash

US prescription drug sales boosted by advertising

Who’s says that research and good medicine are behind the rise in use of prescriptions drugs? It’s got nothing to do with that. Quite the opposite…there’s been much controversy lately with the pharmaceutical industry infiltrating into the FDA and affecting the results of so-called unbiased research.

bmj.com Charatan 321 (7264): 783

Read entire article here

Filed Under: Drug Research Tagged With: advertising, prescription drug

Are Drug Companies Really This Crooked??

January 4, 2014 by James Bogash

I think we can all agree that Western medicine is built upon a foundation of drugs and surgery. Without either, most doctors would truly be lost as to what to do with a patient.

That’s not to say that we actually help our patients by giving them drugs and putting them through surgical procedures.

But, if medicine is so massively dependent upon drugs, this then means that we are just as heavily dependent upon the pharmaceutical companies that make these same drugs. This has proven to be a very bad relationship that has been shown again and again in the research. Drug companies manipulate doctor’s perceptions from medical school into all aspects of practice life. Drug companies manipulate your perceptions through millions of dollars spent in direct to you advertising.

And this is all the legal stuff.

What you don’t usually hear about Is the illegal stuff. And not just hearsay. We’re talking bona fide criminal justice and case law stuff. This particular article goes into some of the criminal behaviors of the drug companies, including:

1. There have been recent, sharp escalations in the frequency with which many giant multinational drug companies repeatedly engage in illegal criminal and civil activity after previously paying enormous fines and being subject to monitoring.

2. From 1991 through 2012 $30.2 BILLION in criminal and civil penalties were paid by drug companies to federal and state governments.
3. More than half of the penalties were either for illegal promotion or illegally overcharging government programs for drugs.

And this is AFTER some of these companies were forced to sign and adhere to US government mandated corporate integrity agreements (CIA) for five years. In other words, the criminal behavior has become such a culture at these companies that these fines are merely the cost of doing business.

All of this would be bad enough if these companies made toilet paper or cardboard boxes. But they don’t. They develop and manufacture the very drugs that are the foundation upon which medicine is built in this country. The drugs they produce have nothing to do with saving or improving lives. It is all about profit.

It’s time to be scared. Very scared.

Filed Under: Drug Research Tagged With: drug company, drug industry

Higher Use& Intro of New Drugs Cause Increased Drug Spending – (09-21-00)

November 21, 2013 by James Bogash

Higher Use& Intro of New Drugs Cause Increased Drug Spending

Remember all those studies saying the the American public is more interested in taking better care of themselves and using natural alternatives?? Well, I for one think those reports are wrong and many people still rely on pharmaceuticals for “answers” to their health problems.

Drug Benefit Trends 12(7):7-8, 2000 Pharmacy benefit costs are rising largely because of higher utilization: more people are taking prescription medicines and taking them for a longer period. Price inflation, by contrast, has had a relatively minor effect on the trend of increasing expenditures for drugs, according to Merck-Medco’s Drug Trend 2000 Report, “Managing Pharmacy Benefit Costs — New Insights for a New Century.” Other reasons for utilization increases include an aging population; new medical guidelines that call for earlier or more aggressive treatment of certain diseases; the enthusiastic reception given by patients and physicians to new drugs that have either modest or significant therapeutic advances; direct-to-consumer advertising; drugs with more convenient dosage forms or fewer side effects; and more health care being delivered on an outpatient basis, which means that drugs are covered under the pharmacy benefit plan, rather than in hospitals or physicians’ offices where drugs are covered under the medical plan.

All but one of the remaining children experienced only minor reactions, including fever, local reactions, and/or lethargy, during the 7 days following immunization.

Filed Under: Drug Research Tagged With: new drugs.

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