Prolotherapy for Osteoarthritis of the Knee

Knee X-rayThe National Institute of Health Division of Alternative and Complimentary Medicine has said that if a treatment works, and its results can be reproduced, then it is not alternative therapy.  Such a wise mantra is at the heart of a study published in the May/June issue of the Annals of Family Medicine and recently reviewed in MedPage.

David Rabago, MD, of the University of Wisconsin in Madison and his associates looked at whether prolotherapy is beneficial for those patients suffering from arthritis of the knee. Prolotherapy involves the injection of sugar water or dextrose into joints for the relief of pain. It has been used in different joints for over 75 years but most of the research studies available on its use suffer from poor scientific design and reproducibility.

This study involved 90 adults with knee arthritis in one or both knees for at least five years.  The mean age of the enrollees was 57 years with 2/3 of the enrollees being women and ¾ overweight or obese.  The enrollees were separated into groups. One group received dextrose injections, another received saline or salt water, and a non-injection exercise group. The injections were given at weeks 1, 5, 9, 13 and 17. 

Prolotherapy required them to make multiple punctures around the knee at various tendon and ligament sites. 22.5 mL of either concentrated dextrose or saline placebo were injected into the knees followed by an intra-articular injection of 6mL of additional fluid.   A third arm of the study included patients given no injections but instructed in a home exercise physical therapy program. 

In the dextrose group, 17 patients received injections in only one knee and 13 had treatment in both knees. In the placebo saline group, 15 had a single knee treated while 13 had both knees treated.   During the study, 14 patients in each group used oral non-steroidal inflammatory drugs to relieve pain and discomfort.  All patients receiving injections reported mild to moderate pain after the procedure and up to 2/3 used oral oxycodone before or after the procedure.

The patients used the Western Ontario McMaster University Osteoarthritis Index to score their pain, function and stiffness. There was a significant difference in the improvement of those receiving the dextrose injections as compared to those receiving saline injections. Ninety-one percent of those receiving the dextrose injections said they would recommend the treatment to others.

This was a preliminary study which showed the effectiveness of an alternative therapy in treating a common and chronic condition. It is clear that these findings necessitate a larger study which can look at the correct dosage to inject and to explore how the sugar injections actually work. It appears to be a relatively inexpensive way to relieve chronic pain and is worthy of further study!

pH Testing For GERD May Save Money

HeartburnHeartburn and dyspepsia are common conditions exacerbated by being overweight, eating too much, eating certain types of foods (red sauces, berries, alcohol, fatty foods, caffeinated beverages, chocolate) reclining after eating, wearing constrictive clothing at the belt line and a host of other items. The heartburn is supposed to be due to the reflux of acidic digestive juices from the stomach into the gullet or esophagus. There is no true physical barrier between the stomach and the lower esophagus like a trap door but there are a group of muscles known as the lower esophageal sphincter. These muscles are supposed to recognize that the stomach contains food and acidic digestive juices and contract and prevent the stomach contents from kicking back up the esophagus and producing heartburn symptoms.

The treatments of choice are; avoiding those foods that produce the heartburn, wearing less constrictive clothing and, medications. The gold standard of medications is the PPI’s or proton pump inhibitors. These would be medicines like Prilosec, Nexium, and Prevacid. The product inserts suggests we take these medications for eight weeks and no longer. Most patients continue to take the medications long after the recommended eight weeks.

In an interview in MedPage, the online journal of the University Of Pennsylvania School Of Medicine, David Kleiman, MD of Weill Cornell Medical College in New York City proposes that at eight weeks patients be given a pH test or what used to be called the “Bernstein Test”.

With the pH test, a thin plastic tube is inserted through the nose and placed so the tip is at the lower portion of the esophagus adjacent to the stomach. You then sample and test the fluid for acidity by measuring its pH. The test costs under $700 and is fairly accurate and safe.

According to Dr. Kleiman, he examined patients with GERD who continued to take PPI’s beyond eight weeks and almost 1/3 of them did not have any signs of acidic material refluxing into the esophagus. When looking at the lower dose PPI’s sold over the counter, versus the prescription items, the average weekly cost of PPI’s varies from $29 to $107. This translates to a cost of between $2000 and $7,300 a year on medicines not needed.

While the idea of inserting a tube to measure acidity as a way to distinguish who should continue PPI’s has its merits, the practical question is “How available is the test and who is doing it?”.

It is always a good idea to discontinue medications you do not need – especially expensive ones. The availability of the testing in local communities may preclude this approach.

Evaluation of Blood in the Urine (Hematuria)

Speciman BottlesI recently had a long discussion with a diabetic patient about the drug Actos. This very effective and relatively safe diabetic drug has now been implicated as increasing the risk of bladder cancer. While the FDA has not removed the drug from the market, it has been removed from the market in Germany.  My patient wondered if he could continue using Actos but send his urine off for testing and evaluation regularly to detect any indication bladder cancer early. I said I preferred switching medications. 

Chance would have it that the April 11, 2013 edition of Journal Watch addressed the question indirectly.  They looked at whether or not it was safe to send urine off for cytology to look for cancerous cells in the evaluation of blood in the urine. Urine cytology, like the Pap smear, looks at cells in the urine from the bladder and tries to diagnose bladder abnormalities and cancers by identifying abnormal cells. The traditional evaluation of blood in the urine includes doing x-ray and imaging studies as well as performing an invasive procedure called a cystoscope (under anesthesia a fiber optic device is inserted into the bladder through the urethra and advanced into the upper collecting tracts.).

In a study performed in the United Kingdom at a teaching hospital, researchers reviewed the records of patients with blood in the urine. Sixty-five percent of the patients had visible bleeding while 35% had only microscopic bleeding. They all underwent imaging of the upper tract, cystoscopy and urine cytology.

A full evaluation of imaging, cystoscopy and cytology was performed on 2,507 patients. Fourteen percent of the patients were ultimately diagnosed with transitional cell cancers of the bladder. The sensitivity and specificity of abnormal cytology were 45% and 89% making cytology not “good enough” to serve as a first line test for patients with unexplained blood in the urine. More than half the patients with bladder cancers had negative cytology and about 105 of patients with negative cytology had bladder cancers.

The study supports the recommendations of the American Urologic Association’s guidelines that recommend against using urine cytology in the initial evaluation of patients with microhematuria.

Cervical Cancer Screening Guidelines – American College of Obstetricians and Gynecologists

Cervical Cancer Screening - Steve Reznick, M.D.On a routine basis my female patients, many of whom have undergone a total hysterectomy, ask me if they need to continue to have Pap smears annually. There has clearly been a great deal of confusion about who should get a Pap smears and when. This communication is an attempt to clear that up.

1. Women who have had a hysterectomy and removal of the cervix (total hysterectomy) and; have never had an abnormal Pap smear (graded a CIN 2 or higher – cervical intraepithelial neoplasia), do not require a Pap smear. If they are still getting them they should be discontinued and never restarted

2. Screening for cervical cancer by any modality should be discontinued after age 65 years in women with evidence of adequate negative prior screening ( 3 consecutive negativ pap smears with the most recent having been done within 5 years and no history of abnormal Pap smears graded CIN 2 or higher).

3. Cervical cancer screening should begin at age 21 years. Women younger than 21 years should not be screened regardless of the age of initiation of sexual activity or the presence of other behavior related risk factors.

4. Women aged 21-29 years should be tested with cervical cytology alone. Screening should be performed every 3 years

5. Women aged 30-65 should have “co testing with cytology and human papillomavirus (HPV) testing every 5 years.

6. In women aged 30-65 years, screening with Pal smear cytology every 3 years is acceptable. Annual screening is not preferred.

7. Women who have a history of cervical cancer, have HIV infection, are immunocompromised, or were exposed to diethylstilbestrol in utero should not follow these minimal routine screening guidelines.

8. Both liquid-based and conventional methods of cervical cytology collection are acceptable for screening.

Breast Cancer Screening DOES SAVE LIVES

Eugenio Paci, MD, of the ISPO Cancer Prevention and Research Unit in Florence, Italy working with a European breast cancer screening group, published data in the Journal of Medical Screening that clearly showed that screening mammograms save lives. The study was necessitated because of recent controversial data presented by the US Preventive Services Task Force (“USPSTF”) calling for women to wait until age 50 to begin mammograms and having them every other year rather than annually. The USPSTF recommendations were based on the belief that too many false positive tests led to too many unnecessary and expensive follow-up tests.

The European researchers found that for every 1,000 women screened from age 50 to 51, and followed to age 79, an estimated 7 to 9 lives would be saved and; an additional four cases of cancer would be diagnosed early. The screening resulted in 170 women having to have a repeat non-invasive test to rule out cancer (such as a repeat mammogram and or ultrasound of the breast) and 30 women would have to undergo an invasive test such as a biopsy.

The researchers looked at a 10 year period in Europe and expected 30 deaths per 1,000 women from breast cancer of which 19 could be prevented by screening. Their figures showed that 14 women need to be screened to diagnose one case of breast cancer and 111 to 143 need to be screened to save one life.

I will continue to recommend that patients learn how to perform a breast self exam and perform it regularly. We will begin screening our high risk patients at age 40 and others at age 50.

A thorough annual breast exam by the patient’s doctor is advised. A decision on annual mammograms versus every other year should be decided by the patient’s risk factors, family and personal health history, current examination and past mammogram findings.

Traditional Colonoscopy vs. No Laxative CT Colon Exam

Research radiologists at the Massachusetts General Hospital in Boston evaluated the accuracy and detail of imaging the colon (a virtual colonoscopy or colonography) with no laxatives as preparation and comparing it with traditional colonoscopy.  There are clear evidence based guidelines suggesting that all low-risk men and women have a screening for colon cancer with a colonoscopy at age 50.  If that study is normal they are directed to repeat it every 10 years.  Routine screening colonoscopies are discontinued after age 80 years old.  There is no question that screening colonoscopies save lives from colon cancer.  There is no question that the laxative taken the day before to clean you out, plus the actual procedure, are reasons that individuals avoid going for colon cancer screening.

The study directors fed their patients a low fiber diet before the scan. The patients drank an oral contrast material that marked stool feces and allowed the radiologists to distinguish colon abnormalities from retained feces and stool.  This virtual colonography was excellent at detecting larger colon adenomas of 10 mm or larger picking up 91% of the existing lesions as compared to 95% with traditional preparation and colonoscopy. The difference between the 91% on virtual colonography and 95% on traditional prep and colonoscopy was not felt to be statistically significant.   The virtual colonography didn’t do as well at detecting the smaller growths.  Researchers pointed out that “the vast majority of polyps that impact cancer and survival outcomes are 10 mm or larger.”  They went on to say that the “the laxative free method would likely be worthwhile as a way to reach the many adults whose strong aversion to laxative bowel preparations stops them from getting screened.”

Clearly getting screened is always preferable to no screening.   The laxative free virtual colonoscopy was not as good as the traditional colonoscopy at finding smaller lesions.

The data in this research study were based on the skill and experience of three radiologists only. Previous studies have emphasized the need to have an experienced radiologist interpret these studies.  The researchers did not discuss the radiation exposure, which is significant, with the virtual colonoscopy.   They additionally did not mention the cost which many health insurance companies will not pay for at this time.

Despite these issues it is wonderful to have another tool in the fight against colon cancer especially to offer to those patients who have said they will “never” have a colonoscopy.

FDA Approves New Prostate Cancer Blood Test

The PSA blood test which has been used to screen for prostate cancer has come under a barrage of criticism in recent weeks. The PSA level increases in many non-cancer conditions and this has led to many biopsies and procedures that created more harm, and cost, than good. For this reason, the prestigious Institute of Medicine (IOM) and the U.S. Preventive Task Force have indicated that men should not be routinely screened for prostate cancer with the PSA blood test.

A new test may be on the horizon.  Beckman Coulter said its application for the Prostate Health Index test has been approved by the FDA. The test measures a PSA precursor protein known as [-2] pro-PSA in men with elevated PSA’s between the level of 4 and 10. This, coupled with the PSA and free PSA, helps create the Prostate Health Index.  The company’s data showed that by using the Prostate Health Index there were 31% fewer negative biopsies of the prostate.   The test will be commercially available by the fall of 2012.

We will make this test available when the commercial labs inform us that they are ready to perform it. It remains to be seen whether the health insurance companies will pay for it immediately.  We will need to monitor whether the promise and initial data are accurate when the test is introduced into the general public. We will also need guidelines on how often to follow this index.

United States Preventive Care Can Be Better, Center for Disease Control Says

Ralph Coates, PhD of the Center for Disease Control (CDC) described in the June 15, 2012 issue of Morbidity and Mortality Weekly Report that by looking back at a U.S. study done between 2007-2010 called “Use of Selected Clinical Preventive Services among Adults,” health providers need to do a more comprehensive job of offering preventive services.

According to the report, only 47% of patients with documented heart and vascular disease were given a recommendation to use aspirin for prevention. They additionally found that only 44% had their blood pressure under control. When looking at cholesterol and lipid control only 33% of the men and 26% of the women were tested with a blood lipid test in the last five years.  Of those patients who did measure their lipid levels, only 32% of the men and women surveyed had their lipids under control. Among diabetics, 13% had poor sugar control with a HgbA1C > 9 (goal is 6-8).

The data indicate that at 37% of the visits, patients weren’t asked about their smoking or tobacco status.  When patients were asked, and answered that they were smoking, only 21% were given smoking cessation counseling and only 7.6 % were prescribed medications or a way to stop smoking.

Screening for cancer needs improvement as well. Twenty percent of women between the ages of 50-74 had not had a mammogram in over two years.  In the same age group, a third of the patients were not current on screening for colon and rectal cancer.

The data was collected prior to the passage of the controversial Affordable Care Act. When the data was analyzed and divided according to socioeconomic status, education level, and health insurance status; it was clear that the poorest and least educated had the fewest screenings. It is hoped that with passage of the new health care law, and new insight by health insurers that it is cheaper to prevent a disease than treat it, these numbers will improve.

There are several other factors that need to be looked at as well. Data is now being collected from electronic medical health records.

I ask my patients about tobacco status on every patient visit.  When I note that the patient is smoking in their electronic health record, there are three or four ways to document counseling has been offered. Only one of them triggers the audit data for the government to review. Our software instructors were unaware of that when they taught us to use the system.  How much of this study is the result of data collection error is unknown.  “Health care providers” – not just physicians, are now delivering health care.

Access to physicians and a shortage of primary care physicians exacerbate the problem. It takes time to extract this information, record it, and counsel the patient. Because PCPs are underpaid, they will continue to see patients in high volumes to cover their expenses, causing the use of comprehensive preventative questioning to remain low.

Prostate Cancer Risk Can Be Predicted With a Single PSA Test

The highly acclaimed Institute of Medicine and now the U.S. Preventive Task Force have recommended against routine screening of asymptomatic men for prostate cancer. Now, a study presented by Christopher Weight, MD from the Mayo Clinic Department of Urology adds more information and confusion to the fire. Dr. Weight presented his data at a recent meeting of the American Urologic Association.

The Mayo Clinic followed men younger than 50 years old for 16.8 years.  They concluded that men at age 40 with a PSA value of less than 1ng/ml had a less than 1% chance of having prostate cancer at age 55. They had less than a 3% chance of having prostate cancer at age 60.  They concluded that men with a baseline PSA < 1% in their 40s appear to be able to safely avoid annual screening until age 55.  “Men with a baseline PSA greater than or equal to 1 have a substantial risk of subsequent biopsy and cancer diagnosis and should be followed annually.”

This is one of the first research studies to quantify the actual relationship of screening young asymptomatic individuals and the subsequent risk of developing the disease.  It is the type of research needed to help guide us to make safe and sane recommendations about the type of screening for prostate cancer and frequency of screening using blood tests, ultrasound and of course digital rectal examination to palpate the prostate. All the patients in the Mayo study received a PSA assessment, digital rectal exam and transurethral ultrasound of the prostate at study entry and biennially thereafter.

This study affirms the recommendation for performing a screening digital rectal exam on all men at age forty and subsequently. It begins to answer the question of who needs follow-up PSA testing and when.  However, more research is clearly needed.