Category Archives: Healthy Life

Understanding Different Types Of Clinical Trials

Clinical trials are carried out on specific patient populations each day and as a result many advances have been made in the treatment of different conditions such as cancer. Those participating in clinical trials often choose to do so with the hope that it would lead to either an improvement in their own condition or in advances to help future generations.

Participation in Clinical Trials

If one is asked to consider participating in a clinical trial it is absolutely vital that one first fully understands the exact purpose of the trial and exactly what participants are required to do during the course of the trial. Never be afraid of asking doctors or researchers questions as this is the best way to make as informed a decision as possible.

After reading about the proposed trial it is well worth noting down key questions to take to any meetings as it is easy to go blank in appointments. As a general rule of thumb it is necessary to take some time to be totally sure that one feels comfortable about both the aims of the trial and the types of participation that will be required.

After receiving a consent form for the trial remember to read it through carefully and before signing ask any last minute questions or raise concerns which have arisen as a result. Also, if at any time during the clinical trial one does not wish to continue then one is able to stop regardless of whether it is a few days or months from completion.

Different Types of Clinical Trials

There are three main types of clinical trials which include phase one, two and three with each phase linked together. Phase One trials will typically involve the initial study of how high a dose of medication may be safely given and the manner in which it is metabolized by the body. At this stage there are usually between 20 to 50 volunteers participating in the clinical trial and if stage one is successful then phase two will begin. In contrast to stage one, this stage will normally require several hundred volunteers to test effectiveness of the medication in terms of specific indications or uses.

Phase three trials basically compare the level of effectiveness of a new treatment against the standard form of treatment. In cases where no standard treatment exists, some patients may be given a placebo and this is known as the control group. Those patients on the new medication are known as the test or study group and usually the patient and the doctor are unaware of which treatment is being provided; this is referred to as randomized double-blind controlled trials. At this stage anywhere up to several thousand volunteers may be needed in the study.

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As highlighted above, clinical trials have been used for many years with the aim of creating advances in medical treatment. Before participating in a trial it is important to take time to consider exactly what is involved and whether it is something that one feels able to follow. At any time during clinical trials participants may decide to discontinue.

Post-Exposure Prophylaxis: The Different Types Of PEPs To Minimize Risk Of HIV Infection

Post-exposure prophylaxis (PEP) was first introduced in 1998 to health-care professionals in San Francisco who took care of HIV patients. When they encountered accidental needle-stick injuries, they risked being infected by HIV. Occupational PEP was then administered to suppress the virus. This has since become a standard care for all medical workers.

PEP involves a course of anti-retroviral drugs to be first administered within 72 hours of exposure. One such regime comprises the following drugs, to be taken twice a day:

  1. One tablet of Zidovudine 300mg/Lamivudine 150mg; and
  2. Two tablets of Lopinavir 200 mg/Ritonavir 50 mg.

The entire regime, which lasts 28 days, has to be completed. Otherwise, its effectiveness will be greatly reduced.

Studies have shown that PEP can reduce chances of HIV infection by as much as 80% if administered in a timely manner.

Non-occupational PEP (NOPEP)

NOPEP is for those who may have been infected by HIV through non-occupational means. These include sexual contacts, sharing of intravenous needles and prevention of mother-to-child transmission.

NOPEP works on the same principles as PEP. Although there is supportive evidence of its effectiveness based on biologic plausibility and animal studies, there is no absolute proof that it can effectively decrease the risk of HIV infection.

An NOPEP regime costs several hundred U.S. dollars and more. Not only must treatment commence within the window period, patients will also have to deal with unpleasant side effects (including nausea, diarrhoea, rashes, headaches etc.), as well as the anxiety of being possibly infected. They also need consultations and follow-up tests at intervals of between three and six months. In addition, NOPEP does not prevent transmission of other sexually transmitted infections (STI). Hence, it should not be treated as a panacea.

HIV Exposure Risks

The list below shows the estimated risk of HIV infection arising from different circumstances:

  • Needle stick injury: 1/300
  • Receptive anal intercourse: 1/100
  • Receptive vaginal intercourse: 1/1000
  • Insertive vaginal intercourse: 1/2000
  • Insertive anal intercourse: 1/2500
  • Receptive oral sex with ejaculation: 1/2500
  • Sharing needles: 1/150
  • Exposure to saliva, urine, tears and sweat are generally risk-safe.

The exact probability of infection is hard to determine because many factors are involved, including the viral load, presence of other STIs, strength of one’s immune system, etc.

PEP Starter Packs

Since PEP is most effective when started as soon as possible after exposure, it is a good idea for serodiscordant/magnetic couples (one partner is HIV+ while the other is HIV-) to have a PEP starter pack on standby. These can be obtained through the HIV specialist whom the HIV+ partner consults.

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Even with safer practices, accidents (e.g. condom breakage) can occur when there is no convenient access to a source of PEP. The starter kit can then be deployed within moments of exposure to minimize the chances of potential infection.

Pre-exposure Prophylaxis (PrEP)

This is a further extension of the principles of PEP and NOPEP, where an anti-retroviral regime is administered before high-risk exposure.

PrEP is now the most promising research in HIV prevention efforts as scientific investigation of vaccines and microbicides continues. However, debate is still on-going in the medical field as to its effectiveness. This is because even for occupational PEP, there have been documented cases of seroconversion. There is also the danger that people will be lulled into complacency, thinking that they can continue to engage in unsafe sexual practices.

A more fundamental solution is to prevent/minimize exposure to HIV through safer sex practices. Compared to the PEP treatment regime, using condoms is much cheaper, convenient and relatively hassle-free.

Inflammation And Alzheimer’s Disease: Moving From Harmful To Beneficial With Vaccines

Alzheimer’s disease is a growing problem with an aging population in the U.S. and worldwide. Alzheimer’s disease is a leading cause of dementia, which is the loss of remembering, reasoning, and thinking. There is still no cure for the disease, although some treatments have helped to slow the progression of the disease. Recently, attention has been focused on the role of inflammation in advancing the disease.

What Are the Characteristics of Alzheimer’s Disease?

Alzheimer’s disease is characterized by two abnormal structures in the brain: beta amyloid protein plaques and neurofibrillary tangles. Beta amyloid is a protein normally produced in the body, but in Alzheimer’s it accumulates in plaques surrounding the neurons (brain cells). It is not known whether the plaques are the cause or the result of the disease.

Tau proteins are responsible for the proper alignment of microtubules that provide support and bring nourishment to the nerve cells. When tau protein undergoes structural changes typically due to increased uptake of phosphorus, it can no longer bind to the microtubules. The microtubules then lose their structural integrity and can no longer support the nerve cells, and become neurofibrillary tangles.

The third player in Alzheimer’s disease are the different forms of Apolipoprotein E. People can inherit three forms of the Apo E: Apo E2, E3, or E4. Apo E3 is protective as it binds the tao protein to the microtubules. The Apo E4 cannot bind to the tao protein, and may facilitate the formation of amyloid plaques. People who are homozygous for E4 are at greater risk to develop Alzheimer’s.

The Role of Inflammation in Alzheimer’s Disease

The presence of amyloid plaques in the brain stimulate an inflammatory response. A type of immune cell known as microglia is stimulated to produce chemicals called cytokines, which in turn activate other components of the immune system. The microglia can engulf and destroy the amyloid plaques. The inflammatory response also stimulates T-lymphocytes to secrete cytokines. Although the initial inflammatory response may be beneficial, overstimulation results in nerve cells being attacked and destroyed.

Development of Vaccines to Prevent or Treat Alzheimer’s Disease

A vaccine is an antigen that stimulates an immune response when administered. Immunity is achieved by the formation of specific B-cell antibodies that react with the invading organism or toxic agent. A typical Alzheimer’s disease vaccine uses a short peptide (protein fragment) of beta-amyloid plaque as the antigen. Administering this vaccine stimulates the body to produce anti-beta amyloid antibodies (active immunity). Passive immunity (administering antibodies to the person) is not very satisfactory, since it requires frequent administration, and can be very expensive.

Read More: Lung Disease In Systemic Lupus Erythematosus: Symptoms And Diagnosis Of Pleurisy .

Elan pharmaceuticals conducted a clinical trial with their experimental vaccine in 2001. The trial was terminated after several months as several patients developed encephalitis (swelling of the brain). Some improvements in patients were noticed, such as reduced beta amyloid deposition, reduced tau levels, and improved cognitive function. After two years, however, the beneficial effects disappeared. Several clinical trials sponsored by pharmaceutical companies involving active or passive immunity against Alzheimer’s disease are currently underway. (Zotova)

Dr. Cynthia Lemere of Harvard Medical School reported on studies developing an Alzheimer’s disease vaccine. The critical aspect of the vaccine was to develop an antigenic region (epitope) that would stimulate B- cell production, while the epitope for T-cell stimulation would remain inactive. In this way, the B-antibodies react in a very specific manner with the beta-amyloid plaques, while harmful T-cell secretions are kept to a minimum. Preliminary results with animal studies are very promising.

Inflammation in Alzheimer’s Disease Must be Controlled to be Beneficial

Inflammation is a normal response of the body to eliminate or confine an invading organism or foreign substance. A vaccine against Alzheimer’s disease should stimulate antibody production against beta-amyloid plaques, while not activating microglia or T-cells that promote an inflammatory response that could damage nerve cells.

Lung Disease In Systemic Lupus Erythematosus: Symptoms And Diagnosis Of Pleurisy In SLE

Although lung (pulmonary) problems are common in systemic lupus they are often not diagnosed until lung disease becomes advanced. Advanced lung disease and pleuropulmonary (affecting the lungs and respiration) problems can significantly contribute to mortality in SLE.

Symptoms and Manifestations

Lung disease (pleurisy) in systemic lupus causes a clinical spectrum of symptoms ranging from mild chest pain to fulminant and rapidly fatal pulmonary hemorrhage.

Inflammation of the pleural sac around the lung (pleurisy), with or withal pleural effusion (excess fluid in the chest cavity) is the most common manifestation in lupus. The pleura is a membrane covering the outside of the lung and the inside of the chest cavity.

Pleural cells produce a small amount of fluid that lubricates the space between the lung and the chest wall. As lupus activity causes the production of immune complexes (formed as antibodies and antigens combine), they complexes initiate an inflammatory response at the pleural membrane. The inflammatory response results in pleuritis.

Pleuritis can cause severe, often sharp, stabbing pain in one or more areas of the chest. Inhaling deeply, coughing, sneezing, or laughing can intensify the pain.

Other pulmonary manifestations frequently seen in SLE include pneumonitis, which refers to inflammation of the lung and pulmonary emboli, which refers to the presence of blood clots in the lung. Pneumonitis, which is usually caused by infectious agents, can cause fever, shortness of breath, chest pain, and cough.

Chronic interstitial lung disease in lupus may cause difficulty breathing during activity, chest pain with symptoms of pleurisy and a chronic dry cough.

Pulmonary embolism can cause chest pain and abnormal oxygen exchange resulting in shortness of breath.

Diagnosis

Imaging tests are primarily used to diagnose lung disease. Chest radiographs, ventilation-perfusion lung scans, gallium scans, and high-resolution CT scans are the tests most commonly used. If chest fluid is present, patients may also have a bronchoalveolar lavage in which fluid is aspirated from the chest cavity.

In addition, pulmonary function tests and arterial blood gas levels may be performed. However, it can be difficult to distinguish respiratory problems such as pneumonia from interstitial lung disease in patients with systemic lupus. A microbiology examination on sputum, a bronchoscopy or a lung biopsy may be performed when infectious pneumonitis is suspected.

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In the past, pleural fluid was examined for the presence of anti-nuclear antibodies (ANA). Recent studies show that the ANA test is only positive in half of patients with lupus pleurisy. In addition, patients with other pulmonary diseases besides lupus can have a positive ANA.

Diagnostic criteria used in the past, including ANA tests and complement levels, made lupus pleurisy difficult to detect and difficult to manage. New studies suggest that an elevated white blood cell count, the presence of lupus erythematosus (LE) cells, and an elevated level of the enzyme lactic dehydrogenase (LDH) are more consistent findings.

Pulmonary embolism can be ruled out with negative results on a blood test known as the quantitative D-dimer test. However, a positive result can occur in other conditions and doesn’t necessarily mean that pulmonary emboli are present. Other tests used to diagnose pulmonary emboli include ventilation-perfusion (breathing and blood flow) scans of the lung.

St. John’s Wort (HypericumPerforatum): Can A Herbal Supplement Treat Major Depression Disorder?

St. John’s Wort is a yellow-flowered herb used to treat health conditions since the time of ancient Greece. The herb’s scientific name is Hypericumperforatum, and is sold in the United States as a dietary supplement. In Europe, St. John’s Wort is used to treat mild to moderate clinical depression.

St. John’s Wort Clinical Studies

While St. John’s Wort has a long history as a depression treatment, much of its reputation is based on historical use. Clinical trials suggest that while St. John’s Wort has some applications as a treatment for depression, it may not be well suited for all types of depression.

The National Center for Complementary and Alternative Medicine (NCCAM) funded one such study. The results of the NCCAM study were that placebos were as effective as St. John’s Wort for moderate to severe major depression disorder. The same study suggested that the antidepressant sertaline was also no more effective than placebo for depression treatment.

While such studies are discouraging, other research suggests that St. John’s Wort at least has potential as a treatment for mild depression. Further study is required to confirm or disprove this possibility.

How St. John’s Wort Treats Depression

It’s not entirely clear which compounds found in St. John’s Wort help people cope with depression. The two most likely active compounds are the chemicals hypericin and hyperforin, both of which are thought to affect neurotransmitters (compounds in the nervous system that act as chemical messengers). Low neurotransmitter levels appear to affect a person’s mood.

Types of St. John’s Wort

St. John’s Wort comes in three basic forms. Capsules or tablets of the herb are available, as are herbal teas made from St. John’s Wort. Liquid extracts are also available. St. John’s extracts are concentrated distillations of the plant chemical compounds.

Whether choosing teas, capsules or St. John’s extract, bear in mind that herbal and dietary supplements – in the U.S. at least – are not as well regulated as medications. The range of quality and purity from one herbal supplement to the next can vary widely, and it’s wise to bear this in mind when purchasing St. John’s Wort or any other natural remedies for depression.

St. John’s Wort, Side Effects and Serotonin Syndrome

St. John’s Wort is usually safe to use, but can cause unwanted side effects. The most common side effects associated with St. John’s Wort include:

  • anxiety
  • diarrhea
  • dizziness
  • dry mouth
  • fatigue
  • headaches
  • insomnia
  • irritability
  • photosensitivity (sensitivity to sunlight)
  • restlessness
  • skin rash
  • stomach problems
  • tingling sensations
  • vivid dreams.

St. John’s Wort can also interfere with the effectiveness of certain medications. People should avoid St. John’s Wort if they are prescribed any of the following:

  • anticancer medication
  • anticoagulants (blood thinners)
  • antidepressants
  • birth control pills
  • cyclosporine
  • digoxin
  • medications used to treat HIV.

Pregnancy and nursing women should avoid St. John’s Wort, as should anyone trying to conceive children. As the herb affects anticoagulants, people scheduled to have surgery should avoid taking St. John’s Wort for at least two weeks before surgery.

Using St. John’s Wort in combination with certain antidepressants can result in a potentially fatal condition known as serotonin syndrome. Before taking any dietary supplement with prescription medication, be sure to talk to a health care professional about possible interactions.

Other Depression Herbs

In addition to St. John’s Wort, a number of other natural remedies for depression exist, including kava kava and ginkgo biloba. Clinical studies into the efficiency of these natural treatments for depression are limited.

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It cannot be overstated: before choosing natural remedies for depression check their safety with a mental health professional and be sure the dietary supplement does not interact with any prescribed or over the counter medications.

Report Encourages Widespread Use Of ASA: Benefits For Men, Women Of Certain Ages

The new recommendations are in a report from the US Preventive Services Task Force.

  • Women age 55 to 79 years old should take ASA to prevent strokes, providing the benefit outweighs the risk of ASA.
  • Men age 45 to 79 years old should take ASA to prevent heart attacks, providing the benefit outweighs the risk of ASA.

These new recommendation are stronger than the 2002 ones from the same group. Along with these new recommendations, the experts present ways to estimate personal benefit and risk. The report is available on the AHRQ website.

How to Calculate Stroke Benefit

The benefit is reduction in stroke risk. Tables are provided to estimate how women may benefit from taking ASA (Report Figure 4). For example, among 65 year old women with a 5% 10-year stroke risk, eight strokes per 1000 women will be prevented by taking ASA.

To Determine Stroke Risk

You can determine your personal stroke risk using the an interactive calculator at the Western Stroke Organization (for the web address, look under “Clinical Considerations, Women). For example, a 65 year old woman with systolic blood pressure of 160 has a 5.2% risk of stroke over 10 years (‘systolic’ is the first set of numbers in a blood pressure reading). If she also is a smoker, the risk jumps to 8.8%.

For a man of the same age, same systolic blood pressure, and a smoker, the ten year stroke risk is almost 14%.

To Determine Heart Attack Risk and Benefit

You can determine your personal heart attack risk using the provided link to an interactive calculator at the Medical College of Wisconsin.

Benefit–heart attacks prevented–is provided in Figure 2 of the report. For example, a 65 year old non-smoking man with no special risks, LDL cholesterol 99, HDL cholesterol 45, has a 10% risk of a heart attack in the next ten years. Taking ASA by 1000 men in this risk profile will prevent 32 heart attacks in ten years.

ASA Risks

Whether or not to take ASA depends on the downside–the risks of taking ASA–as well as the benefits. ASA use increases the risk of serious bleeding from the stomach and elsewhere in the gastrointestinal (GI) tract. The risk is increased in people who have bled once. Previous bleeding from the GI tract is associated with at least double the risk of bleeding from ASA.

The risk is increased four times over in people who concurrently take NSAIDS (Motrin, Aleve, Naprosyn, others). Uncontrolled hypertension increases bleeding risks. Taking warfarin (coumadin, others) is generally considered a contraindication to ASA (ASA should not be used with warfarin).

  • Men have twice the risk of bleeding than women.
  • Enteric coating on ASA has not been shown to reduce the risk of bleeding.
  • There are special safety considerations for older people.

Other Benefits of ASA

Not included in the Task Force’s considerations are other potential benefits from ASA. It may reduce the risk of dangerous colon polyps; however, a recent study indicated it does not reduce the risk of death from colon cancer. (Journal of the National Cancer Institute 2009 (Feb 18); 101:256)

What to Do

The panel encourages shared decision making. Individuals should discuss their potential personal benefits and risks from ASA with their physician.

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