A Comparative Evaluation of Nature's Sunshine Dandelion and Esidrix as Monotherapy in Causing Hypokalemia - Case Study Example

Running head: DESIGNING A NEW CLINICAL A Comparative Evaluation of Nature's Sunshine –Dandelion® and Esidrix® As Monotherapy in Causing Hypokalemia Name Institution Introduction Hypertension is a condition caused by accelerated blood pressure in blood vessels. It is a condition that may result to very adverse consequences if not noted and treated at its early stages. This condition has been treated over the years in many ways, including medication by use of synthetic diuretics such as Thiazide Diuretics. However, on top of these drugs not being cost effective, they have been found to have various side effects, further complicating the condition. Fortunately, there is a herb that has been found to be very effective in treatment of the condition with no side effects. This treatment is undertaken using leaves from Dandelions plants. There is no much study that has been carried out to determine the effect of the leaves from Dandelions plants in the normalization of the blood pressure, especially in conditions of hypertension. However, there is enough evidence to support the fact that this plant has great effects in the normalization of blood pressure (Trower, and Doll, 2008). A study was proposed to be carried out in determination of the medicinal effect of the leaves from the Dandelions plants in normalization of blood sugars as well as comparing their effects with those of using Esidrix® as Monotherapy in causing hypokalemia (Maxine, and McPhee, 2008). Background of the study Hypertension, or high blood pressure, is a condition that usually occurs due to high blood pressure in the arteries. The condition, if noted early enough is easily treatable, especially by just instilling ways of lowering the blood pressure to normal levels. However, most of the times the condition goes unnoticed until when it is too late causing a lot of complications and leading to much harder and more expensive ways of treatment of the condition. This condition may be primary, meaning that the cause may not be found medically, or it may be secondary, resulting from other conditions that may be affecting the heart, kidneys or other related organs or systems. The condition may be treated in many ways, especially through modification of the patient’s lifestyle or through medication such as use of Diuretics such as synthetic Diuretics (Gibson, 2009). Synthetic diuretics are drugs that may be used for treatment of hypertension, especially by effectively lowering the blood pressure to normal levels. “Thiazide Diuretics are some of the most effective drugs that have been used in treatment of cardiovascular hypertension” (Kamath, and Johnson, 2009, p.32). They are very beneficial as they significantly and quickly lower the blood pressure back to normal levels reducing the adverse effects of hypertension. However, the drugs have many disadvantages and may result to very adverse side effects. First, there is caution in how then drugs have to be administered. Only after using an optimal dosage can the drugs be effective. Then, there is caution on who may use the drugs. People at a high risk of developing diabetes can only use he drugs at minimum active levels since the drug induces development of diabetes and other conditions. Also, continuous use of the drug may result to complexity of the hypertension especially if the body of the patient slowly becomes resistant to the effects of the drug (Kamath, and Johnson, 2009). The Dandelions plants are very unique and beneficial types of plants that inhabit very many habitats all over the world. They are not usually thought as very beneficial by many people and are usually overlooked by many and even treated as weeds. However, for the few who know these plants in details, there is a lot to be appreciated of these plants. The leaves from these plants are very unique and usually possess a lot of benefits. They specifically possess a lot of medicinal benefits and can be used for detoxification of the liver, reduction of inflammation, normalization of blood sugars as well as lowering of blood pressure. There are a lot of advantages associated with use of Dandelions leaves in lowering of blood pressure in patients with high blood pressure. First, these leaves are herbal and do not contain a lot of components that may result to adverse side effects that may further complicate the situation. In this aspect, studies have shown that while other treatments of hypertension such as use of synthetic diuretics such as Thiazide Diuretics may result to conditions such as hypokalemia, use of Dandelions leaves does not cause hypokalemia. While almost all the synthetic drugs are very expensive to use as treatment for hypertension, use of this form of treatment by dandelion is quite cost effective. Therefore, there is a preference in use of Dandelions leaves in treatment of hypertension compared to synthetic diuretics (Stargrove, Treasure, and McKee, 2008). There is a need therefore to carry out a study to determine if Dandelions leaves cause hypokalemia and also to compare the results with those of the use of a hydrochlorothiazide such as Esidrix®, which is known to cause hypokalemia in high dosage and if not administered appropriately. Studies have been carried out to determine the effects of use of hydrochlorothiazide to treat hypertension and the data for such clinical tests is available. However, no much study has been carried out to determine the effects of Dandelions leaves as a treatment of hypertension as well as comparing them with use of synthetic diuretics. Therefore, this study would provide a good basis on which to make better decisions on which drug to encourage in the treatment of hypertension (Mark, 2004). Aim of the Study The primary objective of the study is to determine whether or not dandelion causes hypokalemia. In this objective, a trial will be carried out in use of dandelion as a treatment of hypertension and then the results investigated to determine if there is enough evidence showing that it causes hypokalemia. The secondary objective of the study will be to evaluate the efficacy, safety and tolerability of dandelion leaves versus hydrochlorothiazide in controlling the high blood pressure. In this way, a comparison will be carried out between the uses of dandelion and hydrochlorothiazide as a treatment for hypertension and their effects, efficacy, safety and tolerability compared to determine which of the two is the most effective and safe mode of treatment (Wofford, and Hall, 2004). Methods The Study design that will be applied for the study will be single-centre design. This design is effective for the type of study being carried out since it is a clinical study that and will require less treatment to be applied to the subjects. A double-blind treatment will be applied. In this treatment, the subjects and observers will both not be aware of the treatments being applied to any of the subjects. This will hence reduce any for of biasness that may be present if either the subjects now the type of treatment they are being subjected to or if the observers know the type of treatment that the subjects they are observing is being subjected to and more specifically if they have a preference of any of the treatments. The type of study being conducted is a comparative study. The study will involve administration of two different treatments and a comparison of their effects. Since one of the treatments has already been carried out and its data already collected, then one of the treatments for this study will be a control treatment, with subjects maintained at normal conditions and the other treatment will involve administration of dandelion and any effects noted. Then, the difference between the two treatments and also between effects of dandelion and synthetic diuretics will be note using a comparison between the two treatments (Oaksford, & Chater, 1994). Two parallel groups will be involved as the subjects, one in which no change will be caused and it will be taken as a control group, and another in which treatment will be administered in form of dandelion and then the effects noted. The study will give better results for comparison once the treatments are administered at the same time and under the same conditions so as to reduce the effect of other external factors that may interfere with the results from the study. A randomization will be applied in the study. This type of a randomized trial will ensure that biasness is reduced and hence provide better and more reliable results that will also be a true representation of the whole population. This will imply that inferences for expected results for the whole population can easily and accurately be made from the results from the sample population. The clinical trial will be carried out for duration of four weeks, a period that is sufficient enough to ensure that any effects presented by the treatments to be administered can be easily noted while reducing any long-term effects from the treatments in the trial (Patlak, 2004). Selection of Subjects The whole study will constitute of sixty subjects. Thirty of the subjects will be under the control treatment while the rest will be under the research treatment. This number of subjects will be sufficient since the sample size will be large enough to provide the required observations and to behave in a normal way hence avoiding biasness. The inclusion criteria to be used will be consideration of all those who have been diagnosed with hypertension for a period of more than five months and who have not been using any synthetic diuretics for treatment of the disease. Both genders can be considered, with no limit on the number of males or females to be included. Also, only adults of between 18 years and 75 years will be included. In this age bracket, he patients are bound to respond to the treatments in a normal way. The exclusion criteria that will be followed will involve exclusion of all patients below 18 years and those above 75 years. Also, expectant mothers as well as all the patients who have been diagnosed with diabetes will be excluded so as to avoid any factors that may lead to an interference with normal response of patients to the treatments. The outcome variable that will be observed from the trial will be the blood pressure (BP). This variable will be measured daily using specialized equipment. After data has been collected from the clinical trial, it will then be used to achieve the objectives of the study by carrying out its comparison with data already collected from trials using hydrochlorothiazide. The control group will only be included in the study to act as a guidance for determining if there is any factors that could have caused an interference during the trial leading to misleading results. Limitations of the Study The clinical trial has a few drawbacks that are expected. Acquiring the required sample will be a hard thing especially since most of the patients who have been diagnosed with hypertension have already been put under medication, most probably using synthetic diuretics. Hence, though the researcher will try to maintain randomness, some aspect of convenience will be undertaken since the sample will only include those in the group required for the trial. There will also be a challenge since the trial requires a lot of financing which may not be readily available. Study Treatment The research treatment will involve two treatments. The research treatment will involve treatment with dandelion while the other treatment, the control treatment, will involve a placebo which will be used just for determining if there were any external factors interfering with the trial (Salvetti, and Ghiadoni, 2006). Prior and Concomitant Illnesses and Treatments The subjects who will be involved in the trial must have been diagnosed with hypertension for a period of over five months. This will be necessary so as to ensure the effects of the treatments are properly observed. Patients who have previously been diagnosed with hepatitis or diabetes will not be involved in the trial since the effects of the trial may result to adverse conditions of the patients and such patients can only be put under special drugs (Richards, 1997). Study Procedures and Schedule Patients will be administered with dandelion in a pre-defined dosage every day. In this way, changes will be expected to occur every time they take the treatment and hence treatment of level of blood potassium as well as blood pressure will be measured on daily basis. Also, since the study will not tae very long, daily measurements will be better so as to make a detailed observation of the patients (Wright, 2010). Adverse Event (Reactions) Adverse reactions are reactions that may be noted in any of the subjects in their response to the treatments to be administered. In such an event, a subject usually reacts too much to the treatments showing results that are beyond the expected levels and which may have very serious negative health effects. In this trial and any other clinical trial, a lot of n care has to be taken so as to prevent such reactions (Lee, 2009). Incase of such an event, the researcher will immediately withdraw the subject from the trial and try to apply any corrective measures that may be available. For example, if the blood pressure falls below expected levels, the subject may be placed under a different treatment so as to try and raise the blood pressure to normal. Withdrawals Withdrawals of the subjects may be carried out any time an unexpected result is observed, especially incase of adverse reaction of the subjects to the given treatments. Incase a withdrawal is carried out, a replacement shall not be carried out since it would result to the sequential administration of the treatments. Missing data will then be treated differently during statistical analysis hence reducing its effect (Buzzle, 2010). Statistical Procedures Once the trial has been carried out, results that will be realized will be used to determine if dandelion can be used as a substitute to use of synthetic diuretics in treatment of hypertension in patients diagnosed with hypertension, especially at early stages (HBC, 2010). Ethical and Legal Aspects Legal consent will be sought so as to ensure all the subjects are entered into the trial in the right manner. In the same way, the researcher will tae caution to ensure he follows any ethical requirements in such a trial, such as ensuring any subject who experiences adverse reactions is catered for and also making sure that only the correct data in entered for analysis and making of conclusions (Wilkins, 1957). Conclusions Once data has been collected, it will be used for making the required comparisons and from the results obtained, appropriate conclusions will be made showing whether or not dandelion causes any side effects, especially hypokalemia and also explaining which of the two treatments is more appropriate between dandelion and synthetic diuretics. References Buzzle. (2010). Diuretics for High Blood Pressure. Retrieved from http://www.buzzle.com/articles/diuretics-for-high-blood-pressure.html Gibson, Paul. (2009). Hypertension and Pregnancy. New York: McGraw hill. HBC. (2010). Diuretics For High Blood Pressure Overview: Covering list of common diuretics for high blood pressure including their side effects as well as natural and herbal diuretics. Retrieved from http://www.hypertension-bloodpressure-center.com/diuretics-for-high-blood-pressure.html Kamath, D., and Johnson, J. (2009). Uric acid and hypertension: An age-related relationship? London: John Willey& Sons. Lee, A. (2009). Disorders of Potassium Hyperkalemia and Hypokalemia Due to Failed Body Regulation. Australia: Applecross. Mark, N. (2004). Drug treatment of elevated blood pressure. New York: John Wiley & Sons. Maxine, A., and McPhee, S. (2008). Diuretics for High Blood Pressure. New York: McGraw-Hill. Oaksford, M., & Chater, N. (1994). Uric acid and hypertension. Stanford: Stanford Business Books. Patlak , M. (2004). From viper’s venom to drug design: treating hypertension. Minneapolis: West Publishing Company. Richards, J. (1997). Dandelions of Great Britain and Ireland: Handbooks for Field Identification. New York: John Wiley & Sons. Salvetti, A. and Ghiadoni, L. ( 2006). Thiazide Dandelions of Great Britain. New York: John Wiley & Sons. Stargrove, B., Treasure, J., and McKee L. (2008). Herb, nutrient, and drug interactions: clinical implications and therapeutic. Minneapolis: West Publishing Company. Trower, T., and Doll, J. (2008). Dandelion. New York: John Wiley & Sons. Wilkins, W. (1957). New Drugs for Hypertension, with Special Reference to Chlorothiazide. Retrieved from http://www.nejm.org/doi/pdf/10.1056/NEJM195711212572105 Wright, R. (2010). The Dandelion King. Retrieved from http://opinionator.blogs.nytimes.com/2010/04/20/the-dandelion-king/ Wofford, M., and Hall, E. (2004). Pathophysiology and treatment of obesity hypertension. New York: McGraw hill. Read More