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A PRELIMINARY REPORT ON THE EFFECT OF BAMBOO ROOT DECOCTION VERSUS HYDROCHLOROTHIAZIDE TABLET ON THE MEAN ARTERIAL PRESSURE OF HYPERTENSIVE

INDIVIDUALS: A RANDOMIZED, CROSS-OVER, OPEN CLINICAL TRIAL

A RESEARCH PAPER PRESENTED TO THE FACULTY OF THE GRADUATE SCHOOL ATENEO DE ZAMBOANGA UNIVERSITY ZAMBOANGA CITY

IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER IN PUBLIC HEALTH

BY:

CARL STEPHEN B. CUEVAS

APRIL 2010

APPROVAL SHEET

This Research Paper entitled A PRELIMINARY REPORT ON THE EFFECT OF BAMBOO ROOT DECOCTION VERSUS HYDROCHLOROTHIAZIDE TABLET ON THE MEAN ARTERIAL PRESSURE OF HYPERTENSIVE INDIVIDUALS: A RANDOMIZED, CROSS-OVER, OPEN CLINICAL TRIAL prepared and submitted by Carl Stephen B. Cuevas, in partial fulfillment of the requirements for the degree of Master in Public Health, is hereby accepted.

_________________________ Jocelyn D. Partosa Ph.D. Adviser

Approved by the Oral Examination Committee with a grade of PASSED. _________________________ Rosemarie S. Arciaga M.D. Chairman _________________________ Fortunato S. Cristobal M.D. Member _________________________ Jocelyn D. Partosa Ph.D. Member _________________________ Ioustina S. Aranan Ph.D. Member _________________________ Servando D. Halili Jr. Ph.D. Member _________________________ Rex V. Samson M.D. Member

ACCEPTED in partial fulfillment of the requirements for the degree of Master in Public Health.

_________________________ Servando D. Halili Jr. Ph.D. Dean, Graduate School Ateneo de Zamboanga University Zamboanga City

ACKNOWLEDGEMENT

I would like to extend my sincerest gratitude and heartfelt thanks to the following, for without them my endeavor would not be a success: To the Ateneo de Zamboanga University, School of Medicine, my alma mater, for being an instrument in making my dream come true. To Dr. Jocelyn D. Partosa, my adviser, for your patience, support, and guidance, and for generously sharing your time, efforts, knowledge, and expertise. To the Ateneo de Zamboanga University, Graduate School, Research Committee, for your constant guidance, constructive criticisms, and valuable suggestions for the improvement of this study. To Dr. Adnilre D. Verzon, for your steadfast support and encouragement, and for unselfishly sharing your time and efforts. To Mr. Nicanor A. Morales Sr., for introducing bamboo root decoction, this study is dedicated to you, I know you are in His embrace right now, for the friendship beyond compare, I will surely miss you. To Mrs. Fe S. Mangubat, Mrs. Paz R. Dela Pea, and Ms. Joan S. Mangubat, my research assistants, for your full support, cooperation, patience, commitment, perseverance, and efficient performance. To the Residents of Barangay Veterans Village, my respondents, you are the sole reason for the success of this study, for your absolute trust, respect, cooperation, participation, and commitment. To Rain and Caste, my american pitbull terriers, for the fun, joy, and laughter, watching you grow each day is a sense of fulfillment, you are my very own, truly you are a mans best friend. To my Mom, Dad, Anya, Shiobe, Ilyn, and Relatives, my lifetime inspiration, for your unconditional love and insurmountable support, it has always been my dream to make you proud. And most importantly, to our Almighty God, for blessing me with enough wisdom, strength, and perseverance, to Him be the glory, honor, and praise.

Carl Stephen B. Cuevas

LIST OF FIGURES
PAGE Figure 1. Figure 2. Figure 3. Conceptual Framework Flow of Activities Comparison of the Mean Arterial Pressure in the 8 weeks Period of Study in Group A and Group B Comparison of the Mean Arterial Pressure between the Phase I and the Phase II, Phase III, and Phase IV of the Study in Group A and Group B Comparison of the Mean Arterial Pressure between the Phase I and the Phase III of the Study in Group A and Group B Comparison of the Mean Arterial Pressure between the Phase II and the Phase IV of the Study in Group A and Group B Comparison of the Mean Arterial Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group A Comparison of the Mean Arterial Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group B Comparison of the Mean Change on the Mean Arterial Pressure between the Phase II and the Phase IV of the Study in Group A and Group B Comparison of the Mean Change on the Mean Arterial Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group A Comparison of the Mean Change on the Mean Arterial Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group B 16 29

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Figure 4.

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Figure 5.

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Figure 6.

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Figure 7.

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Figure 8.

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Figure 9.

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Figure 10.

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Figure 11.

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Figure 12.

Comparison of the Mean Change on the Mean Systolic Blood Pressure between the Phase II and the Phase IV of the Study in Group A and Group B Comparison of the Mean Change on the Mean Systolic Blood Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group A Comparison of the Mean Change on the Mean Systolic Blood Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group B

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Figure 13.

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Figure 14.

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LIST OF TABLES
PAGE Table 1. Table 2. Profile of the Respondents Comparison of the Profile of the Respondents in Group A and Group B Comparison of the Clinical Symptoms in the 8 weeks Period of Study in Group A Comparison of the Clinical Symptoms in the 8 weeks Period of Study in Group B Comparison of the Clinical Symptoms between the Thiazide Treatment and Bamboo Treatment in Group A and Group B 30 31

Table 3.

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Table 4.

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Table 5.

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TABLE OF CONTENTS
PAGE APPROVAL SHEET ACKNOWLEDGEMENT LIST OF FIGURES AND TABLES TABLE OF CONTENTS ABSTRACT CHAPTER I THE PROBLEM AND ITS SETTING a.) Background of the Study b.) Related Literature c.) Statement of the Problem d.) Objectives e.) Hypotheses f.) Significance g.) Scope and Delimitation h.) Definition of Terms i.) Conceptual Framework METHODOLOGY a.) Research Design b.) Respondents c.) Sampling Design d.) Treatment Allocation e.) Research Setting f.) Research Survey Form g.) Research Assistants h.) Interventions i.) Data Gathering Procedures j.) Statistical Analysis k.) Flow of Activities PRESENTATION OF RESULTS, DISCUSSION, AND ANALYSIS SUMMARY, CONCLUSION, AND RECOMMENDATIONS i ii iii v vi

1 5 11 11 12 12 13 15 16

II

18 18 19 20 21 22 22 24 25 28 29

III

30

IV

56 57 60 65

BIBLIOGRAPHY APPENDICES CURRICULUM VITAE

ABSTRACT

The study was a randomized, cross-over, open clinical trial aimed to compare the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of hypertensive individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. A total of 16 respondents under Stage I Hypertension with no associated comorbidities completed the study, and were randomly assigned into Group A (1st Treatment - Thiazide and 2nd Treatment - Bamboo) and Group B (1st Treatment Bamboo and 2nd Treatment - Thiazide). The results of the 8 weeks period of study showed that bamboo root decoction and hydrochlorothiazide tablet had a significant effect on the mean arterial pressure. The effect was statistically significant (p < 0.05) when analyzed utilizing repeated-measure ANOVA, and clinically important as evidenced by a decreased on the mean arterial pressure from Stage I Hypertension MAP to Prehypertension MAP. Furthermore, the effect of the bamboo root decoction and the hydrochlorothiazide tablet on the mean arterial pressure, mean change on the mean arterial pressure, and mean change on the mean systolic blood pressure had no significant difference when analyzed utilizing t-test. Therefore, the effect of the twice-aday intake of 250 ml of bamboo root decoction is comparable to the effect of the once-aday intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of the respondents. However, despite the results of study showing a trend towards comparability, the study was a preliminary report, and therefore a definite conclusion is not fully attainable and a future research in a larger sample population is recommended.

CHAPTER I THE PROBLEM AND ITS SETTING

Background of the Study


Hypertension is an increasingly important medical and public health issue. The Philippine Society of Hypertension (PSH) in 2005 estimated that about 8 million Filipinos are affected, and tens of thousands are unnecessarily disabled or died prematurely. It is the 5th leading cause of morbidity and deaths from heart diseases due to hypertension ranks 1st as a cause of mortality in the Philippines (Department of Health, 2006). In the Community Diagnosis done by medical students of the Ateneo de Zamboanga University, School of Medicine (ADZU-SOM) in 2006, hypertension ranks 1st as a cause of morbidity and stroke is the 2nd leading cause of death in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. The relationship between high blood pressure and risk of complications is continuous, consistent, and independent of other risk factors. The higher the blood pressure, the greater is the chance of heart attack, heart failure, stroke, kidney disease, and retinopathy. Therefore, the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC), 7th Report in 2003 recommends that all individuals with hypertension be treated. In Barangay Veterans Village, a number of hypertensive individuals claimed on the effectiveness of bamboo root decoction in lowering their blood pressure. These individuals further claimed that the decoction lowers the blood pressure by removing the cholesterol from the body through increasing the frequency of urination,

and therefore relieves mild headache, dizziness, and nape pain, which are symptoms they attribute to hypertension. The practice primarily spread through word of mouth with no literature evidences and supportive confirmation from recognized institutions. However, it continually persists and has been present for quite some time in the community due to the fact that more and more hypertensive individuals are claiming and promoting its effectiveness, and that bamboos particularly Bambusa Blumeana or Kawayan Tinik are bountiful in the area. The process begins by washing and soaking the bamboo roots in water overnight to remove its external stratum. Then the decoction is prepared by boiling around 5 pieces of bamboo roots, about the length of a pen, in 1 liter of water for 1 hour. The roots can be repeatedly used for about 1 week and accordingly with no changes in the potency. A majority of the hypertensive individuals take 2 glasses of the decoction daily, once in the morning as well as once in the afternoon, to serve as an alternative maintenance medication. This prompted the researcher to conduct a study in 2009 to evaluate the effect of twice-a-day intake of 250 ml of bamboo root decoction among hypertensive individuals in Barangay Veterans Village. The results of the 16 weeks period of study showed that bamboo root decoction had a significant effect on the mean arterial pressure as compared to placebo. The effect was statistically significant (p < 0.05) when analyzed utilizing repeated-measure ANOVA, and clinically important as evidenced by a decreased on the mean arterial pressure from Stage I Hypertension MAP to Prehypertension MAP. Therefore, the researcher concluded that twice-a-day intake of bamboo root decoction can serve as an alternative maintenance medication for hypertensive individuals under Stage I Hypertension.

Indeed, herbal medicines may have therapeutically beneficial effects and its utilization is growing at an outstanding rate. The popularity is largely due to their presumed safety, efficacy, cultural acceptability, and lesser side effects compared with prescription medications, and perhaps the most important, they are viewed as costeffective and accessible (Shrivastava et. al., 2007). The Philippines is known for using herbal medicines for the treatment of diseases long before its popularity in the west, and aside from bamboo root decoction, a number of herb preparations have proven to be effective and serve as an alternative maintenance medication for hypertension. These includes lemon grass decoction (Caluscusin, 2010), ginger tea (Aming, 2006), chayote extract (Alamia, 2005), and garlic clove which was endorsed by the Philippine Institute of Traditional and Alternative Health Care (PITAHC) in 1997 (Eleazar, 2004). However, despite of these data, herbal medicines, to evaluate its true effectiveness and subsequent utilization as an alternative medication, must be compared with conventional medicines. Therefore, the researcher on the study conducted in 2009 recommended that twice-a-day intake of bamboo root decoction be compared to the conventional maintenance medication for hypertensive individuals under Stage I Hypertension. Advocating the goal of providing an evidenced-based approach in the treatment of hypertension, the JNC, 7th Report in 2003 recommends thiazide diuretic as a first-line antihypertensive medication particularly in individuals under Stage I Hypertension. In clinical trials comparing diuretic with other antihypertensives, thiazide had been virtually unsurpassed in preventing the cardiovascular complications of hypertension. Thiazides are effective, less expensive, and relatively safe, doses of 25-50 mg/day of hydrochlorothiazide tablet was used in successful low-dose diuretic morbidity trials.

Diuretics have been used for many years as an antihypertensive therapy. It reduces the circulatory volume, cardiac output, and mean arterial pressure. This is most effective in patients with mild to moderate hypertension who have normal renal function, and in elderly individuals who tend to be salt-sensitive or volumedependent hypertensive (Lilly et. al., 1997). Adverse effects include hypokalemia due to renal potassium loss, hyperuricemia due to uric acid retention, carbohydrate intolerance, and hyperlipidemia. However, these are minimized when dosage is maintained at 25 mg/day of hydrochlorothiazide tablet while continuously benefitting from its therapeutic effect (Kasper et. al., 2005). The study aimed to compare the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of hypertensive individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. The preparation and dosage of the bamboo root decoction was based on the study conducted by the researcher in 2009, and the preparation and dosage of the hydrochlorothiazide tablet was based on the recommendation of the JNC, 7th Report in 2003. The study was a randomized, cross-over, open clinical trial. The study was conducted in 4 phases, and each phase was conducted daily for 2 weeks with a total of 8 weeks period of study. The outcome parameter measured was the mean arterial pressure, and the results were analyzed utilizing repeated-measure ANOVA and t-test to determine the level of significance.

Related Literature
Hypertension is the leading attributable risk factor for death and a major contributor to morbidity, mortality, and increasing health care expenditures in the Philippines, as inpatient care and its sequelae is expensive (Wagner et. al., 2008). In clinical trials, antihypertensive therapy has been associated with remarkable reductions in the incidence of stroke, myocardial infarction, and heart failure. Therefore, the ultimate public health goal for hypertensive individuals with no associated comorbidities is to maintain blood pressure levels of < 140/90 mmHg, and with particular attention in those > 50 years of age as systolic blood pressure of > 140 mmHg is a more important risk factor for cardiovascular disease. Attainment of this goal is considered clinically important as it is associated with decreased cardiovascular complications (JNC, 7th Report, 2003). However, the PSH in 2005 estimated that only about 1 in 10 Filipino hypertensive patients are receiving adequate treatment, and given the low socio-economic status of most Filipinos and the high costs of medications in the country, regular use of antihypertensives are not affordable for many individuals (Wagner et. al., 2008). The economic status of the Philippines affect every region, city, province, and municipality, and in Barangay Veterans Village 54.44% of the households are below poverty threshold (Community Diagnosis, ADZU-SOM, 2006). These data reinforced the concept of the study of comparing herbal medicine versus conventional medicine as an antihypertensive therapy. The nature of the treatment is definitely not as essential as the achievement of the goal, which is to maintain blood pressure levels of < 140/90 mmHg.

However, there are no available researches, published or unpublished, similar to the study. All the possible search engines and literatures were thoroughly exhausted by the researcher. The researches available are those that studied independently on the effect of bamboo root decoction and the effect of hydrochlorothiazide tablet. One of these, as mentioned earlier, is the placebo-controlled, parallel, cross-over experimental study conducted by the researcher in 2009 on the effect of twice-a-day intake of bamboo root decoction among hypertensive individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. A total of 32 hypertensive individuals under Stage I Hypertension, presently taking bamboo root decoction as an alternative maintenance medication, not on antihypertensive drug therapy, and with no associated comorbidities participated as respondents. The study was conducted in 4 phases namely, baseline, bamboo, washout, and placebo. Each phase consists of twice-a-day monitoring of blood pressure, heart rate, and clinical symptoms attributed to hypertension for 4 weeks with a total of 16 weeks period of study. The Bamboo Phase consists of twice-a-day intake of 250 ml of bamboo root decoction, and the Placebo Phase consists of twice-a-day intake of 250 ml of placebo. The outcome parameters measured were analyzed utilizing repeated-measure ANOVA to determine the level of significance. The results of the study showed that bamboo root decoction had a significant effect on the mean arterial pressure but had no significant effect on the mean heart rate and on the clinical symptoms attributed to hypertension. The mean arterial pressure decreased of statistical significance (p < 0.05) from the 1st week of the Bamboo Phase until the 3rd week of the Washout Phase, and the mean arterial pressure decreased of clinical importance (Stage I Hypertension MAP to Prehypertension MAP)

from the 1st week of the Bamboo Phase until the 2nd week of the Washout Phase. The mean change on the mean arterial pressure was 17.13 mmHg, and the mean change on the mean systolic blood pressure was 23.40 mmHg. The effect of the twice-a-day intake of bamboo root decoction on the mean arterial pressure was due to its therapeutically diuretic action, as majority of the respondents complaint of frequent urination on the Bamboo Phase of the study. In terms of the adverse effects, there were no complaints of clinical relevance other than thirst, dizziness, and mild headache which spontaneously resolved without medical intervention. The diuretic action of the bamboo root decoction is supported by the literatures of Quisumbing in 1978, Beyerl in 1984, and Jocano in 2003 which provides anecdotal statements that bamboo roots used as a decoction is an efficient diuretic for the treatment of hypertension. However, there are no available literatures providing a systematic evaluation on the chemical analysis of the primary active component causing the therapeutic diuresis. The literatures available are those that provide other chemical components present on the bamboo in relevance to being an alternative antihypertensive medication. These includes natural organic silica which enhances the function of potassium and calcium that helps regulate heart beat, useful in reducing blood fats and cholesterol, and essential in maintaining the structural integrity, elasticity, and permeability of the arteries (DJang, 2007); potassium which helps maintain a normal blood pressure as well as a steady heart rate, and phenolic acid which is a potent antioxidant that prevents vessel injury resulting to arteriosclerosis (LeMire, 2008); and triterpenoid-rich extract which significantly reduces systolic blood pressure as well as serum total cholesterol and triglycerides in hypertensive rats, and friedelin which

has a potent vasodilator effect (Jiao et. al., 2007). The other available literatures are those that provide the primary active component of some herbal medicines utilized as an alternative maintenance medication for hypertension that has a similar diuretic action as bamboo root decoction. These includes the hydroethanolic extract of dandelion leaves (Blumenthal et. al., 2000; Clare et. al., 2009), and the terpinenol aqueous solution of juniper berries (Ripka, 1964; Karasov et. al., 2001). On the other hand, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) in 2002 conducted a randomized, double-blind, active-controlled clinical trial to determine whether treatment with a calcium channel blocker or an angiotensin-converting enzyme inhibitor reduces the incidence of coronary heart disease and other cardiovascular disease events versus treatment with a diuretic. A total of 33,357 individuals > 54 years of age with hypertension and at least 1 other coronary heart disease risk factor from 623 North American Centers participated as respondents. These individuals were randomly assigned to receive either chlorthalidone 12.5-25 mg/day (equivalent of hydrochlorothiazide 25-50 mg/day), amlodopine 2.5-10 mg/day, or lisinopril 10-40 mg/day, for a planned follow-up of approximately 4-8 years. The results of the study showed that the five-year systolic blood pressure were significantly higher in the amlodipine and lisinopril groups compared with the chlorthalidone group. Therefore, the ALLHAT concluded that thiazide diuretics are superior in preventing major forms of cardiovascular disease, less expensive, and should be preferred as first-line antihypertensive medication. In the randomized, parallel, double-blind study conducted by Myers in 1987 on hydrochlorothiazide versus hydrochlorothiazide with amiloride for hypertension in the

elderly, the results following 12 weeks of treatment showed that 25-50 mg/day of hydrochlorothiazide tablet had a mean change on the mean arterial pressure of 19.67 mmHg, and a mean change on the mean systolic blood pressure of 23.00 mmHg. Hydrochlorothiazide has long been the mainstay in the treatment of hypertension. It is convenient to administer, well tolerated, and effective in reducing systolic and diastolic blood pressures for an extended period in patients with mild to moderate essential hypertension. The blood pressure stabilizes at a therapeutic level in 3-7 days and can be maintained indefinitely by a recommended dosage. An initial reduction in the blood pressure is due to a decrease in blood volume and a decrease in cardiac output. However, as volume recovery occurs, the continued hypotensive effect is now due to a decrease in peripheral vascular resistance caused by relaxation of arteriolar smooth muscles. Hydrochlorothiazide is rapidly absorbed from the gastrointestinal tract. It has a bioavailability of about 70%, a plasma half-life of between 5-15 hours, appears to be preferentially bound to red blood cells, and excreted mainly unchanged in the urine. It causes sodium diuresis and volume depletion by acting in the kidney to decrease the reabsorption of sodium through inhibition of the Na+/Clcotransporter on the luminal membrane of the distal convulated tubule. Diuresis is initiated in about 2 hours of oral administration, reaches a maximum in about 4 hours, and last for about 6-12 hours (Brunton et. al., 2006; Howland et. al., 2006). Despite of the absence of available researches similar to the study, some peripheral researches are available that deals on a similar concept of comparing herbal medicine versus conventional medicine. These includes the randomized, double-blind, cross-over trial conducted by Laeger in 1991 on gitadyl versus ibuprofen in patients with

osteoarthrosis; and the meta-analysis of randomized controlled trials conducted by Zhu et. al. in 2008 on the efficacy and safety of chinese herbal medicine for primary dysmenorrhea compared with placebo, no treatment, and conventional medicine. In summary, as mentioned earlier, there are no available researches, published or unpublished, similar to the study. The researches available are those that studied independently on the effect of twice-a-day intake of 250 ml of bamboo root decoction (Cuevas, 2009) and the effect of once-a-day intake of 25 mg of hydrochlorothiazide tablet (ALLHAT, 2002) on individuals with hypertension. The results of both studies showed that bamboo root decoction and hydrochlorothiazide tablet were essentially more effective than placebo and amlodipine or lisinopril respectively as an antihypertensive therapy. On the other hand, Wagner et. al. in 2008 claimed that hypertension is the leading attributable risk factor for death and a major contributor to morbidity, mortality, and increasing health care expenditures in the Philippines, as inpatient care and its sequelae is expensive. Therefore, the JNC, 7th Report in 2003 recommends that all individuals with hypertension be treated, and the ultimate public health goal is to maintain blood pressure levels of < 140/90 mmHg. However, given the low socio-economic status of most Filipinos and the high cost of medications in the country, regular use of antihypertensives are not affordable for many individuals (Wagner et. al., 2008). Again, the nature of the treatment is definitely not as essential as the achievement of the goal, and lastly, the study is a follow-up to the study conducted by the researcher in 2009 which recommended that twice-a-day intake of bamboo root decoction be compared to the conventional maintenance medication for hypertensive individuals under Stage I Hypertension.

Statement of the Problem


What is the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of hypertensive individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay?

Objectives
General Objective The general objective of the study is to compare the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of hypertensive individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. Specific Objectives The specific objectives of the study are to: 1. Determine and compare the mean arterial pressure of the respondents before and after twice-a-day intake of 250 ml of bamboo root decoction. 2. Determine and compare the mean arterial pressure of the respondents before and after once-a-day intake of 25 mg of hydrochlorothiazide tablet. 3. Compare the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of the respondents.

4. Determine and compare the clinical symptoms of the respondents before and after twice-a-day intake of 250 ml of bamboo root decoction and before and after once-a-day intake of 25 mg of hydrochlorothiazide tablet.

Hypotheses
Null Hypothesis There is no significant difference in the effect of twice-a-day intake of 250 ml of bamboo root decoction and the effect of once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of hypertensive individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. Alternative Hypothesis There is a significant difference in the effect of twice-a-day intake of 250 ml of bamboo root decoction and the effect of once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of hypertensive individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay.

Significance
The Philippine National Health Research System (PNHRS) in 2008 launched the National Unified Health Research Agenda (NUHRA) to serve as the nations template for health research and development, in efforts specifying the areas and topics that need to be addressed for 2008-2010. One of the priorities is on health technology development which focuses on the documentation of indigenous practices in the use of medicinal plants for disease intervention. This is reinforced by the approval of the Traditional and

Alternative Medicine Act (TAMA) in 1997 which provides a legitimizing boost to the alternative medicine movement in the Philippines (Stuart, 2004). As mentioned earlier, the researcher on the study conducted in 2009 concluded that twice-a-day intake of bamboo root decoction can serve as an alternative maintenance medication for hypertensive individuals under Stage I Hypertension, and further recommended that twice-a-day intake of bamboo root decoction be compared to the conventional maintenance medication for hypertensive individuals under Stage I Hypertension. Therefore, a result on the study showing that there is no significant difference in the effect of twice-a-day intake of 250 ml of bamboo root decoction and the effect of once-aday intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of the respondents will essentially support the conclusion of the study conducted by the researcher in 2009. The study will then be the researchers contribution to the PNHRS. Furthermore, the results of the study, as a preliminary report, can serve as a foundation for future researches on the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure in a larger sample population, and as a foundation for futures researches on the antihypertensive properties of the bamboo root decoction, particularly the primary active component causing the therapeutically diuretic action.

Scope and Delimitation


The study was limited to compare the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of hypertensive individuals in Barangay Veterans Village,

Municipality of Ipil, Province of Zamboanga Sibugay. The preparation and dosage of the bamboo root decoction was based on the study conducted by the researcher in 2009, and the preparation and dosage of the hydrochlorothiazide tablet was based on the recommendation of the JNC, 7th Report in 2003. The respondents of the study were hypertensive individuals under Stage I Hypertension, diagnosed for the 1st time by a licensed physician, and with no associated comorbidities. Therefore, the results of the study were limited to hypertensive individuals under Stage I Hypertension with no associated comorbidities. The study was a preliminary report on the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure. Therefore, the results of the study can serve as a foundation for future researches in a larger sample population. The study was a randomized, cross-over, open clinical trial. Therefore, the researcher, the research assistants, and the respondents were not blinded on the preparation and dosage of the bamboo root decoction and the hydrochlorothiazide tablet. The study was conducted in 4 phases, and each phase was conducted daily for 2 weeks with a total of 8 weeks period of study. The outcome parameter measured was the mean arterial pressure, and the results were analyzed utilizing repeated-measure ANOVA and t-test to determine the level of significance. The confounders such as the intake of pharmaceutical drugs and bamboo root decoction beyond the scope of the study were minimized by the twice-a-week as well as the after the end of each phase monitoring done by the researcher and the daily monitoring done by the research assistants. However, the intervals in between were beyond the control of the researcher. Lifestyle modifications such as weight reduction, regular exercise, dietary approaches

to stop hypertension (DASH), relaxation therapy, smoking cessation, and alcohol reduction were not part of the interventions. The systematic evaluation on the chemical analysis of the primary active component of the bamboo root decoction causing the therapeutic diuresis was beyond the scope of the study.

Definition of Terms
1. Mean Arterial Pressure (MAP) - computed as diastolic blood pressure multiplied by 2, product plus systolic blood pressure, and sum divided by 3. 2. Stage I Hypertension MAP - mean arterial pressure between 119.99 mmHg and 106.67 mmHg. 3. Prehypertension MAP - mean arterial pressure between 106.66 mmHg and 93.33 mmHg. 4. Stage I Hypertension - systolic blood pressure between 140-159 mmHg and diastolic blood pressure between 90-99 mmHg, with the highest pressure utilized in the classification, and diagnosed by 2 sets of readings at intervals of at least 2 days. 5. Comorbidities - diseases other than hypertension such as diabetes mellitus, heart failure, myocardial infarction, ischemic heart disease, stroke, kidney failure, urinary problems, cancer, and thyroid disorder diagnosed by a licensed physician before the period of study. 6. Comparable - capable of or suitable for comparison, or a mean arterial pressure within the range of Prehypertension MAP.

Conceptual Framework
Herbal Medicine Indigenous Practice Effective Relatively Safe Conventional Medicine Recommended Drug Effective Relatively Safe

Least Expensive Readily Available Culturally Accepted

Less Expensive Not Readily Available Fear of Adverse Effects

Respondents Stage I Hypertension Diagnosed 1st Time No Comorbidities

Bamboo Root Decoction 250 ml Twice-a-Day

Hydrochlorothiazide Tablet 25 mg Once-a-Day

Outcome Parameter Mean Arterial Pressure Twice-a-Day Blood Pressure Monitoring Figure 1. Conceptual Framework

Bamboo root decoction, as herbal medicine, is an indigenous practice for the treatment of hypertension. The 250 ml decoction is taken twice-a-day, and serves as an alternative maintenance medication for hypertensive individuals under Stage I Hypertension (Cuevas, 2009). It is effective; relatively safe; least expensive as it does not actually cost anything, except for the materials needed for its preparation; readily available since Bambusa Blumeana or Kawayan Tinik are bountiful in Barangay Veterans Village; and culturally accepted as it has been present for quite some time, and that more and more hypertensive individuals are claiming and promoting its effectiveness. Hydrochlorothiazide tablet, as conventional medicine, is a recommended drug for the treatment of hypertension. The 25 mg tablet is taken once-a-day, and serves as a first-line antihypertensive medication particularly in individuals under Stage I Hypertension (ALLHAT, 2002). It is effective; relatively safe; less expensive than other antihypertensives as it only costs 6.50 Php per tablet; not readily available since among the > 20 pharmacies located in the Municipality of Ipil, only 1 has a 25 mg of hydrochlorothiazide tablet available; and in rural areas such Barangay Veterans Village, majority of the residents fear the side effects of many pharmaceutical drugs.

CHAPTER II METHODOLOGY

Research Design
The study was a Randomized, Cross-Over, Open Clinical Trial. Therefore, the researcher, the research assistants, and the respondents were not blinded on the preparation and dosage of the bamboo root decoction and the hydrochlorothiazide tablet. The respondents were subjected into block randomization design for the assignment of groups and treatments, and utilized a cross-over experimental design for maintaining the sequence as well as the balance, in which all the respondents received the same number of treatments and participated for the same number of period of study. This design minimized the error of variance as the respondents serves as their own controls, and the validity of the results of the study were statistically efficient even with a smaller sample population.

Respondents
Inclusion Criteria 1. A permanent resident of Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay, except those living in the south-western side mountainous areas that were beyond geographically feasible for both the researcher and the research assistants, and with no serious intentions of leaving the community within the period of study.

2. Hypertensive individuals under Stage I Hypertension, diagnosed for the 1st time by a licensed physician, and with no associated comorbidities. Drop-out Criteria 1. A missed of even a single measurement of blood pressure and/or even a single dosage of 250 ml of bamboo root decoction and/or 25 mg of hydrochlorothiazide tablet. 2. An unexpected relocation of residence beyond Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay.

Sampling Design
The study utilized a Convenience Sampling Design. The researcher conducted a house to house blood pressure monitoring for 1 week (December 14 - 20, 2009) to identify hypertensive individuals under Stage I Hypertension, and enrolled the total count of individuals based on their qualification in the inclusion criteria. A total of 29 individuals were identified for the 1st set of reading and again their blood pressures were monitored for the 2nd set of reading to ensure accuracy of results. A total of 23 potential respondents qualified and they were thoroughly assessed utilizing a complete medical history and physical examination to determine their qualification in the inclusion criteria. These individuals were informally informed about the study and the researcher was able to attain their commitment to participate as respondents. The researcher requested the assistance of the Municipal Health Officer (MHO) of the Municipality of Ipil (December 28, 2009) and again thoroughly assessed the 23 potential respondents utilizing a complete medical history and physical examination

to determine their qualification in the inclusion criteria. A total of 20 respondents qualified and this was done at the Barangay Health Station (BHS) of Barangay Veterans Village. Then the researcher conducted a meeting to formally present the study utilizing visual aids. An open forum discussion ensued after the presentation for further clarity of the study. The meeting ended with the signing of the written informed consent by the respondents. (See Appendix A, Written Informed Consent). A total of 20 respondents participated in the study, however 2 dropped out due to a missed measurement of blood pressure, 1 dropped out due to a missed dosage of bamboo root decoction, and 1 dropped out due to an unexpected relocation of residence at Barangay Concepcion, Municipality of Kabasalan, Province of Zamboanga Sibugay. Therefore, a total of 16 respondents completed the study. The researcher conducted a complete medical history and physical examination of respondents after the end of each phase of the study, to ensure their safety within the period of study. The presence of unexpected unusualities will be further evaluated by the MHO of the Municipality of Ipil and will be given immediate medical intervention.

Treatment Allocation
The study utilized a Block Randomization Design for treatment allocation. The 20 respondents were subjected into block randomization for the assignment of groups and treatments. They were randomly assigned into Group A (1st Treatment - Once-a-Day Intake of 25 mg of Hydrochlorothiazide Tablet and 2nd Treatment - Twice-a-Day Intake of 250 ml of Bamboo Root Decoction) and Group B (1st Treatment - Twice-a-Day Intake of 250 ml of Bamboo Root Decoction and 2nd Treatment - Once-a-Day Intake

of 25 mg of Hydrochlorothiazide Tablet). The process begins by randomly assigning numbers (1-20) to each of the respondents. Then utilizing Microsoft Office Excel 2007, type the words (Bamboo and Thiazide) in a systematic alternating order in each of the 20 rows on the 1st column of the spreadsheet and type the function (=RAND()) in each of the 20 rows on the 2nd column of the spreadsheet, and sort the data in an ascending order on the 2nd column of the spreadsheet. This design minimized the selection bias as well as the confounders that distorts the results of the study, and ensures a close balance of the respondents in Group A and Group B at any time within the period of study.

Research Setting
The study was conducted in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. It is a growing urban and agricultural community strategically located at the western side of the Municipality of Ipil near the heart of the Poblacion, along the National Highway going to Zamboanga City. It is bounded on the north by Barangay Ipil Heights, on the south by Barangay Tiayon, on the west by Barangay Tinay, and on the east by Barangay Don Andres. The total land area is 1,143 hectares, and about 80.00% is agricultural and 20.00% is residential. The geographic features of the community consist of different landscape variations that range from the south-western side mountainous areas to the north-eastern side plains. It has 15 fully organized puroks and a total population of 4,351 individuals with 917 households (See Appendix B, Spot Maps).

Research Survey Form


The research survey form was formulated by the researcher based on the outcome parameter measured in the study, which was the mean arterial pressure. It contains tables for the twice-a-day blood pressure monitoring which were converted into daily and weekly mean arterial pressures as well as checklists for the daily clinical symptoms monitoring which were converted into weekly clinical symptoms by the researcher (See Appendix C, Research Survey Form).

Research Assistants
The researcher conducted a meeting with the MHO of the Municipality of Ipil (December 21, 2009) to formally present the study and attain the permission of utilizing 2 Barangay Health Workers (BHWs) of Barangay Veterans Village as research assistants in the study. Then the researcher conducted a meeting with these individuals to formally present the study utilizing visual aids and attain their commitment to participate as research assistants. These individuals were among the research assistants in the study conducted by the researcher in 2009. This strategy had proven essentially beneficial for reasons which includes: the research assistants have competent knowledge on hypertension and skill on blood pressure monitoring since they are BHWs, and were among the research assistants in the study conducted by the researcher in 2009, as mentioned earlier; the respondents felt secured within the period of study since they personally know the research assistants; the discrepancy in the time of intake of the bamboo root decoction and the hydrochlorothiazide tablet as well as in the blood pressure monitoring were minimized

since the research assistants and the respondents are living in the same community; and the performances of the research assistants were efficient due to the decrease in the workload since 1 research assistant was assigned to only 10 respondents. The research assistants underwent (December 22 - 23, 2009) a lecture on hypertension, demonstration on blood pressure monitoring and utilization of research survey form, and training on preparation of bamboo root decoction. A demonstration on blood pressure monitoring and utilization of research survey form was conducted by the research assistants on 10 individuals with the researcher validating to evaluate potential inter-observer variability, and to attain uniformity and accuracy of results. This was done at the BHS of Barangay Veterans Village with permission from the MHO of the Municipality of Ipil. The data were not subjected into statistical analysis since these were already similar. The researcher provided each of them new aneroid sphygmomanometers and stethoscopes, copies of the research survey form with file folders and pens, materials for the preparation of bamboo root decoction, and hydrochlorothiazide tablets. Then the researcher conducted a re-training of research assistants on blood pressure monitoring and utilization of research survey form before the start of each phase of the study as well as on preparation of bamboo root decoction before the start of Phase II (1st Treatment Weeks) and Phase IV (2nd Treatment Weeks) of the study, to attain uniformity and accuracy of results. The researcher recruited another assistant to identify sources of bamboo roots from Bambusa Blumeana or Kawayan Tinik located in Barangay Veterans Village (December 29, 2009). This individual was assigned in gathering, washing, soaking, removing the external stratum, and cutting of the roots (See Appendix D, Bamboo).

Interventions
Bamboo Root Decoction The preparation and dosage of the 250 ml bamboo root decoction was based on the study conducted by the researcher in 2009, as mentioned earlier. This was prepared daily in the respective homes of the research assistants on the Phase II (1st Treatment Weeks) and Phase IV (2nd Treatment Weeks) of the study. The process begins by washing and soaking the bamboo roots in water overnight to remove its external stratum. Then the decoction was prepared by boiling 50 pieces of bamboo roots, about the length of a pen, in 8 liters of water for 1 hour. The decoction was allowed to cool down by natural process. This was then strained and poured into 250 ml plastic bottles (See Appendix E, Treatments). This preparation was good for 10 respondents per day and the bamboo roots were repeatedly used for 1 week. The respondents were not blinded about the twice-a-day intake of 250 ml of bamboo root decoction. Hydrochlorothiazide Tablet The preparation and dosage of the 25 mg hydrochlorothiazide tablet was based on the recommendation of the JNC, 7th Report in 2003, as mentioned earlier. This was purchased weekly by the researcher from a pharmacy located in Barangay Don Andres, Municipality of Ipil, Province of Zamboanga Sibugay on the Phase II (1st Treatment Weeks) and Phase IV (2nd Treatment Weeks) of the study. The only available 25 mg of hydrochlorothiazide tablet cost 6.50 Php. The researcher properly checked on the foiled packaging of each tablets as well as the manufacture date and expiration date, to ensure the quality of the tablets (See Appendix E, Treatments). The respondents were not blinded about the once-a-day intake of 25 mg of hydrochlorothiazide tablet.

Data Gathering Procedures


The study was conducted in 4 phases, and each phase was conducted daily for 2 weeks with a total of 8 weeks period of study (January 4 - February 28, 2010). The researcher minimized the potential biases in the study by performing at least twice-a-week monitoring of blood pressure and clinical symptoms as well as monitoring of the preparation of bamboo root decoction. The data gathered were compared with those from the research assistants to evaluate potential inter-observer variability, and to attain uniformity and accuracy of results. The data were not subjected into statistical analysis since these were already similar. The research survey forms were collected from the research assistants after the end of each week of the 8 weeks period of study. The twice-a-day blood pressures were converted into daily and weekly mean arterial pressures and the daily clinical symptoms were converted into weekly clinical symptoms by the researcher Blood Pressure Monitoring The blood pressure was monitored utilizing a new aneroid sphygmomanometer and a new stethoscope via the auscultatory method. The respondents must be seated quietly for at least 5 minutes in a chair, with feet on the floor, and arm supported at heart level. Smoking, caffeine, and exercise must be avoided for at least 30 minutes prior to the blood pressure measurement. An adult sized cuff bladder encircling at least 2/3 of the arm was utilized and at least 2 measurements were made at least 2 minutes apart, with the average blood pressure recorded to ensure accuracy of results. The respondents were blinded about their blood pressure readings.

An increase in systolic blood pressure to 200 mmHg and/or diastolic blood pressure to 120 mmHg, and a decrease in systolic blood pressure to 100 mmHg and/or diastolic blood pressure to 70 mmHg within the period of study must be immediately reported to the researcher to ensure the safety of the respondents. However, the data will be analyzed based on the principle of the intention to treat. Clinical Symptoms Monitoring The clinical symptoms complaint by the respondents was monitored utilizing the research survey form. The research assistants were instructed by the researcher not to ask about the symptoms, but instead must be reported by the respondents themselves. Clinical symptoms such as loss of consciousness, severe headache, persistent blurring of vision, chest pain, palpitation, difficulty of breathing, weakness, numbness, edematous extremities, tremors, flank pain, painful urination, no urination, and fever complaint by the respondents within the period of study must be immediately reported to the researcher to ensure the safety of the respondents. However, the data will be analyzed based on the principle of the intention to treat. Every 2 Hours Blood Pressure Monitoring The researcher and the research assistants conducted a blood pressure monitoring on the respondents in Group A and Group B. This was done every 2 hours (8:00 a.m. 10:00 p.m.) on the 1st day (January 18, 2009) of the Phase II (1st Treatment Weeks) of the study, to determine the onset and duration of action of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the twice-a-day intake of 250 ml of bamboo root decoction. This was the basis for the twice-a-day blood pressure monitoring conducted at 10:00 a.m. and 5:00 p.m. in the 8 weeks period of study.

Phase I (Baseline Weeks) The blood pressure and clinical symptoms were monitored by the research assistants at 10:00 a.m. and 5:00 p.m. daily for a total of 2 weeks (January 4 - 17, 2010). The data gathered were recorded utilizing the research survey form and serve as a baseline for comparison of the mean arterial pressure, as the outcome parameter measured in the study Phase II (1st Treatment Weeks) The 25 mg hydrochlorothiazide tablets were delivered daily by the research assistants in the respective homes of the respondents in Group A. The tablet must be taken at 8:00 a.m. daily for a total of 2 weeks (January 18 - 31, 2010). The blood pressure and clinical symptoms were monitored by the research assistants at 10:00 a.m and 5:00 p.m. The data gathered were recorded utilizing the research survey form and serve as a monitoring of the effect of the once-a-day intake of hydrochlorothiazide tablet. The bamboo root decoction placed into 250 ml plastic bottles were delivered daily by the research assistants in the respective homes of the respondents in Group B. The decoction must be taken at 8:00 a.m. and 3:00 p.m. daily for a total of 2 weeks (January 18 - 31, 2010). The blood pressure and clinical symptoms were monitored by the research assistants at 10:00 a.m. and 5:00 p.m. The data gathered were recorded utilizing the research survey form and serve as a monitoring of the effect of the twice-a-day intake of bamboo root decoction. Phase III (Washout Weeks) The blood pressure and clinical symptoms were monitored by the research assistants at 10:00 a.m. and 5:00 p.m. daily for a total of 2 weeks (February 1 - 14, 2010).

The data gathered were recorded utilizing the research survey form and serve as a monitoring of the potential carry-over effects of the once-a-day intake of hydrochlorothiazide tablet and the twice-a-day intake of bamboo root decoction. Phase IV (2nd Treatment Weeks) The bamboo root decoction placed into 250 ml plastic bottles were delivered daily by the research assistants in the respective homes of the respondents in Group A. The decoction must be taken at 8:00 a.m. and 3:00 p.m. daily for a total of 2 weeks (February 15 - 28, 2010). The blood pressure and clinical symptoms were monitored by the research assistants at 10:00 a.m. and 5:00 p.m. The data gathered were recorded utilizing the research survey form and serve as a monitoring of the effect of the twice-a-day intake of bamboo root decoction. The 25 mg hydrochlorothiazide tablets were delivered daily by the research assistants in the respective homes of the respondents in Group B. The tablet must be taken at 8:00 a.m. daily for a total of 2 weeks (February 15 - 28, 2010). The blood pressure and clinical symptoms were monitored by the research assistants at 10:00 a.m. and 5:00 p.m. The data gathered were recorded utilizing the research survey form and serve as a monitoring of the effect of the once-a-day intake of hydrochlorothiazide tablet.

Statistical Analysis
The study utilized Frequency Distribution and Measures of Central Tendency for data processing as well as Repeated-Measure ANOVA and T-Test for statistical analysis to determine the comparability of the profile of the respondents, the mean arterial pressure, and the clinical symptoms.

Flow of Activities
Research Protocol Recruitment of Respondents House to House Bp Monitoring Recruitment of Research Assistants Conduct Lecture and Training Formal Presentation of Study Signing of Written Informed Consent Block Randomization Assigning of Groups and Treatments Phase I Monitoring of Outcome Parameter Phase II (Group A) Once-a-Day Intake of Tablet Monitoring of Outcome Parameter Phase II (Group B) Twice-a-Day Intake of Decoction Monitoring of Outcome Parameter

Phase III Monitoring of Outcome Parameter Phase IV (Group A) Twice-a-Day Intake of Decoction Monitoring of Outcome Parameter Phase IV (Group B) Once-a-Day Intake of Tablet Monitoring of Outcome Parameter

Data Processing and Analysis Research Paper Figure 2. Flow of Activities

CHAPTER III PRESENTATION OF RESULTS, DISCUSSION, AND ANALYSIS

A total of 20 respondents participated in the study, however 2 dropped out due to a missed measurement of blood pressure, 1 dropped out due to a missed dosage of bamboo root decoction, and 1 dropped out due to an unexpected relocation of residence at Barangay Concepcion, Municipality of Kabasalan, Province of Zamboanga Sibugay. Therefore, a total of 16 (80.00%) respondents completed the study.

Table 1. Profile of the Respondents (N = 16) Profile Frequency Age 50 - 54 55 - 59 60 - 64 Sex Female Male PMHx () Comorbidities (+) Comorbidities FHx of HPN Yes No PE Unremarkable Remarkable 16 0 10 6 5 4 7

Percentage

31.25 25.00 43.75

62.50 37.50

16 0

100.00 0.00

10 6

62.50 37.50

100.00 0.00

Table 1 shows that majority of the respondents belong to the 55-59 age group (25.00%) and 60-64 age group (43.75%). This indicates that majority of the respondents (68.75%) are on the elderly stage of life. The mean age of the respondents is 58 years old with a range of 50-64 years. In terms of the sex distribution, majority of the respondents are females (62.50%) as compared to males (37.50%). The sex ratio is 6 males for every 10 females. Majority of the respondents (62.50%) have a family history of hypertension, and all (100.00%) are in the 1st degree relationship. In terms of the past medical history of comorbidities and the physical examination, all (100.00%) are unremarkable.

Table 2. Comparison of the Profile of the Respondents in Group A (N = 8) and Group B (N = 8) (p > 0.05*) Profile Group A Percentage Group B Percentage Age* 50 - 54 55 - 59 60 - 64 Sex* Female Male PMHx* () Comorbidities (+) Comorbidities FHx of HPN* Yes No PE* Unremarkable Remarkable 5 3 62.50 37.50 5 3 62.50 37.50 2 2 4 25.00 25.00 50.00 3 2 3 37.50 25.00 37.50

8 0

100.00 0.00

8 0

100.00 0.00

4 4

50.00 50.00

6 2

75.00 25.00

8 0

100.00 0.00

8 0

100.00 0.00

Table 2 shows that there were no significant difference on the profile of the respondents in Group A and Group B of the study. This indicates that there were no significant difference on the 8 respondents in Group A and the 8 respondents in Group B in terms of age, sex, past medical history of comorbidities, family history of hypertension, and physical examination when analyzed utilizing t-test. The respondents of the study were hypertensive individuals under Stage I Hypertension, diagnosed for the 1st time by a licensed physician, and with no associated comorbidities. They were randomly assigned into Group A (1st Treatment - Once-a-Day Intake of 25 mg of Hydrochlorothiazide Tablet and 2nd Treatment - Twice-a-Day Intake of 250 ml of Bamboo Root Decoction) and Group B (1st Treatment - Twice-a-Day Intake of 250 ml of Bamboo Root Decoction and 2nd Treatment - Once-a-Day Intake of 25 mg of Hydrochlorothiazide Tablet) utilizing block randomization design. The study was a randomized, cross-over, open clinical trial aimed to compare the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of hypertensive individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. The preparation and dosage of the bamboo root decoction was based on the study conducted by the researcher in 2009, and the preparation and dosage of the hydrochlorothiazide tablet was based on the recommendation of the JNC, 7th Report in 2003. The study was conducted in 4 phases, and each phase was conducted daily for 2 weeks with a total of 8 weeks period of study. Phase I serves as the Baseline Weeks, Phase II serves as the 1st Treatment Weeks, Phase III serves as the Washout Weeks, and Phase IV serves as the 2nd Treatment Weeks. The outcome parameter measured was

the mean arterial pressure, and the results were analyzed utilizing repeated-measure ANOVA and t-test to determine the level of significance. The blood pressures were monitored twice-a-day (10:00 a.m. and 5:00 p.m.) in the 8 weeks period of study, and were converted into daily and weekly mean arterial pressures by the researcher.

Group A
Mean Arterial Pressure (mmHg)
115
112.29 112.08 110.83 109.79

Group B
112.71 112.29

110

106.88

105

106.04

100

98.13 97.92 1st Week 2nd Week 3rd Week

97.29 97.08 4th Week 5th Week 6th Week

97.92 97.71 7th Week

97.08 96.88 8th Week

95

Phase I

Phase II

Phase III

Phase IV

Figure 3. Comparison of the Mean Arterial Pressure in the 8 weeks Period of Study in Group A and Group B

Figure 3 shows that the mean arterial pressure was stable for Group A and Group B on the Phase I (Baseline Weeks) of the study, and falls under Stage I Hypertension MAP (119.99 mmHg - 106.67 mmHg). This indicates that the respondents were under Stage I Hypertension. Furthermore, this indicates the validity of the Phase I as Baseline Weeks. Then the mean arterial pressure progressively decreased for Group A and Group B on the Phase II (1st Treatment Weeks) of the study, and falls under

Prehypertension MAP (106.66 mmHg 93.33 mmHg). This indicates that the respondents were under Prehypertension. Furthermore, this indicates the validity of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the twice-a-day intake of 250 ml of bamboo root decoction as treatment for hypertensive individuals under Stage I Hypertension. The effect was clinically important as evidenced by a decreased on the mean arterial pressure from Stage I Hypertension MAP to Prehypertension MAP. Then the mean arterial pressure progressively increased for Group A and Group B on the Phase III (Washout Weeks) of the study. On the 1st week of the Phase III, the mean arterial pressure for Group A falls under Prehypertension MAP (106.66 mmHg - 93.33 mmHg) and the mean arterial pressure for Group B falls under Stage I Hypertension MAP (119.99 mmHg - 106.67 mmHg). On the 2nd week of the Phase III, the mean arterial pressure for Group A and Group B falls under Stage I Hypertension MAP (119.99 mmHg - 106.67 mmHg). This indicates that the respondents were under Stage I Hypertension. Furthermore, this indicates the validity of the Phase III as Washout Weeks. Then the mean arterial pressure progressively decreased for Group A and Group B on the Phase IV (2nd Treatment Weeks) of the study, and falls under Prehypertension MAP (106.66 mmHg - 93.33 mmHg). This indicates that the respondents were under Prehypertension. Furthermore, this indicates the validity of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the twice-a-day intake of 250 ml of bamboo root decoction and as treatment for hypertensive individuals under Stage I Hypertension. The effect was clinically important as evidenced by a decreased on the mean arterial pressure from Stage I Hypertension MAP to Prehypertension MAP.

Group A
Mean Arterial Pressure (mmHg)
115
111.46

Group B

109.79 109.17

110

111.04

105

100

97.71 97.50 Baseline Weeks 1st Treatment Weeks Washout Weeks

97.40 97.40 2nd Treatment Weeks

95 Phase I*

Phase II*

Phase III

Phase IV*

Figure 4. Comparison of the Mean Arterial Pressure between the Phase I and the Phase II, Phase III, and Phase IV of the Study in Group A and Group B (p < 0.05*)

Figure 4 shows that there was a significant difference on the mean arterial pressure between the Phase I (Baseline Weeks) and the Phase II (1st Treatment Weeks) of the study as well as between the Phase I (Baseline Weeks) and the Phase IV (2nd Treatment Weeks) of the study. However, there was no significant difference on the mean arterial pressure between the Phase I (Baseline Weeks) and the Phase III (Washout Weeks) of the study. This indicates that the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the twice-a-day intake of 250 ml of bamboo root decoction had a significant effect on the mean arterial pressure of the respondents in Group A and Group B. The effect was statistically significant (p < 0.05) when analyzed utilizing repeated-measure ANOVA.

Group A
Mean Arterial Pressure (mmHg)
115
111.46

Group B

109.79

110

111.04

109.17

105

100

95
Baseline Weeks Washout Weeks

Phase I*

Phase III*

Figure 5. Comparison of the Mean Arterial Pressure between the Phase I and the Phase III of the Study in Group A and Group B (p > 0.05*)

Figure 5 shows that there was no significant difference on the mean arterial pressure between the Phase I (Baseline Weeks) and the Phase III (Washout Weeks) of the study. This indicates that there was no significant difference on the mean arterial pressure of the respondents in Group A and Group B before the start of the Phase II (1st Treatment Weeks) and the Phase IV (2nd Treatment Weeks) of the study when analyzed utilizing t-test.

Group A
Mean Arterial Pressure (mmHg)
115

Group B

110

105

100

97.71 97.50 1st Treatment Weeks

97.40 97.40 2nd Treatment Weeks

95

Phase II*

Phase IV*

Figure 6. Comparison of the Mean Arterial Pressure between the Phase II and the Phase IV of the Study in Group A and Group B (p > 0.05*)

Figure 6 shows that there was no significant difference on the mean arterial pressure between the Phase II (1st Treatment Weeks) and the Phase IV (2nd Treatment Weeks) of the study. This indicates that there was no significant difference on the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the effect of the twice-a-day intake of 250 ml of bamboo root decoction on the mean arterial pressure of the respondents in Group A and Group B when analyzed utilizing t-test. The mean arterial pressure of the respondents significantly decreased on the twice-a-day intake of 250 ml of bamboo root decoction and the once-a-day intake of 25 mg of hydrochlorothiazide tablet on the Phase II (1st Treatment Weeks) and Phase IV (2nd Treatment Weeks) of the study. The effect was statistically significant (p < 0.05) when analyzed utilizing repeated-measure ANOVA (See Figure 4), and clinically important as evidenced by a decreased on the mean arterial pressure

from Stage I Hypertension MAP to Prehypertension MAP (See Figure 3). Furthermore, the effect of the twice-a-day intake of 250 ml of bamboo root decoction and the effect of the once-a-day intake 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of the respondents had no significant difference when analyzed utilizing t-test (See Figure 6). Therefore, bamboo root decoction, as herbal medicine,

and hydrochlorothiazide tablet, as conventional medicine, are both essentially effective in the treatment of hypertensive individuals under Stage I Hypertension. This is supported by the conclusion of the placebo-controlled, parallel, cross-over experimental study conducted by the researcher in 2009 which claimed that twice-a-day intake of bamboo root decoction can serve as an alternative maintenance medication for hypertensive individuals under Stage I Hypertension as well as the conclusion of the randomized, double-blind, active-controlled clinical trial conducted by the ALLHAT in 2002 which claimed that once-a-day intake of hydrochlorothiazide tablet are superior in preventing major forms of cardiovascular disease, less expensive, and should be preferred as first-line antihypertensive medication.

Thiazide Treatment*
Mean Arterial Pressure (mmHg)
105
101.67

Bamboo Treatment*

100.84

101.67 99.17

100
94.17

99.17 95.84

100.84 96.67 98.34 94.17 96.67

96.67 96.67

95

93.33

93.33

90

85
R1 R2 R3 R4 R5 R6 R7 R8

Group A
Figure 7. Comparison of the Mean Arterial Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group A (p > 0.05*)

Figure 7 shows that the mean arterial pressure between the Thiazide Treatment and the Bamboo Treatment per respondent in Group A was stable with some minimum fluctuations. However, there was no significant difference on the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the effect of the twice-a-day intake of 250 ml of bamboo root decoction on the mean arterial pressure per respondent in Group A when analyzed utilizing t-test.

Thiazide Treatment*
Mean Arterial Pressure (mmHg)
105
100.84 100.84

Bamboo Treatment*

101.67

100
100.00 97.50 94.17 94.17 94.17

100.84 96.67

99.17 97.50 96.67 96.67 96.67

95

93.33

90

85
R1 R2 R3 R4 R5 R6 R7 R8

Group B
Figure 8. Comparison of the Mean Arterial Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group B (p > 0.05*)

Figure 8 shows that the mean arterial pressure between the Thiazide Treatment and the Bamboo Treatment per respondent in Group B was stable with some minimum fluctuations. However, there was no significant difference on the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the effect of the twice-a-day intake of 250 ml of bamboo root decoction on the mean arterial pressure per respondent in Group B when analyzed utilizing t-test.

Group A
Mean Change on MAP (mmHg)
25

Group B

20
13.96 13.37 14.06 13.65

15

10

5
1st Treatment Weeks 2nd Treatment Weeks

Phase II*

Phase IV*

Figure 9. Comparison of the Mean Change on the Mean Arterial Pressure between the Phase II and the Phase IV of the Study in Group A and Group B (p > 0.05*)

Figure 9 shows that there was no significant difference in the mean change on the mean arterial pressure between the Phase II (1st Treatment Weeks) and the Phase IV (2nd Treatment Weeks) of the study. This indicates that there was no significant difference on the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the effect of the twice-a-day intake of 250 ml of bamboo root decoction in the mean change on the mean arterial pressure of the respondents in Group A and Group B when analyzed utilizing t-test. The mean change on the mean arterial pressure on the once-a-day intake of 25 mg of hydrochlorothiazide tablet was 13.82 mmHg and on the twice-a-day intake of 250 ml of bamboo root decoction was 13.72 mmHg in Group A and Group B.

Thiazide Treatment*
Mean Change on MAP (mmHg)

Bamboo Treatment*

25

20
17.50 16.67 14.70 13.34 12.51 14.17 13.33 13.33 13.33 13.34 12.51 14.17 13.33 13.33 15.83 13.33

15

10

5
R1 R2 R3 R4 R5 R6 R7 R8

Group A
Figure 10. Comparison of the Mean Change on the Mean Arterial Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group A (p > 0.05*)

Figure 10 shows that the mean change on the mean arterial pressure between the Thiazide Treatment and the Bamboo Treatment per respondent in Group A was stable with some minimum fluctuations. However, there was no significant difference on the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the effect of the twice-a-day intake of 250 ml of bamboo root decoction in the mean change on the mean arterial pressure per respondent in Group A when analyzed utilizing t-test.

Thiazide Treatment*
Mean Change on MAP (mmHg)

Bamboo Treatment*

25

20
17.50 15.00

15
12.51

13.33 12.50 12.51

13.34 12.51

14.17

14.17 13.33

13.33 13.33 13.33 10.84

14.17

10

5
R1 R2 R3 R4 R5 R6 R7 R8

Group B
Figure 11. Comparison of the Mean Change on the Mean Arterial Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group B (p > 0.05*)

Figure 11 shows that the mean change on the mean arterial pressure between the Thiazide Treatment and the Bamboo Treatment per respondent in Group B was stable with some minimum fluctuations. However, there was no significant difference on the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the effect of the twice-a-day intake of 250 ml of bamboo root decoction in the mean change on the mean arterial pressure per respondent in Group B when analyzed utilizing t-test.

Group A
Mean Change on SBp (mmHg)

Group B

30

25
21.25 16.88 19.69

20

19.69

15

10
1st Treatment Weeks 2nd Treatment Weeks

Phase II*

Phase IV*

Figure 12. Comparison of the Mean Change on the Mean Systolic Blood Pressure between the Phase II and the Phase IV of the Study in Group A and Group B (p > 0.05*)

Figure 12 shows that there was no significant difference in the mean change on the mean systolic blood pressure between the Phase II (1st Treatment Weeks) and the Phase IV (2nd Treatment Weeks) of the study. This indicates that there was no significant difference on the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the effect of the twice-a-day intake of 250 ml of bamboo root decoction in the mean change on the mean systolic blood pressure of the respondents in Group A and Group B when analyzed utilizing t-test. The mean change on the mean systolic blood pressure on the once-a-day intake of 25 mg of hydrochlorothiazide tablet was 20.47 mmHg and on the twice-a-day intake of 250 ml of bamboo root decoction was 18.28 mmHg in Group A and Group B.

Thiazide Treatment*
Mean Change on SBp (mmHg)

Bamboo Treatment*

30

25

22.50 22.50 22.50 20.00 20.00 20.00 20.00 17.50 20.00 20.00 20.00 22.50 20.00 22.50 20.00 17.50

20

15

10
R1 R2 R3 R4 R5 R6 R7 R8

Group A
Figure 13. Comparison of the Mean Change on the Mean Systolic Blood Pressure between the Thiazide Treatment and the Bamboo Treatment per Respondent in Group A (p > 0.05*)

Figure 13 shows that the mean change on the mean systolic blood pressure between the Thiazide Treatment and the Bamboo Treatment per respondent in Group A was stable with some minimum fluctuations. However, there was no significant difference on the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the effect of the twice-a-day intake of 250 ml of bamboo root decoction in the mean change on the mean systolic blood per respondent in Group A when analyzed utilizing t-test.

Thiazide Treatment*
Mean Change on SBp (mmHg)

Bamboo Treatment*

30
27.50

25

22.50 22.50

20
17.50

20.00 17.50 17.50

20.00 17.50

20.00 20.00 20.00 15.00 12.50 12.50

15

10.00

10
R1 R2 R3 R4 R5 R6 R7 R8

Group B
Figure 14. Comparison of the Mean Change on the Mean Systolic Blood Pressure between the Thiazide Treatment and the BambooTreatment per Respondent in Group B (p > 0.05*)

Figure 14 shows that the mean change on the mean systolic blood pressure between the Thiazide Treatment and the Bamboo Treatment per respondent in Group B was stable with some maximum fluctuations. However, there was no significant difference on the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the effect of the twice-a-day intake of 250 ml of bamboo root decoction in the mean change on the mean systolic blood per respondent in Group B when analyzed utilizing t-test. The mean change on the mean arterial pressure and on the mean systolic blood pressure on the twice-a-day intake of 250 ml of bamboo root decoction was 13.72 mmHg and 18.28 mmHg respectively (See Figure 9, Figure 12). This is lower as compared to the 17.13 mmHg mean change on the mean arterial

pressure and the 23.40 mmHg mean change on the mean systolic blood pressure in the study conducted by the researcher in 2009. However, this may be due to the differences in the number of treatment weeks and the research design. In the study conducted by the researcher in 2009, the twice-a-day intake of 250 ml of bamboo root decoction was continuous for 4 weeks and utilized a placebo-controlled, parallel, cross-over experimental design, while in the present study, the twice-a-day intake of 250 ml of bamboo root decoction was not continuous for 4 weeks and utilized a randomized, cross-over, open clinical trial. On the other hand, the mean change on the mean arterial pressure and on the mean systolic blood pressure on the once-a-day intake of 25 mg of hydrochlorothiazide tablet was 13.82 mmHg and 20.47 mmHg respectively (See Figure 9,

Figure 12). This is lower as compared to the 19.67 mmHg mean change on the mean arterial pressure and the 23.00 mmHg mean change on the mean systolic blood pressure in the study conducted by Myers in 1987. However, this may be due to the differences in the number of treatment weeks, the research design, and the dosage of the hydrochlorothiazide tablet. In the study conducted by Myers in 1987, the once-a-day intake of 25 mg of hydrochlorothiazide tablet was continuous for 12 weeks, utilized a randomized, parallel, double-blind study, and the dosage of the hydrochlorothiazide tablet was 25-50 mg/day, while in the present study, the once-a-day intake of 25 mg of hydrochlorothiazide tablet was not continuous for 12 weeks, utilized a randomized, cross-over, open clinical trial, and the dosage of the hydrochlorothiazide tablet was 25 mg/day.

However, despite of the differences in the mean change on the mean arterial pressure and the mean change on the mean systolic blood pressure as compared to other researches, the effect of the twice-a-day intake of 250 ml of bamboo root decoction and the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet in the mean change on the mean arterial pressure and the mean change on the mean systolic blood pressure of the respondents had no significant difference when analyzed utilizing t-test (See Figure 9, Figure 12).

Table 3. Comparison of the Clinical Symptoms in the 8 weeks Period of Study in Group A (N/Symptom/Week = 56) Clinical Phase I Phase II Phase III Phase IV Symptoms Baseline 1st Treatment Washout 2nd Treatment Weeks Weeks Weeks Weeks 2 --3 1 --1 --3 Mild Headache ----1 --1 --1 --Dizziness Nape Pain Frequent Urination Thirsty Loose Bowel Joint Pains Period of Study ----2 ----1st Week 1 --1 --1 2nd Week --36 10 --1 3rd Week 2 19 12 ----4th Week --7 8 --1 5th Week 1 2 5 1 --6th Week 1 27 13 --2 7th Week 1 23 14 ----8th Week

Table 3 shows that there were a total of 7 clinical symptoms namely, mild headache, dizziness, nape pain, frequent urination, thirsty, loose bowel, and joint pains complaint by the respondents in Group A in the 8 weeks period of study.

A total of 4 symptoms namely, mild headache, nape pain, thirsty, and joint pains were complaint by the respondents on the Phase I (Baseline Weeks) of the study. Majority of the complaint was thirsty, and majority was noted on the 1st week. A total of 6 symptoms namely, mild headache, dizziness, nape pain, frequent urination, thirsty, and joint pains were complaint by the respondents on the Phase II (1st Treatment Weeks) of the study. Majority of the complaint was frequent urination, and majority was noted on the 3rd week. A total of 7 symptoms namely, mild headache, dizziness, nape pain, frequent urination, thirsty, loose bowel, and joint pains were complaint by the respondents on the Phase III (Washout Weeks) of the study. Majority of the complaint was thirsty, and majority was noted on the 5th week. A total of 6 symptoms namely, mild headache, dizziness, nape pain, frequent urination, thirsty, and joint pains were complaint by the respondents on the Phase IV (2nd Treatment Weeks) of the study. Majority of the complaint was frequent urination, and majority was noted on the 7th week.

Table 4. Comparison of the Clinical Symptoms in the 8 weeks Period of Study in Group B (N/Symptom/Week = 56) Clinical Phase I Phase II Phase III Phase IV Symptoms Baseline 1st Treatment Washout 2nd Treatment Weeks Weeks Weeks Weeks 2 --4 --1 1 --2 Mild Headache ------------1 --Dizziness Nape Pain Frequent Urination Thirsty Joint Pains Period of Study ----1 --1st Week 1 1 --1 2nd Week 2 31 12 --3rd Week 1 30 10 --4th Week --12 10 --5th Week 1 3 12 1 6th Week 1 39 13 2 7th Week --22 7 --8th Week

Table 4 shows that there were a total of 6 clinical symptoms namely, mild headache, dizziness, nape pain, frequent urination, thirsty, and joint pains complaint by the respondents in Group B in the 8 weeks period of study. A total of 5 symptoms namely, mild headache, nape pain, frequent urination, thirsty, and joint pains were complaint by the respondents on the Phase I (Baseline Weeks) of the study. Majority of the complaint was mild headache, and majority was noted on the 1st week. A total of 4 symptoms namely, mild headache, nape pain, frequent urination, and thirsty were complaint by the respondents on the Phase II (1st Treatment Weeks) of the study. Majority of the complaint was frequent urination, and majority was noted on the 3rd week.

A total of 5 symptoms namely, mild headache, nape pain, frequent urination, thirsty, and joint pains were complaint by the respondents on the Phase III (Washout Weeks) of the study. Majority of the complaint was thirsty, and majority was noted on the 6th week. A total of 6 symptoms namely, mild headache, dizziness, nape pain, frequent urination, thirsty, and joint pains were complaint by the respondents on the Phase IV (2nd Treatment Weeks) of the study. Majority of the complaint was frequent urination, and majority was noted on the 7th week.

Table 5. Comparison of the Clinical Symptoms between the Thiazide Treatment and the Bamboo Treatment in Group A and Group B (p > 0.05*) Clinical Thiazide Treatment Bamboo Treatment Symptoms 25 mg Hydrochlorothiazide 250 ml Bamboo Root Tablet Decoction 6 7 Mild Headache* 2 1 Dizziness* Nape Pain* Frequent Urination* Thirsty* Joint Pains* Respondents 3 116 42 3 Group A and Group B 5 111 49 2 Group A and Group B

Table 5 shows that there were no significant difference on the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet and the effect of the twice-a-day intake of 250 ml of bamboo root decoction on the clinical symptoms namely, mild headache, dizziness, nape pain, frequent urination, thirsty, and joint pains

complaint by the respondents in Group A and Group B on the Phase II (1st Treatment Weeks) and Phase IV (2nd Treatment Weeks) of the study when analyzed utilizing t-test. The 7 clinical symptoms namely, mild headache, dizziness, nape pain, frequent urination, thirsty, loose bowel, and joint paints complaint by the respondents in the 8 weeks period of study were thoroughly evaluated by the researcher. The clinical symptoms complaint by the respondents were of no clinical relevance as all spontaneously resolved without medical intervention. The significant effect of the twice-a-day intake of 250 ml of bamboo root decoction and the once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure were due to the diuretic action of the bamboo root decoction and the hydrochlorothiazide tablet, as majority of the respondents complaint of frequent urination on the Phase II (1st Treatment Weeks) and Phase IV (2nd Treatment Weeks) of the study (See Table 3, Table 4). The diuretic action of the bamboo root decoction is supported by the results of the study conducted by the researcher in 2009 as well as the literatures of Quisumbing in 1978, Beyerl in 1984, and Jocano in 2003 which provides anecdotal statements that bamboo roots used as a decoction is an efficient diuretic for the treatment of hypertension. However, as mentioned earlier, there are no available literatures providing a systematic evaluation on the chemical analysis of the primary active component causing the therapeutic diuresis. On the other hand, the diuretic action of the hydrochlorothiazide tablet is supported by the literatures of Brunton et. al. in 2006 and Howland et. al. in 2006 which claimed that hydrochlorothiazide causes sodium diuresis and volume depletion by acting in

the kidney to decrease the reabsorption of sodium through inhibition of the Na+/Clcotransporter on the luminal membrane of the distal convulated tubule. Diuretics have been used for many years as an antihypertensive therapy. It reduces the circulatory volume, cardiac output, and mean arterial pressure. This is most effective in patients with mild to moderate hypertension who have normal renal function, and in elderly individuals who tend to be salt-sensitive or volumedependent hypertensive (Lilly et. al., 1997). This literature further supports the significant effect of the twice-a-day intake of 250 ml of bamboo root decoction and the once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure, as majority of the respondents (68.75%) are on the elderly stage of life (See Table 1). Furthermore, as mentioned earlier, the respondents of the study were hypertensive individuals under Stage I Hypertension, diagnosed for the 1st time by a licensed physician, and with no associated comorbidities. However, considerations on the various factors that could have affected the results of the study is definitely essential, and these includes: the study was a preliminary report, and therefore a definite conclusion is not fully attainable and a future research in a larger sample population is recommended; the study was a randomized, cross-over, open clinical trial, and therefore the researcher, the research assistants, and the respondents were not blinded on the preparation and dosage of the bamboo root decoction and the hydrochlorothiazide tablet; the confounders such as the intake of pharmaceutical drugs and bamboo root decoction beyond the scope of the study were minimized by the twice-a-week as well as the after the end of each phase monitoring done by researcher and the daily monitoring done by the research assistants,

however the intervals in between were beyond the control of the researcher; lifestyle modifications such as weight reduction, regular exercise, dietary approaches to stop hypertension (DASH), relaxation therapy, smoking cessation, and alcohol reduction were not part of the interventions, however the possibility of adopting these lifestyle modifications within the period of study, as the respondents are aware of being hypertensive individuals under Stage I Hypertension, were again beyond the control of the researcher; and the twice-a-day intake of 250 ml of bamboo root decoction, as an indigenous practice for the treatment of hypertension, has been claimed to be an effective alternative maintenance medication by the hypertensive individuals in the community, and therefore may have distorted the results as a placebo effect on the respondents of the study. As mentioned earlier, hypertension is the leading attributable risk factor for death and a major contributor to morbidity, mortality, and increasing health care expenditures in the Philippines, as inpatient care and its sequelae is expensive (Wagner et. al., 2008). Therefore, the JNC, 7th Report in 2003 recommends that all individuals with hypertension be treated, and the ultimate public health goal for hypertensive individuals with no associated comorbidities is to maintain blood pressure levels of < 140/90 mmHg, and with particular attention in those > 50 years of age as systolic blood pressure of > 140 mmHg is a more important risk factor for cardiovascular disease. Attainment of this goal is considered clinically important as it is associated with decreased cardiovascular complications. However, the PSH in 2005 estimated that only about 1 in 10 Filipino hypertensive patients are receiving adequate treatment, and given the low socio-economic status of most Filipinos and the high costs of medications

in the country, regular use of antihypertensives are not affordable for many individuals (Wagner et. al., 2008). The economic status of the Philippines affect every region, city, province, and municipality, and in Barangay Veterans Village 54.44% of the households are below poverty threshold (Community Diagnosis, ADZU-SOM, 2006). Again, the nature of the treatment, herbal medicine or conventional medicine, is definitely not as essential as the achievement of the goal, which is to maintain blood pressure levels of < 140/90 mmHg.

CHAPTER IV SUMMARY, CONCLUSION, AND RECOMMENDATIONS

The study was a randomized, cross-over, open clinical trial aimed to compare the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of hypertensive individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. The results of the 8 weeks period of study showed that bamboo root decoction and hydrochlorothiazide tablet had a significant effect on the mean arterial pressure. The effect was statistically significant (p < 0.05) when analyzed utilizing repeatedmeasure ANOVA, and clinically important as evidenced by a decreased on the mean arterial pressure from Stage I Hypertension MAP to Prehypertension MAP. Furthermore, the effect of the bamboo root decoction and the hydrochlorothiazide tablet on the mean arterial pressure, mean change on the mean arterial pressure, and mean change on the mean systolic blood pressure had no significant difference when analyzed utilizing t-test. Therefore, the effect of the twice-a-day intake of 250 ml of bamboo root decoction is comparable to the effect of the once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of the respondents. However, despite the results of study showing a trend towards comparability, the study was a preliminary report, and therefore a definite conclusion is not fully attainable and a future research in a larger sample population is recommended. Furthermore, a future research on the systematic evaluation on the chemical analysis of the primary active component of the bamboo root decoction causing the therapeutically diuretic action is also recommended.

BIBLIOGRAPHY

Alamia, F. V. (2005). The Effect of Twice-A-Day Intake of Chayote Extract among Hypertensive Individuals in Sergio Osmea Sr., Zamboanga del Norte. ADZU-SOM. [http://som.adzu.edu.ph/research/index.php] Aming, S. N. (2006). The Effect of Twice-A-Day Intake of Ginger Tea on the Blood Pressure of Hypertensive Individuals in Barangay La Victoria, Aurora, Zamboanga del Sur. ADZU-SOM. [http://som.adzu.edu.ph/research/index.php] ALLHAT. (2002). Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker versus Diuretic. The Journal of the American Medical Association, Volume 288, Number 23. [http://jama.ama-assn.org/cgi/content/full/288/23/2981] Apion, F. N. et. al. (2006). Community Diagnosis of Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. ADZU-SOM. [unpublished] Beyerl, P. (1984). Bamboo. The Master Book of Herbalism. [http://openlibrary.org /b/OL2571845M/master_book_of_herbalism] Blumenthal, M. et. al. (2000). Taraxacum Officianale, Alternative Medicine Review Monographs, Herbal Medicine: Expanded Commission E Monographs. Thorne Research Incorporated, Newton, MA: Integrative Medicine Communications; 2000:7883. [http://www.thorne.com/media/alternative_medicine_review/monogra phs/Taraxicum_mono.pdf] Brunton Ph.D., L. et. al. (2006). Diuretics. Goodman and Gilmans The Pharmacological Basis of Therapeutics, 11th Edition, Section V, Chapter 28, Pages 737-769. Caluscusin, I. R. (2010). The Effect of Twice-A-Day Intake of Lemon Grass Decoction among Hypertensive Individuals in Barangay Situbo, Municipality of Tampilisan, Province of Zamboanga del Norte. ADZU-SOM. [http://som.adzu.edu.ph /research/index.php] Clare, B. A. et. al. (2009). The Diuretic Effect in Human Subjects of an Extract of Taraxacum Officianale Folium Over a Single Day. Journal of Alternative and Complementary Medicine, PMID: 19678785 [PubMed - indexed for MEDLINE]. [http://www.ncbi.nlm.nih.gov/pubmed/19678785]

Cuevas, C. S. (2009). The Effect of Twice-A-Day Intake of Bamboo Root Decoction among Hypertensive Individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. ADZU-SOM. [http://som.adzu.edu.ph /research/index.php] DJang M.D., A. (2007). Bamboo Silica. LongeVita Scientific Incorporated. [http://www. longevita.com/Detail.asp?ProductID=101] Department of Health. (2006). Hypertension: Morbidity and Mortality. National Center for Disease Prevention and Control, DOH, Philippines. [http://www.doh.gov.ph/] Eleazar, G. (2004). Integrating Traditional and Complementary Medicine in the National Health Care: Current Situation in the Philippines. PITAHC, DOH, Philippines. [www.doh.gov.ph/pitahc] Howland Ph.D., R. et. al. (2006). Diuretic Drugs. Lippincotts Illustrated Reviews, Pharmacology, 3rd Edition, Unit IV, Chapter 22, Pages 257-270. Jiao, J. et. al. (2007). Antihyperlipidemic and Antihypertensive Effect of TriterpenoidRich Extract from Bamboo Shavings and Vasodilator Effect of Friedelin on Phenylephrine-Induced Vasoconstriction in Thoracic Aortas of Rats. Phytotherapy Research, PMID: 17639555 [PubMed - indexed for MEDLINE]. [http://www.ncbi.nlm.nih.gov/pubmed/17639555] Jocano, F. L. (2003). Folk Medicine in a Philippine Municipality. Philippine Medicinal Plants, Philippine Alternative Medicine. [http://www.stuartxchange.com/AltMed Sources.html] JNC, 7th Report. (2003). National High Blood Pressure Education Program. United States Department of Health and Human Services, National Institute of Health, National Heart, Lung, and Blood Institute. [http://www. nhlbi.nih.gov/guidelines/hypertension/jnc7full.pdf] Karasov, W. et. al. (2001). Plant Secondary Compounds as Diuretics: An Overlooked Consequence. The Society for Integrative and Comparative Biology, Oxford Journals, Life Sciences. [http://icb.oxfordjournals.org/cgi/content/full/41/4/890] Kasper M.D., D. et. al. (2005). Hypertensive Vascular Disease. Harrisons Principles of Internal Medicine, 16th Edition, Section 4, Chapter 230, Pages 1463-1481. Laeger, U. (1991). Glitadyl versus Ibuprofen in Patients with Osteoarthrosis, The Results of a Double-Blind, Randomized Cross-Over Study. Journal of Alternative and Complementary Medicine, PMID: 1781051 [PubMed - indexed for MEDLINE]. [http://www.ncbi.nlm.nih.gov/pubmed/1781051]

LeMire, B. (2008). Bamboology: Bamboo Facts. BambooBurger. [http://www.bamboo burger.com] Lilly M.D., L. et. al. (1997). Hypertension. Pathophysiology of Heart Disease, A Collaborative Project of Medical Students and Faculty, 2nd Edition, Chapter 13, Pages 267-288. Myers M.D., M. (1987). Hydrochlorothiazide with or without Amiloride for Hypertenison in the Elderly. Archives of Internal Medicine, PMID: 329697 [PubMed indexed for MEDLINE]. [http://www.ncbi.nlm.nih.gov/pubmed/329697] PNHRS. (2008). Shortlisted Priorities, Updated NUHRA 2008-2020. Philippine National Health Research System. [http://www.healthresearch.ph/priority-areas.html] PSH. (2005). Understanding Hypertension. Lay Information Guide, Philippine Society of Hypertension. [http://www.psh.org.ph/v2/index.php?page=lay-info] Quisumbing Ph.D., E. (1978). Bamboo. Medicinal Plants of the Philippines, Pages 90-91. Ripka, O. (1964). Diuretic Effect of Terpinenol, A Constituent of Juniper Oil. Journal of Alternative and Complementary Medicine, PMID: 14179969 [PubMed - indexed for MEDLINE]. [http://www.ncbi.nlm.nih.gov/pubmed/14179969] Shrivastava M.Pharm. M.B.A., S. et. at. (2007). The Pharmacists Role in Herbal Care. Medscape Today, Medscape Pharmacists. [http://www.medscape.com/ view-article/556464] Stuart M.D., G. (2004). Traditional and Alternative Medicine Act. Philippine Alternative Medicine. [http://www.stuartxchange.org/AltMed.html] Wagner, A. et. al. (2008). Cost of Hospital Care for Hypertension in an Insured Population without an Outpatient Medicines Benefit: An Observational Study in the Philippines. BMC Health Services Research, Volume 8, PMCID: PMC2518143. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2518143/] Zhu, X. et. al. (2008). Chinese Herbal Medicine for Primary Dysmennorhoea. Cochrane Database of Systematic Reviews (2):CD005288, PMID: 18425916 [PubMed - indexed for MEDLINE]. [http://www.ncbi.nlm.nih.gov/pubmed/ 18425916]

APPENDIX A WRITTEN INFORMED CONSENT

I, _________________________, have attended the presentation of the study entitled A PRELIMINARY REPORT ON THE EFFECT OF BAMBOO ROOT DECOCTION VERSUS HYDROCHLOROTHIAZIDE TABLET ON THE MEAN ARTERIAL PRESSURE OF HYPERTENSIVE INDIVIDUALS: A RANDOMIZED, CROSSOVER, OPEN CLINICAL TRIAL on December _____, 2009.

The study is a randomized, cross-over, open clinical trial aimed to compare the effect of twice-a-day intake of 250 ml of bamboo root decoction versus once-a-day intake of 25 mg of hydrochlorothiazide tablet on the mean arterial pressure of hypertensive individuals in Barangay Veterans Village, Municipality of Ipil, Province of Zamboanga Sibugay. The study will be conducted in 4 phases, and each phase will be conducted daily for 2 weeks with a total of 8 weeks period of study (January 4 - February 8, 2010). The researcher will conduct a complete medical history and physical examination of respondents after the end of each phase of the study, to ensure their safety within the period of study. The presence of unexpected unusualities will be further evaluated by the MHO of the Municipality of Ipil and will be given immediate medical intervention. The researcher will adhere to the code of confidentiality of all data pertaining to the respondents, and will respect the right of the respondents to withdraw at any time within the period of study.

The study has been fully explained to my understanding by the researcher, and I am affixing my signature indicative of my commitment to participate as a respondent.

_________________________ Respondent Signature Over Printed Name

_________________________ Witness Signature Over Printed Name

_________________________ Witness Signature Over Printed Name

APPENDIX B SPOT MAPS

MUNICIPALITY OF IPIL, PROVINCE OF ZAMBOANGA SIBUGAY

BARANGAY VETERANS VILLAGE

APPENDIX C RESEARCH SURVEY FORM

Name: ____________________ Address: ____________________ Phase: ____________________

Age/Sex: ____________________ Group: ____________________ Week: ____________________

BP A. M. P. M. MAP mmHg

Mon

Tues

Wed

Thurs

Fri

Sat

Sun

Average

Mon

Tues

Wed

Thurs

Fri

Sat

Sun

Average

Symptoms M.Headache Dizziness Nape Pain L.B.M. F.Urination Thirsty L.O.C. S.Headache B.O.V. Chest Pain Palpitation D.O.B. Weakness Numbness Edematous Tremors Flank Pain P.Urination N.Urination Fever

Mon

Tues

Wed

Thurs

Fri

Sat

Sun

Total

APPENDIX D BAMBOO

Bambusa Blumeana or Kawayan Tinik belongs to the genus Bambusa, family Poaceae, subfamily Bambusoideae, and tribe Bambuseae. It is known as Thorny Branch Bamboo that originated in Southeast Asia. Bambusa Blumeana is a slightly smaller version of Bambusa Arundinacea. It is a medium-sized vigorous bushy bamboo with attractive sprays of very fine leaves, numerous small hooked thorns at lower branches, and produces extraordinary dark purple tinged shoots with prominent bulging leaf blades.

APPENDIX E TREATMENTS

BAMBOO ROOT DECOCTION Materials 5 pieces of 6 inches long bamboo roots (Bambusa Blumeana or Kawayan Tinik) 1 small basin 1 liter of water 1 steel pot 1 ladle 1 strainer 1 pitcher 2 pieces of 250 ml plastic bottles Procedure 1. Thoroughly wash the bamboo roots with water. 2. Soak the bamboo roots in a small basin of water overnight. 3. Manually remove the external stratum of the bamboo roots. 4. Boil 5 pieces of bamboo roots in 1 liter of water for 1 hour. 5. Allow the decoction to cool down by natural process. 6. Strain and pour the decoction into 250 ml plastic bottles.

HYDROCHLOROTHIAZIDE TABLET Generic Name Hydrochlorothiazide (R2=H, R3=H, R6=Cl) Classification Diuretic of the Thiazide Class Preparation 25 mg Tablet Manufacture Date April 2009 Expiration Date April 2011

CURRICULUM VITAE

PERSONAL INFORMATION Name Age Sex Civil Status Date of Birth Address Religion Father Mother : : : : : : : : : Carl Stephen Barretto Cuevas 27 years old Male Single April 23, 1982 May Drive, Porcentro, Guiwan, Zamboanga City Roman Catholic Manuel Gonzales Cuevas Herminia Chua Barretto

EDUCATIONAL BACKGROUND GRADUATE Degree School Place Year of Graduation COLLEGE Degree School Place Year of Graduation HIGH SCHOOL School Place Year of Graduation ELEMENTARY School Place Year of Graduation : : : Immaculate Conception Archdiocesan School M. Natividad Street, Tetuan, Zamboanga City 1995 : : : Immaculate Conception Archdiocesan School C. Atilano Street, Tetuan, Zamboanga City 1999 : : : : Bachelor of Science in Nursing Brent Hospital and Colleges Incorporated R. T. Lim Boulevard, Zamboanga City 2005 : : : : Doctor of Medicine Ateneo de Zamboanga University La Purisima Street, Zamboanga City 2009