The Effectiveness of Psidium guajava Leaf Tea as an Adjunct Treatment to

Simvastatin in Lowering the Total Cholesterol Level of Hyperlipidemic Patients in Selected Barangays of

San Juan City: A Clinical Trial

Fudotan, Yuki Kenneth Ellison B.| Gabon, Danica Nicole S.| Galang, Sophia Ma. Roxanne A.| Gamboa, Domina Flor L.| Ganal, Dominiel Denver L.| Acbang, Jeanine D.| Acebedo, Mark Gerard P.| Espiritu Santo, Klarisse C.| Estillore, Breena Reubee T.| Fernandez, Justine

Joy D.

CARDIOVASCULAR DISEASE

• Remains to be one of the leading causes of death in the Philippines

• FNRI reported on the 7th NNS (2008)– Mean total cholesterol of participants was 186.8

mg/dL• 68.6% having the desirable level of <200 mg/Dl• 21.2% classified as borderline high having 200-239

mg/dL• 10.2% classified as having high cholesterol levels of

>240 mg/dL

Psidium guajava

• Guava leaf tea might be effective in reducing the total cholesterol among hyperlipidemic patients. Previous researchers (Rahmat et al, 2006; Deguchi & Miyazaki, 2010; Barbalho et al 2012; Oriaifo et al 2014) have noted the beneficial effect of guava leaf tea on parameters of hypercholesterolemia of human subjects due to its phytochemical properties.

OBJECTIVES OF THE STUDY

• To determine the effect of drinking guava leaf tea on the total cholesterol levels of hyperlipidemic patients

• To determine whether the guava leaf tea has the potential to be an adjunct treatment in patients who are taking statins

HYPOTHESIS

• There is a significant decrease in the total cholesterol level observed among the selected hyperlipidemic patients who are taking statin drugs after drinking guava leaf tea for a period of 28 days.

• Ingestion of guava leaf tea will have no side effects on hyperlipidemic patients who are taking statin drugs after drinking guava leaf tea for a period of 28 days.

METHODOLOGY

METHODOLOGYPreparation of Guava Leaf Tea and the Placebo

• Fresh guava leaves were washed and dried under the sun for three days until the leaves were brittle and brown

• Guava Leaf Tea/Infusion was prepared by boiling 40g of guava leaves per 100ml of purified water

• 500 mL of the infusion (good for 5 days) are transferred into a 500ml bottle

METHODOLOGYPreparation of Guava Leaf Tea and the Placebo

• For the control group, an artificial food coloring was mixed with purified water until the color matched with that of the treatment

• Preservation was instructed for both the treatment and control group: One bottle for 5 days, to be refrigerated not frozen, would be given and resupplied every week until the experiment period was over.

METHODOLOGY

Study Subjects

• Residents of different barangays in San Juan City with ages 20 to ≥ 70 years old selected by fishbowl technique

• Patients diagnosed with hyperlipidemia and are currently taking statins

Study Subjects

• Previous study by Deguchi and Miyazaki (2010) showed that the standard deviation in the total cholesterol level is 20 mg/dL.

• Thus, N = [[(zα)2 *2* (s)2]/ (d)2 ]*2Where: zα = confidence level = 95% = 1.96s = standard deviation = 20d = difference to be detected = 15 N = (1.96)^2*2* (20)^2/(15)^2 = 14 = 14 * 2= 28 participants

*.20 for dropouts= 34 participants

METHODOLOGY

Study Subjects

• Residents of different barangays in San Juan City with ages 20 to ≥ 70 years old selected by fishbowl technique

• Patients diagnosed with hyperlipidemia and are currently taking statins

Study Subjects• 34 residents of different barangays in San

Juan City with ages 20 to ≥ 70 years old • Patients diagnosed with hyperlipidemia and

are currently taking statins

• Those who satisfied the inclusion-exlusion criteria were included in the study

METHODOLOGY

Study Design

METHODOLOGY

Study Subjects

• Residents of different barangays in San Juan City with ages 20 to ≥ 70 years old selected by fishbowl technique

• Patients diagnosed with hyperlipidemia and are currently taking statins

Blood Sample Collection and Analysis

• Blood samples were collected by 6 RMTS from the participants following overnight fasting of at least 10 hours (10-12 hours)

• The collected blood samples were stored in tubes treated with Tris-EDTA buffer to prevent coagulation of the blood

• The blood samples were subjected to centrifugation at UERM Hospital Central Lab

• Extracted serum were then brought to Global Health Diagnostics in Diliman, Quezon City to be analyzed.

METHODOLOGYStatistical Analysis

• Independent t-test was used to analyze the significant difference between mean values of total cholesterol level in the control group and treatment group

• Paired t-test was used to analyze the significant

difference in the mean total cholesterol levels both in the control and treatment groups before and after the treatment phase. Statistical Package for Social Sciences (SPSS) version 19.0 was used.

RESULTS AND DISCUSSION

Table 1. Demographic characteristics of hyperlipidemic patients in selected barangays of San Juan City, Manila.

Parameter Control Group (n=14)

Mean+/- SD

Treatment Group (n=14)

Mean +/- SD

p-value

Age 58.36 +/- 10 58.50 +/- 8 0.968

Height (cm) 163.57 +/- 7 154.79 +/- 10

0.11

Weight (kg) 62.21 +/- 11 63.64 +/- 10 0.718

BMI (kg/m2) 23.17 +/- 3 27.92 +/- 6 0.56

Table 2. Comparison of total cholesterol levels between control and treatment group during the baseline phase and treatment phase

(Mean +/- SD).

Total Cholesterol

Control Group

Treatment Group

p-value

Baseline phase

(mol/L)

4.60 +/- 0.85

5.12 +/- 0.95

0.134

Treatment phase

(mol/L)

3.95 +/- 0.63

4.28 +/- 0.69

0.187

• There is no significant decrease in the TCL among hyperlipidemic patients after the administration of 0.4g/mL of Psidium guajava leaf tea within 4-week period.

Table 3. Comparison of the mean decrease in TCL level via paired t-test within the control and treatment groups.

Control Group

p-value(paired t-test)

Treatment Group

p-value(paired t-test)

Mean decrease in TCL level

after treatment phase (mol/L)

0.65 +/- 0.22

0.0120.84 +/-

0.260.002

% Decrease in the Total

Cholesterol Level after the

treatment phase

14.13

16.41

• There is a significant decrease in comparing the results of the baseline and treatment phases of both control and treatment group at p=0.012 and p=0.002 respectively.

Comparison in the % decrease in TCL in the control and treatment groups after the treatment phase

• A study conducted by Ojezele and Agunbiade on the phytochemical constituents of Psidium guajava leaf extract reveals high concentrations of bioactive substances like tannin, polyphenol, saponin and alkaloid.

• These bioactive substances may be responsible to the trend seen in the reduction of total cholesterol among hyperlipidemic patients included in the study.

• The sample size met the number of required subjects of 28 wherein dropout rate is considered (original sample size was 34), thus, it excludes in explaining the null effect of guava leaf tea in significantly decreasing TCL when use as an adjunct to statin drugs.

CONCLUSION

• Psidium guajava leaf tea is not effective as an adjunct treatment to Simvastatin in lowering the total cholesterol level of hyperlipidemic patients at a concentration of 0.4g/mL within a 4-week period.

• Constipation was reported by one of the respondents of treatment group after ingestion of guava leaf tea on Day 2; however, larger trials are still needed to confirm the correlation.

THANK YOU!!!

The Effectiveness of Psidium guajava Leaf Tea as an Adjunct Treatment to

Simvastatin in Lowering the Total Cholesterol Level of Hyperlipidemic Patients in Selected Barangays of

San Juan City: A Clinical Trial

Fudotan, Yuki Kenneth Ellison B.| Gabon, Danica Nicole S.| Galang, Sophia Ma. Roxanne A.| Gamboa, Domina Flor L.| Ganal, Dominiel Denver L.| Acbang, Jeanine D.| Acebedo, Mark Gerard P.| Espiritu Santo, Klarisse C.| Estillore, Breena Reubee T.| Fernandez, Justine

Joy D.