A Comparative Randomized Study of Guggulu and Atorvastatin Hypercholesterolemia Patients

 

Ch. Nagabhushanam*1, P Ramesh babu2, NK Durga Devi1,  A Vasu2 and G Devala Rao1

1K.V.S.R Siddhartha College of pharmaceutical sciences, Vijayawada-10

2P.Ramesh babu Citi Cardiac centre,Vijayawada-8.

 

 

ABSTRACT:

Obesity is an important health hazard a known risk factor for several diseases like coronary heart disease (CHD), angina pectoris hypertension, cardiac failure etc... Recent investigations and national cholesterol education program, adult treatment panel-III (NCEP, ATP-III) guidelines stating that the LDL-cholesterol is the primary target of treatment in clinical lipid management. In this manuscript to evaluate the safety and efficacy of Googol and Atorvastatin after excluding patients with exclusion criteria, thirty adult patients were allotted to study the medication. Randomly atorvastatin (20mg) was allotted to fifteen patients and guggulu (250mg) for fifteen patients for six weeks were allotted, before and after the treatment lipoprotein profile estimation was done. Weekly once checked for side effects. Out of thirty patients only twenty five were available for efficacy analysis (14 in guggulu group and 11 in atorvastatin group) the rest were dropouts. There is a satisfactory 7 significant reduction in LDL-cholesterol from the basic line value in atorvastatin group (29.5%) in comparison with guggul group (7%). HDL- cholesterol levels were raised in Atorvastatin group (4%) but there is no change in guggul group etc. By these results we can conclude that Atorvastatin is superior to guggul in lowering LDL-cholesterol and raising HDL-cholesterol.

 

KEY WORDS: Atorvastatin, Guggul, LDL-cholesterol, HDL-cholesterol, triglycerides, patients.

 

INTRODUCTION

The use of complementary and alternative medical practices in recent times is growing rapidly. In this manuscript we review some of the most commonly used, biologically based approaches including herbs, pharmaceutical therapeutics, that are encountered in caring for patients with cardiovascular diseases.

 

Obesity is an important health hazard, a known risk factor for several diseases and emerging as a big problem, coronary heart disease (CHD) is a major cause of morbidity and mortality worldwide(1,2).  Recent investigations and National Cholesterol Education Program, Adult Treatment Panel-III (NCEP, ATP-III) stating that the elevated Low Density Lipoprotein-cholesterol (LDL-C), reduced High Density Lipoprotein- cholesterol (HDL-C) (3). So the primary target of treatment in clinical lipid management was lowering of LDL-C and improvement in HDL-C levels.

 

NCEP, ATP-III suggests the use of statins in cardiovascular diseases(4), these will reduce the LDL-C by inhibiting rate limiting step in cholesterol biosynthesis. Guggulu (Commiphora Wightii) a native of India has been used in Ayurvedic medicine for thousands of years to treat obesity and arthritis(5,6,7,8,9,10,11). Guggulu extracts were first used in Asia to manage cholesterol levels and increasing popular in United States.

 

 

 

S. No

LDL-C

VLDL-C

S.C

Before

After

% change

Before

After

% change

Before

After

% change

1

134

130

3

30

30

0

208

202

3

2

130

124

5

30

30

0

204

200

2

3

131

123

6

30

30

0

202

200

1

4

131

120

8

30

30

0

203

198

2

5

134

118

12

31

30

3

208

201

3

6

139

128

8

33

31

6

206

205

1

7

132

128

3

31

30

3

205

201

2

8

141

132

6

34

31

9

215

208

4

9

148

139

6

38

35

8

225

208

8

10

134

129

4

30

30

0

208

202

3

11

130

123

5

33

30

9

205

200

3

12

132

126

6

30

30

0

203

198

3

13

142

128

10

32

30

6

214

207

4

14

138

122

12

32

30

6

210

200

5

AVG

135

126

7

32

31

3

209

202

4

Table 1 :Lipid profile of Atorvastatin(Group-I) before and after treatment:

 

Table 2 :Lipid profile of Guggulu(Group-II) before and after treatment:

S.

No

LDL-C

HDL-C

S.C

T.G

Before

After

% change

Before

After

% change

Before

After

% change

Before

After

% change

1

132

104

21

47

44

6

210

179

15

150

148

3

2

141

106

25

44

44

0

225

190

16

200

160

20

3

131

103

21

39

42

7

200

175

13

150

150

0

4

133

105

21

42

43

2

221

194

12

230

180

22

5

143

110

23

38

44

16

220

193

12

156

153

2

6

138

110

12

40

44

10

210

186

15

160

152

5

7

141

107

24

40

44

10

216

186

14

175

160

9

8

142

108

24

39

42

8

212

181

15

158

153

3

9

139

112

19

39

42

7

210

186

12

160

151

6

10

130

111

15

45

44

2

205

185

10

154

150

3

11

143

113

21

39

41

5

221

193

13

156

148

5

Avg

138

108

29.5

41

43

4

214

186

13

168

154

8

 

 

MATERIALS AND METHODS:

Materials used:

Lipivas (Atorvastatin-20mg) tablets

Suddha guggulu (Guggulu-250mg) capsules

 

Grouping of patients:

Thirty patients are randomly devided into 2 groups

Group-I (Atorvastatin group)

Group-II (Guggulu group)

 

Each group consists of 15 patients, for these patients study medication was allocated which contained Atorvastatin-20mg or Guggulu-250mgafter a through clinical examination, fasting blood sample was obtained to get a baseline cholesterol levels. A base line routine such as Hb%, CBC, platelet count, and biochemical investigations for renal functions such as blood urea andserum creatinine level, liver function tests such as bilirubin, SGPT and SGOT were estimated for safety evaluation. Patients were examined for every 15 days. All baseline investigations were repeated after 45 days of study course.

 

RESULTS AND DISCUSSION:

Out of the 30 patients only 25 were available for efficacy analysis, 14 in guggulu group and 11 in Atorvastatin group and the rest were dropouts. There was a statistically significant reduction in LDL-C from the baseline value in Atorvastatin group (29.5%) in comparison with guggulu group (7%). HDL-C values are raised in Atorvastatin group 4% and no change in guggulu group. There was a statistically significant reduction in serum cholesterol from baseline value in Atorvastatin group (13%) in comparison with guggulu group (4%), the levels of VLDL-C (3%) in guggulu group and no change in Atorvastatin group.

 

This study was specifically designed to compare the safety and efficacy of guggulu against Atorvastatin. Across the dose ranges, Atorvastatin 20 mg and Guggulu 250 mg were selected for this study. Atorvastatin was selected due to its high safety and efficacy when compared with other statins like simvastatin, pravastatin, lovastatin, fluvastatin. NCEP, ATP-III suggested that the use of lower doses in initial stages of treatment for the hyperlipidemics gives better results basing on that we selected the dose of Atorvastatin 20mg for the study.  Studies like “Hyperlipidemic and Antioxidant effects of Commiphora Wightii as an adjunct to dietary therapy in patients with hypercholesterolemia’’ done by sing RB, Niaz MN et al. “Guggululipid for the treatment of hypercholesterolemia randomized controlled trial” done by Szapary PO, Wolfe ML, Bleodon LT et al. shown guggulu 250mg dose  was effective in hypercholesterolemia patients. Graphical representation of effect of Atorvastatin and Guggulu were shown in (figure 1). Lipid profile of Atorvastatin(Group-I) and Guggulu  (Group-II) before and after treatment were given in the Tables 1and2.The best profiles of the same were given in the Tables 3and4 respectively.

 

Table 3: GROUP-I (Atorvastatin group)

 

S.

NO

PARAMETER

BEFORE

AFTER

% CHANGE

1

SERUM

CHOLESTEROL

214

186

13

2

LDL-C

138

108

29.5

3

HDL-C

41

43

4

4

SERUM

TRIGLYCERIDES

168

154

8

 

Table 4: GROUP-II (Guggulu group)

S.

NO

PARAMETER

BEFORE

AFTER

% CHANGE

1

SERUM

CHOLESTEROL

209

202

4

2

LDL-C

135

126

7

3

VLDL-C

32

31

3

 

 

Figure 1:Graphical representation of effect of Atorvastatin and Guggulu

 

Reports produced by the Guggulu group were not matching with previous researches. May be this is due to small population and small duration of study.

 

CONCLUSION:

Atorvastatin is superior to Guggulu in lowering LDL-C and raising HDL-C, but it is better to use guggulu in patients having liver disease or hypersensitive to statins.

 

REFERENCES:

1.       National task force on the prevention and treatment of obesity. Very low calorie diets JAMA 1993; 270: 967-974.

2.       Ayurvedic and collateral herbal treatments for hyperlipidemia : a systemic review of  randomized controllrd trials and quassi – experimental designs.

3.       The expert panes summary of the National Cholesterol Education Program (NCEP) Adult Treatment Panel-III guidelines.

4.       Complementary and alternative medicine in cardiovascular disease: a review of biologically based approaches. American heart journal. 147(3):401-411 mar: 2004 Miller, Kelly L M D: Liebowitz, Richard.S.

5.       Jellin JM, Gregory PJ, batz fetal, guggulu therapeutic research faculty. Natural medicines comprehensive  database www.naturaldatabase.com (accessed 2004 jun’24)

6.       Der Marde rosian A, Beutler JA, Eds, facts companions: the review of natural products St. Louis wolters kluwer: 2004.

7.       GUGULIPID: a natural cholesterol – lowering agent. Urizar NL, Moore DD. Department of molecular cellular biology, Baylor college of medicine, Houstan, Texas

8.       The hypolipidemic natural product Commiphora Mukul and its component guggulsterone inhibit oxidative modification of LDL. Wang X, Greiberger J, Ledinski G, Kager G, Paigen B, Jerjens G. the Jackson laboratory, Bar Harbor ME04609, USA.

9.       Hyperlipidimic and antioxidant effects of commiphora mukul as an adjunct to dietary therapy in patients with hypercholesterolemia. Singh RB,Niaz MA, Ghosh S. heart Research Laboratory, medical hospital and research center, Moradabad, India.

10.     Guggul for hyperlipidemia: a review by the natural Standard Research collaboration.  Ulbricht C, Basch E, Szapary P, Hammerness P, Axentsev V, Boon H, Kroll D. Massachusetts general hospital,USA.

11.     Effect of commiphora mukul in patients of hyperlipidemia with special reference to HDL-C. verma SK< Bordia A.

 

 

Received on 01.02.2010

Accepted on 18.03.2010     

© A&V Publication all right reserved

Research J. Pharmacology and Pharmacodynamics 2(2): March –April 2010: 188-189