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Chinese herbal medicines for hypertriglyceridaemia

  1. Zhao Lan Liu1,2,
  2. George Q Li2,
  3. Alan Bensoussan3,
  4. Hosen Kiat4,
  5. Kelvin Chan2,3,
  6. Jian Ping Liu1,*

Editorial Group: Cochrane Metabolic and Endocrine Disorders Group

Published Online: 6 JUN 2013

Assessed as up-to-date: 11 MAY 2012

DOI: 10.1002/14651858.CD009560.pub2


How to Cite

Liu ZL, Li GQ, Bensoussan A, Kiat H, Chan K, Liu JP. Chinese herbal medicines for hypertriglyceridaemia. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD009560. DOI: 10.1002/14651858.CD009560.pub2.

Author Information

  1. 1

    Beijing University of Chinese Medicine, Centre for Evidence-Based Chinese Medicine, Beijing, China

  2. 2

    University of Sydney, Faculty of Pharmacy, Sydney, Australia

  3. 3

    University of Western Sydney, CompleMED, School of Science & Health, Sydney, NSW, Australia

  4. 4

    Cardiac Health Institute, The Australian School of Advanced Medicine, Macquarie University, Sydney, NSW, Australia

*Jian Ping Liu, Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, 11 Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China. jianping_l@hotmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 6 JUN 2013

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Characteristics of included studies [ordered by study ID]
Liu 2008

MethodsParallel randomised controlled clinical trial

Comparative study design (2-sided confidence interval)

Randomisation ratio: 1:1


ParticipantsInclusion criteria: primary hyperuricaemia, blood uric acid concentration > 420 mmol/L (male), > 360 mmol/L (female); TG > 117 mmol/L; age: 18 - 75 years old; participants without using uric acid-lowering drugs

Exclusion criteria: acute gout episode patients; secondary hyperuricaemia patients; patients with severe primary co-morbidities on heart, liver, renal and blood systems and mental disorders

Diagnostic criteria: not mentioned in the original article


InterventionsNumber of study centres: 1

Treatment before study: not mentioned in the original article

Titration period: 4 weeks


OutcomesOutcomes reported in abstract of publication: blood uric acid, TG


Study detailsRun-in period: not mentioned in the original article

Study terminated before regular end: no


Publication detailsLanguage of publication: Chinese

Unclear funding

Publication status: peer review journal


Stated aim of studyQuote: "To investigate the clinical effectiveness and safety of Zhusuanhuoxue decoction on the patients suffered from primary hyperuricaemia combined with hypertriglyceridaemia."


NotesTG: triglycerides


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generationLow riskQuote: "Random number table was used to distribute the 60 participants to two groups"

Allocation concealmentUnclear riskComment: no detailed information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: no detailed information

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: no detailed information

Incomplete outcome data addressed
All outcomes
Low riskComment: no missing data

Free of selective reportingLow riskComment: all the prespecified outcomes in the methods section of the article were reported in the results section

Free of other biasUnclear riskComment: no information on the basic characteristics of the two groups of participants and no information on funding

Miao 2008

MethodsParallel randomised controlled clinical trial

Comparative study design (2-sided confidence interval)

Randomisation ratio: 1:1


ParticipantsInclusion criteria: not specified

Exclusion criteria: participants with severe liver or kidney diseases or hypothyroidism or drug-induced liver injury, or familial dyslipidaemia and those refused to comply with the trial

Diagnostic criteria: TG ≥ 2.26 mmol/L, FBG < 7mmol/L, PBG < 10mmol/L; TCM differentiation: vein blood stasis syndrome


InterventionsNumber of study centres: 1

Treatment before study: not mentioned in the original article

Titration period: 6 weeks


OutcomesOutcomes reported in abstract of publication: TG


Study detailsRun-in period: not mentioned in the original article

Study terminated before regular end: no


Publication detailsLanguage of publication: Chinese

Unclear funding

Publication status: peer review journal


Stated aim of studyQuote: "To investigate the clinical effectiveness and safety of Chinese integrative medicine on patients suffering from hypertriglyceridaemia with type 2 diabetes"


NotesFBG: fasting blood glucose; PBG: plasma blood glucose; TCM: traditional Chinese medicine; TG: triglycerides


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generationLow riskQuote: "Random number table was used to distribute the 60 participants to two groups"

Allocation concealmentUnclear riskComment: no detailed information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: no detailed information

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: no detailed information

Incomplete outcome data addressed
All outcomes
Low riskComment: no missing data

Free of selective reportingHigh riskComment: adverse effects were reported in the results section but were not prespecified in the methods section of the article

Free of other biasUnclear riskComment: no information on the basic characteristics of the two group participants and no information on funding

Tan 2010

MethodsParallel randomised controlled clinical trial

Comparative study design (2-sided confidence interval)

Randomisation ratio: 3:2


ParticipantsInclusion criteria: not mentioned in the original article

Exclusion criteria: secondary hyperuricaemia; active stage of gouty arthritis; patients with severe primary co-morbidities on heart, liver, renal and blood systems and mental disorders; age less than 18 years old; pregnant or breast feeding period; allergic condition or allergic to the tested medicine; do not meet the inclusion criteria; do not comply the trial or data missing; illegible TCM differentiation.

Diagnostic criteria: TG > 1.7 mmol/L; SUA > 440 mmol/L with acute gouty arthritis attack at least twice a year or SUA > 535 mmol/L without symptoms; TCM differentiation: damp and hot clip stasis.


InterventionsNumber of study centres: 1

Treatment before study: not mentioned in the original article

Titration period: 30 days


OutcomesOutcomes reported in abstract of publication: blood triglycerides, SUA and symptoms


Study detailsRun-in period: not mentioned in the original article

Study terminated before regular end: no


Publication detailsLanguage of publication: Chinese

No commercial funding

Publication status: peer review journal


Stated aim of studyQuote: "To observe the clinical effects of Chushihuayu decoction on the level of serum uric acid and triglycerides in patients with hyperuricaemia and hypertriglyceridaemia"


NotesSUA: serum uric Acid; TCM: traditional Chinese medicine; TG: triglycerides


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generationLow riskQuote: "Random number table was used to distribute the 60 participants to two groups"

Allocation concealmentUnclear riskComment: no detailed information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: no detailed information

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: no detailed information

Incomplete outcome data addressed
All outcomes
Low riskComment: no missing data

Free of selective reportingLow riskComment: all the prespecified outcome in the methods section of the article were reported in the results section

Free of other biasLow riskComment: the basic characteristics of the two group participants were comparable and no commercial funding; other risk of bias features not detected

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Cui 2005Claimed randomised clinical study without elaboration of the methods of random sequence generation. The intervention and the control group both used Chinese herbal medicines and the intervention group did not meet the inclusion criteria of this review.

Feng 2004Claimed randomised clinical study without elaboration of the methods of random sequence generation. The participants included hypercholesterolaemic and hypertriglyceridaemic patients and did not meet the inclusion criteria.

Li 2010Claimed randomised clinical study without elaboration of the methods of random sequence generation. The participants included hypercholesterolaemic and hypertriglyceridaemic patients and did not meet the inclusion criteria.

Lin 1999Claimed randomised clinical study without elaboration of the methods of random sequence generation. The participants included hypercholesterolaemic and hypertriglyceridaemic patients and did not meet the inclusion criteria.

Liu 2006Claimed randomised clinical study without elaboration of the methods of random sequence generation. The participants included hypercholesterolaemic and hypertriglyceridaemic patients and did not meet the inclusion criteria.

Lv 2005Claimed randomised clinical study without elaboration of the methods of random sequence generation. The participants included hypercholesterolaemic and hypertriglyceridaemic patients and did not meet the inclusion criteria.

Yang 2009Claimed randomised clinical study without elaboration of the methods of random sequence generation.

 
Comparison 1. Chushi Huayu decoction versus benzbromarone

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Serum triglycerides1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Adverse effects (total)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Adverse effects (gastrointestinal)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 4 Adverse effects (renal colic)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 5 Adverse effect (acute arthritis)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 2. Huoxue Huayu Tongluo decoction plus gemfibrozil versus gemfibrozil

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Serum triglycerides1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Number of patients with triglycerides ≥ 2.2 mmol/L1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Adverse effects (stomachache)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 3. Zhusuan Huoxue decoction plus lifestyle intervention versus fenofibrate capsules plus lifestyle intervention

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Serum triglycerides1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Adverse effect (elevated ALT)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Summary of findings for the main comparison. Chinese herbal medicines for hypertriglyceridaemia

Traditional Chinese herbal medicines compared with western medicine for hypertriglyceridaemia

Patient or population: participants with hypertriglyceridaemia
Settings: not always specified
Intervention: traditional Chinese herbal medicines

Comparison: benzbromarone, gemfibrozil, fenofibrate

OutcomesNo of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Death from any causeSee commentSee commentNot investigated

Cardiovascular or cerebrovascular eventsSee commentSee commentNot investigated

Adverse events

[follow-up: 4 to 6 weeks]
See commentSee commentNo serious adverse events were reported in the three included studies

Health-related quality of lifeSee commentSee commentNot investigated

CostsSee commentSee commentNot investigated

Serum triglyceride concentrations (mmol/L)

[follow-up: 4 to 6 weeks]

a. Zhusuan Huoxue decoction + lifestyle intervention vs fenofibrate + lifestyle intervention

b. Huoxue Huayu Tongluo decoction plus gemfibrozil vs gemfibrozil

c. Chushi Huayu decoction vs benzbromarone
a. 60 (1)

b. 60 (1)

c. 60 (1)
⊕⊝⊝⊝
very lowa
a. Statistically significant higher triglyceride levels after Zhusuan Huoxue decoction

b. No statistically significant differences

c. Statistically significant lower triglyceride levels after Chushi Huayu decoction

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 aDue to very serious indirectness, low number of studies and patients, and inconsistency of results
 
Table 1. Overview of study populations

Characteristic

Study ID
Intervention(s) and comparator(s)[N] screened / eligible[N] randomised[N] safety[N] ITT[N] finishing study[%] of randomised participants
finishing study

Liu 2008Zhusuan Huoxue decoction plus lifestyle intervention-30303030100

Fenofibratea30303030100

total:60606060100

Miao 2008Huoxue Huayu Tongluo decoction plus gemfibrozil-30303030100

Gemfibrozilb30303030100

total:60606060100

Tan 2010Chushi Huayu decoction-30303030100

Benzbromaronec20202020100

total:50505050100

Total All interventions 9090

All comparators 8080

All interventions and comparators 170170

 "-" denotes not reported
aFenofibrate: a cholesterol-lowering drug belonging to the fibric acid derivatives group
bGemfibrozil: a triglycerides-lowering drug belonging to the fibric acid derivatives group
cBenzbromarone: a potent uricosuric agent for treatment of gout introduced in the 1970 but also used as a triglycerides lowering drug
ITT: intention-to-treat
 
Table 2. Chinese herbal medicines and their ingredients

Study IDChinese formulaBotanical name of ingredient

Liu 2008Zhusuan Huoxue decoction

 
Astragalus membranaceous,Poria cocos,Alisma plantago-aquatica, Plantago asiatica, Rheum palmatum, Eucommia ulmoides, Codonopsis pilosula,Panax notoginseng, Carthamus tinctorius, Saliva miltiorrhiza, Imperata cylindrica. 

Miao 2008Huoxue Huayu Tongluo decoction

 
Saliva miltiorrhiza, Carthamus tinctorius, Angelica sinensis, Ligusticum chuanxiong, Paeonia lactiflora, Rehmannia glutinosa, Astragalus membranaceous.

Additional herbs for hypertension: Gastrodia elata, Uncaria macrophylla.

Additional herbs for coronary heart disease:  Curcuma aromatica, Citrus aurantium. 

Additional herbs for peripheral neuropathy: Lonicera japonica, Trachelospermum jasminoides

Additional herbs for retinopathy: Lycium barbarum, Chrysanthemum morifolium.  

Additional herbs for nephropathy: Rehmannia glutinosa, Cornus officinalis.

Tan 2010Chushi Huayu decoctionSmilax glabra, Dioscorea hypoglauca, Coix lacryma-jobi var. ma-yuen, Leonurus heterophylus,  Lysimachia christinae, Plantago asiatica, Saliva miltiorrhiza, Astragalus membranaceous,Rheum palmatum, Glycyrrhiza uralensis.