Ginkgo biloba for intermittent claudication

Saskia PA Nicolaï; Lotte M Kruidenier; Bianca LW Bendermacher; Martin H Prins; Rutger A Stokmans; Pieter PHL Broos; Joep AW Teijink

doi:10.1002/14651858.CD006888.pub3

银杏叶提取物治疗间歇性跛行

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Referencias

References to studies included in this review

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Bauer U. 6‐Month double‐blind randomised clinical trial of Ginkgo biloba extract versus placebo in two parallel groups in patients suffering from peripheral arterial insufficiency. Arzneimittelforschung 1984;34(6):716‐20.

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References to studies excluded from this review

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Additional references

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References to other published versions of this review

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estudios excluidos
otras referencias

Nicolaï SP, Kruidenier LM, Bendermacher BL, Prins MH, Teijink JA. Ginkgo biloba for intermittent claudication. Cochrane Database of Systematic Reviews 2009, Issue 2. [DOI: 10.1002/14651858.CD006888.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos

Bauer 1984

Methods	Study design: double blind randomised clinical trial. Method of randomisation: divided at random.
Participants	Country: Germany. Setting: outpatient setting. Number randomised: 79 (treatment group: 44, control group: 35). Age: mean 60.9 years. Sex: 61 males and 18 females. Inclusion criteria: patients with PAD (stage IIb according to Fontaine), predominantly on one site, lasting > 1 year; ACD less than or equal to 300 metres. Exclusion criteria: Unco‐operative patients; patients with other vaso‐active medication; other stage of Fontaine’s classification; concomitant illness: pathology of the veins; anaemia; non compensated cardiac insufficiency; recent myocardial infarction; uncontrolled hypertension; other causes of walking impairment; poorly controlled diabetes; important kidney or hepatic insufficiency; recent treatment with anticoagulant drugs.
Interventions	Treatment: 40 mg GbE three times daily. (Coated tablets containing 40 mg GbE. Manufacturer: Intersan, Institut für pharmazeutische und Klinische Forschung GmbH, Ettlingen, Germany) Control: placebo. Duration: 24 weeks.
Outcomes	Walking distance: ACD and ICD by treadmill testing (3 km/h and 10% incline); subjective estimate of pain by a VAS; plethysmography; systolic ankle pressures at rest and after exercise; tolerance.
Notes	In three other articles the clinical course is described of the treatment group after 1 year (Bauer 1986a), 2 years (Bauer 1986b) and 3 years (Bauer 1986c). However, the control group is not mentioned. Funding: not stated
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Patients were divided at random into 2 equal groups.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	The placebo group received matching placebo tablets which were taken in the same manner.

Blume 1996

Methods	Study design: double blind randomised clinical trial. Method of randomisation: EPD number generator.
Participants	Country: Germany. Setting: ambulant patient seeking consultation at a angiological practice. Number randomised: 60 (treatment group: 30, control group: 30). Age: aged between 47 and 82, median treatment group 71 (95% CI 65.2 to 74.8), median control group 68.6 (95% CI 65.5 to 73.2). Sex: 42 males and 18 females. Inclusion criteria: patients with PAD (stage IIb according to Fontaine) angiographically confirmed; stable walking distance in spite of constant walking training; ICD less than 150 metres. Exclusion criteria: age < 18 years; cardiac infarction during the preceding 6 months; NYHA stage III or IV cardiac insufficiency; diastolic pressure > 120 mmHg; renal insufficiency; functional hepatic disorders; respiratory insufficiency or orthopaedic disorder as limiting factor of the walking distance; venous insufficiency stage II (Basle Classification; badly manageable diabetes mellitus; anaemia; hematocrit > 48%; fibrinogen > 500 mg/dl; use of platelet aggregation inhibitor; anti‐inflammatory agents or analgesics; pregnancy or expected insufficient compliance.
Interventions	Treatment: 40 mg Ginkgo biloba special extract GbE 761 three times daily. (40 mg film‐coated tablet containing dry extract from Ginkgo biloba leaves (50:1) 40 mg, adjusted at 9.6 mg Ginkgo flavone glycosides and 2.4 mg terpene lactones (ginkgolides, bilobalide). Manufacturer: Dr. Wilmar Schwabe Arzneimittel / Pharmaceuticals, Karlsruhe, Germany). Control: placebo. Duration: 24 weeks.
Outcomes	Walking distance: ACD and ICD by treadmill testing (3 km/h and 12% incline); ABI; subjective estimate of pain by a VAS; adverse drug reactions.
Notes	Maximum level trained patients with IC. Funding: not stated. Conflicts of interests: One of the authors is employed by one of the manufacturers Dr. Willmar Schwabe, Karlsruhe, Germany.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomly assigned using an EPD random number generator was used for allocation.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Low risk	There was an externally indistinguishable placebo and neither the patient nor the examiner or any other person directly involved in the study was able to see which group a patient belonged to.

Blume 1998

Methods	Study design: double blind randomised clinical trial. Method of randomisation: not stated.
Participants	Country: Germany. Setting: not stated. Number randomised: 41 (treatment group 21, control group 20). Age: mean treatment group 66.4, mean control group 68.2. Sex: treatment group 14 males and 7 females, control group 15 males and 4 females. Inclusion criteria: patients with PAD (stage IIb according to Fontaine) angiographically confirmed. PAD > 6 months present. Exclusion criteria: not stated.
Interventions	Treatment: 80 mg Ginkgo biloba special extract EgB 761 two times daily. (80 mg film‐coated tablet containing dry extract from Ginkgo biloba leaves (35‐67:1) 80 mg, standardised at 19.2 mg Ginkgo flavone glycosides and 4.8 mg terpene lactones (ginkgolides, bilobalide). Manufacturer: Dr. Wilmar Schwabe Arzneimittel / Pharmaceuticals, Karlsruhe, Germany). Control: placebo. Duration: 24 weeks.
Outcomes	Walking distance: ACD and ICD by treadmill testing (3 km/h and 12% incline); tolerance of Ginkgo biloba special extract EgB 761.
Notes	Funding: not stated. Conflicts of interests: One of the authors is employed by one of the manufacturers Dr. Willmar Schwabe, Karlsruhe, Germany.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information
Allocation concealment (selection bias)	Unclear risk	Insufficient information
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Insufficient information

Bulling 1991

Methods	Study design: double blind randomised clinical trial. Method of randomisation: not stated.
Participants	Country: Germany. Setting: outpatient setting. Number randomised: 36, 33 were evaluated, treatment group 17, control group 16. Age: mean treatment group 62.8, mean control group 63.3. Sex: treatment group; 12 males and 5 females, control group; 12 males and 4 females. Inclusion criteria: patients with PAD (stage IIb according to Fontaine); ICD at least 50 metres and at most 200 metres. Exclusion criteria: venous complaints; anaemia; decompensated cardiac insufficiency; unstable angina pectoris; coronary heart disease; respiratory insufficiency; non‐controlled hypertension; recent myocardial infarction; badly adjustable diabetes; disease of liver and kidneys; orthopaedic reason for walking restriction.
Interventions	Treatment: standardised Ginkgo biloba extract 761. (The drug extract ratio is 50:1, the standardised content of flavone glycosides is 24% (9.6 mg/40 mg extract), and that of terpene lactones 6% (2.4 mg/40 mg extract) Rökan®) Control: placebo. Duration: 24 weeks.
Outcomes	Walking distance: ACD and ICD by treadmill testing (3 km/h and 10% incline); number of "tip‐toe" stands; systolic ankle pressure in the posterior tibial artery; plasma viscosity and haematocrit; adverse reactions.
Notes	All patients received exercise therapy in combination with participation in this trial. Funding: not stated.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	The placebo tablets had an identical appearance.

Diehm 1990

Methods	Study design: double blind randomised clinical trial. Method of randomisation: computerised randomisation program.
Participants	Country: Germany. Setting: not stated. Number randomised: 40, treatment group 22, control group 18. Age: mean treatment group 62.2, mean control group 63.0. Sex: treatment group; 21 males and 1 female, control group; 17 males and 1 female. Inclusion criteria: Patients with PAD (stage IIb according to Fontaine); ICD of 50 to 200 m; age between 40 and 75 years; precisely reproducible pain localization under exercise; pressure in posterior tibial artery > 50 mmHg; ABI < 0.85; Broca deviation < 30 %; abstinence from nicotine. Exclusion criteria: myocardial infarction within half a year before enrolment; heart failure NYHA III or IV; severe chronic venous insufficiency; insufficiently controllable diabetes mellitus; malabsorption; liver disorder: transaminase levels above 3 times the upper limit of the normal range; renal disorder: serum creatinin level above 3.0 mg/dl; gait impairment due to orthopaedic or neurological diseases; respiratory insufficiency limiting walking distance; angina pectoris limiting walking distance; uncontrolled hypertension.
Interventions	Treatment: 120 mg Ginkgo biloba special extract EgB 761 daily. Control: placebo. Duration: 12 weeks.
Outcomes	Walking distance: ACD and ICD by treadmill testing (5 km/h and 10% incline); adverse reactions.
Notes	Conflicts of interests: Internal rapport of Dr. Wilmar Schwabe Arzneimittel/Pharmaceuticals, Karlsruhe, Germany.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomised with a computerised randomisation program.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Tablets of identical appearance, packed and labelled in identical way.

Drabaek 1996

Methods	Study design: double blind randomised cross‐over study. Method of randomisation: not stated.
Participants	Country: Denmark. Setting: Not stated. Number randomised: 18. Age: 59 to 82 years (median age 74). Sex: not stated. Inclusion criteria: Stable form of IC more than 6 months; ACD 50 to 500 metres; ABI < 0.85. Exclusion criteria: Chronic obstructive pulmonary disease; diabetes mellitus; artrosis; angina pectoris; cardiac insufficiency.
Interventions	Treatment: 120 mg GbE GB 8 daily. Control: placebo. Duration:6 months, 3 months treatment and 3 months placebo.
Outcomes	Walking distance: ACD and ICD by treadmill testing (individual speed (2.5 to 4 km/h) and incline (8 to 16% incline); ABI; subjective estimate of pain by a VAS; cognitive functions: concentration and short term memory.
Notes	Only the first study period (3 months) before the cross‐over is considered. Funding: not stated.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Insufficient information.

Gardner 2008

Methods	Study design: double blind randomised clinical trial. Method of randomisation: computerised randomisation program.
Participants	Country: USA. Setting: patients recruited from the local community through advertisement. Number randomised: 62, treatment group 31, control group 31. Age: mean treatment group 69, mean control group 70. Sex: treatment group 13 males and 18 females, control group 24 males and 7 females. Inclusion criteria: Patients with a resting ABI < 0.90; ACD between 1 and 10 minutes; drop in ABI after exercise of at least 25%. (For diabetics all ABI values were allowed). Exclusion criteria: major surgery; chronic disease in the last three months; use of pentoxifylline, carnitine, arginine, prostacycline, dietary antioxidant supplements, supplements containing Ginkgo biloba.
Interventions	Treatment: 300 mg standardised Ginkgo biloba extract 761 daily (180 mg with breakfast and 120 mg with dinner). (60 mg tablet standardised at 24% Ginkgo flavone glycosides and 6% terpene lactones. Manufacturer: Dr. Wilmar Schwabe Arzneimittel/Pharmaceuticals, Karlsruhe, Germany). Control: placebo. Duration: 4 months.
Outcomes	ABI; walking distance: ACD and ICD by treadmill testing (3.2 km/h and 10% incline); flow‐mediated vasodilatation of the brachial artery; antibodies to epitopes of oxidized LDL; walking impairment questionnaire; QoL: MOS SF‐36 questionnaire.
Notes	Funding: NIH grant R01 AT002004.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was performed by generating random numbers assigned to treatment and control and assigning each new participant the next number in sequence.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Low risk	Subjects, study staff, and laboratory technicians were blinded to treatment assignments until the conclusions of the trial.

Mouren 1994

Methods	Study design: double blind randomised clinical trial. Method of randomisation: not stated
Participants	Country: France. Setting: patients recruited from the outpatient clinic. Number randomised: 20. Age: not stated. Sex: not stated. Inclusion criteria: patients between the ages of 35 and 75 years suffering from IC (stage II according to Fontaine); diagnosed for more than 1 year; stable for three months; ACD on treadmill (3.2 km/h and 10% incline) > 100 metres and < 500 metres; transcutaneous partial pressure of oxygen in rest > 40 mmHg. Exclusion criteria: Patients with stage III and IV arterial disease; recent acute arterial occlusion; any form of peripheral circulatory insufficiency due to causes other than atherosclerosis; planned surgical revascularisation; decompensated heart failure; coronary insufficiency; poorly controlled hypertension; locomotor handicap.
Interventions	Treatment: 160 mg EGb 761 two times daily. Control: placebo. Duration: 4 weeks.
Outcomes	Transcutaneous partial pressure of oxygen in rest; transcutaneous partial pressure of oxygen after exercise; functional impairment by VAS.
Notes	Although walking distances were not reported, functional impairment as measured by a VAS was used for the analysis. Funding: not stated
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was performed by random number generation.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Insufficient information.

Natali 1985

Methods	Study design: double blind randomised clinical trial. Method of randomisation: not stated.
Participants	Country: France. Setting: outpatient setting. Number randomised: 18, treatment group 9, control group 9. Age: treatment group 60.8, control group 66.2. Sex: treatment group 7 males and 2 females, control group 8 males and 1 female. Inclusion criteria: Patients with PAD (stage IIb according to Fontaine); age 30 to 75 years; occlusive lesions of deep femoral arteries verified by arteriography; stable condition. Exclusion criteria: non co‐operative patient; significant psychiatric disorder; physical condition that does not allow exercise tests to be performed; any other ailment that could influence the course of the PAD or interfere with the assessment of treatment effects (e.g. Parkinson's disease, tumours); treatment of the same type as the product studied; treatment that could interfere with the assessment of treatment effects.
Interventions	Treatment: 160 mg Ginkgo biloba special extract EgB 761 daily. Control: placebo. Duration: 6 months.
Outcomes	Walking distance: ACD and ICD by treadmill testing (3 km/h and 5% incline); adverse reactions.
Notes	Conflicts of interests: Internal rapport of Dr. Wilmar Schwabe Arzneimittel/Pharmaceuticals, Karlsruhe, Germany
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Patients were randomised.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	The intervention and the placebo were presented the same way.

Peters 1998

Methods	Study design: double blind randomised clinical trial. Method of randomisation: assigned at random.
Participants	Country: Germany. Setting: multicenter study. Number randomised: 109, treatment group 52, control group 59. Age: mean treatment group 62.8, mean control group 61.2. Sex: treatment group 29 males and 23 females, control group 34 males and 23 females. Inclusion criteria: Patients with PAD (stage IIb according to Fontaine) angiographically confirmed; older than 18 years; IC for more than 6 months; ICD < 150 metres. Exclusion criteria: severe impairment of heart, liver and/or kidney; walking limitation due to respiratory insufficiency or orthopaedic disorder; poorly controlled diabetes; pathologically altered hemorrheology; drugs for the same indication as the test substance; use of platelet aggregation inhibitors; anti‐inflammatories; or analgesics.
Interventions	Treatment: 40 mg standardised Egb 761 three times daily. (1 film‐coated tablet contains 40 mg special extract EGb 761 from Ginkgo biloba leaves (35‐67:1), standardised to 9.6 mg (24%) of ginkgo flavone glycosieds and 2.4 (6%) to terpene lactones. Manufacturer: Dr. Wilmar Schwabe Arzneimittel/Pharmaceuticals, Karlsruhe, Germany). Control: placebo. Duration: 24 weeks.
Outcomes	Walking distance: ACD and ICD by treadmill testing (3 km/h and 12% incline); ABI; subjective assessment of therapeutic outcome using VAS; tolerance.
Notes	During the course of thee study, participation in a walking exercise program was offered for all patients. Funding: Not stated. Conflicts of interests: One of the authors is employed by one of the manufacturers Dr. Willmar Schwabe, Karlsruhe, Germany.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Patients were assigned at random.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Insufficient information.

Salz 1980

Methods	Study design: double blind randomised cross‐over study. Method of randomisation: assigned at random.
Participants	Country: Germany. Setting: not stated. Number randomised: 29, treatment group 13, control group 13. Age: mean age males 69.0, mean age females 64.4. Sex: 11 males and 18 females. Inclusion criteria: Patients with PAD (stage IIb according to Fontaine) in both legs. Exclusion criteria:not stated.
Interventions	Treatment: 40 mg standardised Egb 761 two times daily 2 tablets. (Rökan®). Control: placebo. Duration: two times 6 week cross‐over study.
Outcomes	Walking distance: ACD and ICD assessed by walking with 2 steps per second; Ratschow‐test; maximal time of toe‐standing; temperature of the skin; laboratory parameters.
Notes	Only the first study period (6 weeks) before the cross‐over is considered. Funding: Not stated.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were assigned to the trial according to a random code van 1 to 30 in a consecutive way.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Insufficient information.

Schoop 1997

Methods	Study design: double blind randomised clinical trial. Method of randomisation: not stated.
Participants	Country: Germany. Setting: not stated. Number randomised: 205, treatment group 105, control group 100. Age: mean treatment group 64.3, mean control group 67.2. Sex: treatment group 80 males and 25 females, control group 77 males and 23 females. Inclusion criteria: Patients with PAD (stage IIb according to Fontaine). Exclusion criteria: not stated.
Interventions	Treatment: 40 mg standardised GbE three times daily. (1 film‐coated tablet contains 40 mg dry extract from Ginkgo biloba leaves (50:1), standardised to 9.6 mg of ginkgo flavone glycosieds and 2.4 to terpene lactones. (ginkgolides, bilobalide). Manufacturer: not stated). Control: placebo. Duration: 24 weeks.
Outcomes	Walking distance: ICD by treadmill testing (3 km/h and 12% incline); tolerance.
Notes	Funding: not stated.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Insufficient information.

Thomson 1990

Methods	Study design: double blind randomised clinical trial. Method of randomisation: randomly allocated.
Participants	Country: United Kingdom. Setting: not stated. Number randomised: 49, treatment group 25, control group 24. Age: not stated. Sex: not stated. Inclusion criteria: Patients with PAD (stage IIb according to Fontaine) affecting the iliac or femoral arteries, involving predominantly one leg. Exclusion criteria: ICD > 300 metres; alternating side of pain; poorly controlled diabetes; significant concomitant illness.
Interventions	Treatment: Ginkgo biloba extract (Tanakan®). Control: placebo. Duration: 24 weeks.
Outcomes	Walking distance: ICD by treadmill testing (4 km/h and 10 degrees (= 17.6% incline)); recovery times; systolic ankle pressure at rest and after exercise; tolerance.
Notes	Funding: The work was supported and assisted by Ipsen International (one of the manufacturers).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Randomisation to Ginkgo biloba or placebo was made in a double blind manner.

Wang 2007

Methods	Study design: double blind randomised clinical trial. Method of randomisation: randomly allocated.
Participants	Country: Australia. Setting: not stated. Number randomised: 22, treatment group 11, control group 11. Age: mean treatment group 71.6, mean control group 71.2. Sex: treatment group 9 males and 2 females, control group 11 males. Inclusion criteria: Patients with stable IC for at least 6 months; 50‐80 years of age; ABI at rest < 0.90 and after exercise < 0.80. Exclusion criteria: resting ischaemic pain; ulceration; gangrene; unable to walk on treadmill with 3.2 km/h, exercise capacity limited by angina; congestive heart failure; chronic obstructive pulmonary disease or arthritis.
Interventions	Treatment: 240 mg standardised GbE 761 daily. (The Ginkgo biloba tablets were standardized to 26.7% ginkgo flavone glycosides and 6.7% terpenoids (ginkgolides or bilobalide). Manufacturer: not stated). Control: placebo. Duration: 12 weeks.
Outcomes	Walking distance: ACD and ICD by treadmill testing (3.2 km/h and 0% incline); ABI in rest and after exercise; plasma viscosity; whole blood viscosity; peak VO_2; walking economy.
Notes	Only the first 12 weeks of the study in which Ginkgo biloba treatment was compared with placebo is considered. The second part was a 12‐week supervised treadmill walking programme, while the subjects continued taking the same dosage of Ginkgo biloba or placebo. Funding: The Ginkgo biloba and placebo tablets were kindly donated by Mayne Health Consumer Products, Australia.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Subjects were randomly allocated following a randomisation code. The code was created by a computerised program.
Allocation concealment (selection bias)	Low risk	The code was administered by a third party who was not involved in the study.
Blinding (performance bias and detection bias) All outcomes	Low risk	The code was revealed to the subject and the researcher after the database of the study was completed.

ABI: ankle brachial index
ACD: absolute claudication distance
GbE: Ginkgo biloba extract
ICD: initial claudication distance
LDL: low density lipoprotein
PAD: peripheral arterial disease
VAS: visual analogue scale

Characteristics of excluded studies [ordered by study ID]

Ir a:

estudios incluidos

Study	Reason for exclusion
Ambrosi 1975	Separate data for patients diagnosed with PAD stage II according to Fontaine were not available.
Baitsch 1986	This study compares Ginkgo biloba extract with dextran in patients with PAD stage IV according to Fontaine.
Berndt 1987	Ginkgo biloba extract is compared with buflomedil.
Bohmer 1988	(According to Fontaine), diagnosed for more than 1 year.
Courbier 1977	Separate data for patients diagnosed with PAD stage II according to Fontaine were not available.
Frileux 1975	Separate data for patients diagnosed with PAD stage II according to Fontaine were not available.
Garzya 1981	Separate data for patients diagnosed with PAD stage II according to Fontaine were not available.
Horsch 1998	Ginkgo biloba extract is compared with naftidrofuryl in patients with PAD stage III and IV according to Fontaine.
Li 1998	Primary aim of this study was to compare diabetic and non‐diabetic PAD patients.
Michelini 1998	This study compares the combination of Ginkgo biloba extract, magnesium and Levo‐arginine with acetylsalicyl acid.
Rudofsky 1987	Double blind randomised cross‐over study evaluating the short term effect (60 minutes) of Ginkgo biloba extract versus placebo in patients with PAD stage II according to Fontaine.
Sandreau 1989	This study only included patients diagnosed with PAD stage III according to Fontaine.
Schweizer 1999	This study compares two dosages of Ginkgo biloba extract without a placebo group.

Data and analyses

Open in table viewer

Comparison 1. Ginkgo biloba versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Absolute claudication distance (expressed as kilocalories) at the end of the study Show forest plot	11	477	Mean Difference (IV, Random, 95% CI)	3.57 [‐0.10, 7.23]
Open in figure viewer Analysis 1.1 Comparison 1 Ginkgo biloba versus placebo, Outcome 1 Absolute claudication distance (expressed as kilocalories) at the end of the study.
2 Absolute claudication distance (expressed as kilocalories) after 24 weeks Show forest plot	6	321	Mean Difference (IV, Random, 95% CI)	4.72 [2.27, 7.16]
Open in figure viewer Analysis 1.2 Comparison 1 Ginkgo biloba versus placebo, Outcome 2 Absolute claudication distance (expressed as kilocalories) after 24 weeks.
3 Absolute claudication distance (expressed as kilocalories) after 12 to 16 weeks Show forest plot	8	339	Mean Difference (IV, Random, 95% CI)	1.36 [‐2.63, 5.36]
Open in figure viewer Analysis 1.3 Comparison 1 Ginkgo biloba versus placebo, Outcome 3 Absolute claudication distance (expressed as kilocalories) after 12 to 16 weeks.
4 Absolute claudication distance (expressed as kilocalories) after 6 to 8 weeks Show forest plot	5	236	Mean Difference (IV, Random, 95% CI)	2.19 [‐0.62, 4.99]
Open in figure viewer Analysis 1.4 Comparison 1 Ginkgo biloba versus placebo, Outcome 4 Absolute claudication distance (expressed as kilocalories) after 6 to 8 weeks.
5 Initial claudication distance (expressed as kilocalories) at the end of the study Show forest plot	13	723	Mean Difference (IV, Random, 95% CI)	1.84 [‐0.92, 4.61]
Open in figure viewer Analysis 1.5 Comparison 1 Ginkgo biloba versus placebo, Outcome 5 Initial claudication distance (expressed as kilocalories) at the end of the study.
6 Initial claudication distance (expressed as kilocalories) after 24 weeks Show forest plot	8	564	Mean Difference (IV, Random, 95% CI)	2.15 [‐2.06, 6.36]
Open in figure viewer Analysis 1.6 Comparison 1 Ginkgo biloba versus placebo, Outcome 6 Initial claudication distance (expressed as kilocalories) after 24 weeks.
7 Initial claudication distance (expressed as kilocalories) after 12 to 16 weeks Show forest plot	9	441	Mean Difference (IV, Random, 95% CI)	1.54 [‐0.04, 3.12]
Open in figure viewer Analysis 1.7 Comparison 1 Ginkgo biloba versus placebo, Outcome 7 Initial claudication distance (expressed as kilocalories) after 12 to 16 weeks.
8 Initial claudication distance (expresses as kilocalories) after 6 to 8 weeks Show forest plot	6	335	Mean Difference (IV, Random, 95% CI)	2.72 [0.75, 4.69]
Open in figure viewer Analysis 1.8 Comparison 1 Ginkgo biloba versus placebo, Outcome 8 Initial claudication distance (expresses as kilocalories) after 6 to 8 weeks.
9 Ankle brachial index and ankle pressure at the end of study Show forest plot	6	274	Std. Mean Difference (IV, Random, 95% CI)	‐0.22 [‐0.58, 0.15]
Open in figure viewer Analysis 1.9 Comparison 1 Ginkgo biloba versus placebo, Outcome 9 Ankle brachial index and ankle pressure at the end of study.
10 Quality of life (expressed as a Visual Analoque Scale for complaints) Show forest plot	5	208	Std. Mean Difference (IV, Random, 95% CI)	0.38 [‐0.94, 1.70]
Open in figure viewer Analysis 1.10 Comparison 1 Ginkgo biloba versus placebo, Outcome 10 Quality of life (expressed as a Visual Analoque Scale for complaints).

Figure 1

Methodological quality summary: review authors' judgments about each methodological quality item for each included study.

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Figure 2

Methodological quality graph: review authors' judgments about each methodological quality item presented as percentages across all included studies.

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Figure 3

Forest plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.1 Absolute claudication distance (expressed as kilocalories) at the end of the study.

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Figure 4

Forest plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.2 Absolute claudication distance (expressed as kilocalories) after 24 weeks.

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Figure 5

Forest plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.3 Absolute claudication distance (expressed as kilocalories) after 12 to 16 weeks.

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Figure 6

Forest plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.4 Absolute claudication distance (expressed as kilocalories) after 6 to 8 weeks.

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Figure 7

Forest plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.5 Initial claudication distance (expressed as kilocalories) at the end of the study.

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Figure 8

Forest plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.6 Initial claudication distance (expressed as kilocalories) after 24 weeks.

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Figure 9

Forest plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.7 Initial claudication distance (expressed as kilocalories) after 12 to 16 weeks.

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Figure 10

Forest plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.8 Initial claudication distance (expresses as kilocalories) after 6 to 8 weeks.

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Figure 11

Forest plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.9 Ankle brachial index and ankle pressure at the end of study.

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Figure 12

Forest plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.10 Quality of life (expressed as a Visual Analogue Scale for complaints).

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Figure 13

Funnel plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.1 Absolute claudication distance (expressed as kilocalories) at the end of the study. On the horizontal axis the effect estimate of Ginkgo biloba versus placebo on the absolute claudication distance at the end of the study is presented as the mean difference. The vertical axis presents the standard error of the intervention effect on a reversed scale.

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Figure 14

Funnel plot of comparison: 1 Ginkgo biloba versus placebo, outcome: 1.2 Absolute claudication distance (expressed as kilocalories) after 24 weeks. On the horizontal axis the effect estimate of Ginkgo biloba versus placebo on the absolute claudication distance after 24 weeks is presented as the mean difference. The vertical axis presents the standard error of the intervention effect on a reversed scale.

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Analysis 1.1

Comparison 1 Ginkgo biloba versus placebo, Outcome 1 Absolute claudication distance (expressed as kilocalories) at the end of the study.

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Analysis 1.2

Comparison 1 Ginkgo biloba versus placebo, Outcome 2 Absolute claudication distance (expressed as kilocalories) after 24 weeks.

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Analysis 1.3

Comparison 1 Ginkgo biloba versus placebo, Outcome 3 Absolute claudication distance (expressed as kilocalories) after 12 to 16 weeks.

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Analysis 1.4

Comparison 1 Ginkgo biloba versus placebo, Outcome 4 Absolute claudication distance (expressed as kilocalories) after 6 to 8 weeks.

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Analysis 1.5

Comparison 1 Ginkgo biloba versus placebo, Outcome 5 Initial claudication distance (expressed as kilocalories) at the end of the study.

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Analysis 1.6

Comparison 1 Ginkgo biloba versus placebo, Outcome 6 Initial claudication distance (expressed as kilocalories) after 24 weeks.

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Analysis 1.7

Comparison 1 Ginkgo biloba versus placebo, Outcome 7 Initial claudication distance (expressed as kilocalories) after 12 to 16 weeks.

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Analysis 1.8

Comparison 1 Ginkgo biloba versus placebo, Outcome 8 Initial claudication distance (expresses as kilocalories) after 6 to 8 weeks.

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Analysis 1.9

Comparison 1 Ginkgo biloba versus placebo, Outcome 9 Ankle brachial index and ankle pressure at the end of study.

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Analysis 1.10

Comparison 1 Ginkgo biloba versus placebo, Outcome 10 Quality of life (expressed as a Visual Analoque Scale for complaints).

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Comparison 1. Ginkgo biloba versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Absolute claudication distance (expressed as kilocalories) at the end of the study Show forest plot	11	477	Mean Difference (IV, Random, 95% CI)	3.57 [‐0.10, 7.23]

2 Absolute claudication distance (expressed as kilocalories) after 24 weeks Show forest plot	6	321	Mean Difference (IV, Random, 95% CI)	4.72 [2.27, 7.16]

3 Absolute claudication distance (expressed as kilocalories) after 12 to 16 weeks Show forest plot	8	339	Mean Difference (IV, Random, 95% CI)	1.36 [‐2.63, 5.36]

4 Absolute claudication distance (expressed as kilocalories) after 6 to 8 weeks Show forest plot	5	236	Mean Difference (IV, Random, 95% CI)	2.19 [‐0.62, 4.99]

5 Initial claudication distance (expressed as kilocalories) at the end of the study Show forest plot	13	723	Mean Difference (IV, Random, 95% CI)	1.84 [‐0.92, 4.61]

6 Initial claudication distance (expressed as kilocalories) after 24 weeks Show forest plot	8	564	Mean Difference (IV, Random, 95% CI)	2.15 [‐2.06, 6.36]

7 Initial claudication distance (expressed as kilocalories) after 12 to 16 weeks Show forest plot	9	441	Mean Difference (IV, Random, 95% CI)	1.54 [‐0.04, 3.12]

8 Initial claudication distance (expresses as kilocalories) after 6 to 8 weeks Show forest plot	6	335	Mean Difference (IV, Random, 95% CI)	2.72 [0.75, 4.69]

9 Ankle brachial index and ankle pressure at the end of study Show forest plot	6	274	Std. Mean Difference (IV, Random, 95% CI)	‐0.22 [‐0.58, 0.15]

10 Quality of life (expressed as a Visual Analoque Scale for complaints) Show forest plot	5	208	Std. Mean Difference (IV, Random, 95% CI)	0.38 [‐0.94, 1.70]

Comparison 1. Ginkgo biloba versus placebo

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Referencias

References to studies included in this review

Bauer 1984 {published data only}

Blume 1996 {published data only}

Blume 1998 {published data only}

Bulling 1991 {published data only}

Diehm 1990 {unpublished data only}

Drabaek 1996 {published data only}

Gardner 2008 {published and unpublished data}

Mouren 1994 {published data only}

Natali 1985 {unpublished data only}

Peters 1998 {published data only}

Salz 1980 {published data only}

Schoop 1997 {published data only}

Thomson 1990 {published data only}

Wang 2007 {published data only}

References to studies excluded from this review

Ambrosi 1975 {published data only}

Baitsch 1986 {published data only}

Berndt 1987 {published data only}

Bohmer 1988 {published data only}

Courbier 1977 {published data only}

Frileux 1975 {published data only}

Garzya 1981 {published data only}

Horsch 1998 {published data only}

Li 1998 {published data only}

Michelini 1998 {published data only}

Rudofsky 1987 {published data only}

Sandreau 1989 {published data only}

Schweizer 1999 {published data only}

Additional references

ATC 2002

Bauer 1986a

Bauer 1986b

Bauer 1986c

Bendermacher 2005

Bendermacher 2006

de Backer 2008

de Backer 2008a

Fontaine 1954

Fowkes 1991

Girolami 1999

Hankey 2006

Higgins 2008

Hooi 1998

Horsch 2004

Kleijnen 1992

Korth 1988

Leng 2004

Letzel 1992

Meijer 1998

Moher 2000

Murabito 2002

Pincemail 1989

Pittler 2000

Robak 1988

Robless 2008

Rutherford 1997

Schneider 1992

References to other published versions of this review

Cochrane 2009

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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Instituciones a las que se accedió previamente

Usuarios institucionales

Instituciones a las que se accedió previamente

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