Effects of a Ginkgo biloba extract on forearm haemodynamics in healthy volunteers.

The aim was to validate possible vasodilating effects of a Ginkgo biloba extract with a secondary aim of finding a pharmacodynamic signal relating to the active component of these extracts. We studied the effect of G. biloba extract on forearm haemodynamics in 16 healthy subjects (nine females, seven males) with a median age of 32 years (range: 21-47). The study was conducted as a randomized, double-blinded cross-over design using oral treatment with G. biloba extract (Gibidyl Forte(R) t.i.d. or placebo for 6 weeks. Forearm blood flow and venous capacity were measured by strain-gauge plethysmography. Blood pressure was measured by standard sphygmomanometry, and forearm vascular resistance (FVR) was derived. Measurements were made at baseline and after 3, 6, 9 and 12 weeks of treatment. Forearm blood flow was significantly higher during active treatment after 3 and 6 weeks as compared with placebo treatment for 3 and 6 weeks (P<0.05). Mean arterial blood pressure was unchanged, making the calculated FVR significantly lower during active treatment (P<0.02). It is concluded that oral treatment with a G. biloba extract (Gibidyl Forte(R)) is able to dilate forearm blood vessels causing increments in regional blood flow without changing blood pressure levels in healthy subjects. The increments in blood flow may be used as a biological signal for pharmacokinetic studies.

[The effect of Ginkgo biloba extract in patients with intermittent claudication]. / Effekten af Ginkgo biloba-ekstrakt hos patienter med claudicatio intermittens.

Eighteen patients with stable intermittent claudication were randomized in a double blind cross-over study comparing the effects of the Ginkgo biloba extract GB-8 at a dose of 120 mg o.d. with placebo. All patients were treated for three months with the active extract and three months with placebo. The effects of treatment on arterial insufficiency were quantified by measurements of systemic and peripheral systolic blood pressures, and pain-free and maximal walking distances on a tread-mill. Questionnaires based on visual analogue scales were used to quantify the severity of leg pain, impairment of concentration, and inability to remember. Short-term memory was objectively assessed. We did not find any significant changes in either peripheral blood pressures, walking distances or the severity of leg pain. Systemic blood pressure was reduced both by placebo and GB-8. The impairment of concentration and the inability to remember were both reduced, when comparing results during active treatment to placebo. Short-term memory did not change significantly. In conclusion, our study has shown that treatment with the Ginkgo biloba extract GB-8 improves some cognitive functions in elderly patients with moderate arterial insufficiency, whereas the extract did not change signs and symptoms of vascular disease in the patients.

ACE inhibition with spirapril improves diastolic function at rest independent of vasodilation during treatment with spirapril in mild to moderate hypertension.

The effects of the ACE inhibitor spirapril and of hydrochlorothiazide on left ventricular diastolic function were studied. Thirteen patients with mild to moderate essential hypertension completed this randomized, double-blinded, placebo-controlled, crossover study. After a three-week run-in period the patients entered three periods lasting four weeks each, wherein they were treated with placebo, spirapril, or hydrochlorothiazide. Blood pressure, hemodynamic variables (stroke volume, heart rate, cardiac output, index of contractility, and systemic vascular resistance), echocardiography (left ventricular mass), and Doppler-derived atrial to early (A/E)-ratio velocity time integrals (VTI) were measured at the end of each of the four periods. Spirapril lowered the A/E-ratio VTIs (0.57, 0.12-1.00) (P < 0.02) as compared with both placebo (0.80, 0.50-2.67) and hydrochlorothiazide (0.83, 0.44-1.25), and the drug normalized the A/E-ratio VTI in those patients with elevated values. The hemodynamic variables, left ventricular mass, and end-systolic wall stress were unchanged during all three treatments. There were no significant changes in mean blood pressure during the treatment periods. These results indicate that spirapril lowers A/E ratio within four weeks in patients with mild to moderate essential hypertension. It thereby seems able to improve left ventricular diastolic function. The effect is not dependent upon changes in hemodynamic variables, blood pressure, left ventricular mass, or end-systolic wall stress.

[Padma-28, a herbal preparation, increases walking distance in patients with intermittent claudication]. / Padma-28, et urtepraeparat, øger gangdistancen hos patienter med claudicatio intermittens.

Thirty-six patients with stable intermittent claudication were randomized in a doubleblind study either to treatment with two tablets of Padma-28 twice daily (containing 340 mg dried herbal mixture composed according to an ancient lamaistic prescription) or placebo for four months. Effect of treatment was quantified by measurements of systemic and peripheral systolic blood pressures, and pain-free and maximal walking distances on a tread-mill. The actively treated group attained a significant increase in pain-free walking distance from 115 m (72-218) to 227 m (73- >1000, p < 0.05). The placebo group did not show significant changes in either pain-free or maximal walking distance. Significant changes in systemic or peripheral blood pressures could not be demonstrated in any of the groups. In conclusion, our study has shown that treatment with Padma-28 over a four month period significantly increases the walking distance in patients with stable intermittent claudication of long duration.

Electrical impedance measured changes in thoracic fluid content during thoracentesis.

In patients (seven females and 11 males) with pleural effusion due to pulmonary (n = 13) or cardiac disease (n = 5) the change in baseline transthoracic impedance (Z0) was measured by electrical impedance (BoMed's NCCOM-3, 70 kHz) during thoracentesis. Data were obtained before and after withdrawal of each 500 ml, and at the end of the thoracentesis. We found a close linear correlation (r = 0.97) between changes in Z0 and the volume of aspirated pleural effusion (y = 0.415.x+0.093). The variability of the estimated thoracic fluid volumes was analysed with a plot of the residuals from the regression line, and we found that changes in thoracic fluid volume estimated by impedance technique would be within +/- 302 ml (= 2 SD). However, the absolute value of Z0 before thoracentesis could not differentiate the group of patients with pleural effusion from normal subjects (n = 28).

A botanical compound, Padma 28, increases walking distance in stable intermittent claudication.

Thirty-six patients with a median age of sixty-seven years and a median duration of intermittent claudication of five years were randomized to either active treatment with Padma 28 or placebo. The effect of treatment was quantified by measurements of systemic and peripheral systolic blood pressures and by measurements of the pain-free and the maximal walking distance on a treadmill. The ankle pressure index (ankle systolic pressure/arm systolic pressure) was calculated. The group randomized to active treatment received two tablets bid containing 340 mg of a dried herbal mixture composed according to an ancient lamaistic preparation (Padma 28). After active treatments, administered over a period of four months in a double-blinded, randomized design, the patients allocated to this group attained a significant increase in the pain-free walking distance from 52 m (20-106) to 86 m (24-164; P < 0.05) and in the maximal walking distance from 115 m (72-218) to 227 m (73- > 1,000; P < 0.05). The patient-group receiving placebo treatments did not show any significant changes in either the painfree or the maximal walking distance. The authors could not demonstrate any significant changes in the ankle pressure index either during active or during placebo treatment. In conclusion, this study has shown that treatment with Padma 28 over a period of four months significantly increased the walking distance in patients with stable, intermittent claudication of long duration.

[Systolic blood pressure at rest and during submaximal and maximal exercise on ergometer bicycle. The value of automatic and auscultatory determination]. / Systolisk blodtryk i hvile og under submaksimal og maksimal arbejdsbelastning på ergometercykel. Voerdien af automatisk og auskultatorisk bestemmelse.

Fifteen normal subjects participated in this comparison of systolic blood pressure measurement determined both automatically (AU) with the Kivex Ergometrics 900 and by the standard auscultatorically method (AM). Maximal exercise, was achieved by work performed on an electronically braked ergometer bicycle. In the first part of this study, simultaneous measurements of systolic blood pressure were made by the Kivex device and by the standard method at rest, every minute during exercise, and one minute after stopping exercise. The differences (two standard deviations) between AU and AM (n = 229) were +/- 19 mmHg at rest, +/- 15 mmHg at submaximal level, and +/- 49 mmHg at maximal exercise level. The acceptable difference was determined to +/- 15 mmHg by Bland and Altman. In the second part of this study, the differences between simultaneously measured auscultatoric systolic blood pressure by two observers (n = 205) was +/- 10 mmHg at rest, +/- 9 mmHg at submaximal level, and +/- 10 mmHg at the maximal exercise level. It can therefore be concluded that Kivex automatic blood pressure device, Ergometrics 900, is unable to measure accurately systolic blood pressure with sufficient agreement in normal subjects at the maximal stress level or at rest. However, at the submaximal exercise level, the Kivex device was able to measure systolic blood pressure with an acceptable agreement with the standard method. Therefore, the blood pressure results obtained by the Kivex device are highly influenced by the exercise level. The agreement between two observers using standard auscultatory method for systolic blood pressure measurement was found to be acceptable at all levels of exercise.