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Placebo controlled double blind study with pentoxifylline of walking performance in patients with intermittent claudication.

A double blind placebo-controlled randomised crossover study was performed with Pentoxifylline (Trental 400 tablets with 400 mg active ingredient) in 24 patients (19 males, 5 females, aged between 40 and 71 years) suffering from peripheral occlusive arteriopathy of stage II severity (Fontaine's classification). In 12 patients (group I) the treatment was started with placebo, and in another 12 subjects with Pentoxifylline (group II). The dosage was 3 tablets of either formulation t.d.s., the treatment periods were 8 weeks each with a two week washout between. The standardised walking test (120 steps/min under metronome control) was used for the assessment of the walking capacity. There was a significant 60% increase in pain-free walking distance in either Pentoxifylline treatment periods, whereas there were no clinically relevant changes in the placebo periods. When comparing the two starting periods only, there was an increase in the Pentoxifylline group from 223 to 359 m on average and in the placebo group from 208 to 215 m, patients in both groups being comparable at basal level as to the distribution of sex, age, location of occlusion, duration of disease as well as in respect to the walking capacity. No adverse reactions were recorded during the trial.

Adult↗

Efficacy of indobufen in the treatment of intermittent claudication.

The aim of this trial was to assess the activity of indobufen compared with placebo in peripheral occlusive arterial disease of the lower limbs of atherosclerotic or diabetic origin. Fifty-two outpatients were admitted to the randomized, double-blind study and were given either an indobufen 200-mg tablet (28 subjects) or placebo (24) for six months. Painfree walking distance on a treadmill at a constant speed (4 km/h) and slope (10 degrees) was assessed before and after three and six months' treatment. The painfree walking distance before treatment with indobufen or placebo averaged 153 +/- 23.02 (mean +/- SE) and 199 +/- 30.58 (mean +/- SE) meters respectively. After six months' treatment with active drug or placebo, this parameter reached 610 +/- 115.36 (p less than 0.01) and 243 +/- 32.49 (p greater than 0.05) meters respectively. The difference between the two treatments was statistically significant in favor of indobufen (p less than 0.01 Dunn's test).

Clinical Trials as Topic↗

Double-blind comparison of captopril with nifedipine in hypertension complicated by intermittent claudication.

In a double-blind, crossover trial 12 patients with hypertension and peripheral arterial disease were randomized to three months' treatment with captopril 25-50 mg twice daily or nifedipine SR 20-40 mg twice daily. While both treatments were equally effective at lowering blood pressure, postexercise calf blood flow availability was greater during treatment with captopril (P less than 0.04). This was not reflected in walking capacity assessed by treadmill exercise. The results suggest that both captopril and nifedipine are appropriate antihypertensive agents in patients with peripheral arterial disease.

Blood Pressure↗

Quality of life in a group of patients with intermittent claudication.

In view of the increasing importance of chronic diseases in recent years, not only quantity but also quality of life has been taken into consideration. The aim of this study was to verify the quality of life in patients with peripheral obstructive arteriopathies of second degree according to the Leriche-Fontaine classification. Therefore, the authors administrated three different questionnaires to patients selected among those who came to the Angiology Ambulatory Care of the Medical Clinic of the University of Trieste. The questionnaires used were the following: McMaster Health Index Questionnaire (MHIQ), "Squibb" Quality of Life, General Health Index Questionnaire (GHIQ). The analysis of the results of the questionnaires shows the severe limitation of physical capacities of this kind of patients (overall mean functional limitation of 69% of the maximum value of 1, corresponding to an ideal state of well-being, with negative peaks of 50%). A negative tendency regarding social life and relationship is represented by different scores (from 52% to 66% of ideal maximum) from different items and questionnaires. Also the items concerning somatic disorders, sleeplessness, and states of anxiety gave results near the percentage of 70% and for this reason were indicative of a state of unwell-being. The data obtained from the items regarding the presence of a state of depression gave a result less predictable: a score of 87% with peaks over 90% could be indicative of a positive tendency. This last result, consistent with others of analogous studies in the literature, seems to indicate that peripheral arterial disease, even if physically restricting, does not have a strong impact on the psychological and emotional equilibrium of the patients.

Activities of Daily Living↗

Intermittent claudication in athletes.

All reported cases have occurred in the anterior tibial or rarely peroneal compartments. Case I and V in this series follow this same pattern. Case II and III are unusual in that they are the first recorded cases of this syndrome occuring in the calf of a leg. In Case IV the syndrome was present both in the anterior compartment as well as in the calf. Case III in addition, demonstrated arteriographic evidence of impairment of blood flow preoperatively which was relieved by fasciotomy. It is this author's opinion that this syndrome develops due to obstruction of venous drainage by a rise in pressure in the myofascial compartment with exercise. Perhaps it occurs in athletes because the muscle hypertrophy in these patients in greater than that in the general public and the margin of safety is reduced. It is not necessary to perform complicated or painful investigative studies to make the diagnosis. Kennelly and Blumberg state that "a convincing history is all that is necessary," and the author is in complete agreement with this statement. Fasciotomy gives complete relief and is earnestly recommended both to relieve symptoms and to prevent the catastrophic consequences of muscle necrosis. In fact, in severe cases it is best to advise cessation of physical exercise until the operation can be done in order that this severe complication does not develop.

Adult↗

Intermittent claudication of one cerebral hemisphere.

A 13-year-old girl consistently developed unilateral sensory and motor symptoms on hyperventilation, suggesting the diagnosis of hysteria. Investigation disclosed hypoplasia of one internal carotid artery and part of the circle of Willis, responsible for compromising blood flow to one hemisphere sufficiently to produce ischemic deficit during hypocapnia.

Adolescent↗