WHO monographs on selected medicinal plants - travolekar.ru
WHO monographs on selected medicinal plants - travolekar.ru WHO monographs on selected medicinal plants - travolekar.ru
Cortex Salicis Daily consumption of the extract with 240.0 mg salicin per day affected platelet aggregation to a lesser extent than acetylsalicylate (27). Chronic lower back pain Standardized extracts of the bark exhibited analgesic effects similar to those of higher doses of acetylsalicylic acid. A daily dose of 1572.0 mg of an extract of the crude drug (standardized to 15.2% salicin or 240.0 mg salicin per day) was superior to placebo in the treatment of pain in patients with osteoarthritis of the hip and the knee, and in patients with exacerbations of chronic low back pain. In two open studies, unspecified extracts of the crude drug exhibited similar efficacy to the normal treatment regime of nonsteroidal antirheumatic drugs and the efficacy was similar to that of refecoxib (18). A randomized placebo-controlled clinical study evaluated the efficacy of a willow bark extract in 210 patients with chronic lower back pain. The patients were assigned to receive an orally administered willow bark extract with either 120.0 mg (low dose) or 240.0 mg (high dose) of salicin, or a placebo, with tramadol as the sole rescue medication, in the 4-week trial. The principal outcome measure was the proportion of patients who were pain-free without tramadol for at least 5 days during the final week of the study. A total of 191 patients completed the study. The number of painfree patients in the last week of treatment was 27 (39%) of 65 in the group receiving high-dose extract, 15 (21%) of 67 in the group receiving lowdose extract, and 4 (6%) of 59 in the group treated with placebo (p < 0.001). The response in the group treated with the high dose was evident after only 1 week of treatment. Significantly more patients in the group receiving the placebo required tramadol during each week of the study (p < 0.001). One patient in the treatment group suffered a severe allergic reaction (14). An open, non-randomized study (postmarketing surveillance) assessed the efficacy of an extract of the crude drug in three groups of patients aged 18–80 years presenting over an 18-month period with acute exacerbations of low back pain. The first group of 115 patients was prescribed a daily dose of the extract containing 120.0 mg of salicin. A second group of 112 patients was prescribed the extract equivalent to 240.0 mg salicin per day. A third “control” or “comparator” group of 224 patients received conventional therapy. In the patients who had received conventional therapy, the exacerbations had been shorter but the pain was more intense as judged by Arhus Index and Total Pain Index. After 4 weeks of treatment, about 40% of patients in the group treated with the extract equivalent to 240 mg salicin per day were free of pain. In the group treated with extract containing 120.0 mg of salicin, as a whole, about 19% of patients were 315
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<str<strong>on</strong>g>WHO</str<strong>on</strong>g> <str<strong>on</strong>g>m<strong>on</strong>ographs</str<strong>on</strong>g> <strong>on</strong> <strong>selected</strong> <strong>medicinal</strong> <strong>plants</strong><br />
after oral administrati<strong>on</strong>. More than 50% of a salicin dose was recovered<br />
as salicin and saligenin from the intestinal tracts 1 h after treatment and<br />
15.8% of the dose was still present as saligenin 4 h after administrati<strong>on</strong>.<br />
When given to germ-free rats, 19.8% of the salicin dose was recovered<br />
intact, mainly from the cecum, and no saligenin was detected even at 4 h<br />
after treatment. These results indicate that salicin is a pro-d<strong>ru</strong>g that is<br />
gradually transported to the lower part of the intestine, hydrolysed to<br />
saligenin by intestinal bacteria, and c<strong>on</strong>verted to salicylic acid after absorpti<strong>on</strong>.<br />
It thus produces an antipyretic acti<strong>on</strong> without causing gastric<br />
injury (25).<br />
Toxicology<br />
Intragastric administrati<strong>on</strong> of a 40% ethanol extract of the bark to rats at<br />
a dose of 1.6 ml/kg bw for 13 weeks had no effect <strong>on</strong> kidney functi<strong>on</strong>,<br />
haematological parameters, liver functi<strong>on</strong> or cholesterol levels (26). Histological<br />
evaluati<strong>on</strong> of the animals after killing showed no pathological<br />
changes in the brain, heart, lungs, b<strong>on</strong>e, kidneys, liver, reproductive organs,<br />
mammary tissue, stomach or intestines (26).<br />
The median lethal dose range of a 30% ethanol extract of the bark was<br />
28.0–42.0 ml/kg bw in mice (both sexes) (26).<br />
Clinical pharmacology<br />
Anticoagulant activity<br />
A study was performed to investigate the anticoagulant activity of a bark<br />
extract used in the treatment of 51 patients with chr<strong>on</strong>ic back pain. Thirty-five<br />
patients suffering from acute exacerbati<strong>on</strong>s of chr<strong>on</strong>ic low back<br />
pain received randomly and double-blind either the extract (corresp<strong>on</strong>ding<br />
to 240 mg salicin/day; n = 19) or a placebo (n = 16). A further 16 patients<br />
with stable chr<strong>on</strong>ic ischaemic heart disease were given 100 mg acetylsalicylate<br />
per day. Platelet aggregati<strong>on</strong> was studied after drawing blood<br />
from the treated patients using an aggregometer. Arachid<strong>on</strong>ic acid (500 μg/<br />
ml), adenosine diphosphate (2 × 10 −5 M) and collagen (0.18 μg/ml) were<br />
used as aggregating agents. The mean maximal arachid<strong>on</strong>ic acid-induced<br />
platelet aggregati<strong>on</strong> was 61%, 78% and 13% for the groups treated with<br />
extract, placebo and acetylsalicylate, respectively. Acetylsalicylate had a<br />
significant inhibitory effect <strong>on</strong> platelet aggregati<strong>on</strong> compared to the extract<br />
(p = 0.001) and placebo (p = 0.001). There was also a significant difference<br />
between the placebo and the extract-treated groups in the maximal<br />
platelet aggregati<strong>on</strong> induced by arachid<strong>on</strong>ic acid (p = 0.04) and ADP<br />
(p = 0.01). No statistical difference was found between platelet aggregati<strong>on</strong><br />
in the three groups when collagen was added to the human platelets.<br />
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