WHO monographs on selected medicinal plants - travolekar.ru

WHO monographs on selected medicinal plants - travolekar.ru WHO monographs on selected medicinal plants - travolekar.ru

20.01.2015 Views

ong>WHOong> ong>monographsong> on selected medicinal plants pain-free at 4 weeks, but only 8% of those who did not resort to supplementary treatment. In the group receiving conventional therapy, 18% of patients were pain-free. Better pain relief in the group treated with the equivalent of 240.0 mg salicin was accompanied by a reduction in the use of supplementary conventional treatments (15). Migraine A placebo-controlled double-blind clinical trial involving 54 patients assessed the efficacy of a topical medication containing salicin for the treatment of either migraines and/or tension-type headaches. All the patients had headaches consistent with the International Classification of Headache Disorders (HIS) criteria for migraines and/or tension-type headaches, and had suffered from headaches for at least 1 year up to approximately 40 years. The patients were divided into two groups. One group received a placebo topical medication. The other group received a topical medication containing salicin. Neither preparation induced any stinging sensation. The patients were instructed to apply the medication, which was in a roll-on form, to the frontal region at the onset of a headache, take their usual oral or parenteral medications, apply a mask which covered the eyes and frontal region, and then lie down. They subsequently filled out forms rating the degree of relief which they attributed to the topical medications and the masks using a scale of 0 to 10. They were also asked if this form of treatment had helped or not. Seven of the 20 patients who received the placebo stated that the medication and mask helped. This group rated the treatment an average of 4.31 on the scale of 0 to 10. Twenty-eight of 34 patients who received salicin stated that it was effective. This group rated it 7.42 on the scale of 0 to 10 (p < 0.001). The majority of the patients treated with salicin stated that the duration of their headaches was significantly reduced, as was their need for analgesic and/or narcotic medications. This study demonstrates a significant difference between placebo and salicin in association with the photoprotective mask in treating migraines and/or tension-type headaches with associated frontalis pain and photophobia (17). Osteoarthritis A clinical study involving 78 patients assessed the efficacy of a chemically standardized willow bark extract in the treatment of osteoarthritis. Willow bark extract, at a dose corresponding to 240.0 mg salicin/day, was compared to a placebo in a 2-week, double-blind, randomized controlled trial. The primary outcome measure was the pain dimension of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. Secondary outcome measures included the stiffness and physical 316

Cortex Salicis function dimensions of the WOMAC, daily visual analogue scales (VAS) on pain and physical function, and final overall assessments by both patients and investigators. The results demonstrated a statistically significant difference between the subjects who received active treatment and the placebo group in the WOMAC pain dimension (d = 6.5 mm, 95% confidence intervals (CI), 0.2–12.7 mm, p = 0.047); the WOMAC pain score was reduced by 14% from the baseline level after 2 weeks of active treatment, whereas there was an increase of 2% in the placebo group. The patient diary VAS confirmed the results, and the final overall assessments showed superiority of the willow bark extract over the placebo (patients’ assessment, p = 0.0002; investigators’ assessment, p = 0.0073) (19, 20). A double-blind, randomized, controlled clinical trial assessed the efficacy of an extract of the bark (containing 17.6% total salicin), at a dose of 240.0 mg per day, in the treatment of patients with chronic arthritic pain. Eighty-two subjects with chronic arthritic pain were randomly assigned for 2 months without cross-over to receive either the extract or a placebo. The results demonstrated a small but statistically significant improvement in pain symptoms (p < 0.05), although the improvement was less in patients with osteoarthritis. No other significant changes in any other measures or in the use of other self-prescribed analgesics were observed (28). The efficacy of a standardized willow bark extract was investigated in two randomized, controlled, double-blind trials with follow-up for 6 weeks, in patients with osteoarthritis and rheumatoid arthritis. One hundred and twenty-seven outpatients with osteoarthritis of the hip or knee and a pain score of at least 30 mm, and 26 outpatients with active rheumatoid arthritis were randomly allocated to one of three groups. Patients in the first group received willow bark extract, corresponding to 240 mg of salicin/day; patients in the second group, diclofenac at a dose of 100 mg/day; and the third group, a placebo (n = 43, 43 and 41, respectively). The main outcome measure was the pain subscore. In the rheumatoid arthritis trial, patients were randomly assigned to receive either willow bark extract, corresponding to 240 mg salicin/day (n = 13) or a placebo (n = 13). The main outcome measure was the patient’s assessment of pain rated on a 100-mm visual analogue scale. In the osteoarthritis trial, pain scores decreased by 8 mm (17%) in the group treated with willow bark and by 23 mm (47%) in the group treated with diclofenac, compared with 5 mm (10%) in the patients who received the placebo. The difference between the scores following treatment with willow bark extract and treatment with placebo was not statistically significant (–2.8 mm; 95% CI –12.1 to 6.4 mm; p = 0.55, analysis of covariance (ANCOVA)), but the difference between the outcomes of treatment with diclofenac and with 317

Cortex Salicis<br />

functi<strong>on</strong> dimensi<strong>on</strong>s of the WOMAC, daily visual analogue scales (VAS)<br />

<strong>on</strong> pain and physical functi<strong>on</strong>, and final overall assessments by both patients<br />

and investigators. The results dem<strong>on</strong>strated a statistically significant<br />

difference between the subjects who received active treatment and<br />

the placebo group in the WOMAC pain dimensi<strong>on</strong> (d = 6.5 mm, 95%<br />

c<strong>on</strong>fidence intervals (CI), 0.2–12.7 mm, p = 0.047); the WOMAC pain<br />

score was reduced by 14% from the baseline level after 2 weeks of active<br />

treatment, whereas there was an increase of 2% in the placebo group. The<br />

patient diary VAS c<strong>on</strong>firmed the results, and the final overall assessments<br />

showed superiority of the willow bark extract over the placebo (patients’<br />

assessment, p = 0.0002; investigators’ assessment, p = 0.0073) (19, 20).<br />

A double-blind, randomized, c<strong>on</strong>trolled clinical trial assessed the efficacy<br />

of an extract of the bark (c<strong>on</strong>taining 17.6% total salicin), at a dose of<br />

240.0 mg per day, in the treatment of patients with chr<strong>on</strong>ic arthritic pain.<br />

Eighty-two subjects with chr<strong>on</strong>ic arthritic pain were randomly assigned<br />

for 2 m<strong>on</strong>ths without cross-over to receive either the extract or a placebo.<br />

The results dem<strong>on</strong>strated a small but statistically significant improvement<br />

in pain symptoms (p < 0.05), although the improvement was less in patients<br />

with osteoarthritis. No other significant changes in any other measures<br />

or in the use of other self-prescribed analgesics were observed (28).<br />

The efficacy of a standardized willow bark extract was investigated in<br />

two randomized, c<strong>on</strong>trolled, double-blind trials with follow-up for<br />

6 weeks, in patients with osteoarthritis and rheumatoid arthritis. One<br />

hundred and twenty-seven outpatients with osteoarthritis of the hip or<br />

knee and a pain score of at least 30 mm, and 26 outpatients with active<br />

rheumatoid arthritis were randomly allocated to <strong>on</strong>e of three groups. Patients<br />

in the first group received willow bark extract, corresp<strong>on</strong>ding to<br />

240 mg of salicin/day; patients in the sec<strong>on</strong>d group, diclofenac at a dose of<br />

100 mg/day; and the third group, a placebo (n = 43, 43 and 41, respectively).<br />

The main outcome measure was the pain subscore. In the rheumatoid<br />

arthritis trial, patients were randomly assigned to receive either willow<br />

bark extract, corresp<strong>on</strong>ding to 240 mg salicin/day (n = 13) or a<br />

placebo (n = 13). The main outcome measure was the patient’s assessment<br />

of pain rated <strong>on</strong> a 100-mm visual analogue scale. In the osteoarthritis trial,<br />

pain scores decreased by 8 mm (17%) in the group treated with willow<br />

bark and by 23 mm (47%) in the group treated with diclofenac, compared<br />

with 5 mm (10%) in the patients who received the placebo. The difference<br />

between the scores following treatment with willow bark extract and<br />

treatment with placebo was not statistically significant (–2.8 mm; 95%<br />

CI –12.1 to 6.4 mm; p = 0.55, analysis of covariance (ANCOVA)), but the<br />

difference between the outcomes of treatment with diclofenac and with<br />

317

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