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Biomedical subjects

S Chrubasik

Publications and source records attributed to S Chrubasik.

At least 37 records · Page 2Linked to original sources
PubMed2002

Comparison of outcome measures during treatment with the proprietary Harpagophytum extract doloteffin in patients with pain in the lower back, knee or hip.

Besides checking estimates of effectiveness and safety of using the proprietary Harpagophytum extract Doloteffin, this postmarketing surveillance compared various disease-specific* and generic** measures of effect. We enrolled 250 patients suffering from nonspecific low back pain (Back group: n = 104) or osteoarthritic pain in the knee (Knee group: n = 85) or hip (Hip group: n = 61). They took an 8-week course of Doloteffin at a dose providing 60 mg harpagoside per day. The measures of effect on pain and disability included the percentage changes from baseline of established instruments (Arhus low back pain index*, WOMAC index*, German version of the HAQ**) and unvalidated measures (total pain index*, three score index*, the patient's global assessment** of the effectiveness of treatment). Patients also received a diary for the daily recording of their pain and any additional treatments for it. The three groups differed in age, weight and characteristics of initial pain. 227 patients completed the study. Multivariate analysis confirmed that several dimensions of effect were recorded by the several outcome measures but, in all groups, both the generic and disease-specific outcome measures improved by week 4 and further by 8. In multivariable analysis, the improvement tended to be more when the initial pain and disability score was more: older patients tended to improve less than younger, the hip group tended to improve convincingly more than the back group, whereas the improvement in the knee group was less readily differentiated from that in the back group. The subgroup of Back patients who required NSAIDs during the 8 weeks used significantly more per patient than patients in the other two groups, but that requirement also declined more with time. About 10% of the patients suffered from minor adverse events that could possibly have been attributable to Doloteffin. Between 50% and 70% of the patients benefitted from Doloteffin with few adverse effects. Thus, Doloteffin is well worth considering for osteoarthritic knee and hip pain and nonspecific low back pain.

Aged↗
PubMed2001

Effect of salicis cortex extract on human platelet aggregation.

The bark of Salix species contains several prodrugs of salicylate, mainly salicin. The aim of this study was to investigate if during pain treatment with Salicis cortex extract platelet aggregation was affected. A total of 51 patients were enrolled in the study. Thirty-five patients suffering from acute exacerbations of chronic low back pain received randomly and double-blind either Salicis cortex extract with 240 mg salicin/day (n = 19) or placebo (n = 16). Further sixteen patients with stable chronic ischemic heart disease were given 100 mg acetylsalicylate per day. Platelet aggregation was studied using an aggregometer. As aggregating agents, arachidonic acid (500 micrograms/ml), adenosine di-phosphate (2 x 10(-5) M) and collagen (0.18 microgram/ml) were used. The mean maximal arachidonic acid induced platelet aggregation was 61%, 78% and 13% in the Salicis cortex extract, placebo and acetylsalicylate groups. Acetylsalicylate had a significant inhibitory effect on platelet aggregation compared to Salicis cortex extract (p = 0.001) and placebo (p = 0.001). There was also a significant difference between the placebo and the willow bark-treated groups in the maximal platelet aggregation induced by arachidonic acid (p = 0.04) and ADP (p = 0.01). No statistical difference was found between the groups when collagen was applied to the human platelets. Daily consumption of Salicis cortex extract with 240 mg salicin per day affects platelet aggregation to a far lesser extent than acetylsalicylate. Further investigation needs to clarify if this finding is of clinical relevance in patients with impaired thrombocyte function.

Adenosine Diphosphate↗
PubMed2001

Potential economic impact of using a proprietary willow bark extract in outpatient treatment of low back pain: an open non-randomized study.

An open, non-randomised, study (postmarketing surveillance) was carried out on three groups of patients aged 18 to 80 presenting over an 18 month period with acute exacerbations of low back pain. The objective was to assess the possible economic impact of including a regular dose of proprietary willow bark extract (Assalix) in the treatment provided. A first group of 115 patients, presenting to 3 general practitioners in the first 3 months, was prescribed a daily dose of extract containing 120 mg of salicin (group W120). They also had access, if necessary, to the range of conventional treatments allowed for in the general practitioners' budgets. A second group of 112 patients presenting to the same general practitioners over the next 15 months, was prescribed extract equivalent to 240 mg salicin per day (group W240). A third "control" or "comparator" group of 224 patients, presenting to 3 orthopedists (specialists in physical medicine) over the whole 18 month period, received only the conventional therapeutic options allowed in the orthopedists' budgets (Group C). In the group C patients, the exacerbations had been shorter but the pain had been more intense as judged by Arhus Index and Total Pain Index. After 4 weeks of treatment, about 40% of group W240 patients were free of pain whether or not they had to resort to supplementary treatments. In group W120 as a whole, about 19% of patients were pain-free at 4 weeks, but only 8% of those who did not resort to supplementary treatment. In group C, 18% of patients were painfree. These findings were reflected reasonably well in the changes in the Arhus Index and Total Pain Index, and the findings in group W240 were consistent with those in a previous randomised controlled trial. Multivariable modelling to examine for possible confounding effects tended to identify membership of group W240 as an independent explanator of better pain relief than membership of group C. Though the measures of effect tended to be similar in group W120 as a whole and group C, the avoidance of more expensive conventional treatments in group W120 meant that the average cost per patient of treatment was reduced by about 35-50% (health service and private costings respectively). The better pain relief in group W240 was accompanied by an even smaller reliance on supplementary conventional treatments than in group W120 but the extra savings on these were outweighed by the extra cost of the additional Assalix so that the average cost per patient was reduced by 14-40% of the costs in group C. The possibility is discussed that, if orthopedists had relied more on regular full dosing with NSAIDs, they might have increased the effectiveness and reduced the cost of their treatment, though with the possibility of more side effects. Substituting established NSAIDs with COX-2 inhibitors might reduce the side effects, but at greater cost than with the Assalix.

Adolescent↗
PubMed2001

Treatment of low back pain with a herbal or synthetic anti-rheumatic: a randomized controlled study. Willow bark extract for low back pain.

OBJECTIVES: To compare the effects of a proprietary extract of willow bark (Assalix) and a selective inhibitor (rofecoxib) of the enzyme cyclo-oxygenase-2 (COX-2). METHODS: An open, randomized, post-marketing study was carried out in an out-patients clinic on two groups of patients aged 18 to 80 yr presenting over a 6-month period with acute exacerbations of low back pain. Using computer-generated random list, 114 patients were allocated to receive a daily dose of herbal extract containing 240 mg of salicin [PAID (phyto-anti-inflammatory drug) group] and 114 were allocated to receive 12.5 mg of the synthetic COX-2 inhibitor rofecoxib [NSAID (non-steroidal anti-inflammatory drug) group]. The doses were chosen according to existing recommendations. All patients were free to use whatever additional conventional treatments were thought necessary. The outcome measures were a modified Arhus index, its pain component and the Total Pain Index. RESULTS: Groups were well matched. After 4 weeks of treatment, the Arhus index had improved by about 20%, its pain component by about 30% and the Total Pain Index by about 35%. The number of pain-free patients (visual analogue scale score <2) was about 20 in each group. About 60% of the patients in each group responded well to the treatment (as judged by an improvement of >/=30% in the Total Pain Index relative to its baseline). The improvement was also reflected reasonably well in the physicians' and patients' judgements of the effectiveness of treatment, which were largely concordant. Few patients of either group resorted to the additional conventional treatment options. The incidence of adverse events was similar in the two groups. Treatment with rofecoxib was about 40% more expensive than that with Assalix. CONCLUSION: There was no significant difference in effectiveness between the two treatments at the doses chosen. Treatment with Assalix was less expensive.

Adolescent↗
PubMed2000

Treatment of low back pain exacerbations with willow bark extract: a randomized double-blind study.

PURPOSE: Herbal medicines are widely used for the treatment of pain, although there is not much information on their effectiveness. This study was designed to evaluate the effectiveness of willow (Salix) bark extract, which is widely used in Europe, for the treatment of low back pain. SUBJECTS AND METHODS: We enrolled 210 patients with an exacerbation of chronic low back pain who reported current pain of 5 or more (out of 10) on a visual analog scale. They were randomly assigned to receive an oral willow bark extract with either 120 mg (low dose) or 240 mg (high dose) of salicin, or placebo, with tramadol as the sole rescue medication, in a 4-week blinded 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. RESULTS: The treatment and placebo groups were similar at baseline in 114 of 120 clinical features. A total of 191 patients completed the study. The numbers of pain-free patients in the last week of treatment were 27 (39%) of 65 in the group receiving high-dose extract, 15 (21%) of 67 in the group receiving low-dose extract, and 4 (6%) of 59 in the placebo group (P <0.001). The response in the high-dose group was evident after only 1 week of treatment. Significantly more patients in the placebo group required tramadol (P <0.001) during each week of the study. One patient suffered a severe allergic reaction, perhaps to the extract. CONCLUSION: Willow bark extract may be a useful and safe treatment for low back pain.

Administration, Oral↗
PubMed2000

Phyto-anti-inflammatories. A systematic review of randomized, placebo-controlled, double-blind trials.

Herbal treatments are often used to treat rheumatic symptoms. This systematic review is aimed at determining the clinical efficacy of this approach. Computer literature searches are carried out to locate all placebo-controlled, double-blind, randomized trials in this area. Nineteen studies meet the inclusion criteria. They are heterogeneous in terms of remedies tested, patients treated, and trial methodology applied. Most of the studies suggest that herbal remedies can have symptomatic effects beyond placebo. It is concluded that phyto-anti-inflammatories have considerable, albeit under-researched, potential in the symptomatic treatment of rheumatic disorders.

Anti-Inflammatory Agents↗
PubMed2000

Physicochemical properties of harpagoside and its in vitro release from Harpagophytum procumbens extract tablets.

The objective of this investigation was to characterize the active-component harpagoside of Harpagophytum extract from a physico-chemical perspective and to determine its in-vitro release from tablets according to DAB 1996. It was found that both pure harpagoside and harpagoside in Harpagophytum extract have an octanol-water distribution coefficient of approximately 4 which is neither dependent on temperature nor on pH. The mean harpagoside content in Harpagophytum tablets of Batch 9102 was 16.4 mg (S.D. 0.2; S.E. 0.03). Related to a tablet weight of 365 mg (100%), this corresponds to a haragoside content of 4.5% (S.D. 0.049; S.E. 0.006). On average the tablets disintegrate after 18 +/- 3 minutes (mean +/- SD). The tablets taken from Batch 9102 released the active component harpagoside well, with a t50 of 13.5 min, a t90 of 23 min and a t95 of 25 min in relation to 16.5 mg of harpagoside per dose. Harpagoside content decreased by about 10% in artificial gastric fluid within a period of 3 hours and remained stable in artificial intestinal fluid for a period of 6 hours.

Analgesics↗
PubMed1999

Effectiveness of Harpagophytum extract WS 1531 in the treatment of exacerbation of low back pain: a randomized, placebo-controlled, double-blind study.

Two daily doses of oral Harpagophytum extract WS 1531 (600 and 1200, respectively, containing 50 and 100 mg of the marker harpagoside) were compared with placebo over 4 weeks in a randomized, double-blind study in 197 patients with chronic susceptibility to back pain and current exacerbations that were producing pain worse than 5 on a 0-10 visual analogue scale. The principal outcome measure, based on pilot studies, was the number of patients who were pain free without the permitted rescue medication (tramadol) for 5 days out of the last week. The treatment and placebo groups were well matched in physical characteristics, in the severity of pain, duration, nature and accompaniments of their pain, the Arhus low back pain index and in laboratory indices of organ system function. A total of 183 patients completed the study. The numbers of pain-free patients were three, six and 10 in the placebo group (P), the Harpagophytum 600 group (H600) and the Harpagophytum 1200 group (H1200) respectively (P = 0.027, one-tailed Cochrane-Armitage test). The majority of responders' were patients who had suffered less than 42 days of pain, and subgroup analyses suggested that the effect was confined to patients with more severe and radiating pain accompanied by neurological deficit. However, subsidiary analyses, concentrating on the current pain component of the Arhus index, painted a slightly different picture, with the benefits seeming, if anything, to be greatest in the H600 group and in patients without more severe pain, radiation or neurological deficit. Patients with more pain tended to use more tramadol, but even severe and unbearable pain would not guarantee that tramadol would be used at all, and certainly not to the maximum permitted dose. There was no evidence for Harpagophytum-related side-effects, except possibly for mild and infrequent gastrointestinal symptoms.

Analgesics, Opioid↗
PubMed1998

A survey on pain complaints and health care utilization in a German population sample.

A postal survey was carried out on every 71st person aged between 18 and 80 in the population registers in County Regierungsbezirk Karlsruhe in the State of Baden-Würtemberg. It asked 2127 persons whether they had, in the previous 6 months, experienced any form of unduly prolonged pain (as distinct from brief intercurrent self-limiting episodes related to injury inflammation etc.) and, if so, to specify its location, duration, severity and persistence. It also sought information on the resulting calls on healthcare professionals and the degree of satisfaction with treatments received. The age and gender distributions of the sample selected for survey matched those in the population from which it was drawn. Of the 1420 respondents, only 1304 declared their age and gender--a condition for inclusion in the analysis. Of these, 610 reported some form of unduly prolonged pain, which had lasted more than a year in 530. For all pain lasting longer than a year, the estimated prevalence of mild pain was 11%, severe 25% and intolerable 3.5%: the corresponding estimates for persistent as opposed to episodic pain were 2% for mild, 10% for sever and 1% for intolerable. Pain was present in more than one anatomical location in most of those who reported it. Musculoskeletal pain was overwhelmingly the most common. Increasing age, obesity and being female pre-disposed to the reporting of pain, with women being more liable to report headache and pain in the neck and shoulder. One hundred and thirty-six pain reporters either gave no information on consultation or sought no help from healthcare professionals: a third of the remainder consulted more than one professional, with general practitioners and specialists in physical medicine (niedergelassener Orthopäde) being the most common. A wide variety of treatments were used, with oral medications, massage, exercises, mud pack and heat treatment being the most popular; two-thirds of sufferers used more than one type of treatment. The most popular types of treatment tended also to be the most successful, except for oral medication (which was also the most heterogeneous). Multiple logistic regression analyses identified consistent associations between duration and severity of pain, the number of sites where it was reported, the numbers of healthcare professionals consulted and the number of treatments tried, and the same groupings of features were associated with decreased likelihood of overall satisfaction with treatment received.

Adolescent↗
PubMed1996

Use of alfentanil for in vitro fertilization oocyte retrieval.

STUDY OBJECTIVES: To determine alfentanil levels with a specific radioimmunoassay in serum and ovarian follicular fluid. DESIGN: Observational study. SETTING: University hospital. PATIENTS: 14 ASA status I women undergoing oocyte retrieval for in vitro fertilization. INTERVENTIONS: General anesthesia was induced with alfentanil 15 micrograms/kg and midazolam 2 mg and maintained with alfentanil 0.5 mg, 60% nitrous oxide (N2O) in oxygen (O2) and midazolam up to a total of 4 mg. Oocyte retrieval was performed using a transvaginal ultrasound guided technique, 34 to 36 hours after human chorionic gonadotrophin administration. MEASUREMENTS AND MAIN RESULTS: Mean procedure time for oocyte retrieval was 18 +/- 2.4 (SEM) minutes. All patients were fully awake within 5 minutes and all patients except one were able to move from the operating table to the stretcher with minimal help. Mean total protein concentration in the follicular fluid was 3.8 +/- 0.4 mg%. Maximal serum alfentanil concentrations (Cmax) were attained 5 minutes after start of the procedure (tmax) and were 92 +/- 20 ng/ml. In contrast, alfentanil concentrations in the follicular fluid increased constantly throughout the procedure up to 8.9 +/- 0.8 ng/ml at 15 minutes. Clinical pregnancy rate was 3 of 14 patients. CONCLUSION: It is evident that during the oocyte retrieval procedure, the alfentanil concentrations in the follicular fluid are about ten-fold smaller than the serum alfentanil concentrations at the same time points. Similar pharmacokinetics have been shown when propofol was used as anesthetic. The low accumulation of alfentanil in the follicular fluid increases the attractiveness of alfentanil for anesthesia during oocyte retrieval for in vitro fertilization.

Adult↗
PubMed1996

Patient-controlled epidural diamorphine for post-operative pain: verbal rating and visual analogue assessments of pain.

Twenty-two patients were studied while receiving epidural analgesia with diamorphine after major lower abdominal surgery under combined regional and general anaesthesia. Epidural PCA began when the intraoperative epidural block with bupivacaine wore off enough for the patient to request treatment. It was started with 2 mg of diamorphine and continued with a reducible background infusion that was initially set at 0.2 mg h-1 and supplemented by on-demand doses of 0.2 mg, with a lockout time of 15 min. The patients received routine post-operative monitoring and care, with pain at rest being assessed on a four-point verbal rating scale (VRS, none, mild, moderate, severe) at 5, 10, 15, 30, 45, 60, 90 and 120 min from the start of ePCA, then hourly until 24 h and then 2-hourly until 48 h. VRS on coughing and a 10 cm visual analogue score (VAS) at rest and on coughing were recorded at the same times at 4 h, then 4 hourly until 24 h and then at 48 h, at which times, blood samples were also taken to measure morphine concentrations by radioimmunoassay. Analgesia started promptly and reached a maximum at between 30 and 45 min, accompanied by maximum sedation. Thereafter clinically acceptable analgesia was maintained without undue sedation for 48 h, though pain on coughing was less well controlled than pain at rest. After the initial loading dose of diamorphine, the 95% confidence intervals (CI) for further consumption were 3.7 to 17 mg (average 9.7) in the first 24 h and 2.1 to 12.9 mg (average 6.7 mg) in the second 24 h. The plasma morphine concentrations rose to a plateau by about 15 min, with concentrations within 95% CI from 0 to 11 ng mliters-1 (average 5 ng mliters-1. The VRS and VAS pain scores were analysed by a conservative approach that treated them as ordinal data, and by a parametric approach that treated them as interval data. Both approaches conveyed broadly similar information about the post-operative analgesia.

Abdomen↗
PubMed1996

[Treatment of pain with peridural administration of opioids].

The advantages and disadvantages associated with epidural opioids require careful selection of the opioid and its dosage. There is presently no ideal opioid available for epidural use. Comparative pharmacokinetic data help to select the appropriate epidural opioid. Morphine (provided it is given in small doses and volumes) is very appropriate for epidural pain treatment, especially for longer periods of treatment, due to excellent analgesia and very low systemic morphine concentrations. The faster onset of analgesia with epidural pethidine, alfentanil und fentanyl make these opioids recommendable. However, due to the increased risk of respiratory depression during continuous treatment, these drugs should not be given over extended periods. Epidural administration of methadone, sufentanil und buprenorphine cannot be recommended since the advantages over systemic use do not outweigh the risks. Epidural tramadol may be useful in clinical routine, if opioids are not available and supervision of the patient is not guaranteed, because tramadol is not restricted by law and has a low potential for central depressive effects. The safety of the patients should be paramount. If patients are harmed by inappropriate opioids or dose regimens this will discredit a valuable for treating postoperative pain. Postoperative epidural dosages should be as low as possible and be titrated to the patient's individual needs for analgesia. Epidural morphine treatment is an alternative to step 4 of the WHO treatment regimen for patients with intractable pain or those suffering from systemic opioid side effects. Careful selection of patients helps to increase successful treatment. If implantable devices (ports or pumps, according to the life expectancy) are employed, the intrathecal route of administration is preferable to the epidural route, as the latter has a 10 times higher morphine dose requirement.

Analgesia, Epidural↗
PubMed1995

[Treatment of postoperative pain with peridural administration of opioids].

The advantages and disadvantages associated with epidural opioids require careful selection of the opioid and its dose regimen. There is no ideal opioid available for epidural use. Comparative pharmacokinetic data help selection of the appropriate epidural opioid. Morphine (provided it is given in small doses and volumes) is very appropriate for epidural pain treatment, especially for longer periods of treatment, due to the excellent analgesia and very low systemic morphine concentrations. The faster onset of analgesia makes the epidural application of pethidine, alfentanil and fentanyl recommendable. However, due to the increased risk of respiratory depression during continuous treatment, these opioids should not be given over longer treatment periods. Epidural administration of methadon, sufentanil and buprenorphine cannot be recommended since the advantages over systemic use do not outweigh the risks. Epidural tramadol is useful in clinical routine if opioids are not available and supervision of the patient is not guaranteed, because the opioid is not restricted by law and has a low potential for central depressive effects. Nalbuphine and butorphanol should not be selected for epidural use until the benefit/risk ratio is defined. The safety of patients is paramount. If patients are harmed by inappropriate opioids or dose regimens, this will unjustly discredit a valuable treatment of postoperative pain.

Analgesia, Epidural↗