Current medical research and opinion
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Randomized Controlled Trial Comparative Study Clinical Trial
Controlled clinical trial on the efficacy and safety of oral sulodexide in patients with peripheral occlusive arterial disease.
One hundred and seven adult outpatients with Leriche stage II peripheral occlusive arterial disease took part in this open, controlled trial. Patients were randomly treated over a six-month period either with sulodexide capsules containing 250 lipoproteinlipase releasing units (LRU, two capsules twice daily for 176 days on average: 56 patients), or with pentoxifylline 400 mg tablets (one tablet three times a day for 180 days on average: 51 patients). The incidences of diabetes, hyperlipoproteinaemias, smoking habit and other risk factors were the same in the two groups. ⋯ In the pentoxifylline group 17.6% of patients complained of gastroenteric disorders (nausea, vomiting, dyspepsia), or of headache and dizziness. In one patient of this latter group insomnia was also present. Systemic tolerance of both drugs was consistently good.
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Randomized Controlled Trial Comparative Study Clinical Trial
A comparison of etodolac (Ultradol) with acetaminophen plus codeine (Tylenol #3) in controlling post-surgical pain in vasectomy patients.
The efficacy and safety of etodolac (Ultradol) and acetaminophen plus codeine [A + C (Tylenol #3)] in controlling post-surgical pain were compared in an open-label, randomized, parallel-group outpatient study. Patients who were voluntarily having a vasectomy performed for sterilization were assigned to receive either etodolac 200 mg (20 patients) or A + C (20 patients). All medication was taken as required for up to 7 days. ⋯ Results of the study indicated that patients taking etodolac were more likely to say they could return to work 24 hours after their vasectomy (p = 0.04). There were no other statistically significant differences between the two groups of patients. The results from this study indicate that etodolac and A + C are equally efficacious and well-tolerated for the control of post-vasectomy pain and that patients may observe an increased benefit with etodolac by being able to return to work sooner.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Ibuprofen and diclofenac sodium in the treatment of osteoarthritis: a comparative trial of two once-daily sustained-release NSAID formulations.
An investigator-blind, parallel-group, multicentre study was undertaken to compare the efficacy and tolerability of once-daily, sustained-release (s-r) ibuprofen and diclofenac sodium in patients (mean age 59.8 years) suffering from painful osteoarthritis affecting chiefly the knee and/or hip. Patients attending eight Swiss centres received either two s-r tablets of ibuprofen (daily dose 1600 mg; n = 30) or a single s-r diclofenac 100 mg tablet (n = 31) each evening for 21 days. Clinical assessments were performed prior to initiating therapy and after 7 and 21 days of treatment. ⋯ In conclusion, although both NSAID treatments improved the clinical condition of patients with painful osteoarthritis, statistically significant differences in favour of once-daily s-r ibuprofen (1600 mg) were demonstrated in terms of efficacy, indicating a potential therapeutic advantage for this formulation. Ibuprofen was also better tolerated than diclofenac sodium (100 mg/day), the latter being associated with gastrointestinal side effects in a significant proportion of patients. Sustained-release ibuprofen (Brufen Retard) thus represents an important addition to the available therapeutic armamentarium of once-daily NSAID formulations.
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Randomized Controlled Trial Comparative Study Clinical Trial
Investigation into the duration of action of sustained-release ibuprofen in osteoarthritis and rheumatoid arthritis.
The duration of action of sustained-release ibuprofen ('Brufen Retard') was investigated in a 14-day double-blind study involving 14 osteoarthritis and 10 rheumatoid arthritis patients. The recommended once-daily dosage of this preparation (1600 mg taken in the evening) provided effective control of arthritic symptoms for both patient groups, with significant overall improvements in pain and stiffness compared to baseline. ⋯ The 24-hour clinical action underlying these findings is consistent with ibuprofen plasma profiles obtained with the sustained-release preparation in earlier pharmacokinetic studies. It is likely that the greater sensitivity of rheumatoid patients to withdrawal of a single day's active treatment in this study reflects a more severe inflammatory disease process than that of the osteoarthritis patients.
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Randomized Controlled Trial Clinical Trial
The efficacy of pre-operative controlled-release indomethacin in the treatment of post-operative pain.
A double-blind, placebo-controlled study in patients undergoing lumbar laminectomy was carried out to assess the morphine-sparing effect of a controlled-release indomethacin formulation ('Flexin Continus' tablets, 75 mg). Thirty patients were randomly allocated to receive 1 tablet of active or placebo study medication pre-operatively and their pain scores on visual analogue scale (VAS) and their morphine consumption, delivered by Patient Controlled Analgesia (PCA), were recorded over the 24-hour post-operative period. ⋯ At the 12-hour time point, the difference in morphine consumption approached statistical significance (p = 0.074). It is concluded that the pre-operative administration of controlled-release indomethacin reduces post-operative morphine requirements and significantly reduces VAS pain scores on recovery.