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Maintenance therapy with proglumetacin was studied in an open investigation in 25 patients with classical or definite rheumatoid arthritis and in 34 patients with osteoarthrosis. Proglumetacin (150 mg) was administered twice daily, at meals, and therapy was continued without interruption for 12 months. Patients with rheumatoid arthritis showed a progressive improvement in objective parameters (erythrocyte sedimentation rate, haemoglobin) and in semi-objective parameters (pain, articular tenderness, number of painful joints, morning stiffness, grip strength, Ritchie articular index). Patients with osteoarthrosis also showed a progressive improvement in objective parameters (movement angles of the affected joints) and in subjective parameters (pain, mobility, response to therapy). During the study, 4 patients reported occasional nausea (3 with vomiting), and 3 reported episodes of slight headache. These symptoms did not require interruption of treatment. Haematology, blood chemistry and urinalysis were not adversely affected by the treatment. Five drop-outs were recorded in the rheumatoid arthritis group: 2 because patients failed to report, 2 because of severe relapses which required a radical change in the therapeutic programme and 1 for incorrect enrollment. Fourteen drop-outs were recorded in the osteoarthrosis group: 6 because the patients failed to report, 4 because of orthopaedic surgery and 4 because it was necessary to change the therapeutic programme. No drop-out was due to an intolerance to proglumetacin. It is concluded that proglumetacin appears to have the effectiveness of tolerability features required for a first-choice medicament for long-term maintenance treatment of patients with rheumatoid arthritis or with osteoarthrosis.
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PMID:Maintenance therapy of rheumatoid arthritis and of osteoarthrosis with proglumetacin. 684 68

A controlled trial was designed to compare both the long-term efficacy and the safety of fenbufen and indomethacin in patients with osteoarthritis. One hundred and ten patients of both sexes (aged 33 to 79 years) who had both subjective and objective (including radiological) evidence of osteoarthritis, and who met the minimal entry criteria, were enrolled into the studies. Patients were randomly assigned to receive either fenbufen capsules b.i.d. (600-1000 mg/day) or identical appearing indomethacin capsules b.i.d. (750-125 mg/day). Thirty-seven fenbufen and 26 indomethacin patients completed twelve months of treatment. Both fenbufen and indomethacin provided statistically nd clinically significant improvement at months 1, 3, 6, 9 and 12. There were no significant differences in improvement between the two treatment groups. Fenbufen-treated patients, however, reported fewer occurrences (4) of severe drug-related adverse experiences than indomethacin-treated patients (20). Significantly fewer headaches were reported with fenbufen and the number of patients terminating treatment because of adverse experiences was significantly greater with indomethacin. Fenbufen, in this patient population, provided a superior ratio of benefits to risk for the long-term treatment of osteoarthritis.U
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PMID:Long-term, double-blind randomized parallel group studies comparing fenbufen and indomethacin in patients with osteoarthritis. 704 4

Two groups of patients, each consisting of 20 patients suffering from spinal osteoarthrosis, coxarthrosis or gonarthrosis participated in a double-blind comparative trial. They received either Lonazolac-Ca (200 mg three times daily) or Naproxen (250 mg twice daily plus 1 placebo capsule in between doses) for three weeks. The therapeutic response was assessed by monitoring pain intensity at rest and on exercise, joint tenderness and joint movement, muscular tension, morning stiffness and walking ability. In spinal osteoarthrosis vertebral flexibility was also measured. Nine out of 11 parameters showed significant improvement with Lonazolac-Ca, whereas only 6 out of 11 improved with Naproxen. However, no clinically relevant differences were recorded between both medications. Laboratory tests in both treatment groups revealed no changes in haematological or biochemical parameters nor in urinanalysis results. Drug-related gastro-intestinal side effects were observed in 2 patients of each treatment group. The patients on Lonazolac-Ca tolerated their medication with the aid of concomitant antacids whereas Naproxen had to be discontinued. One case of dermatitis, which was probably not drug-related was observed in each group. One patient suffering from migraine experienced vertigo and headache on taking Lonazolac-Ca; although this was probably not drug-related medication was discontinued.
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PMID:[Double-blind comparative trial of lonazolac-Ca versus naproxen in spinal osteoarthrosis, coxarthrosis and gonarthrosis (author's transl)]. 704 48

With the increased incidence of whiplash injury following the introduction of compulsory car seat belts, a large number of reports have dealt with the aftermath of this condition. Previous studies, however, focused on somatic symptoms on the one hand or considered only psychological or neuropsychological variables on the other hand, often in loosely defined or selected groups of patients. No study so far has analyzed the long-term outcome in a nonselected group of patients using a clear injury definition considering patient history; somatic, radiologic, and neuropsychological findings; and features of the injury mechanisms assessed soon after trauma and during follow-up. the present investigation was designed to assess these combined factors. According to a strict definition of whiplash injury, we assessed a consecutive nonselected sample of 117 patients with recent injury who had similar sociocultural and educational backgrounds. The patients had been in automobile crashes and were all equally covered by accident insurance according to the country-wide scheme. Initial examination was performed 7.2 +/- 4.2 days after trauma, and follow-up examinations 3, 6, 12, and 24 months later. At baseline, features of injury mechanism, subjective complaints, and different aspects of patient history were documented and cervical spine X rays performed. At all examinations patients underwent neurologic examination and cognitive and psychosocial factor assessment. At 2 years, patients were divided into symptomatic and asymptomatic groups and then compared with regard to the initial findings. In addition, symptomatic patients who were disabled at the 2-year follow-up examination and symptomatic patients not disabled (that is, they were able to work at the pretraumatic level) were compared regarding initial and 2-year findings. At 2 years, 18% of patients still had injury-related symptoms. With regard to baseline findings the following significant differences were found: Symptomatic patients were older, had higher incidence of rotated or inclined head position at the time of impact, had higher prevalence of pretraumatic headache, showed higher intensity of initial neck pain and headache, complained of a greater number of symptoms, had a higher incidence of symptoms of radicular deficit and higher average scores on a multiple symptom analysis, and displayed more degenerative signs (osteoarthrosis) on X ray. In addition, symptomatic patients scored higher with regard to impaired well-being and performed worse on tasks of attentional functioning and showed more concern with regard to long-term suffering and disability.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:Long-term outcome after whiplash injury. A 2-year follow-up considering features of injury mechanism and somatic, radiologic, and psychosocial findings. 756 68

The safety of a fixed combination of diclofenac 50mg/misoprostol 200 micrograms has been evaluated in clinical trials involving almost 2000 patients. Short term trials have been conducted in patients with osteoarthritis (n = 1032) and rheumatoid arthritis (n = 685) over 1 or 3 months. Patients randomly received either diclofenac alone or diclofenac/misoprostol. In both groups, the most frequently reported adverse events were gastrointestinal in nature, with abdominal pain reported most frequently (in 22.6% of patients receiving diclofenac/misoprostol and 19.8% of patients receiving diclofenac), followed by diarrhoea (19.5 vs 11.3%), nausea (11.0 vs 6.5%) and dyspepsia (10.6 vs 7.8%). The most frequent nongastrointestinal adverse event was headache, which occurred in 7.9% of diclofenac/misoprostol recipients and 9.3% of diclofenac recipients. Although diclofenac/misoprostol was associated with a slightly higher prevalence of adverse events than diclofenac in these studies, the majority were of mild or moderate severity, and the treatment groups were similar as regards the number of patient withdrawals resulting from adverse events. An interim analysis of the results of an ongoing trial of longer term administration of diclofenac/misoprostol (for up to 24 months) has been conducted. In this uncontrolled study, patients with rheumatoid arthritis, osteoarthritis or ankylosing spondylitis received diclofenac/misoprostol for up to 24 months; to date 1003 patients have been enrolled and treatment has been continued for 6, 12, 18 and 24 months in 640, 327, 108 and 13 patients, respectively. As in the short term trials, the adverse events reported most commonly in this study have been predominantly gastrointestinal.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Review of the safety of diclofenac/misoprostol. 768 86

The risk of renal papillary necrosis and renal dysfunction due to the chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) is unknown. In a prospective study of 259 heavy analgesic users seen in a general medical hospital over an 11-year-period beginning in January 1982, 69 new cases of analgesic nephropathy with renal papillary necrosis were confirmed by intravenous urogram (26.6%), ultrasonography (30.4%), and/or computed tomography (43%). Twenty-nine of these patients (42%) had consumed excessive quantities of NSAIDs alone; an additional nine patients (13%) had consumed NSAIDs predominantly in combinations with paracetamol, aspirin, phenacetin, caffeine, and/or traditional herbal medications. Of those patients who consumed NSAIDs alone, 17 had consumed only a single type of NSAID and the remaining 12 had consumed multiple types of NSAIDs. The amount of NSAIDs administered ranged from 1,000 to 26,600 capsules or tablets over a 2- to 25-year period. Renal impairment (serum creatinine, 126 to 778 mumol/L) was noted in 26 of these 38 patients (64.8%). The reasons given for consuming NSAIDs include gouty arthritis (18 patients), osteoarthritis (seven patients), rheumatoid arthritis (six patients), chronic headache (three patients), gouty arthritis plus chronic headache (three patients), and chronic backache (one patient). All patients were prescribed these drugs and were followed medically. The occurrence of analgesic nephropathy was predominantly in males (male to female ratio, 1.9:1). Most of the patients did not have the characteristic psychological profile attributed previously to analgesic abuse nephropathy. Associated addictive habits, such as the use of psychotropic drugs and sleeping tablets, purgative abuse, and alcoholism, were absent.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Chronic renal disease and papillary necrosis associated with the long-term use of nonsteroidal anti-inflammatory drugs as the sole or predominant analgesic. 802 20

We report the findings of a total population survey of Thugbah community in the Eastern Province of Saudi Arabia (SA) to determine its point prevalence of neurological diseases. During this two-phase door-to-door study, all Saudi nationals living in Thugbah were first screened by trained interviewers using a pretested questionnaire (sensitivity 98%, specificity 89%) administered at a face-to-face interview. Individuals with abnormal responses were then evaluated by a neurologist using specific guidelines and defined diagnostic criteria to document neurological disease. The questionnaire was readministered blind by a neurologist to all those with abnormal responses and a 1-in-20 random sample of those without abnormal responses, respectively. The family members of an individual with an abnormal response were also screened to improve accuracy. A total of 23,227 Saudis (98% of the eligible subjects) were screened and those residing in Thugbah on the reference date (22,630) were used to calculate the point prevalence rates. Forty-two percent of those screened were in the first decade of life and only 1.5% were more than 60 years old. There were marginally more females (50.2%) than males (49.8%). Consanguineous marriages especially between first cousins were present in 54.6%. The demographic characteristics of Thugbah community were similar to those in other parts of SA. The overall crude prevalence ratio (PR) for all forms of neurological disease was 131/1,000 population. All subsequent PRs are per 1,000 population. Headache syndromes were the most prevalent disorder (PR 20.7). The PR for all seizure disorders was 7.60, and the epilepsies (6.54) were more frequent than febrile convulsions (0.84). Mental retardation, cerebral palsy syndrome, and microcephaly were common pediatric problems with PRs of 6.27, 5.30 and 1.99, respectively. Stroke, Parkinson's disease, and Alzheimer's disease were uncommon with respective PRs of 1.8, 0.27 and 0.22. Central nervous system (CNS) malformations (0.49) such as hydrocephalus and meningomyelocele were more prevalent than spinal muscular atrophy (0.13), congenital brachial palsy (0.13) and narcolepsy (0.04). Multiple sclerosis was rare (0.04). Osteoarthritis and low back pain syndromes were the main non-neurological conditions seen. The major medical diseases that may be neurologically relevant were diabetes mellitus, hypertension, and connective tissue disorders.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:A community survey of neurological disorders in Saudi Arabia: the Thugbah study. 827 77

The records of 193 randomly chosen patients with CMD referred 2.5 yr previously were examined retrospectively for anamnestic, clinical and radiological findings and observations related to treatment. These data were supplemented with information from questionnaires sent to all treated patients in which their opinion on the treatment outcome was asked. Within the patient group, four diagnostic subgroups were distinguished. Three subgroups consisted of patients with the diagnoses CMD with a mainly myogenous component, osteoarthrosis and internal derangement respectively, whereas the fourth subgroup consisted of patients who did not fit into one of these categories. Differences between the four groups were found concerning mean age, the prevalence of a limited range of motion, headache, psychosocial factors, loss of posterior tooth support and objective treatment outcome. The patients with CMD with a mainly myogenous component showed the highest percentages of CMD associated disorders, the least successful treatment outcome and the highest percentage of renewed treatment. The patients with internal derangement showed the lowest mean age, the highest prevalence of a limited range of motion and the best treatment outcome. The patients in the osteoarthrosis group showed the highest mean age and the highest percentage of loss of posterior tooth support. It may be concluded that the evaluation of diagnostic subgroups of CMD patients has to be preferred in the assessment of a heterogeneous group of patients with CMD.
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PMID:Characteristics and treatment outcome of diagnostic subgroups of CMD patients: retrospective study. 837 Feb 58

This 4-week, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicenter study was designed to compare the efficacy and safety of etodolac and nabumetone in the treatment of patients with active osteoarthritis (OA) of the knee. Ninety-one patients received etodolac 400 mg twice daily, 89 received nabumetone 1500 mg once daily, and 90 received placebo. Both active treatments significantly improved the patients' condition relative to baseline (P < or = 0.001) at all evaluations during treatment and relative to placebo (P < or = 0.05) by visit 4. Improvement relative to placebo in investigator's global assessments was earlier in the etodolac group (ie, by visit 3) than in the nabumetone group. At visit 4, improvement in investigator's and patient's global assessment scores, and in the distribution of investigator's assessment scores, was significantly (P < or = 0.05) greater in the etodolac group than in the nabumetone group. Other than hypokalemia, which occurred only in three patients in the nabumetone group (P = 0.035), there were no significant differences among the groups in the frequency of study events or premature discontinuation from the study as a result of study events. Study events considered at least possibly treatment related were reported for 26 patients in the etodolac group (28.6%), 20 in the nabumetone group (22.5%), and 23 in the placebo group (25.6%). The most frequently reported symptoms for all groups were dyspepsia, nausea, and headache. Four patients treated with nabumetone (4.5%) had elevations in aspartate aminotransferase or alanine aminotransferase during treatment. The results of this study show that etodolac 400 mg twice daily is at least as effective as nabumetone 1500 mg once daily and is equally well tolerated in the treatment of patients with active OA of the knee; etodolac may have an earlier onset of action and/or a relatively greater efficacy in patient and investigator global assessments than nabumetone.
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PMID:Double-blind, placebo-controlled comparison of the safety and efficacy of orally administered etodolac and nabumetone in patients with active osteoarthritis of the knee. 856 24

Ro 15-8081, a substituted cyclohexanol hydrochloride, inhibits the re-uptake of norepinephrine and of serotonin. Its antinociceptive properties have been demonstrated in animals and then confirmed in humans after single-dose administration. The objective was to determine the analgesic efficacy and the safety of Ro 15-8081 in osteoarthritis of the hip and knee (femoro-tibial location) after multiple-dose application. The design for studying dosage employed 5 parallel groups in an international multicenter, double-blind, randomized trial having a duration of 2 weeks. Drugs studied were: 20 mg Ro 15-8081 (divided into 2 doses), 50 mg Ro 15-8081 (divided into 2 doses), 100 mg Ro 15-8081 (divided into 2 doses), placebo twice daily or 20 mg/day piroxicam (piroxicam in the morning and placebo in the evening). Piroxicam was used as a reference drug in order to validate clinical testing. Assessment criteria were pain (100-mm VAS) and function (Lequesne's index). A responder (main assessment criterion) was defined as a patient exhibiting a reduction of at least 30% of pain (VAS) during the study (intention-to-treat analysis). A total of 522 patients were enrolled in the study. A clear beneficial effect of piroxicam was observed when compared with placebo (70% and 48% of responders in piroxicam and placebo groups respectively; P < 0.0001). Multigroup comparison showed a statistically significant difference between Ro 15-8081 groups and the placebo group regarding mean change in pain between D1 and Dend and the rate of VAS responders. Comparison (Dunnett's t or chi 2 tests) between each individual Ro 15-8081 and the placebo group reached statistical significance for the 100 mg Ro 15-8081 group (mean change in pain between D1 and Dend: P = 0.05; percentage of responders: P = 0.0008) but no statistically significant difference for the other dosages of Ro 15-8081. Fifty-three patients withdrew from the study because of adverse events and/or inefficacy, mainly in 50 and 100 mg Ro 15-8081 groups and in a dose-related manner. The adverse events which appeared to be drug related were mainly dryness of the mouth, insomnia, headache, constipation, nausea, dizziness, nervousness, palpitation. This study suggests that 100 mg Ro 15-8081 per day divided into 2 doses has (1) an analgesic effect in hip or knee osteoarthritis and (2) poor acceptability in the conditions of the study regimen application.
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PMID:Ro 15-8081 in osteoarthritis of hip and knee: a double-blind placebo-controlled multicentre dose-ranging study on analgesia. 886 51


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