Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0917801 (insomnia)
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An on-going multi-centre, double-blind, parallel-group study is being carried out to compare the efficacy and tolerability of sustained-release (SR) formulations of etodolac and diclofenac in patients with degenerative joint disease (osteoarthritis) of the knee. An interim analysis of the findings has been made for 64 patients from two centres which have now completed their part in the study. Thirty-two patients were randomly assigned to receive 600 mg etodolac SR once daily for 4 weeks; the remaining 32 patients received 100 mg diclofenac SR. Primary efficacy assessments rated on a 5-point categorical scale were patient and physician overall assessments of the patient's condition, night pain and pain intensity. Secondary efficacy parameters included weight-bearing pain, stiffness duration, joint tenderness on pressure, degree of swelling and erythema, degree of knee flexion and time to walk 15 metres. The results showed that for both etodolac SR and diclofenac SR treatment groups there was an improvement from baseline in all efficacy parameters at the last visit and no statistically significant difference was observed between treatments. However, although not statistically significant, the improvement rate in the patient's condition at Week 2 was slightly greater in the etodolac SR treatment group, suggesting that improvement may occur more rapidly with etodolac SR than with diclofenac SR. With regard to tolerability, 5 patients in the etodolac SR treatment group and 3 in the diclofenac SR group withdrew from the study because of adverse reactions. Two events (dyspepsia and mouth ulceration) in the etodolac SR group and 4 events (headache, glossitis, depression and insomnia) in the diclofenac SR group were considered to be definitely drug-related. Dyspepsia was reported by 3 patients (1 withdrawal) treated with etodolac SR and by 4 patients (2 withdrawals) treated with diclofenac SR. A statistically significant decrease was observed in haemoglobin and haematocrit values after 4 weeks of treatment in the diclofenac SR group, but this was not considered to be clinically important. In addition, there were no clinically significant changes in blood chemistry and urinalysis for either treatments. In conclusion, the results of the present study indicate that 600 mg etodolac SR once daily for 4 weeks is effective in the treatment of patients with degenerative joint disease of the knee, as is 100 mg diclofenac SR. In addition, both drugs have comparable tolerability profiles.
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PMID:Double-blind comparison of etodolac SR and diclofenac SR in the treatment of patients with degenerative joint disease of the knee. 146 39

Osteoarthritis (OA) is a common painful inflammatory condition occurring mainly in the later half of life. Hip and knee are the joints mostly affected. Petiveria alliacea (tipi) popularly known as an anti-rheumatic medicine, has been used by OA patients to relief pain. This one-week cross-over double-blind trial has preliminary evaluated the analgesic effect of tipi tea in 14 patients with hip and knee OA. Imperata exaltata (sape) was used as the Placebo tea. The pain assessments that were made at baseline and before the start of the second treatment period by treatment groups were comparable. While taking tipi or placebo tea patients experienced a statistically significant improvement in pain on motion and pain at night. The comparison between the improvements reported while on tipi and placebo tea, however, did not disclose any statistically significant difference. At the conclusion of the study 7 patients preferred tipi tea and 6 preferred placebo tea (NS). Two patients reported insomnia, one during placebo treatment and the other during tipi treatment.
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PMID:The effectiveness of tipi in the treatment of hip and knee osteoarthritis--a preliminary report. 184 10

A double-blind, crossover study was carried out in 31 patients with rheumatoid arthritis or osteoarthritis who suffered from insomnia which was considered to be caused primarily by their disease. Patients received 7-day courses of 400 mg chlormezanone, 200 mg chlormezanone and placebo in a pre-determined random order. Patients rated chlormezanone significantly (p less than 0.025) more effective than placebo in overcoming sleep disturbance and preferred the 400 mg dose. There was also a trend towards better quality of sleep with chlormezanone, although this did not attain statistical significance in this relatively small study. Daytime alertness was similar for both active and placebo treatment periods. Chlormezanone, therefore, would seem to be a useful addition to antirheumatic therapy when there is related insomnia.
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PMID:Treatment of sleep disturbance in arthritis with chlormezanone. 635

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

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. Both treatments were efficacious, but statistically significant differences in favour of s-r ibuprofen were observed for the principal measure of efficacy, the investigator's assessment of the overall change in clinical condition; by Day 21, 37% of ibuprofen-treated patients vs 10% of diclofenac-treated patients were 'much improved' (p = 0.04). Patients' assessments of the efficacy of their treatment also favoured s-r ibuprofen at Day 7 for the relief of night pain (p = 0.048), at Day 21 for alleviation of day pain (p = 0.006) and for the ability to carry out normal activities (p = 0.01), and at both Days 7 and 21 for quality of sleep (p = 0.04 and 0.03, respectively). The patients' overall opinion of treatment was also significantly in favour of s-r ibuprofen, which was rated 'good or excellent' by 80% (24/30), compared with only 38% of patients (11/29) receiving s-r diclofenac sodium (p = 0.002). Two patients (6%) receiving s-r diclofenac sodium ceased treatment owing to dizziness and severe diarrhoea, respectively; there were no withdrawals in the ibuprofen-treated group. Ten (32%) patients in the s-r diclofenac group reported a total of 12 adverse events (mostly gastrointestinal in nature), compared with three (10%) patients in the s-r ibuprofen group who reported only three events (abdominal pain, insomnia and constipation). 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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PMID:Ibuprofen and diclofenac sodium in the treatment of osteoarthritis: a comparative trial of two once-daily sustained-release NSAID formulations. 901 Jun 10

Moderate exercise for middle-aged and older adults is emerging as an important adjuvant to the treatment of many diseases. These include cardiovascular disease, diabetes, osteoporosis, osteoarthritis, insomnia, deconditioning, and (to a degree) obesity. A recent report from the United States Surgeon General recommends that most adults exercise most if not all days of the week, accumulating 180 minutes of moderate intensity exercise weekly. If your patients have been previously sedentary, encourage them to start a slow, stepwise exercise program. Ongoing support, encouragement, and follow-up can help them commit to and maintain a program of regular exercise.
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PMID:Exercise at midlife: how and why to prescribe it for sedentary patients. 915 19

A prospective, open trial to evaluate the safety and efficacy of oral meloxicam 7.5 mg once daily over a period of 28 days in Thai patients with osteoarthritis was conducted in 3 major hospitals in Bangkok, Thailand. A total of 137 patients were enrolled and completed the study protocol. The mean age of the patients was 57.6 years and 88 per cent were female. Pain on movement and pain at rest evaluated after treatment by visual analog scale (VAS) were significantly improved with respect to the baseline status (p<0.001). The final efficacy was reported as satisfactory or good in 97 per cent and 94 per cent as determined by patients and physicians respectively. Patient status evaluated at the end of the study reported improvement of their arthritic condition in 84 per cent. Drug tolerability assessed by patients and physicians and was good or satisfactory in 99 per cent and 98 per cent. GI adverse event was reported in 8.8 per cent. Other adverse events were itching/rash in 2.0 per cent and headache/insomnia in 1.5 per cent of patients. No patients withdrew from the study due to adverse events. No GI bleeding or perforation were observed. No hospitalization was observed during the study. There was no significant change of blood chemistry and hematological profile between pre and post treatment examination. Results from this study suggest that oral meloxicam 7.5 mg for 28 days is a safe and effective treatment regimen with high GI tolerability profile for the treatment of osteoarthritis in Thai patients.
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PMID:Safety and efficacy of meloxicam 7.5 mg in the treatment of osteoarthritis in Thai patients. 1185 78

The present study tested cognitive-behavioral therapy (CBT) for insomnia in older adults with osteoarthritis, coronary artery disease, or pulmonary disease. Ninety-two participants (mean age = 69 years) were randomly assigned to classroom CBT or stress management and wellness (SMW) training, which served as a placebo condition. Compared with SMW, CBT participants had larger improvements on 8 out of 10 self-report measures of sleep. The type of chronic disease had no impact on these outcomes. The hypothesis that CBT would improve daytime functioning more than SMW was only supported by a global rating measure. These results add to findings that challenge the dichotomy between primary and secondary insomnia and suggest that psychological factors are likely involved in insomnias that are presumed to be secondary to medical conditions.
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PMID:A placebo-controlled test of cognitive-behavioral therapy for comorbid insomnia in older adults. 1639 89

Obesity is associated with many diseases, particularly diabetes, hypertension, osteoarthritis, and heart disease. The obesity incidence has increased at an alarming rate in recent years, becoming a worldwide health problem, with incalculable social costs. Two different obesity-treatment drugs are currently on the market: orlistat, which reduces intestinal fat absorption via inhibiting pancreatic lipase; and sibutramine, an anorectic or appetite suppressant. Both drugs have hazardous side-effects, including increased blood pressure, dry mouth, constipation, headache, and insomnia. For this reason, a wide variety of natural materials have been explored for their obesity treatment potential. These are mainly complex products having several components with different chemical and pharmacological features. This review aimed to survey the literature covering natural products with anti-obesity activity and to review the scientific data, including experimental methodologies, active components, and mechanisms of action against obesity.
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PMID:Possible anti-obesity therapeutics from nature--a review. 2073 1

Sleep disorders and various common acute and chronic medical conditions directly or indirectly affect the quality and quantity of one's sleep or otherwise cause excessive daytime fatigue. This article reviews the potential contribution of several prevalent medical conditions - allergic rhinitis, asthma, chronic obstructive pulmonary disease, rheumatoid arthritis/osteoarthritis - and chronic fatigue syndrome and clinical sleep disorders - insomnia, obstructive sleep apnea, narcolepsy, periodic limb movement of sleep, and restless legs syndrome - to the risk for drowsy-driving road crashes. It also explores the literature on the cost-benefit of preventive interventions, using obstructive sleep apnea as an example. Although numerous investigations have addressed the impact of sleep and medical disorders on quality of life, few have specifically addressed their potential deleterious effect on driving performance and road incidents. Moreover, since past studies have focused on the survivors of driver crashes, they may be biased. Representative population-based prospective multidisciplinary studies are urgently required to clarify the role of the fatigue associated with common ailments and medications on traffic crash risk of both commercial and non-commercial drivers and to comprehensively assess the cost-effectiveness of intervention strategies.
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PMID:Sleep disorders, medical conditions, and road accident risk. 2113 Feb 15


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