Pragmatic randomised controlled trial of local corticosteroid injection and naproxen for treatment of lateral epicondylitis of elbow in primary care. Efficacy of diclofenac in lateral epicondylitis of the elbow also treated with immobilization. The University of Montreal Orthopaedic Research Group. The effectiveness of topical diclofenac for lateral epicondylitis. Efficacy of pantoprazole in the prevention of peptic ulcers, induced by non-steroidal anti-inflammatory drugs: a prospective, placebo-controlled, double-blind, parallel-group study. Comparison of the efficacy of local corticosteroid injection and physical therapy for the treatment of adhesive capsulitis. Prevention of gastroduodenal damage induced by non-steroidal anti-inflammatory drugs: controlled trial of ranitidine. The effect of ranitidine on NSAID related dyspeptic symptoms with and without peptic ulcer disease of patients with rheumatoid arthritis and osteoarthritis. The role of viscosupplementation with hylan G-F 20 (Synvisc) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing hylan G-F 20 alone, hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone. Short course prednisolone for adhesive capsulitis (frozen shoulder or stiff painful shoulder): a randomised, double blind, placebo controlled trial.
To compare the clinical effectiveness of local corticosteroid injection, standard non-steroidal anti-inflammatory drugs, and simple analgesics for the early treatment of lateral epicondylitis in primary care.
                Multicentre pragmatic randomised controlled trial.
                23 general practices in North Staffordshire and South Cheshire.
                164 patients aged 18-70 years presenting with a new episode of lateral epicondylitis. Interventions: Local injection of 20 mg methylprednisolone plus lignocaine, naproxen 500 mg twice daily for two weeks, or placebo tablets. All participants received a standard advice sheet and co-codamol as required.
                Participants' global assessment of improvement (five point scale) at four weeks. Pain, function, and "main complaint" measured on 10 point Likert scales at 4 weeks, 6 months, and 12 months.
                Over 2 years, 53 subjects were randomised to injection, 53 to naproxen, and 58 to placebo. Prognostic variables were similar between groups at baseline. At 4 weeks, 48 patients (92%) in the injection group were completely better or improved compared with 30 (57%) in the naproxen group (P<0.001) and 28 (50%) in the placebo group (P<0.001). At 12 months, 43 patients (84%) in the injection group had pain scores </=3 compared with 45 (85%) in the naproxen group and 44 (82%) in the placebo group (P>0.05).
                Early local corticosteroid injection is effective for lateral epicondylitis. Outcome at one year was good in all groups, and effective early treatment does not seem to influence this. To evaluate the efficacy of an oral nonsteroidal anti-inflammatory drug in the treatment of lateral epicondylitis.
                Multicenter double-blind randomized controlled trial in which the following hypothesis was tested: whether diclofenac sodium provided a 20% or greater improvement over rest and cast immobilization in the response rate to treatment of lateral epicondylitis beyond and over rest in an experimental group compared with a control group after 4 weeks of treatment.
                Recruitment from urban general practices and referrals to 4 university hospitals.
                During a 1-year period, 206 subjects aged 18 to 60 years with lateral epicondylitis were recruited from the clientele treated by family physicians. Thirty subjects refused to participate and 47 presented with exclusion criteria, leaving 129 subjects who entered the study. One subject withdrew after 21 days.
                The experimental group was treated with a daily dose of diclofenac sodium (150 mg) for 28 days, while the control group received a placebo during the same period. In addition, both groups were immobilized in a cast for 14 days and were told not to perform repetitive movements of the involved limb for 21 days.
                Measuring instruments consisted of grip strength measurements with a squeeze dynamometer, a visual analog pain scale, a visual analog function scale, and an 8-item pain-free function index.
                A statistically and clinically significant reduction of pain was associated with treatment with diclofenac, but no clinically significant difference in grip strength or functional improvement could be detected between the 2 groups. Secondary effects (diarrhea and abdominal pain) were significantly more frequent in the diclofenac-treated group.
                Taking into account the limited improvement noted over rest and cast immobilization and the number of associated adverse events, it is difficult to recommend the use of diclofenac in the treatment of lateral epicondylitis at the dosage used in this study. Gastrointestinal upset and local pain commonly limit the use of oral nonsteroidal anti-inflammatory drugs and corticosteroid injection as treatments for lateral epicondylitis. Transdermal administration of an anti-inflammatory drug could avoid these adverse effects.
                To determine the effectiveness of topical diclofenac as a treatment of lateral epicondylitis.
                A convenience sample of 14 subjects meeting clinical criteria of chronic lateral epicondylitis participated in this randomized, double blind, crossover study. Each subject applied a pluronic lecithin liposomal organo-gel (PLO) over the affected lateral elbow three times daily for I week, followed by a 1-week "washout" period of no gel. A second topical PLO gel was then applied similarly for 1 week. Both gels were identical, but only one gel contained 2% diclofenac. Treatment order was randomized, and both the subject and tester were blinded. Pain and isometric wrist extension strength were measured using a visual analog pain scale (VAS) and a mounted manual muscle testing dynamometer, respectively, at the following time periods: just before application of the first gel, the last day of using the first gel, the last day of the washout week, and the last day of using the second gel. Analysis was performed using repeated measures analysis of variance.
                When subjects used diclofenac PLO, pain was significantly less than that during the pretreatment, washout, and placebo PLO periods (mean VAS: diclofenac PLO, 2.1; pretreatment, 3.5; washout, 3.4; placebo PLO, 3.6). Average wrist extension strength was significantly greater when subjects used diclofenac PLO (8.4 kg) than it was before treatment (5.9 kg). One subject developed a local rash while using diclofenac PLO.
                Topical 2% diclofenac in PLO appears to provide effective short-term reduction in elbow pain and wrist extensor weakness associated with chronic lateral epicondylitis. To evaluate the efficacy of pantoprazole in preventing gastrointestinal lesions in patients with rheumatic diseases receiving continuous, long-term treatment with non-steroidal anti-inflammatory drugs.
                This was a prospective, randomised, double-blind, unbalanced, placebo-controlled, parallel group study. Outpatients (n= 104, age range 22-80 years, mean age 59.5) with rheumatoid arthritis or osteoarthritis, requiring chronic intake of NSAIDs (at least 8 weeks prior to the start of the study), were randomised and enrolled to receive either 40 mg pantoprazole (n=70) or placebo (n=34) once daily, for 12 weeks. Patients had endoscopically confirmed gastric and duodenal lesions grade 0, 1 or 2 (Lanza classification grade 0: normal to hyperaemic mucosa; grade 1: 1 to 3 erosions, submucosal haemorrhage or petechiae, grade 2: 4 to 10 erosions, submucosal haemorrhages or petechiae). Clinical and endoscopic evaluations were performed at baseline, after 4, and 12 weeks. The primary end-point of the study was the incidence of gastric or duodenal ulcers after 4 and 12 weeks of treatment.
                Patients (n=95) were evaluated: 65 in the pantoprazole group and 30 in the placebo group. When considering all patients (those with Lanza score grade 0, 1, 2 at baseline), the overall proportion of patients in remission was 82% and 77% after 4 weeks, and 72% and 59% after 12 weeks in pantoprazole and placebo groups, respectively (cumulative survival analysis according to Kaplan-Meier). The difference between the treatment groups was even more marked when only those patients with normal mucosa at baseline (grade 0) were considered. After 12 weeks, the proportion of patients in remission was 82% (95% confidence limits 70% - 94% in the pantoprazole and 55% (95% confidence limits 33% - 77%) in the placebo treatment group, p=O.036. Adverse events were reported in 4% and 6% of patients in pantoprazole and placebo treatment groups, respectively
                Pantoprazole 40 mg once daily was well tolerated and is more effective than placebo in the prevention of peptic ulcers in patients with rheumatic diseases who require continuous, long-term, treatment with NSAIDs. Adhesive capsulitis is a common musculoskeletal disorder mainly affecting middle aged adults. It is associated with generalized pain and tenderness in the shoulder joint with severe loss of active and passive ranges of motion in all planes. The aim of this study was to compare the efficacy of local steroid injection and physical therapy measures for treating this disorder. Ten male and 10 female patients were enrolled in the study. The patients were divided randomly into two groups and treated with either 40 mg methylprednisolone acetate injection with local anesthetic (group A) or physical therapy measures plus nonsteroidal anti-inflammatory drugs (group B). The mean ages of the patients were 55.6+/-12.2 years in group A and 56.4+/-7.1 years in group B. Clinical assessment was performed on initial visit and at the 2nd and 12th weeks. Active and passive range of motion was recorded and the visual analogue scale was used to evaluate pain intensity. At initial visit, these data in both groups of patients were not statistically different. Although both treatment regimens resulted in significant improvement in range of motion, the differences between mean external rotation at the 2nd and 12th weeks were not statistically significant in either group. The improvement in range of motion at the end of the study was similar in both groups (P>0.05). All patients reported improvement during the study. The differences between mean VAS scores at the 2nd and 12th weeks were statistically significant in both groups. In conclusion, local steroid injection therapy was found to be as effective as physical therapy for the treatment of adhesive capsulitis. To evaluate the prophylactic effect of ranitidine 150 mg twice daily in patients requiring one of the following non-steroidal anti-inflammatory drugs: naproxen, piroxicam, diclofenac, and indomethacin. In addition, risk factors were studied in order to help in targeting of such treatment to specific groups of patients.
                Double blind, placebo controlled, randomised, parallel group with endoscopic assessments at 0, 4, and 8 weeks.
                Multicentre outpatient study at secondary referral centres in five European countries. PATIENTS--297 patients with rheumatoid arthritis or osteoarthritis over the age of 18 without lesions in the stomach and duodenum at baseline endoscopy (after one week without taking non-steroidal anti-inflammatory drugs). Those taking other antirheumatic agents, concomitant ulcerogenic drugs, or treatment for peptic ulcers within the previous 30 days were excluded. Age, sex, arthritic disease, and type of non-steroidal anti-inflammatory drug used were comparable in the two treatment groups. In all, 263 patients completed the trial.
                Ranitidine 150 mg twice daily or placebo (plus the selected non-steroidal anti-inflammatory drug) was prescribed within five days after the baseline endoscopy for two consecutive periods of four weeks. Paracetamol was permitted during the study, but not antacids. Patients were withdrawn if the most severe grade of damage (including ulceration) was found at the four week endoscopy or when indicated, or with lesser damage at the investigator's discretion.
                Frequency of gastric and duodenal ulceration or lesions, or both.
                The cumulative incidence of peptic ulceration by eight weeks was 10.3% (27/263); 2 out of 135 (1.5%) developed duodenal ulceration in the ranitidine group, compared with 10 out of 126 (8%) taking placebo. The frequency of gastric ulceration was the same (6%) for the two groups at eight weeks. Though significantly fewer gastric lesions developed in the ranitidine group by eight weeks. The frequency of non-ulcerative lesions in the duodenum did not differ greatly for the two groups at either time point. Twelve out of 75 (16%) patients taking piroxicam developed peptic ulceration, of whom two thirds had duodenal ulceration. Patients with a history of peptic ulcer were particularly susceptible to recurrent ulceration, against which ranitidine offered some protection.
                Ranitidine 150 mg twice daily significantly reduced the incidence of duodenal ulceration but not gastric ulceration when prescribed concomitantly with one of four commonly used non-steroidal anti-inflammatory drugs. The efficacy of ranitidine in the treatment of NSAID-related dyspeptic symptoms with and without peptic ulcer disease (PUD) was investigated in 124 patients with rheumatoid arthritis (RA) and osteoarthritis (OA). The patients, who continued the use of NSAIDs were investigated by gastroduodenoscopy. Patients with PUD received open label ranitidine 150 mg b.i.d. and the patients without PUD were randomly allocated to receive ranitidine 150 mg b.i.d. or placebo for 4 weeks. PUD was found in 36 (26%) consecutive patients who presented with dyspeptic symptoms. Of these patients dyspeptic symptoms had disappeared in 8 (26%) of 31 evaluable patients and PUD was healed in 18 (56%) patients after 4 weeks of treatment. After 8 weeks of treatment PUD was healed in 27 (87%) patients. Of the remaining patients without PUD dyspeptic symptoms had disappeared in 24 (26%) of the ranitidine-treated patients which was significantly better (p < 0.02) than the 5 (6%) placebo-treated patients. The minor mucosal lesions found in this patient group improved to a similar extent in the ranitidine and placebo-treated patients although 1 placebo-treated patient deteriorated and 2 placebo-treated patients developed PUD during the 4 weeks of study. The results of this study show that oral ranitidine 150 mg b.i.d. is effective in the treatment of both dyspeptic symptoms and mucosal lesions in RA and OA patient who continue the use of NSAIDs. To determine the safety and efficacy of viscosupplementation with hylan G-F 20, a cross-linked hyaluronan preparation, used either alone or in combination with continuous non-steroidal anti-inflammatory drug (NSAID) therapy, a randomized, controlled, multicenter clinical trial, assessed by a blinded assessor, was conducted in 102 patients with osteoarthritis (OA) of the knee. All patients were on continuous NSAID therapy for at least 30 days prior to entering the study. Patients were randomized into three parallel groups: (1) NSAID continuation plus three control arthrocenteses at weekly intervals; (2) NSAID discontinuation but with three weekly intra-articular injections of hylan G-F 20; and (3) NSAID continuation plus three injections, one every week, intra-articular injections of hylan G-F 20. Outcome measures of pain and joint function were evaluated by both the patients and an evaluator at baseline and weeks 1, 2, 3, 7 and 12, with a follow-up telephone evaluation at 26 weeks. At 12 weeks all groups showed statistically significant improvements from baseline, but did not differ from each other. A statistical test for the equivalence, the q-statistic, demonstrated that viscosupplementation with hylan G-F 20 was at least as good or better than continuous NSAID therapy for all outcome measurements except activity restriction. At 26 weeks both groups receiving hylan G-F 20 were significantly better than the group receiving NSAIDs alone. A transient local reaction was observed in three patients after hylan G-F 20 injection; only one patient withdrew from the study as a result and all recovered without any sequela. Hylan G-F 20 is a safe and effective treatment for OA of the knee and can be used either as a replacement for or an adjunct to NSAID therapy. To determine whether a short course of prednisolone is superior to placebo for improving pain, function, and range of motion in adhesive capsulitis.
                Double blind, randomised, placebo controlled trial.
                Community based rheumatology practice in Australia.
                50 participants (24 active, 26 placebo); 46 completed the 12 week protocol. Entry criteria were age > or =18 years, pain and stiffness in predominantly one shoulder for > or =3 weeks, and restriction of passive motion by >30 degrees in two or more planes.Interventions: 30 mg oral prednisolone/day for three weeks or placebo.
                Overall, night, and activity related pain, SPADI, Croft shoulder disability questionnaire, DASH, HAQ, SF-36, participant rated improvement, and range of active motion measured at baseline and at 3, 6, and 12 weeks.
                At 3 weeks, there was greater improvement in overall pain in the prednisolone group than in the placebo group (mean (SD) change from baseline, 4.1 (2.3) v 1.4 (2.3); adjusted difference in mean change between the two groups, 2.4 (95% CI, 1.1 to 3.8)). There was also greater improvement in disability, range of active motion, and participant rated improvement (marked or moderate overall improvement in 22/23 v 11/23; RR = 2 (1.3 to 3.1), p = 0.001). At 6 weeks the analysis favoured the prednisolone group for most outcomes but none of the differences was significant. At 12 weeks, the analysis tended to favour the placebo group.
                A three week course of 30 mg prednisolone daily is of significant short term benefit in adhesive capsulitis but benefits are not maintained beyond six weeks.
There remains limited evidence from which to draw firm conclusions about the benefits or harms of topical or oral NSAIDs in treating lateral elbow pain. Although data from five placebo-controlled trials suggest that topical NSAIDs may be beneficial in improving pain (for up to 4 weeks), non-normal distribution of data and other methodological issues precluded firm conclusions. Some people may expect a mild transient skin rash. Evidence about the benefits of oral NSAIDs has been conflicting, although oral NSAID use may result in gastrointestinal adverse effects in some people. No direct comparisons between oral and topical NSAIDs were available. Some trials demonstrated greater benefit from glucocorticoid injection than from NSAIDs in the short term, but this was not apparent in all studies and was not apparent by 6 months in the only study that included longer-term outcomes.