Biomedical subjects

G Wells

Publications and source records attributed to G Wells.

At least 37 records · Page 2Linked to original sources

PubMed2003

Rocuronium versus succinylcholine for rapid sequence induction intubation.

BACKGROUND: Patients requiring emergent endotracheal intubation often require a rapid sequence induction intubation (RSI) technique to protect against gastric aspiration, to facilitate intubation, or to protect against increased intracranial pressure. Succinylcholine is the most common muscle relaxant used because it has a fast onset and a short duration. Unfortunately it can have serious side effects as a result of it's membrane depolarizing effect and release of potassium. Rocuronium has been suggested to create intubating conditions similar to succinylcholine. Previous studies have been underpowered to determine equivalence and there has been no previous meta-analysis performed. OBJECTIVES: To determine if rocuronium creates comparable intubating conditions to succinylcholine during RSI intubation. Comparisons were made with succinylcholine based on the dose of rocuronium, use of a narcotic, emergent versus elective intubation, age group and the induction agent used. The primary outcome was excellent intubation conditions. A secondary outcome of clinically acceptable conditions was also performed. These were all dichotomous outcomes using cutpoints from a four point scale by Goldberg to evaluate intubation conditions. SEARCH STRATEGY: We searched MEDLINE (1966-March 2000), EMBASE (1988-March 2000) and the Cochrane Central Register of Controlled Trials (CENRAL) (March 2000) for randomized controlled trials (RCT) or controlled clinical trials (CCT) relating to the use of rocuronium and succinylcholine. Foreign language journals were included. References of identified studies were hand-searched for citations missed by the electronic searches. SELECTION CRITERIA: All trials meeting the inclusion criteria (comparison of rocuronium and succinylcholine, one of study's main outcomes was scoring of intubation conditions) were included. DATA COLLECTION AND ANALYSIS: Data were extracted and methodological quality was assessed independently by two reviewers for allocation concealment. The outcomes were combined using MetaView 4.1 with risk differences for all categories and RR for the excellent outcomes with a random effects model. MAIN RESULTS: 40 studies were identified; 26 were combined for analysis. Overall, rocuronium was inferior to succinylcholine, with a RR=0.87 (95%CI = 0.81 to 0.94) (N=1606). In the group that used propofol for induction of anaesthesia, the intubation conditions were similar, with a RR=0.96 (95%CI = 0.87 to 1.06) (N=640). No major adverse events were reported. REVIEWER'S CONCLUSIONS: Succinylcholine created superior intubation conditions to rocuronium when comparing excellent intubation conditions. Using the less stringent outcome, clinically acceptable intubation conditions, the two agents were not statistically different. Intubation conditions were not statistically different between succinylcholine and rocuronium when propofol was used.

Androstanols↗

PubMed2003

Acetaminophen for osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is the most common form of arthritis. Published guidelines and expert opinion are divided over the relative role of acetaminophen (also called paracetamol or Tylenol) and non-steroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacologic therapy. The comparative safety of acetaminophen and NSAIDs is important to consider as NSAIDs have the potential for serious gastrointestinal, renal, and cardiovascular toxicities, and acetaminophen in high dosages (greater than or equal to 2 grams per day), may also have the potential for serious upper gastrointestinal toxicity. OBJECTIVES: To assess the efficacy and safety of acetaminophen versus placebo and versus NSAIDs (ibuprofen, arthrotec, celecoxib,naproxen, rofecoxib) for treating OA. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (Issue 3, 2002), MEDLINE (up to July 2002), and Current Contents (up to March 2002). Reference lists of identified RCTs and pertinent review articles were also hand searched. SELECTION CRITERIA: Published randomized controlled trials (RCTs) evaluating the efficacy and safety of acetaminophen alone in OA were considered for inclusion. DATA COLLECTION AND ANALYSIS: Pain, physical function and global assessment outcomes were reported. Results for continuous outcome measures were expressed as standardized mean differences. Dichotomous outcome measures were pooled using relative risk and the number needed to treat was calculated. MAIN RESULTS: Six RCTs and 1689 participants were included in the review. One study compared acetaminophen to placebo, and five compared acetaminophen to NSAIDs. In the placebo-controlled RCT, acetaminophen was shown to be clearly superior to placebo with a similar safety profile. The number needed to treat to achieve an improvement in pain was three. In the comparator-controlled RCTs, acetaminophen was less effective overall than NSAIDs in terms of pain reduction and global assessments but both drugs had similar efficacy in terms of improvements in functional status. No significant difference was found between the safety of acetaminophen and NSAIDs, although patients taking NSAIDS were more likely to withdraw due to GI events. REVIEWER'S CONCLUSIONS: The evidence to date suggests that NSAIDs are superior to acetaminophen for improving knee and hip pain in people with OA but have not been shown to be superior in improving function. The size of the treatment effect was modest, and the mean trial duration was only six weeks, therefore, additional considerations need to be factored in when making the decision between using acetaminophen or NSAIDs. In OA subjects with moderate-to-severe levels of pain, NSAIDs appear to be more effective than acetaminophen.

Acetaminophen↗

PubMed2003

Intensity of exercise for the treatment of osteoarthritis.

BACKGROUND: Therapeutic exercise is used as one modality to treat people with osteoarthritis (OA). OBJECTIVES: To evaluate the effectiveness of therapeutic exercise of differing intensities on objective and subjective measures of disease activity in people with OA. SEARCH STRATEGY: We searched MEDLINE, EMBASE, Pedro, Current Contents, Sports Discus and CINAHL up to and including December 2002. The Cochrane Field of Rehabilitation and Related Therapies and the Cochrane Musculoskeletal Review Group were also contacted for a search of their specialized registers. Handsearching was conducted on all retrieved articles for additional studies. SELECTION CRITERIA: Comparative controlled studies, such as randomized controlled trials, controlled clinical trials, cohort studies or case/control studies, of therapeutic exercises compared to control or active interventions in people with OA were eligible. No language restrictions were applied. Abstracts were also accepted. DATA COLLECTION AND ANALYSIS: Two independent reviewers identified potential articles from the literature search. These reviewers extracted data using pre-defined extraction forms. Consensus was reached on all data extraction. The two reviewers used a five point scale to assess the quality of the selected articles. Randomization, double-blinding and description of withdrawals were assessed. MAIN RESULTS: One study involving 39 participants met the inclusion criteria. The review indicates that there were no significant differences between high intensity and low intensity aerobic exercise on participants with OA of the knee for functional status, gait, pain and aerobic capacity (Mangione 1999). REVIEWER'S CONCLUSIONS: Both high intensity and low intensity aerobic exercise appear to be equally effective in improving a patient's functional status, gait, pain and aerobic capacity for people with OA of the knee. Further research involving a greater number of subjects, and a larger number of studies involving a control group is needed to further substantiate these results.

Exercise Therapy↗

PubMed2003

Continuous passive motion following total knee arthroplasty.

BACKGROUND: Knee arthroplasty (KA) is a common intervention that can enhance the quality of life for patients with osteoarthritis (OA) and rheumatoid arthritis (RA). Post-surgery rehabilitation protocols often include continuous passive motion (CPM). However, CPM protocols vary considerably amongst institutions. OBJECTIVES: The purpose of the current meta-analysis is to evaluate the effectiveness of continuous passive motion following total knee arthroplasty. SEARCH STRATEGY: An electronic search of MEDLINE (1966 to 2002), EMBASE (1988 to 2002), CINAHL (1982 to 2002), HEALTH STAR (1991 to 1994) and CURRENT CONTENTS (1997 to 2002) was conducted to identify randomized controlled trials. SELECTION CRITERIA: Following an a priori protocol, only randomized controlled trials of CPM for the treatment of participants post KA were eligible. Subjects were 18 years of age or older and had a pre-surgery diagnosis of degenerative joint disease. Both the experimental and control groups received physiotherapy. In addition to the physiotherapy intervention, the experimental group received CPM. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion. Data were then extracted and the quality of the trial assessed using predetermined forms. Outcome measures of interest were: active and passive knee range of motion (ROM) length of hospital stay, pain, swelling and quadriceps strength. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed; in which case, a random effects model was used. Results were analyzed as weighted mean differences (WMD) with 95% confidence intervals (CI). Standardized mean differences (SMD) were used when different scales were used to measure the same concept (e.g. pain). Dichotomous outcomes were presented as a relative risk. MAIN RESULTS: Fourteen trials were retained for analysis. Results favouring CPM were found for the main comparison of CPM combined with physiotherapy (PT) versus PT alone at end of treatment. For the primary outcomes of interest, CPM combined with PT was found to statistically significantly increase active knee flexion (WMD 4.30 degrees, 95% CI: 1.96, 6.63) and decrease length of stay (WMD -0.69 days, 95% CI: -1.35, -0.03). CPM was also found to decrease the need for post-operative manipulation (RR 0.12, 95% CI: 0.03, 0.53). CPM did not significantly improve passive knee flexion and passive or active knee extension. REVIEWER'S CONCLUSIONS: CPM combined with PT, may offer beneficial results compared to PT alone in the short term rehabilitation following total knee arthroplasty.

Arthroplasty, Replacement, Knee↗

PubMed2003

Transcutaneous electrical nerve stimulation (TENS) for the treatment of rheumatoid arthritis in the hand.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic, inflammatory, system disease. It commonly affects the small peripheral joints (such as fingers and wrist). The main goals of intervention for RA are preventing joint deformity, preserving joint function, and reducing inflammation and pain. Transelectrical nerve stimulation (TENS) is a form of electrotherapy and is thought to produce analgesia according to the gate control theory. OBJECTIVES: To determine the efficacy and safety of TENS in the treatment of RA of the hand. The primary outcomes of interest were relief of grip pain and resting pain intensity, relief of joint tenderness, number of tender joints and patient assessment of disease. The secondary objective was to determine the most effective mode of TENS application in pain control. SEARCH STRATEGY: We searched for relevant studies, in English, in the Cochrane field of physical and related therapies, the Cochrane Controlled Trials Register, MEDLINE, EMBASE, HEALTHSTAR, Sports Discus, CINAHL, Current Contents, and the PEDro database, up to October 2002. SELECTION CRITERIA: Two independent reviewers selected the trials that met predetermined inclusion criteria. DATA COLLECTION AND ANALYSIS: Study results were extracted by two independent reviewers. Continuous outcomes were analyzed by weighted mean difference (WMD) using a fixed effects model. MAIN RESULTS: Three RCTs, involving 78 people, were included in this review. AL-TENS and C-TENS were compared to placebo and to each other. Administration of 15 minutes of AL-TENS a week, for 3 weeks, resulted in a significant decrease in rest pain (67% relative benefit, 45 points absolute benefit on 100 mm VAS scale) but not in grip pain compared to placebo. AL-TENS did result in a clinical beneficial improvement in muscle power scores with a relative difference of 55%, and an absolute benefit of 0.98, compared to placebo. No significant difference was found between one 20-minute treatment duration of C-TENS versus AL-TENS, or C-TENS versus placebo on decrease in mean scores for rest pain or grip pain, or on the number of tender joints. Results showed a statistically significant reduction in joint tenderness, but no clinical benefit from C-TENS over placebo in relief of joint tenderness. No statistically significant difference was shown between 15 days of treatment with C-TENS or AL-TENS in relief of joint pain, although there was a clinically important benefit of C-TENS over AL-TENS on patient assessment of change in disease (risk difference 21%, NNT 5). REVIEWER'S CONCLUSIONS: There are conflicting effects of TENS on pain outcomes in patients with RA. AL-TENS is beneficial for reducing pain intensity and improving muscle power scores over placebo while, conversely, C-TENS resulted in no clinical benefit on pain intensity compared with placebo. However C-TENS resulted in a clinical benefit on patient assessment of change in disease over AL-TENS. More well designed studies with a standardized protocol and adequate number of subjects are needed to fully conclude the effect of C-TENS and AL-TENS in the treatment of RA of the hand.

Arthritis, Rheumatoid↗

PubMed2003

Thermotherapy for treatment of osteoarthritis.

BACKGROUND: Osteoarthritis is a degenerative joint disease that affects mostly the weight-bearing joints in the knees and hips. As the affected joint degenerates pain and restriction of movement often occur. Inflammation can also occur sometimes resulting in edema of the joint with OA. Treatment focuses on decreasing pain and improving movement. OBJECTIVES: To determine the effectiveness of thermotherapy in the treatment of OA of the knee. The outcomes of interest were relief of pain, reduction of edema, and improvement of flexion or range of motion (ROM) and function. SEARCH STRATEGY: Two independent reviewers selected randomized and controlled clinical trials with participants with clinical and/or radiological confirmation of OA of the knee; and interventions using heat or cold therapy compared with standard treatment and/or placebo. Trials comparing head to head therapies, such as two different types of diathermy, were excluded. SELECTION CRITERIA: Randomized and controlled clinical trials including participants with clinical or radiographical confirmation of OA of the knee; and interventions using heat or cold compared to standard treatment or placebo were considered for inclusion. DATA COLLECTION AND ANALYSIS: Study results were extracted by two independent reviewers. Outcomes were continuous in nature (pain, strength, improvement) and were analyzed by weighted mean difference using a fixed effects model. Graphical data were used when table data were not available. MAIN RESULTS: Three randomized controlled trials, involving 179 patients, were included in this review. The included trials varied in terms of design, outcomes measured, cryotherapy or thermotherapy treatments and overall methodological quality. In one trial, administration of 20 minutes of ice massage, 5 days per week, for 3 weeks, compared to control demonstrated a clinically important benefit for knee OA on increasing quadriceps strength (29% relative difference). There was also a statistically significant improvement, but no clinical benefit in improving knee flexion ROM (8% relative difference) and functional status (11% relative difference). Another trial showed that cold packs decreased knee edema. REVIEWER'S CONCLUSIONS: Ice massage compared to control had a statistically beneficial effect on ROM, function and knee strength. Cold packs decreased swelling. Hot packs had no beneficial effect on edema compared with placebo or cold application. Ice packs did not effect pain significantly compared to control in patients with OA. More well designed studies with a standardized protocol and adequate number of subjects are needed to evaluate the effect of thermotherapy in the treatment of OA of the knee.

Cryotherapy↗

PubMed2003

Risedronate for the prevention and treatment of postmenopausal osteoporosis.

BACKGROUND: Postmenopausal osteoporosis results in an increased susceptibility to low-trauma fractures due to reduced bone volume and microarchitectural deterioration. Risedronate, a third generation bisphosphonate, has been shown in multiple clinical trials to reduce fracture risk and improve bone mineral density in postmenopausal women with osteoporosis. First and second generation bisphosphonates are known to have gastrointestinal side-effects and risedronate may be better tolerated. OBJECTIVES: To systematically review the efficacy of risedronate on bone density, and fracture reduction in postmenopausal women. SEARCH STRATEGY: The Cochrane Controlled Trials Registry Medline, and Current Contents were searched from 1990 - 2001. The electronic search was supplemented by handsearching four osteoporosis journals and their conference proceedings, as well as contacting content experts and industry sources for unpublished data. SELECTION CRITERIA: We included eight trials that randomised women to risedronate or an alternative (placebo or calcium and /or vitamin D) and measured bone mineral density for at least one year. DATA COLLECTION AND ANALYSIS: For each trial three independent reviewers assessed the methodological quality and abstracted data. Data was extracted for outcomes of fracture, bone mineral density and adverse events. The more conservative random effects model was used to pool data. The quality of trials was assessed according to the Jadad five-point scale. MAIN RESULTS: Both vertebral and non-vertebral fractures were statistically and clinically reduced with risedronate. Eleven out of one hundred women who received risedronate had a vertebral fracture compared to 17 out of one hundred of those who received an alternative treatment (pooled relative risk for vertebral fractures of 0.64 (95% CI 0.52 - 0.77). Three percent of participants who received risedronate had a non-vertebral fracture compared to 4.6% of those who received an alternative treatment (pooled relative risk for nonvertebral fractures of 0.73 (95% CI 0.61 - 0.87). The weighted mean difference for the percent change from baseline for bone mineral density with 5 mg daily for lumbar spine, femoral neck and trochanter was 4.54% (95%CI 4.12 - 4.97), p<0.01; 2.75% (95% CI 2.32 - 3.17), p<0.01; and 4.38% (95% CI 3.51 - 5.25), p<0.01 respectively. REVIEWER'S CONCLUSIONS: There is good evidence for the efficacy of risedronate in the reduction of both vertebral and non-vertebral fractures. In addition, there is evidence from randomized trials that risedronate is able to achieve this without increasing risk for overall withdrawals due to adverse effects.

Bone Density↗

PubMed2003

Etanercept for the treatment of rheumatoid arthritis.

BACKGROUND: Etanercept is a soluble tumour necrosis factor alpha-receptor DMARD for the treatment of rheumatoid arthritis (RA). OBJECTIVES: To assess the efficacy and safety of etanercept for the treatment of RA. SEARCH STRATEGY: Five electronic databases were searched from 1966 to February 2003 with no language restriction. SELECTION CRITERIA: All randomized controlled trials (minimum 6 month duration) comparing three possible combinations 1) etanercept (10 mg or 25 mg twice weekly) with methotrexate (MTX) to MTX alone 2) etanercept to MTX, or 3) etanercept to placebo were eligible. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data and assessed the methodological quality of the trails. The American College of Rheumatology (ACR) core set of disease activity measures for RA clinical trials, radiographic, withdrawals and toxicity outcomes were analyzed. MAIN RESULTS: Three trials were included in this review. Two trials compared an experimental group who were started on etanercept compared to a control group; both groups had the same ongoing background therapy of nonsteroidals in both trials plus in one trial one group was on stable methotrexate. In these two trials the ACR 20, ACR 50 and ACR 70 response rates at 6 months were statistically significantly and clinically important with etanercept 25 mg subcutaneous injections (SC) twice weekly. Sixty-four percent of people receiving etanercept ache vied an ACR 20 response compared to 15% of controls and the number needed to treat (NNT) with etanercept is 2 people. Thirty-nine percent of those receiving etanercept achieved an ACR 50 response compared to 4% of taking control treatment and the NNT is three. Fifteen percent of people taking etanercept achieved an ACR 70 compared to 1% of controls with a NNT of 7 people. In the third trial of starting etanercept compared to starting methotrexate the number of participants who achieved an ACR 20, 50 or response at 6 and 12 months were not statistically significant for either etanercept dose. Etanercept treatment showed a statistically significantly and clinically important affect on joint damage as measured by the Sharp erosion score. Among participants who received etanercept 72% had no increase in their erosion score compared to 60% of participants in the methotrexate group. Withdrawal and toxicity results were acceptable. REVIEWER'S CONCLUSIONS: Etanercept 25 mg SC twice weekly was more efficacious than control treatment for ACR 20, 50 and 70 at 6 months, and over 12 months it slowed joint damage.

Antirheumatic Agents↗

PubMed2003

Calcium supplementation on bone loss in postmenopausal women.

BACKGROUND: Although calcium is one the simplest and least expensive strategies for preventing osteoporotic fractures calcium supplementation is nevertheless not without controversy (Kanis 1989; Nordin 1990). The Food and Drug Administration in the US has permitted a bone health claim for calcium-rich foods, and the NIH in its Consensus Development Process approved a statement that high calcium intake reduces the risk of osteoporosis. OBJECTIVES: To assess the effects of calcium on bone density and fractures in postmenopausal women. SEARCH STRATEGY: We searched Cochrane Controlled Register, MEDLINE and EMBASE up to 2001, and examined citations of relevant articles and proceedings of international meetings. SELECTION CRITERIA: Trials that randomized postmenopausal women to calcium supplementation or usual calcium intake in the diet and reported bone mineral density of the total body, vertebral spine, hip, or forearm or recorded the number of fractures, and followed patients for at least one year were considered for inclusion. DATA COLLECTION AND ANALYSIS: Three independent reviewers assessed the methodologic quality and extracted data for each trial. For each bone density site (lumbar spine, total body, combined hip and combined forearm), we calculated the weighted mean difference in bone density between treatment and control groups using the percentage change from baseline. We constructed regression models in which the independent variables were year and dose, and the dependent variable was the effect size. This regression was used to determine the years across which pooling was appropriate. Heterogeneity was assessed. For each fracture analysis we calculated a risk ratio. MAIN RESULTS: Fifteen trials, representing 1806 participants, were included. Calcium was more effective than placebo in reducing rates of bone loss after two or more years of treatment. The pooled difference in percentage change from baseline was 2.05% (95% CI 0.24 to 3.86) for total body bone density, 1.66% (95% CI 0.92 to 2.39) for the lumbar spine at 2 years, 1.60% (95% CI 0.78 to 2.41) for the hip, and 1.91% (95% CI 0.33 to 3.50) for the distal radius. The relative risk of fractures of the vertebrae was 0.79 (95% CI 0.54 to 1.09); the relative risk for non-vertebral fractures was 0.86 (95% CI 0.43 to 1.72). REVIEWER'S CONCLUSIONS: Calcium supplementation alone has a small positive effect on bone density. The data show a trend toward reduction in vertebral fractures, but it is unclear if calcium reduces the incidence of non vertebral fractures.

Bone Density↗

PubMed2003

The assessment of the economic return from controlled clinical trials. A framework applied to clinical trials of colorectal cancer follow-up.

Clinical trials can be considered health interventions as their primary aim is to impact on the health of a population. Given that resources are scarce for both health care and health related research, trials could be designed such that they can be demonstrated to be cost-effective, i.e., the costs of conducting the trial are justified given the forecasted long-term benefits. We demonstrate how a model can be used to predict the cost-effectiveness of undertaking a clinical trial comparing alternative regimens of colorectal cancer follow-up. The model forecasts costs and survival under two scenarios, with and without conducting a clinical trial, with the outcome assessed in terms of years to payback for the clinical trial. The methodology shown can be used both to provide information on appropriate trial design and/or in prioritizing between potential trials.

Journal Article↗

PubMed2002

Exercise for preventing and treating osteoporosis in postmenopausal women.

BACKGROUND: Osteoporosis is a condition resulting in an increased risk of skeletal fractures due to a reduction in the density of bone tissue. Prevention of osteoporotic-related fractures is dependent on the ability to detect individuals with low bone mass, including those women who are asymptomatic. Treatment of osteoporosis involves the use of either anti-resorptive (e.g. estrogen and bisphosphonate) or bone formation agents (e.g. fluoride and PTH). The value of exercise as an intervention for the prevention of postmenopausal bone loss is a controversial subject. OBJECTIVES: To examine the effectiveness of exercise therapy at preventing bone loss and fractures in postmenopausal women. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Group's specialised register, MEDLINE, EMBASE, Current Contents and the Cochrane Controlled Trials Registry up to January 2000 according to the methods suggested by Dickersin et al and Haynes et al and the Cochrane Handbook. We hand searched reference lists and consulted content experts. SELECTION CRITERIA: This review was proceeded by a peer reviewed protocol published in the Cochrane Library. Two reviewers independently selected all randomized controlled trials (RCTs) which met our predetermined inclusion criteria. DATA COLLECTION AND ANALYSIS: The same two reviewers abstracted the data using predetermined forms and assessed trial quality using a validated assessment tool. For dichotomous outcomes (fractures), relative risks were calculated using fixed effects models. For continuous data, weighted mean differences (WMD) of the percentage change from baseline were calculated. Where heterogeneity existed (determined by a chi square test), a random effects model was used. MAIN RESULTS: Eighteen randomized controlled trials (RCTs) met the inclusion criteria. The trials had a mean methodological quality score of 2.53. Aerobics, weight bearing and resistance exercises were all effective on the BMD of the spine. The WMD for the combined aerobics and weight bearing program on the spine was 1.79 [95%CI (0.58, 3.01)]. The analyzed results showed walking to be effective on both BMD of the spine 1.31[95%CI (-0.03, 2.65) and the hip 0.92[95%CI (0.21, 1.64). Aerobic exercise was effective in increasing BMD of the wrist 1.22[95%CI (0.71, 1.74)]. REVIEWER'S CONCLUSIONS: Aerobics, weight bearing and resistance exercises are all effective in increasing the BMD of the spine in postmenopausal women. Walking is also effective on the hip. The quality of the reporting of the trials in the meta-analysis was low, in particular, in the areas of allocation concealement and blinding.

Exercise↗

PubMed2002

Electromagnetic fields for the treatment of osteoarthritis.

BACKGROUND: As the focus for osteoarthritis (OA) treatment shifts away from drug therapy, we consider the effectiveness of pulsed electric stimulation which is proven to stimulate cartilage growth on the cellular level. OBJECTIVES: 1)To assess the effectiveness of pulsed electric stimulation for the treatment of osteoarthritis (OA). 2) To assess the most effective and efficient method of applying an electromagnetic field, through pulsed electromagnetic fields (PEMF) or electric stimulation, as well as the consideration of length of treatment, dosage, and the frequency of the applications. SEARCH STRATEGY: We searched PREMEDLINE, MEDLINE, HealthSTAR, CINAHL, PEDro, and the Cochrane Controlled Trials Register (CCTR) up to and including 2001. This included searches through the coordinating offices of the trials registries of the Cochrane Field of Physical and Related Therapies and the Cochrane Musculoskeletal Group for further published and unpublished articles. The electronic search was complemented by hand searches and experts in the area. SELECTION CRITERIA: Randomized controlled trials and controlled clinical trials that compared PEMF or direct electric stimulation against placebo in patients with OA. DATA COLLECTION AND ANALYSIS: Two reviewers determined the studies to be included in the review based on inclusion and exclusion criteria (JH,VR) and extracted the data using pre-developed extraction forms for the Cochrane Musculoskeletal Group. The methodological quality of the trials was assessed by the same reviewers using a validated scale (Jadad 1996). Osteoarthritis outcome measures were extracted from the publications according to OMERACT guidelines (Bellamy 1997) and additional secondary outcomes considered. MAIN RESULTS: Only three studies with a total of 259 OA patients were included in the review. Electrical stimulation therapy had a small to moderate effect on outcomes for knee OA, all statistically significant with clinical benefit ranging from 13-23% greater with active treatment than with placebo. Only 2 outcomes for cervical OA were significantly different with PEMF treatment and no clinical benefit can be reported with changes of 12% or less. REVIEWER'S CONCLUSIONS: Current evidence suggests that electrical stimulation therapy may provide significant improvements for knee OA, but further studies are required to confirm whether the statistically significant results shown in these trials confer to important benefits.

Clinical Trials as Topic↗

PubMed2002

Deep transverse friction massage for treating tendinitis.

BACKGROUND: Deep transverse friction massage (DTFM) is one of several physiotherapy interventions suggested for the management of pain due to iliotibial band friction syndrome (ITBFS). OBJECTIVES: To assess the effectiveness of DTFM for treating ITBFS observed in runners. SEARCH STRATEGY: We searched the Medline, Embase, Healthstar, Sports Discus, CINAHL, the Cochrane Controlled Trials Register, PEDro, the specialized registry of the Cochrane musculoskeletal group and the Cochrane field of Physical and Related Therapies up to the end of December 2000, using the sensitive search strategy developed by the Cochrane Collaboration. The search was complemented with bibliography searching of the reference list of the trials retrieved from the electronic search. Key experts in the area were contacted for further published and unpublished articles. SELECTION CRITERIA: All randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing therapeutic ultrasound against placebo or another active intervention in patients with patellofemoral pain syndrome were selected. DATA COLLECTION AND ANALYSIS: Two reviewers determined the studies to be included based on inclusion and exclusion criteria (LB, VR). Data were independently abstracted by two reviewers (VR, LB), and checked by a third reviewer (BS) using a pre-developed form of the Cochrane Musculoskeletal Group. The same two reviewers, using a validated scale, assessed the methodological quality of the RCTs and CCTs independently. Iliotibial band friction syndrome outcome measures were extracted from the publications. The pooled analysis was performed using weighted mean differences (WMDs) for pain relief as described as 1) daily pain; 2) pain while running and 3) percentage of maximum pain when running. A chi-square test was used to assess heterogeneity among trials. Fixed effects models were used throughout and random effects for outcomes showing heterogeneity. MAIN RESULTS: One RCT, including 17 patients with ITBFS was included. The experimental group (DTFM combined to rest, stretching exercises, cryotherapy and therapeutic ultrasound) (n=9) was compared to the control group (rest, stretching exercises, cryotherapy and therapeutic ultrasound only) (n=8). This trial showed no statistical difference in the three types of pain relief measured after four consecutive sessions of DTFM combined with other physiotherapy modalities for runners. Despite lack of statistical significance, there was a clinically important relative percentage difference in pain while running of 22%. REVIEWER'S CONCLUSIONS: DTFM combined with other physiotherapy modalities did not show consistent benefit over control of pain for runners experiencing ITBFS. These conclusions are limited by the low methodological quality of the one small sample size trial (n=17) included. No conclusions can be drawn about the use or non use of DTFM for the treatment of ITBFS. Future trials, utilizing appropriate methods and adequate sample sizes are needed before conclusions can be drawn regarding the effect of massage on iliotibial band friction syndrome.

Clinical Trials as Topic↗

PubMed2002

Rofecoxib for the treatment of rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) is a systemic auto-immune disorder, in which the synovial lining of many joints and tendon sheaths are persistently inflamed. OBJECTIVES: To assess the efficacy and toxicity of rofecoxib for treating RA. SEARCH STRATEGY: We searched the following databases up to December 2000: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, National Research Register, NHS Economic Evaluation Database, Health Technology Assessment database. The bibliographies of retrieved papers were scanned for additional references. The manufacturers of rofecoxib, MSD, were also approached by the UK National Institue for Clincal Excellence to submit additional evidence to inform it's appraisal on the use of cyclo-oxygenase inibitors for arthritis. SELECTION CRITERIA: Relevant studies were randomised controlled trials of parallel group design evaluating the efficacy and/or toxicity of rofecoxib in RA, both placebo based and comparative trials were eligible. Relevant outcome criteria had to be available to evaluate efficacy and/or toxicity, such as the OMERACT outcomes. DATA COLLECTION AND ANALYSIS: Data were abstracted independently by two reviewers and the results were compared for the degree of agreement. A validated tool (Jadad 1995) was used to score the quality of the randomised controlled trials. The planned analysis was to pool, where appropriate, continuous outcome measures using mean or standardized mean differences, and dichotomous outcome measures using relative risk ratios. MAIN RESULTS: Two randomised controlled trials evaluating the efficacy and toxicity of rofecoxib in RA were identified and met the criteria. One compared rofecoxib to placebo and the other compared rofecoxib to naproxen. The overall number of ACR 20 responders who had received 25mg (82/ 171 = 48%) or 50mg (86/161 = 53%) was statistically significantly more than those receiving placebo (58/168 = 35% ) (RR 1.39 CI: 1.07, 1.80 and RR 1.55 CI: 1.20, 1.99 respectively) with no statistically significant differences between the 25 and 50 mg doses. The safety profile of rofecoxib was similar to that of placebo. In the comparative trial, rofecoxib at a dosage of 50 mg/day demonstrated similar efficacy to naproxen at a dosage of 500 mg twice daily. However, the combined rate of clinically significant complicated gastro-intestinal events (GI) (perforations, ulcers, bleeds, or obstructions) was lower with rofecoxib than with naproxen (RR 0.46, 95% CI, 0.34 to 0.63) due to a reduction in the number of ulcers and bleeds. Patients taking rofecoxib had a greater risk of having a myocardial infarction (MI) than patients taking naproxen (RR 4.03, 95% CI, 2.86 to 5.68). REVIEWER'S CONCLUSIONS: In patients with RA, rofecoxib demonstrates a greater degree of efficacy than placebo, while having a comparable safety profile. Rofecoxib demonstrates a similar degree of efficacy as naproxen, but with a significantly lower rate of ulceration and gastrointestinal bleeding. Rofecoxib was associated with a greater risk for MI, but the exact significance and pathophysiology of this possible relationship is unclear.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2002

Infliximab for the treatment of rheumatoid arthritis.

BACKGROUND: Infliximab is a human murine chimeric anti-tumour necrosis factor alpha monoclonal antibody recently approved for the treatment of refractory RA. OBJECTIVES: To assess the efficacy and safety of infliximab for the treatment of rheumatoid arthritis. SEARCH STRATEGY: Electronic databases including Biological Abstracts, CINAHL, Current Contents, Dissertation Abstracts, EBM Reviews, HealthSTAR and MEDLINE were searched from 1966 to March 2002. Rheumatoid arthritis was searched as an exploded MESH heading. Infliximab was searched as a text word as it is not currently indexed. The search was not limited by language, year of publication or type of publication. The specific search strategy is shown below. SELECTION CRITERIA: All randomized controlled trials comparing infliximab 1, 3, 5 or 10 mg/kg with methotrexate(MTX) to MTX alone, or without MTX to placebo, with a minimum duration of 6 months and at least 2 infusions were eligible. DATA COLLECTION AND ANALYSIS: Data was extracted by 2 independent reviewers and the methodological quality of the trials was assessed using a validated assessment tool scale. Outcome variables included the ACR core set of disease activity measures for RA clinical trials and radiographic outcome data. Withdrawals and toxicity were also included. End of trial results were pooled. Continuous data were pooled using weighted mean differences and dichotomous data using relative risks. MAIN RESULTS: Two trials with a total of 529 patients met the inclusion criteria. Patients fulfilling the American Rheumatism Association 1987 RA diagnostic criteria were randomized to receive either infliximab 1mg/kg (with and without MTX), 3mg/kg(with and without MTX), 10mg/kg of infliximab (with and without MTX) or placebo infusion plus MTX. Infusions were given every 4 or 8 weeks. After 6 months ACR 20, ACR 50 and ACR 70 response rates were significantly improved in all infliximab doses compared to control. The number needed to treat with infliximab to achieve an ACR 20, 50 or 70 response in patients with refractory RA under specialist care ranged from 2.9 to 3.3 for ACR 20, 3.6 to 4.8 for ACR 50 and 5.9 to 12.5 for ACR 70 depending on the dose (3mg/kg or 10mg/kg given either every 4 or 8 weeks). Total withdrawals and withdrawals due to lack of efficacy were lower for all doses of infliximab versus controls. Withdrawals for adverse events and withdrawals for other reasons were not statistically significantly different for those receiving infliximab from control. REVIEWER'S CONCLUSIONS: Treatment with infliximab for 6 and 12 months significantly reduces RA disease activity and appeared to have an acceptable safety profile in these trials. Total radiographic scores improved, fewer patients showed radiographic progression, and more patients showed radiographic improvement with infliximab treatment at 12 months compared to controls. However, only 2 trials met the inclusion criteria, and these results are largely driven by the largest trial. The available efficacy and toxicity data is relatively short-term (6-12 months). In order to detect rare events that may be associated with infliximab, larger and longer term studies are required.

Antibodies, Monoclonal↗

PubMed2002

Acupuncture and electroacupuncture for the treatment of RA.

BACKGROUND: Acupuncture has been used by rehabilitation specialists as an adjunct therapy for the symptomatic treatment of rheumatoid arthritis (RA). Acupuncture is a traditional Chinese medicine where thin needles are inserted in specific documented points believed to represent concentration of body energies. In some cases a small electrical impulse is added to the needles. Once the needles are inserted in some of the appropriate points, endorphins, morphine-like substances, have been shown to be released in the patient's system, thus inducing local or generalised analgesia. OBJECTIVES: To evaluate the effects of acupuncture or electroacupuncture on the objective and subjective measures of disease activity in patients with RA. SEARCH STRATEGY: A comprehensive search was done up to September 2001 with MEDLINE, EMBASE, PEDro, Current Contents, Sports Discus and CINAHL. The Cochrane Field of Rehabilitation and Related Therapies and the Cochrane Musculoskeletal Review Group were also contacted for a search of their specialized registers. Handsearching was conducted on all retrieved papers and content experts were contacted to identify additional studies. SELECTION CRITERIA: Comparative controlled studies, such as randomized controlled trials and control clinical trials in patients with RA were eligible. No language restrictions were applied. Abstracts were accepted. DATA COLLECTION AND ANALYSIS: Two independent reviewers identified potential articles from the literature search. These reviewers extracted data using pre-defined extraction forms. Consensus was reached on all the extracted data. Quality was assessed by two reviewers using a five (5) point validated tool that measured the quality of randomization, double-blinding and description of withdrawals. MAIN RESULTS: Two studies (n=84) met the inclusion criteria. One used acupuncture (~~David 1999~~) while the other used electroacupuncture (~~Man 1974~~). In the first study using acupuncture, no significant difference was found between groups for to erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), the visual analogue scale for pain (VAS P), the visual analogue scale for patient's global assessment (VAS G), the number of swollen joints, the number of tender joints, to the general health questionnaire (GHQ), the score on the modified disease activity scale (DAS) or in the decrease in analgesic intake. In the second study, using electroacupuncture, a significant decrease in knee pain was reported in the experimental group, 24 hours post treatment, when compared to the placebo group (weighted mean difference of -2.0 with 95% CI -3.6,-4.0). REVIEWER'S CONCLUSIONS: Although the results of the ~~Man 1974~~ study show that electroacupuncture may be beneficial to reduce symptomatic knee pain in patients with RA 24 hours post treatment, the reviewers concluded that the poor quality of the trial, including the small sample size proclude its recommendation. The reviewers further conclude that acupuncture has no effect on ESR, CRP, pain, patient's global assessment, number of swollen joints, number of tender joints, general health, disease activity and reduction of analgesics. These conclusions are limited by methodological considerations such as the type of acupuncture (acupuncture vs electroacupuncture), the site of intervention, the low number of clinical trials and the small sample size of the included studies.

Acupuncture Therapy↗

PubMed2002

Celecoxib for rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) is a systemic auto-immune disorder, involving persistent joint inflammation. NSAIDs are used to control the symptoms of RA, but are associated with significant gastro-intestinal toxicity, including a risk of potentially life threatening gastroduodenal perforations, ulcers and bleeds. The NSAIDs known as the selective Cox II inhibitors, of which celecoxib is a member, were developed in order to reduce the GI toxicity, but are more expensive. OBJECTIVES: To establish the efficacy and safety of celecoxib in the management of RA by systematic review of available evidence. SEARCH STRATEGY: We searched the following databases up to August 2002: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, National Research Register, NHS Economic Evaluation Database, Health Technology Assessment Database. The bibliographies of retrieved papers and content experts were consulted for additional references. SELECTION CRITERIA: All eligible randomised controlled trials (RCTs) were included. No unpublished RCTs were included in this edition of the review. DATA COLLECTION AND ANALYSIS: Data were abstracted independently by two reviewers. Data was analysed using a fixed effects model. A validated checklist was used to score the quality of the RCTs. The planned analysis was to pool, where appropriate continuous outcomes using mean differences and dichotomous outcomes using relative risk ratios. This was not however possible due to the lack of data. MAIN RESULTS: Five RCTs were included (4465 participants); three of the studies also enrolled individuals with OA. The comparators were placebo, naproxen, diclofenac and ibuprofen. The evidence reviewed suggests that celecoxib controls the symptoms of RA to a similar degree to that of the active comparators examined (naproxen, diclofenac and ibuprofen). When compared to placebo, the percentage of patients showing improvement according to ACR 20 criteria at week 4 were 42/82 (51%) in the twice daily celecoxib 200mg group and 43/82 (52%) in the twice daily celecoxib 400mg group; these were significantly different from the placebo group in which 25/85 (29%) improved. The six month data reviewed support a reduced rate of UGI complications with celecoxib but there is also evidence to suggest that these benefits may not be evident in the long-term and that celecoxib offers no additional benefit in patients who are also receiving cardio-prophylactic low dose aspirin. REVIEWER'S CONCLUSIONS: For an individual with RA the potential benefits of celecoxib need to be balanced against the uncertainty that the short-term reduced incidence of upper GI complications are maintained in the long-term and its increased cost in comparison to traditional NSAIDs.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2002

Meta-analysis of randomised controlled trials of the effectiveness of antiarrhythmic agents at promoting sinus rhythm in patients with atrial fibrillation.

OBJECTIVE: To conduct a meta-analysis of randomised controlled trials to estimate the effectiveness of antiarrhythmic drugs at promoting sinus rhythm in patients with atrial fibrillation. DESIGN: Articles were identified by using a comprehensive search of English language papers indexed in Medline from 1966 to August 2001. For the outcomes of sinus rhythm and death, a random effects model was used to model repeated assessments within a study at different time points. SETTING: Emergency departments and ambulatory clinics. PATIENTS: Patients with atrial fibrillation. INTERVENTIONS: Antiarrhythmic agents grouped according to their Vaughan-Williams class. MAIN OUTCOME MEASURES: Sinus rhythm and mortality. RESULTS: 91 articles met a priori criteria for inclusion in the analysis. Median duration of follow up was one day (range 0.04-1096, mean (SD) 46 (136) days). The median proportion of patients in sinus rhythm at follow up was 55% (range 0-100%) and 32% (range 0-90%) receiving active treatment and placebo, respectively. Median survival was 99% (range 55-100%) and 99% (range 55-100%). Compared with placebo, the following drug classes were associated with increased sinus rhythm at follow up: IA (treatment difference 21.5%, 95% confidence interval (CI) 16.3% to 26.8%); IC (treatment difference 33.1%, 95% CI 23.3% to 42.9%); and III (treatment difference 17.4%, 95% CI 11.5% to 23.3%). Class IC drugs were associated with increased sinus rhythm at follow up compared with class IV drugs (treatment difference 43.2%, 95% CI 11.5% to 75.0%). There was no significant difference in mortality between any drug classes. CONCLUSIONS: Class IA, IC, and III drugs are associated with increased sinus rhythm at follow up compared with placebo. It is unclear whether any antiarrhythmic drug class is associated with increased or decreased mortality.

Anti-Arrhythmia Agents↗