Clinical Health Updates

Use stepped approach in managing knee pain in older adults

Clinical Question:
What is a reasonable approach to managing knee pain in older adults in primary care?

Bottom Line:
This guideline, developed through a reasonable and explicit process, suggests a stepped approach to managing patients who are aged 50 years or older and have knee pain due to degenerative joint disease. This guideline, like most others in existence, suffers from not having been tested for real-world feasibility or effectiveness.

Reference:
Porcheret M, Jordan K, Croft P. Treatment of knee pain in older adults in primary care: development of an evidence-based model of care. Rheumatology 2007;46:638-648.

Study Design:
Practice guideline

Synopsis:
To develop a stepped model of care for the treatment of knee pain in older adults in primary care based on recommended interventions. A systematic search was undertaken to identify interventions recommended for knee osteoarthritis or knee pain in clinical guidelines and systematic reviews. Following this, a nominal group consensus exercise was conducted with members of the Primary Care Rheumatology Society to allocate the interventions to a stepped model of care. Twenty-seven recommended interventions were identified from 77 publications following the systematic search.
A four-step model of care incorporating these interventions was developed through the consensus exercise.
Step 1 comprised ten interventions that should be offered to all older adults with knee pain, but could also be provided through self-care. These included exercise, weight loss, paracetamol and written information.
Steps 2 and 3 comprised 10 and 6 interventions, respectively, to be considered for people with persisting pain and disability. These included pharmacological interventions such as non-steroidal anti-inflammatory drugs in step 2 and intra-articular corticosteroids in step 3, and non-pharmacological interventions such as physiotherapy in step 2 and occupational therapy in step 3.
Step 4 was referral for surgery.

History of fall and gait/balance problem confer high risk for falls

Clinical Question:
What clinical factors predict a high risk for falls in the elderly?

Bottom Line:
Screening for risk of falling during the clinical examination begins with determining if the patient has fallen in the past year. For patients who have not previously fallen, screening consists of an assessment of gait and balance. Patients who have fallen or who have a gait or balance problem are at higher risk of future falls.

Reference:
Ganz DA, Bao Y, Shekelle PG, Rubenstein LA. Will my patient fall? JAMA 2007;297:77-86.

Study Design:
Decision rule (development only)

Synopsis:
Effective multifactorial interventions reduce the frequent falling rate of older patients by 30% to 40%. However, clinical consensus suggests reserving these interventions for high-risk patients. Limiting fall prevention programs to high-risk patients implies that clinicians must recognize features that predict future falls. The authors identified the prognostic value of risk factors for future falls among older patients. Search of MEDLINE (1966-September 2004), CINAHL (1982-September 2004), and authors’ own files to identify prospective cohort studies of risk factors for falls that performed a multivariate analysis of such factors. Two reviewers independently determined inclusion of articles and assessed study quality. Disagreements were resolved by consensus. Included studies were those identifying the prognostic value of risk factors for future falls among community-dwelling persons 65 years and older. Clinically identifiable risk factors were identified across 6 domains: orthostatic hypotension, visual impairment, impairment of gait or balance, medication use, limitations in basic or instrumental activities of daily living, and cognitive impairment. Eighteen studies met inclusion criteria and provided a multivariate analysis including at least 1 of the risk factor domains. The estimated pretest probability of falling at least once in any given year for individuals 65 years and older was 27% (95% confidence interval, 19%-36%). Patients who have fallen in the past year are more likely to fall again [likelihood ratio range, 2.3-2.8]. The most consistent predictors of future falls are clinically detected abnormalities of gait or balance (likelihood ratio range, 1.7-2.4). Visual impairment, medication variables, decreased activities of daily living, and impaired cognition did not consistently predict falls across studies. Orthostatic hypotension did not predict falls after controlling for other factors.

Alendronate (Fosamax) therapy unnecessary for most women after 5 years

Clinical Question:
What is the optimal duration of therapy with alendronate for women with postmenopausal osteoporosis?

Bottom Line:
Women who discontinued alendronate after 5 years showed a moderate decline in BMD and a gradual rise in biochemical markers but no higher fracture risk other than for clinical vertebral fractures compared with those who continued alendronate. These results suggest that for many women, discontinuation of alendronate for up to 5 years does not appear to significantly increase fracture risk. However, women at very high risk of clinical vertebral fractures may benefit by continuing beyond 5 years.

Reference:
Black DM, Schwartz AV, Ensrud KE, et al. Effects of continuing or stopping alendronate after 5 years of treatment. The Fracture Intervention Trial Long-term Extension (FLEX): A randomized trial. JAMA 2006;296:2927-38.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
The optimal duration of treatment of women with postmenopausal osteoporosis is uncertain. The authors compared the effects of discontinuing alendronate treatment after 5 years vs continuing for 10 years. They did a randomized, double-blind trial conducted at 10 US clinical centers that participated in the Fracture Intervention Trial (FIT). One thousand ninety-nine postmenopausal women who had been randomized to alendronate in FIT, with a mean of 5 years of prior alendronate treatment. Randomization to alendronate, 5 mg/d (n = 329) or 10 mg/d (n = 333), or placebo (n = 437) for 5 years (1998-2003). The primary outcome measure was total hip bone mineral density (BMD); secondary measures were BMD at other sites and biochemical markers of bone remodeling. An exploratory outcome measure was fracture incidence. Compared with continuing alendronate, switching to placebo for 5 years resulted in declines in BMD at the total hip (-2.4%; 95% confidence interval [CI], -2.9% to -1.8%; P<.001) and spine (-3.7%; 95% CI, -4.5% to -3.0%; P<.001), but mean levels remained at or above pretreatment levels 10 years earlier. Similarly, those discontinuing alendronate had increased serum markers of bone turnover compared with continuing alendronate: 55.6% (P<.001) for C-telopeptide of type 1 collagen, 59.5% (P < .001) for serum n = propeptide of type 1 collagen, and 28.1% (P<.001) for bone-specific alkaline phosphatase, but after 5 years without therapy, bone marker levels remained somewhat below pretreatment levels 10 years earlier. After 5 years, the cumulative risk of nonvertebral fractures (RR, 1.00; 95% CI, 0.76-1.32) was not significantly different between those continuing (19%) and discontinuing (18.9%) alendronate. Among those who continued, there was a significantly lower risk of clinically recognized vertebral fractures (5.3% for placebo and 2.4% for alendronate; RR, 0.45; 95% CI, 0.24-0.85) but no significant reduction in morphometric vertebral fractures (11.3% for placebo and 9.8% for alendronate; RR, 0.86; 95% CI, 0.60-1.22). A small sample of 18 transilial bone biopsies did not show any qualitative abnormalities, with bone turnover (double labeling) seen in all specimens.

Herbs (devil’s claw, white willow bark, and cayenne) effective in low back pain

Clinical Question:
Are herbal medicines more effective than placebo in treating adults with low back pain?

Bottom Line:
If these authors have included all the relevant studies, it appears that there is modest evidence that herbal remedies (oral Harpagophytum procumbens [devil’s claw] and Salix alba [white willow bark], as well as topical Capsicum frutescens [cayenne]) alleviate acute episodes of chronic nonspecific low back pain in adults. Additional trials testing these herbal medicines against standard treatments will clarify their equivalence in terms of efficacy. The quality of reporting in these trials was generally poor; thus, trialists should refer to the CONSORT statement in reporting clinical trials of herbal medicines.

Reference:
Gagnier JJ, van Tulder MW, Berman B, Bombardier C. Herbal medicine for low back pain: a Cochrane review. Spine 2007;32:82-92.

Study Design:
Systematic review

Synopsis:
The authors did a systematic review of randomized controlled trials to determine the effectiveness of herbal medicine compared with placebo, no intervention, or “standard/accepted/conventional treatments” for nonspecific low back pain. The following databases were searched: Medline (1966 to April 2003), Embase (1980 to April 2003), Cochrane Controlled Trials Register (Issue 1, 2003), and Cochrane Complementary Medicine (CM) field Trials Register. Additionally, reference lists in review articles, guidelines, and in the retrieved trials were checked. Randomized controlled trials (RCTs), using adults (>18 years of age) suffering from acute, subacute, or chronic nonspecific low back pain. Types of interventions included herbal medicines defined as a plant that is used for medicinal purposes in any form. Primary outcome measures were pain and function. Two reviewers (J.J.G. and M.W.T.) conducted electronic searches in all databases. One reviewer (J.J.G.) contacted content experts and acquired relevant citations. Authors, title, subject headings, publication type, and abstract of the isolated studies were downloaded or a hard copy was retrieved. Methodologic quality and clinical relevance were assessed separately by two individuals (J.J.G. and M.W.T.). Disagreements were resolved by consensus. Ten trials were included in this review. Two high-quality trials utilizing Harpagophytum procumbens (Devil’s claw) found strong evidence for short-term improvements in pain and rescue medication for daily doses standardized to 50 mg or 100 mg harpagoside with another high-quality trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib. Two moderate-quality trials utilizing Salix alba (White willow bark) found moderate evidence for short-term improvements in pain and rescue medication for daily doses standardized to 120 mg or 240 mg salicin with an additional trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib. Three low-quality trials using Capsicum frutescens (Cayenne) using various topical preparations found moderate evidence for favorable results against placebo and one trial found equivalence to a homeopathic ointment.

Acupuncture reduces post-op knee pain

Clinical Question:
Does acupuncture of the ear reduce the need for pain medication following knee surgery?

Bottom Line:
Auricular acupuncture reduced the requirement for ibuprofen after ambulatory knee surgery relative to an invasive needle control procedure. However, the difference in the amount of pain medication used is small (400 mg ibuprofen), and given the cost of acupuncture and the relative safety of such a small dose of ibuprofen, these results are of questionable practical value. This study does suggest that further study of acupuncture for knee pain is needed.

Reference:
Usichenko TI, Kuchling S, Witstruck T, et al. Auricular acupuncture for pain relief after ambulatory knee surgery: a randomized trial. CMAJ 2007;176:179-183.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
Auricular acupuncture is a promising method for postoperative pain relief. However, there is no evidence for its use after ambulatory surgery. The authors tested whether auricular acupuncture is better than invasive needle control for complementary analgesia after ambulatory knee surgery. One hundred and twenty patients undergoing ambulatory arthroscopic knee surgery under standardized general anesthesia were randomly assigned to receive auricular acupuncture or a control procedure. Fixed indwelling acupuncture needles were inserted before surgery and retained in situ until the following morning. Postoperative rescue analgesia was directed to achieve pain intensity less than 40 mm on a 100-mm visual analogue scale. The primary outcome measure was the postoperative requirement for ibuprofen between surgery and examination the following morning. Intention-to-treat analysis showed that patients from the control group (n = 59) required more ibuprofen than patients from the auricular acupuncture group (n = 61): median (interquartile range) 600 (200-800) v. 200 (0-600) mg (p = 0.012). Pain intensity on a visual analogue scale was similar in both groups at all time points registered. The majority of patients in both groups believed that they had received true acupuncture and wanted to repeat it in future.

Guidelines (ESCISIT): Management of RA

Clinical Question:
How should patients with newly diagnosed rheumatoid arthritis be managed?

Bottom Line:
These guidelines, from the European League Against Rheumatism recommend early diagnosis and rapid initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs) even before the patient’s symptoms meet official criteria for rheumatoid arthritis (RA). For most patients the initial choice of DMARD is methotrexate. Anti-inflammatory drug therapy, exercise, occupational therapy, and hydrotherapy should be used to treat pain and maintain function.

Reference:
Combe B, Landewe R, Lukas C, et al. EULAR recommendations for the management of early arthritis: report of a task force of the European Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2007;66:34-45.

Study Design:
Practice guideline

Synopsis:
To formulate EULAR recommendations for the management of early arthritis. In accordance with EULAR’s “standardised operating procedures”, the task force pursued an evidence based approach and an approach based on expert opinion. A steering group comprised of 14 rheumatologists representing 10 European countries. The group defined the focus of the process, the target population, and formulated an operational definition of “management”. Each participant was invited to propose issues of interest regarding the management of early arthritis or early rheumatoid arthritis. Fifteen issues for further research were selected by use of a modified Delphi technique. A systematic literature search was carried out. Evidence was categorised according to usual guidelines. A set of draft recommendations was proposed on the basis of the research questions and the results of the literature search.. The strength of the recommendations was based on the category of evidence and expert opinion. Fifteen research questions, covering the entire spectrum of “management of early arthritis”, were formulated for further research; and 284 studies were identified and evaluated. Twelve recommendations for the management of early arthritis were selected and presented with short sentences. The selected statements included recognition of arthritis, referral, diagnosis, prognosis, classification, and treatment of early arthritis (information, education, non-pharmacological interventions, pharmacological treatments, and monitoring of the disease process). On the basis of expert opinion, 11 items were identified as being important for future research.

Tennis elbow: injection better short-term, worse long-term

Clinical Question:
Is a steroid injection or physical therapy more effective than general treatment in patients with tennis elbow?

Bottom Line:
Physiotherapy combining elbow manipulation and exercise has a superior benefit to wait and see in the first six weeks and to corticosteroid injections after six weeks, providing a reasonable alternative to injections in the mid to long term. The significant short term benefits of corticosteroid injection are paradoxically reversed after six weeks, with high recurrence rates, implying that this treatment should be used with caution in the management of tennis elbow.

Reference:
Bisset L, Beller E, Jull G, Brooks P, Darnell R, Vicenzino B. Mobilisation with movement and exercise, corticosteroid injection, or wait and see for tennis elbow: randomised trial. BMJ 2006;333:939.

Study Design:
Randomized controlled trial (single-blinded)

Synopsis:
To investigate the efficacy of physiotherapy compared with a wait and see approach or corticosteroid injections over 52 weeks in tennis elbow. The authors did a single blind randomised controlled trial. In a community setting, Brisbane, Australia consiting of 198 participants aged 18 to 65 years with a clinical diagnosis of tennis elbow of a minimum six weeks’ duration, who had not received any other active treatment by a health practitioner in the previous six months. Eight sessions of physiotherapy; corticosteroid injections; or wait and see. Global improvement, grip force, and assessor’s rating of severity measured at baseline, six weeks, and 52 weeks. Corticosteroid injection showed significantly better effects at six weeks but with high recurrence rates thereafter (47/65 of successes subsequently regressed) and significantly poorer outcomes in the long term compared with physiotherapy. Physiotherapy was superior to wait and see in the short term; no difference was seen at 52 weeks, when most participants in both groups reported a successful outcome. Participants who had physiotherapy sought less additional treatment, such as non-steroidal anti-inflammatory drugs, than did participants who had wait and see or injections.

Acetaminophen=celecoxib in DJD

Clinical Question:
Are celecoxib and paracetamol equivalent in providing pain relief in patients with degenerative joint disease?

Bottom Line:
In this short-term study emphasizing individual response, acetaminophen and celecoxib (Celebrex) are virtually indistinguishable in improving pain, stiffness, and function in patients with clinically diagnosed degenerative joint disease (DJD). SR paracetamol is more useful than celecoxib for most patients of whom management is uncertain.

Reference:
Yelland MJ, Nikles CJ, McNairn N, Del Mar CB, Schluter PJ, Brown RM. Celecoxib compared with sustained-release paracetamol for osteoarthritis: a series of n-of-1 trials. Rheumatology 2007;46:135-140.

Study Design:
Cross-over trial (randomized)

Synopsis:
To assess the use of n-of-1 trials for short-term choice of drugs for osteoarthritis, with particular reference to comparing the efficacy of sustained-release [SR] paracetamol with celecoxib in individual patients. The authors did an evaluation of community-based patients undergoing n-of-1 trials which consisted of double-blind, crossover comparisons of celecoxib 200 or 400 mg/day with sustained-release paracetamol 1330 mg three times a day in three pairs of 2 week treatment periods per drug with random order of the drugs within pairs. Outcomes evaluated were pain and stiffness in sites nominated by the patient, functional limitation scores, preferred medication, side effects and changes in drug use after an n-of-1 trial. Participants were 59 patients with osteoarthritis in multiple sites (hip 6, knee 24, hand 6, shoulder/neck 8, back 14, foot 5), with pain for >/=1 month severe enough to warrant consideration of long-term use of celecoxib but for whom there was doubt about its efficacy. Forty-one n-of-1 trials were completed. Although on average, celecoxib showed better scores than SR paracetamol [0.2 (0.1) for pain, 0.3 (0.1) for stiffness and 0.3 (0.1) for functional limitation], 33 of the 41 individual patients (80%) failed to identify the differences between SR paracetamol and celecoxib in terms of overall symptom relief. Of the eight patients who were able to identify the differences, seven had better relief with celecoxib and one with SR paracetamol. In 25 out of 41 [61%] patients, subsequent management was consistent with their trial results.

Acupuncture effective for long-term back pain relief

Clinical Question:
Is acupuncture effective for long-term relief of low back pain?

Bottom Line:
Weak evidence was found of an effect of acupuncture on persistent non-specific low back pain at 12 months, but stronger evidence of a small benefit at 24 months. Referral to a qualified traditional acupuncturist for a short course of treatment seems safe and acceptable to patients with low back pain.

Reference:
Thomas KJ, MacPherson H, Thorpe L, et al. Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain. BMJ 2006;333:623.

Study Design:
Randomized controlled trial (nonblinded)

Synopsis:
Acupuncture has been shown to be effective for some patients for short-term relief of low back pain. The researchers of this study evaluated the long-term effect following a short course of acupuncture. They enrolled 241 patients with nonspecific low back pain of 4 to 52 weeks’ duration. Patients with identified causes of pain or red flag symptoms (spinal disease, prolapsed central disc, progressive motor weakness, and so forth) were excluded. The patients were randomized, using concealed allocation, to receive 10 weekly treatments with acupuncture or to receive usual care, including physical therapy, manipulation, exercises, and drugs at the discretion of the patients’ usual physicians. Patients were aware of the treatment they received, since no sham acupuncture was used. The primary outcome was the bodily pain dimension of the SF-36, a widely used scale to evaluate back pain that ranges from 0 to a best score of 100 (no pain). Twelve months after treatment, scores improved from a baseline average of 30 to an average of 64 in the acupuncture care group and an average of 58 in the usual care group. At 2 years after treatment, acupuncture scores were statistically better than usual care: 68 versus 60, though this difference might not be clinically noticeable. Patient satisfaction was higher with acupuncture. Patient expectation of benefit of acupuncture was weakly associated with greater improvement. Acupuncture treatment was more expensive than usual care, but was cost effective based on the health gain associated with the treatment

Gout and the risk of acute myocardial infarction

Clinical Question:
Are hyperuricemia and gouty arthritis independent risk factors for acute myocardial infarction (MI)?

Bottom Line:
The independent risk relationship between hyperuricemia and acute MI is confirmed. Gouty arthritis is associated with an excess risk of acute MI, and this is not explained by its well-known links with renal function, metabolic syndrome, diuretic use, and traditional cardiovascular risk factors.

Reference:
Gout and the risk of acute myocardial infarction.Krishnan E, Baker JF, Furst DE, Schumacher HR.Arthritis Rheum. 2006 Aug;54(8):2688-96

Study Design:
Randomized Controlled Trial

Synopsis:
To determine if hyperuricemia and gouty arthritis are independent risk factors for acute myocardial infarction (MI) and, if so, whether they are independent of renal function, diuretic use, metabolic syndrome, and other established risk factors. The authors performed multivariable logistic and instrumental variable probit regressions on data from the Multiple Risk Factor Intervention Trial (MRFIT). Overall, there were 12,866 men in the MRFIT who were followed up for a mean of 6.5 years. There were 118 events of acute MI in the group with gout (10.5%) and 990 events in the group without gout (8.43%; P = 0.018). Hyperuricemia was an independent risk factor for acute MI in the multivariable regression models, with an odds ratio (OR) of 1.11 (95% confidence interval [95% CI] 1.08-1.15, P < 0.001). In multivariable regressions in which the above risk factors were used as covariates, gout was found to be associated with a higher risk of acute MI (OR 1.26 [95% CI 1.14-1.40], P < 0.001). Subgroup analyses showed that a relationship between gout and the risk of acute MI was present among nonusers of alcohol, diuretics, or aspirin and among those who did not have metabolic syndrome, diabetes mellitus, or obesity. In separate analyses, a relationship between gout and the risk of acute MI was evident among those with and without those hyperuricemia.