Essential Evidence Plus

For more summaries of evidence-based medical research, visit www.essentialevidenceplus.com.

GOUT

Fructose-Rich Beverage Intake Associated with Increased Risk of Gout in Women

Clinical question: Does fructose-rich beverage intake increase the risk of gout in women?

Bottom line: Increasing daily fructose intake is significantly associated with increasing risk of gout in women. Sugar-sweetened sodas and orange juice are the biggest culprits, followed by apple juice and other juice drinks. Diet soda and fruit intake was not associated with risk of gout. (LOE) = 2b, individual cohort study or low quality randomized controlled trials (<80% follow-up).

Reference: Choi HK, Willett W, Curhan G. Fructose-rich beverages and risk of gout in women. JAMA. 2010;304(20):2270-2278.

Study design: Cohort (prospective)

Funding Source: Foundation

Setting: Population-based

Synopsis: These investigators analyzed data from the Nurses’ Health Study, a well-known prospective cohort study established in 1976. This information is updated every two years and the follow-up rate is higher than 90%. As part of the study, women answered validated food frequency questionnaires including information summing their intake of sugar-sweetened soda, diet soda, and fruit juice. In addition, participants provided information on their weight, medication use, and medical conditions.

Beginning in 1984, these investigators included questionnaires asking for information pertaining to a physician diagnosis of gout meeting standard rheumatology criteria. Two board-certified rheumatologists reviewed a random sample of medical records to validate reported diagnoses. Multivariate analyses were performed to adjust outcomes for potentially confounding variables including age, alcohol intake, body mass index, hormone or diuretic use, coffee intake, and daily consumption of purine-rich foods.

Spanning 22 years, the authors documented 778 newly diagnosed and confirmed cases of gout among 78,906 women. One or two servings of sugar-sweetened soda per day compared with less than one serving per month was significantly associated with an increased risk of gout (absolute risk difference of 36 and 68 additional cases per 100,000 patient-years). Diet soda was not associated with risk of gout. Among fruit juices, orange juice contained the highest concentration of fructose, followed by apple juice and other juices. The corresponding increased risk of gout for orange juice consumption of one or two servings per day compared with less than one serving per month was 14 and 47 additional cases per 100,000 patient-years. Total fruit intake was not associated with risk of gout.

OSTEOARTHRITIS

Risk Factors Plus Symptoms to Diagnose Knee OA

Clinical question: How should the diagnosis of knee osteoarthritis be made?

Bottom line: These European guidelines suggest that presence of risk factors and typical symptoms can make the diagnosis of knee osteoarthritis (OA) without radiographic changes; in fact, risk factors plus typical symptoms “overrule” a normal X-ray result. Other recommendations (see synopsis for the complete list): red flags suggest other diagnoses; MRI, ultrasound, or laboratory tests are not necessary to make the diagnosis; aspirate an effusion to rule out other causes. (LOE) = 2a, systematic reviews (with homogeneity) of cohort studies.

Reference: Zhang W, Doherty M, Peat G, et al. EULAR evidence-based recommendations for the diagnosis of knee osteoarthritis. Ann Rheum Dis. 2010(3);69:483-489.

Study design: Practice guideline

Funding Source: Foundation

Setting: Various (guideline)

Synopsis: These guidelines come from the European League Against Rheumatism and represent both the best evidence as well as expert consensus regarding the diagnosis of knee OA in clinical practice. A committee of 17 experts assembled the best evidence and developed 10 statements regarding the diagnosis of a syndrome for which there is not a firm diagnostic standard (though the American College of Radiology has a classification scheme for research purposes, radiography is not the only marker of OA). The recommendations from the group are as follows (not all of the 10 statements were recommendations):

1. Risk factors predict knee OA: older than 50 years, female, overweight, previous knee injury, joint laxity, heavy use, family history, and presence of Heberden’s nodes.
2. Typical symptoms are use-related pain, often worse at the end of the day and relieved by rest; the feeling of “giving way”; only mild morning or inactivity stiffness. Symptoms may be episodic or variable.
3. In patients older than 40 years with use-related pain, short-lived morning stiffness, functional limitation, and one or more typical examination findings, a diagnosis can be made without X-rays, and may be made even with a normal-appearing X-ray.
4. Red flags: severe local inflammation, erythema, progressive pain unrelated to usage all suggest other diagnoses.
5. MRI or ultrasound are not necessary to make the diagnosis; nor are laboratory tests, except when there is a high suspicion of other diagnoses.
6. A palpable effusion should be aspirated to exclude inflammatory disease and to identify crystals.

OSTEOPOROSIS

Oral Bisphosphonate Use Not Associated with Increased Risk of Esophageal Cancer

Clinical question: Does long-term treatment of osteoporosis with oral bisphosphonates increase the risk of esophageal cancer?

Bottom line: This study found no evidence of a significant association between oral bisphosphonate use and an increased risk of esophageal cancer or gastric cancer. (LOE) = 2b, individual cohort study or low-quality randomized controlled trials (<80% follow-up).

Reference: Cardwell CR, Abnet CC, Cantwell MM, Murray LJ. Exposure to oral bisphosphonates and risk of esophageal cancer. JAMA. 2010;304(6):657-663.

Study design: Cohort (prospective)

Funding Source: Government

Setting: Outpatient (any)

Synopsis: Esophagitis is a relatively common adverse event reported with oral bisphosphonate use. It is uncertain whether this also leads to an increased risk of esophageal cancer. These investigators analyzed information obtained from the United Kingdom General Practice Research Database, a previously validated database including the records of 500 general practitioners in the United Kingdom.

From January 1, 1996, to December 31, 2006, each patient who was prescribed a bisphosphonate was matched to a single control patient of the same sex, with the same year of birth, and in the same general practice. All cancer-related outcomes and prescription use was verified by an individual masked to whether patients were in the bisphosphonate cohort or the control cohort. The mean follow-up time was 4.5 years in each group, with a maximum follow-up period of 12.9 years.

From a total of 46,036 oral bisphosphonate users and an equal number of matched control patients, 287 confirmed cases of esophageal or gastric cancer were recorded. There was no difference in combined esophageal and gastric cancer incidence between the two groups before and after adjusting for potential confounders such as tobacco and alcohol use. There was also no difference based on type or dosage of bisphosphonate or duration of use.

PAIN

Acupuncture Effective for Chronic Shoulder Pain

Clinical question: Is acupuncture effective in decreasing pain in patients with chronic shoulder pain?

Bottom line: A treatment series of 15 acupuncture sessions produced significantly greater pain relief than sham acupuncture or conservative treatment in patients with chronic shoulder pain not due to osteoarthritis or rheumatoid arthritis. This benefit lasted for at least three months after the end of treatment. (LOE) = 2b, individual cohort study or low-quality randomized controlled trials (<80% follow-up).

Reference: Molsberger AF, Schneider T, Gotthardt H, Drabik A. German randomized acupuncture trial for chronic shoulder pain (GRASP)—A pragmatic, controlled, patient-blinded, multi-centre trial in an outpatient care environment. Pain. 2010;151(1):146-154.

Study design: Randomized controlled trial (single-blinded)

Funding Source: Government

Allocation: Concealed

Setting: Outpatient (specialty)

Synopsis: These German investigators enrolled 424 patients with chronic, one-sided shoulder pain lasting between six weeks and two years with a pain score of at least 50 mm on a 100-mm visual analog scale (average score = 66 mm). The patients were randomly assigned (allocation concealed) to receive acupuncture performed by a trained orthopedist, sham acupuncture, or conventional conservative treatment. Acupuncture was delivered in 15 treatments, one to three per week, using between five and 10 needle points placed according to the location of the pain with mild to strong needle manipulation. Sham acupuncture was administered similarly, with 8 needles placed in nonacupuncture points. Conservative therapy consisted of diclofenac 50 mg daily with 15 treatments of exercise or physical therapy, including modalities. Using intention-to-treat analysis, the main outcome—a decrease of at least 50% in pain scores three months after the end of treatment—occurred significantly more often (P < .001) in the acupuncture group (65%) than in the sham acupuncture group (24%) or the conservative therapy group (37%). This difference remained when analyzing only patients who received all treatments (per-protocol analysis), which is important since dropouts were significant: 17% in the acupuncture group, 45% in the sham treatment group, and 21% in conservative treatment group. Pain was also significantly better in the acupuncture group immediately after treatment.

TENS Ineffective in Chronic Low Back Pain

Clinical question: Is transcutaneous electrical nerve stimulation effective in treating patients with chronic low back pain or painful diabetic neuropathy?

Bottom line: If these authors have identified all the relevant studies, the data on transcutaneous electrical nerve stimulation (TENS) in the treatment of chronic back pain or painful neuropathy are fairly limited and more studies with high methodologic rigor are warranted. Based on the available literature, two high-quality studies failed to show TENS to be superior to sham TENS or other therapies in treating chronic back pain. The authors found no high-quality studies of TENS in painful neuropathy. (LOE) = 2a-, systematic reviews of cohort studies displaying worrisome heterogeneity.

Reference: Dubinsky RM, Miyasaki J. Assessment: Efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2010;74(2):173-176.

Study design: Meta-analysis (randomized controlled trials)

Funding Source: Unknown/not stated

Setting: Various (meta-analysis)

Synopsis: The authors based this guideline on a systematic review of clinical trials identified in MEDLINE and the Cochrane Library. To be included, the studies had to compare transcutaneous electrical nerve stimulation (TENS) with a control therapy (placebo or other therapy) in treating painful neurologic disorders. They don’t describe searching for unpublished studies, whether they used independent reviewers to determine study inclusion, or how they assessed methodologic quality of the included studies.

Two reviewers independently assigned a level of evidence for each recommendation and conflicts were reconciled by consensus. A total of nine studies were included. In the treatment of low back pain, they identified two high-quality studies and three mediocre studies. The two high-quality studies compared TENS with sham TENS and both failed to show that TENS is superior. One of the mediocre studies found no clinically meaningful improvements in pain scores, while two of the mediocre studies showed improvements in pain scores. The authors found three studies using TENS in the treatment of painful diabetic neuropathy, none of which were of high methodologic quality.

Despite the tendency for studies with poor methods to favor interventions, the authors conclude that TENS probably confers modest benefit in pain relief from neuropathy. They also point out that no studies compared TENS with other active treatments. The authors disclosed financial support from several pharmaceutical companies and device manufacturers.

FALLS

Patient-Specific Fall Prevention Plan Reduces Fall Rates in Older Hospitalized Patients

Clinical question: Does the use of a fall prevention kit to create a tailored plan based on a patient’s individual fall risk reduce fall rates in hospitals?

Bottom line: Using a Fall Prevention Tool Kit (FPTK) that relies on information technology to provide decision support and incorporates tailored fall prevention interventions including bed posters, patient education handouts, and patient-specific plans of care decreases falls during hospitalization, specifically in patients older than 65 years. (LOE) = 1b, individual randomized controlled trials (with narrow confidence interval).

Reference: Dykes PC, Carroll DL, Hurley A, et al. Fall prevention in acute care hospitals. JAMA. 2010;304(17): 1912-1918.

Study design: Randomized controlled trial (nonblinded)

Funding Source: Foundation

Allocation: Unconcealed

Setting: Inpatient (ward only)

Synopsis: Investigators identified a total of eight medical units within four hospitals with fall rates higher than the mean for their institution and were not involved in other fall prevention efforts. At each hospital, the intervention unit was matched to a control unit with a similar rate of falls. In the control units, usual care for fall prevention included the following: assessing the patients’ fall risk using the validated Morse Fall Scale (MFS), placing generic “high risk for falls” signs above the beds of patients with high MFS scores, educating patient and family members with standard booklets and handouts, and documenting the plan manually in the health record. In the intervention units, the staff completed the MFS using a FPTK that provided decision support on the use of evidence-based interventions to prevent falls based on a patient’s baseline risk. Possible interventions included consulting physical therapy, assisting with toileting, providing ambulatory aids, and enabling bedside alarms. Furthermore, in the intervention units, tailored bed posters and educational handouts were printed according to these patient-specific plans.

Patients in both control and intervention units had similar mean MFS scores on admission. Over the course of six months, there were fewer patients with falls in the intervention units compared with the control units (67 versus 87; P = .02). After adjusting for factors, including hospital site, age, and sex, the fall rate per 1,000 patient-days was decreased in the intervention units (3.15 versus 4.18; 95% CI, 0.57–2.01; P = .04). Notably, the fall rate was only significantly decreased for those patients older than 65 years who received the intervention (2.66 versus 4.75; 0.61–3.56; P = .003). The authors estimate that the FPTK interventions can prevent one fall per 862 patient-days, or one fall per 287 patients during a typical three-day hospital stay. There was no difference in fall-related injuries between the two groups.