Results of a RCT assessing saline and xylitol nasal irrigation for CRS and fatigue in Gulf War illness.

OBJECTIVE: To assess the efficacy of saline nasal irrigation (S-NI) and xylitol nasal irrigation (X-NI) for chronic rhinosinusitis in participants with Gulf War illness (GWI). METHODS: This 26 week, 3-arm (1:1:1) randomized controlled trial examined veterans meeting criteria for GWI with moderate-to-severe chronic rhinosinusitis and fatigue symptoms. All participants received standard of care for chronic rhinosinusitis (CRS); additionally, S-NI or X-NI participants added twice-daily NI using 2% saline or 5% xylitol solutions. Outcomes included disease-specific quality of life (primary; sino-nasal outcome test [SNOT-20]; 0-100 points), overall quality of life (Short-Form 36), and fatigue (Multidimensional Fatigue Index). Outcome assessors were blind to allocation group. Intention-to-treat analysis used repeated measures modeling; statistical significance was evaluated at the two-sided α level of .05. RESULTS: Randomization (N = 40) produced three similar groups regarding sex (male, 80%), age (53.8 ± 7.8 years), duration (19.8 ± 7.7 years), and illness severity (48.5 ± 12.7 SNOT-20 points). Age- and gender-adjusted between-group comparison showed that X-NI participants, compared with control, reported improved SNOT-20 scores at 8 weeks (13.5 points, 95% confidence interval [CI] -27.9 to 0.9) and at 26 weeks (15.4 points, 95% CI -30.1 to -0.6). S-NI participants improved by 13.4 points (95% CI -28.8, 2.1) at 26 weeks compared with control.The improvement in both NI groups approached minimal clinical important difference compared to control for the SNOT-20 in the general population. Secondary outcomes were not different between groups. Satisfaction in both irrigation groups was high. CONCLUSIONS: This randomized controlled trial suggests that NI with saline or xylitol improves chronic sinus symptoms among participants with GWI with improvement scores similar to those in the general population. LEVEL OF EVIDENCE: 1b, individual randomized controlled trial.

Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial.

OBJECTIVES: To assess the effects of mindfulness-based relapse prevention for alcohol dependence (MBRP-A) intervention on drinking and related consequences. METHODS: 123 alcohol-dependent adults in early recovery, recruited from outpatient treatment programs, were randomly assigned to MBRP-A (intervention plus usual-care; N = 64) or Control (usual-care-alone; N = 59) group. MBRP-A consisted of eight-weekly sessions and home practice. Outcomes were assessed at baseline, 8 weeks and 26 weeks (18 weeks post-intervention), and compared between groups using repeated measures analysis. RESULTS: Outcome analysis included 112 participants (57 MBRP-A; 55 Control) who provided follow-up data. Participants were 41.0 ±â€¯12.2 years old, 56.2% male, and 91% white. Prior to "quit date," they reported drinking on 59.4 ±â€¯34.8% (averaging 6.1 ±â€¯5.0 drinks/day) and heavy drinking (HD) on 50.4 ±â€¯35.5% of days. Their drinking reduced after the "quit date" (before enrollment) to 0.4 ±â€¯1.7% (HD: 0.1 ±â€¯0.7%) of days. At 26 weeks, the MBRP-A and control groups reported any drinking on 11.5 ±â€¯22.5% and 5.9 ±â€¯11.6% of days and HD on 4.5 ±â€¯9.3% and 3.2 ±â€¯8.7% of days, respectively, without between-group differences (ps ≥ 0.05) in drinking or related consequences during the follow-up period. Three MBRP-A participants reported "relapse," defined as three-consecutive HD days, during the study. Subgroup analysis indicated that greater adherence to session attendance and weekly home practice minutes were associated with improved outcomes. CONCLUSIONS: MBRP-A as an adjunct to usual-care did not show to improve outcomes in alcohol-dependent adults in early recovery compared to usual-care-alone; a return to drinking and relapse to HD were rare in both groups. However, greater adherence to MBRP-A intervention may improve long-term drinking-related outcomes.

Cost of opioid-treated chronic low back pain: Findings from a pilot randomized controlled trial of mindfulness meditation-based intervention.

OBJECTIVE: Opioid-treated chronic low back pain (CLBP) is debilitating, costly, and often refractory to existing treatments. This secondary analysis aims to pilot-test the hypothesis that mindfulness meditation (MM) can reduce economic burden related to opioid-treated CLBP. DESIGN: Twenty-six-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone. SETTING: Outpatient. PARTICIPANTS: Thirty-five adults with opioid-treated CLBP (≥30 morphine-equivalent mg/day) for 3 + months enrolled; none withdrew. INTERVENTION: Eight weekly therapist-led MM sessions and at-home practice. OUTCOME MEASURES: Costs related to self-reported healthcare utilization, medication use (direct costs), lost productivity (indirect costs), and total costs (direct + indirect costs) were calculated for 6-month pre-enrollment and postenrollment periods and compared within and between the groups. RESULTS: Participants (21 MM; 14 control) were 20 percent men, age 51.8 ± 9.7 years, with severe disability, opioid dose of 148.3 ± 129.2 morphine-equivalent mg/d, and individual annual income of $18,291 ± $19,345. At baseline, total costs were estimated at $15,497 ± 13,677 (direct: $10,635 ± 9,897; indirect: $4,862 ± 7,298) per participant. Although MM group participants, compared to controls, reduced their pain severity ratings and pain sensitivity to heat stimuli (p < 0.05), no statistically significant within-group changes or between-group differences in direct and indirect costs were noted. CONCLUSIONS: Adults with opioid-treated CLBP experience a high burden of disability despite the high costs of treatment. Although this pilot study did not show a statistically significant impact of MM on costs related to opioid-treated CLBP, MM can improve clinical outcomes and should be assessed in a larger trial with long-term follow-up.

Qualitative Assessment of Patients Receiving Prolotherapy for Knee Osteoarthritis in a Multimethod Study.

OBJECTIVE: Randomized and open-label studies assessing prolotherapy for knee osteoarthritis have found quantitative improvement on the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC) compared with baseline status and control therapies. This study assessed the qualitative response of participants receiving prolotherapy, an injection-based complementary treatment for symptomatic knee osteoarthritis (OA). DESIGN: Qualitative study using semi-structured in-depth interviews at 52 weeks after enrollment; transcribed responses were discussed by coauthors to identify themes; disagreement was resolved by consensus. SETTING: Outpatient. PARTICIPANTS: Twenty-two participants treated with prolotherapy for symptomatic knee OA who were exited from three randomized and open-label studies. INTERVENTIONS: Intra- and extra-articular hypertonic dextrose injection (prolotherapy). MAIN OUTCOME MEASURES: Patient narrative and composite WOMAC questionnaire (0-100 points) scores. RESULTS: Participants had baseline demographic and knee OA severity similar to those of participants in three prior intervention trials, as well as similar robust follow-up WOMAC score change (19.9 ± 12.6 points), suggesting a representative subsample. Seven themes were identified from participant narratives: (1) improvement in knee-specific quality of life (n = 18), (2) safety and comfort, (3) pretreatment counseling enhanced treatment adherence and optimism, (4) overall positive experience with prolotherapy, (5) limited response to prolotherapy (n = 4), (6) consistency with anecdotal clinical prolotherapy experience; and (7) functional improvement without pain reduction. CONCLUSIONS: Most participants reported substantially improved knee-specific effects, resulting in improved quality of life and activities of daily living; four participants reported minimal or no effect. Clear, complete description of procedural rationale may enhance optimism about and adherence to treatment appointments.

Hypertonic dextrose injection (prolotherapy) for knee osteoarthritis: Long term outcomes.

OBJECTIVE: Knee osteoarthritis (OA) is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. Recent 52-week randomized controlled and open label studies have reported improvement of knee OA-specific outcomes compared to baseline status, and blinded saline control injections and at-home exercise therapy (p<0.05). However, long term effects of prolotherapy for knee OA are unknown. We therefore assessed long-term effects of prolotherapy on knee pain, function and stiffness among adults with knee OA. DESIGN: Post clinical-trial, open-label follow-up study. SETTING: Outpatient; adults with mild-to-severe knee OA completing a 52-week prolotherapy study were enrolled. INTERVENTION AND OUTCOME MEASURES: Participants received 3-5 monthly interventions and were assessed using the validated Western Ontario McMaster University Osteoarthritis Index, (WOMAC, 0-100 points), at baseline, 12, 26, 52 weeks, and 2.5 years. RESULTS: 65 participants (58±7.4 years old, 38 female) received 4.6±0.69 injection sessions in the initial 17-week treatment period. They reported progressive improvement in WOMAC scores at all time points in excess of minimal clinical important improvement benchmarks during the initial 52-week study period, from 13.8±17.4 points (23.6%) at 12 weeks, to 20.9±2.8 points, (p<0.05; 35.8% improvement) at 2.5±0.6 years (range 1.6-3.5 years) in the current follow-up analysis. Among assessed covariates, none were predictive of improvement in the WOMAC score. CONCLUSIONS: Prolotherapy resulted in safe, significant, progressive improvement of knee pain, function and stiffness scores among most participants through a mean follow-up of 2.5 years and may be an appropriate therapy for patients with knee OA refractory to other conservative care.

Dextrose and morrhuate sodium injections (prolotherapy) for knee osteoarthritis: a prospective open-label trial.

OBJECTIVES: This study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status. DESIGN: This was a prospective three-arm uncontrolled study with 1-year follow-up. SETTING: The setting was outpatient. PARTICIPANTS: The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined). INTERVENTION: The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6 mL 25% dextrose was performed through an inferomedial approach. OUTCOME MEASURES: The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction. RESULTS: The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events. CONCLUSIONS: Prolotherapy using dextrose and morrhuate sodium injections for participants with mild-to-severe KOA resulted in safe, significant, sustained improvement of WOMAC-based knee pain, function, and stiffness scores compared to baseline status.

Association between disease-specific quality of life and magnetic resonance imaging outcomes in a clinical trial of prolotherapy for knee osteoarthritis.

OBJECTIVE: To assess the relation between knee osteoarthritis (KOA)-specific quality of life (QOL) and intra-articular cartilage volume (CV) in participants treated with prolotherapy. KOA is characterized by CV loss and multifactorial pain. Prolotherapy is an injection therapy reported to improve KOA-related QOL to a greater extent than blinded saline injections and at-home exercise, but its mechanism of action is unclear. DESIGN: Two-arm (prolotherapy, control), partially blinded, controlled trial. SETTING: Outpatient. PARTICIPANTS: Adults with ≥3 months of symptomatic KOA (N=37). INTERVENTIONS: Prolotherapy: 5 monthly injection sessions; CONTROL: blinded saline injections or at-home exercise. MAIN OUTCOME MEASURES: Primary: KOA-specific QOL scores (baseline, 5, 9, 12, 26, and 52wk; Western Ontario and McMaster University Osteoarthritis Index). Secondary: KOA-specific pain, stiffness, function (Western Ontario McMaster University Osteoarthritis Index subscales), and magnetic resonance imaging-assessed CV (baseline, 52wk). RESULTS: Knee-specific QOL improvement among prolotherapy participants exceeded that among controls (17.6±3.2 points vs 8.6±5.0 points; P=.05) at 52 weeks. Both groups lost CV over time (P<.05); no between-group differences were noted (P=.98). While prolotherapy participants lost CV at varying rates, those who lost the least CV ("stable CV") had the greatest improvement in pain scores. Among prolotherapy participants, but not control participants, the change in CV and the change in pain (but not stiffness or function) scores were correlated; each 1% CV loss was associated with 2.7% less improvement in pain score (P<.05). CONCLUSIONS: Prolotherapy resulted in safe, substantial improvement in KOA-specific QOL compared with control over 52 weeks. Among prolotherapy participants, but not controls, magnetic resonance imaging-assessed CV change (CV stability) predicted pain severity score change, suggesting that prolotherapy may have a pain-specific disease-modifying effect. Further research is warranted.

Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial.

PURPOSE: Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. METHODS: Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. RESULTS: No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. CONCLUSIONS: Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.

Value associated with mindfulness meditation and moderate exercise intervention in acute respiratory infection: the MEPARI Study.

BACKGROUND AND OBJECTIVES: Acute respiratory infection (ARI) is among the most common, debilitating and expensive human illnesses. The purpose of this study was to assess ARI-related costs and determine if mindfulness meditation or exercise can add value. METHODS: One hundred and fifty-four adults ≥50 years from Madison, WI for the 2009-10 cold/flu season were randomized to (i) wait-list control (ii) meditation or (iii) moderate intensity exercise. ARI-related costs were assessed through self-reported medication use, number of missed work days and medical visits. Costs per subject were based on cost of generic medications, missed work days ($126.20) and clinic visits ($78.70). Monte Carlo bootstrap methods evaluated reduced costs of ARI episodes. RESULTS: The total cost per subject for the control group was $214 (95% CI: $105-$358), exercise $136 (95% CI: $64-$232) and meditation $65 (95% CI: $34-$104). The majority of cost savings was through a reduction in missed days of work. Exercise had the highest medication costs at $16.60 compared with $5.90 for meditation (P = 0.004) and $7.20 for control (P = 0.046). Combining these cost benefits with the improved outcomes in incidence, duration and severity seen with the Meditation or Exercise for Preventing Acute Respiratory Infection study, meditation and exercise add value for ARI. Compared with control, meditation had the greatest cost benefit. This savings is offset by the cost of the intervention ($450/subject) that would negate the short-term but perhaps not long-term savings. CONCLUSIONS: Meditation and exercise add value to ARI-associated health-related costs with improved outcomes. Further research is needed to confirm results and inform policies on adding value to medical spending.

Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up.

OBJECTIVE: The objective of this study was to determine whether prolotherapy, an injection-based complementary treatment for chronic musculoskeletal conditions, improves pain, stiffness, and function in adults with symptomatic knee osteoarthritis (KOA) compared to baseline status. DESIGN: This was a prospective, uncontrolled study with 1-year follow-up. SETTING: The study was conducted in an outpatient setting. PARTICIPANTS: Adults with at least 3 months of symptomatic KOA, recruited from clinical and community settings, participated in the study. INTERVENTIONS: Participants received extra-articular injections of 15% dextrose and intra-articular prolotherapy injections of 25% dextrose at 1, 5, and 9 weeks, with as-needed treatments at weeks 13 and 17. OUTCOME MEASURES: Primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). Secondary outcome measure was the validated Knee Pain Scale (KPS). Tertiary outcome measure was procedure-related pain severity and participant satisfaction. RESULTS: Thirty-six (36) participants (60 ± 8.7 years old, 21 female) with moderate-to-severe KOA received an average of 4.3 ± 0.7 prolotherapy injection sessions over a 17-week treatment period and reported progressively improved scores during the 52-week study on WOMAC and KPS measures. Participants reported overall WOMAC score improvement 4 weeks after the first injection session (7.6 ± 2.4 points, 17.2%), and continued to improve through the 52-week follow-up (15.9 ± 2.5 points, p<0.001, 36.1%). KPS scores improved in both injected (p<0.001) and uninjected knees (p<0.05). Prescribed low-dose opioid analgesia effectively treated procedure-related pain. Satisfaction was high and there were no adverse events. Female gender, age 46-65 years old, and body-mass index of 25 kg/m(2) or less were associated with greater improvement on the WOMAC instrument. CONCLUSIONS: In adults with moderate to severe KOA, dextrose prolotherapy may result in safe, significant, sustained improvement of knee pain, function, and stiffness scores. Randomized multidisciplinary effectiveness trials including evaluation of potential disease modification are warranted to further assess the effects of prolotherapy for KOA.

Placebo effects and the common cold: a randomized controlled trial.

PURPOSE: We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open-label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all. METHODS: We undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later. RESULTS: Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence interval [CI]) were -0.16 days (95% CI, -0.90 to 0.58 days) for illness duration and -22 severity points (95% CI, -70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, -0.28 to 1.12 days) and 22 severity points (95% CI, -19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group blinded to echinacea, and 70 pg/mL and 1 cell for the group with open-label echinacea, also not statistically significant. Among the 120 participants who at intake rated echinacea's effectiveness as greater than 50 on a 100-point scale for which 100 is extremely effective, illness duration was 2.58 days shorter (95% CI, -4.47 to -0.68 days) in those blinded to placebo rather than no pill, and mean global severity score was 26% lower but not significantly different (-97.0, 95% CI, -249.8 to 55.8 points). In this subgroup, neither duration nor severity differed significantly between the group blinded to echinacea and the open-label echinacea group. CONCLUSIONS: Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea. These findings support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions.

Echinacea for treating the common cold: a randomized trial.

BACKGROUND: Echinacea is widely used to treat the common cold. OBJECTIVE: To assess the potential benefits of echinacea as a treatment of common cold. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00065715) SETTING: Dane County, Wisconsin. PATIENTS: 719 patients, aged 12 to 80 years, with new-onset common cold. INTERVENTION: Patients were assigned to 1 of 4 parallel groups: no pills, placebo pills (blinded), echinacea pills (blinded), or echinacea pills (unblinded, open-label). Echinacea groups received the equivalent of 10.2 g of dried echinacea root during the first 24 hours and 5.1 g during each of the next 4 days. Indistinguishable placebo tablets contained only inert ingredients. MEASUREMENTS: The primary outcome was the area under the curve for global severity, with severity assessed twice daily by self-report using the Wisconsin Upper Respiratory Symptom Survey, short version. Secondary outcomes included interleukin-8 levels and neutrophil counts from nasal wash, assessed at intake and 2 days later. RESULTS: Of the 719 patients enrolled, 713 completed the protocol. Mean age was 33.7 years, 64% were female, and 88% were white. Mean global severity was 236 and 258 for the blinded and unblinded echinacea groups, respectively; 264 for the blinded placebo group; and 286 for the no-pill group. A comparison of the 2 blinded groups showed a 28-point trend (95% CI, -69 to 13 points) toward benefit for echinacea (P = 0.089). Mean illness duration in the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared with 6.87 days in the blinded placebo group and 7.03 days in the no-pill group. A comparison of the blinded groups showed a nonsignificant 0.53-day (CI, -1.25 to 0.19 days) benefit (P = 0.075). Median change in interleukin-8 levels and neutrophil counts were also not statistically significant (30 ng/L and 1 cell/high-power field [hpf] in the no-pill group, 39 ng/L and 1 cell/hpf in the blinded placebo group, 58 ng/L and 2 cells/hpf in the blinded echinacea group, and 70 ng/L and 1 cell/hpf in the open-label echinacea group). LIMITATION: Higher-than-expected variability limited power to detect small benefits. CONCLUSION: Illness duration and severity were not statistically significant with echinacea compared with placebo. These results do not support the ability of this dose of the echinacea formulation to substantively change the course of the common cold. PRIMARY FUNDING SOURCE: National Center for Complementary and Alternative Medicine, National Institutes of Health.

Pediatric folk beliefs of inner-city black Chicagoans.

OBJECTIVES: To estimate the familiarity of black inner-city Chicagoans with pediatric folk beliefs identified by key informants. STUDY DESIGN: Five black staff members at an inner-city clinic identified 10 African American folk beliefs regarding pediatric care. A survey of 606 African American patients in Chicago assessed familiarity with these beliefs, and with medical recommendations regarding immunization and sleep position. RESULTS: The 2 medical recommendations were more familiar and more believed than any of the identified folk beliefs. The most widely known folk belief was that it is dangerous for a woman to go outdoors 4 to 6 weeks after she has a baby, which was familiar to 93% of respondents. The most believed cultural item was that it is bad to stand where an infant has to roll his eyes back to see you, which was familiar to 86% of respondents and thought true by 86% of those familiar with it. Respondents born in a southern state were significantly more likely to have heard of taping a coin over an umbilicus that sticks out (odds ratio [OR], 1.51; 95% confidence interval [Cl], 1.01-2.26; p = .045) and less likely to agree with infant back or side position for sleep (OR, 0.35; 95% CI, 0.14-0.85; p = .021). CONCLUSION: The widespread familiarity with specific folk beliefs in this population suggests that an understanding of these beliefs may be important for culturally competent providers of pediatric care in Chicago's inner city. Further research is needed to determine whether these findings are reproducible in other socioeconomic and geographic settings.

Substance use disorders in a primary care sample receiving daily opioid therapy.

UNLABELLED: The primary goal of this paper was to present a comprehensive picture of substance use disorders in a sample of patients receiving opioid therapy from their primary care physician. A second goal was to determine the relation of positive urine screens and aberrant drug behaviors to opioid use disorders. The study recruited 801 adults receiving daily opioid therapy from the primary care practices of 235 family physicians and internists in 6 health care systems in Wisconsin. The 6 most common pain diagnoses were degenerative arthritis, low back pain, migraine headaches, neuropathy, and fibromyalgia. The point prevalence of current (DSM-IV criteria in the past 30 days) substance abuse and/or dependence was 9.7% (n=78) and 3.8% (30) for an opioid use disorder. A logistic regression model found that current substance use disorders were associated with age between 18 and 30 (OR=6.17: 1.99 to 19.12), severity of lifetime psychiatric disorders (OR=6.17; 1.99 to 19.12), a positive toxicology test for cocaine (OR=5.92; 2.60 to 13.50) or marijuana (OR=3.52; 1.85 to 6.73), and 4 aberrant drug behaviors (OR=11.48; 6.13 to 21.48). The final model for opioid use disorders was limited to aberrant behaviors (OR=48.27; 13.63 to 171.04) as the other variables dropped out of the model. PERSPECTIVE: This study found that the frequency of opioid use disorders was 4 times higher in patients receiving opioid therapy compared with general population samples (3.8% vs 0.9%). The study also provides quantitative data linking aberrant drug behaviors to opioid use disorders.

CAM therapies among primary care patients using opioid therapy for chronic pain.

BACKGROUND: Complementary and alternative medicine (CAM) is an increasingly common therapy used to treat chronic pain syndromes. However; there is limited information on the utilization and efficacy of CAM therapy in primary care patients receiving long-term opioid therapy. METHOD: A survey of CAM therapy was conducted with a systematic sample of 908 primary care patients receiving opioids as a primary treatment method for chronic pain. Subjects completed a questionnaire designed to assess utilization, efficacy and costs of CAM therapies in this population. RESULTS: Patients were treated for a variety of pain problems including low back pain (38.4%), headaches (9.9%), and knee pain (6.5%); the average duration of pain was 16 years. The median morphine equivalent opioid dose was 41 mg/day, and the mean dose was 92 mg/day. Forty-four percent of the sample reported CAM therapy use in the past 12 months. Therapies utilized included massage therapy (27.3%, n = 248), chiropractic treatment (17.8%, n = 162), acupuncture (7.6%, n = 69), yoga (6.1%, n = 55), herbs and supplements (6.8%, n = 62), and prolotherapy (5.9%, n = 54). CAM utilization was significantly related to age female gender, pain severity income pain diagnosis of neck and upper back pain, and illicit drug use. Medical insurance covered chiropractic treatment (81.8%) and prolotherapy (87.7%), whereas patients primarily paid for other CAM therapies. Over half the sample reported that one or more of the CAM therapies were helpful. CONCLUSION: This study suggests CAM therapy is widely used by patients receiving opioids for chronic pain. Whether opioids can be reduced by introducing such therapies remains to be studied.

Qualitative aspects of nasal irrigation use by patients with chronic sinus disease in a multimethod study.

PURPOSE: We qualitatively assessed attitudes regarding use of hypertonic saline nasal irrigation (HSNI) for frequent rhinosinusitis and chronic sinonasal symptoms in a 3-part, multimethod study. METHODS: We conducted semistructured, in-depth interviews with 28 participants who recently used nasal irrigation in studies assessing HSNI. RESULTS: Four themes emerged: (1) HSNI improved self-management of sinus symptoms, creating a sense of empowerment; (2) HSNI produced rapid and long-term improvement in quality of life; (3) participants identified discomfort, time, and mild side effects as barriers to HSNI use; and (4) participants identified aspects of training and at-home use that overcame these barriers. CONCLUSION: HSNI is a safe, well-tolerated, inexpensive, effective, long-term therapy that patients with chronic sinonasal symptoms can and will use at home with minimal training and follow-up. Success with HSNI will likely be improved by patient education.

Dietary calcium intake among women attending primary care clinics in Wisconsin.

BACKGROUND: Osteoporosis and related fractures are becoming more prevalent as the population ages. Primary care professionals counsel all women about adequate calcium intake as part of an overall osteoporosis preventive strategy. Population data shows that the average calcium intakes in women are substantially lower than standard recommendations. No data is available on dietary calcium intakes among a primary care population. This study looks at dietary calcium intakes and calcium supplementation among a sample of women attending 4 primary care clinics in Wisconsin. METHODS: A total of 210 women completed food frequency questionnaires while waiting to see a health care professional in the waiting room of 4 primary care clinics. The women estimated amount of high calcium foods eaten per day and frequency of ingestion per week. Women also indicated whether or not they were taking a calcium supplement. RESULTS: The overall mean calcium intake was 1309 mg per day. Women who were nonsmokers, postmenopausal, older, Caucasian, or who had been diagnosed with osteopenia or osteoporosis had higher calcium intakes. Over half of the study population took a calcium supplement regularly. CONCLUSION: Women in a primary care population in Wisconsin had higher dietary calcium intakes than women from population studies. Primary care professionals need to continue counseling women about adequate calcium and vitamin D intakes as part of an overall osteoporosis prevention program.

The efficacy of hypertonic saline nasal irrigation for chronic sinonasal symptoms.

OBJECTIVE: To assess quality of life (QOL) in patients with sinonasal symptoms in response to hypertonic saline nasal irrigation (HSNI), and to assess HSNI use patterns. STUDY DESIGN AND SETTING: The study was an uncontrolled 12-month follow-up to a randomized controlled trial (RCT) and used HSNI in a community setting. We included 54 participants with recurrent or chronic sinonasal symptoms. Forty participants had been in the intervention group of a previous study; 14 had been control participants. Primary outcome measures were the Rhinosinusitis Disability Index (RSDI), a sinus-symptom severity assessment (SIA), and the Sino-Nasal Outcomes Test (SNOT-20). Secondary outcome measures were frequency and pattern of HSNI use, side effects and satisfaction. RESULTS: Among participants using HSNI in the prior RCT, RSDI scores continued to improve, from 73.2 +/- 2.6 points to 80.6 +/- 2.4 points (P < 0.001). SIA and SNOT-20 scores remained stable. Former control participants reported QOL improvement similar to that of HSNI users in the prior RCT. RSDI scores improved from 62.0 +/- 3.9 points to 79.7 +/- 3.7 points (P < 0.05), SNOT-20 scores improved from 43.5 +/- 5.7 points to 28.4 +/- 4.8 points, and SIA scores improved from 4.2 +/- 0.3 points to 2.6 +/- 0.3 points (P < 0.01). Mean HSNI use for all participants was 2.4 irrigations per week; 33% of participants used HSNI regularly, 55% when symptomatic. Side effects were minor; satisfaction was high. CONCLUSIONS: Participants with chronic sinonasal symptoms reported improved QOL and frequent, satisfying use of HSNI. SIGNIFICANCE: HSNI is an effective adjunctive treatment of chronic sinonasal symptoms.

Using benefit harm tradeoffs to estimate sufficiently important difference: the case of the common cold.

CONTEXT: The term "sufficiently important difference" (SID) refers to the overall amount of benefit that people consider sufficient to justify the costs and risks of treatment. Little is known about patient preferences regarding benefits and harms of common cold treatments. OBJECTIVES: To develop methods to assess SID and to estimate SID for common cold. DESIGN: The authors conducted in-person and telephone interviews with people with colds, using benefit harm tradeoff methods. The hypothetical benefit of reduction in length of illness was traded off against best estimates of costs and risks. First, the authors briefly described costs, risks, and possible symptomatic benefits of 4 treatment scenarios, based on evidence regarding vitamin C, echinacea, zinc, and pleconaril, an antiviral. Hypothetical benefit (reduction of illness duration) was then varied until the cold sufferer indicated that the treatment was minimally desirable. PARTICIPANTS: Interviews were conducted in person with 149 community-recruited adult participants, once at the beginning of their colds, and then again within a few days after symptoms had resolved. Additionally, 162 adult callers with self-identified colds completed interviews via telephone. RESULTS: A total of 460 benefit harm tradeoff interviews (1840 treatment scenarios) estimated overall mean SID as 52.6 h (95% CI, 50.6 to 54.6). For the scenario based on vitamin C, mean SID was estimated as 26.1 h (95% CI, 23.2 to 29.3), with 142 of 460 (31%) saying they would take it regardless of duration benefit, and 22 of 460 (5%) saying they would not take it, regardless of duration benefit. For the echinacea-based scenario, mean SID was estimated at 36.8 h (33.4 to 40.2), with 105 (23%) favoring and 41 (9%) rejecting treatment, regardless of duration benefit. For the zinc lozenge-based scenario, mean SID was estimated as 64.8 h (61.0 to 67.9), with 42 (9%) favoring and 109 (24%) rejecting treatment. For the prescription antiviral-based scenario, mean SID was estimated as 82.6 h (78.7 to 86.7), with 29 (6%) favoring and 223 (48%) rejecting. Severity of illness at the time of interview did not appear to significantly influence responses. Possible side effects, treatment type (tablet v. lozenge v. liquid), monetary costs, and opportunity costs (e.g., getting to the doctor or pharmacy, dosing frequency) did appear to be important in influencing these preference patterns. CONCLUSIONS: Our study suggests that, on average, people want the duration of their colds to be reduced by between 26 and 65 h to justify potential harms of popular cold treatments. A prescription antiviral would require a greater benefit (83 h) to justify larger perceived risks.

Services integration and cost-effectiveness.

Alcohol treatment services are increasingly combined with other health and social services to address the needs of multiple-problem clients. Hence, it has been of growing policy interest to find the most effective and the most cost-effective ways of linking these services. This symposium presents some recent studies in this area. The small but growing body of studies in this area has great potential to inform public policy debates.