Blood Lead Levels of Children Using Traditional Indian Medicine and Cosmetics: A Feasibility Study.

BACKGROUND: Traditional Indian cosmetics and Ayurvedic medicines may contain lead. Previous studies have shown a relationship between eye cosmetic use (kohl) in children and elevated blood lead levels (BLLs) > 10 µg/dL. However, an association between Ayurvedic use and elevated BLLs in children is unknown and understudied. METHODS: We assessed the feasibility of collecting BLLs in children attending Ayurvedic outpatient settings in India. Our pilot study took place over 3 days in the summer of 2010 at a large public Ayurveda hospital and a small pediatric clinic in southern India. Using a trained interpreter, we administered a standardized questionnaire in Malayalam, assessing sociodemographics, Ayurvedic medicine use, kohl use, and other potential risk factors for lead exposure, to parents of pediatric outpatients. We also analyzed BLLs using a portable lead analyzer. RESULTS: The study enrolled 29 children (mean age, 3.8 years). The mean BLL was 6.7 µg/dL (SD = 3.5; range, 3.5-20.2). Seventy-two percent of the children used Ayurvedic medicine in the past 2 years and 55% reported kohl use. Mean BLL of Ayurvedic users and nonusers was 6.2 µg/dL and 8.5 µg/dL, respectively (P = .08). Kohl users had a statistically significant higher BLL than nonusers (8.0 µg/dL vs 5.3 µg/dL, P = .03). CONCLUSIONS: It is feasible to collect BLLs in pediatric Ayurvedic outpatient clinics in southern India. Collaborative relationships with community members and hospital staff were essential. Further research is needed to investigate Ayurveda and kohl use as risk factors for elevated lead burden among Indian children.

Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial.

BACKGROUND: Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain. OBJECTIVE: To determine whether yoga is noninferior to PT for cLBP. DESIGN: 12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927). SETTING: Academic safety-net hospital and 7 affiliated community health centers. PARTICIPANTS: 320 predominantly low-income, racially diverse adults with nonspecific cLBP. INTERVENTION: Participants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice. MEASUREMENTS: Primary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life. RESULTS: One-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups. LIMITATIONS: Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up. CONCLUSION: A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain. PRIMARY FUNDING SOURCE: National Center for Complementary and Integrative Health of the National Institutes of Health.

"We're all in this together": A qualitative study of predominantly low income minority participants in a yoga trial for chronic low back pain.

OBJECTIVE: To explore the experiences of low-income minority adults taking part in a yoga dosing trial for chronic low back pain. DESIGN: Individual semi-structured interviews were conducted with nineteen participants recruited from a randomized yoga dosing trial for predominantly low-income minority adults with chronic low back pain. Interviews discussed the impact of yoga on low back pain and emotions; other perceived advantages or disadvantages of the intervention; and facilitators and barriers to practicing yoga. Interviews were audio taped and transcribed, coded using ATLAS.ti software, and analyzed with inductive and deductive thematic analysis methods. SETTING: Boston Medical Center, Boston, MA, USA. RESULTS: Participants viewed yoga as a means of pain relief and attributed improved mood, greater ability to manage stress, and enhanced relaxation to yoga. Overall, participants felt empowered to self-manage their pain. Some found yoga to be helpful in being mindful of their emotions and accepting of their pain. Trust in the yoga instructors was a commonly cited facilitator for yoga class attendance. Lack of time, motivation, and fear of injury were reported barriers to yoga practice. CONCLUSIONS: Yoga is a multidimensional treatment for low back pain that has the potential to favorably impact health in a predominantly low-income minority population.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

BACKGROUND: Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. METHODS/DESIGN: This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.

Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial.

Background. Previous studies have demonstrated that once-weekly yoga classes are effective for chronic low back pain (cLBP) in white adults with high socioeconomic status. The comparative effectiveness of twice-weekly classes and generalizability to racially diverse low income populations are unknown. Methods. We conducted a 12-week randomized, parallel-group, dosing trial for 95 adults recruited from an urban safety-net hospital and five community health centers comparing once-weekly (n = 49) versus twice-weekly (n = 46) standardized yoga classes supplemented by home practice. Primary outcomes were change from baseline to 12 weeks in pain (11-point scale) and back-related function (23-point modified Roland-Morris Disability Questionnaire). Results. 82% of participants were nonwhite; 77% had annual household incomes <$40,000. The sample's baseline mean pain intensity [6.9 (SD 1.6)] and function [13.7 (SD 5.0)] reflected moderate to severe back pain and impairment. Pain and back-related function improved within both groups (P < 0.001). However, there were no differences between once-weekly and twice-weekly groups for pain reduction [-2.1 (95% CI -2.9, -1.3) versus -2.4 (95% CI -3.1, -1.8), P = 0.62] or back-related function [-5.1 (95% CI -7.0, -3.2) versus -4.9 (95% CI -6.5, -3.3), P = 0.83]. Conclusions. Twelve weeks of once-weekly or twice-weekly yoga classes were similarly effective for predominantly low income minority adults with moderate to severe chronic low back pain. This trial is registered with ClinicalTrials.gov NCT01761617.