Robert B. Saper

Lead, Mercury, and Arsenic in US- and Indian-Manufactured Ayurvedic Medicines Sold via the Internet

CONTEXT Lead, mercury, and arsenic have been detected in a substantial proportion of Indian-manufactured traditional Ayurvedic medicines. Metals may be present due to the practice of rasa shastra (combining herbs with metals, minerals, and gems). Whether toxic metals are present in both US- and Indian-manufactured Ayurvedic medicines is unknown. OBJECTIVES To determine the prevalence of Ayurvedic medicines available via the Internet containing detectable lead, mercury, or arsenic and to compare the prevalence of toxic metals in US- vs Indian-manufactured medicines and between rasa shastra and non-rasa shastra medicines. DESIGN A search using 5 Internet search engines and the search terms Ayurveda and Ayurvedic medicine identified 25 Web sites offering traditional Ayurvedic herbs, formulas, or ingredients commonly used in Ayurveda, indicated for oral use, and available for sale. From 673 identified products, 230 Ayurvedic medicines were randomly selected for purchase in August-October 2005. Country of manufacturer/Web site supplier, rasa shastra status, and claims of Good Manufacturing Practices were recorded. Metal concentrations were measured using x-ray fluorescence spectroscopy. MAIN OUTCOME MEASURES Prevalence of medicines with detectable toxic metals in the entire sample and stratified by country of manufacture and rasa shastra status. RESULTS One hundred ninety-three of the 230 requested medicines were received and analyzed. The prevalence of metal-containing products was 20.7% (95% confidence interval [CI], 15.2%-27.1%). The prevalence of metals in US-manufactured products was 21.7% (95% CI, 14.6%-30.4%) compared with 19.5% (95% CI, 11.3%-30.1%) in Indian products (P = .86). Rasa shastra compared with non-rasa shastra medicines had a greater prevalence of metals (40.6% vs 17.1%; P = .007) and higher median concentrations of lead (11.5 microg/g vs 7.0 microg/g; P = .03) and mercury (20,800 microg/g vs 34.5 microg/g; P = .04). Among the metal-containing products, 95% were sold by US Web sites and 75% claimed Good Manufacturing Practices. All metal-containing products exceeded 1 or more standards for acceptable daily intake of toxic metals. CONCLUSION One-fifth of both US-manufactured and Indian-manufactured Ayurvedic medicines purchased via the Internet contain detectable lead, mercury, or arsenic.

Effects of yoga on the autonomic nervous system, gamma-aminobutyric-acid, and allostasis in epilepsy, depression, and post-traumatic stress disorder

A theory is proposed to explain the benefits of yoga practices in diverse, frequently comorbid medical conditions based on the concept that yoga practices reduce allostatic load in stress response systems such that optimal homeostasis is restored. It is hypothesized that stress induces (1) imbalance of the autonomic nervous system (ANS) with decreased parasympathetic nervous system (PNS) and increased sympathetic nervous system (SNS) activity, (2) underactivity of the gamma amino-butyric acid (GABA) system, the primary inhibitory neurotransmitter system, and (3) increased allostatic load. It is further hypothesized that yoga-based practices (4) correct underactivity of the PNS and GABA systems in part through stimulation of the vagus nerves, the main peripheral pathway of the PNS, and (5) reduce allostatic load. Depression, epilepsy, post traumatic stress disorder (PTSD), and chronic pain exemplify medical conditions that are exacerbated by stress, have low heart rate variability (HRV) and low GABAergic activity, respond to pharmacologic agents that increase activity of the GABA system, and show symptom improvement in response to yoga-based interventions. The observation that treatment resistant cases of epilepsy and depression respond to vagal nerve stimulation corroborates the need to correct PNS underactivity as part of a successful treatment plan in some cases. According to the proposed theory, the decreased PNS and GABAergic activity that underlies stress-related disorders can be corrected by yoga practices resulting in amelioration of disease symptoms. This has far-reaching implications for the integration of yoga-based practices in the treatment of a broad array of disorders exacerbated by stress.

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

As yoga has gained popularity as a therapeutic intervention, its safety has been questioned in the lay press. Thus, this review aimed to systematically assess and meta-analyze the frequency of adverse events in randomized controlled trials of yoga. MEDLINE/PubMed, Scopus, the Cochrane Library, and IndMED were screened through February 2014. Of 301 identified randomized controlled trials of yoga, 94 (1975-2014; total of 8,430 participants) reported on adverse events. Life-threatening, disabling adverse events or those requiring intensive treatment were defined as serious and all other events as nonserious. No differences in the frequency of intervention-related, nonserious, or serious adverse events and of dropouts due to adverse events were found when comparing yoga with usual care or exercise. Compared with psychological or educational interventions (e.g., health education), more intervention-related adverse events (odds ratio = 4.21, 95% confidence interval: 1.01, 17.67; P = 0.05) and more nonserious adverse events (odds ratio = 7.30, 95% confidence interval: 1.91, 27.92; P < 0.01) occurred in the yoga group; serious adverse events and dropouts due to adverse events were comparable between groups. Findings from this review indicate that yoga appears as safe as usual care and exercise. The adequate reporting of safety data in future randomized trials of yoga is crucial to conclusively judge its safety.

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 <

Yoga in the Real World: Perceptions, Motivators, Barriers, and patterns of Use.

40,000. The samples 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.

Bioaccessibility of lead and arsenic in traditional Indian medicines

Background: Yoga is a mind-body exercise practiced by nearly 16 million US adults. Clinical yoga research has yielded promising findings in physical and mental health outcomes. However, research in non-patient populations is limited. The purpose of this study is to survey a non-clinical population to better understand yoga use in a real-world setting. Methods: This study used a pre-post test design in a convenience sample of adults registered for a 4-week beginner yoga program within a network of five yoga studios in Austin, Texas. Students were linked via e-mail to baseline and endpoint surveys. Analyses were descriptive. Results: Six hundred four students completed the baseline survey, and 290 (48%) completed the 4-week endpoint survey. Baseline demographics were similar to those in national surveys, with respondents being primarily female (86%), white (88%), and college educated (78%). The primary barrier to practice was time (55%). Respondents perceived yoga primarily as an exercise activity (92%), spiritual activity (73%), or a way to manage or treat a health condition (50%). Main reasons for taking yoga were general wellness (81%), physical exercise (80%), and stress management (73%). Ninety-eight percent believed yoga would improve their health, with 28% taking yoga to alleviate a health condition. On average, respondents practiced 3 to 4 hours/week in and out of class. Conclusions: Respondent demographics were consistent with national survey data. Data show that yoga is perceived several ways. Information on practice patterns provides new information, which may improve understanding of how non-clinical populations incorporate yoga into daily life for health management.

Determination of in vitro bioaccessibility of Pb, As, Cd and Hg in selected traditional Indian medicines.

Arsenic and lead have been found in a number of traditional Ayurvedic medicines, and the practice of Rasa Shastra (combining herbs with metals, minerals and gems), or plant ingredients that contain these elements, may be possible sources. To obtain an estimate of arsenic and lead solubility in the human gastrointestinal tract, bioaccessibility of the two elements was measured in 42 medicines, using a physiologically-based extraction test. The test consisted of a gastric phase at pH 1.8 containing organic acids, pepsin and salt, followed by an intestinal phase, at pH 7 and containing bile and pancreatin. Arsenic speciation was measured in a subset of samples that had sufficiently high arsenic concentrations for the X-ray absorption near edge structure analysis used. Bioaccessible lead was found in 76% of samples, with a large range of bioaccessibility results, but only 29% of samples had bioaccessible arsenic. Lead bioaccessibility was high (close to 100%) in a medicine (Mahayograj Guggulu) that had been compounded with bhasmas (calcined minerals), including naga (lead) bhasma. For the samples in which arsenic speciation was measured, bioaccessible arsenic was correlated with the sum of As(V)-O and As(III)-O and negatively correlated with As-S. These results suggest that the bioaccessible species in the samples had been oxidized from assumed As-S raw medicinal ingredients (realgar, As(4)S(4), added to naga (lead) bhasma and As(III)-S species in plants). Consumption at recommended doses of all medicines with bioaccessibile lead or arsenic would lead to the exceedance of at least one standard for acceptable daily intake of toxic elements.

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

In vitro bioaccessibility of Pb, As, Cd and Hg in five traditional Indian medicine samples was measured as a determinant of bioavailability. The method is based on simulation of human digestion in the passage of material from the gastric to intestinal portions of the gastrointestinal tract. Total concentration and concentration in extracts from gastric and intestinal phases were analyzed for Pb, As and Cd by dynamic reaction cell inductively coupled plasma mass spectrometry (DRC-ICP-MS) and for Hg by direct mercury analyzer (DMA). Total lead ranged from 1.9 to 36000 µg g(-1). In each of the samples bioaccessibility of lead was significantly higher (range 28-88%) in the gastric phase than in the intestinal phase (range 1.4-75.4%). Only Ekangvir Ras had measurable arsenic (304 µg g(-1)). Its bioaccessibility in the gastric phase and intestinal phase was 82.6% and 78.1%, respectively. Only Ayu-Nephro-Tone had measurable cadmium (14.4 µg g(-1)). Its bioaccessibility in the gastric phase and intestinal phase was 80.5% and 2.2%, respectively. Three samples had measurable mercury (range 37 µg g(-1)-10000 µg g(-1)). Mercury in these samples was not bioaccessible. For the samples with measurable amount of metal, the estimated daily amount of bioaccessible (EDAB) metal was calculated. When compared with the most liberal published safety guideline, EDAB-Pb in Mahayograj Guggulu and Ekangvir Ras were 37 and 45 fold greater. When compared with the most conservative published safety guideline, all samples had higher EDAB-Pb or EDAB-As than the suggested limits. The EDAB-Cd and EDAB-Hg were acceptably below published safety limits.

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

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.

Complementary and Alternative Medicine Use Among Patients with Thyroid Cancer

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 yogas 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.