PECULIARITIES OF EATING BEHAVIOR IN CHILDREN WITH AUTISTIC SPECTRUM DISORDERS.

OBJECTIVE: The aim: To determine of the nutrition peculiarities in children with ASD. PATIENTS AND METHODS: Materials and methods: The study involved 37 children with ASD from 2 -12 years and thier mothers, in according to reveal its disorder effect on the clinical course of ASD in children. RESULTS: Results: It was shown role of irrational nutrition of the mother during pregnancy, peculiarities of family food traditions, problems of breastfeeding and com-plementary feeding. Eating behavior of mothers during pregnancy were: monotonous nutrition and an inadequate diet. The family food preferences were: varied and included both traditional and specific food preferences ( vegan, vegeterian, monotony diet). CONCLUSION: Conclusions: The analysis of the eating behavior in the ASD children, taking into account the age peculiarities, was carried out. Intolerance to certain products was noted. Also effectiveness of the elimination diet was shown. Elimination from the diet of the white flour products within 6 months has a positive result which evaluated by digestive and cognitive signs.

Proximate composition, pasting and functional properties of composite flour blends from cassava and chia seeds flour.

The study established the proximate composition, pasting, and functional properties of cassava flour (CF) blended with chia seeds flour (CSF). Composite flour was prepared by blending CF with CSF in the ratios of 95:05, 90:10, 85:15, 80:20, and 75:25 with CF and CSF used as controls, respectively. The effect of blending significantly (p < 0.05) increased protein, fat, fibre, and ash contents as CSF increased. On other hand, moisture and carbohydrate contents decreased significantly. Pasting properties of composite flour blends decreased significantly (p < 0.05) as the incorporation of CSF increased and a noticeable change was observed for composite flour (75:25) except for peak time and pasting temperature. Functional properties of water absorption capacity (WAC) of CSF were significantly different with CF and composite flour blends. Oil absorption capacity (OAC) of CF and CSF were significantly different, while the composite flour blends had varied OAC due to the inclusion of the different amounts of CSF. The swelling capacity (SC) of CF and CSF were not significantly different, but composite flour blends were significantly different from both CSF and CF. The least gelation concentration (LGC) and bulk density (BD) increased significantly as chia seeds increased. Increased concentration of chia CSF in the composite flour blends showed to alter the functional properties. This study recommends composite flour 75:25 for processing semiliquid products like porridge due to reduced pasting properties values that may be associated with increased energy density compared to CF.

Mutually inclusive mechanisms of drought-induced tree mortality.

Unprecedented tree dieback across Central Europe caused by recent global change-type drought events highlights the need for a better mechanistic understanding of drought-induced tree mortality. Although numerous physiological risk factors have been identified, the importance of two principal mechanisms, hydraulic failure and carbon starvation, is still debated. It further remains largely unresolved how the local neighborhood composition affects individual mortality risk. We studied 9435 young trees of 12 temperate species planted in a diversity experiment in 2013 to assess how hydraulic traits, carbon dynamics, pest infestation, tree height and neighborhood competition influence individual mortality risk. Following the most extreme global change-type drought since record in 2018, one third of these trees died. Across species, hydraulic safety margins (HSMs) were negatively and a shift towards a higher sugar fraction in the non-structural carbohydrate (NSC) pool positively associated with mortality risk. Moreover, trees infested by bark beetles had a higher mortality risk, and taller trees a lower mortality risk. Most neighborhood interactions were beneficial, although neighborhood effects were highly species-specific. Species that suffered more from drought, especially Larix spp. and Betula spp., tended to increase the survival probability of their neighbors and vice versa. While severe tissue dehydration marks the final stage of drought-induced tree mortality, we show that hydraulic failure is interrelated with a series of other, mutually inclusive processes. These include shifts in NSC pools driven by osmotic adjustment and/or starch depletion as well as pest infestation and are modulated by the size and species identity of a tree and its neighbors. A more holistic view that accounts for multiple causes of drought-induced tree mortality is required to improve predictions of trends in global forest dynamics and to identify mutually beneficial species combinations.

Manual Lymphatic Drainage Increases the Number of Opened Lymphatic Pathways in Patients with Lower Limb Lymphedemas: A Sequential Research on 80 Patients.

The purpose of this study was to lymphoscintigraphically assess the effect of skin mobilization, nonspecific massage, and manual lymphatic drainage (MLD) on the root of the lower limb in patients with lower limb lymphedema. Lower limb root lymphoscintigraphical exams of 80 patients with lower limb lymphedema were analyzed. All patients underwent our stand 3 phase protocol and then were subjected to the 4th phase which included 3 subphases. Images were taken directly after the injection (subphase 1), after pinching and stretching the injection site (subphase 2), after nonspecific massage was applied to the injected site (subphase 3) and after manual lymphatic drainage of the injected site (subphase 4). The number of opened lymphatic pathways was analyzed and compared after and between each subphase (SP). SP 1 displayed open lymphatic pathways in 22 of the 80 cases (27.5%). SP 2 displayed newly opened lymphatic pathways in 48 of the 80 cases (60.0%). SP 3 displayed newly opened lymphatic pathways in 57 of the 80 cases (71.3%). Only 9 of these 57 cases did not show improvement following the next SP. SP 4 displayed newly opened lymphatic pathways in 60 of the 80 cases (75.1%). MLD improved the visualization of the lymphatic pathways in 48 cases (60%) compared to phase 3. MLD was the only technique to allow visualization of the lymphatic drainage at the level of the root of the edematous limb in 6 cases (7.5%). Physical therapy leads to a greater number of lymphatic collaterals opening in a region where no other complex decongestive therapy technique can be applied.

Evaluation and handling of constipation in critical patients. / Evaluación y abordaje del estreñimiento en el paciente crítico.

OBJECTIVE: To evaluate the effectiveness of nursing care against constipation and to identify, analyze and evaluate causes and consequences. METHODOLOGY: Observational, descriptive and prospective study in polyvalent ICU tertiary hospital (2013-2015). INCLUSION CRITERIA: >18 years, stay >7 days, connected to respiratory support, with nasogastric tube and enteral or mixed nutrition. Patients with gastrointestinal pathology, encephalopathic and jejunostomy/ileostomy were excluded. The studied variables (age, sex, weight, height, pathology, medical treatment, nutrition and volume type, depositional characteristics, quantity and frequency, corrective measures and complications) were collected by ad hoc grill. It is authorized by the CEIC. RESULTS: 139 patients with a mean age of 62 years and average stay of 11 days were analyzed; 63% suffered from constipation. Opiates and antacid were the drugs administered most frequently (99%), even though patients who took muscle relaxants, iron supplements and/or calcium and anti-hypertensive were the ones who suffered most from constipation (77%; 75%; 70%) The fiber free diet was the most widely used (60% constipated), followed by dietary fiber (51% constipated), and the combination of both (85% constipated). 56% used laxatives as a corrective measure, Magnesium Hydroxide being the most widely used; 54% began the first day. Gastric retention was the most relevant complication (49%). CONCLUSION: Constipation is a real multifactorial problem. We recommend: • Intensified surveillance in patients with drugs that promote constipation. • Use high-fiber diets from the outset. • Apply laxatives and prokinetics early and in combination. We need to create a protocol for prophylaxis and management of constipation.

Content Validation of a Catalog of Exercises for Judo.

This study aimed to assess the content validity of a catalog of 76 judo exercises. Two groups of raters comprising 16 judo experts evaluated the following content validity indicators: Clarity of Language, Practical Pertinence, Theoretical Relevance, and the Dimension of each exercise. The results confirmed the content validity of the judo training catalog with indicators showing scores greater than 0.80. These findings suggest that all 76 judo exercises are pertinent, representative of judo training and understandable for judo coaches. Thus, this catalog of judo exercises may help judo coaches in the selection and recording of exercises.

Alcohol-related deficient fracture healing is associated with activation of FoxO transcription factors in mice.

The process of fracture healing is complex, and poor or incomplete healing remains a significant health problem. Proper fracture healing relies upon resident mesenchymal stem cell (MSC) differentiation into chondrocytes and osteoblasts, which are necessary for callus formation and ossification. Alcohol abuse is a leading contributor to poor fracture healing. Although the mechanism behind this action is unknown, excessive alcohol consumption is known to promote systemic oxidative stress. The family of FoxO transcription factors is activated by oxidative stress, and FoxO activation antagonizes Wnt signaling, which regulates mesenchymal stem cell differentiation. We hypothesize that alcohol exposure increases oxidative stress leading to deficient fracture repair by activating FoxO transcription factors within the fracture callus which disrupts chondrogenesis of mesenchymal stem cells. Our laboratory has developed an experimental model of delayed fracture union in mice using ethanol administration. We have found that ethanol administration significantly decreases external, cartilaginous callus formation, and hallmarks of endochondral ossification, and these changes are concomitant with increases in FoxO expression and markers of activation in fracture callus tissue of these mice. We were able to prevent these alcohol-induced effects with the administration of the antioxidant n-acetyl cysteine (NAC), suggesting that alcohol-induced oxidative stress produces the perturbed endochondral ossification and FoxO expression. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:2106-2115, 2016.

Serum carnitine concentration is decreased in patients with Lyme borreliosis.

BACKGROUND: Lyme borreliosis (LB) is a serious infectious disease. Carnitine plays a crucial role in metabolism and inflammatory responses. Carnitine may be important in improving neuronal dysfunction and loss of neurons. AIM: To evaluate serum carnitine concentration in adult patients with various clinical types of LB. MATERIAL/METHODS: Groups: 1) patients with erythema migrans (EM, n=16), 2) neuroborreliosis (NB, n=10), 3) post-Lyme disease (PLD, n=22) and healthy controls (HC, n=32). Total (TC) and free (FC) carnitine were determined with the spectrophotometric method. RESULTS: TC levels (44.9±10.4, 28.0±8.4, 35.9±15.6 µmol/L) in the EM, NB and PLD patients were lower than in HC (54.0±11.4 µmol/L), p < 0.001. FC levels (32.7±7.7, 23.6±6.8, 26.3±11.2 µmol/L) in the EM, NB and PLD patients were lower than in HC (40.5±7.6 µmol/L), p < 0.001. AC levels (12.2±5.2, 4.4±2.6, 9.6±7.4 µmol/L) in the EM, NB and PLD patients were lower in the NB and PLD patients than in HC (13.5±8.40 µmol/L), p <0.001. AC/FC ratio was 0.31±0.14, 0.18±0.09, 0.39±0.33 in the EM, NB and PLD patients. CONCLUSIONS: LB patients exhibit a significant decrease of their serum carnitine concentrations. The largest changes were in the NB and PLD patients. To prevent late complications of the disease a possibility of early supplementation with carnitine should be considered. Further studies are required to explain the pathophysiological significance of our findings.

Surgical approach to intussusception in older children: influence of lead points.

BACKGROUND: The likelihood of a lead point as the cause of ileocolic intussusception increases as children get older. This study looks at whether a different management strategy should be employed in older patients. METHODS: 7 year multi-institutional retrospective study of intussusception in patients aged <12 years. RESULTS: Ileocolic intussusception with complete data was found in 153 patients: 109 0-2 years, 34 3-5 years, and 10 6-12 years, respectively. Bloody stools occurred in 42/143 of 0-5 years and 0/10 of 6-12 years, p<0.001. Combined hydrostatic and/or surgical reduction was successful in 113/143 0-5 year olds vs 5/10 6-12 year olds, p<0.001. Enemas were safe but reduced only 1 patient over age 5. Resections were required in 29 patients (15 idiopathic, 14 lead points). Lead points were found in 4/109 children under 3 years, in 5/34 aged 3-5 years and 5/10 aged 6-12 years (p=0.04 vs 3-5 years and p <0.001 vs 0-5 years). Lead points consisted of 7 Meckel's diverticula and 7 others. CONCLUSION: Children older than 5 years are much more likely to have a pathologic lead point and early surgical intervention should be considered. In this study, enema reduction was safe but minimally beneficial in this age group.

Occipital C1-C2 neuromodulation decreases body mass and fat stores and modifies activity of the autonomic nervous system in morbidly obese patients--a pilot study.

BACKGROUND: Autonomic and vagal neuromodulation has been suggested for the treatment of morbid obesity. Occipital nerves remain in close anatomical relation to vagal nerve roots at the entrance to medulla oblongata. The aim of the study was to evaluate the effect of C1-C2 occipital neuromodulation on autonomic activity, body mass, and composition. METHODS: Five obese patients were included in the study (three women and two men, BMI 43-49, average age 43.3, range 24-55). Two electrodes were placed bilaterally in the C1-C2 region subcutaneously under local anesthesia. Stimulation was started 24 h after implantation and continued for 8 weeks. Patients activated stimulators for 12 h every day and turned the stimulators off at night. No other treatment including diet or change in lifestyle was introduced during the study. The following parameters were evaluated: body mass (0, 4th, and 8th week), body composition (bioimpedance study), food intake, quality of life, and heart rate variability (HRV) (0 and 8th week). RESULTS: No adverse events were observed in this group. One patient reported amelioration of constipation and one reported two incidents of salivation. The average body mass decrease was 5.6 kg in 4 weeks and 8.7 kg in 8 weeks. Body composition study showed a 2-month decrease in body fat of 7.9 kg on average. HRV revealed increased parasympathetic tone (LF/HF 4.4 ± 4.3 SD vs. 1.6 ± 1.7 SD). CONCLUSIONS: C1-C2 occipital stimulation seems being capable of decreasing body mass and affecting a positive shift in body composition and significantly increases the activity of the autonomic nervous system.

Evaluation of horizontal transmission of bovine viral diarrhea virus type 1a from experimentally infected white-tailed deer fawns (Odocoileus virginianus) to colostrum-deprived calves.

OBJECTIVE: To assess the transmission of bovine viral diarrhea virus (BVDV) from experimentally infected white-tailed deer fawns to colostrum-deprived calves by use of a BVDV strain isolated from hunter-harvested white-tailed deer. ANIMALS: 5 white-tailed deer (Odocoileus virginianus) fawns and 6 colostrum-deprived calves. PROCEDURES: Fawns were inoculated intranasally with a noncytopathic BVDV-1a isolate (2 mL containing 10(6.7) TCID(50)/mL), and 2 days after inoculation, animals were commingled until the end of the study. Blood and serum samples were obtained on days -6, 0, 7, 14, and 21 after inoculation for reverse transcriptase PCR assay, virus neutralization, and BVDV-specific antibody ELISA. Nasal, oral, and rectal swab specimens were collected on days 0, 3, 7, 14, 17, and 21 for reverse transcriptase PCR testing. By 21 days after inoculation, all animals were euthanized and necropsied and tissues were collected for histologic evaluation, immunohistochemical analysis, and virus isolation. RESULTS: All fawns became infected and shed the virus for up to 18 days as determined on the basis of reverse transcriptase PCR testing and virus isolation results. Evidence of BVDV infection as a result of cohabitation with acutely infected fawns was detected in 4 of the 6 calves by means of reverse transcriptase PCR testing and virus isolation. CONCLUSIONS AND CLINICAL RELEVANCE: On the basis of these findings, BVDV transmission from acutely infected fawns to colostrum-deprived calves appeared possible.

Development and certification of green tea-containing standard reference materials.

A suite of three green tea-containing Standard Reference Materials (SRMs) has been issued by the National Institute of Standards and Technology (NIST): SRM 3254 Camellia sinensis (Green Tea) Leaves, SRM 3255 Camellia sinensis (Green Tea) Extract, and SRM 3256 Green Tea-Containing Solid Oral Dosage Form. The materials are characterized for catechins, xanthine alkaloids, theanine, and toxic elements. As many as five methods were used in assigning certified and reference values to the constituents, with measurements carried out at NIST and at collaborating laboratories. The materials are intended for use in the development and validation of new analytical methods, and for use as control materials as a component in the support of claims of metrological traceability.

Infection of cesarean-derived colostrum-deprived pigs with porcine circovirus type 2 and Swine influenza virus.

Porcine circovirus type 2 (PCV2) and swine influenza virus (SIV) are important pathogens for porcine respiratory disease complex, which is economically significant worldwide. The pathogenesis of PCV2-SIV coinfection is unknown. In this study, we focused on establishing a challenge model for PCV2 to determine whether SIV influences PCV2 replication and increases the severity of PCV2-associated disease. Cesarean-derived colostrum-deprived pigs were inoculated intratracheally with cell culture medium only (negative control group), PCV2 only, or PCV2 followed 1 wk later with SIV H1N1. Two pigs from each group were necropsied at 12, 21, 28, and 35 d after inoculation. Coinfection with SIV did not increase the number of PCV2 genomic copies in serum or target tissues or the severity of microscopic lesions associated with PCV2 in lung or lymph node. The antibody titer to PCV2 did not differ significantly between PCV2-SIV- and PCV2-infected groups. In conclusion, SIV H1N1 did not influence PCV2 replication in dually infected pigs in this study.

In vitro antilisterial effects of citrus oil fractions in combination with organic acids.

The objectives of this study were to screen activity of citrus essential oil fractions (EOs) alone and in combination with organic acids against 2 species of Listeria. Five citrus EOs were initially screened by disc diffusion assay for antibacterial activity. Cold pressed terpeneless Valencia orange oil (CP terpeneless oil) had the strongest bacteriostatic (MIC) and bactericidal (MBC) properties at 0.55% and 1.67%, respectively. Four organic acids were tested for effectiveness against Listeria. Citric and malic acids proved to be the most effective with MBC of 1.1% alone. Assays were conducted to determine synergistic effects of EOs and citric or malic acids. There was a significant decrease in MIC and MBC to 0.04% EO plus 0.12% malic or citric acid. EOs from citrus paired with organic acids offer the potential as an all-natural antimicrobial for improving the safety of all-natural foods.

Establishing a regional pediatric surgical service in the setting of universal health care: a glimpse into the future.

PURPOSE: Increasing health care expense and rising numbers of uninsured Americans have led many to propose a national health insurance. This study describes the process, rationale, and requirements in creating a regional pediatric surgical service in the setting of a single-payer system. METHODS: Our health care system consists of 10 medical centers providing comprehensive care to more than 3 million members. All services are provided by salaried physicians/practitioners to prepaid members. Before July 2004, pediatric surgical care was performed at multiple medical centers with many services contracted out. Starting July 2004, a multidisciplinary, comprehensive pediatric perioperative plan was established. Implementation has occurred in steps; current status and preliminary results are reviewed. RESULTS: Strict guidelines for pediatric anesthesia and requirements for support services, personnel, and equipment were defined. Pediatric surgery is now performed at 3 community medical centers and 1 tertiary, teaching hospital. Operative cases were assigned to each center based on age, complexity, level of postoperative care, and location. A single high-volume, center for complex care has been established. Access to care was excellent; more than 90% of outpatient consultations were seen within 2 weeks. Utilization of services was 94% in 2006 and 98% in 2007. Physician and patient satisfaction were high. Additional pediatric surgeons have been hired and nearly all care has been internalized. Given the proximity to a major children's hospital, specialty services have not been duplicated. CONCLUSION: Establishing a multidisciplinary, comprehensive pediatric perioperative plan provided standards for supporting pediatric surgical services at community hospitals. This regional service may be a model for the future of specialty care, especially in the setting of a single-payer system.

Contrast enema for pediatric intussusception: is reflux into the terminal ileum necessary for complete reduction?

PURPOSE: Complete contrast enema reduction of intussusception is traditionally considered confirmed when contrast is seen refluxing into the terminal ileum. Operative intervention is typically indicated when the intussusception is not completely reduced. This study reviews the outcomes after symptomatic reduction of intussusception without requiring reflux of contrast into the terminal ileum. METHODS: A retrospective review of all pediatric patients treated for intussusception between 1996 and 2006 was performed. Diagnostic modality, operative reports, and hospital records were reviewed. RESULTS: One hundred sixty-eight patients were treated for intussusception during the study period. Median age was 9.9 months (59 days to 16.7 years). One hundred thirty-seven (81.5%) patients underwent contrast enema as the initial diagnostic/therapeutic modality. On contrast enema, 15 (10.9%) patients demonstrated reduction of the intussusception but without contrast refluxing into the terminal ileum. All 15 patients had improvement of symptoms. Six (40%) patients underwent operative intervention and were found to have a completely reduced intussusception. Two (13.3%) patients had repeat contrast enema the next day confirming complete reduction. The remaining 7 (46.7%) patients were observed without further radiographic studies, and all 7 patients were discharged the following day tolerating full feedings. There were no recurrent intussusceptions. CONCLUSION: Nonoperative management may be used in patients with reduced intussusception despite lack of contrast refluxing into the terminal ileum if symptoms resolve.

Certification of standard reference materials containing bitter orange.

A suite of three dietary supplement standard reference materials (SRMs) containing bitter orange has been developed, and the levels of five alkaloids and caffeine have been measured by multiple analytical methods. Synephrine, octopamine, tyramine, N-methyltyramine, hordenine, total alkaloids, and caffeine were determined by as many as six analytical methods, with measurements performed at the National Institute of Standards and Technology and at two collaborating laboratories. The methods offer substantial independence, with two types of extractions, two separation methods, and four detection methods. Excellent agreement was obtained among the measurements, with data reproducibility for most methods and analytes better than 5% relative standard deviation. The bitter-orange-containing dietary supplement SRMs are intended primarily for use as measurement controls and for use in the development and validation of analytical methods.

Petroleum resins adsorption onto quartz sand: near infrared (NIR) spectroscopy study.

In this paper we have tried to evaluate adsorption parameters of petroleum resins. Near infrared (NIR) spectroscopy is applied for resins bulk concentration evaluation during adsorption process. NIR experimental scheme and parameters are provided. NIR spectra range of 9000-13,000 cm(-1) is chosen. Quartz sand (0.2-0.8 mm fraction) is used as adsorbent; benzene is used as solvent. Different approaches of "NIR spectra-resins concentration" calibration model building are discussed. Partial least squares (PLS) regression method is used. Langmuir model is chosen for experimental data fitting. Combined usage of kinetic and isothermic data gives us ability to evaluate the maximal adsorbed mass density, the equilibrium constant of adsorption, and the rate constants of adsorption (and desorption). The rate constants of resins adsorption and desorption are found to be concentration independent.

Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain.

OBJECTIVE: To determine whether a short course of traditional acupuncture improves longer term outcomes for patients with persistent non-specific low back pain in primary care. DESIGN: Pragmatic, open, randomised controlled trial. SETTING: Three private acupuncture clinics and 18 general practices in York, England. PARTICIPANTS: 241 adults aged 18-65 with non-specific low back pain of 4-52 weeks' duration. INTERVENTIONS: 10 individualised acupuncture treatments from one of six qualified acupuncturists (160 patients) or usual care only (81 patients). MAIN OUTCOME MEASURES: The primary outcome was SF-36 bodily pain, measured at 12 and 24 months. Other outcomes included reported use of analgesics, scores on the Oswestry pain disability index, safety, and patient satisfaction. RESULTS: 39 general practitioners referred 289 patients of whom 241 were randomised. At 12 months average SF-36 pain scores increased by 33.2 to 64.0 in the acupuncture group and by 27.9 to 58.3 in the control group. Adjusting for baseline score and for any clustering by acupuncturist, the estimated intervention effect was 5.6 points (95% confidence interval -0.2 to 11.4) at 12 months (n = 213) and 8.0 points (2.8 to 13.2) at 24 months (n = 182). The magnitude of the difference between the groups was about 10%-15% of the final pain score in the control group. Functional disability was not improved. No serious or life threatening events were reported. CONCLUSIONS: 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. TRIAL REGISTRATION: ISRCTN80764175 [controlled-trials.com].

Longer term clinical and economic benefits of offering acupuncture care to patients with chronic low back pain.

OBJECTIVES: To test whether patients with persistent non-specific low back pain, when offered access to traditional acupuncture care alongside conventional primary care, gained more long-term relief from pain than those offered conventional care only, for equal or less cost. Safety and acceptability of acupuncture care to patients, and the heterogeneity of outcomes were also tested. DESIGN: A pragmatic, two parallel group, randomised controlled trial. Patients in the experimental arm were offered the option of referral to the acupuncture service comprising six acupuncturists. The control group received usual care from their general practitioner (GP). Eligible patients were randomised in a ratio of 2:1 to the offer of acupuncture to allow between-acupuncturist effects to be tested. SETTING: Three non-NHS acupuncture clinics, with referrals from 39 GPs working in 16 practices in York, UK. PARTICIPANTS: Patients aged 18-65 years with non-specific low back pain of 4-52 weeks' duration, assessed as suitable for primary care management by their general practitioner. INTERVENTIONS: The trial protocol allowed up to ten individualised acupuncture treatments per patient. The acupuncturist determined the content and the number of treatments according to patient need. MAIN OUTCOME MEASURES: The Short Form 36 (SF-36) Bodily Pain dimension (range 0-100 points), assessed at baseline, and 3, 12 and 24 months. The study was powered to detect a 10-point difference between groups at 12 months post-randomisation. Cost--utility analysis was conducted at 24 months using the EuroQoL 5 Dimensions (EQ-5D) and a preference-based single index measure derived from the SF-36 (SF-6D). Secondary outcomes included the McGill Present Pain Index (PPI), Oswestry Pain Disability Index (ODI), all other SF-36 dimensions, medication use, pain-free months in the past year, worry about back pain, satisfaction with care received, and safety and acceptability of acupuncture care. RESULTS: A total of 159 patients were in the 'acupuncture offer' arm and 80 in the 'usual care' arm. All 159 patients randomised to the offer of acupuncture care chose to receive acupuncture treatment, and received an average of eight acupuncture treatments within the trial. Analysis of covariance, adjusting for baseline score, found an intervention effect of 5.6 points on the SF-36 Pain dimension [95% confidence interval (CI) -1.3 to 12.5] in favour of the acupuncture group at 12 months, and 8 points (95% CI 0.7 to 15.3) at 24 months. No evidence of heterogeneity of effect was found for the different acupuncturists. Patients receiving acupuncture care did not report any serious or life-threatening events. No significant treatment effect was found for any of the SF-36 dimensions other than Pain, or for the PPI or the ODI. Patients receiving acupuncture care reported a significantly greater reduction in worry about their back pain at 12 and 24 months compared with the usual care group. At 24 months, the acupuncture care group was significantly more likely to report 12 months pain free and less likely to report the use of medication for pain relief. The acupuncture service was found to be cost-effective at 24 months; the estimated cost per quality-adjusted (QALY) was 4241 pounds sterling (95% CI 191 pounds sterling to 28,026 pounds sterling) using the SF-6D scoring algorithm based on responses to the SF-36, and 3598 pounds sterling (95% CI 189 pounds sterling to 22,035 pounds sterling) using the EQ-5D health status instrument. The NHS costs were greater in the acupuncture care group than in the usual care group. However, the additional resource use was less than the costs of the acupuncture treatment itself, suggesting that some usual care resource use was offset. CONCLUSIONS: Traditional acupuncture care delivered in a primary care setting was safe and acceptable to patients with non-specific low back pain. Acupuncture care and usual care were both associated with clinically significant improvement at 12- and 24-month follow-up. Acupuncture care was significantly more effective in reducing bodily pain than usual care at 24-month follow-up. No benefits relating to function or disability were identified. GP referral to a service providing traditional acupuncture care offers a cost-effective intervention for reducing low back pain over a 2-year period. Further research is needed to examine many aspects of this treatment including its impact compared with other possible short-term packages of care (such as massage, chiropractic or physiotherapy), various aspects of cost-effectiveness, value to patients and implementation protocols.