Effectiveness of aromatherapy for prevention or treatment of disease, medical or preclinical conditions, and injury: protocol for a systematic review and meta-analysis.

BACKGROUND: Aromatherapy - the therapeutic use of essential oils from plants (flowers, herbs or trees) to treat ill health and promote physical, emotional and spiritual well-being - is one of the most widely used natural therapies reported by consumers in Western countries. The Australian Government Department of Health (via the National Health and Medical Research Council) has commissioned a suite of independent evidence evaluations to inform the 2019-20 Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies. This protocol is for one of the evaluations: a systematic review that aims to examine the effectiveness of aromatherapy in preventing and/or treating injury, disease, medical conditions or preclinical conditions. METHODS: Eligibility criteria: randomised trials comparing (1) aromatherapy (delivered by any mode) to no aromatherapy (inactive controls), (2) aromatherapy (delivered by massage) to massage alone or (3) aromatherapy to 'gold standard' treatments. POPULATIONS: any condition, pre-condition, injury or risk factor (excluding healthy participants without clearly identified risk factors). OUTCOMES: any for which aromatherapy is indicated. Searches: Cochrane Central Register of Controlled Trials (CENTRAL), with a supplementary search of PubMed (covering a 6-month lag period for processing records in CENTRAL and records not indexed in MEDLINE), AMED and Emcare. No date, language or geographic limitations will be applied. DATA AND ANALYSIS: screening by two authors, independently (records indexed by Aromatherapy or Oils volatile or aromatherapy in title; all full text) or one author (remaining records) with second author until 80% agreement. Data extraction and risk of bias assessment (ROB 2.0) will be piloted by three authors, then completed by a single author and checked by a second. Comparisons will be based on broad outcome categories (e.g. pain, emotional functioning, sleep disruption) stratified by population subgroups (e.g. chronic pain conditions, cancer, dementia) as defined in the analytic framework for the review. Meta-analysis or other synthesis methods will be used to combine results across studies. GRADE methods will be used to assess certainty of evidence and summarise findings. DISCUSSION: Results of the systematic review will provide a comprehensive and up-to-date synthesis of evidence about the effectiveness of aromatherapy. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021268244.

Improving adherence to acute low back pain guideline recommendations with chiropractors and physiotherapists: the ALIGN cluster randomised controlled trial.

BACKGROUND: Acute low back pain is a common condition, has high burden, and there are evidence-to-practice gaps in the chiropractic and physiotherapy setting for imaging and giving advice to stay active. The aim of this cluster randomised trial was to estimate the effects of a theory- and evidence-based implementation intervention to increase chiropractors' and physiotherapists' adherence to a guideline for acute low back pain compared with the comparator (passive dissemination of the guideline). In particular, the primary aim of the intervention was to reduce inappropriate imaging referral and improve patient low back pain outcomes, and to determine whether this intervention was cost-effective. METHODS: Physiotherapy and chiropractic practices in the state of Victoria, Australia, comprising at least one practising clinician who provided care to patients with acute low back pain, were invited to participate. Patients attending these practices were included if they had acute non-specific low back pain (duration less than 3 months), were 18 years of age or older, and were able to understand and read English. Practices were randomly assigned either to a tailored, multi-faceted intervention based on the guideline (interactive educational symposium plus academic detailing) or passive dissemination of the guideline (comparator). A statistician independent of the study team undertook stratified randomisation using computer-generated random numbers; four strata were defined by professional group and the rural or metropolitan location of the practice. Investigators not involved in intervention delivery were blinded to allocation. Primary outcomes were X-ray referral self-reported by clinicians using a checklist and patient low back pain-specific disability (at 3 months). RESULTS: A total of 104 practices (43 chiropractors, 85 physiotherapists; 755 patients) were assigned to the intervention and 106 practices (45 chiropractors, 97 physiotherapists; 603 patients) to the comparator; 449 patients were available for the patient-level primary outcome. There was no important difference in the odds of patients being referred for X-ray (adjusted (Adj) OR: 1.40; 95% CI 0.51, 3.87; Adj risk difference (RD): 0.01; 95% CI - 0.02, 0.04) or patient low back pain-specific disability (Adj mean difference: 0.37; 95% CI - 0.48, 1.21, scale 0-24). The intervention did lead to improvement for some key secondary outcomes, including giving advice to stay active (Adj OR: 1.96; 95% CI 1.20, 3.22; Adj RD: 0.10; 95% CI 0.01, 0.19) and intending to adhere to the guideline recommendations (e.g. intention to refer for X-ray: Adj OR: 0.27; 95% CI 0.17, 0.44; intention to give advice to stay active: Adj OR: 2.37; 95% CI 1.51, 3.74). CONCLUSIONS: Intervention group clinicians were more likely to give advice to stay active and to intend to adhere to the guideline recommendations about X-ray referral. The intervention did not change the primary study outcomes, with no important differences in X-ray referral and patient disability between groups, implying that hypothesised reductions in health service utilisation and/or productivity gains are unlikely to offset the direct costs of the intervention. We report these results with the caveat that we enrolled less patients into the trial than our determined sample size. We cannot recommend this intervention as a cost-effective use of resources. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12609001022257 . Retrospectively registered on 25 November 2009.

Assessment of the Methods Used to Develop Vitamin D and Calcium Recommendations-A Systematic Review of Bone Health Guidelines.

BACKGROUND: There are numerous guidelines developed for bone health. Yet, it is unclear whether the differences in guideline development methods explain the variability in the recommendations for vitamin D and calcium intake. The objective of this systematic review was to collate and compare recommendations for vitamin D and calcium across bone health guidelines, assess the methods used to form the recommendations, and explore which methodological factors were associated with these guideline recommendations. METHODS: We searched MEDLINE, EMBASE, CINAHL, and other databases indexing guidelines to identify records in English between 2009 and 2019. Guidelines or policy statements on bone health or osteoporosis prevention for generally healthy adults aged ≥40 years were eligible for inclusion. Two reviewers independently extracted recommendations on daily vitamin D and calcium intake, supplement use, serum 25 hydroxyvitamin D [25(OH)D] level, and sunlight exposure; assessed guideline development methods against 25 recommended criteria in the World Health Organization (WHO) handbook for guideline development; and, identified types identified types of evidence underpinning the recommendations. RESULTS: we included 47 eligible guidelines from 733 records: 74% of the guidelines provided vitamin D (200~600-4000 IU/day) and 70% provided calcium (600-1200 mg/day) recommendations, 96% and 88% recommended vitamin D and calcium supplements, respectively, and 70% recommended a specific 25(OH)D concentration. On average, each guideline met 10 (95% CI: 9-12) of the total of 25 methodological criteria for guideline development recommended by the WHO Handbook. There was uncertainty in the association between the methodological criteria and the proportion of guidelines that provided recommendations on daily vitamin D or calcium. Various types of evidence, including previous bone guidelines, nutrient reference reports, systematic reviews, observational studies, and perspectives/editorials were used to underpin the recommendations. CONCLUSIONS: There is considerable variability in vitamin D and calcium recommendations and in guideline development methods in bone health guidelines. Effort is required to strengthen the methodological rigor of guideline development and utilize the best available evidence to underpin nutrition recommendations in evidence-based guidelines on bone health.

Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol.

BACKGROUND: Non-pharmacological, non-surgical interventions are recommended as the first line of treatment for osteoarthritis (OA) of the hip and knee. There is evidence that exercise therapy is effective for reducing pain and improving function in patients with knee OA, some evidence that exercise therapy is effective for hip OA, and early indications that manual therapy may be efficacious for hip and knee OA. There is little evidence as to which approach is more effective, if benefits endure, or if providing these therapies is cost-effective for the management of this disorder. The MOA Trial (Management of OsteoArthritis) aims to test the effectiveness of two physiotherapy interventions for improving disability and pain in adults with hip or knee OA in New Zealand. Specifically, our primary objectives are to investigate whether:1. Exercise therapy versus no exercise therapy improves disability at 12 months;2. Manual physiotherapy versus no manual therapy improves disability at 12 months;3. Providing physiotherapy programmes in addition to usual care is more cost-effective than usual care alone in the management of osteoarthritis at 24 months. METHODS: This is a 2 x 2 factorial randomised controlled trial. We plan to recruit 224 participants with hip or knee OA. Eligible participants will be randomly allocated to receive either: (a) a supervised multi-modal exercise therapy programme; (b) an individualised manual therapy programme; (c) both exercise therapy and manual therapy; or, (d) no trial physiotherapy. All participants will continue to receive usual medical care. The outcome assessors, orthopaedic surgeons, general medical practitioners, and statistician will be blind to group allocation until the statistical analysis is completed. The trial is funded by Health Research Council of New Zealand Project Grants (Project numbers 07/199, 07/200). DISCUSSION: The MOA Trial will be the first to investigate the effectiveness and cost-effectiveness of providing physiotherapy programmes of this kind, for the management of pain and disability in adults with hip or knee OA. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ref: ACTRN12608000130369.

A multimicronutrient-fortified seasoning powder enhances the hemoglobin, zinc, and iodine status of primary school children in North East Thailand: a randomized controlled trial of efficacy.

Anemia and co-existing deficiencies of zinc, iron, iodine, and vitamin A occur among children in many developing countries including NE Thailand, probably contributing to impairments in growth, immune competence, and cognition. Sustainable strategies are urgently required to combat these deficiencies. We assessed the efficacy of a micronutrient-fortified seasoning powder served with a school lunch on reducing anemia and improving the micronutrient status of rural NE Thai children. Children (n = 569) aged 5.5-13.4y from 10 schools were randomly assigned to receive a seasoning powder either unfortified or fortified with zinc (5 mg), iron (5 mg), vitamin A (270 microg), and iodine (50 microg) (per serving) and incorporated into a school lunch prepared centrally and delivered 5 d/wk for 31 wk. Teachers monitored school lunch consumption. Baseline and final micronutrient status, hemoglobinopathies, and infection or inflammation were assessed from blood and urine samples. For the primary outcome, anemia (based on hemoglobin), no intervention effect was apparent (odds ratio: 1.02 95% CI: 0.69, 1.51) after adjustment for design strata. The odds of zinc (based on serum zinc) and urinary iodine deficiency in the fortified group were 0.63 (0.42, 0.94) and 0.52 (0.38, 0.71) times those in the unfortified group, respectively. Fortification had no effect on serum retinol (0.61: 0.25,1.51), ferritin (1.12: 0.43, 2.96), or mean red cell volume (1.16: 0.82, 1.64). Therefore, a micronutrient-fortified seasoning powder is a promising vehicle for improving zinc, iodine, and hemoglobin status, and its potential for incorporation into lunch programs in day care centers and schools in NE Thailand warrants investigation.

Dietary-induced changes in fatty acid composition of human plasma, platelet, and erythrocyte lipids follow a similar time course.

The dietary-induced changes in the fatty acid composition of plasma, platelet, and erythrocyte lipids were measured as a function of time. Healthy adults consumed a diet rich in saturated fat (18% total energy, TE) for 19 d and then crossed over, without washout, to a diet rich in (n-6) polyunsaturated fat (10% TE) for a further 19 d. The fatty acid composition of plasma and blood cell lipids was measured in blood samples collected from fasting subjects on d 0, 1, 2, 5, 8, 12, and 19 of consuming the diet rich in (n-6) polyunsaturated fats. The linoleic acid composition of all plasma, platelet, and erythrocyte lipids increased to a plateau within 19 d, reaching at least 70% of maximum within 5 d. The maximum increase in linoleic acid composition of erythrocyte phosphatidylcholine was 3.8 mol% at d 12; the increase at d 1 was 2 mol% and at d 5 was 3.2 mol%. The decrease in pentadecanoic acid composition followed a similar time course in all lipids with the exception of plasma phospholipids. Our results show that the time course of dietary-induced changes in erythrocyte fatty acid composition is similar to that in plasma and platelet lipids. These results provide convincing, albeit indirect evidence that the exchange of fatty acids from plasma to erythrocytes and platelets is a major determinant of their membrane fatty acid composition.

Are breast-fed infants and toddlers in New Zealand at risk of iodine deficiency?

OBJECTIVE: This study assessed the iodine status of New Zealand infants and toddlers and explored factors that might influence their iodine status. METHODS: A community-based, cross-sectional survey of 6- to 24-mo-old children was conducted in three cities in the South Island of New Zealand. Iodine status was determined by a casual urine sample. Breast-feeding mothers were asked to provide a breast milk sample for iodine determination. Caregivers collected a 3-d weighed diet record from their children to investigate associations between dietary patterns and urinary iodine excretion. RESULTS: The median urinary iodine concentration for the group (n = 230) was 67 microg/L (interquartile range 37-115) with 37% (95% confidence interval 30.5-43.4) of children having a urinary iodine concentration lower than 50 microg/L. When children were classified by current feeding method, those children who were currently formula-fed had a significantly higher median urinary iodine concentration (99 microg/L) than did children who were currently breast-fed (44 microg/L; P < 0.000). The mean iodine concentration in breast milk was 22 microg/L (n = 39). After multivariate analysis using estimates from 3-d diet records, only percentage of energy from infant formula was significantly associated with urinary iodine concentration (P = 0.005). CONCLUSIONS: This study found mild iodine deficiency in a group of New Zealand infants and toddlers. Children who consumed infant formula, which is fortified with iodine, had better iodine status than did children who were currently breast-fed because breast milk contained low levels of iodine.

Dietary and biochemical selenium status of urban 6- to 24-month-old South Island New Zealand children and their postpartum mothers.

A community-based, cross-sectional survey was conducted in the South Island of New Zealand to assess the dietary and biochemical selenium status of children (n = 136) and their mothers (n = 302), and to assess factors influencing selenium status. Serum and plasma samples from children and their mothers were analyzed for selenium using graphite furnace atomic absorption spectrometry. Dietary selenium intakes were analyzed from 3-d weighed diet records, and food sources of selenium were quantified. Mean dietary selenium intakes in infants (6-11.9 mo), toddlers (12-24 mo), and mothers were below recommended levels. Toddlers had higher selenium intakes than infants (13.7 +/- 8.4 and 7.9 +/- 6.2 microg/d, respectively, P = 0.0001) and the selenium density of their diets was also higher [3.2 +/- 1.7 and 2.4 +/- 1.7 microg/(MJ . d), respectively, P = 0.003]. Household smoking was associated with lower serum selenium concentrations in infants and toddlers (P = 0.02). South Island women who were currently pregnant had lower plasma selenium concentrations (0.74 +/- 0.15 micromol/L) than nonpregnant lactating and nonpregnant nonlactating women (0.94 +/- 0.16 and 0.93 +/- 0.16 micromol/L, respectively, P = 0.0001). Clearly, pregnant women, infants and toddlers are at risk of suboptimal selenium status, and further research is warranted to assess potential effects in these groups. The finding of an association between household smoking and lower selenium concentrations in children should be investigated further. Dietary interventions are recommended to improve dietary selenium intakes in South Island children and their mothers.

Increases in blood folate indices are similar in women of childbearing age supplemented with [6S]-5-methyltetrahydrofolate and folic acid.

The natural diastereoisomer [6S]-5-methyltetrahydrofolate ([6S]-5-MTHF) may be a safer fortificant than folic acid for neural tube defect (NTD) prevention because it is unlikely to mask vitamin B-12 deficiency. An inverse relationship between NTD risk and blood folate concentrations has been reported. In this randomized, placebo-controlled, double-blind trial, we compared the effects of [6S]-5-MTHF and folic acid supplementation for 24 wk on plasma folate and red cell folate (RCF) in women of childbearing age (18-49 y). Women (n = 104) were randomly assigned to receive a supplement containing [6S]-5-MTHF (113 micro g/d), folic acid (100 micro g/d) or placebo. The mean estimated linear increase in plasma folate concentration was 0.3 [95% confidence interval (CI): 0.1, 0.5], and 0.4 (0.2, 0.6) nmol/(L. wk) in the [6S]-5-MTHF and folic acid groups, respectively. The mean estimated linear increase in RCF was 7.4 (95% CI: 4.5, 10.3), and 8.3 (4.4, 12.3) nmol/(L. wk) in the [6S]-5-MTHF and folic acid groups, respectively. There were no differences in the slopes between the [6S]-5-MTHF group and the folic acid group in either plasma folate (P = 0.48) or RCF (P = 0.70). At 24 wk, estimated mean increases in plasma folate concentrations were 6.9 (95% CI: 1.7, 12.2) and 9.2 (3.3, 15.1) nmol/L, and in RCF, 251 (143, 360) and 275 (148, 402) nmol/L, in the [6S]-5-MTHF and folic acid groups, respectively, relative to the placebo group. These data suggest that low dose [6S]-5-MTHF and folic acid supplementation increase blood folate indices to a similar extent. A steady state in the blood indices had not been reached by 24 wk.

Dietary intakes of 6-24-month-old urban South Island New Zealand children in relation to biochemical iron status.

OBJECTIVE: To investigate food sources and intakes of iron, and dietary factors associated with serum ferritin levels in 6-24-month-old children. DESIGN: A cross-sectional survey employing proportionate cluster sampling was conducted in 1998/1999. Dietary intakes were assessed using a non-consecutive 3-day weighed food record. Serum ferritin and C-reactive protein were analysed from non-fasting venepuncture blood samples and general sociodemographic data were collected. SETTING: Cities of Christchurch, Dunedin and Invercargill, New Zealand. SUBJECTS: Randomly selected healthy 6-24-month-old non-breast-feeding children (n = 226). RESULTS: Total iron intakes (+/- standard deviation (SD)) among non-breast-feeding infants (< 12 months old; n = 42) and toddlers (> or = 12 months old; n = 184) were 8.4 +/- 2.9 mg day(-1) and 5.0 +/- 2.5 mg day(-1), respectively. Fifteen per cent of infants and 66% of toddlers were at risk of inadequate iron intakes. Main sources of dietary iron were infant formula (60%) for infants and cereals (31%) for toddlers. Meat contributed on average 2% and 10% of dietary iron in the infant and toddler diets, respectively. Dietary factors positively associated with serum ferritin were intakes of iron and vitamin C, whereas intakes of calcium and dietary fibre were negatively associated. For each 1% increase in percentage of energy from iron-fortified formula concomitant with a 1% decrease from dairy products, there was a 4.2% increased odds of replete iron stores (ferritin > or = 20 microg l(-1)). CONCLUSIONS: Toddlers were at higher risk of sub-optimal iron intakes than infants. Results suggest that a diet high in bioavailable iron is important for optimising the iron stores of young children in New Zealand.