Antioxidants Discovery for Differentiation of Monofloral Stingless Bee Honeys Using Ambient Mass Spectrometry and Metabolomics Approaches.

Stingless bee honey (SBH) is a natural, sweet product produced by stingless bees (Meliponini tribe) that has been used as a traditional medicine to treat various illnesses. It has been shown that SBH has high nutritional value and health-promoting properties due to the presence of plant bioactive compounds from different botanical flora of the foraged nectar. In this study, the antioxidant activities of seven monofloral honeys from acacia, agarwood, coconut, dwarf mountain pine (DMP), Mexican creeper (MC), rubber, and starfruit botanical origins were investigated. The antioxidant properties of SBH studied had a range from 19.7 to 31.4 mM TE/mg for DPPH assays, 16.1 to 29.9 mM TE/mg for ABTS assays, 69.0 to 167.6 mM TE/mg for ORAC assays, and 45.5 to 89.3 mM Fe2+/mg for FRAP assays. Acacia honey showed the highest level of antioxidant properties. The models built from mass spectral fingerprints from direct ambient mass spectrometry showed distinct clusters of SBH by botanical origin and correlated with the antioxidant properties. An untargeted liquid chromatography-mass spectrometry (LC-MS) metabolomics approach was undertaken to identify the antioxidant compounds that could explain the unique antioxidant and compositional profiles of the monofloral SBH by its botanical origin. The antioxidants that were identified predominantly consisted of alkaloids and flavonoids. Flavonoid derivatives, which are potent antioxidants, were found to be key markers of acacia honey. This work provides the fundamental basis for the identification of potential antioxidant markers in SBH associated with the botanical origin of the foraged nectar.

A novel screening method for free non-standard amino acids in human plasma samples using AccQ·Tag reagents and LC-MS/MS.

There are at least 500 naturally occurring amino acids, of which only 20 standard proteinogenic amino acids are used universally across all organisms in the synthesis of peptides and proteins. Non-standard amino acids can be incorporated into proteins or are intermediates and products of metabolic pathways. While the analysis of standard amino acids is well-defined, the analysis of non-standard amino acids can be challenging due to the wide range of physicochemical properties, and the lack of both reference standards and information in curated databases to aid compound identification. It has been shown that the use of an AccQ·Tag™ derivatization kit along with LC-MS/MS is an attractive option for the analysis of free standard amino acids in complex samples because it is fast, sensitive, reproducible, and selective. It has been demonstrated that the most abundant quantitative transition for MS/MS analysis of 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate (AQC) derivatized amino acids corresponds to the fragmentation of the molecule at the 6-aminoquinoline carbonyl group producing a common m/z 171 fragment ion and occurs at similar mass spectrometry collision energy and cone voltages. In this study, the unique properties of AQC derivatized amino acids producing high intensity common fragment ions, along with chromatographic separation of amino acids under generic chromatography conditions, were used to develop a novel screening method for the detection of trace levels of non-standard amino acids in complex matrices. Structural elucidation was carried out by comparing the MS/MS fragment ion mass spectra generated with in silico predicted fragmentation spectra to enable a putative identification, which was confirmed using an appropriate analytical standard. This workflow was applied to screen human plasma samples for bioactive thiol-group modified cysteine amino acids and S-allylmercaptocysteine (SAMC), S-allylcysteine sulfoxide (SACS or alliin) and S-propenylcysteine (S1PC) are reported for the first time to be present in human plasma samples after the administration of garlic supplements.

Determinants for asthma control, quality of life and use of complementary and alternative medicine in asthmatic pediatric patients in four cities.

BACKGROUND: Asthma is a significant chronic health problem worldwide. Management aims at disease control by reducing functional impairment and exacerbations and improving quality of life (QoL). We report a multi-center study to survey asthma control and QoL in four cities in the Pearl River Delta. METHODS: The conjoint survey involved ten Hong Kong pediatric hospitals/units, two Shenzhen hospitals, two Macau hospitals, and two Guangzhou hospitals on asthma control (using Asthma Control Test) and QoL (Pediatric Allergic Disease Quality of Life Questionnaire, PADQLQ). Acceptability of a treatment is graded as very good/good/fair/poor. RESULTS: Good asthma control was only reported in 80% subjects in Hong Kong, but higher in sister cities (85-94%, P < 0.001). Allergic rhinitis, "incense burning", and "smoker in family" were prevalent among the four cities. Logistic regression showed better control of asthma was associated with better PADQLQ (B = - 0.029, P < 0.001), better acceptability of bronchodilator (B = - 1.488, P = 0.025), negatively with "smoker in family" (B = - 0.83, P = 0.015) and various PADQLQ domains. Conversely, worse PADQLQ was associated with allergic rhinitis severity (B = 4.77, P < 0.001), poor control of asthma (B = 7.56, P < 0.001), increased frequency of traditional Chinese medicine use (B = 1.7, P < 0.05), increased frequency of bronchodilator usage (B = 1.05, P < 0.05), "smoker in family" (B = 4.05, P < 0.05), and incense burning at home (B = 3.9, P < 0.05). CONCLUSIONS: There are some clinical and cultural differences among the four southern Chinese cities within the Guangdong province. This study identifies potentially modifiable environmental and treatment factors associated with poor asthma control and QoL for health-care interventions. Having a smoker in the family is independently associated with poor asthma control and QoL.

Primary Nonadherence to Overactive Bladder Medications in an Integrated Managed Care Health Care System.

BACKGROUND: Treatment for overactive bladder (OAB) remains suboptimal, in part because of patient nonadherence to medications. Primary nonadherence is when patients fail to pick up their initial prescriptions. OBJECTIVE: To measure primary nonadherence to OAB medications within 30 days of a first OAB prescription order using electronic medical records from a U.S. managed care health care system METHODS: A retrospective cohort study was conducted using electronic medical records from the Kaiser Permanente Southern California (KPSC) database to identify patients with new OAB prescriptions between January 1, 2007, and December 31, 2013. The index date was defined as the first order of an OAB prescription. Patients had to be aged ≥ 18 years on the index date and were required to have 12 months of continuous membership with drug benefit eligibility before, during, and after the index date. Patients were defined as primary nonadherent if they did not pick up their new OAB prescriptions within 30 days of the order date. Descriptive statistics and a multivariable logistic regression analysis with backward selection were conducted to identify factors associated with patients who were primary nonadherent versus adherent. RESULTS: There were 9,050 patients with a new OAB prescription order; 1,662 (18%) of these were primary nonadherent. Patients with primary nonadherence were younger in age (56.9 [SD ± 16.0] years vs. 63.9 [SD ± 14.8] years; P < 0.001) and more likely to have commercial insurance (65.9% vs. 46.2%; P < 0.001). They also had lower mean Charlson Comorbidity Index (CCI) scores (1.99 vs. 2.70; P < 0.001), fewer OAB-related comorbidities, fewer concomitant medications (P < 0.005), and fewer overall prescriptions dispensed in the previous 12 months (P < 0.001) compared with adherent patients. Significant factors such as commercial insurance (P = 0.013), race other than white (P = 0.020), CCI = 0 versus CCI ≥ 2 (P = 0.001), urinary tract infections (P < 0.001), and falls (P = 0.047) were associated with a higher likelihood of primary nonadherence versus adherence. CONCLUSIONS: Nearly 1 in 5 patients did not pick up their new OAB medications within 30 days of the order date. Knowledge of factors associated with primary nonadherence may inform strategies for improving management of OAB. DISCLOSURES: This study was supported by a research grant provided by Astellas Pharma Global Development. Rashid and Lin do not have any financial interests or potential conflict of interest with regard to the work. Vassilakis, Kristy, and Ng were employees of Astellas Pharma Global Development when this study was conducted. Study concept and design were contributed by Rashid and Ng, along with the other authors. Rashid and Lin collected the data, and data interpretation was performed by Rashid, Ng, and Lin, along with Vassilakis and Kristy. The manuscript was written by Rashid and Ng, along with Vassilakis and Lin, and revised by Rashid, Ng, and Lin.

Evaluating Outcomes in Patients with Overactive Bladder within an Integrated Healthcare Delivery System Using a Treatment Patterns Analyzer.

BACKGROUND: Overactive bladder (OAB) is a relatively common disease that has been linked to a variety of comorbidities, reductions in quality of life, and increased healthcare costs. Antimuscarinic agents are the standard of care among pharmacologic treatments for OAB, but these drugs are linked to high levels of anticholinergic burden, especially in the elderly. OBJECTIVE: To demonstrate how efficient data analysis can be used to identify gaps in care as a result of improvement strategies for OAB within an integrated healthcare delivery system setting. METHODS: We developed an OAB treatment patterns analyzer, a clinical outcomes software analysis program, to identify gaps in care, high anticholinergic burden, and potential quality improvement initiatives. Deidentified pharmacy and medical claims data from an integrated delivery network were imported into the OAB treatment patterns analyzer. Patients with a diagnosis of OAB who were continuously enrolled in the network between January 1, 2009, and December 31, 2013, were identified and were imported into the analyzer. The analyzer used National Drug Code; International Classification of Diseases, Ninth Edition, Clinical Modification; Current Procedural Terminology; and UB-92 codes to measure treatment patterns, comorbid conditions, anticholinergic burden, concomitant use with anticholinesterases, costs, and healthcare resource utilization. RESULTS: Of 157,710 members in the integrated delivery network population, 7309 patients met the study eligibility criteria. Of patients taking medications for OAB, 85% were nonadherent and 73% discontinued treatment within 1 year. Among 1147 patients in the integrated healthcare delivery system who were using medications for OAB, 39 (3.4%) patients were concomitantly taking anticholinesterase drugs and an antimuscarinic agent. The per-month plan-paid cost per member was $318.67. Of all the patients with OAB within the population, the rates of all-cause office visits, emergency department visits, and hospitalizations were 81%, 6%, and 4%, respectively. The rate of clinically relevant anticholinergic burden was 16%, with higher rates among patients with dementia who were also receiving a branded (20%) or generic (24%) antimuscarinic drug. CONCLUSION: In patients using medications for the treatment of OAB, the rates of medication persistence and adherence were poor. Antimuscarinic medications may place certain patient populations at risk for increased anticholinergic burden. Data included in the analyzer can be used to implement member-specific strategies to prevent poor outcomes and reduce associated healthcare costs and utilization.

A randomized placebo-controlled trial of traditional Chinese medicine as an add-on therapy to oral montelukast in the treatment of mild persistent asthma in children.

OBJECTIVES: Traditional Chinese medicine are commonly used for treatment of asthma. However, there are only very limited data about its efficacy in children. Therefore, we aimed to determine the efficacy of augmented Yu Ping Feng San (aYPFS) as an add-on to oral montelukast compared with montelukast alone for treatment of mild persistent asthma in children. DESIGN: A single centre, placebo-controlled, double-blinded, randomized control trial was carried out. Participants with age 6-18 years who had mild persistent asthma were randomized according to random number list to receive either aYPFS plus montelukast for 24 weeks or placebo plus montelukast for 24 weeks. Primary outcome measure was lung function parameters. Secondary outcome measures were Asthma Control Test™ (ACT™) and Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ) scores, symptom-free days, short-acting ß2-agonist use, use of rescue oral corticosteroids, days of hospitalization for asthma and number of emergency consultation with GPs or AED department. RESULTS: Twenty-eight participants were randomized to aYPFS group and twenty-nine to placebo group. There was no significant difference in baseline characteristics. There was significant improvement in ACT™ score in aYPFS group (up to 6.9% change from baseline) (p=0.016) but not in the control group. There were no significant differences between groups in other primary and secondary outcome parameters. Dropout because of adverse effects is comparable in both groups. CONCLUSION: Traditional Chinese medicine aYPFS as an add-on to montelukast improved symptoms of asthma control. Further studies with larger sample size are needed to evaluate its efficacy and safety in childhood asthma.

Estimated Budget Impact of Increased Use of Mirabegron, A Novel Treatment for Overactive Bladder.

BACKGROUND: Oral pharmacological treatment for overactive bladder (OAB) consists of antimuscarinics and the beta-3 adrenergic agonist mirabegron. Antimuscarinic adverse events (AEs) such as dry mouth, constipation, and blurry vision can result in frequent treatment discontinuation rates, leaving part of the OAB population untreated. Antimuscarinics also contribute to a patient's anticholinergic cognitive burden (ACB), so the Beers Criteria recommends cautious use of antimuscarinics in elderly patients who take multiple anticholinergic medications or have cognitive impairment. Since mirabegron does not affect the cholinergic pathways, it is unlikely to contribute to a patient's ACB. OBJECTIVE: To estimate the health care costs associated with the pharmacological treatment of OAB with mirabegron and antimuscarinics from U.S. commercial payer and Medicare Advantage perspectives, using a budget impact model. METHODS: For this budget impact model, 2 analyses were performed. The primary analysis estimated the budgetary impact of increasing the use of mirabegron in a closed patient cohort treated with oral pharmacological treatments. The secondary analysis modeled the economic impact in an open cohort by allowing untreated patients to begin treatment with mirabegron after potential contraindication, intolerance, or lack of effectiveness of antimuscarinics. The analyses were performed over a 3-year time horizon. The economic impact of increased mirabegron use was quantified using direct medical costs, including prescription costs and health resource utilization (HRU) costs. Costs of comorbidities included pharmacy and medical costs of treating OAB-related urinary tract infections (UTI), skin rashes, and depression. An analysis of a large single-site integrated health network database was commissioned to quantify ACB-related HRU in terms of the increases in yearly outpatient and emergency department visits. Based on this analysis, the model associated each unit increase in ACB score with increased HRU and probability of mild cognitive impairment. Clinical outcomes of increased use of mirabegron were presented as the number of AEs and comorbidity episodes that could be avoided. One-way sensitivity analyses were performed to quantify the expected budget impact over the range of uncertainty for the key input variables. RESULTS: Primary analysis calculated the impact of increasing the use of mirabegron from 4.5% to 5.3%, 7.1%, and 9.4% in years 1, 2, and 3, respectively, among oral pharmacological OAB treatments that included generic and branded antimuscarinics: oxybutynin, tolterodine, trospium, darifenacin, fesoterodine, and solifenacin. For a 1 million-member U.S. commercial payer plan, the total prescription costs increased, and the total medical costs decreased during the 3-year time horizon, yielding increases of $0.005, $0.016, and $0.031 from current per member per month (PMPM) costs and $0.90, $2.92, and $5.53 from current per treated member per month (PTMPM) costs, an average of less than 2% of current OAB treatment costs. For the Medicare Advantage plan, the resulting incremental PMPM costs were $0.010, $0.034, and $0.065, and the incremental PTMPM costs were $0.93, $3.04, and $5.76; all were less than 4% of the current cost. The secondary analysis estimated the budgetary effects of reducing the untreated population by 1% annually by initiating treatment with mirabegron. For a commercial payer, this resulted in PMPM cost increases of $0.156, $0.311, and $0.467 from the current value, while the incremental PTMPM cost increased by $6.17, $11.67, and $16.61. For the Medicare Advantage plan, the incremental increases in PMPM costs were $0.277, $0.553, and $0.830, and in PTMPM costs were $6.42, $12.15, and $17.29. Clinically, treating more OAB patients resulted in fewer OAB-related comorbidities from both health plan perspectives, since most events associated with nontreatment could be avoided. In the Medicare Advantage population of the secondary analysis, the total numbers of avoided events were predicted as 452 UTIs, 2,598 depression diagnoses, and 3,020 skin rashes during the time horizon of the model. CONCLUSIONS: Mirabegron addresses an unmet need for therapy for certain OAB patients, for whom antimuscarinics are not recommended because of a risk of cognitive impairment and who are intolerant to the anticholinergic AEs. Using mirabegron involves moderate additional economic cost to a commercial or Medicare Advantage health plan for which medical cost savings can offset a substantial part of increased pharmacy costs. DISCLOSURES: Funding for this study was provided by Astellas. Perk, Wielage, T. Klein, and R. Klein are employed by Medical Decision Modeling, a contract research company that was paid to perform the described outcomes research and build the model contained in this study. Campbell and Perkins are employed by the Regenstrief Institute, which conducted a database analysis for this research. Campbell reports consultancy fees from Astellas, as well as pending grants from Merck, Sharpe, and Dohme Corp. Posta, Yuran, and Ng are employed by Astellas Pharma Global Development, the developer of mirabegron. Study concept and design were contributed by Perk, Wielage, R. Klein, and Ng. Campbell, T. Klein, and Perkins took the lead in data collection, assisted by Perk, Wielage, and Ng. Data interpretation was performed by Posta and Yuran, along with Perk, Wielage, R. Klein, Ng, Campbell, and Perkins. The manuscript was written by Perk and R. Klein, along with Wielage, T. Klein, Posta, Yuran, and Ng, and revised by all the authors.

Complementary and alternative medicine for childhood asthma: an overview of evidence and patents.

Asthma is a prevalent childhood atopic disease associated with significant impairment of quality of life. Management relies on avoidance of triggers such as food and aeroallergens, the use of inhaled bronchodilators/corticosteroids and anti-allergic or immune-modulating therapies. Inhaled corticosteroids (ICSs) and bronchodilators have been the mainstay of treatment. In China as well as throughout Asia, myths and misconceptions on western medicine and corticosteroids are prevalent and result in non-adherence of treatment. A wide variety of complementary and alternative medicines (CAM) are available. Some of these have undergone extensive clinical trials and have been documented to have some therapeutic effects on asthma. Nevertheless, the majority of these treatment modalities is not efficacious and may even be detrimental. This article overviews the evidence for the clinical efficacy of all major CAM modalities. Despite CAM modalities are extensively used by the patients with asthma, very few CAM patents are available. This article also discusses recent patents pertinent to asthma. Only a few patents on herbal medicine for asthma have been evaluated but therapeutic efficacy is not substantially documented. Parents seeking CAM for asthma must consult qualified registered practitioners before using it.

A discussion: the future role of homeopathy in the National Health Service (NHS).

Homeopathy has been provided by the National Health Service in the UK for over 60 years, funded largely by taxpayer's money. However, in recent years, its provision has come under much criticism questioning its true value. Taking a neutral stance, arguments both for and against the provision of homeopathy on the NHS is presented. It includes issues such as the evidence and safety profile of homeopathy, but also takes into account costs and benefits of homeopathy in a wider perspective. Overall, the provision of homeopathy is justified as long as there is a need within the population, occupying a complementary role alongside conventional medicine.

Hospital visits and costs following outpatient treatment of CAP with levofloxacin or moxifloxacin.

BACKGROUND: Hospital admissions (inpatient and emergency room) are a major source of medical costs for community-acquired pneumonia (CAP) initially treated in the outpatient setting. Current CAP treatment guidelines do not differentiate between outpatient treatment with levofloxacin and moxifloxacin. OBJECTIVE: Compare health care resource use and medical costs to payers for CAP outpatients initiating treatment with levofloxacin or moxifloxacin. RESEARCH DESIGN AND METHODS: CAP episodes were identified in the PharMetrics database between 2Q04 and 2Q07 based on: pneumonia diagnosis, chest X-ray and treatment with levofloxacin or moxifloxacin. Subsequent 30-day risk of pneumonia-related hospital visits and 30-day health care costs to payers for levofloxacin vs. moxifloxacin treatment were estimated after adjusting for pre-treatment demographics, health care resource use and pneumonia-specific risk factors using propensity score and exact factor matching. RESULTS: A total of 15,472 levofloxacin- and 6474 moxifloxacin-initiated CAP patients were identified. Among 6352 matched pairs, levofloxacin treatment was associated with a 35% reduction in the odds of pneumonia-related hospital visits (odds ratio = 0.65, P = 0.004), lower per-patient costs for pneumonia-related hospital visits (102 dollars vs. 210 dollars, P = 0.001), lower pneumonia-related total costs (medical services and prescription drugs, 363 dollars vs. 491 dollars, P < 0.001) and lower total costs (1308 dollars vs. 1446 dollars, P < 0.001) vs. moxifloxacin over the 30-day observation period. LIMITATIONS: Although observational analyses of claims data provide large sample sizes and reflect routine care, they do have several inherent limitations. Since randomization of subjects is not possible, adequate statistical techniques must be used to ensure that patient characteristics are well-balanced between treatment groups. In addition, data may be missing or miscoded. CONCLUSIONS: CAP outpatients initiated with levofloxacin generated substantially lower costs to payers compared to matched patients initiated with moxifloxacin. The cost savings for patients initiated with levofloxacin were largely attributable to reduced rates of pneumonia-related hospitalization or ER visits.

Radiotherapy-induced pacemaker and implantable cardioverter defibrillator malfunction.

It is well known that ionizing radiation can interfere with circuits in permanent pacemakers and implantable cardioverter defibrillators. Contemporary implantable cardiac devices use complementary metal-oxide silicon in combination with other very sensitive transistors. These sensitive components are especially susceptible to electromagnetic and ionizing radiation, which can potentially cause permanent damage. Electromagnetic interference is, in general, a transient phenomenon. Radiologic imaging tests have been implicated in rare cases of implantable device dysfunction and these events have been mostly transient. The American Association of Physicists in Medicine last published recommendations regarding irradiation of pacemakers in 1994. This publication is outdated and may not be pertinent for the current technology used both in the field of artificial cardiac pacing and defibrillation and in the field of radiation oncology. Updated guidelines are definitely needed.

Low-level chronic mercury exposure in children and adolescents: meta-analysis.

BACKGROUND: Mercury is a well-known neurotoxin. There are three kinds of mercury exposure: elemental mercury poisoning, inorganic mercury poisoning and organomercury poisoning. Organomercury is the most toxic. Twenty-four hour urine for mercury and blood mercury are the gold standards for diagnosis of mercury poisoning, including low-level chronic mercury exposure. Other tests for mercury level are discussed. The purpose of the present paper was to review recent data on the nature, pathophysiology, pharmacokinetics, diagnostic methods, treatment and the linkage to neurodevelopmental disabilities of mercury exposure in children. METHODS: A literature search was undertaken of MEDLINE (1980-2003), and American Academy of Pediatrics, American Medical Association, American Dental Association, World Health Organization and Center for Disease Control websites. The search string 'mercury' was used in MEDLINE and articles were selected as appropriate by two independent reviewers. All relevant information was reviewed and data were extracted by two independent reviewers. RESULTS: Based on the meta-analysis of the accuracy of hair mercury, hair mercury levels correlated with mercury level in blood (sample size weighted correlation coefficient, r w = 0.61), with 24 h urine ( r w = 0.46) and with cord blood ( r w = 0.64). However, the correlation for hair mercury level with 24 h urine level and blood level was not high enough to replace them in clinical decision-making of individual patient. Epidemiological evidence has shown that low-level mercury poisoning is not a cause of autism (relative risk = 0.49, 95%CI = 0.36-0.66). The risk of neurodevelopmental disabilities from low-level exposure to methylmercury from the regular consumption of fish is still controversial even after combining results from different epidemiological studies worldwide. There is a lack of data in the literature about the effect of chelation therapy in children with neurodevelopmental disabilities. CONCLUSION: Mercury poisoning should be diagnosed only with validated methods. There is no evidence to support the association between mercury poisoning and autism.

Parental use of the term "Hot Qi" to describe symptoms in their children in Hong Kong: a cross sectional survey "Hot Qi" in children.

BACKGROUND: The Chinese term "Hot Qi" is often used by parents to describe symptoms in their children. The current study was carried out to estimate the prevalence of using the Chinese term "Hot Qi" to describe symptoms in children by their parents and the symptomatology of "Hot Qi". METHOD: A cross sectional survey by face-to-face interview with a semi-structured questionnaire was carried out in a public hospital and a private clinic in Hong Kong. The parental use of the term "Hot Qi", the symptoms of "Hot Qi" and the remedies used for "Hot Qi" were asked. RESULTS: 1060 pairs of children and parents were interviewed. 903 (85.1%) of parents claimed that they had employed the term "Hot Qi" to describe their children's symptoms. Age of children and place of birth of parents were the predictors of parents using the term "Hot Qi". Eye discharge (37.2%), sore throat (33.9%), halitosis (32.8%), constipation (31.0%), and irritable (21.2%) were the top five symptoms of "Hot Qi" in children. The top five remedies for "Hot Qi" were the increased consumption of water (86.8%), fruit (72.5%), soup (70.5%), and the use of herbal beverages "five-flower-tea" (a combination of several flowers such as Chrysanthemum morifolii, Lonicera japonica, Bombax malabaricum, Sophora japonica, and Plumeria rubra) (57.6%) or selfheal fruit spike (Prunella vulgaris) (42.4%). CONCLUSION: "Hot Qi" is often used by Chinese parents to describe symptoms in their children in Hong Kong. Place of birth of parents and age of the children are main factors for parents to apply the term "Hot Qi" to describe symptoms of their children. The common symptoms of "Hot Qi" suggest infections or allergy.

A double-blind, randomized, placebo-controlled trial of acupuncture for the treatment of childhood persistent allergic rhinitis.

OBJECTIVE: To compare active acupuncture with sham acupuncture for the treatment of persistent allergic rhinitis among children. METHODS: Subjects with persistent allergic rhinitis were recruited from the pediatric outpatient clinic. They were randomized to receive either active acupuncture or sham acupuncture. Main outcome measures included daily rhinitis scores, symptom-free days, visual analog scale scores for immediate effects of acupuncture, daily relief medication scores, blood eosinophil counts, serum IgE levels, nasal eosinophil counts, patients' and parents' preferences for treatment modalities, and adverse effects. RESULTS: Eighty-five patients were recruited from the pediatric outpatient clinic at Kwong Wah Hospital, in Hong Kong. Thirteen patients withdrew before randomization; 35 patients (mean age: 11.7 +/- 3.2 years) were randomized to receive active acupuncture for 8 weeks, and 37 patients (mean age: 11 +/- 3.8 years) were randomized to receive sham acupuncture for 8 weeks. Acupuncture was performed twice per week for both groups. Both the assessing pediatricians and the patients were blinded. There were significantly lower daily rhinitis scores and more symptom-free days for the group receiving active acupuncture, during both the treatment and follow-up periods. The visual analog scale scores for immediate improvement after acupuncture were also significantly better for the active acupuncture group. There was no significant difference in the following outcome measures between the active and sham acupuncture groups: daily relief medication scores, blood eosinophil counts, serum IgE levels, and nasal eosinophil counts, except for the IgE levels before and 2 months after acupuncture in the sham acupuncture group. No severe adverse effects were encountered. Numbness, headache, and dizziness were found in both the active and sham acupuncture groups, with no difference in incidence, and the effects were self-limiting. CONCLUSIONS: This study showed that active acupuncture was more effective than sham acupuncture in decreasing the symptom scores for persistent allergic rhinitis and increasing the symptom-free days. No serious adverse effect was identified. A large-scale study is required to confirm the safety of acupuncture for children.