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There is increasing concern regarding the number of painful medical procedures that infants must undergo and the potential risks of alleviating infant pain with conventional pharmacologic agents. This article is Part I of a two-part series that aims to provide an overview of the literature on complementary and alternative (CAM) approaches for pain and distress related to medical procedures among infants up to six weeks of age. The focus of this article is a review of the empirical literature on sucrose with or without non-nutritive sucking (NNS) for procedural pain in infancy. Computerized databases were searched for relevant studies including prior reviews and primary trials. The most robust evidence was found for the analgesic effects of sucrose with or without NNS on minor procedural pain in healthy full-term infants. Despite some methodological weaknesses, the literature to date supports the use of sucrose, NNS and other sweetened solutions for the management of procedural pain in infancy.

Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs) of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection.

Evidence-based approach on the safety of acupuncture had been lagging behind both in the West and the East, but reliable data based on some prospective surveys were published after the late 1990s. In the present article, we, focusing on ‘Japanese acupuncture’, review relevant case reports and prospective surveys on adverse events in Japan, assess the safety of acupuncture practice in this country, and suggest a strategy for reducing the therapists’ error. Based on the prospective surveys, it seems reasonable to suppose that serious adverse events are rare in standard practice by adequately trained acupuncturists, regardless of countries or modes of practice. Almost all of adverse reactions commonly seen in acupuncture practice—such as fatigue, drowsiness, aggravation, minor bleeding, pain on insertion and subcutaneous hemorrhage—are mild and transient, although we should be cautious of secondary injury following drowsiness and needle fainting. After demonstrating that acupuncture is inherently safe, we have been focusing on how to reduce the risk of negligence in Japan, as well as educating acupuncturists more about safe depth of insertion and infection control. Incident reporting and feedback system is a useful strategy for reducing therapist errors such as forgotten needles. For the benefit of acupuncture patients in Japan, it is important to establish mandatory postgraduate clinical training and continued education system.

This article is the second in a two-part series reviewing the empirical evidence for complementary and alternative medicine (CAM) approaches for the management of pain related to medical procedures in infants up to 6 weeks of age. Part I of this series investigated the effects of sucrose with or without non-nutritive sucking (NNS). The present article examines other CAM interventions for procedural pain including music-based interventions, olfactory stimulation, kangaroo care and swaddling. Computerized databases were searched for relevant studies including prior reviews and primary trials. Preliminary support was revealed for the analgesic effects of the CAM modalities reviewed. However, the overall quality of the evidence for these approaches remains relatively weak. Additional well-designed trials incorporating rigorous methodology are required. Such investigations will assist in the development of evidence-based guidelines on the use of CAM interventions either alone or in concert with conventional approaches to provide safe, reliable analgesia for infant procedural pain.

The present study is an extension of our previous work carried out on Cynodon dactylon. This study deals with the critical evaluation of glycemic potential of ethanolic extract of defatted C. dactylon. The doses of 250, 500 and 750 mg kg^–1 bw of the extract were administered orally to normal as well as Streptozotocin-induced diabetic rats to study its glycemic potential. The effect of repeated oral administration of the same doses of ethanolic extract was also studied on serum lipid profile of severely diabetic (SD) rats. The dose of 500 mg kg^–1 bw was identified as the most effective dose as it lowered the blood glucose levels of normal by 42.12% and of diabetic by 43.42% during fasting blood glucose (FBG) and glucose tolerance test respectively. The SD rats were also treated daily with this identified dose of 500 mg kg^–1 bw for 2 weeks and a significant reduction of 56.34% was observed in FBG level. Total cholesterol, low density lipoprotein and triglyceride levels were also decreased by 32.94, 64.06 and 48.46% respectively in SD rats whereas, cardioprotective high density lipoprotein increased by 16.45%. The reduced urine sugar level and increased body weight are additional advantages. These evidences clearly indicate that the ethanolic extract of defatted C. dactylon has high antidiabetic potential along with good hypolipidemic profile.

Safety and anti-diabetic effects of Glucolevel, a mixture of dry extract of leaves of the Juglans regia L, Olea europea L, Urtica dioica L and Atriplex halimus L were evaluated using in vivo and in vitro test systems. No sign of toxic effects (using LDH assay) were seen in cultured human fibroblasts treated with increasing concentrations of Glucolevel. Similar observations were seen in vivo studies using rats (LD50: 25 g/kg). Anti-diabetic effects were evidenced by the augmentation of glucose uptake by yeast cells (2-folds higher) and by inhibition of glucose intestinal absorption (~49%) in a rat gut-segment. Furthermore, treatment with Glucolevel of Streptozotocin-induced diabetic rats for 2–3 weeks showed a significant reduction in glucose levels [above 400 ± 50 mg/dl to 210 ± 22 mg/dl (P < 0.001)] and significantly improved sugar uptake during the glucose tolerance test, compared with positive control. In addition, glucose levels were tested in sixteen human volunteers, with the recent onset of type 2 diabetes mellitus, who received Glucolevel tablets 1 x 3 daily for a period of 4 weeks. Within the first week of Glucolevel consumption, baseline glucose levels were significantly reduced from 290 ± 40 to 210 ± 20 mg/dl. At baseline, a subgroup of eleven of these subjects had glucose levels below 300 mg% and the other subgroup had levels ≥ 300 mg%. Clinically acceptable glucose levels were achieved during the 2–3 weeks of therapy in the former subgroup and during the 4th week of therapy in the latter subgroup. No side effect was reported. In addition, a significant reduction in hemoglobin A1C values (8.2 ± 1.03 to 6.9 ± 0.94) was found in six patients treated with Glucolevel. Results demonstrate safety, tolerability and efficacy of herbal combinations of four plants that seem to act differently but synergistically to regulate glucose-homeostasis.

Here, 45 Chinese herbs that regulate blood circulation were analyzed for antioxidant activity using the oxygen radical absorbance capacity (ORAC) assay. A recent publication by Ou et al. identified a close relationship between in vitro antioxidant activity and classification of Chinese herbs as yin or yang. The 45 Chinese herbs in this study could be assigned the traditional characteristics of natures (cold, cool, hot and warm), flavors (pungent, sweet, sour, bitter and salty) and functions (arresting bleeding, promoting blood flow to relieve stasis, nourishing blood and clearing away heat from blood). These characteristics are generalized according to the theory of yin and yang. We identified a broad range, 40–1990 µmol Trolox Equivalent/g herbs, of antioxidant activity in water extracts. There was no significant correlation between ORAC values and natures or functions of the herbs. There was a significant relationship between flavors and ORAC values. Bitter and/or sour herbs had the highest ORAC values, pungent and/or sweet herbs the lowest. Other flavors had intermediate values. Flavors also correspond with the yin/yang relationship and our results are supportive of the earlier publication. We reported for the first time antioxidant properties of many Chinese herbs. High antioxidant herbs were identified as Spatholobus suberectus vine (1990 µmol TE/g), Sanguisorba officinalis root (1940 µmol TE/g), Agrimonia pilosa herb (1440 µmol TE/g), Artemisia anomala herb (1400 µmol TE/g), Salvia miltiorrhiza root (1320 µmol TE/g) and Nelembo nucifera leaf (1300 µmol TE/g). Antioxidant capacity appears to correlate with the flavors of herbs identified within the formal TCM classification system and may be a useful guide in describing their utility and biochemical mechanism of action.

Propolis contains resinous substances collected by honey bees from various plant sources and has been used as a traditional folk medicine since ca 300 BC. Nowadays, the use of evidence-based complementary and alternative medicine (CAM) is increasing rapidly and so is the use of propolis in order to treat or support the treatment of various diseases. Much attention has been focused on propolis from Populus sp. (Salicaceae) and Baccharis dracunculifolia (Asteracea), but scientific information about the numerous other types of propolis is still sparse. We gathered six samples of red propolis in five states of Northeastern Brazil. The beehives were located near woody perennial shrubs along the sea and river shores. The bees were observed to collect red resinous exudates on Dalbergia ecastophyllum (L) Taub. (Leguminosae) to make propolis. The flavonoids of propolis and red resinous exudates were investigated using reversed-phase high-performance liquid chromatography and reversed-phase high-performance thin-layer chromatography. We conclude that the botanical origin of the reddish propolis is D. ecastophyllum. In areas where this source (D. ecastophyllum) was scarce or missing, bees were collecting resinous material from other plants. Propolis, which contained the chemical constituents from the main botanical origin, showed higher antimicrobial activity.

Skin impedance at acupuncture points (APs) has been used as a diagnostic/therapeutic aid for more than 50 years. Currently, researchers are evaluating the electrophysiologic properties of APs as a possible means of understanding acupuncture's mechanism. To comprehensively assess the diagnostic, therapeutic and mechanistic implications of acupuncture point skin impedance, a device capable of reliably recording impedances from 100 k to 50 M at multiple APs over extended time periods is needed. This article describes design considerations, development and testing of a single channel skin impedance system (hardware, control software and customized electrodes). The system was tested for accuracy against known resistors and capacitors. Two electrodes (the AMI and the ORI) were compared for reliability of recording over 30 min. Two APs (LU 9 and PC 6) and a nearby non-AP site were measured simultaneously in four individuals for 60 min. Our measurement system performed accurately (within 5%) against known resistors (580 k–10 M) and capacitors (10 nF–150 nF). Both the AMI electrode and the modified ORI electrode recorded skin impedance reliably on the volar surface of the forearm (r = 0.87 and r = 0.79, respectively). In four of four volunteers tested, skin impedance at LU 9 was less than at the nearby non-AP site. In three of four volunteers skin impedance was less at PC 6 than at the nearby non-AP site. We conclude that our system is a suitable device upon which we can develop a fully automated multi-channel device capable of recording skin impedance at multiple APs simultaneously over 24 h.

Analyses of 2002 National Health Interview supplement on complementary and alternative medicine (NHI%AM) indicate that approximately 38 million adults in the US (18.9% of the population) used natural herbs or supplements in the preceding 12 months, but only one-third told their physician about this use. The objectives of this study are: (i) to determine subpopulation rates of patient–physician communication about herbal product and natural supplement use and (ii) to identify the relative influence of patient factors and interaction factors associated with patient-physician communication about herb and supplement use. Logistic secondary analysis was done by using the complementary and alternative medicine supplement of the 2002 National Health Interview Survey. Subjects were a random stratified sample of US adults who used herbs in the past 12 months (n = 5 196) and self-reported rates of disclosure to physicians about herb and supplement use. Results show that disclosure rates were significantly lower for males, younger adults, racial and ethnic minorities and less intensive users of medical care. Across subpopulations, disclosure was the exception rather than the norm. Given the potential risks of delayed or inappropriate treatment and adverse drug reactions and interactions, physicians should be aware of herb and supplement use and counsel patients on the potential risks and benefits of these treatments.

We investigated the effects of tai chi on disease activity, flexibility and depression in patients with ankylosing spondylitis (AS). We allocated 40 patients to either a tai chi treatment group or a no-treatment control group. The tai chi group performed 60 min of tai chi twice weekly for eight consecutive weeks and 8 weeks of home-based tai chi, after which the group showed significant improvement in disease activity and flexibility compared to the control group. All outcome measures were significantly lower in the tai chi group than they were during pre-treatment, while they did not change in the control group. These findings suggest that tai chi can improve disease activity and flexibility for patients with AS. Tai chi is an easily accessible therapy for patients and, as such, may be an effective intervention for AS. However, we cannot completely discount the possibility that the placebo effect was responsible for the improvement.

‘Oketsu’ is a pathophysiologic concept in Japanese traditional (Kampo) medicine, primarily denoting blood stasis/stagnant syndrome. Here we have explored plasma protein biomarkers and/or diagnostic algorithms for ‘Oketsu’. Sixteen rheumatoid arthritis (RA) patients were treated with keishibukuryogan (KBG), a representative Kampo medicine for improving ‘Oketsu’. Plasma samples were diagnosed as either having an ‘Oketsu’ (n = 19) or ‘non-Oketsu’ (n = 29) state according to Terasawa's ‘Oketsu’ scoring system. Protein profiles were obtained by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOF MS) and hierarchical clustering and decision tree analyses were performed. KBG treatment for 4 or 12 weeks decreased the ‘Oketsu’ scores significantly. SELDI protein profiles gave 266 protein peaks, whose expression was significantly different between the ‘Oketsu’ and ‘non-Oketsu’ states. Hierarchical clustering gave three major clusters (I, II, III). The majority (68.4%) of ‘Oketsu’ samples were clustered into one cluster as the principal component of cluster I. The remaining ‘Oketsu’ profiles constituted a minor component of cluster II and were all derived from patients cured of the ‘Oketsu’ state at 12 weeks. Construction of the decision tree addressed the possibility of developing a diagnostic algorithm for ‘Oketsu’. A reduction in measurement/pre-processing conditions (from 55 to 16) gave a similar outcome in the clustering and decision tree analyses. The present study suggests that the pathophysiologic concept of Kampo medicine ‘Oketsu’ has a physical basis in terms of the profile of blood proteins. It may be possible to establish a set of objective criteria for diagnosing ‘Oketsu’ using a combination of proteomic and bioinformatics-based classification methods.

This study aimed to investigate the practice of apitherapy - using bee products such as honey, pollen, propolis, royal jelly and bee venom to prevent or treat illness and promote healing - among German beekeepers and to evaluate their experiences with these therapies. A questionnaire incorporating two instruments on beekeepers’ physical and mental health and working practice was included in three German beekeeping journals and readers were asked to complete it. The instrument included questions on the use of apitherapy. Simple descriptive methods, bivariate correlation, cross-tabulation and one-way ANOVA were used to analyze the data. Altogether 1059 completed questionnaires were received. The beekeepers reported the most effective and favorable therapeutic effects with honey, followed by propolis, pollen and royal jelly. The factors associated with successful experiences were: age, number of hives tended, health consciousness, positive experiences with one product and self-administration of treatment. Beekeepers were asked for which condition they would employ propolis and pollen. They reported that they used propolis most frequently to treat colds, wounds and burns, sore throats, gum disorders and also as a general prophylactic, while pollen was most commonly used as a general prophylactic and, less frequently, in treating prostate diseases. No adverse experiences were reported. The potential benefit of bee products is supported by the positive experiences of a large group of beekeepers who use some of these products to treat a wide range of conditions. The indications and treatments given here may be important in selecting bee products and designing future trials.

We summarize the results from a series of investigations of Japanese style acupuncture and moxibustion therapies on symptoms of the common cold that have been conducted (FTLE 1999–03, supported by the Foundation for Training and Licensure Examination in Anma- Massage- Acupressure, Acupuncture and Moxibustion). We also discuss the various interventions and concerns that we faced during these investigations. The subjects were students and teachers. The pilot study (FTLE1999) of a two arm (real and non-treatment control) RCT at a Japanese acupuncture school showed that manual acupuncture to a specific needling point at the throat clearly reduced symptoms of the common cold. The first multi-center (five centers) RCT (FTLE 2000) revealed a significant reduction in cold symptoms, by general linear model analysis (between groups, P = 0.024). To reduce the technical variation, we employed indirect moxibustion to the neck points as a uniform intervention in the next project (FTLE 2001) without statistically significant results. Then we elongated the periods of treatment from 2 to a maximum of 12 weeks (FTLE 2002) with different interventions accompanied by 4 weeks follow-up. The results were still not statistically significant. As the final project, we tried to develop a new experimental design for individualized intervention by conducting n-of-1 trials using elderly subjects in a health care center but without detecting a clear effect. In conclusion, the safety of Japanese acupuncture or moxibustion was sufficiently demonstrated; however, a series of clinical trials could not offer convincing evidence to recommend the use of Japanese style acupuncture or moxibustion for preventing the common cold. Further studies are required as the present trials had several limitations.