A contemporary understanding of Chinese Medicine (CM) regards CM diagnosis as a functional vegetative state that may be treated by vegetative reflex therapies such as acupuncture. Within this context, traditional mind-body exercises such as Qigong can be understood as an attempt to enhance physiological proprioception, by combining a special state of"awareness"with posture, movement, and breath control. We have formerly trained young auditing flutists in"White Ball"Qigong to minimize anxiety-induced cold hands and lower anxiety-induced heart rate. Functional changes occurred 2-5 min after training and were observed over the whole training program, allowing the children to control their symptoms. In our current work, we report that warm fingers and calm hearts could be induced by the children even without Qigong exercises. Thus, these positive changes once induced and"conditioned"vegetatively were stable after weeks of training. This may show the mechanism by which Qigong acts as a therapeutic measure in disease: positive vegetative pathways may be activated instead of dysfunctional functional patterns. The positive vegetative patterns then may be available in critical stressful situations. Qigong exercise programs may therefore be understood as an ancient vegetative biofeedback exercise inducing positive vegetative functions which are added to the individual reactive repertoire.

OBJECTIVES. To evaluate the effectiveness of Baduanjin Qigong exercise on sleep, fatigue, anxiety, and depressive symptoms in chronic fatigue syndrome- (CFS-) like illness and to determine the dose-response relationship.

METHODS. One hundred fifty participants with CFS-like illness (mean age = 39.0, SD = 7.9) were randomly assigned to Qigong and waitlist. Sixteen 1.5-hour Qigong lessons were arranged over 9 consecutive weeks. Pittsburgh Sleep Quality Index (PSQI), Chalder Fatigue Scale (ChFS), and Hospital Anxiety and Depression Scale (HADS) were assessed at baseline, immediate posttreatment, and 3-month posttreatment. The amount of Qigong self-practice was assessed by self-report.

RESULTS. Repeated measures analyses of covariance showed a marginally nonsignificant (P = 0.064) group by time interaction in the PSQI total score, but it was significant for the"subjective sleep quality"and"sleep latency"items, favoring Qigong exercise. Improvement in"subjective sleep quality"was maintained at 3-month posttreatment. Significant group by time interaction was also detected for the ChFS and HADS anxiety and depression scores. The number of Qigong lessons attended and the amount of Qigong self-practice were significantly associated with sleep, fatigue, anxiety, and depressive symptom improvement.

CONCLUSION. Baduanjin Qigong was an efficacious and acceptable treatment for sleep disturbance in CFS-like illness. This trial is registered with Hong Kong Clinical Trial Register: HKCTR-1380.

BACKGROUND: Inflammatory cytokine levels are often elevated in people with Parkinson's disease (PD). People with PD often experience sleep disturbances that significantly impact quality of life. Past studies suggest inflammatory cytokines may be associated with various symptoms of PD. Benefits of Qigong, a mind-body exercise, have been shown in different neurological conditions, but there is still a lack of clinical evidence in the PD population.

METHODS: Ten people with PD were recruited and randomly assigned into two groups receiving six weeks of Qigong (experimental group) or sham Qigong (control group) intervention. The levels of TNF-α, IL-1β, and IL-6 in subjects' serum and sleep quality were measured before and after the intervention.

RESULTS: After the intervention, the serum level of TNF-α in the experimental group was significantly decreased in all subjects, while the level in the control group showed a trend to increase. Qigong exercise significantly improved sleep quality at night. There was a strong correlation between changes in the level of TNF-α and sleep quality.

CONCLUSION: Qigong exercise decreased TNF-α level in people with PD and helped improve sleep quality. TNF-α may have a potential to influence the sleep quality in people with PD.

OBJECTIVE: Tinnitus is a frequent disorder which is very difficult to treat. Qigong is a mindful exercise and an important constituent of traditional Chinese medical practice. Here we performed a randomized controlled trial to evaluate the effect of a Qigong intervention on patients with tinnitus. We hypothesized that especially tinnitus patients with somatosensoric components may benefit from the mind-body technique of Qigong.

METHODS: Eighty patients with tinnitus of at least 3 months duration were randomly assigned to an intervention group (n=40) consisting of 10 Qigong training sessions in 5 weeks or a waiting-list control group (n=40). Tinnitus severity was assessed with a visual analogue scale (VAS) and with a tinnitus questionnaire (TBF-12) before treatment, immediately after treatment, and 1 and 3 months after treatment.

RESULTS: Qigong did not cause any side effects and was completed by 80% of the assigned patients. Compared with the control group, Qigong participants experienced improvement in tinnitus severity, as reflected by a significant reduction in both the VAS and the TBF-12. In the subgroup of patients with somatosensoric tinnitus, Qigong effects were more pronounced, resulting in a highly significant improvement in both scales compared to the waiting-list group.

CONCLUSION: These findings suggest that Qigong interventions could be a useful complement to the therapeutic management of patients with tinnitus and especially for those with somatosensoric components. Satisfaction with the intervention, a high degree of completion, and stability of the effects for at least 3 months after the intervention further underscore the potential of Qigong in the treatment of tinnitus.

BACKGROUND:Radiotherapy may lead to side effects that undermine patients' quality of life (QOL). Although mind-body practices like qigong appear to improve QOL in cancer survivors, little is known about their benefits for patients who are receiving radiotherapy. Thus, in the current randomized controlled trial, the authors examined the efficacy of a qigong intervention on QOL in women with breast cancer during and after treatment.

METHODS:Ninety-six women with breast cancer were recruited from a cancer center in Shanghai, China, and were randomized to a qigong group (N = 49) or a waitlist control group (N = 47). Women in the qigong group attended 5 weekly classes over 5 or 6 weeks of radiotherapy. QOL outcomes (ie, depressive symptoms, fatigue, sleep disturbance, and overall QOL) and cortisol slopes were assessed at baseline, during treatment, at the end of treatment, 1 month later, and 3 months later.

RESULTS:The mean age of the women was 46 years (range, 25-64 years). Seven percent of women had stage 0 disease, 25% had stage I disease, 40% had stage II disease, and 28% had stage III disease. Fifty-four percent of women underwent mastectomy. Multilevel analyses revealed that women in the qigong group reported less depressive symptoms over time than women in the control group (P = .05). Women who had elevated depressive symptoms at the start of radiotherapy reported less fatigue (P<.01) and better overall QOL (P<.05) in the qigong group compared with the control group, and these findings were clinically significant. No significant differences were observed for sleep disturbance or cortisol slopes.

CONCLUSIONS:The current results indicated that qigong may have therapeutic effects in the management of QOL among women who are receiving radiotherapy for breast cancer. Benefits were particularly evident for patients who had preintervention elevated levels of depressive symptoms.

Autism is commonly associated with sensory and self-regulatory disturbances. This article presents a randomized controlled study evaluating the effect of a 5-month intervention directed toward improving sensory impairment, digestion, and sleep in 46 children with autism < age 6. The intervention, Qigong Sensory Training (QST), is a qigong massage intervention based in Chinese medicine. It is two-pronged: Trainers work with children directly 20 times over 5 months, and parents give the massage daily to their children. Improvement was evaluated in two settings--preschool and home--by teachers (blind to group) and parents. Teacher evaluations showed that treated children had significant classroom improvement of social and language skills and reduction in autistic behavior compared with wait-list control participants. These findings were confirmed by parent data, indicating that the gains had generalized across contexts. A model and supporting data for understanding and treating sensory and self-regulation problems in autism is presented.

This study was designed to investigate the efficacy of Qigong as a non-pharmacological treatment of hypertension and evaluate the contribution of Qigong in the blood pressure (BP) reduction of essential hypertension patients. Fifty-eight patients volunteered to participate in this study and were randomly divided into either a Qigong group (n = 29), or a wait list control group (n = 29). In response to 10 weeks of Qigong, systolic blood pressure (SBP), diastolic blood pressure (DBP), and rate pressure product (RPP) were decreased significantly. There was a significant reduction of norepinephrine, epinephrine, cortisol, and stress level by the Qigong. These results suggest that Qigong may reduce BP and catecholamines via stabilizing the sympathetic nervous system. Therefore, Qigong is an effective nonpharmacological modality to reduce BP in essential hypertensive patients.

PURPOSE:The purpose of this pilot study was to examine the effect of a Chinese traditional exercise program, Qigong Yi Jinjing (QYJJ), on patients with chronic obstructive pulmonary disease (COPD).

METHODS:One hundred and thirty eligible COPD patients were randomly divided into three groups: the QYJJ group (n = 42), the self-management exercise group (n = 43), and the control group (n = 45). Data were collected and analyzed at baseline and again at one, three, and six months. A pulmonary rehabilitation index, consisting of pulmonary function, six-minute walk test, Regulatory Emotion Self-Efficacy questionnaire, and exercise of the COPD Assessment Test widely used to evaluate health-related quality of life (HRQL) in participants with COPD, was measured.

RESULTS:Compared with the other groups, participants in QYJJ group had significantly better lung function (forced expiratory volume in one second: F = 8.96, p = 0.000; forced expiratory volume in one second/forced vital capacity: F = 11.55, p = 0.000; the percentage of forced expiratory volume in one second in prediction: F = 24.27, p = 0.000); walked a longer distance (F = 152.52, p = 0.000), and had more satisfactory HRQL (F = 14.08, p = 0.000). QYJJ training also contributed to improving the ability of emotion regulation (F = 36.56, p = 0.000). There were significant positive changes in expressing positive affect (F = 56.25, p = 0.000) and managing despondency/distress (F = 21.58, p = 0.000), apart from the ability to regulate anger/irritation (F = 1.20, p = 0.305). The longer QYJJ is practiced, the more effective the influence is on the pulmonary rehabilitation-related index measures.

CONCLUSIONS:These results indicate that QYJJ exercise produced positive effects on pulmonary function, physical activity, emotion regulation self-efficiency (modulating the expression of despondency or distress and experiencing and expressing positive affect), and HRQL in patients with COPD.

OBJECTIVES:Sleep disturbances and fatigue are common in prostate cancer patients undergoing radiotherapy. Prior research suggests mind-body techniques may improve these outcomes. We conducted a randomized-controlled trial of qigong/tai chi (QGTC) in men with prostate cancer undergoing radiotherapy.

METHODS:Men with prostate cancer starting definitive radiation were randomized to one of three groups: (1) QGTC; (2) light exercise (LE); or (3) wait list control (WLC). Sleep disturbances (PSQI) and fatigue (BFI) were assessed at baseline, mid-radiotherapy (T2), during the last week of radiotherapy (T3) and at 1 (T4) and 3 months (T5) after the end of radiotherapy. Patients in the QGTC and LE groups attended three 40-minute classes per week throughout radiotherapy.

RESULTS:Ninety patients were randomized to the three groups (QGTC = 26; LE = 26; WLC = 24). QGTC group reported longer sleep duration at mid-XRT (QGTC = 7.01 hours; LE = 6.42; WL = 6.50; p = 0.05) but this difference did not persist over time. There were no group differences in other domains of sleep or fatigue. Exploratory analyses conducted to examine the effect of health-related QOL (EPIC and AUA score) on sleep and fatigue showed significant correlations across multiple domains.

CONCLUSIONS:QGTC during radiation for prostate cancer resulted in superior sleep duration midway through radiation, but this effect was not durable and there were no differences in other domains of sleep or fatigue. Exploratory analysis demonstrated that both sleep and fatigue were highly correlated with prostate cancer related physical symptoms. Future mind-body intervention studies should incorporate multi-modal therapy focused on improving physical symptoms in this population.

Beneficial effects of Mediterranean diet (MD) have been consistently documented. However, to fully understand the public health implications of MD adherence, an informative step is to quantify these effects in terms of survival time differences. The aim of this study was to evaluate the impact of MD on survival, presenting results in terms of differences in median age at death. We used data from 71,333 participants from a large population-based cohort of Swedish men and women, followed-up between January 1, 1998, and December 31, 2012. A total score of MD, ranging from 0 to 8, was calculated by including information on vegetables and fruits consumption, legumes and nuts, non-refined/high fiber grains, fermented dairy products, fish, red meat, use of olive oil/rapeseed oil, and moderate alcohol intake. Multivariable-adjusted differences in median age at death were estimated with Laplace regression and presented as a function of the MD score. During 15 years of follow-up we documented 14,697 deaths. We observed a linear dose-response association between the MD score and median age at death, with higher score associated with longer survival. The difference in median age at death between participants with the extreme scores (0 vs 8) of MD was up to 2 years (23 months, 95 % CI: 16-29). In this study we documented that adherence to MD may accrue benefits up to 2 years of longer survival.

BACKGROUND:Raisins are a significant source of dietary fiber and polyphenols, which may reduce cardiovascular disease (CVD) risk by affecting lipoprotein metabolism and inflammation. Walking represents a low intensity exercise intervention that may also reduce CVD risk. The purpose of this study was to determine the effects of consuming raisins, increasing steps walked, or a combination of these interventions on blood pressure, plasma lipids, glucose, insulin and inflammatory cytokines.

RESULTS:Thirty-four men and postmenopausal women were matched for weight and gender and randomly assigned to consume 1 cup raisins/d (RAISIN), increase the amount of steps walked/d (WALK) or a combination of both interventions (RAISINS + WALK). The subjects completed a 2 wk run-in period, followed by a 6 wk intervention. Systolic blood pressure was reduced for all subjects (P = 0.008). Plasma total cholesterol was decreased by 9.4% for all subjects (P<0.005), which was explained by a 13.7% reduction in plasma LDL cholesterol (LDL-C) (P<0.001). Plasma triglycerides (TG) concentrations were decreased by 19.5% for WALK (P<0.05 for group effect). Plasma TNF-alpha was decreased from 3.5 ng/L to 2.1 ng/L for RAISIN (P<0.025 for time and group x time effect). All subjects had a reduction in plasma sICAM-1 (P<0.01).

CONCLUSION:This research shows that simple lifestyle modifications such as adding raisins to the diet or increasing steps walked have distinct beneficial effects on CVD risk.

BACKGROUND: Evidence supports the effectiveness of cognitive behavioural approaches in improving the symptoms of the irritable bowel syndrome (IBS). Duration, cost and resistance of many patients towards a psychological therapy have limited their acceptance. AIM: To evaluate the effectiveness of a psycho-educational intervention on IBS symptoms.

METHODS: Sixty-nine IBS patients (72% female) were randomised to an intervention or a wait-list control group. The IBS class consisted of education on a biological mind body disease model emphasising self-efficacy and practical relaxation techniques.

RESULTS: Patients in the intervention showed significant improvement on GI symptom severity, visceral sensitivity, depression and QoL postintervention and most of these gains were maintained at 3-month follow-up (Hedge's g = -0.46-0.77). Moderated mediation analyses indicated change in anxiety, visceral sensitivity, QoL and catastrophising due to the intervention had moderate mediation effects (Hedge's g = -0.38 to -0.60) on improvements in GI symptom severity for patients entering the trial with low to average QoL. Also, change in GI symptom severity due to the intervention had moderate mediation effects on improvements in QoL especially in patients with low to average levels of QoL at baseline. Moderated mediation analyses indicated mediation was less effective for patients entering the intervention withhigh QoL.

CONCLUSIONS: A brief psycho-educational group intervention is efficacious in changing cognitions and fears about the symptoms of the irritable bowel syndrome, and these changes are associated with clinically meaningful improvement in symptoms and quality of life. The intervention seems particularly tailored to patients with low to moderate quality of life baseline levels.

BACKGROUND:A group of adults can be identified with chronic non-responding anxiety symptoms who have repeatedly accessed treatments through their GP, such as cognitive behaviour therapy, bibliotherapy and medication, but with no effect. These patients make heavy use of health service resources with no beneficial outcome. This study aims to test the effect of an acupuncture formula of three specific acupuncture points, suggested in a previous pilot study.

METHOD:40 participants from a psychiatry waiting list were randomised into one of two groups: group 1 (n=25) received 10 weeks of acupuncture at PC6, HT7 and LR3, and group 2 was a waiting list control group. The waiting list group (n=15) then received acupuncture. Both groups were followed up for 10 weeks after treatment. The outcome measure was the State and Trait Anxiety Inventory.

RESULTS:36 patients completed the study, with two dropouts in each group. State anxiety scores in the acupuncture group decreased from 57.7 (SD 13.1) to 38.8 (12.0); scores in the waiting list control group decreased from 61.5 (11.6) to 60.6 (11.7). The difference was highly significant (p<0.0001). Similar changes were seen for trait anxiety scores. The control group showed similar statistically significant improvements when they received acupuncture. The improvements were maintained after 10 weeks of follow-up in each group.

CONCLUSIONS:Acupuncture is a promising intervention for patients with chronic anxiety symptoms that have proven resistant to other forms of treatment.

A higher dietary inflammatory index (DII®) score is associated with inflammation and incidence of coronary heart disease (CHD). We hypothesized that a Mediterranean diet (MedDiet) intervention would reduce DII score. We assessed dietary data from a randomized controlled trial comparing 6-month MedDiet versus low-fat diet intervention, inpatients with CHD. We aimed to determine the DII scores of the prescribed diets' model meal plans, followed by whether dietary intervention led to lower (i.e., more anti-inflammatory) DII scores and consequently lower high sensitivity C-reactive protein (hs-CRP) and interleukin-6 (hs-IL-6). DII scores were calculated from 7-day food diaries. The MedDiet meal plan had a markedly lower DII score than the low-fat diet meal plan (-4.55 vs. -0.33, respectively). In 56 participants who completed the trial (84% male, mean age 62 ± 9 years), the MedDiet group significantly reduced DII scores at6 months (n = 27; -0.40 ± 3.14 to -1.74 ± 2.81, P = .008) and the low-fat diet group did not change (n = 29; -0.17 ± 2.27 to 0.05 ± 1.89, P = .65). There was a significant post-intervention adjusted difference in DII score between groups (compared to low-fat, MedDiet decreased by -1.69 DII points; P = .004). When compared to the low-fat diet, the MedDiet non-significantly reduced hs-IL-6 (-0.32 pg/mL, P = .29) and increased hs-CRP (+0.09 mg/L, P = .84). These findings demonstrated that MedDiet intervention significantly reduced DII scores compared to a low-fat diet. However, in this small cohort of patients with CHD this did not translate to a significant improvement in measured inflammatory markers. The effect of improvement in DII with MedDiet should be tested in larger intervention trials and observational cohorts.

OBJECTIVE:To observe the therapeutic effect of acupuncture in the treatment of patients with knee osteoarthritis (KOA) in the early stage.

METHODS:A total of 60 KOA patients were randomized into medication group and acupuncture combined with medication (acupuncture) group (＝ 30 in each group). Patients of the medication group were treated by external application of Diclofenac Diethylamine Emulgel around the affected joint, 3 times a day for 2 successive weeks and reasonable exercising training. Patients of the acupuncture group received routine medication and reasonable exercising training and acupuncture of-points, Zusanli (ST36), Yanglingquan (GB34), Yinlingquan (SP9), Neixiyan (EX-LE4) and Dubi (ST35) at affected side with filiform needles which were manipulated with uniform reinforcing-reducing method for a while, followed by retaining the needles for 30 min. The treatment was conducted once every other day for 2 weeks. The pain degree was assessed by using visual analog scale (VAS) and the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) scale (0－240 points) was used to evaluate the severity of KOA, and the"Diagnosis of Syndromes of Traditional Chinese Medicine"was used to assess the therapeutic effect after the treatment.

RESULTS:After the treatment, the VAS and WOMAC scores of both medication and acupuncture groups were significantly and respectively decreased in comparison with their own pre-treatment (<0.05), and the scores of the two indexes of the acupuncture group were evidently lower than those of the medication group (<0.05). Of the two 30 cases in the medication and acupuncture groups, 5 (16.67%) and 6 (20.00%) were cured, 17 (56.67%) and 19 (63.33%) experienced marked improvement, 6 (20.00%) and 4 (13.33%) were effective, 2 (6.67%) and 1 (3.33%) were ineffective, with the effective rate of cure plus marked effectiveness being 73.33% and 83.33%, respectively. No significant difference was found between the two groups in the therapeutic effect (>0.05).

CONCLUSION:Acupuncture combined with medication has a better therapeutic effect in the treatment of KOA in the early stage than that of the simple medication.

OBJECTIVE:To observe the clinical effedt of auricular pressure combined with Chinese herbal medicine for amblyopia.

METHODS:A total of 66 child patients with amblyopia were randomly divided into Chinese herbal medicine (control) and herbal medicine+ auricular pressure (treatment) groups, with 33 patients in each group. The patients in the control group were treated with Chinese medical herbs as Danggui (Radix Angelicae Sinensis), Gouqizi (Fructus Lycii), Baijuhua (Flos Chrysanthemi), Baizhu (Rhizoma Atractylodis Macrocephalae), Shudi (Radix Rehmanniae Proeparata), Baishao (Radix Paeoniae Alba) , etc. according to syndrome differentiation, while the patients in the treatment group were treated by auricular pressure of otopoints Yan (Eye), Gan (Liver), Shen (Kidney), Xin (Heart), Mu 1 (Eye-1), Mu 2(Eye-2), and Pi (Spleen) and herbal medicines (being the same to the control group). The treatment was conducted for 6 months. After the treatment, the clinical effect, improvement degree of vision, onset time of improvement, and recurrence rate in the 3 and 6 months' follow-up visit were analyzed.

RESULTS:Of the 45 and 47 eyes in the treatment and control groups, 22 and 15 were basically cured, 12 and 5 had marked improvement, 9 and 20 were improved, 2 and 7 failed in the treatment, with the effective rates being 75. 56% and 42.55%, respectively. In comparison with pre-treatment, the visual acuity in both control group and treatment group were improved (P<0. 05). The numbers of children who had improvement of visual acuity after 2 weeks, one month in the control group and treatment group were 26 and 31 eyes, 10 and 11 eyes, respectively. The recurrence rate 6 months after the treatment was 50. 00 % in the control group and 16. 28% in the treatment group. The effective rate of the treatment group was significantly superior to that of the control group (P<0. 05).

CONCLUSION:Auricular pressure combined with Chinese medical herb treatment is effective in improving visual acuity, and had a higher efficacy, faster action, and lower recurrence rate in amblyopia children in comparison with simple herbal medicine treatment.

OBJECTIVE: To observe the effect of acupuncture on the fatigue degree in patients with chronic fatigue syndrome (CFS). METHODS: Seventy CFS patients were equally randomized into control and treatment groups according to randomized block design. Acupuncture was applied to Baihui (GV 20), Danzhong (CV 17), Zhongwan (CV 12), etc., for patients in treatment group, and to non-acupoints (2 cm respectively to the abovementioned acupoints) for those in control group. The treatment was given once every other day, 14 times altogether. The fatigue degree and the therapeutic effect were assessed by Chalder's fatigue scale (FS). RESULTS: A total of 64 cases (32/group) were finished in this study. After the treatment, the physical FS (5.0 +/- 2.4 vs 6.8 +/- 1.5), mental FS (1.8 +/-1.8 vs 3.1 +/- 1.5) and the total FS (6.8 +/- 3.8 vs 9.9 +/- 2.5) in treatment group, physical FS (5.0 +/- 2.5 vs 6.4 +/- 1.5) and the total FS (7.5 +/- 3.4 vs 9.6 +/- 2.8) in control group decreased significantly compared with pre-treatment (P < 0.01, P < 0.05). There was no marked change in mental FS (2.5 +/- 11.6 vs 3.2 +/- 11.6) in control group after the treatment (P > 0.05). Comparison between two groups showed no significant differences in the 3 indexes (P > 0.05). CONCLUSION: Acupuncture can relieve CFS patients' physical and mental fatigue and the therapeutic effect of acupuncture of acupoints is relatively better than that of non-acupoints in reducing mental fatigue.

OBJECTIVE:To observe the therapeutic effect of ear-electroacupuncture (Ear-EA) on dysmenorrhea in patients with endometriosis and to explore its underlying mechanism.

METHODS:A total of 80 endometriosis patients were randomly and equally divided into ear-EA group and body-EA group. EA (50 Hz, 0.5-0.8 mA) was applied to auricular points (Uterus, Subcortex, Shenmen, Endocrine, etc.) and body acupoints [Tianshu (ST 25), Qihai (CV 6), Guanyuan (CV 4), Sanyinjiao (SP 6), Diji (SP 8), Uterus (EX-CA 1), etc.] respectively for 30 min, once every other day for 3 months. Dysmenorrhea severity score (DSS) was assessed and plasma prostaglandin (PGE2) and 6-Keto-PGF1alpha levels detected by radioimmunoassay.

RESULTS:Compared with pre-treatment, DSS lowered significantly during the 1st and 2nd menstrual cycle in body-EA group, and during the 1st, 2nd and 3rd menstruation in ear-EA group; and the DSS of ear-EA group during the 3rd menstruation was evidently lower than that of body-EA group (P<0.05). During the 3rd menstrual onset after the treatment, plasma PGE2 contents in both groups decreased obviously (P<0.01), and plasma 6-Keto-PGF1alpha, levels increased considerably in comparison with pre-treatment (P<0.01). Comparison between two groups during the 3rd menstruation showed that plasma PGE2 level of ear-EA group was markedly lower than that of body-EA group, and 6-Keto-PGF1alpha, level of ear-EA group was significantly higher than that of body-EA group (P<0.05). No significant difference was found between two groups in clinical therapeutic effect (P>0.05).

CONCLUSION:Both ear-EA and body-EA can effectively relieve endometriosis-induced dysmenorrhea, and the former is superior to the later in reducing pain severity, which may be closely related to their effects in reducing plasma PGE2 and raising 6-Keto-PGF1alpha level.

Background:Approximately one-third of people with schizophrenia have elevated levels of anti-gliadin antibodies of the immunoglobulin G type (AGA IgG)— a higher rate than seen in healthy controls. We performed the first double-blind clinical trial of gluten-free versus gluten-containing diets in a subset of patients with schizophrenia who were positive for AGA IgG.

Methods:In this pilot feasibility study, 16 participants with schizophrenia or schizoaffective disorder who had elevated AGA IgG (≥ 20 U) but were negative for celiac disease were admitted to an inpatient unit for a 5-week trial. All participants received standardized gluten-free meals and were randomized in a double-blind fashion to receive a shake containing 10 g of gluten flour or 10 g of rice flour each day. Participantswere rated for psychiatric, cognitive and gastrointestinal symptoms at baseline and endpoint.

Results:Of the 16 participants, 14 completed the 5-week trial (2 discontinued early for administrative reasons). Compared with participants on the gluten-containing diet, participants on the gluten-free diet showed improvement on the Clinical Global Impressions scale (Cohen d =–0.75) and in negative symptoms (Cohen d = –0.53). We noted no improvement in positive or global cognitive symptoms, but did observe an improvement in attention favouring the gluten-free diet (Cohen d = 0.60). Robust improvements in gastrointestinal adverse effects occurred in the gluten-free group relative to the glutencontaining group. Adverse effects were similar between groups.

Limitations:This study was limited by its small sample size; larger studies are needed.

Conclusion:This feasibility study suggests that removal of gluten from the diet is associated with improvement in psychiatric and gastrointestinal symptoms in people with schizophrenia or schizoaffective disorder.

PURPOSE:This pilot trial aimed to assess if cooling hands and feet with crushed ice during receipt of paclitaxel helps prevent peripheral neuropathy.

METHODS:This prospective, randomized trial compared cryotherapy to standard care in patients initiating paclitaxel weekly x 12. For those on cryotherapy, hands and feet were cooled starting 15 min prior to and ending 15 min after each paclitaxel dose. EORTC QLQ-CIPN20 was completed at baseline, weekly x12, then monthly x6. Area under the curve (AUC) was calculated for subscale scores, adjusting for baseline, and compared between arms (Wilcoxon rank-sum test). Cross-study comparisonsused data from 2 prior similarly-conducted neuropathy trials.

RESULTS:Forty-six patients were accrued. Three withdrew and one was ineligible. Of the remaining 42 (21 cryotherapy, 21 control), 39 (19 cryotherapy, 20 control) were analyzable for AUC. Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26). However, the control arm of the current trial experienced less neuropathy than did the placebo arms of two previous similar trials. When our cryotherapy arm was compared to the combined control arms from all three trials, the cryotherapy arm had less neuropathy (Wilcoxon Rank-Sum p = 0.01).

CONCLUSION:While there was no difference in CIPN20 scores identified between the 2 study arms in the current phase II trial, further investigation is needed given that the control arm experienced less neuropathy than was expected.