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Background: The internet can provide evidence-based patient education to overcome time constraints of busy ambulatory practices. Health informationprescriptions (HIPs) can be effectivelyintegrated into clinic workflow, but compliance to visit health information sites such as Medline Plus is limited.Objective: Compare the efficacy of paper (pHIP)and email (eHIP) links to deliver HIPs; evaluate patient satisfaction with the HIP process and MedlinePlus information; assess reasons for noncompliance to HIPs.Method: Of 948 patients approached at two internal medicine clinics affiliated with an academic medical centre, 592 gave informed consent after meeting the inclusion criteria. In this randomised controlled trial, subjects were randomised to receive pHIP or eHIP for accessing an intermediate website that provided up to five MedlinePlus links for physician-selected HIP conditions. Patients accessing the intermediate website were surveyed by email to assess satisfaction with the health information.Survey non-responders were contacted by telephone to determine the reasons for no response.Results: One hundred and eighty-one patients accessed the website, with significantly more 'filling' eHIP than pHIP (38% vs 23%; P < 0.001). Most(82%) survey respondents found the website information useful, with 77% favouring email for future HIPs delivery. Lack of time, forgot, lost instructions or changed mind were reasons given for not accessing the websites.Conclusions: Delivery of MedlinePlus-based HIPs in clinic is more effective using email prescriptions than paper. Satisfaction with the HIP information was high, but overall response was low and deserves further investigation to improve compliance and related outcomes. [ABSTRACT FROM AUTHOR]

Background: The effect of a self-regulatory intervention with its focus on planning sunscreen use is evaluated in comparison to a standard educational condition. Purpose: This paper studied whether planning mediates between the experimental conditions and the behavioral outcome. Further, it is examined who benefits more: already motivated or unmotivated individuals. Method: College students ( N = 253) were randomly assigned to two groups: a self-regulatory and a standard-care condition. Sunscreen use, intention to use sunscreen, and planning were assessed at two points in time, 1 month apart. Results: The self-regulatory intervention improved planning to use sunscreen but not the behavior directly. Planning emerged as the mediator between conditions and later sunscreen use, controlling for baseline behavior. Moreover, participants who were less motivated benefited more from the intervention. Conclusions: Although it is generally assumed that planning interventions are best designed for already motivated persons, the present findings suggest that less prepared individuals might have more to gain from a brief self-regulatory intervention. [ABSTRACT FROM AUTHOR]

The negative impacts of parental mental health problems on children and adolescents are well known, but the relationship between a child's depression and their parents' health is not so well understood. Being a carer/parent of someone with mental illness can be associated with negative outcomes for the caregiver. This paper reports the associations between the mental health of adolescents with major depression and their parents, before and after treatment of the adolescent's depression. Data were collected as part of the Adolescent Depression Antidepressants and Psychotherapy Trial, a randomised controlled trial of selective serotonin reuptake inhibitors with and without cognitive behaviour therapy in 208 clinic-recruited adolescents with major depression. The baseline severity of depression in the adolescent was significantly associated with both maternal and paternal mental health (as rated by the General Health Questionnaire). This effect was not confounded by other psychiatric symptoms. The degree of improvement in parental and child mental health was positively correlated across time. Our results support the hypothesis that there is a significant association between parental mental health and adolescent depressive symptoms. This study was not able to establish the direction of this association. In clinical practice, the findings demonstrate the importance of considering the mental health of the parents when treating depressed adolescents. [ABSTRACT FROM AUTHOR]

Objective To investigate the clinical effects and safety of electroacupuncture (EA) in the treatment of overactive bladder (OAB) refractory to first-line anticholinergic treatment. Methods Women diagnosed with OAB who were refractory to first-line anticholinergic treatment were referred for EA therapy. 50 women enrolled in this single-blind randomised controlled trial and were randomised 1:1 to EA or sham EA (SEA). The EA and SEA groups were treated with 30 sessions (5 sessions a week for 6 weeks), and each session lasted 30 min. OAB symptom scores (OABSS), King's Health Questionnaire scores (KHQ) and urodynamic parameters were used to assess treatment effects. Safety was also evaluated. Results 45 women completed all aspects of the study (23 in the EA group and 22 in the SEA group). The OABSS and KHQ showed statistically significant improvements in the EA group compared with the SEA group after 6 weeks of treatment (p<0.05). There were no statistical differences in the maximum flow rate and postvoid residual (p>0.05), but there were statistical improvements in the first sensation of bladder filling, first urge to void and maximum cystometric capacity (p<0.05) in the EA group compared with the SEA group. No serious adverse events occurred in either group. Conclusions EA appears to be an effective, safe and minimally invasive treatment for women with OAB. Further studies with longer follow-up are needed to evaluate whether it could be a therapeutic option for OAB refractory to treatment with anticholinergics. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate 20 days and 3 months follow-up effectiveness of cardiac rehabilitation (CR) enhanced by resistance/balance training and telephone-support program compared to usual CR care in improving quality of life, clinical course and physical activity behavior. Design: Single-centre randomized controlled trial. Setting: Inpatient CR clinic Subjects: 116 (76.1 ± 6.7 years, 50% male) patients 14.5 ± 5.9 days after valve surgery/intervention were randomized to intervention group (IG, n = 60) or control group (CG, n = 56). Intervention: Additional resistance/balance training (3 days/week) during phase-II CR and telephone-support program during 3-month follow-up. CG patients were provided with usual CR care. Main measures: Short Form 36 Health Survey scales, European Quality of Life 5 Dimensions 3 Level Version QoL index, visual analog scale, clinical course, and physical activity behavior assessed with standardized questionnaires. Results: IG reported statistically significant higher mental component score (48.5 ± 6.91 vs. 40.3 ± 11.21 at the baseline, 50.8 ± 9.76 vs. 42.6 ± 9.82 after 20 days, 49.4 ± 8.45 vs. 40.5 ± 8.9 after 12 weeks follow up), general health (48.6 ± 3.17 vs. 45.0 ± 2.95 at the baseline, 53.6 ± 3.02 vs. 43.8 ± 2.55 after 20 days, 53.2 ± 3.11 vs. 44.2 ± 3.07 after 12 weeks) and role limitations due to emotional problems (48.5 ± 15.2 vs. 27.7 ± 11.5 at the baseline, 72.7 ± 12.6 vs. 30.5 ± 11.2 after 20 days, 66.6 ± 14.2 vs. 36.1 ± 11.2 after 12 weeks) in all three assessments (p < 0.05). CG patients had more documented hospital admissions (4 (8%) vs 10 (25%), p = 0.027), atrial fibrillation paroxysms (3 (6.0%) vs. 10 (35.0%), p = 0.011) and blood pressure swings (13 (26%) vs. 20 (50%), p = 0.019). IG patients chose more different physical activities (1.7 ± 0.7 vs. 1.25 ± 0.63, p = 0.002), spent more time being physical active every day (195.6 ± 78.6 vs. 157.29 ± 78.8, p = 0.002) Conclusions: The addition of resistance/balance exercises and telephone-support program 12 weeks after to the CR could linked to higher physical activity levels and fewer clinical complications but did not lead to a significant improvement in quality of life. [ABSTRACT FROM AUTHOR]

To compare the immediate effects of voluntary-induced stepping response training (VSR) and DynSTABLE perturbation training (DST) on protective stepping in patients with stroke. A randomized controlled trial (registration number: TCTR20170827001) was conducted in 34 patients with chronic stroke who were randomly allocated to the VSR (n = 17) or DST (n = 17) group. The VSR group was instructed to lean forward to induce protective stepping, while the DST group experienced support surface translation. All participants received one session of training (3 set, 10 min for each set with 10-minute rest in between). Step length, step width, number of steps and center of mass (CoM) position during protective stepping were assessed using a computer-assisted rehabilitation environment (CAREN) system prior to and immediately after training. Two-way ANOVA was used to compare between groups and times. Both types of training resulted in an increase in step width, but step length increased and there was a more positive COM position exhibited following DST (p <.05) than following VSR. Single-step incidence increased, whereas multiple-step incidence decreased significantly in both groups. Only participants in the VSR group generated protective stepping with the affected leg in a larger percentage of trials (27%) after training than before training. Both DST and VSR led to changes in protective stepping parameters after a single session of training. VSR may be a feasible alternative to equipment-based training but requires further study. VSR and DST trainings improved protective stepping in stroke. Step length and CoM control at foot touchdown increased after DST training. VSR training for 50 minutes led to increase affected stepping and reduce grasping. Step width, affected step length, and single step increased after both trainings. Without instrument, VSR increased steps execution and performance similar to DST. [ABSTRACT FROM AUTHOR]

Objective: This randomized, blinded, placebo-controlled clinical trial compared the levels of interferon γ (IFN-γ), prostaglandin E2 (PGE2), and interleukin 6 (IL-6) in the gingival crevicular fluid (GCF) from generalized aggressive periodontitis (GAgP) patients treated with nonsurgical therapy associated or not with amoxicillin/metronidazole adjunctive. Method and Materials: Thirty-nine GAgP patients were followed during 6 months. The patients were randomly allocated to one of the groups: experimental (scaling and root planing plus 375 mg amoxicillin and 250 mg metronidazole for 7 days) and control (scaling and root planing + placebo). Probing pocket depth (PPD), relative clinical attachment level (rCAL), gingival margin position (GMP), and IL-6, IFN-γ, and PGE2 levels in GCF were evaluated at baseline, and at 3 and 6 months after treatment. Results: Both therapies promoted PPD reductions, rCAL gains, and recession in GMP at the end of the study, with the experimental group presenting an additional PPD reduction in fullmouth analysis and deep pockets at the 3- and 6-month follow-ups (P < .05). During the period of the study, only the experimental group promoted a reduction in PGE2 levels in deep pockets at 3 and 6 months, while IFN-γ and IL-6 levels remained unchanged. However, the differences in the immunologic parameters were not statistically significant among the groups. Conclusion: It can be concluded that amoxicillin/ metronidazole associated with nonsurgical therapy promotes an additional PPD reduction in the treatment of GAgP; however, this therapy did not promote additional benefits in the evaluated immunologic parameters. [ABSTRACT FROM AUTHOR]

Introduction. Simultaneous Bilateral Cataract Surgery (SBCS) is still a relatively controversial procedure. The main objection is the risk of bilateral endophthalmitis or bilateral refractive error. However, SBCS has also some advantages (faster visual rehabilitation, lower risk of nosocomial infection, and lower cost). Performing surgery on both eyes in one session has one additional advantage which has not yet been described in the literature (according to the information available to authors). It allows surgeons to distinguish the effect of minor differences in the surgical protocol on the subjective perception of the procedure more accurately, which is a more suitable method than comparing two independent groups of patients. Purpose. To compare the effect of minor changes in the surgical protocol during SBCS on intraindividual subjective perception of surgery (pain, pressure, glare, and perception of the duration of the surgery). Methods. During the surgery of the right and left eyes of one patient, we randomly changed one surgical parameter (use of intracameral anesthesia, light intensity of the operating microscope, type of eyelid speculum, creation of the posterior circular capsulorhexis, and communication with the patient during surgery). Patients immediately after both surgeries subjectively evaluated the perception of pain (on the scale 0–10), pressure, and glare (on the scale 0–5) and estimated the duration of the surgery, separately for each eye. Each change was evaluated in a group of 50 patients. Results. In the control group with no parameters changed, we noted no difference in subjective perception of the first and second surgery. In subgroups, where we changed the protocol, we detected only minor differences in subjective perception of pain, pressure, glare, and duration of the surgery. Only one statistically significant difference in subjective pain perception was in the subgroup where we used eye intracameral anesthesia (0.34 eyes with intracameral anesthesia, 0.44 eyes with only topical anesthesia). We did not note any statistically significant differences in the perception of the time of surgery. Conclusion. SBCS can be used to optimize the parameters of cataract surgery. In our study, we noted a positive effect of intracameral anesthesia on subjective perception of surgery. [ABSTRACT FROM AUTHOR]

Objectives: Acute coronary syndrome (ACS) is an acute disease with high mortality. Although early percutaneous coronary intervention (PCI) is proved to be the practical approach in treating ACS, the incidence of cardiovascular events is still far from satisfactory. The combination of Suxiao Jiuxin Pill (SJP) and Western medicine is one conventional approach in the treatment of ACS. Many elementary and clinical trials have proved the efficacy and safety in the improvement of cardiocerebral vascular conditions. The aim of this project is to evaluate the safety and efficacy of SJP on ACS with early PCI patients. Trial Design: This is a multicenter randomized, double-blind placebo-controlled trial. Trial registration: ChiCTR-TRC-13003053. Settings: Hospitals. Subjects: A total of 200 ACS with early PCI patients were randomly divided into SJP group (n = 100) and placebo group (n = 100). Interventions: The SJP group was treated with routine treatment and SJP (taking eight SJP pills orally each time, three times per day). The placebo group was treated with routine treatment along with equal amounts of SJP placebo. The course of treatment was 6 months and a follow-up visit at 12 months. Outcome Measures: Assessments of major adverse cardiovascular events (MACE), safety assessments, adverse events, left ventricular systolic function (LVEF), Seattle angina questionnaire (SAQ), troponin C (cTNI), C-reactive protein (CRP), fibrinogen (Fib), and cystatin C (cysC). Results: The SJP group had a relatively low incidence of MACE than the placebo (p < 0.05, odds ratio: 1.916, 95% confidence interval [0.999–3.674]). LVEF was significantly higher in the SJP group than the placebo group on the 360-day follow-up (p < 0.01). SJP had a significant increase score in the SAQ subscale of physical limitation, angina frequency, and treatment satisfaction (p < 0.05). There is no significant difference in the cTNI and CRP level between the two groups. The serum concentration of Fib and cysC in the SJP was significantly decreased compared with the placebo (p < 0.05). The numbers of adverse events between the two groups were not statistically different (p > 0.05). Conclusions: SJP is associated with a reduction in MACE, and an improvement of heart function and quality of life in ACS patients with early PCI, and is probably safe to use. [ABSTRACT FROM AUTHOR]

Background and Aim Parental acceptance is an important parameter in selecting the proper behavior management technique during pediatric dental treatment. The present study aimed to compare the effects of different informing methods on acceptance of parents about behavior management techniques used in pediatric dentistry. Methods & Materials This quasi-experimental study was conducted on one 162 parents of 3-7-year-old uncooperative children who were candidates for dental treatment. They were randomly divided into three groups. Their acceptance about six behavior management techniques including general anesthesia, voice control, hand-over-mouth, parental separation, active and passive physical restraint were assessed by a questionnaire. After determining the level of acceptance, the information about the techniques was presented through three ways include writing, verbal and visual methods. Finally, their acceptance of each technique and the reasons for non-acceptance were re-evaluated. Data were analyzed in SPSS v.23 software using ANOVA and t-test. Ethical Considerations This study obtained its ethical approval from the Research Ethics Committee of Arak University of Medical Sciences under code: IR.ARAKMU.REC.1398.102. Results The informing methods significantly increased the parents’ acceptance about behavior management techniques. According to the ANOVA results, the effect of visual presentation method in general anesthesia technique was significantly lower than that of other methods (P<0.05), while its effect in active physical restraint technique was significantly greater than that of other methods (P<0.05). There was no statistically significant difference between the effects of informing methods in other behavior management techniques. Conclusion Informing parents about pediatric behavior management techniques increase their acceptance. Informing by visual presentation is the most effective method for increasing their acceptance of physical restraint technique, while in their acceptance of general anesthesia technique other informing methods are more effective. [ABSTRACT FROM AUTHOR]

Objectives: To compare 3 mouthwashes: 0.20% chlorhexidine (CHX) with Anti‐Discoloration System (ADS), 0.20% CHX and 0.12% CHX with 0.05% cetylpyridinium chloride (CPC), in terms of reduction of plaque and gingival bleeding and side effects. Methods: Mild gingivitis patients were randomly divided into three Groups: they underwent professional oral hygiene and received instructions: oral rinse with 10 mL for 1', twice a day, 30' after tooth brushing, for 14 days. Primary outcomes were plaque and gingival bleeding, assessed with Plaque Control Record and Gingival Bleeding Index. Feedback questionnaire and spectrophotometer evaluated secondary outcomes: adverse events. Timing of the study was T0 (baseline), T1 (professional oral hygiene) and T2 (14th day after mouthwash use). Results: Sixty‐six patients were recruited, two patients dropped out, and 64 patients completed the study. PCR T1‐T2 mean variation was 30.67 (SD = 15.22; 95% CI 23.55 to 37.80; P = 0.000), 19.93 (SD = 11.03; 95% CI 14.90 to 24.95; P = 0.000) and 16.24 (SD = 15.35; 95% CI 9.60 to 22.88; P = 0.000) respectively in Groups 0.2% CHX + ADS, 0.2% CHX and 0.12% CHX + CPC. GBI mean variation (T0‐T2) was −9.82 (SD = 9.27; 95% CI −5.48 to 14.16; P = 0.000), −19.31 (SD = 11.33; 95% CI −14.15 to −24.47; P = 0.000) and −21.13 (SD = 12.56; 95% CI −15.70 to −26.56; P = 0.000) respectively in Groups 0.2% CHX + ADS, 0.2% CHX and 0.12% CHX + CPC. Statistical significance was found in lower efficacy of 0.2% CHX + ADS Group. Patients tolerated 0.12% CHX + CPC mouthwash better in bleeding perception (95.5%; P = 0.046), burning sensation (13.6%; P = 0.006), and mouthwash taste (100%; P = 0.000). Results on staining were no statistically significant (P = 0.106). Conclusions: Addition of CPC allows reduction of CHX percentage in mouthwash formulation while keeping equal efficacy and less side effects. ADS addition decreases CHX efficacy in reducing plaque and bleeding, while resulting more tolerated than CHX. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acupuncture in patients with vascular cognitive impairment no dementia (VCIND) in comparison with citicoline, an agent for cognitive disturbances associated with chronic cerebral disorders. Design: A randomized controlled multicenter trial. Setting: In three hospitals in Beijing, China. Subjects: A total of 216 patients with VCIND were recruited. Interventions: Patients with VCIND (mean age of 65.4 years) were randomized to receive acupuncture (two sessions per week) or oral citicoline (100 mg three times daily) over three months. Main measures: The primary outcome was the change from baseline to three months in cognitive symptom, measured by Alzheimer's disease Assessment Scale, cognitive subscale (ADAS-cog). Secondary outcomes included changes from baseline to six months in ADAS-cog, executive function measured by the Clock Drawing Test (CDT), and functional disability measured by the Ability of Daily Living (ADL) scale at three and six months. Results: At three months, the acupuncture group had a greater decrease in mean ADAS-cog score (−2.33 ± 0.31) than the citicoline group (−1.38 ± 0.34) with a mean difference of −0.95 (95% CI, −1.84 to −0.07, P = 0.035). The mean change from baseline to six months in ADAS-cog also significantly favored acupuncture treatments (acupuncture change −2.61 vs citicoline −1.25, difference: −1.36 points; 95% CI, −2.20 to −0.51; P = 0.002). There was no difference between the two groups on CDT and ADL scores at either time point. Conclusion: Compared with citicoline, acupuncture has comparable and even superior efficacy with improved cognitive and daily living performance as a complementary and alternative medicine treatment for VCIND. [ABSTRACT FROM AUTHOR]

Objective: To determine the short-term effects of supplying hospital inpatients with earplugs and eye masks, preparatory to a full-scale trial. Design: A single-centre, open-label, two-arm, parallel group, randomized-controlled trial. Setting: A total of 13 medical and surgical wards in a large teaching hospital in the United Kingdom. Participants: Everyone admitted to hospital aged 18 years or older, who stayed overnight and had the mental capacity and sufficient understanding of English to give consent, the ability to complete the study questionnaire and the ability to use earplugs and eye masks unaided was considered. Interventions: The intervention group was provided with earplugs and eye masks for use the following night, and the control group received standard care. Main measures: Sleep quality assessed using the SleepSure questionnaire after the first night of using the intervention, use of earplugs and eye masks, number of falls throughout their inpatient stay, use of zopiclone during inpatient stay, length of stay and recruitment rate. Results: A total of 1600 patients were admitted; out of which, 626 (39%) were eligible and 206 (13% total, 33% eligible) recruited (intervention group, 109). The intervention group's mean sleep quality score was 6.33 (95% confidence interval (CI): 5.89–6.77), compared with 5.09 (95% CI: 4.66–5.52) in the control group (p < 0.001). There were no differences in use of zopiclone, falls or length of stay between the groups. Of the intervention group, 91 (86%) reported using the earplugs and/or eye masks. Conclusions: The intervention seems feasible, and effective, but trial eligibility rate and rate of recruitment into the study were limited. [ABSTRACT FROM AUTHOR]

Objective: The UK's Initial Operational Response (IOR) is a new process for improving the survival of multiple casualties following a chemical, biological, radiological or nuclear incident. Whilst the introduction of IOR represents a patient-focused response for ambulant casualties, there is currently no provision for disrobe and dry decontamination of nonambulant casualties. Moreover, the current specialist operational response (SOR) protocol for nonambulant casualty decontamination (also referred to as "clinical decontamination") has not been subject to rigorous evaluation or development. Therefore, the aim of this study was to confirm the effectiveness of putatively optimized dry (IOR) and wet (SOR) protocols for nonambulant decontamination in human volunteers. Methods: Dry and wet decontamination protocols were objectively evaluated using human volunteers. Decontamination effectiveness was quantified by liquid chromatography-mass spectrometry analysis of the recovery of a chemical warfare agent simulant (methylsalicylate) from skin and hair of volunteers, with whole-body fluorescence imaging to quantify the skin distribution of residual simulant. Results: Both the dry and wet decontamination processes were rapid (3 and 4 min, respectively) and were effective in removing simulant from the hair and skin of volunteers, with no observable adverse effects related to skin surface spreading of contaminant. Conclusions: Further studies are required to assess the combined effectiveness of dry and wet decontamination under more realistic conditions and to develop appropriate operational procedures that ensure the safety of first responders. [ABSTRACT FROM AUTHOR]

ABSTRACT Background In intensive care units ( ICUs), patients cannot sleep well. Aromatherapy is used for depression, anxiety, relaxation and disorders related with sleep and stress. Aim This study aimed to investigate the effect of lavender essential oil on the sleep quality and anxiety level of patients in coronary ICU. Participants A total of 60 patients in coronary ICU participated in this study. Design A randomized controlled study was conducted with 60 patients in a province located in the southeast of Turkey. Methods After informing the patients in both groups about the study, they were administered a questionnaire, Pittsburgh Sleep Quality Index ( PSQI) and the Beck Anxiety Inventory ( BAI) scale. The patients in the intervention group were given 2% lavender essential oil via inhalation for 15 days after which they were administered the same scales again to evaluate the sleep quality and anxiety. As for the control group, they were administered the same scales again after 15 days without the inhalation of lavender essential oil. Results Comparison of the PSQI and BAI scores of the patients in the control and intervention groups before and after the intervention showed statistically significant differences in the change in favour of the intervention group ( p < 0·05). Conclusion Lavender essential oil increased quality of sleep and reduced level of anxiety in patients with coronary artery disease. Relevance to clinical practice As a non-invasive, cheap, easily applicable, cost-effective, independent nursing intervention and appropriate for cardiac patients, lavender essential oil could be applied in ICUs. [ABSTRACT FROM AUTHOR]

Background/Objectives: Higher fibre intakes are associated with risk reduction for chronic diseases. However, many people find difficulty in consuming sufficient fibre through their diet. Supplements may be an effective alternative. We aimed to investigate the effects of PolyGlycopleX® (PGX®), a proprietary polysaccharide complex and a proprietary Psyllium product (PgxSyl™) (PSY) on diet, body weight and composition in overweight and obese individuals. Subjects/Methods: This was a double-blind 52 weeks study with 159 people randomized to 3 groups: control (rice flour); PGX (PGX) and proprietary psyllium (PSY). Participants did not change any of their usual habits or diet except they consumed 5 g of supplement taken with a total of 500 ml of water 5-10 min before meals. Results: Weight was significantly lower in the PGX group compared to control at 3 (-1.6 kg [0.57, 2.67, p = 0.003]), 6(-2.6 kg [1.01, 4.13, p = 0.001]) and 12 months (-2.6 kg [0.59, 4.64, p = 0.012]) and in the PSY group compared to control group at 3 (-1.1 kg [0.07, 2.12, = 0.037]) and 6 months (-2.4 kg [0.95, 3.93, p = 0.002]). This was a difference of - 2.8% for the PGX group and - 1.5% for the PSY group compared to control after 12 months supplementation. Body Fat was significantly lower in PGX compared to control at 6 (-1.8 kg [0.63, 2.95, p = 0.003]) and 12 months (-1.9 kg [0.43, 3.36, p = 0.012]) and in PSY compared to control at 6 (-1.9 kg [0.84, 3.04, p = 0.001]) and 12 months (-1.4 kg [0.08, 2.71, p = 0.038]). Conclusions: PGX was better than PSY at maintaining dietary changes and weight loss over the 12 month intervention period, with no change to exercise. A simple strategy of PGX supplementation may offer an effective solution to long-term weight-loss and then management without the need for other nutrient modification. [ABSTRACT FROM AUTHOR]

Objective: To verify effects of kinesio taping (KT) in shoulder subacromial impingement syndrome (SIS) when compared to sham taping applied in the same way with KT. Patients and Methods: Patients were randomized as group 1 (n = 21) KT group and group 2 (n = 20) sham-taping group. Taping was applied every three days, three times during the study period. We assessed all the patients at baseline, at the end of the taping period (12th day), and at one-month post-intervention. We assessed pain on the 100 mm visual analog scale (VAS). Shoulder range of motion (ROM), Constant Scores, and Nottingham Health Profile (NHP) scores were evaluated. Results: Of the 41 participants, 13 were males (32%) and 28 were females (68%). The mean age was 45 ± 15 years (range 20–65 years). We documented a significant decrease in VAS for nocturnal pain, and Constant Score in both groups. The KT group showed additional significant change in NHP pain and physical activity scores. Conclusion: KT and sham taping generated similar results regarding pain and Constant Scores. [ABSTRACT FROM AUTHOR]

Aim. To compare a gel made with chamomile (Chamomilla recutita) with a cream of urea as an intervention to delay the time to occurrence of radiation dermatitis. Background. Radiation dermatitis is one of the most common adverse effects of radiotherapy in patients with head and neck cancer. It is characterized by erythema, itching, pain, skin breakage and burning sensation, and there is no consensus on how to prevent it. Design. The study is a randomized controlled clinical trial. Methods. We will recruit 48 individuals with head and neck cancer who will be starting their radiotherapy and randomize them to receive either gel of chamomile or cream of urea, as an intervention for prevention of radiation dermatitis. Social-demographic data will be collected at baseline, and clinical data will be collected before the initiation of radiotherapy. Participants will be followed weekly to assess development of radiation dermatitis. The protocol is funded by Conselho Nacional de Pesquisa e Desenvolvimento Cientıfico (Brazil). The study was approved by a research ethics committee. Discussion. Given the clinical relevance of preventing radiation dermatitis and the lack of evidence supporting specific preventive interventions, it is important to study new products that might be efficacious to prevent this complication. This article presents the protocol of a randomized controlled trial comparing a gel made with chamomile (intervention) with a cream of urea (control) to prevent radiation dermatitis in patients with head and neck cancer undergoing radiotherapy. [ABSTRACT FROM AUTHOR]

Objectives. To determine the effect of sodium (Na) reduction on occurrence of headaches. Methods. In the Trial of Nonpharmacologic Interventions in the Elderly, 975 men and woman (aged 60-80 years) with hypertension were randomized to a Na-reduction intervention or control group and were followed for up to 36 months. The study was conducted between 1992 and 1995 at 4 clinical centers (Johns Hopkins University, Wake Forest University School of Medicine, Robert Wood Johnson Medical School, and the University of Tennessee). Results. Mean difference in Na excretion between the Na-reduction intervention and control group was significant at each follow-up visit (P < .001) with an average difference of 38.8 millimoles per 24 hours. The occurrence of headaches was significantly lower in the Na-reduction intervention group (10.5%) compared with control (14.3%) with a hazard ratio of 0.59 (95% confidence interval = 0.40, 0.88; P = .009). The risk of headaches was significantly associated with average level of Na excretion during follow-up, independent of most recent blood pressure. The relationship appeared to be nonlinear with a spline relationship and a knot at 150 millimoles per 24 hours. Conclusions. Reduced sodium intake, currently recommended for blood pressure control,may also reduce the occurrence of headaches in older persons with hypertension. [ABSTRACT FROM AUTHOR]

Depression is a potentially life threatening affective disorder that is highly prevalent in individuals with autism spectrum disorders (ASD). This study aimed to evaluate the feasibility, acceptability and preliminary efficacy of a cognitive behavioural intervention for depression in adolescents with ASD. Participants were randomly assigned to the intervention group, or wait-list control group. Although recruitment was extremely difficult, attendance was favourable and attrition was low, and participants reported being satisfied with the programme. No significant treatment effect was revealed on the Beck Depression Inventory or Emotion Regulation Questionnaire. However despite the small sample size ( n = 20), there was a trending treatment effect measured by the Depression Anxiety Stress Scale: Depression Subscale. Limitations and areas of future research are discussed. [ABSTRACT FROM AUTHOR]

ABSTRACT Background Endotracheal suctioning has been identified as a painful procedure for critically ill patients. Aim To determine the effect of music therapy on pain intensity, sedation level and physiological parameters during endotracheal suctioning of mechanically ventilated patients in cardiovascular surgery intensive care unit (ICU). Design Experimental survey. Methods The study was conducted between May 2010 and June 2013 in Ordu Medical Park Hospital Cardiovascular Surgery Intensive Care Unit. The study sample consisted of 66 patients (33 experimental and 33 control) who complied with the criteria of inclusion for the study. Data was collected using the 'Patient Information Form', 'Critical-Care Pain Observation Tool', 'Ramsay Sedation Scale' and 'Form of Physiological Parameters'. Results The mean scores of the Ramsay Sedation Scale during endotracheal aspiration were respectively 1·88 and 1·55 in the experimental and control group and the difference between the groups was statistically significant ( p = 0·003). The mean score of Critical-Care Pain Observation Tool during endotracheal suctioning in the experimental group was found to be lower statistically than those of the control group ( p < 0·001). There were no significant differences before, during and 20 min after suctioning between the two groups with regard to systolic blood pressure, diastolic blood pressure, heart rate and oxygen saturation ( p > 0·05). Conclusions The results of this study implies that music therapy can be effective practice for nurses attempting to reduce patients' pain and control sedation level in patients on mechanical ventilators during endotracheal suctioning. Relevance to clinical practice It is recommended that music therapy should be added to the routine nursing care for mechanically ventilated patients. [ABSTRACT FROM AUTHOR]

Background: Fluid restriction (FR) in persons with heart failure (HF) is often prescribed, yet self-regulation and the troublesome symptom of thirst are difficult for patients to manage. Aims: The purpose of this pilot study was to test an educational and behavioral intervention (EBI) on adherence with prescribed FR and outcome measures of fluid congestion, symptom distress, and health related quality of life (HRQL). Secondary aims were to describe the relationships between self-reported and objectively measured determinants of fluid status and symptoms, and assess the psychometric properties of piloted instruments, and intervention effect sizes. Methods: NYHA Class II-IV (n=25, 44-83 years, 56% male, 20% minority, mean EF 23.0+11.7%) participants were randomized to the EBI or attention control (AC) and evaluated at baseline, 3 and 6 months. Results: EBI patients trended toward decreasing fluid ingestion (p=0.08), experienced less HF symptom frequency (p=0.13) and severity (p=0.06), and increased symptoms of thirst (p<0.01) across time. Whereas HRQL remained stable in the EBI group, it improved in the AC group over time (p=0.01). There were no significant differences in clinical measures of fluid congestion between groups. Conclusions: These outcomes suggest that patients receiving the EBI drank slightly less fluid, experienced less typical HF symptoms, greater thirst distress and stable HRQOL. Moderate to large effect sizes for the measures used were observed, and outcomes suggest that a randomized trial of various levels of FR would not potentiate fluid congestion but should specifically address preservation of HRQOL and thirst symptoms. [ABSTRACT FROM AUTHOR]

Substantial evidence links antenatal depression, anxiety and stress with negative effects on foetal development, resulting in enduring problems in child development. Despite this, there is a paucity of research on intervention programmes designed to address depression and anxiety, and none that include infant outcomes. We aimed to evaluate the efficacy of a brief treatment for maternal depression and anxiety in pregnancy in a sample of women with a diagnosed depressive disorder. We developed a cognitive behavioural therapy treatment for antenatal depression and anxiety and evaluated it in a feasibility trial. This was followed by a pilot randomised controlled trial (RCT) which collected data on the efficacy of the brief intervention and follow-up data on infants. The feasibility study ( n = 25) yielded promising results for adherence, acceptability and improvements in depression and anxiety (Beck Depression Inventory and Beck Anxiety Inventory). The RCT ( n = 54) again showed excellent adherence and acceptability and supported the efficacy of the treatment. Strong reductions in anxiety were observed during pregnancy, and improvements in depression were maintained at 9 months representing a moderately large effect size. Nine-month infant outcomes showed several medium to large effects favouring the intervention in domains including problem solving, self-regulation and stress reactivity, which were independent of maternal postnatal mood. Treating severe depression and anxiety during pregnancy with a brief cognitive behavioural therapy (CBT) intervention appears feasible and worthwhile. To reliably detect clinically meaningful effects on infant outcomes, larger RCTs are likely to be required. [ABSTRACT FROM AUTHOR]

Objectives:Behavioral and psychological symptoms of dementia (BPSD) cause significant stress and distress to both aged-care residents and staff. This study evaluated a training program to assist staff to manage BPSD in residential care. Method:A randomised controlled trial (RCT) was employed. The study was included in the Australian and New Zealand Clinical Trial Register residential care facilities. Staff (n= 204) and residents (n= 187) were from 16 residential care facilities. Facilities were recruited and randomly assigned to four staff training conditions: (1) training in the use of a BPSD-structured clinical protocol, plus external clinical support, (2) a workshop on BPSD, plus external clinical support, (3) training in the use of the structured clinical protocol alone, and (4) care as usual. Staff and resident outcome measures were obtained pre-intervention, three months and six months post-intervention. The primary outcome was changes in BPSD, measured using the Cohen-Mansfield Agitation Inventory (CMAI) as well as frequency and duration of challenging behaviors. Secondary outcomes were changes in staff adjustment. Results:There were improvements in challenging behaviors for both intervention conditions that included training in the BPSD instrument, but these were not maintained in the condition without clinical support. The training/support condition resulted in sustained improvements in both staff and resident variables, whereas the other conditions only led to improvement in some of the measured variables. Conclusion:These results demonstrate the effectiveness of the BPSD protocol in reducing BPSD and improving staff self-efficacy and stress. [ABSTRACT FROM AUTHOR]

Background: Diabetes is becoming a very important health issue in rapidly developing nations and there is an urgent need to improve overall diabetes self-management education in these countries. Although e-health is an emerging theme, only a few successful web-based studies on diabetes self-management have been reported. Purpose: We describe the development, implementation, and process evaluation of an Internet-delivered dietary intervention program ( myDIDeA) for diabetic patients in a developing country. Method: Specific dietary components to be included in the intervention module were first identified through a comprehensive review of literature and guidelines. The lesson plans and the study website were then developed based on the evidence, Transtheoretical Model's Stages of Change and user-centered design approach. Finally, the effectiveness of the website was tested through a randomized-controlled trial to promote dietary change in patients with type 2 diabetes. The participants in the intervention group ( n = 66) were given access to myDIDeA for 6 months. Process evaluation in form of intervention adherence and program reception were conducted at post intervention. Results: The response rate for the process evaluation was 89 %. On average, each participant logged in at least once for each lesson plan and spent almost 12 min on the site. The participants' content satisfaction, acceptability, and usability scores were satisfactory. The primary outcome of the trial, Dietary Knowledge, Attitude, and Behavior score was strongly correlated with content satisfaction ( r = 0.826, p < 0.001), acceptability ( r = 0.793, p < 0.001) and usability of the website ( r = 0.724, p < 0.001), and moderately correlated with frequency of log-in ( r = 0.501, p < 0.05) and duration spent in the website ( r = 0.399, p < 0.05). Conclusion: The process evaluation of myDIDeA demonstrates its feasibility, and future studies should identify the possibility of extending the use of Internet-based intervention programs to other health behaviors and issues related to self-management of chronic conditions. In addition, interactivity, peer support via social media, and other means to stimulate the interest of participants can be explored. [ABSTRACT FROM AUTHOR]

Aims To assess the relations of menthol cigarette use with measures of cessation success in a large comparative effectiveness trial ( CET). Design Participants were randomized to one of six medication treatment conditions in a randomized double-blind, placebo-controlled clinical trial. All participants received six individual counseling sessions. Setting Community-based smokers in two communities in Wisconsin, USA. Participants A total of 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. The analysis sample comprised 1439 participants: 814 white non-menthol smokers, 439 white menthol smokers and 186 African American ( AA) menthol smokers. There were too few AA non-menthol smokers ( n = 16) to be included in the analyses. Interventions Nicotine lozenge, nicotine patch, bupropion sustained release, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge and placebo. Measurements Biochemically confirmed 7-day point-prevalence abstinence assessed at 4, 8 and 26 weeks post-quit. Findings In longitudinal abstinence analyses (generalized estimating equations) controlling for cessation treatment, menthol smoking was associated with reduced likelihood of smoking cessation success relative to non-menthol smoking [model-based estimates of abstinence = 31 versus 38%, respectively; odds ratio ( OR) = 0.71, 95% confidence interval ( CI) = 0.59, 0.86]. In addition, among menthol smokers, AA women were at especially high risk of cessation failure relative to white women (estimated abstinence = 17 versus 35%, respectively; OR = 2.63, 95% CI = 1.75, 3.96; estimated abstinence rates for AA males and white males were both 30%, OR = 1.06, 95% CI = 0.60, 1.66). Conclusion In the United States, smoking menthol cigarettes appears to be associated with reduced cessation success compared with non-menthol smoking, especially in African American females. [ABSTRACT FROM AUTHOR]

Background and purpose -- Even small design modifications of uncemented hip stems may alter the postoperative 3-D migration pattern. The Furlong Active is an uncemented femoral stem which, in terms of design, is based on its precursor--the well-proven Furlong HAC--but has undergone several design changes. The collar has been removed on the Active stem along with the lateral fin; it is shorter and has more rounded edges in the proximal part. We compared the migration patterns of the uncemented Furlong HAC stem and the modified Furlong Active stem in a randomized, controlled trial over 5 years using radiostereometry (RSA). Patients and methods -- 50 patients with primary osteoarthritis were randomized to receive either the HAC stem or the Active stem. The patients underwent repeated RSA examinations (postoperatively, at 3 months, and after 1,2, and 5 years) and conventional radiography, and they also filled out hip-specific questionnaires. Results -- During the first 3 months, the collarless Active stem subsided to a greater extent than the collar-fitted HAC stem (0.99 mm vs. 0.31 mm, p = 0.05). There were, however, no other differences in movement measured by RSA or in clinical outcome between the 2 stems. After 3 months, both stem types had stabilized and almost no further migration was seen. Interpretation -- The Active stem showed no signs of unfavorable migration. Our results suggest that the osseointegration is not compromised by the new design features. [ABSTRACT FROM AUTHOR]

Background. Plantar heel pain can be managed with dry needling of myofascial trigger points; however, there is only poor-quality evidence supporting its use. Objective. The purpose of this study was to evaluate the effectiveness of dry needling for plantar heel pain. Design. The study was a parallel-group, participant-blinded, randomized controlled trial. Setting. The study was conducted in a university health sciences clinic. Patients. Study participants were 84 patients with plantar heel pain of at least 1 month’s duration. Intervention. Participants were randomly assigned to receive real or sham trigger point dry needling. The intervention consisted of 1 treatment per week for 6 weeks. Participants were followed for 12 weeks. Measurements . Primary outcome measures included first-step pain, as measured with a visual analog scale (VAS), and foot pain, as measured with the pain subscale of the Foot Health Status Questionnaire (FHSQ). The primary end point for predicting the effectiveness of dry needling for plantar heel pain was 6 weeks. Results. At the primary end point, significant effects favored real dry needling over sham dry needling for pain (adjusted mean difference: VAS first-step pain= -14.4 mm, 95% confidence interval [95% CI] = -23.5 to -5.2; FHSQ foot pain= 10.0 points, 95% CI=1.0 to 19-1), although the between-group difference was lower than the minimal important difference. The number needed to treat at 6 weeks was 4 (95% CI=2 to 12). The frequency of minor transitory adverse events was significantly greater in the real dry needling group (70 real dry needling appointments [32%] compared with only 1 sham dry needling appointment [<1%]). Limitations. It was not possible to blind the therapist. Conclusion. Dry needling provided statistically significant reductions in plantar heel pain, but the magnitude of this effect should be considered against the frequency of minor transitory adverse events. [ABSTRACT FROM AUTHOR]

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Objective:This study investigated improvements in quality of life associated with eight weeks of montelukast and/or intranasal steroid treatment for moderate to severe allergic rhinitis.Methods:A single-centre, prospective, randomised, double-blind, placebo-controlled study was carried out. Assessments were made using the Rhinoconjunctivitis Quality of Life Questionnaire and symptom scales.Results:A total of 128 patients (aged 13–51 years) were randomly assigned to one of two groups. In the montelukast group, patients were treated with montelukast tablets and fluticasone propionate nasal spray (n = 64). In the placebo group, treatment comprised a placebo and fluticasone propionate. The results showed significant improvements in symptom scores and quality of life scores for both groups after one month and two months of treatment, compared with baseline values; these improvements were significantly greater for the montelukast group compared with the placebo group. The mean number of loratadine tablets taken by each patient during the study period was only 0.73 for the montelukast group compared with 9 for the placebo group.Conclusion:The combination of montelukast tablets and fluticasone propionate nasal spray improved symptom control and overall quality of life for moderate to severe allergic rhinitis patients. [ABSTRACT FROM PUBLISHER]

BackgroundMajor depressive disorder (MDD) and generalized anxiety disorder (GAD) have the highest co-morbidity rates within the internalizing disorders cluster, yet no Internet-based cognitive behavioural therapy (iCBT) programme exists for their combined treatment.MethodWe designed a six-lesson therapist-assisted iCBT programme for mixed anxiety and depression. Study 1 was a randomized controlled trial (RCT) comparing the iCBT programme (n = 46) versus wait-list control (WLC; n = 53) for patients diagnosed by structured clinical interview with MDD, GAD or co-morbid GAD/MDD. Primary outcome measures were the Patient Health Questionnaire nine-item scale (depression), Generalized Anxiety Disorder seven-item scale (generalized anxiety), Kessler 10-item Psychological Distress scale (distress) and 12-item World Health Organization Disability Assessment Schedule II (disability). The iCBT group was followed up at 3 months post-treatment. In study 2, we investigated the adherence to, and efficacy of the same programme in a primary care setting, where patients (n = 136) completed the programme under the supervision of primary care clinicians.ResultsThe RCT showed that the iCBT programme was more effective than WLC, with large within- and between-groups effect sizes found (>0.8). Adherence was also high (89%), and gains were maintained at 3-month follow-up. In study 2 in primary care, adherence to the iCBT programme was low (41%), yet effect sizes were large (>0.8). Of the non-completers, 30% experienced benefit.ConclusionsTogether, the results show that iCBT is effective and adherence is high in research settings, but there is a problem of adherence when translated into the ‘real world’. Future efforts need to be placed on developing improved adherence to iCBT in primary care settings. [ABSTRACT FROM PUBLISHER]

A diet rich in fibre seems to protect against the metabolic syndrome (MetS), but there is scarce information about the role of fibre intake in patients with the MetS and diabetes. The aim of the present study was to evaluate the effects of soluble fibre from partially hydrolysed guar gum (PHGG) on the MetS and cardiovascular risk factors in patients with type 2 diabetes. In the present randomised controlled clinical trial, forty-four patients with type 2 diabetes (males 38·6 %, age 62 (SD 9) years, diabetes duration 14·2 (SD 9·6) years) and the MetS underwent clinical, laboratory and dietary evaluations at baseline, 4 and 6 weeks. All patients followed their usual diet and the intervention group (n 23) received an additional 10 g/d of PHGG. In the intervention group, waist circumference (WC), glycated Hb (HbA1c), 24 h urinary albumin excretion (UAE) and serum trans-fatty acids (FA) were reduced in comparison with baseline after 4 and 6 weeks: WC 103·5 (SD 9·5) to 102·1 (SD 10) to 102·3 (SD 9·7) cm; HbA1c 6·88 (SD 0·99) to 6·64 (SD 0·94) to 6·57 (SD 0·84) %; 24 h UAE 6·8 (interquartile range 3·0–17·5) to 4·5 (interquartile range 3·0–10·5) to 6·2 (interquartile range 3·0–9·5) mg; trans-FA 71 (interquartile range 46–137) to 67 (interquartile range 48–98) to 57 (interquartile range 30–110) mg/l (P<0·05 for all). The only change in the control group was weight reduction: 77·0 (SD 13·5) to 76·2 (SD 13·3) to 76·1 (SD 13·4) kg (P=0·005). Other MetS components (blood pressure, TAG, HDL-cholesterol, fasting plasma glucose), total and LDL-cholesterol, C-reactive protein and endothelin-1 did not change in either group. In patients with type 2 diabetes and the MetS, the addition of PHGG to the usual diet improved cardiovascular and metabolic profiles by reducing WC, HbA1c, UAE and trans-FA. [ABSTRACT FROM AUTHOR]

Background Little is known about interventions to help men and their partners cope with the after effects of prostate cancer treatment. The lack of in-depth descriptions of the intervention content is hindering the identification of which intervention (or component of an intervention) works. Aim To describe the development and evaluation of the content of a self-management psychosocial intervention for men with prostate cancer and their partners. Design A feasibility randomized controlled trial including structure, process, and outcome analysis. Methods This 9-week intervention commences on completion of treatment and consists of three group and two telephone sessions. The intervention focuses on symptom management, sexual dysfunction, uncertainty management, positive thinking and couple communication. Forty-eight couples will be assigned to either the intervention or a control group receiving usual care. Participants will be assessed at baseline, immediately postintervention and at 1 and 6 months postintervention. Outcome measures for patients and caregivers include self-efficacy, quality of life, symptom distress, uncertainty, benefits of illness, health behaviour, and measures of couple communication and support. An additional caregiver assessment will be completed by the partner. Discussion The main purpose of this feasibility study is to investigate the acceptability of the CONNECT programme to men with prostate cancer and their partners and to gain feedback from the participants and facilitators to make changes to and enhance the programme. Reasons why men do not want to participate will be collated to enhance recruitment in the future. We will also test recruitment strategies, randomization procedures, and the acceptability of the questionnaires. Ethical approval granted December 2010. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to evaluate the effectiveness of specially processed cereal (SPC) as a suitable adjunctive treatment for Meniere's disease. Methods: We performed a randomized double-blinded, placebo-controlled, crossover study in a tertiary referral center of patients who had a diagnosis of Meniere's disease based on the guidelines of the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery ( AAO-HNS). The main outcome measure was the AAO-HNS Functional Level Scale (FLS). Results: Thirty-nine patients completed the study without any reported complications. The mean pretreatment FLS score for the entire study cohort was 3.8 (median, 4; range, 1 to 6). The overall FLS score improved significantly (p < 0.001 ), to 2.8 (median, 3), after SPC treatment. No patients showed worsening on the FLS during SPC or placebo treatment. Of the 39 patients, 23 showed improvement on the FLS, and no change was observed in the remaining 16. The median improvement on the FLS in these 23 patients was 2 points (mean, 1.7; range, 1 to 4). The mean FLS score after placebo cereal treatment was not significantly different from baseline (p = 0.452), but was significantly higher than that after SPC treatment (mean, 3.7; p < 0.001). The marginal difference observed between the baseline FLS score and the placebo FLS score was due to the fact that 5 patients reported 1 -point improvements on the FLS after placebo treatment. Nevertheless, significantly fewer patients improved on placebo than on SPC (p < 0.001). Conclusions: Treatment with SPC appears to be well tolerated by most patients (91%) without any complications. More than half (59%) of the study cohort reported subjective improvement in functional level. [ABSTRACT FROM AUTHOR]

Background. Interpersonal psychotherapy (IPT) seems to be as effective as cognitive behavioral therapy (CBT) in the treatment of major depression. Because the onset of panic attacks is often related to increased interpersonal life stress, IPT has the potential to also treat panic disorder. To date, a preliminary open trial yielded promising results but there have been no randomized controlled trials directly comparing CBT and IPT for panic disorder. Method. This study aimed to directly compare the effects of CBT versus IPT for the treatment of panic disorder with agoraphobia. Ninety-one adult patients with a primary diagnosis of DSM-III or DSM-1V panic disorder with agoraphobia were randomized. Primary outcomes were panic attack frequency and an idiosyncratic behavioral test. Secondary outcomes were panic and agoraphobia severity, panic-related cognitions, interpersonal functioning and general psychopathology. Measures were taken at 0, 3 and 4 months (baseline, end of treatment and follow-up). Results. Intention-to-treat (ITT) analyses on the primary outcomes indicated superior effects for CBT in treating panic disorder with agoraphobia. Per-protocol analyses emphasized the differences between treatments and yielded larger effect sizes. Reductions in the secondary outcomes were equal for both treatments, except for agoraphobic complaints and behavior and the credibility ratings of negative interpretations of bodily sensations, all of which decreased more in CBT. Conclusions. CBT is the preferred treatment for panic disorder with agoraphobia compared to IPT. Mechanisms of change should be investigated further, along with long-term outcomes. [ABSTRACT FROM AUTHOR]

The study was conducted to examine the relative effectiveness of cognitive behavior therapy with a cultural tailoring intervention compared to brief medication management. The study used a two-arm randomized controlled trial in which participant assignment was stratified by gender. The intervention condition received eight weekly 40-min individualized counseling sessions of culturally tailored cognitive behavior therapy, while the control condition received eight weekly 10-min individualized counseling sessions of medication management. Both conditions received nicotine patches for 8 weeks. Data were collected at baseline and at four follow-up points (one and 4 weeks, and three and 6 months post-quit). Treatment outcomes were presented as an intention-to-treat analysis. Thirty Korean immigrants participated in the study. At 6-month follow-up, 57.1% of participants in the intervention and 18.8% of participants in the control had 7-day point prevalence abstinence (odds ratio = 5.8, 95% confidence interval = 1.12-26.04, P = 0.04). Participants' self-reported abstinence was biochemically verified with exhaled carbon monoxide and salivary cotinine levels. A combination of the culturally tailored cognitive behavior therapy and nicotine replacement therapy had a better treatment outcome compared to brief medication management. The promising result suggests a need to further test the intervention in larger samples and longer follow-up assessments before it can be adapted in clinical settings. [ABSTRACT FROM AUTHOR]

Background: Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) - a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study. Methods: 78 men aged 25-50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator's Global assessment and Subjects' opinion. Results: In subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P < 0.0001). Similar results were observed in each of the remaining four domains of the IIEF (orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P < 0.001. Thirty-five out of 39 (90%) subjects from the VXP group and one (3%) from the placebo group wished to continue with the treatment they received. Investigator's global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject's rating for tolerability of treatment was similar in both groups. Conclusions: VigRX Plus was well tolerated and more effective than placebo in improving sexual function in men. [ABSTRACT FROM AUTHOR]