Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK.

OBJECTIVES: To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. DESIGN: Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. SETTING: 2 private herbal practices in the UK. PARTICIPANTS: 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. INTERVENTION: 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. MAIN OUTCOME MEASURES: Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. RESULTS: Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. CONCLUSIONS: A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control. TRIAL REGISTRATION NUMBER: ISRCTN 31072075; Results.

Depression and anxiety in ovarian cancer: a systematic review and meta-analysis of prevalence rates.

OBJECTIVES: To systematically review the literature pertaining to the prevalence of depression and anxiety in patients with ovarian cancer as a function of treatment stage. DESIGN: Systematic review and meta-analysis. PARTICIPANTS: 3623 patients with ovarian cancer from primary research investigations. PRIMARY OUTCOME MEASURE: The prevalence of depression and anxiety in patients with ovarian cancer as a function of treatment stage. RESULTS: We identified 24 full journal articles that met the inclusion criteria for entry into the meta-analysis resulting in a pooled sample size of 3623 patients. The meta-analysis of prevalence rates identified pretreatment, on-treatment and post-treatment depression prevalences of 25.34% (CI 22.79% to 28.07%), 22.99% (CI 19.85% to 26.46%) and 12.71% (CI 10.14% to 15.79%), respectively. Pretreatment, on-treatment and post-treatment anxiety prevalences were 19.12% (CI 17.11% to 21.30%), 26.23% (CI 22.30% to 30.56%) and 27.09% (CI 23.10% to 31.49%). CONCLUSIONS: Our findings suggest that the prevalence of depression and anxiety in women with ovarian cancer, across the treatment spectrum, is significantly greater than in the healthy female population. With the growing emphasis on improving the management of survivorship and quality of life, we conclude that further research is warranted to ensure psychological distress in ovarian cancer is not underdiagnosed and undertreated.

A quantitative analysis of the prevalence of clinical depression and anxiety in patients with prostate cancer undergoing active surveillance.

OBJECTIVE: To quantitatively determine the prevalence of anxiety and depression in men on active surveillance (AS). DESIGN: Cross-sectional questionnaire survey. SETTING: Secondary care prostate cancer (PCa) clinics across South, Central and Western England. PARTICIPANTS: 313 men from a total sample of 426 with a histological diagnosis of PCa currently managed with AS were identified from seven UK urology departments. The mean age of respondents was 70 (51-86) years with the majority (76%) being married or in civil partnerships. 94% of responders were of white British ethnicity. PRIMARY OUTCOME MEASURES: The prevalence of clinically meaningful depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS; score ≥8/21). SECONDARY OUTCOME MEASURES: Patient demographic data (age, employment, relationship, ethnic and educational status). Each demographic variable was cross-tabulated against patients identified as depressed or anxious to allow for the identification of variables that were significantly associated with depression and anxiety. In order to determine predictors for depression and anxiety among the demographic variables, logistic regression analyses were conducted, with p<0.05 considered as indicating statistical significance. RESULTS: The prevalence of clinical anxiety and depression as determined via the HADS (HADS ≥8) was 23% (n=73) and 12.5% (n=39), respectively. Published data from men in the general population of similar age has shown prevalence rates of 8% and 6%, respectively, indicating a twofold increase in depression and a threefold increase in anxiety among AS patients. Our findings also suggest that AS patients experience substantially greater levels of anxiety than patients with PCa treated radically. The only demographic predictor for anxiety or depression was divorce. CONCLUSIONS: Patients with PCa managed with AS experienced substantially higher rates of anxiety and depression than that expected in the general population. Strategies to address this are needed to improve the management of this population and their quality of life.

Psychological covariates of longitudinal changes in back-related disability in patients undergoing acupuncture.

OBJECTIVES: To identify psychological covariates of longitudinal changes in back-related disability in patients undergoing acupuncture. MATERIALS AND METHODS: A longitudinal postal questionnaire study was conducted with data collection at baseline (pretreatment), 2 weeks, 3, and 6 months later. A total of 485 patients were recruited from 83 acupuncturists before commencing acupuncture for back pain. Questionnaires measured variables from 4 theories (fear-avoidance model, common-sense model, expectancy theory, social-cognitive theory), clinical and sociodemographic characteristics, and disability. Longitudinal multilevel models were constructed with disability over time as the outcome. RESULTS: Within individuals, reductions in disability (compared with the person's individual mean) were associated with reductions in: fear-avoidance beliefs about physical activity (ß=0.11, P<0.01) and work (ß=0.03, P<0.05), catastrophizing (ß=0.28, P<0.05), consequences (ß=0.28, P<0.01), concerns (ß=0.17, P<0.05), emotions (ß=0.16, P<0.05), and pain identity (ß=0.43, P<0.01). Within-person reductions in disability were associated with increases in: personal control (ß=-0.17, P<0.01), comprehension (ß=-0.11, P<0.05) and self-efficacy for coping (ß=-0.04, P<0.01). Between individuals, people who were less disabled had weaker fear-avoidance beliefs about physical activity (ß=0.12, P<0.01), had more self-efficacy for coping (ß=-0.07, P<0.01), perceived less severe consequences of back pain (ß=0.87, P<0.01), had more positive outcome expectancies (ß=-0.30, P<0.05), and appraised acupuncture appointments as less convenient (ß=0.92, P<0.05). DISCUSSION: Illness perceptions and, to a lesser extent, self-efficacy and expectancies can usefully supplement variables from the fear-avoidance model in theorizing pain-related disability. Positive changes in patients' beliefs about back pain might underpin the large nonspecific effects of acupuncture seen in trials and could be targeted clinically.

Mindfulness for the self-management of fatigue, anxiety, and depression in women with metastatic breast cancer: a mixed methods feasibility study.

The impact of living with metastatic breast cancer (MBC) is considerable and psychosocial support can be beneficial. Mindfulness-based stress reduction (MBSR) can help self-management of anxiety, depression, quality of life (QoL), and fatigue and has been evaluated in early-stage breast cancer but not MBC. This study investigated the acceptability and feasibility of providing MBSR for women with MBC and of introducing MBSR into a National Health Service (NHS) setting. A mixed methods convergent design was used. Eligible women with MBC, an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2, stable disease, and life expectancy of at least 6 months were invited to attend (by their oncologist) an 8-week MBSR course. Qualitative interviews with patients, a focus group, and interview with NHS staff were held to explore acceptability and feasibility of MBSR. Questionnaires at baseline, during (weeks 4, 8), and after (weeks 16, 24) the course measured fatigue, anxiety and depression, mindfulness, disease-specific QoL, and generic preference based QoL. Of 100 women approached, 20 joined the study. One woman dropped out prior to the intervention due to illness progression. Nineteen women took part in 3 MBSR courses. Recruitment to 2 of the 3 courses was slow. Commitment to 8 weeks was a reason for non-participation, and proved challenging to participants during the course. Participants found the course acceptable and reported many cumulative and ongoing benefits. These included feeling less reactive to emotional distress and more accepting of the disruption to life that occurs with living with MBC. There was high attendance, completion of course sessions, adherence to home practice, excellent follow-up rates, and high questionnaire return rates. MBSR was acceptable to MBC patients, who perceived benefits such as improved anxiety and QoL; but the MBSR course requires a considerable time commitment. There is scope to tailor the intervention so that it is less intensive.

Depression and anxiety in prostate cancer: a systematic review and meta-analysis of prevalence rates.

OBJECTIVES: To systematically review the literature pertaining to the prevalence of depression and anxiety in patients with prostate cancer as a function of treatment stage. DESIGN: Systematic review and meta-analysis. PARTICIPANTS: 4494 patients with prostate cancer from primary research investigations. PRIMARY OUTCOME MEASURE: The prevalence of clinical depression and anxiety in patients with prostate cancer as a function of treatment stage. RESULTS: We identified 27 full journal articles that met the inclusion criteria for entry into the meta-analysis resulting in a pooled sample size of 4494 patients. The meta-analysis of prevalence rates identified pretreatment, on-treatment and post-treatment depression prevalences of 17.27% (95% CI 15.06% to 19.72%), 14.70% (95% CI 11.92% to 17.99%) and 18.44% (95% CI 15.18% to 22.22%), respectively. Pretreatment, on-treatment and post-treatment anxiety prevalences were 27.04% (95% CI 24.26% to 30.01%), 15.09% (95% CI 12.15% to 18.60%) and 18.49% (95% CI 13.81% to 24.31%), respectively. CONCLUSIONS: Our findings suggest that the prevalence of depression and anxiety in men with prostate cancer, across the treatment spectrum, is relatively high. In light of the growing emphasis placed on cancer survivorship, we consider that further research within this area is warranted to ensure that psychological distress in patients with prostate cancer is not underdiagnosed and undertreated.

Manipulative therapies for infantile colic.

BACKGROUND: Infantile colic is a common disorder, affecting around one in six families, and in 2001 was reported to cost the UK National Health Service in excess of £65 million per year (Morris 2001). Although it usually remits by six months of age, there is some evidence of longer-term sequelae for both children and parents.Manipulative therapies, such as chiropractic and osteopathy, have been suggested as interventions to reduce the severity of symptoms. OBJECTIVES: To evaluate the results of studies designed to address efficacy or effectiveness of manipulative therapies (specifically, chiropractic, osteopathy and cranial manipulation) for infantile colic in infants less than six months of age. SEARCH METHODS: We searched following databases: CENTRAL (2012, Issue 4), MEDLINE (1948 to April Week 3 2012), EMBASE (1980 to 2012 Week 17), CINAHL (1938 to April 2012), PsycINFO (1806 to April 2012), Science Citation Index (1970 to April 2012), Social Science Citation Index (1970 to April 2012), Conference Proceedings Citation Index - Science (1990 to April 2012) and Conference Proceedings Citation Index - Social Science & Humanities (1970 to April 2012). We also searched all available years of LILACS, PEDro, ZETOC, WorldCat, TROVE, DART-Europe, ClinicalTrials.gov and ICTRP (May 2012), and contacted over 90 chiropractic and osteopathic institutions around the world. In addition, we searched CentreWatch, NRR Archive and UKCRN in December 2010. SELECTION CRITERIA: Randomised trials evaluating the effect of chiropractic, osteopathy or cranial osteopathy alone or in conjunction with other interventions for the treatment of infantile colic. DATA COLLECTION AND ANALYSIS: In pairs, five of the review authors (a) assessed the eligibility of studies against the inclusion criteria, (b) extracted data from the included studies and (c) assessed the risk of bias for all included studies. Each article or study was assessed independently by two review authors. One review author entered the data into Review Manager software and the team's statistician (PP) reviewed the chosen analytical settings. MAIN RESULTS: We identified six studies for inclusion in our review, representing a total of 325 infants. There were three further studies that we could not find information about and we identified three other ongoing studies. Of the six included studies, five were suggestive of a beneficial effect and one found no evidence that manipulative therapies had any beneficial effect on the natural course of infantile colic. Tests for heterogeneity imply that there may be some underlying difference between this study and the other five.Five studies measured daily hours of crying and these data were combined, suggesting that manipulative therapies had a significant effect on infant colic - reducing average crying time by one hour and 12 minutes per day (mean difference (MD) -1.20; 95% confidence interval (CI) -1.89 to -0.51). This conclusion is sustained even when considering only studies with a low risk of selection bias (sequence generation and allocation concealment) (MD -1.24; 95% CI -2.16 to -0.33); those with a low risk of attrition bias (MD -1.95; 95% CI -2.96 to -0.94), or only those studies that have been published in the peer-reviewed literature (MD -1.01; 95% CI -1.78 to -0.24). However, when combining only those studies with a low risk of performance bias (parental 'blinding'), the improvement in daily crying hours was not statistically significant (MD -0.57; 95% CI -2.24 to 1.09).One study considered whether the reduction in crying time was clinically significant. This found that a greater proportion of parents of infants receiving a manipulative therapy reported clinically significant improvements than did parents of those receiving no treatment (reduction in crying to less than two hours: odds ratio (OR) 6.33; 95% CI 1.54 to 26.00; more than 30% reduction in crying: OR 3.70; 95% CI 1.15 to 11.86).Analysis of data from three studies that measured 'full recovery' from colic as reported by parents found that manipulative therapies did not result in significantly higher proportions of parents reporting recovery (OR 11.12; 95% CI 0.46 to 267.52).One study measured infant sleeping time and found manipulative therapy resulted in statistically significant improvement (MD 1.17; 95% CI 0.22 to 2.12).The quality of the studies was variable. There was a generally low risk of selection bias but only two of the six studies were evaluated as being at low risk of performance bias, three at low risk of detection bias and one at low risk of attrition bias.One of the studies recorded adverse events and none were encountered. However, with only a sample of 325 infants, we have too few data to reach any definitive conclusions about safety. AUTHORS' CONCLUSIONS: The studies included in this meta-analysis were generally small and methodologically prone to bias, which makes it impossible to arrive at a definitive conclusion about the effectiveness of manipulative therapies for infantile colic.The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not, based on contemporaneous crying diaries, and this difference was statistically significant. The trials also indicate that a greater proportion of those parents reported improvements that were clinically significant. However, most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias, the results did not reach statistical significance. Further research is required where those assessing the treatment outcomes do not know whether or not the infant has received a manipulative therapy.There are inadequate data to reach any definitive conclusions about the safety of these interventions.

A systematic literature review of complementary and alternative medicine prevalence in EU.

BACKGROUND: Studies suggest that complementary and alternative medicine (CAM) is widely used in the European Union (EU). We systematically reviewed data, reporting research quality and the prevalence of CAM use by citizens in Europe; what it is used for, and why. METHODS: We searched for general population surveys of CAM use by using Ovid MEDLINE (1948 to September 2010), Cochrane Library (1989 to September 2010), CINAHL (1989 to September 2010), EMBASE (1980 to September 2010), PsychINFO including PsychARTICLES (1989 to September 2010), Web of Science (1989 to September 2010), AMED (1985 to September 2010), and CISCOM (1989 to September 2010). Additional studies were identified through experts and grey literature. Cross-sectional, population-based or cohort studies reporting CAM use in any EU language were included. Data were extracted and reviewed by 2 authors using a pre-designed extraction protocol with quality assessment instrument. RESULTS: 87 studies were included. Inter-rater reliability was good (kappa = 0.8). Study methodology and quality of reporting were poor. The prevalence of CAM use varied widely within and across EU countries (0.3-86%). Prevalence data demonstrated substantial heterogeneity unrelated to report quality; therefore, we were unable to pool data for meta-analysis; our report is narrative and based on descriptive statistics. Herbal medicine was most commonly reported. CAM users were mainly women. The most common reason for use was dissatisfaction with conventional care; CAM was widely used for musculoskeletal problems. CONCLUSION: CAM prevalence across the EU is problematic to estimate because studies are generally poor and heterogeneous. A consistent definition of CAM, a core set of CAMs with country-specific variations and a standardised reporting strategy to enhance the accuracy of data pooling would improve reporting quality.

Does needling sensation (de qi) affect treatment outcome in pain? Analysis of data from a larger single-blind, randomised controlled trial.

BACKGROUND: Insertion of an acupuncture needle into an acupuncture point typically generates a range of sensations called 'de qi'. Most acupuncturists are taught that obtaining de qi is important when treating patients with pain but this can be quite uncomfortable for patients. OBJECTIVE: This study assesses the importance of the strength of de qi, on the clinical outcome in osteoarthritic pain. METHOD: This study was part of a larger randomised, single-blind, multifactorial trial involving three interventions: real acupuncture (RA), Streitberger needle (SN) and mock electrical stimulation for the treatment of patients with osteoarthritis (OA) of the hip and knee. Patients were treated twice a week for 4 weeks. The two outcomes relevant to this study were pain reduction assessed by visual analogue scale and the Park needling sensation questionnaire, both measured at completion of the study. Two arms of the trial were analysed (RA and SN). Reduction in pain was correlated against strength of de qi for both RA and SN. Those who felt de qi were compared with those who did not. RESULTS: 147 patients were recruited to the study (140 completed) with a mean pain reduction of 15.2 mm and mean de qi score of 6.2. There was no significant correlation between the strength of de qi and improvement in pain (p=0.49). There was also no significant difference in pain relief (p=0.52) between those who felt de qi and those who did not using the de qi subscale of the Park questionnaire. CONCLUSION: These data suggest that the presence and intensity of de qi has no effect on the pain relief obtained for patients with OA. This result may have implications for both acupuncture treatment and for future trial methodology.

Prevalence of complementary medicine use in pediatric cancer: a systematic review.

CONTEXT: Complementary and alternative medicine (CAM) is used by pediatric patients with cancer, but the actual frequency of CAM use is undetermined. OBJECTIVE: In this systematic review we summarize the current evidence on the prevalence of CAM use in pediatric patients with cancer and assess the reported quality of included studies. METHODS: We systematically searched 6 major electronic databases, reference lists of existing reviews, and personal files. We included full articles about primary research studies (without language restriction) that reported the prevalence of CAM use if all or a defined subsample of participants were pediatric patients with cancer. Detailed information regarding methods and results was extracted from the original articles. A quality-assessment tool was rigorously developed on the basis of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and used to assess reported study quality. Formal tests of interrater agreement were conducted. RESULTS: We included 28 studies with survey data (collected from 1975 to 2005) from 3526 children. In 20 studies with 2871 participants, the prevalence of any CAM use (since cancer diagnosis) ranged from 6% to 91%; considerable heterogeneity across studies precluded meta-analysis. Study quality was mixed and not correlated with CAM prevalence. Herbal remedies were the most popular CAM modality, followed by diets/nutrition and faith-healing. Commonly reported reasons for CAM use included to help cure or fight the child's cancer, symptomatic relief, and support of ongoing use of conventional therapy. There was little evidence of an association between CAM use and patients' sociodemographic characteristics. CONCLUSIONS: Many pediatric patients with cancer use CAM. It is important that pediatricians be aware of this fact and encourage open communication with patients and their parents. Using standardized survey methods and CAM definitions in future studies could improve their quality and help generate comparable data. Our quality-assessment tool could prove valuable for other reviews of prevalence studies.

Psychiatric aftercare and suicide risk: a case-control study using blind rating.

Blindly abstracted records of last episode of care together with aftercare records of 39 psychiatric patient suicides and their matched controls were rated blind for suicidal talk during aftercare, reduction of aftercare at last appointment and high-low suicide risk. Neither suicidal talk nor reduction of aftercare was confirmed as a predictor of suicide, although trends in the predicted directions were observed. Blind estimates of high-low risk correctly identified a significant minority (40%) of suicides but at the cost of misclassifying 60% as controls. Evidence is still lacking that clinicians blind to case identity may, from records, reliably distinguish a majority of suicides from their matched controls. Some implications for practice and research are discussed.

Elevation of Candida IgG antibodies in patients with medically unexplained symptoms.

BACKGROUND: The hypothesis that an immunologic reaction to Candida yeasts, present in the gastrointestinal tract, causes a diffuse collection of multisystem symptoms is not generally accepted within conventional medicine. A questionnaire, the Fungus Related Disease Questionnaire (FRDQ-7), was previously developed and used to identify patients for a randomized, placebo-controlled trial of the nonabsorbed antifungal drug nystatin. Nystatin was superior to placebo in relieving these symptoms. This provides some support for the hypotheses that underpin the "Candida syndrome". AIM: The aim of this study was to identify a population with a high (>9) FRDQ-7 score and symptom-free controls and, subsequently, to explore the relationship between FRDQ-7 scores and Candida immunoglobulin (Ig)A, IgG, and IgM levels. DESIGN: This was a case-controlled study. METHODS: Santelmann has suggested that the FRDQ-7 describes people with Candida syndrome if the FRDQ-7 score is >9; 35 patients with medically unexplained symptoms, between ages 18 and 64, were selected for the study if they scored > 9 on the FRDQ-7 questionnaire. Serum Candida IgA, IgG, and IgM measurements were undertaken both for this group and a group of 45 healthy age- and gender-matched controls, and the Ig concentrations were compared. RESULTS: Candida IgG concentration was significantly higher in the noncontrol group than in the control group (p < 0.001). No significant difference was found for Candida IgA or IgM concentrations. CONCLUSIONS: Further studies are required to identify whether there is a causal link for the elevation of serum IgG found in this subgroup of patients with increased FRDQ-7 scores, or whether these two observations are parallel manifestations of a common underlying disorder.

Do skin prick and conjunctival provocation tests predict symptom severity in seasonal allergic rhinoconjunctivitis?

BACKGROUND: In the investigation of seasonal allergic rhinoconjunctivitis (SAR), quantitative skin and conjunctival allergen challenge tests are used to measure individual allergen sensitivity. These tests are reproducible and relate well to prevalence but their relationship to symptom severity is less well established. OBJECTIVE: We wished to determine if quantitative skin prick tests (QSPT) and conjunctival provocation tests (CPTs) using a single grass pollen allergen extract are reproducible and predict symptom severity in SAR. METHODS: We retrospectively analysed data from 91 participants in a previously published randomized placebo controlled study of low dosage allergen immunotherapy who were randomized to receive placebo treatment. We examined the relationship between pre-seasonal QSPT, CPT and SAR symptoms. RESULTS: We found a high level of reproducibility when repeated measures were compared for both the QSPT (P < 0.001) and the CPT (P < 0.001) and moderate correlation (0.49) between the standard skin prick test (SPT) and the QSPT (P < 0.001). We found weak negative correlation (-0.27) between the QSPT and the CPT (P < 0.001). We found no correlation between seasonal symptom, use of rescue medication or quality of life (QOL) scores and pre-seasonal QSPT or CPT. Conclusion In the assessment of seasonal rhinoconjunctivitis, quantitative skin and conjunctival allergen challenge tests are strongly reproducible, although there is no correlation between these tests and seasonal symptom, use of rescue medication or QOL scores.

A non-invasive method for in situ quantification of subpopulation behaviour in mixed cell culture.

Ongoing advances in quantitative molecular- and cellular-biology highlight the need for correspondingly quantitative methods in tissue-biology, in which the presence and activity of specific cell-subpopulations can be assessed in situ. However, many experimental techniques disturb the natural tissue balance, making it difficult to draw realistic conclusions concerning in situ cell behaviour. In this study, we present a widely applicable and minimally invasive method which combines fluorescence cell labelling, retrospective image analysis and mathematical data processing to detect the presence and activity of cell subpopulations, using adhesion patterns in STRO-1 immunoselected human mesenchymal populations and the homogeneous osteoblast-like MG63 continuous cell line as an illustration. Adhesion is considered on tissue culture plastic and fibronectin surfaces, using cell area as a readily obtainable and individual cell specific measure of spreading. The underlying statistical distributions of cell areas are investigated and mappings between distributions are examined using a combination of graphical and non-parametric statistical methods. We show that activity can be quantified in subpopulations as small as 1% by cell number, and outline behaviour of significant subpopulations in both STRO-1+/- fractions. This method has considerable potential to understand in situ cell behaviour and thus has wide applicability, for example in developmental biology and tissue engineering.

A single-blinded, randomized pilot study evaluating the aroma of Lavandula augustifolia as a treatment for mild insomnia.

BACKGROUND: Insomnia is the most common of all sleep complaints and is under-researched. The current treatments of choice are conventional hypnotics agents, but these have potential for serious adverse reactions. Uncontrolled and anecdotal evidence suggests that lavender oil is an effective treatment for insomnia, but this has not been formally investigated. OBJECTIVES: The aims of this study were to evaluate the proposed trial methodology and the efficacy of Lavandula augustifolia (lavender) on insomnia. INTERVENTIONS: INTERVENTIONS consisted of Lavandula augustifolia (treatment) and sweet almond oil as placebo/control. The aroma was supplied via an Aromastream device (Tisserand Aromatherapy, Sussex, UK). DESIGN: This was a pilot study with randomized, single-blind, cross-over design (baseline, two treatment periods, and a washout period, each of 1 week duration). SUBJECTS AND SETTING: Volunteers with defined insomnia treated on a domiciliary basis participated in the study. OUTCOME MEASURES: Outcomes were assessed with the following: Pittsburgh Sleep Quality Index (PSQI) indicating insomnia (score > 5 at entry); Borkovec and Nau (B&N) Questionnaire evaluating treatment credibility; and Holistic Complementary and Alternative Medicine Questionnaire (HCAMQ) assessing attitudes to CAM and health beliefs. RESULTS: Ten (10) volunteers (5 male and 5 female) were entered and completed the 4 week study. Lavender created an improvement of -2.5 points in PSQI (p = 0.07, 95% CI - 4.95 to - 0.4). Each intervention was equally credible and belief in CAM did not predict outcome. Women and younger volunteers with a milder insomnia improved more than others. No period or carry-over effect was observed. CONCLUSION: The methodology for this pilot study appeared to be appropriate. Outcomes favor lavender, and a larger trial is required to draw definitive conclusions.

Can a standardized acupuncture technique palliate disabling breathlessness: a single-blind, placebo-controlled crossover study.

STUDY OBJECTIVES: The management of disabling breathlessness is poor, and a standardized form of acupuncture has been reported as offering benefit. This study was designed to evaluate the efficacy of standardized acupuncture treatment. DESIGN: A single-blind, randomized, crossover study. SETTING: This study was carried out on a domiciliary basis in Southampton (UK). INTERVENTIONS: This study evaluated a standardized acupuncture technique vs an appropriately validated placebo/control (mock transcutaneous electrical nerve stimulation [TENS]) for disabling, nonmalignant breathlessness (largely COPD). The acupuncture was provided by an appropriately trained nurse acupuncturist. Each patient received six treatments in each phase of the study, with an intervening 2-week washout period. MEASUREMENTS AND RESULTS: The primary outcome was worst breathlessness (visual analog scale, 0 to 100 mm), with the sample size based on an 80% power to detect a 10-mm difference between treatment means. Secondary outcomes included the St George's respiratory questionnaire score and treatment credibility. RESULTS: Thirty-six patients were entered into the study (33 with COPD), and 24 patients completed both treatment phases. The primary outcome improved significantly during the course of the study, but there were no significant treatment differences between acupuncture and the placebo/control of mock TENS for either primary or secondary outcomes. The placebo was shown to be a credible control. There was no evidence of a carryover effect from the first to second phase of the study. CONCLUSION: This standardized acupuncture technique does not show specific efficacy in disabling nonmalignant breathlessness, but those entered into the study did experience clinically significant benefit from both treatments.

Can suicides be identified from case records? A case control study using blind rating.

A majority of case control studies of suicide risks in psychiatric patients reveal an excess of risk factors in cases. None of the case control studies has been conducted blind to case identity. The present study examined the possibility that skilled clinicians could identify suicides blind from case records of last episode of care. Records of 39 suicides of psychiatric patients and their matched controls (N = 78) were abstracted blind and dichotomously rated for suicide by seven raters. Success in identification of cases approximated to chance expectation. Pending replication, these disappointing findings call in question the clinical utility of risk factor findings to date, their validity as a basis for significant change in service provision and the medico-legal significance of records in suicide-related civil law suits.

Enzyme potentiated desensitisation in treatment of seasonal allergic rhinitis: double blind randomised controlled study.

OBJECTIVE: To assess the efficacy of enzyme potentiated desensitisation in the treatment of severe summer hay fever poorly controlled by pharmacotherapy. DESIGN: Double blind randomised placebo controlled parallel group study. SETTING: Hospital in Hampshire. PARTICIPANTS: 183 participants aged between 18 and 64 with a history of severe summer hay fever for at least two years; all were skin prick test positive to timothy grass pollen. 90 randomised to active treatment; 93 randomised to placebo. INTERVENTIONS: Active treatment: two injections of enzyme potentiated desensitisation, given between eight and 11 weeks apart, each comprising 200 Fishman units of beta glucuronidase, 50 pg 1,3-cyclohexanediol, 50 ng protamine sulphate, and a mixed inhaled allergen extract (pollen mixes for trees, grasses, and weeds; allergenic fungal spores; cat and dog danders; dust and storage mites) in a total volume of 0.05 ml of buffered saline. Placebo: two injections of 0.05 ml buffered saline solution. MAIN OUTCOME MEASURES: Proportion of problem-free days; global rhinoconjunctivitis quality of life scores assessed weekly during pollen season. RESULTS: The active treatment group and the placebo group did not differ in the proportion of problem-free days, quality of life scores, symptom severity scores, change in quantitative skin prick provocation threshold, or change in conjunctival provocation threshold. No clinically significant adverse reactions occurred. CONCLUSIONS: Enzyme potentiated desensitisation showed no treatment effect in this study.