Randomized controlled trials of herbal interventions underreport important details of the intervention

Objective

To examine the quality of reporting and predictors of reporting in randomized clinical trials (RCTs) of herbal medicine interventions.

Study Design and Setting

We searched Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, and Academy of Microscope Enhanced Dentistry up to December 2007 for any English language RCT of 11 commonly used herbal medicine interventions. Two individuals separately and independently assessed all trials using the Consolidated Standards of Reporting Trials (CONSORT) checklist for herbal medicines interventions. We randomly selected 100 of these trials, extracted a set of potential predictor variables identified through a literature search and consultation with experts, and performed a conceptually driven stepwise elimination regression analyses for predictor variables.

Results

The 406 trials reported on average 38% of the information suggested in the checklist. Regression analyses revealed better overall reporting in trials with a participant flow diagram (P = 0.008), those of Panax quinquefolius (P = 0.018), and those published in more recent years (P = 0.02).

Conclusion

Our results indicate that RCTs of herbal medicine interventions frequently do not report important characteristics of the intervention. Trialists should refer to the CONSORT for herbal medicines when reporting their trials.     

Infections in children with down syndrome and acute myeloid leukemia: a report from the Canadian infections in AML research group

Background

Children with Down syndrome (DS) are at high risk of infectious toxicity when treated with acute lymphoblastic leukemia chemotherapy protocols optimized in children without DS. Our objective was to determine if children with DS and acute myeloid leukemia (AML) have a different risk of infection when treated with chemotherapy protocols developed for children with DS compared to AML treatment protocols developed for children without DS.

Methods

We conducted a retrospective, population-based cohort study that included DS children?≤?18 years of age with de novo, non-M3 AML diagnosed between January 1995 and December 2004, and treated at 15 Canadian centers. Patients were monitored for infection from initiation of AML treatment until recovery from the last cycle of chemotherapy, conditioning for hematopoietic stem cell transplantation, relapse, persistent disease or death (whichever occurred first). Trained research associates abstracted all information from each site.

Results

There were 31 children with DS included; median age was 1.7 (range 0.1-11.1) years. Eleven were treated according to a DS-specific protocol while 20 were treated with non-DS specific protocols. A total of 157 courses of chemotherapy were delivered. Microbiologically documented sterile site infection occurred in 11.9% and 14.3% of DS-specific and non-DS specific AML treatment courses respectively. Sepsis was rare and there were no infection-related deaths. In multiple regression, treatment with a DS-specific protocol was independently associated with a reduction in microbiologically documented sterile site infection (adjusted odds ratio (OR) 0.65, 95% confidence interval (CI) 0.42-0.99; P?=?0.044), and clinically documented infection (adjusted OR 0.36, 95% CI 0.14-0.91; P?=?0.031) but not bacteremia (adjusted OR 0.73, 95% CI 0.44-1.22; P?=?0.231).

Conclusions

Our study suggests that children with DS do not experience excessive infectious toxicity during treatment for AML compared to children without DS. Incorporation of DS-specific AML treatment protocols is associated with a more favorable infection profile for children with DS-AML.

     

Determinants of quality of life in children with chronic somatic disease: pilot data from the GapS Questionnaire

Purpose

Quality of life (QoL) is a ubiquitous yet poorly defined concept; the precise determinants of QoL are rarely identified. We used pilot data from the GapS Questionnaire to investigate the most important determinants of QoL in children with chronic somatic illness.

Methods

We enrolled 92 participants including 60 parents and 32 of their children. The sample comprised rheumatology, diabetes, epilepsy, gastroenterology, cystic fibrosis, and day unit patients. Trained interviewers administered the GapS Questionnaire to parents, and to children if ≥10 years. We determined the relative importance of different items for QoL.

Results

Child participants had a mean age of 14.7 years. Children identified “having good friendships”, “being happy most days”, and “getting along with parents” as most important. Parents ranked most highly “being allowed to do all the things you like doing”, “getting told you have done a good job at something”, and “being physically able to do everything you enjoy doing”.

Conclusions

Physical health items were not as important as social and psychological determinants of QoL in our pilot sample.     

INAUGURAL ARTICLE by a Recently Elected Academy Member:The characteristics and chronology of the earliest Acheulean at Konso,Ethiopia

The Acheulean technological tradition, characterized by a large (>10 cm) flake-based component, represents a significant technological advance over the Oldowan. Although stone tool assemblages attributed to the Acheulean have been reported from as early as circa 1.6–1.75 Ma, the characteristics of these earliest occurrences and comparisons with later assemblages have not been reported in detail. Here, we provide a newly established chronometric calibration for the Acheulean assemblages of the Konso Formation, southern Ethiopia, which span the time period ∼1.75 to <1.0 Ma. The earliest Konso Acheulean is chronologically indistinguishable from the assemblage recently published as the world’s earliest with an age of ∼1.75 Ma at Kokiselei, west of Lake Turkana, Kenya. This Konso assemblage is characterized by a combination of large picks and crude bifaces/unifaces made predominantly on large flake blanks. An increase in the number of flake scars was observed within the Konso Formation handaxe assemblages through time, but this was less so with picks. The Konso evidence suggests that both picks and handaxes were essential components of the Acheulean from its initial stages and that the two probably differed in function. The temporal refinement seen, especially in the handaxe forms at Konso, implies enhanced function through time, perhaps in processing carcasses with long and stable cutting edges. The documentation of the earliest Acheulean at ∼1.75 Ma in both northern Kenya and southern Ethiopia suggests that behavioral novelties were being established in a regional scale at that time, paralleling the emergence of Homo erectus-like hominid morphology.     

The impact of a small-scale irrigation scheme on malaria transmission in Ziway area, Central Ethiopia

Objective To assess the impact of a small‐scale irrigation scheme in Ziway area, a semi‐arid area in the Central Ethiopian Rift Valley, on malaria transmission. Method Parasitological, entomological and socio‐economic studies were conducted in a village with and a village without irrigation. Blood smear samples were taken from individuals during the dry and wet seasons of 2005/2006. Socio‐economic data were collected from household heads and key agricultural and health informants through interviews and questionnaires. Larval and adult mosquitoes were sampled during the dry and short wet seasons of 2006. Female anopheline mosquitoes were tested by enzyme‐linked immunosorbent assay for blood meal sources and sporozoite infections. Results Malaria prevalence was higher in the irrigated village (19%, P < 0.05) than the non‐irrigated village (16%). In the irrigated village, malaria prevalence was higher in the dry season than in the wet season while the reverse occurred in the non‐irrigated village. Households with access to irrigation had larger farm land sizes and higher incomes, but also higher prevalence of malaria. Larval and adult abundance of the malaria vectors, Anopheles arabiensis and Anopheles pharoensis, was higher in the irrigated than in the non‐irrigated village throughout the study period. Furthermore, the abundance of An. pharoensis was significantly higher than that of An. arabiensis during the dry irrigated period of the year. Canal leakage pools, irrigated fields and irrigation canals were the major breeding habitats of the two vector mosquitoes. Plasmodium falciparum sporozoite infection rates of 1.18% and 0.66% were determined for An. arabiensis and An. pharoensis in the irrigated village. Peak biting activities of the vectors occurred before 22:00 h, which is a source of concern that the effectiveness of ITNs may be compromised as the mosquitoes feed on blood before people go to bed. Conclusion Irrigation schemes along the Ethiopian Rift Valley may intensify malaria by increasing the level of prevalence during the dry season. To reduce the intensity of malaria transmission in the small‐scale irrigation schemes currently in operation in Ethiopia, year‐round source reduction by using proper irrigation water management, coupled with health education, needs to be incorporated into the existing malaria control strategies.     

Sero-prevalence of brucellosis in occupationally exposed people in Addis Ababa, Ethiopia

OBJECTIVE: Brucellosis is a Zoonosis, recognized worldwide as a serious public health hazard and economically significant disease. The etiologic agent of this disease is a bacterial species of the genus Brucella that causes undulant fever, sterility and other systemic illnesses in human. Thus, the aim of this study was to undertake seroepidemiological study of brucellosis on occupationally exposed persons in Addis Ababa abattoirs enterprise and different dairy farms. METHODS: Three hundred thirty six human individuals were screened using Rose Bengal Plate Test (RBPT) and the sera were further subjected to 2- Mercapto Ethanol Test (2-MET). Simultaneously, survey was conducted in farms and slaughterhouse to investigate epidemiological factors. RESULTS: An overall seroprevalence rate of 4.8% (16/336) was determined by taking RBPT+/2MET+ as confirmatory test (P < 0.05). Some of the risk factors contributing to the occurrence of the disease include occupation, gender, and unsafe handling of infected materials. Raw milk and meat consumption, lack of awareness and use of detergents were also found as important factors. CONCLUSION: The seroprevalence of brucellosis is expected to be more in other areas of the Region, where there is high human-animal contact and high number of cattle population with a respective traditional system of animal rearing.     

Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review

Context  Developers of health care software have attributed improvements in patient care to these applications. As with any health care intervention, such claims require confirmation in clinical trials. Objectives  To review controlled trials assessing the effects of computerized clinical decision support systems (CDSSs) and to identify study characteristics predicting benefit. Data Sources  We updated our earlier reviews by searching the MEDLINE, EMBASE, Cochrane Library, Inspec, and ISI databases and consulting reference lists through September 2004. Authors of 64 primary studies confirmed data or provided additional information. Study Selection  We included randomized and nonrandomized controlled trials that evaluated the effect of a CDSS compared with care provided without a CDSS on practitioner performance or patient outcomes. Data Extraction  Teams of 2 reviewers independently abstracted data on methods, setting, CDSS and patient characteristics, and outcomes. Data Synthesis  One hundred studies met our inclusion criteria. The number and methodologic quality of studies improved over time. The CDSS improved practitioner performance in 62 (64%) of the 97 studies assessing this outcome, including 4 (40%) of 10 diagnostic systems, 16 (76%) of 21 reminder systems, 23 (62%) of 37 disease management systems, and 19 (66%) of 29 drug-dosing or prescribing systems. Fifty-two trials assessed 1 or more patient outcomes, of which 7 trials (13%) reported improvements. Improved practitioner performance was associated with CDSSs that automatically prompted users compared with requiring users to activate the system (success in 73% of trials vs 47%; P = .02) and studies in which the authors also developed the CDSS software compared with studies in which the authors were not the developers (74% success vs 28%; respectively, P = .001). Conclusions  Many CDSSs improve practitioner performance. To date, the effects on patient outcomes remain understudied and, when studied, inconsistent.