Development and evaluation of an instrument for the critical appraisal of randomized controlled trials of natural products

<p>Abstract</p> <p>Background</p> <p>The efficacy of natural products (NPs) is being evaluated using randomized controlled trials (RCTs) with increasing frequency, yet a search of the literature did not identify a widely accepted critical appraisal instrument developed specifically for use with NPs. The purpose of this project was to develop and evaluate a critical appraisal instrument that is sufficiently rigorous to be used in evaluating RCTs of conventional medicines, and also has a section specific for use with single entity NPs, including herbs and natural sourced chemicals.</p> <p>Methods</p> <p>Three phases of the project included: 1) using experts and a Delphi process to reach consensus on a list of items essential in describing the identity of an NP; 2) compiling a list of non-NP items important for evaluating the quality of an RCT using systematic review methodology to identify published instruments and then compiling item categories that were part of a validated instrument and/or had empirical evidence to support their inclusion and 3) conducting a field test to compare the new instrument to a published instrument for usefulness in evaluating the quality of 3 RCTs of a NP and in applying results to practice.</p> <p>Results</p> <p>Two Delphi rounds resulted in a list of 15 items essential in describing NPs. Seventeen item categories fitting inclusion criteria were identified from published instruments for conventional medicines. The new assessment instrument was assembled based on content of the two lists and the addition of a Reviewer's Conclusion section. The field test of the new instrument showed good criterion validity. Participants found it useful in translating evidence from RCTs to practice.</p> <p>Conclusion</p> <p>A new instrument for the critical appraisal of RCTs of NPs was developed and tested. The instrument is distinct from other available assessment instruments for RCTs of NPs in its systematic development and validation. The instrument is ready to be used by pharmacy students, health care practitioners and academics and will continue to be refined as required.</p

Initial assessment of recharge areas for large karst springs: a case study from the central Zagros Mountains, Iran

Sousan Spring emerges from the Keyno Anticline, Zagros Mountains (Iran), and the mean annual discharge is ~24 m3 /s. Geological and hydrochemical evaluations suggest that the spring recharge is from the limestone Ilam-Sarvak Formation (Cretaceous) but the Mafaroon Fault, a major thrust feature, influences the regional groundwater flow path by juxtaposing other strata. Geological, geochemical, stable isotope and water balance studies were employed to interpret this behavior. Using the isotope data, the sources and elevations of the recharge area were found. Temporal variations of the isotopic data were compared with variations of electrical conductivity (EC). Unexpectedly, high EC was associated with a relative increase of discharge and depletion of δ18O. Several hypotheses were investigated and approximate water balance studies employed for validation. It was found that an elongated catchment on the Keyno Anticline plus a lesser catchment on a pair of parallel anticlines recharge the aquifer. While the long groundwater flow path along the Keyno Anticline plus guidance by Mafaroon Fault and the adjacent Garou shaly strata lead to increased EC in the Sousan Spring at the end of the dry season, a flow pulse from two adjoining anticlines (Mahalbakh and Shirgoon) arrives at the same time to increase the discharge and deplete the δ18O signal. Apparently the spring did not experience true base flow conditions during the recorded hydrological year. Although the spring response to specific precipitation events was similar to typical karst aquifers, standard interpretation of recession curves and related coefficients will not be practical at Sousan