RESUMO
BACKGROUND: Constipation is known as a common adverse effect of antipsychotics. Advice for its management remains inadequate. This study is designed to investigate the efficacy and safety of electro-acupuncture (EA) for antipsychotic-related constipation. METHODS: This is a single-centric, parallel-group, randomized controlled trial with blinded participants, outcome assessor, and statistician. One hundred twelve participants will be randomly assigned into the EA group or sham acupuncture (SA) group in a 1:1 ratio. The study will last for 22 weeks for each participant, including a 2-week baseline assessment period, an 8-week treatment period, and a follow-up for 12 weeks. The primary outcome is the change of mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8 from baseline. Secondary outcomes include the change from baseline of mean weekly CSBMs during the follow-up period, mean weekly spontaneous bowel movements (SBMs), overall CSBM response rate, scores on Bristol Stool Form Scale (BSFS), straining level, Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of life questionnaire (PAC-QOL), and Brief Psychiatric Rating Scale (BPRS). Adverse events and medicine use will be recorded as well. DISCUSSION: The study is designed based on a rigorous methodology to evaluate the efficacy and safety of EA for antipsychotic-related constipation. The finding will be published in peer-reviewed journals as reliable evidence. TRIAL REGISTRATION: ClinicalTrials.gov ChiCTR2000032582. Registered May 3, 2020, with the Chinese Clinical Trial Registry.
Assuntos
Terapia por Acupuntura , Antipsicóticos , Eletroacupuntura , Antipsicóticos/efeitos adversos , Constipação Intestinal/induzido quimicamente , Constipação Intestinal/diagnóstico , Constipação Intestinal/terapia , Eletroacupuntura/efeitos adversos , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
This paper took four kinds of common soil and water conservation plants of the study area, Caragana microphylla, Salix psammophila, Artemisia sphaerocephala and Hippophae rhamnides at ages of 4 as the research object. Thirteen indicators, i.e., single shrub to reduce wind velocity ration, shelterbelt reducing wind velocity ration, community reducing wind velocity ration, taproot tensile strength, representative root constitutive properties, representative root elasticity modulus, lateral root branch tensile strength, accumulative surface area, root-soil interface sheer strength, interface friction coefficient, accumulative root length, root-soil composite cohesive, root-soil composite equivalent friction angle, reflecting the characteristics of windbreak and roots, were chose to evaluate the differences of foliage-root coupling soil-reinforcement and anti-erosion among four kinds of plants by analytic hierarchy process (AHP) under the condition of spring gale and summer rainstorm, respectively. The results showed the anti-erosion index of foliage-root coupling was in the sequence of S. psammophila (0.841) > C. microphylla (0.454) > A. sphaerocephala (-0.466) > H. rhamnides (-0.829) in spring gale, and C. microphylla (0.841) > S. psammophila (0. 474) > A. sphaerocephala (-0.470) > H. rhamnides (-0.844) in summer rainstorm. S. psammophila could be regarded as one of the most important windbreak and anti-erosion species, while C. microphylla could be the most valuable soil and water conservation plant for the study area.