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1.
Braz. j. otorhinolaryngol. (Impr.) ; 88(4): 491-496, July-Aug. 2022. tab
Article in English | LILACS-Express | LILACS | ID: biblio-1394156

ABSTRACT

Abstract Introduction: Tongue cancer is one of the most common subtypes of head and neck cancer. The aggressive effects of treatment cause aesthetic, psychosocial and functional deficits, especially dysphagia, which affects patient quality of life. Rehabilitation, which is essential for functional maximum recovery, helps patients deal with new and altered structures and has a positive impact on quality of life. Objective: To verify the impact of speech therapy on swallowing quality of life in tongue cancer patients after treatment. Methods: This parallel randomized clinical trial was conducted at a public hospital in Porto Alegre, RS, Brazil. Before and after the intervention, a quality of life questionnaire (the Deglutition Handicap Index) was employed, dysphagia severity was assessed with fiberoptic endoscopic evaluation of swallowing, and the Functional Oral Intake Scale carried out. The experimental group underwent four-week sessions of speech therapy over one month, while the control group received the institution's usual follow-up. Results: Thirty individuals treated for tongue cancer were divided into a study and a control group. Deglutition Handicap Index scores decreased significantly (approximately 40 points) (p < 0.001) after the intervention in the study group. There was a significant correlation between improved quality of life, reduced dysphagia severity and increased in Functional Oral Intake Scale scores (p <0.001). Conclusion: After speech therapy, quality of life scores related to deglutition and dysphagia severity improved in patients treated for tongue cancer.


Resumo Introdução: O câncer de língua é um dos subtipos mais comuns do câncer de cabeça e pescoço. Os efeitos agressivos do tratamento causam impactos estéticos, psicossociais e funcionais, principalmente a disfagia, os quais afetam a qualidade devida do paciente. A reabilitação, essencial para a máxima recuperação funcional, auxilia o paciente a lidar com as novas estruturas e tem impacto positivo na qualidade de vida. Objetivo: Verificar o impacto da fonoterapia na Qualidade de Vida relacionada à deglutição de pacientes tratados por câncer de língua. Método: Ensaio clínico randomizado paralelo, realizado em um hospital público de Porto Alegre, RS, Brasil. Antes e após a intervenção, os participantes foram avaliados por meio de um questionário de Qualidade de Vida (o Índice de Desvantagem da Deglutição), classificados quanto a gravidade da disfagia (por meio do exame de Videoendoscopia da Deglutição) e quanto ao nível da escala funcional de ingestão por via oral. O grupo experimental foi submetido a quatro sessões semanais de fonoterapia no período de um mês, enquanto o grupo controle recebeu o acompanhamento habitual da instituição. Resultados: Trinta indivíduos tratados para câncer de língua foram divididos em um grupo estudo e um grupo controle. Houve uma diminuição significativa, de aproximadamente 40 pontos (p <0,001), nos escores de Qualidade de Vida após a intervenção no grupo experimental. Verificou-se correlação significativa entre a melhora da Qualidade de Vida, a redução da gravidade da disfagia e o aumento dos níveis da escala funcional de ingestão por via oral (p <0,001). Conclusão: Após a fonoterapia, pacientes tratados por câncer de língua apresentaram melhora nos escores de Qualidade de Vida relacionada à deglutição e na gravidade da disfagia.

2.
Int. arch. otorhinolaryngol. (Impr.) ; 26(1): 111-118, Jan.-Mar. 2022. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1364913

ABSTRACT

Abstract Introduction Inferior turbinate surgery is often performed concomitantly with rhinoseptoplasty. As inferior turbinates play a major role in allergic rhinitis, it seems reasonable to suggest that inferior turbinate surgery reduces allergy. Objective To assess the impact of nasal turbinate surgery on non-obstructive allergic symptoms (nasal discharge, sneezing, pruritus, and allergic conjunctivitis) and on the use of allergic medication in patients with allergic rhinitis undergoing rhinoseptoplasty. Methods Secondary analysis of aggregated data from two randomized controlled trials. Participants with allergic rhinitis aged 2: 16 years were recruited. Data from two groups were analyzed: patients with rhinoseptoplasty and concomitant turbinate reduction (intervention group) and patients with rhinoseptoplasty only (control group). The 90-day postoperative frequency of non-obstructive allergic symptoms and of nasal steroid and oral antihistamine use were analyzed. Results A total of 100 patients were studied. The groups were similar in terms of allergic symptom intensity and mean age. The frequency of non-obstructive allergic symptoms decreased 90 days postoperative in both groups (p < 0.01). There was no difference between the groups in the frequency of non-obstructive allergic symptoms at 90 days (p = 0.835). Topical nasal steroid and oral histamine antagonist use decreased in the intervention group at 90 days (p < 0.05). Conclusions Ninety days after the surgery, turbinate reduction performed in association with rhinoseptoplasty did not reduce the frequency of non-obstructive allergic symptoms more than rhinoplasty alone. However, the observed decrease in nasal steroid and oral antihistamine use suggests an impact of turbinate reduction on medication use in patients with allergic rhinitis undergoing rhinoseptoplasty. Trial Registration ClinicalTrials.gov database (NCT01457638 and NCT02231216).

3.
Fisioter. Pesqui. (Online) ; 29(1): 22-28, jan.-mar. 2022. tab, graf
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1375474

ABSTRACT

RESUMO Indivíduos acometidos pelo acidente vascular encefálico (AVE) se beneficiam de diferentes estratégias terapêuticas que apresentam comprovação da eficácia por meio da condução de ensaios clínicos aleatorizados (ECA) bem delineados. Compreender as etapas do estudo pode auxiliar os pesquisadores na realização de futuros ensaios clínicos. Dessa forma, o objetivo deste estudo foi descrever o processo de recrutamento, retenção, presença e adesão na condução de um ECA realizado com indivíduos pós-AVE na fase crônica na cidade de Belo Horizonte (MG), Brasil, com o propósito de investigar a eficácia do treino específico da tarefa para membros superiores e inferiores na melhora do nível de atividade física e mobilidade. Nos resultados, foi observado que dos 674 potenciais participantes, não foi possível contatar 240; 384 não foram avaliados por não atenderem aos critérios de elegibilidade. Participaram da avaliação presencial 50 indivíduos e 14 não fizeram parte do estudo pelo mesmo motivo. Apenas 36 indivíduos iniciaram as intervenções (taxa de recrutamento de 5,3%). Uma taxa de retenção de 80,6% foi observada. Sete indivíduos abandonaram o estudo, principalmente por desinteresse pelas atividades. A taxa de presença foi de 80,9%, e o principal motivo para ausência nas sessões foi incompatibilidade de horário com as consultas médicas. A taxa de adesão foi de 82,7%, com 180 interrupções durante as sessões, sendo sair mais cedo o motivo mais comum. Esses resultados indicam algumas dificuldades no processo de condução do ECA com indivíduos na fase crônica do AVE envolvendo treino específico da tarefa. Apesar dessas dificuldades, a intervenção proposta pode ser considerada viável.


RESUMEN Las personas afectadas por accidente cerebrovascular (ACV) tienen a su disposición diferentes estrategias terapéuticas que muestran evidencia de eficacia a través de la realización de ensayos clínicos aleatorizados (ECA) bien diseñados. Conocer las etapas del estudio puede ayudar a los investigadores a realizar futuros ensayos clínicos. Así, el objetivo de este estudio fue describir el proceso de selección, retención, asistencia y adherencia de un ECA realizado con individuos post-ACV en fase crónica en la ciudad de Belo Horizonte (Brasil), para investigar la efectividad del entrenamiento específico de tareas para las extremidades superiores e inferiores en la mejora del nivel de actividad física y la movilidad. En los resultados se observó que, de los 674 potenciales participantes, no fue posible contactar a 240; y 384 no fueron evaluados por no cumplir con los criterios de elegibilidad. Cincuenta personas participaron en la evaluación presencial y 14 no formaron parte del estudio por la misma razón. Solo 36 personas empezaron las intervenciones (tasa de selección del 5,3%). Se observó una tasa de retención del 80,6%. Siete personas abandonaron el estudio, principalmente por falta de interés en las actividades. La tasa de asistencia fue del 80,9%, y el principal motivo de ausencia a las sesiones fue la incompatibilidad de horario con las citas médicas. La tasa de adherencia fue del 82,7%, con 180 interrupciones durante las sesiones, y la salida anticipada fue la razón más frecuente. Los resultados apuntan algunas dificultades en el proceso de realización del ECA con individuos en fase crónica del ACV con relación al entrenamiento específico de tarea. A pesar de esto, la intervención propuesta puede considerarse viable.


ABSTRACT Individuals who suffered stroke benefit from different therapeutic strategies whose efficacy has been proved by well-designed randomized controlled trials (RCTs). Understanding study steps may assist researchers in conducting future RCTs. Thus, the objective of this study was to describe the process of recruitment, retention, attendance, and adherence in conducting RCTs with individuals in the chronic phase of stroke in the municipality of Belo Horizonte/MG/Brazil, with the purpose of investigating the efficacy of specific task training for both lower and upper limbs in improving patients' physical activity and mobility. Results showed that, of the 674 potential participants, it was impossible to contact 240 individuals and 384 were excluded from our sample for failing to meet eligibility criteria. In total, 50 individuals participated in clinical evaluations and 14 were excluded from the study for the same reason. Overall, 36 individuals started the interventions, a 5.3% recruitment rate. An 80.6% retention rate was observed. In total, seven individuals left the study, mainly due to lack of interest in the activities. We found an 80.9% attendance rate, and the main reason for missing medical appointments was incompatibility with treatment schedule. We also observed an 82.7% adherence rate. Of these, 180 interrupted sessions were mainly due to patients leaving early. These results indicate some difficulties found in conducting RCTs with individuals in the chronic phase of stroke, especially regarding specific task training. Despite these difficulties, the proposed intervention can be considered feasible.

4.
Article in English | WPRIM | ID: wpr-922578

ABSTRACT

OBJECTIVE@#To compare the clinical effects of interactive dynamic scalp acupuncture (IDSA), simple combination therapy (SCT), and traditional scalp acupuncture (TSA) on cognitive function, depression and anxiety in patients with post-stroke cognitive impairment.@*METHODS@#A total of 660 patients with post-stroke cognitive impairment who were admitted to 3 hospitals in Shenzhen City between May 2017 and May 2020 were recruited and randomly assigned to the IDSA (218 cases), SCT (222 cases) and TSA groups (220 cases) according to a random number table. All the patients received conventional drug therapy for cerebral stroke and exercise rehabilitation training. Scalp acupuncture and computer-based cognitive training (CBCT) were performed simultaneously in the IDSA group, but separately in the morning and in the afternoon in the SCT group. The patients in the TSA group underwent scalp acupuncture only. The course of treatment was 8 weeks. Before treatment (M0), 1 (M1) and 2 months (M2) after treatment, as well as follow-up at 1 (M3) and 2 months (M4), the cognitive function of patients was assessed using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment Scale (MoCA) Scales; depression, anxiety, sleep quality, and self-care ability of patients were assessed using Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), Pittsburgh Sleep Quality Index (PSQI), and Modified Barthel Index (MBI), respectively. During this trial, all adverse events (AEs) were accurately recorded.@*RESULTS@#There were no significant differences in the MMSE, MoCA, HAMD, HAMA, PSQI, and MBI scores among the 3 groups at M0 (all P>0.05). In the IDSA group, the MMSE, MoCA and MBI scores from M2 to M4 were significantly higher than those in the SCT and TSA groups, while the HAMD, HAMA and PSQI scores were significantly reduced (all P<0.01). The changes of all above scores (M2-M0, M4-M0) were significantly superior to those in the SCT and TSA groups (all P<0.01, except M4-M0 of HAMD). At M2, the severity of MMSE, HAMD, HAMA, PSQI and MBI in the IDSA group was significantly lower than that in the SCT and TSA groups (all P<0.01). There was no serious AE during this trial.@*CONCLUSIONS@#IDSA can not only significantly improve cognitive function, but also reduce depression, anxiety, which finally improves the patient's self-care ability. The effect of IDSA was significantly better than SCT and TSA. (Trial registration No. ChiCTR1900027206).


Subject(s)
Acupuncture Therapy , Anxiety/therapy , Cognition , Depression/therapy , Humans , Scalp , Sleep Quality , Stroke/therapy , Treatment Outcome
5.
Journal of Integrative Medicine ; (12): 221-229, 2022.
Article in English | WPRIM | ID: wpr-929231

ABSTRACT

BACKGROUND@#Different homeopathic approaches have been used as supportive care for coronavirus disease 2019 (COVID-19) cases, but none has been tested in a clinical trial.@*OBJECTIVES@#To investigate the effectiveness and safety of the homeopathic medicine, Natrum muriaticum LM2, for mild cases of COVID-19.@*DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS@#A randomized, double-blind, two-armed, parallel, single-center, placebo-controlled clinical trial was conducted from June 2020 to April 2021 in São-Carlos, Brazil. Participants aged > 18 years, with influenza-like symptoms and positive result from a real-time polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 were recruited and randomized (1:1) into two groups that received different treatments during a period of at-home-isolation. One group received the homeopathic medicine Natrum muriaticum, prepared with the second degree of the fifty-millesimal dynamization (LM2; Natrum muriaticum LM2), while the other group received a placebo.@*OUTCOME MEASURES@#The primary endpoint was time until recovery from COVID-19 influenza-like symptoms. Secondary measures included a survival analysis of the number and severity of COVID-19 symptoms (influenza-like symptoms plus anosmia and ageusia) from a symptom grading scale that was informed by the participant, hospital admissions, and adverse events. Kaplan-Meier curves were used to estimate time-to-event (survival) measures.@*RESULTS@#Data from 86 participants were analyzed (homeopathy, n = 42; placebo, n = 44). There was no difference in time to recovery between two groups among participants who were reporting influenza-like symptoms at the beginning of monitoring (homeopathy, n = 41; placebo, n = 41; P = 0.56), nor in a sub-group that had at least 5 moderate to severe influenza-like symptoms at the beginning of monitoring (homeopathy, n = 15; placebo, n = 17; P = 0.06). Secondary outcomes indicated that a 50% reduction in symptom score was achieved significantly earlier in the homeopathy group (homeopathy, n = 24; placebo, n = 25; P = 0.04), among the participants with a basal symptom score ≥ 5. Moreover, values of restricted mean survival time indicated that patients receiving homeopathy might have improved 0.9 days faster during the first five days of follow-up (P = 0.022). Hospitalization rates were 2.4% in the homeopathy group and 6.8% in the placebo group (P = 0.62). Participants reported 3 adverse events in the homeopathy group and 6 in the placebo group.@*CONCLUSION@#Results showed that Natrum muriaticum LM2 was safe to use for COVID-19, but there was no statistically significant difference in the primary endpoints of Natrum muriaticum LM2 and placebo for mild COVID-19 cases. Although some secondary measures do not support the null hypothesis, the wide confidence intervals suggest that further studies with larger sample sizes and more symptomatic participants are needed to test the effectiveness of homeopathic Natrum muriaticum LM2 for COVID-19.@*TRIAL REGISTRATION@#UMIN Clinical Trials Registry ID: JPRN-UMIN000040602.


Subject(s)
COVID-19/therapy , Double-Blind Method , Homeopathy , Humans , Influenza, Human/drug therapy , Materia Medica/therapeutic use , Primary Health Care , Treatment Outcome
6.
Journal of Integrative Medicine ; (12): 230-236, 2022.
Article in English | WPRIM | ID: wpr-929230

ABSTRACT

BACKGROUND@#Constipation is a common chronic bowel disorder with an incidence of more than 50% in the elderly population. Complementary and alternative medicine is a cost-effective and satisfactory treatment for constipation used widely by the elderly.@*OBJECTIVE@#This study evaluates the efficacy of an herbal formula made from Foeniculum vulgare Mill. and Rosa damascena for the treatment of constipation in an elderly population and consequent changes to their quality of life.@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTION@#This double-blind randomized active controlled clinical trial, with parallel group allocation ratio of 1:1, was conducted in a referral clinic in Afzalipour Hospital, affiliated to Kerman University of Medical Sciences in Kerman, Southeastern Iran. Individuals over 60 years of age, diagnosed with functional constipation (based on the Rome IV criteria), were included in this study. Participants received a sachet of 10 g F. vulgare and R. damascena (herbal formula group) or polyethylene glycol 4000 (PEG 4000 group) with a glass of warm water two times a day for 4 weeks and were followed up for 4 additional weeks.@*MAIN OUTCOME MEASURES@#Constipation severity, stool consistency, and the quality of life were used as the primary outcomes. Drug side effects were used as a secondary outcome. The outcomes were assessed using the Constipation Assessment Scale, the Bristol Stool Form Scale, and the Patient Assessment of Constipation Quality of Life questionnaire.@*RESULTS@#A total of 25 participants in each group completed the four-week treatment cycle and the eight-week follow-up. At the end of the four-week treatment cycle, all clinical outcomes had significant improvements in both groups (P < 0.05). The analysis of constipation severity (P < 0.001), stool consistency (P < 0.001), and the quality of life (P < 0.001) showed significant improvements with fewer side effects (mild diarrhea) and a longer duration of symptom relief in the herbal formula group compared to the PEG 4000 group.@*CONCLUSION@#Although both interventions significantly improved the treatment outcomes, constipation severity, stool consistency and the quality of life were improved more effectively by the herbal formula than by PEG 4000; however, the mechanism of action is not yet understood.@*TRIAL REGISTRATION@#This trial was registered in the Iranian Registry of Clinical Trials (IRCTID: IRCT20200108046056N1).


Subject(s)
Aged , Constipation/drug therapy , Double-Blind Method , Foeniculum , Humans , Iran , Middle Aged , Quality of Life , Rosa , Treatment Outcome
7.
Journal of Integrative Medicine ; (12): 145-152, 2022.
Article in English | WPRIM | ID: wpr-929212

ABSTRACT

BACKGROUND@#Core muscle functional strength training (CMFST) has been reported to reduce injuries to the lower extremity. However, no study has confirmed whether CMFST can reduce the risk of low back pain (LBP).@*OBJECTIVE@#This study identified the effects of CMFST on the incidence of LBP in military recruits.@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTION@#We performed a prospective, open-label, randomized, controlled study in a population of young healthy male naval recruits from a Chinese basic combat training program. Participants were randomly assigned to either the core group or the control group. In additional to normal basic combat training, recruits in the core group underwent a CMFST program for 12 weeks, while recruits in the control group received no extra training.@*MAIN OUTCOME MEASURES@#At the beginning of the study and at the 12th week, the number of participants with LBP was counted, and lumbar muscle endurance was measured. In addition, when participants complained of LBP, they were assessed using the visual analog scale (VAS) and Roland Morris Disability Questionnaire (RMDQ).@*RESULTS@#A total of 588 participants were included in the final analysis (295 in the core group and 293 in the control group). The incidence of LBP in the control group was about twice that of the core group over the 12-week study (20.8% vs 10.8%, odds ratio: 2.161-2.159, P < 0.001). The core group had better lumbar muscle endurance at 12 weeks than the control group ([200.80 ± 92.98] s vs [147.00 ± 84.51] s, P < 0.01). There was no significant difference in VAS score between groups, but the core group had a significantly lower RMDQ score at week 12 than the control group (3.33 ± 0.58 vs 5.47 ± 4.41, P < 0.05).@*CONCLUSION@#This study demonstrated that the CMFST effectively reduced the incidence of LBP, improved lumbar muscle endurance, and relieved the dysfunction of LBP during basic military training.


Subject(s)
Humans , Low Back Pain/prevention & control , Male , Military Personnel , Muscles , Prospective Studies , Resistance Training , Treatment Outcome
8.
Article in English | WPRIM | ID: wpr-928953

ABSTRACT

OBJECTIVE@#To assess the effectiveness of Jiuwei Zhuhuang Powder (JWZH), a Tibetan patent medicine in treating upper respiratory tract infection (URTI) associated cough in children.@*METHODS@#The study was a multicenter, randomized, open-label, controlled trial. A total of 142 children aged 2 to 14 years old, with URTI-associated cough within 48 h of onset, were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence. Children were treated with JWZH (1 to 1.5 g, twice to thrice daily) in the treatment group or conventional treatment (Pediatric Paracetamol, Artificial Cow-bezoar and Chlorphenamine Maleate Granules, 0.25 to 1 g, thrice daily) in the control group for 5 days. The primary endpoints were the time to cough resolution and 4-day cough resolution rate. The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period.@*RESULTS@#A total of 138 children were included in the intention-to-treat analysis, with 71 cases in the treatment group and 67 cases in the control group. Compared with the conventional treatment, the children receiving JWZH had a shorter time to cough resolution [hazard ratio, 2.10; 95% confidence interval (CI), 1.29-3.40; P=0.003]. The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment (2 days vs. 3 days; P<0.001). The 4-day cough resolution rate in the JWZH group was higher than that of the control group (94.4% vs. 74.6%; risk difference: 19.8%, 95% CI: 8.1%-31.5%; relative risk: 1.265, 95% CI: 1.088-1.470; P=0.001). There were no statistically significant differences in the improvement of other symptoms caused by URTI (P>0.05). Adverse events was reported in 5.6% (4/71) and 4.5% (3/67) in participants of JWZH and PPACCM groups (P>0.05), respectively, which were all mild and resolved without treatment.@*CONCLUSION@#JWZH seemed to be a safe and effective therapy for URTI-associated cough in children. (Trial registration No. ChiCTR2000039421).


Subject(s)
Child , Cough/drug therapy , Drugs, Chinese Herbal , Humans , Nonprescription Drugs , Powders , Respiratory Tract Infections/drug therapy
9.
Article in English | WPRIM | ID: wpr-928952

ABSTRACT

OBJECTIVE@#To explore the efficacy and safety of Zhuang medicine medicated thread moxibustion (ZMTM) on psoriasis vulgaris.@*METHODS@#A multicenter, randomized, parallel controlled clinical trial was designed. A total of 241 outpatients with psoriasis vulgaris were randomly divided into a control group (120 cases) and a treatment group (121 cases) using a central block randomization from June 2015 to May 2018. The control group was treated with Western medicines alone including pidotimod dispersible tablets, vitamin B compound tablets, and compound cod liver oil-zinc oxide ointment. The treatment group was treated with ZMTM every 2 days combined with Western medicines. The two groups received continuous intervention for 30 days. The primary outcome was Psoriasis Area and Severity Index (PASI), and the secondary outcomes included Itch Rating Scale, Dermatology Quality of Life Index (DLQI), Hamilton Anxiety Rating Scale (HAMA), as well as PASI response rate. Meanwhile, adverse events were evaluated during the whole clinical trial. Follow-up was carried out 30 days after treatment.@*RESULTS@#There were 5 cases of shedding in this trial. In intention-to-treat analysis, 236 cases were included and each group contained 118 cases. On the 30th and 60th days, PASI scores of patients in each group were significantly lower than that at baseline (P<0.01) and the PASI score reduction of the treatment group was greater than that of the control group (P<0.01). Itch Rating Scale, DLQI, and HAMA scale were decreased in both groups after treatment, and the treatment group showed a better therapeutic effect (P<0.01). The response rates of PASI 50 and 75 were significantly higher than those in the control group [81.4% (96/118), 43.2% (51/118) vs. 41.5% (49/118), 11.0% (13/118), respectively, P<0.05]. During follow-up, the improvements in scores of PASI, Itch Rating Scale, DLQI, and HAMA of the treatment group were significantly greater than those of the control group (P<0.01). The response rates of PASI 50 and 75 in the treatment group were significantly higher than those in the control group, respectively (both P<0.05). No obvious adverse reaction was found in either group.@*CONCLUSION@#ZMTM combined with Western medicines showed a better therapeutic effect in the treatment of psoriasis vulgaris without obvious adverse reaction. (Trial Registration No. ChiCTR-IOR-16008159).


Subject(s)
Humans , Moxibustion/adverse effects , Psoriasis/drug therapy , Quality of Life , Severity of Illness Index , Treatment Outcome
10.
Article in English | WPRIM | ID: wpr-928929

ABSTRACT

OBJECTIVE@#To explore the therapeutic effect of Bushen Yiqi Huoxue Decoction BYHD) in patients with diminished ovarian reserve (DOR).@*METHODS@#A total of 180 patients with DOR diagnosed from December 2013 to December 2014 were equally assigned into progynova and duphaston (E+D) group, Zuogui Pill group and BYHD group with 60 cases in each by computerized randomization. Patients received E+D, Zuogui Pill or BYHD for 12 months, respectively. Follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), anti-Müllerian hormone (AMH), antral follicle count (AFC), ovarian volume, endometrial thickness, and the resistance indices (RIs) of ovarian arteries and uterine arteries were observed before and after treatment.@*RESULTS@#Nine women (4 from the E+D group, 3 from the Zuogui Pill group, and 2 from the BYHD group) withdrew from the study. After 6 months, Zuogui Pill and BYHD significantly decreased FSH and LH and increased endometrial thickness and AMH (all P<0.01). BYHD also resulted in E2 elevation (P<0.05), ovary enlargement (P<0.05), AFC increase (P<0.01), and RI of ovarian arteries decrease (P<0.05). After 12 months, further improvements were observed in the Zuogui Pill and BYHD groups (all P<0.01), but BYHD showed better outcomes, with lower FSH, larger ovaries and a thicker endometrium compared with the Zuogui Pill group (all P<0.01). However, E+D only significantly increased endometrial thickness (P<0.01) and no significant improvements were observed in the RI of uterine arteries in the three groups.@*CONCLUSIONS@#BYHD had a favorable therapeutic effect in patients with DOR by rebalancing hormone levels, promoting ovulation, and repairing the thin endometrium. The combination of tonifying Shen (Kidney), benefiting qi and activating blood circulation may be a promising therapeutic strategy for DOR.


Subject(s)
Anti-Mullerian Hormone/pharmacology , Drugs, Chinese Herbal , Female , Follicle Stimulating Hormone , Humans , Luteinizing Hormone , Ovarian Reserve
11.
Article in Chinese | WPRIM | ID: wpr-928338

ABSTRACT

OBJECTIVE@#To observe clinical efficacy of chiropractic manipulation in the treatment of degenerative scoliosis (DS).@*METHODS@#From June 2017 to September 2019, 120 patients with degenerative scoliosis were randomly divided into treatment group (60 cases) and control group(60 cases). The patients in treatment group were treated with chiropractic manipulation once every other day for 4 weeks. The patients in control group were treated with eperisone hydrochloride tablets combined with thoracolumbar orthopedic(TSLO)brace, oral eperisone hydrochloride tablets 50 mg three times a day, wearing TSLO brace for not less than 8 hours a day. The course of treatment was 4 weeks. After the patients were selected into the group, visual analogue scale (VAS) and Oswestry Disability Index (ODI) were recorded before treatment, 1, 2, 3, 4 weeks after treatment and 1 month after treatment. The full length X-ray of the spine was taken before and 4 weeks after treatment, and the scoliosis Cobb angle, sagittal vertical axis (SVA) and lumbar lordosis (LL) were measured and compared. The adverse reactions during the treatment were recorded.@*RESULTS@#There were significant differences in VAS and ODI between two groups at each time point after treatment (P<0.001), VAS and ODI at 2 weeks after treatment (PVAS=0.025, PODI=0.032) and 3 weeks after treatment(PVAS=0.040, PODI=0.044) in treatment group were significantly different from those in control group, but there was no significant difference in VAS and ODI at other time points between treatment group and control group (P>0.05). There was significant difference in Cobb angle between treatment group(P=0.010) and control group(P=0.017) after treatment, but there was no significant difference in LL and SVA between treatment group and control group. There was no significant difference in Cobb angle, LL and SVA between two groups before and after treatment. During the treatment, there were 4 mild adverse reactions in the control group and no adverse reactions in the treatment group.@*CONCLUSION@#Chiropractic manipulation can effectively relieve pain and improve lumbar function in patients with degenerative scoliosis. The onset of action is faster than that oral eperisone hydrochloride tablets combined with TSLO brace, and it has better safety and can improve Cobb angle of patients with degenerative scoliosis.


Subject(s)
Humans , Lordosis , Lumbar Vertebrae , Manipulation, Chiropractic , Retrospective Studies , Scoliosis/therapy , Spinal Fusion , Treatment Outcome
12.
Article in Chinese | WPRIM | ID: wpr-928192

ABSTRACT

This study aims to systematically evaluate the effect of oral Chinese patent medicines on hypertension with network Meta-analysis. Randomized controlled trials on the treatment of hypertension with oral Chinese patent medicine combined with conventional western medicine were retrieved from China National Knowledge Infrastructure(CNKI), Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library(from establishment of the database to August 2021). Two researchers independently screened the articles, extracted the data, and evaluated article quality. Then R 4.1.0 was employed for data analysis. Finally, 195 eligible articles were screened out, involving 22 546 patients and 18 oral Chinese patent medicines. The results of the network Meta-analysis are as follows. In terms of reducing systolic blood pressure(SBP) and diastolic blood pressure(DBP), Xuesaitong, Qiangli Dingxuan Tablets, Songling Xuemaikang Capsules combined with conventional western medicine are superior. In improving blood lipids, the overall effects of Xinmaitong Capsules, Compound Xueshuantong Capsules, Ginkgo Folium preparations, Yindan Xinnaotong Soft Capsules, and Naoxintong Capsules combined with conventional western medicine are outstanding. In terms of regulating endothelial function, Yindan Xinnaotong Soft Capsules, Xinmaitong Capsules, Zhenju Jiangya Tablets, Compound Danshen Dripping Pills, Xuesaitong with conventional western medicine have certain advantages. As for the safety, the incidence of adverse reactions of conventional western medicine combined with oral Chinese patent medicines is lower than that of conventional western medicine alone. In summary, compared with conventional western medicine alone, the 18 oral Chinese patent medicines combined with conventional western medicine in the treatment of hypertension show advantages in improving blood pressure, blood lipids, and endothelial function. Among them, Xuesaitong, Qiangli Dingxuan Tablets, and Songling Xuemaikang Capsules may be the best oral Chinese patent medicines for lowering blood pressure. The conclusion needs to be further verified by more high-quality studies.


Subject(s)
Antihypertensive Agents , Capsules , Drugs, Chinese Herbal/adverse effects , Humans , Hypertension/drug therapy , Network Meta-Analysis , Nonprescription Drugs
13.
Article in Chinese | WPRIM | ID: wpr-928115

ABSTRACT

The clinical randomized controlled trials(RCTs) of Chinese patent medicine in the treatment of chronic obstructive pulmonary disease(COPD) were reviewed and analyzed to provide references for clinical research, guideline development, policy formulation, and quality improvement of clinical evidence. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, EMbase were searched for RCTs of Chinese patent medicine for COPD as a source of clinical evidence from database inception to December 31, 2019. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. A total of 733 RCTs of Chinese patent medicine for COPD were included, among which 228 RCTs had a sample size higher than 100, accounting for 31.1% of total RCTs. Eighty-eight Chinese patent medicines were involved, including 40 oral medicines and 48 injections. A total of 327 RCTs mentioned intervention and control measures(Chinese patent medicine + conventional treatment vs conventional treatment), accounting for 43.0%. In addition, 94.40% of the RCTs reported the course of treatment, and 53.20% of the RCTs determined 8-14 d as the intervention course. The evaluation indicators adopted were numerous, among which physicochemical indicators(70.57%) and symptoms/signs(24.35%) were the most frequently employed. The operation of allocation concealment and blinding was not standard. Registration and the procedure related to ethics were mostly missing. The results indicate that there are prominent methodological problems in the clinical trials of Chinese patent medicine in the treatment of COPD, affecting the reliability and practicability of the trials. It is necessary to further standardize the design, implementation, and quality control of clinical trials of Chinese patent medicine in the treatment of COPD, highlight the clinical value of Chinese patent medicine for COPD, and improve the quality of evidence.


Subject(s)
China , Clinical Trials as Topic , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Pulmonary Disease, Chronic Obstructive/drug therapy , Reproducibility of Results
14.
Article in Chinese | WPRIM | ID: wpr-928114

ABSTRACT

The present study reviewed the clinical randomized controlled trials(RCTs) of Chinese patent medicine for pneumonia to provide references for clinical research, guideline development, and policy formulation, and promote the quality improvement of clinical evidence. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed were searched for RCTs of Chinese patent medicine for pneumonia from database inception to December 31, 2019. A total of 1 245 RCTs were included, involving 84 Chinese patent medicines, including 45 oral medicines and 39 injections. Specifically, 85.9% of RCTs had treatment course not exceeding 14 d; 43.3% of RCTs had a sample size of more than 100 cases and 6.1% of RCTs more than 200 cases; 13 types of interventions/controls were included in the RCTs, with Chinese patent medicine + western medicine vs western medicine as the top one used(32.6%). In outcome indicators, symptoms/signs(3 285) and physicochemical detection(2 066) were the most frequently applied. In the methodological evaluation, "allocation concealment" was not clearly described or mentioned in 71.2% of RCTs, and "blinding" in 23.9% of RCTs met the normative standards. Registration and research ethics were not clearly reported. There are many methodological deficiencies in terms of design and implementation in included RCTs, which may impact the reliability and practicability of the results of RCTs. Additionally, key standards were unclear(such as disease classification methods and selection of core outcome indicators). In conclusion, RCTs should give priority to the preciseness and scientificity of the protocol, strengthening quality control of the processes and accelerating the standardized research of key links.


Subject(s)
China , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Nonprescription Drugs , Pneumonia/drug therapy , Randomized Controlled Trials as Topic , Reproducibility of Results
15.
Article in Chinese | WPRIM | ID: wpr-928113

ABSTRACT

The clinical randomized controlled trial(RCT) of Chinese patent medicine in the treatment of influenza were reviewed and analyzed to provide basic information for clinical decision and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, and Cochrane Library were searched for RCTs of Chinese patent medicine for influenza published from database inception to July 25, 2021. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. Ninety-two RCTs of Chinese patent medicine for influenza published between 2005 and 2021, were included, among which 17 RCTs(18.48%) had a sample size higher than 200 and the average sample size was about 145. Twenty-seven Chinese patent medicines were involved, including twenty-one oral medicines and six injections. The Chinese patent medicines in trials reported in more than five papers included Lianhua Qingwen Capsules/Gra-nules, Tanreqing Injection, and Reduning Injection. Fourteen intervention protocols were reported, of which Chinese patent medicine+western medicine+conventional treatment vs western medicine+conventional treatment(20.65%) was the most frequently employed. Additionally, 85.87% of the RCTs reported the course of treatment, and 80.43% of the RCTs determined 3-7 d as the intervention course. Forty-five outcome indicators were extracted, which were used 434 times, including symptoms/signs, physicochemical detection, safety events, TCM symptoms/syndromes, quality of life, long-term prognosis, and economic evaluation. Symptoms/signs(61.52%) exhibited the highest frequency. Methodological problems were prevalent in the included trials. The findings reveal that there are few clinical trials on influenza treatment by Chinese patent medicine, and the methodological problems are prominent, affec-ting the reliability and practicability of the trials. In the future research, the value characteristics of Chinese patent medicine should be highlighted and the quality control in the whole process should be strengthened based on the scientific and rigorous design.


Subject(s)
China , Clinical Trials as Topic , Drugs, Chinese Herbal/therapeutic use , Humans , Influenza, Human/drug therapy , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Quality of Life , Reproducibility of Results
16.
Article in Chinese | WPRIM | ID: wpr-928112

ABSTRACT

To systematically collect and analyze clinical randomized controlled trial(RCT) of Chinese patent medicine treatment for stroke in 2020, in order to provide basic information for clinical decision-making and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, EMbase were searched for RCTs of Chinese patent medicine for stroke in 2020. The publication, sample size, intervention and control measures, course of treatment, outcome indicators, methodological quality and other contents were statistically analyzed.A total of 68 RCTs studies on Chinese patent medicine for stroke were included in 2020, of which 29(42.60%) were RCTs with sample size>100 cases. A total of 41 kinds of proprietary Chinese medicines were involved, including 23 kinds of oral proprietary Chinese medicines and 18 kinds of injections. A total of 18 intervention/control cases were included in RCTs, and 19 cases(Chinese patent medicine+Western medicine vs Western medicine) were applied in RCTs, accounting for 27.90%. The duration of treatment was reported in 91.18% of the studies, and the intervention duration was 8-14 days in 50.00% of the studies. Evaluation indexes were widely used, among which physical and chemical testing indexes(49.36%) were the most widely used. According to the methodological quality evaluation, the overall methodological quality of the study is not high, especially the implementation of the allocation hidden, blind method is not accurate, and the registration, ethics and other links are often missing. In conclusion, 2020 implementation of proprietary Chinese medicine in the treatment of stroke research methodology problems is outstanding, the similar function scale large range of optional, no specification selection criteria, reliability and practicability of the impact study, need to further standardize the proprietary Chinese medicine in the treatment of stroke study design, implementation and quality control, and highlight the value of proprietary Chinese medicine in the treatment of stroke and improve the quality of the evidence.


Subject(s)
China , Clinical Trials as Topic , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Reproducibility of Results , Stroke/drug therapy
17.
Article in Chinese | WPRIM | ID: wpr-928111

ABSTRACT

The present study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine in the treatment of heart failure to provide references for follow-up clinical research design, guideline update, and policy formulation, and promote the improvement of clinical evidence quality. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, VIP, Wanfang, SinoMed, PubMed, and Web of Science were searched for RCTs of Chinese patent medicine in the treatment of heart failure from database inception to December 31, 2020. The di-sease type, publication time, sample size, intervention/control setting, course of treatment, evaluation indexes, and methodological quality were analyzed and evaluated. A total of 1 631 RCTs were included, including 1 622 in Chinese and 9 in English. It was first published in 1995, with the largest number of publications in 2016. There were only 56 RCTs(3.43%) with a sample size≥200. Seventy-eight types of Chinese patent medicines were involved, including 49 types of oral drugs and 29 types of injections. There were 34 intervention/control protocols, which were dominated by Chinese patent medicine+conventional treatment vs conventional treatment, accounting for 28.51%(n=465). About 94.0% of RCTs reported the course of treatment, mainly 14-56 days. The evaluation indexes were mainly physical and chemical tests and symptoms/signs, and left ventricular ejection fraction(LVEF) was the most frequently used measurement index. In enumeration indexes, clinical efficacy(response rate) was used the most frequently. Methodologically, 92.0% of the research subjects were rated as high risk of blindness. There were only 13 RCTs(0.80%) reporting registered information. It is necessary to further standardize the design, implementation, and quality control of clinical studies in order to improve the quality of evidence and avoid research waste.


Subject(s)
China , Drugs, Chinese Herbal/therapeutic use , Heart Failure/drug therapy , Humans , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Randomized Controlled Trials as Topic , Stroke Volume , Ventricular Function, Left
18.
Article in Chinese | WPRIM | ID: wpr-928110

ABSTRACT

The present study collected, collated, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine published in Chinese and English journals in 2020, and summarized clinical evidence of Chinese patent medicine in stages, providing references for follow-up clinical research and evidence transformation and application. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, and EMbase were searched for RCTs of Chinese patent medicine published in 2020, and their research characteristics and methodological quality were analyzed and evaluated. A total of 1 285 research papers on Chinese patent medicine(1 257 in Chinese/28 in English) were included, involving 146 054 patients and 639 Chinese patent medicines, including 526 oral drugs, 68 injections, and 45 external drugs. A total of 412 diseases in 23 types were involved, which were dominated by circulatory system diseases and respiratory system diseases, specifically, cerebral infarction and angina pectoris. The sample size ranged from 20 cases to 2 673 cases, and 57.67% of RCTs had samples sizes less than 100. Single-center trials were the main ones, and multi-center trials only accounted for 4.75%(n=61). In terms of methodological quality, 52.91% of the RCTs had unclear descriptions or incorrect application of randomization methods, and the implementation of allocation concealment and blinding methods has not been paid much attention. In conclusion, compared with the conditions in 2019, the number of RCTs published in 2020 has decreased, and the research interest in respiratory diseases has increased, while the quality control in the process of research design and implementation has not been improved. Therefore, it is necessary to strengthen the methodological training of researchers and promote the output of high-quality research evidence.


Subject(s)
China , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Nonprescription Drugs , Quality Control
19.
Article in Chinese | WPRIM | ID: wpr-927965

ABSTRACT

The purpose of the study is to analyze the outcomes of randomized controlled trial(RCT) of Chinese herbal medicine formula(CHMF) in the treatment of gastrointestinal dysfunction in sepsis in recent two years. We systematically searched four Chinese databases, three English databases, and two clinical trial registries to analyze the reports of outcome indicators of clinical trials, and evaluated the risk of bias by using the ROB tool of Cochrane Collaboration. After screening, 55 clinical RCTs were included. The results showed that the current clinical studies of gastrointestinal dysfunction in sepsis reported the efficacy and safety indicators. The efficacy indicators included APACHE Ⅱ scores, gastrointestinal dysfunction scores, bowel sound scores, and inflammatory indicator such as C-reactive protein and procalcitonin. The safety indicators mainly include gastrointestinal reactions, skin reactions, and other adverse events and adverse reactions. However, there was no distinction between primary and secondary outcomes. The relevant indicators of health economics were not reported, and the quality of research methodology was poor. Therefore, we suggest that future researchers should be well prepared in the top-level design stage and actively construct the core outcome set, so as to improve the quality of clinical trials.


Subject(s)
Drugs, Chinese Herbal/therapeutic use , Gastrointestinal Diseases/drug therapy , Humans , Medicine, Chinese Traditional , Randomized Controlled Trials as Topic , Research Design , Sepsis/drug therapy
20.
Article in Chinese | WPRIM | ID: wpr-927936

ABSTRACT

The present study analyzed the efficacy evaluation indexes of the randomized controlled trials(RCTs) of Chinese medi-cine in the treatment of rheumatic heart disease to lay the foundation for the construction of the corresponding core outcome index set. Clinical RCTs with a definite diagnosis of rheumatic heart disease were retrieved from CNKI, Wanfang, VIP, Sino Med, Pub Med, EMbase, and Cochrane Library from January 1, 2010, to December 31, 2020. Thirty-five RCTs were included, involving 3 314 patients and 41 efficacy evaluation indexes, which covered seven domains [traditional Chinese medicine(TCM) symptoms/syndromes, symp-toms/signs, physical and chemical examination, quality of life, long-term prognosis, economic evaluation, and safety events]. Physi-cal and chemical examination(56. 91%) and symptoms/signs(29. 27%) were the more frequently applied. The number of indexes used in a single trial ranged from 1 to 15, with an average of 4. The measurement time points of the top five indexes in the frequency of use were as follows: total response rate was reported at five measurement time points, ranging from 14 days to 6 months; left ventri-cular ejection fraction was measured at eight time points ranging from 5 days to 6 months; left ventricular end systolic diameter was measured at six time points, ranging from 5 days to 6 months; interleukin-2(IL-2) and tumor necrosis factor-α(TNF-α) were repor-ted 28 days after treatment. At present, there are many problems in the efficacy outcome indexes of RCTs in the treatment of rheumatic heart disease with TCM, such as large difference in quantity, unclear primary and secondary indexes, unreasonable selection of " surro-gate indexes", insufficient attention to long-term prognostic indexes and safety event indexes, non-standard application of composite in-dexes, long measurement period, and lack of TCM characteristics. It is urgent to establish the core outcome set for TCM treatment of rheumatic heart disease.


Subject(s)
Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Quality of Life , Randomized Controlled Trials as Topic , Rheumatic Heart Disease/drug therapy , Treatment Outcome
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