Efficacy and Safety of Jianpi Jieyu Decoction for Patients with Mild-to-Moderate Depression of Xin (Heart)-Pi (Spleen) Deficiency Syndrome: A Multi-centre Randomized Controlled Study / 中国结合医学杂志

OBJECTIVE@#To evaluate the efficacy and safety of Jianpi Jieyu Decoction (JJD) for treating patients with mild-to-moderate depression of Xin (Heart)-Pi (Spleen) deficiency (XPD) syndrome.@*METHODS@#In this multi-center, randomized, controlled study, 140 patients with mild-to-moderate depression of XPD syndrome were included from Xiyuan Hospital of China Academy of Chinese Medical Sciences and Botou Hospital of Traditional Chinese Medicine from December 2017 to December 2019. They were randomly divided into JJD group and paroxetine group by using a random number table, with 70 cases in each group. The patients in the JJD group were given JJD one dose per day (twice daily at morning and evening, 100 mL each time), and the patients in the paroxetine group were given paroxetine (10 mg/d in week 1; 20 mg/d in weeks 2-6), both orally administration for a total of 6 weeks. The primary outcome was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) score at week 6 from baseline. The secondary outcomes included the Hamilton Anxiety Scale (HAMA) score, Traditional Chinese Medicine Symptom Scale (TCMSS), and Clinlcal Global Impression (CGI) scores at the 2nd, 4th, and 6th weekends of treatment, HAMD-17 response (defined as a reduction in score of >50%) and HAMD-17 remission (defined as a score of ⩽7) at the end of the 6th week of treatment. Adverse events (AEs) were also recorded.@*RESULTS@#From baseline to week 6, the HAMD-17 scores decreased 10.2 ± 4.0 and 9.1 ± 4.9 points in the JJD and paroxetine groups, respectively (P=0.689). The HAMD-17 response occurred in 60% of patients in the JJD group and in 50% of those in the paroxetine group (P=0.292); HAMD-17 remission occurred in 45.7% and 30% of patients, respectively (P=0.128). The differences of CGI scores at the 6th week were not statistically significant (P>0.05). There were significant differences in HAMD-17 scores between the two groups at 2nd and 4th week (P=0.001 and P=0.014). The HAMA scores declined 8.1 ± 3.0 and 6.9 ± 4.3 points from baseline to week 6 in the JJD and paroxetine groups, respectively (P=0.905 between groups). At 4th week of treatment, there was a significant difference in HAMA between the two groups (P=0.037). TCMSS decreased 11.4 ± 5.1, and 10.1 ± 6.8 points in the JJD and paroxetine groups, respectively (P=0.080 between groups). At the 6th week, the incidence of AEs in the JJD group was significantly lower than that in the paroxetine group (7.14% vs. 22.86%, P<0.05).@*CONCLUSION@#Compared with paroxetine, JJD was associated with a significantly lower incidence of AEs in patients with mild-to-moderate depression of XPD syndrome, with no difference in efficacy at 6 weeks. (Trial registration No. ChiCTR2000040922).

Systematic review and Meta-analysis of efficacy and safety of Toutongning Capsules in treatment of tension-type headache / 中国中药杂志

This study aims to systematically evaluate the clinical efficacy and safety of Toutongning Capsules in the treatment of tension-type headache(TTH), so as to provide a corresponding basis for clinical treatment. Eight commonly used medical research databases and two clinical trial registration systems were retrieved with the time interval from the establishment of the database or system to November 2020. The randomized controlled trials of Toutongning Capsules in the treatment of TTH were screened out according to the pre-set criteria. The quality of the included papers was evaluated by the bias risk assessment tool in Cochrane Reviewers Handbook 6.1 and the data were statistically analyzed by RevMan v5.4 provided by Cochrane collaboration. A total of 13 studies were included and the quality of methodology was generally low. Meta-analysis showed that Toutongning Capsules assisted with western medicine therapy can effectively reduce the pain intensity(MD_(VAS)=-1.94,95%CI[-2.50,-1.38],P<0.000 01;MD_(NRS)=-0.83,95%CI[-0.86,-0.80],P<0.000 01), headache duration(SMD=-0.98,95%CI[-1.17,-0.79],P<0.000 01), headache frequency(MD=-1.01,95%CI[-1.16,-0.85],P<0.000 01), headache index(MD=-11.13,95%CI[-12.10,-10.16],P<0.000 01), anxiety and depression scale score(MD_(HAMA)=-4.02,95%CI[-6.58,-1.46],P=0.002;MD_(HAMD)=-2.67,95%CI[-4.04,-1.29],P=0.000 1), while Toutongning Capsules as monotherapy only reduced the headache score(MD=-2.24,95%CI[-2.97,-1.51],P<0.000 01). The available clinical studies demonstrate that Toutongning Capsules combined with western medicine in the treatment of TTH can improve the related outcome indicators, but the clinical safety and efficacy of Toutongning Capsules alone remain unclear. Due to the small number and low quality of the included studies, large-sample, multi-center, high-quality and strictly designed randomized controlled trials are still needed to verify the clinical efficacy in the future.

Systematic review and Meta-analysis of efficacy and safety of gastrodin in treatment of tension-type headache / 中国中药杂志

The efficacy of gastrodin as a Chinese herbal medicine extract in the treatment of tension-type headache has been confirmed. This paper systematically reviewed the efficacy and safety of gastrodin in the treatment of tension-type headache, aiming to provide a new choice for the treatment of this disease. In this study, four Chinese databases, four English databases and two trial registries were searched from the date of establishment to September 2020. The related randomized controlled trials(RCTs) were screened out according to the predetermined criteria. The bias risk assessment tool developed by Cochrane collaboration was used to evaluate the quality of the reports. RevMan 5.4.1 was used for Meta-analysis, and GRADE system for the evidence-based evaluation on the quality of outcome indicators. A total of 177 articles were retrieved and 8 articles were finally included for analysis, with a total sample size of 1 091 cases, which included 565 cases in the treatment group and 526 cases in the control group. The overall quality of included stu-dies was not high. The results of Meta-analysis are as follows:(1)In terms of headache frequency, gastrodin group was better than wes-tern medicine group(MD=-2.90, 95%CI[-3.76,-2.03], P<0.000 01).(2)In terms of number of abnormal blood vessels in TCD, gastrodin group was better than western medicine group(MD=-88.96, 95%CI[-102.36,-75.55], P<0.000 01).(3)In terms of effective rate, gastrodin group was better than western medicine group(RR=1.47, 95%CI[1.29, 1.68], P<0.000 01). The results of subgroup analysis are as follows:(1)Effective rate based on age, for the patients upper age limit 40-46 years old, gastro-din group was better than western medicine group(RR=1.69, 95%CI[1.50, 1.90], P<0.000 01); for the patients upper age limit 55-60 years old, gastrodin group was better than western medicine group(RR=1.27, 95%CI[1.16, 1.38], P<0.000 01).(2)Effective rate based on dosage form, both the gastrodin capsules and injection groups were better than western medicine group(RR_(capsules)=1.42, 95%CI[1.08, 1.88], P=0.01; RR_(injection)=1.50, 95%CI[1.26, 1.77], P<0.000 01). GRADE evaluation showed that the above outcomes had low quality of evidence. Only one article detailed the occurrence of adverse reactions and thus the present study cannot make a positive conclusion on the safety of gastrodin in the treatment of tension-type headache. The small number and low quality of the included reports affected the reliability of the results. In the future, more high-quality randomized controlled trails are needed to improve the evaluation on the efficacy and safety of gastrodin in the treatment of tension-type headache.

Outcome indicators in randomized controlled trials on traditional Chinese medicine intervention for tension-type headache in recent five years / 中国中药杂志

To evaluate the application of outcome indicators in randomized controlled trials(RCTs) concerning the treatment of tension-type headache(TTH) with traditional Chinese medicine(TCM) in recent five years, so as to provide a basis for the study of core outcome set(COS) for TCM intervention in TTH. The RCTs on TCM treatment of TTH in recent five years were systematically retrieved from CNKI, Wanfang, VIP, CBM, EMbase, PubMed, Cochrane Library, Web of Science, ClinicalTrials.gov and China Clinical Trial Registry. After literature screening, data extraction and evaluation of the risk of bias, the outcome indicators in the included RCTs were subjected to qualitative analysis. The preliminary search yielded 19 042 articles, and 10 983 were left after the elimination of duplication. Finally, 52 RCTs(48 in Chinese and 4 in English) were included for qualitative analysis. The outcome indicators of RCTs included in this study were classified into seven domains: TCM syndrome, symptom and sign, physical and chemical detection, quality of life, long-term prognosis, economic evaluation, and safety event. The findings demonstrated that headache characteristic index in the symptom and sign domain was the index with the highest reporting frequency and reporting rate. Seventeen RCTs used TCM syndrome score as the outcome indicator. Further analysis revealed that there existed such problems in research design as non-distinction between primary and secondary outcome indicators, great difference in the adopted measurement tools for outcome indicators, and the neglect of measurement time of outcome indicators. Moreover, the syndrome indicators reflecting TCM advantages, objective evaluation indicators, safety and health-economic indicators were lacking. These limitations have affected the quality and reliability of RCTs on TTH treatment with TCM. It is suggested that the efficacy and characteristics of TCM should be combined into current clinical research, and the COS in RCTs regarding TCM treatment of TTH should be established according to internationally recognized standard procedures.

Changes of postoperative velopharyngeal function in children with cleft palate under 5 years old / 华西口腔医学杂志

OBJECTIVE@#To demonstrate the regularity of velopharyngeal function recovery after primary cleft palatoplasty and its correlation with different surgical procedures, ages, cleft types, and follow-up times.@*METHODS@#Patients with cleft palate under 5 years old who had more than two follow-up records were included in this study, and consecutive evaluations of postoperative velopharyngeal function were performed. Univariate and multivariate logistic regression analysis were used to reveal the regularity of postoperative velopharyngeal function and the possible influencing factors.@*RESULTS@#A total of 165 patients were included. Inconsistent functions of the velopharyngeal closure were observed in 31 patients, of which velopharyngeal insufficiency (VPI) in the first follow-up converted to velopharyngeal competence (VPC) in the second follow-up, accounting for 18.79% of the total, and 134 patients had consistent velopharyngeal function. The patients in the group who had consistent velopharyngeal function were younger than those in the group who were inconsistent, and the differences between the two groups were statistically significant. The younger the operation age, the patient's velopharyngeal function was more likely to stabilize at the first follow-up. At the time of the first follow-up in 15, 28, and 40 months, the probability that the patients had stable postoperative velopharyngeal function was 80%, 90%, and 95%, respectively.@*CONCLUSIONS@#The recovery of velopharyn-geal function after surgery is a dynamic process. The velopharyngeal status of patients can be converted from VPI to VPC. Meanwhile, VPC cannot switch to VPI. The follow-up time is the most important factor affecting the consistency of the evaluation of velopharyngeal function. Choosing appro-priate follow-up time is the key to obtain the stable evaluation of velopharyngeal function.

Velopharyngeal closure pattern and speech characteristics of patients congenital velopharyngeal insufficiency / 华西口腔医学杂志

OBJECTIVE@#To analyze velopharyngeal closure patterns and speech characteristics of patients with congenital velopharyngeal insufficiency.@*METHODS@#Patients visiting the Department of Cleft Lip and Palate Surgery, West China Hospital of Stomatology, Sichuan University between 2009 and 2017 were reviewed. Outcomes of subjective speech evaluation, including resonance, consonant articulation, and correction rate, were analyzed. Furthermore, the mobility of soft palate and pharyngeal walls under nasopharyngeal fiberscope were analyzed retrospectively.@*RESULTS@#A total of 47 cases were retrieved and subjected to nasopharyngeal fiberscopic examination. Among them, 29 (61.7%) demonstrated a circular closure pattern, 16 (34.0%) showed a coronal pattern, and 2 (4.3%) had a sagittal pattern. Furthermore, 25 (53.2%) presented medium soft-palate mobility, 22 (46.8%) had weak lateral pharyngeal wall mobility, and 41 (87.2%) had no posterior pharyngeal wall mobility. Among all of the patients, 23 (48.9%) presented medium hypernasality, accounting for the highest proportion. Consonant misarticulation occurred in 89.4% of the cases. The articulation manners with the highest correction rate were in the following order: nasal, lateral, fricatives, stops, and affricates. The articulation places with the highest correction rate were in the following order: bilabial, alveolar, velar, and linguadental.@*CONCLUSIONS@#Circular closure was the most prevalent velopharyngeal closure pattern among patients with congenital velopharyngeal insufficiency, and consonant omission was the most common articulation abnormality.

Varying width ratio patterns of posterior hard palate cleft to posterior maxillary tuberosity plane in cleft palate / 华西口腔医学杂志

OBJECTIVE@#The varying width ratio patterns of posterior hard palate cleft to posterior maxillary tuberosity plane and their relationship with growth and development were studied in specific-age patients with simple cleft palate before surgery to provide a reference for evaluating operation difficulty and predetermining operative period.@*METHODS@#A total of 581 patients with simple cleft palate who received surgical treatment and are aged 8 months to 38 years participated in this study. All patients were categorized into seven groups based on age at preoperative measurement. The widths of posterior maxillary tuberosity plane and hard palate cleft were selected from the preoperative direct measurements. The relative width ratio of the hard palate to posterior maxillary tuberosity plane in each patient was used to objectively reflect the relative width of cleft palate.@*RESULTS@#For patients with simple cleft palate, the widths of posterior maxillary tuberosity plane and hard palate showed remarkably increasing trends.@*CONCLUSIONS@#The transverse proportion of cleft palate fissure in the upper mandible increases statistically with age, suggesting the need for complex operation.

Factors affecting the postoperative velopharyngeal function among aged patients with cleft palate / 华西口腔医学杂志

OBJECTIVE@#To explore the prognostic factors affecting the primary surgical management of aged patients with cleft palate.@*METHODS@#This study reviewed aged patients with cleft palate who received Furlow palatoplasty (surgical age≥5 years) at the cleft center at West China Hospital of Stomatology from 2009 to 2014. The study retrieved intraoperative mea-surements, including velar length, pharyngeal depth, cleft width, maxillary width, cleft palate index, and palatopharyngeal ratio. Speech evaluation results at follow-up at least a year after surgery were also obtained. Logistic regression and retrospec-tive analyses were performed to identify correlative prognostic factors.@*RESULTS@#One hundred and thirty-one patients were included (70 males and 61 females). Dichotomy logistic regression analysis revealed that pharyngeal depth was the only mea-surement considerably associated with postoperative velopharyngeal function. Pharyngeal depth deeper than 16 mm indicated high risk of postoperative velopharyngeal insufficiency.@*CONCLUSIONS@#Pharyn-geal depth is a significant prognostic factor for the primary surgical management of aged patients with cleft palate. Pharyn-goplasty might be considered when planning the primary management of aged patients.

Outcome and influential factors of speech therapy delivered to cleft patients with post-operative velopharyngeal competence / 华西口腔医学杂志

<p><b>OBJECTIVE</b>To analyze the training technique, intervention timing, and other related factors involved in the speech therapy delivered to cleft patients with velopharyngeal competence after surgery.</p><p><b>METHODS</b>A retrospective study was conducted on 32 patients who received phonology-articulation speech therapies during 2012 to 2013 in Dept. of Cleft Lip and Palate, West China Hospital of Stomatology, Sichuan University. All patients achieved normal speech one year after therapy. Information collected included the types and number of consonant articulation error, the overall period of training, the interval between surgery and speech training, and the age during speech training. Statistical analyses were performed in SPSS 16.0.</p><p><b>RESULTS</b>Ten patients received less than five sessions of training, seventeen received six to ten sessions, and five received eleven to twenty sessions. The number of sessions was positively correlated with the number of errors (r(s)=0.394, P=0.026). On the average, each additional error cost another 0.570 session for correction (confidence interval: 0.137-1.004). Moreover, the number of sessions was negatively correlated with age (P=0.055). Patients between 5 to 10 years old took significantly lesser sessions than those above 10 years. No correlation was found between the number of sessions and the interval between surgeries and trainings.</p><p><b>CONCLUSIONS</b>Appropriate speech therapy efficiently rehabilitate the speech condition of cleft patients with velopharyngeal sufficiency after surgery. The number of errors is directly proportional to the number of sessions needed. Patients above 10 years require more sessions than those less than 10 years.</p>