A cross-sectional study of the endorsement proportion of reporting guidelines in 1039 Chinese medical journals.

BACKGROUND: Reporting quality is a critical issue in health sciences. Adopting the reporting guidelines has been approved to be an effective way of enhancing the reporting quality and transparency of clinical research. In 2012, we found that only 7 (7/1221, 0.6%) journals adopted the Consolidated Standards of Reporting Trials (CONSORT) statement in China. The aim of the study was to know the implementation status of CONSORT and other reporting guidelines about clinical studies in China. METHODS: A cross-sectional bibliometric study was conducted. Eight medical databases were systematically searched, and 1039 medical journals published in mainland China, Hong Kong, Macau, and Taiwan were included. The basic characteristics, including subject, language, publication place, journal-indexed databases, and journal impact factors were extracted. The endorsement of reporting guidelines was assessed by a modified 5-level evaluation tool, namely i) positive active, ii) positive weak, iii) passive moderate, iv) passive weak and v) none. RESULTS: Among included journals, 24.1% endorsed CONSORT, and 0.8% endorsed CONSORT extensions. For STROBE (STrengthening the Reporting of Observational Studies in Epidemiology), PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), STARD (An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies), CARE (CAse REport guidelines), the endorsement proportion were 17.2, 16.6, 16.4, and 14.8% respectively. The endorsement proportion for SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), TRIPOD (Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis), AGREE (Appraisal of Guidelines, Research, and Evaluation), and RIGHT (Reporting Items for Practice Guidelines in Healthcare) were below 0.7%. CONCLUSIONS: Our results showed that the implementation of reporting guidelines was low. We suggest the following initiatives including i) enhancing the level of journal endorsement for reporting guidelines; ii) strengthening the collaboration among authors, reviewers, editors, and other stakeholders; iii) providing training courses for stakeholders; iv) establishing bases for reporting guidelines network in China; v) adopting the endorsement of reporting guidelines in the policies of the China Periodicals Association (CPA); vi) promoting Chinese medical journals into the international evaluation system and publish in English.

The willingness to attend the first dental visit within 1 year of age: An analysis applying Andersen's behavioral model of health service utilization.

BACKGROUND: The first dental visit (FDV) within 1 year of age is important for establishing good oral health behaviors for young children, but delayed FDVs are common. AIM: This study aimed to investigate the predisposing, enabling, and need factors of maternal willingness to attend the FDV for infants. DESIGN: A cross-sectional survey was conducted among mothers of infants aged 11-14 months. A questionnaire was developed based on Andersen's behavioral model of health service utilization. Data regarding the FDV, FDV willingness, and reasons for not attending the FDV were collected. Logistic regression models were used to investigate the associated factors. RESULTS: Of 658 infants, only 2.7% (18) had a Thirty percent (191/640) of mothers reported their willingness to attend the FDV in the next 3 months. Nearly two-thirds of mothers reported not attending the FDV since their children's teeth were healthy. Maternal perceptions of their infants' oral health status were negatively associated with willingness to undergo the FDV, whereas family social support was positively associated with willingness to undergo the FDV. CONCLUSIONS: Need factors play a key role in the utilization of FDV. Improving parental awareness of FDV might help parents voluntarily attend the FDV, and offering support from the family and healthcare system levels enables access to paediatric dental care.

Protocol of the CONSORT and SPIRIT Extension for multicenter clinical trials.

Background: Multicenter clinical trials play an indispensable role for assessing the efficacy of a new intervention or treatment, particularly in Phase II or III studies. Previous studies have shown that these studies often suffer from inadequate reporting of key details related to their design, implementation, and analysis, both in the protocol and final reports. This limitation reduces the practical and scientific value of the findings. Furthermore, the lack of guidance on how to report multicenter features can contribute to poor reporting. Therefore, this study aims to develop guidelines to improve the reporting of multicenter trials, including two Extensions of the CONSORT 2010 and the SPIRIT 2013. Methods/design: The standard methodology for developing health research reporting guidelines involves the following steps: (i) Identifying the need for development and launching the research project; (ii) Preparing the registration and reviewing the literatures; (iii) Proposing the initial Checklists and conducting the Delphi exercise; (iv) Arranging the consensus meeting and formulating the Checklists; (v) Conducting the pilot test and drafting explanatory documents (E&E); (vi) Seeking comments from advisory group and finalizing the guidelines; and (vii) Developing the publication and dissemination strategies. Conclusion: By using the CONSORT and SPIRIT checklists as starting points, the development of extensions specific to multicenter trials can help researchers design and report high-quality clinical research. This, in turn, can facilitate the application of study findings in the current evidence-based healthcare system.

STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement.

OBJECTIVES: Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely "The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM)." METHODS: A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline. RESULTS: A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided. CONCLUSIONS: The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.

Reporting and data sharing level for COVID-19 vaccine trials: A cross-sectional study.

BACKGROUND: The results and data availability of vaccine trials directly affect the decisions of healthcare providers, the public, and policymakers as to whether the vaccine should be applied. However, the reporting and data sharing level of COVID-19 vaccine studies are not clear. METHODS: A cross-sectional study was conducted. A systematic search up to 9 May 2021 in 12 databases and an updated search to 6 July 2021 were conducted in the Cochrane Living Systematic Review and Network Meta-Analysis database to identify COVID-19 vaccine trials. The basic characteristics of included trials were summarized. The reporting level was assessed according to the CONSORT checklist. The data sharing level was assessed by open science practices. Types of incomplete reporting including protocol deviation, lack of primary outcomes clarity, and the omission of harms were analyzed. FINDINGS: Finally, thirty-six COVID-19 vaccine articles reporting on 40 randomized controlled trials were included in this analysis. Based on the CONSORT checklist, the mean reporting score was 29.7 [95% confidence interval 28.7, 30.7]. Thirty-one articles (31/36, 86.1%) had data sharing statements, twenty-five articles (25/36, 69.4%) provided access to the source data. Twenty-seven articles (27/36, 75.0%) had protocol deviation, lack of primary outcomes clarity, or the omission of harms. INTERPRETATION: The reporting and data sharing level of COVID-19 vaccine trials were not optimal. We hope that the reporting and data sharing of future trials will be improved. We recommend establishing a comprehensive, accurate data sharing system for future vaccine trials. FUNDING: This work was supported by the National Key R&D Program of China (2019YFC1710400; 2019YFC1710403).

Chinese herbal medicines in the treatment of ulcerative colitis: a review.

OBJECTIVE: To investigate how the ulcerative colitis (UC) be treated with Chinese herbal medicines (CHM), using Chinese medicine (CM) pattern (zheng) identification, in the current clinical practice. METHODS: A total of 7 electronic databases were systematically searched for UC clinical studies with CHM interventions (including single herbs and CHM formulas) published in English and Chinese from the date of their inception to November 25, 2020. Descriptive statistics were adopted to demonstrate the characteristics of study design, and to collate the commonly CM patterns of UC and frequently used CHM herbs and formulas. Further, IBM SPSS Modeler 18.0 and Cytoscape 3.7.1 software were used to analyze and visualize the associations between different categories of CHM and their zheng indications. RESULTS: A total of 2311 articles were included in this study, of which most (> 90%) were RCTs with CHM formulas. The most common zheng of UC was Large intestine dampness-heat, while the basic type of CM patten was Spleen deficiency. The most frequently used classical formula was Bai-Tou-Weng-Tang, followed by Shen-Ling-Bai-Zhu-San, and the commonly used proprietary CHM was Xi-Lei-San (enema). Sulfasalazine and Mesalazine are commonly used as concomitant western medicines. The most frequently used single medicinals were Huang Lian and Bai Zhu, which also identified as the core herbs for different CM patterns. CONCLUSION: This study examined the application of CHM interventions for UC and summarized their characteristics in clinical practice. These data indicated there were limited information about the safety assessment of CHM formulas and further RCTs including CM pattern(s) with strict design are necessary.

Assessment of the reporting quality of randomised controlled trials of massage.

OBJECTIVE: To assess the reporting quality of randomised controlled trials (RCTs) of massage, particularly whether necessary elements related to massage interventions were adequately reported. METHODS: A total of 8 electronic databases were systematically searched for massage RCTs published in English and Chinese from the date of their inception to June 22, 2020. Quality assessment was performed using three instruments, namely the CONSORT (Consolidated Standards of Reporting Trials) 2010 Checklist (37 items), the CONSORT Extension for NPT (Nonpharmacologic Treatments) 2017 checklist (18 items), and a self-designed massage-specific checklist (16 items) which included massage rationale, intervention and control group details. Descriptive statistics were additionally used to analyse the baseline characteristics of included trials. RESULTS: A total of 2,447 massage RCTs were identified, of which most (96.8%) were distributed in China. For the completeness of CONSORT, NPT Extension, and massage-specific checklists, the average reporting percentages were 50%, 10% and 45%, respectively. Of 68 assessed items in total (exclusion of 3 repeated items on intervention), 42 were poorly presented, including 18 CONSORT items, 15 NPT items, and 9 massage-specific items. Although the overall quality of reporting showed slightly improvement in articles published after 2010, the international (English) journals presented a higher score of the CONSORT and NPT items, while the Chinese journals were associated with the increased score of massage-specific items. CONCLUSION: The quality of reporting of published massage RCTs is variable and in need of improvement. Reporting guideline "CONSORT extension for massage" should be developed.

A Scoping Review of Cross-Sectional Studies on Traditional Chinese Medicine.

Cross-sectional studies on traditional Chinese medicine (TCM-CSs) have become the most published type of TCM observational study; however, the research scope of current TCM-CSs is unknown. A scoping review of the literature was performed. A descriptive approach to summarize the core study characteristics was prepared, along with structured tables and figures to identify salient points of similarities and differences noted across studies. The reporting quality of TCM-CSs was assessed according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) cross-sectional checklist. Eight databases (Embase, CENTRAL, MEDLINE, AMED, CBM, CNKI, WanFang, and VIP) were systematically searched for TCM-CSs published up until 20 January 2020. The literature screening and evaluating were independently conducted by two researchers. When there was disagreement, a third-party senior researcher made the judgment. A total of 198 TCM-CSs published between 1997 and 2019 were included, 160 English studies and 38 Chinese studies, respectively. More TCM-CSs were published in each successive year. The journal Evidence-Based Complementary and Alternative Medicine published more TCM-CSs (24) than any other journal. Most TCM-CSs were conducted in mainland China (81, 40.9%), followed by Taiwan, China (44, 22.2%) and HKSAR, China (19, 9.6%). The most commonly used sampling method was purposive sampling (94, 47.5%), following by convenience sampling (60, 30.3%). The research topics can be summarized in four major categories as follows: constitution-related research (11.1%), TCM pattern-related research (18.7%), TCM intervention-related research (55.1%), and others (15.6%). The average sufficient reporting rate of included TCM-CSs according to the STROBE cross-sectional checklist was 45.6%. Papers written in English reported 9 items (items 2, 4, 14a, 16a, 18, 19, 20, 21, and 22) more frequently than papers written in Chinese. The number of TCM-CSs is increasing. Research topics are diverse; however, the reporting quality is unsatisfactory. In particular, TCM-CSs need greater transparency and standardization.

Potential Targets for Treatment of Coronavirus Disease 2019 (COVID-19): A Review of Qing-Fei-Pai-Du-Tang and Its Major Herbs.

COVID-19 has been declared a pandemic by WHO on March 11, 2020. No specific treatment and vaccine with documented safety and efficacy for the disease have been established. Hence it is of utmost importance to identify more therapeutics such as Chinese medicine formulae to meet the urgent need. Qing Fei Pai Du Tang (QFPDT), a Chinese medicine formula consisting of 21 herbs from five classical formulae has been reported to be efficacious on COVID-19 in 10 provinces in mainland China. QFPDT could prevent the progression from mild cases and shorten the average duration of symptoms and hospital stay. It has been recommended in the 6th and 7th versions of Clinical Practice Guideline on COVID-19 in China. The basic scientific studies, supported by network pharmacology, on the possible therapeutic targets of QFPDT and its constituent herbs including Ephedra sinica, Bupleurum chinense, Pogostemon cablin, Cinnamomum cassia, Scutellaria baicalensis were reviewed. The anti-oxidation, immuno-modulation and antiviral mechanisms through different pathways were collated. Two clusters of actions identified were cytokine storm prevention and angiotensin converting enzyme 2 (ACE2) receptor binding regulation. The multi-target mechanisms of QFPDT for treating viral infection in general and COVID-19 in particular were validated. While large scale clinical studies on QFPDT are being conducted in China, one should use real world data for exploration of integrative treatment with inclusion of pharmacokinetic, pharmacodynamic and herb-drug interaction studies.

A scoping review of cohort studies assessing traditional Chinese medicine interventions.

BACKGROUNDS: Identifying topics and assessing the reporting quality of Traditional Chinese Medicine (TCM) cohort studies. METHODS: A scoping review of the literature was performed. A descriptive approach to summarize the core study characteristics was prepared, along with structured tables and figures to identify salient points of differences noted across studies. The reporting quality of TCM cohort studies was assessed according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)-cohort checklist. RESULTS: A total of 199 TCM cohort studies were included. The largest number of TCM cohort studies was conducted in Mainland China (70.9%). The TCM cohort study was first published in 2003. The top three diseases studied were Acquired Immune Deficiency Syndrome (AIDS), Stroke, and Asthma. As for the intervention methods, Chinese herbal medicine formulas (60.3%), acupuncture (14.1%) and single herbs (12.6%) accounted for the majority, followed by moxibustion (4.0%) and qigong (2.0%). The overage sufficient reporting rate of included TCM cohort studies according to the STROBE-cohort checklist was 42.9%. Comparing with Chinese literature, the reporting rates of English literature in most items were higher. CONCLUSION: For the application of cohort studies to inform the effects of TCM interventions, the interventions assessed and conditions studied were diverse, the reporting quality was unsatisfied.

Effectiveness of the Chinese herbal formula TongXieYaoFang for irritable bowel syndrome: a systematic review.

OBJECTIVE: Irritable bowel syndrome (IBS) is a common problem, but treatment is unsatisfactory. Although Chinese herbal medicines have been tried, there are limited data to support their usage. The authors set out to systematically review the effectiveness of the Chinese herbal medicine TongXieYaoFang (TXYF) and TXYF with different Chinese herbal additions (TXYF-A) in the management of IBS in order to make evidence-based recommendations. METHODS: The authors searched the literature to identify randomized trials of TXYF or TXYF-A for patients with IBS by using MEDLINE, EMBASE, the Cochrane Controlled Trials Register (CCTR), the Cochrane Complementary Medicine Fields Specialized Register from 1966 to 2004, the CMB Disc database from January 1978 to December 1988, and the Full Text Chinese Journal database from January 1994 to December 2004. Standard forms regarding study design, treatment course, outcome measures, and adverse events were used to abstract data. Studies were assigned a quality score based on published methodology. Relative risk (RR) and 95% confidence interval (CI) were analyzed. RESULTS: Twelve studies (n = 1125) that met the criteria for review were identified. There was heterogeneity in the studies with regard to herbal formulas, control medicine, treatment course, and outcome measurement. The quality of all studies was low. The pooled analyses of effectiveness for the near-term (immediately after finishing the treatment course), short-term (3 months after finishing the treatment course), and long-term (6 months or more after finishing the treatment course) effectiveness showed that the effect of TXYF-A was better than that of conventional medicine in four, two, and six studies, respectively. The RRs were 1.34 (95% CI 1.16-1.54, p < 0.05), 1.39 (95% CI 1.17-1.64, p < 0.05), and 1.34 (95% CI 1.12-1.61, p < 0.05), respectively. Overall, combining all data from the 12 studies, the effectiveness of TXYF-As was higher than that in control groups, with statistical significance and RR of 1.35 (95% CI 1.21-1.50, p < 0.05). CONCLUSIONS: There is evidence to indicate the potential usefulness of TXYF-A for IBS patients. The results were limited by the poor quality and heterogeneity of these studies. Further studies with carefully designed, randomized double-blinded placebo-controlled trials will be needed to confirm the effectiveness of TXYF or TXYF-A for IBS.

Improving the quality of randomized controlled trials in Chinese herbal medicine, part I: clinical trial design and methodology.

OBJECTIVE: To discuss the quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) with respect to design and methodology, and provide suggestions for further improvement in future clinical trials. METHODS: A search of the Cochrane Library was conducted to identify RCTs of CHM on line in July 2005. Quality of the RCTs was assessed using a 11-item checklist modified from the revised CONSORT statement, with 2 items specific to CHM (i.e. herb preparation form and quality control of herbs). RESULTS: The search yielded 167 RCTs that were selected for assessment. All trials included statements about the interventions, objectives, primary outcome design, statistical methods, and herb preparation form. Although 163 (97.6%) trials reported inclusion criteria, exclusion criteria were only reported in 26 (15.6%) trials. Fewer than 10% of trials clearly stated the random allocation sequence generation methods, and only 2.4% mentioned allocation concealment. The vast majority (86.8%) of trials were open-label, while only 13.2% used blinding. Almost half (45.5%) administered the CHM intervention as a tea or decoction. Only one trial (0.6%) reported a sample size calculation, and a single trial (0.6%) discussed quality control of the CHM intervention. CONCLUSION: The overall methodologic quality of RCTs in CHM was poor. It is essential to improve the design of future RCTs in this clinical area. RECOMMENDATIONS: (1) Investigator conducting RCTs should have formal training about clinical trial design; (2) A flow chart is recommended to ensure that all essential steps of clinical trial design are included. (3) Conducting pilot studies prior to RCTs may help improve their design; (4) Registration of clinical trials and publishing their protocols prior to enrollment may reduce publication bias and solicit peer reviews of the proposed design; (5) Collaboration between CHM investigators and traditional medicine academic research centers interested in integrative medicine may lead to quality improvement of RCTs of CHM.

Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design.

OBJECTIVE: To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. METHODS: A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. RESULTS: Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. CONCLUSION: A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. RECOMMENDATIONS: (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical characteristics of test intervention as closely as possible and is completely inert; (5) No treatment control groups should only be used when withholding treatment is ethical and objectives outcomes will not be subject to bias due to absent blinding; (6) Crossover control groups may be appropriate in chronic and stable conditions.

Improving the quality of randomized controlled trials in Chinese herbal medicine, part IV: applying a revised CONSORT checklist to measure reporting quality.

OBJECTIVE: To discuss the quality of reporting in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the reporting of future clinical studies in this therapeutic area. METHODS: A search of the Cochrane Library was conducted to identify RCTs of CHM. A revised CONSORT checklist designed for CHM clinical studies was implemented. The revised CONSORT checklist contained 63 items, including the following new items added specifically for CHM: (1) "syndrome of disease" based on Chinese medicine theories; (2) rationale of CHM formula; (3) formula composition; (4) preparation form of CHM; (5) quality control of CHM. RESULTS: The overall reporting quality of the RCTs as assessed with the revised CONSORT checklist varied between 19% and 44%, with a median score of 32% (standard deviation 8%). CONCLUSION: The overall quality of reporting of RCTs of CHM evaluated with a revised CONSORT checklist was poor, reflecting the need for improvements in reporting future clinical trials in this area. RECOMMENDATIONS: To improve the quality of reporting of RCTs of CHM, we recommend adopting a revised CONSORT checklist that includes items specific to CHM. We also recommend that editors of CHM journals require authors to use a structured approach to presenting their trials as a condition of publication.

Improving the quality of randomized controlled trials in Chinese herbal medicine, part III: quality control of Chinese herbal medicine used in randomized controlled trials.

OBJECTIVE: To discuss quality control of Chinese herbal medicine (CHM) in randomized controlled trials (RCTs), and to provide suggestions for improving this aspect in future clinical study in this therapeutic area. METHODS: A search of the Cochrane Library was conducted to identify RCTs of CHM. Quality control information reported in those RCTs was then assessed independently. RESULTS: The search yielded a total of 167 RCTs of CHM for a variety of conditions. A total of 11 CHM preparations were used in those RCTs. Only one trial discussed quality control of the CHM interventions used. Issues affecting the safety and efficacy of CHM products used in RCTs were discussed including standardization of raw herbal materials, processing methods, screening for product contamination, and effects of combination products. CONCLUSION: The overall quality of reporting of RCTs of CHM was poor, reflecting the need for improvements in reporting future clinical trials in this area. RECOMMENDATIONS: To improve quality control of CHM used in RCTs in future, we recommend developing and implementing guidelines such as Good Agricultural Practice (GAP) for Chinese crude drugs, and current Good Manufacturing Practice (GMP) specific to CHM products. Chemical analyses of individual herbs of CHM and combination products are also recommended to provide reference standards for quality control.

[Quantitative analysis of the palatal features affected by digit-sucking habit using a laser scanning system].

OBJECTIVE: To investigate the influence of digit-sucking habit on palatal features in pre-school children by using a laser scanning system. METHODS: Forty pre-school children were chosen according to the results of questionnaires, among which 20 with digit-sucking habit(digit-sucking group) and 20 without any oral habits(control group). Impression of the upper jaw was taken from each child. After laser scanning the plaster casts, and three-dimensional reconstruction by the computer, parameters of anterior and posterior palatal length, width and height were measured, ratios of height/width, length/width and width ratio of anterior and posterior palatal were analyzed. The differences of palatal features between two groups were analyzed by t test. RESULTS: There was statistical significance between digit-sucking group and control group in posterior palatal width, anterior palatal length and anterior palatal height. The ratios of height/width and length/width in both posterior and anterior areas were statistically significant (P < 0.05). Compared to the control group, the results indicated that palatal features were relatively deeper, narrower and more protrusive in digit-sucking group. CONCLUSION: The digit-sucking habit may have some deleterious impacts on the palatal features in pre-school children with primary dentition. And it is practical to measure the spacial palatal features by using laser scanning system to some extent.

[Association between preterm low birth weight and maternal cytokine levels of saliva and gingival crevicular fluid].

OBJECTIVE: To examine the hypothesis that periodontitis was one of the sources of inflammation in preterm low birth weight (PLBW) mothers and investigate the relationship between PLBW and inflammatory factors. METHODS: The samples of saliva and gingival crevicular fluid (GCF) were collected from 83 PLBW mothers (PLBW group) and 44 normal birth weight (NBW) mothers (NBW group). The levels of IL-1beta and IL-6 were analyzed by enzyme-linked immunosorbent assay. The concentrations of cytokines in saliva and GCF were compared between the two groups. RESULTS: IL-1beta level in saliva of PLBW group was higher than which of NBW group significantly [(78.32+/-11.81) ng/L vs. (39.66+/-11.89) ng/L, P<0.05]. There was no statistically significant difference on IL-6 level in saliva [(17.45+/-3.13) ng/L vs. (16.28+/-0.66) ng/L], IL-1beta level in GCF [(93.58+/-13.22) ng/L vs. (81.38+/-9.28) ng/L] and IL-6 level in GCF [(15.35+/-0.28) ng/L vs. (14.87+/-0.37) ng/L) between two groups, but those of PLBW group were higher than NBW group. Significant negative correlations existed between gestational age at delivery and probing depth. It was also found significant negative correlations between gestational age at delivery and IL-6 (r=-0.274, P<0.01), between the weight of the new born infants and IL-6 levels in saliva (r=-0.424, P<0.01), IL-1beta level in GCF (r=-0.231, P<0.01). CONCLUSIONS: There was a tendency presenting the higher inflammatory cytokine in GCF and saliva, the shorter gestation period and the lower birth weight. The levels of cytokine in saliva and GCF were higher in PLBW mothers. The correlation may be exist between maternal periodontitis and PLBW.