Hongjin Xiaojie Capsule, a Chinese patent medicine, for treating moderate to severe cyclical breast pain: A single-blind randomized controlled trial.

BACKGROUND: Moderate to severe breast pain has major effects on the quality of life for patients. Patent Chinese medicines are widely used in the treatment of breast pain due to their stable dosage form and good efficacy. OBJECTIVE: To evaluate the beneficial effects and safety of Hongjin Xiaojie Capsule (HJXJC), a Chinese patent medicine, for the treatment of cyclical breast pain. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: This is a multicenter, single-blind randomized controlled trial conducted in 3 medical centers in China from 2019 to 2021. Patients with moderate to severe cyclic breast pain were randomly divided into the intervention group (who took HJXJC, four capsules per dose, three times a day for 12 weeks) and the control group (waiting for the treatment) in a 1:1 ratio. MAIN OUTCOME MEASURES: The primary outcome was pain duration, and the patients recorded measurements at baseline and at the end of weeks 4, 8, 12 and 16 on a patient log card. RESULTS: The full analysis set (FAS) population included 298 participants (intervention group, n = 150; control group, n = 148), while the per-protocol analysis set (PPS) included 274 participants. After 12 weeks, the duration of breast pain was significantly shorter in the intervention group (FAS: mean difference, -6.69; 95% CI, -7.58 to -5.80; P < 0.01, vs control. PPS: mean difference, -7.09; 95% CI, -8.01 to -6.16; P < 0.01, vs control). The Short-form McGill Pain Questionnaire (SF-MPQ) scores were significantly lower in the intervention group (FAS: mean difference, -12.55; 95% CI, -13.90 to -11.21; P < 0.01, vs control. PPS: mean difference, -13.07; 95% CI, -14.48 to -11.66; P < 0.01, vs control). The above indicators continued to be significantly different through week 16. Moreover, in the intervention group, breast lumps shrank after 12 weeks and the size of breast lumps was statistically smaller than that in the control group (P < 0.05), whereas the sizes of breast nodules and uterine fibroid showed no statistically significant difference compared with the control group (P > 0.05). At weeks 8 and 12, the dysmenorrhea scores in the intervention group were lower than those in the control group (P < 0.05). No obvious adverse reactions were observed in any group. CONCLUSION: HJXJC can significantly shorten the duration of breast pain, reduce breast pain, reduce the size of breast lumps, and relieve dysmenorrhea. However, it has no significant effect on the size of breast nodules or uterine fibroid. TRIAL REGISTRATION: This trial has been registered at the ISRCTN Registry. Number: ISRCTN44184398. PLEASE CITE THIS ARTICLE AS: Zhang Q, Fan YY, Wu XQ, Huo YD, Wang CH, Liang SB, Wang T, Zhong R, Wang X, Lai BY, Pei XH, Liu JP. Hongjin Xiaojie Capsule, a Chinese patent medicine, for treating moderate to severe cyclical breast pain: A single-blind randomized controlled trial. J Integr Med. 2024; 22(5): 552-560.

Nationwide survey of physicians' familiarity and awareness of diabetes guidelines in China: a cross-sectional study.

OBJECTIVE: This study aims to investigate physicians' familiarity and awareness of four diabetes guidelines and their practice of the recommendations outlined in these guidelines. DESIGN: A cross-sectional study. SETTING: An online questionnaire survey was conducted among physicians affiliated with the Specialist Committee for Primary Diabetes Care of China Association of Chinese Medicine, using the snowball sampling method to ensure a broader representation of physicians. PARTICIPANTS: 1150 physicians from 192 cities across 30 provinces in China provided complete data. RESULTS: Tertiary care hospital physicians (TCPs) exhibited the highest familiarity with the Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (91.3%), followed by the National Guidelines for the Prevention and Control of Diabetes in Primary Care (76.8%), the Standards of Medical Care in Diabetes (72.2%) and the Guidelines for Prevention and Treatment of Diabetes in Chinese Medicine (63.8%). Primary care practitioners (PCPs) exhibited familiarity with these four guidelines at about 50% or less. Self-reported reference to modern diabetes guidelines by physicians is more frequent than traditional Chinese medicine (TCM) diabetes guidelines, with rates at 73.2% and 33.8%, respectively. Approximately 90% of physicians provided instructions on self-monitoring of blood glucose to their patients with diabetes. Less than one-third of physicians referred patients to a specialised nutritionist. In terms of health education management, TCPs reported having a diabetes health management team at the rate of 75.7%, followed by secondary care hospital physicians at 57.0% and PCPs at 27.5%. Furthermore, approximately 40% of physicians did not fully grasp hypoglycaemia characteristics. CONCLUSIONS: Familiarity and awareness of the screening guidelines varied among physicians in different hospital settings. Importantly, significant discrepancies were observed between physicians' awareness and their self-reported reference to modern medicine guidelines and TCM guidelines. It is essential to consistently provide education and training on diabetes management for all physicians, particularly PCPs.

Clinical Effectiveness and Safety of Chinese Herbal Medicine Compound Kushen Injection as an Add-On Treatment for Breast Cancer: A Systematic Review and Meta-Analysis.

OBJECTIVE: To systematically evaluate the effect and safety of compound Kushen injection (CKI) as an add-on treatment on the treatment for breast cancer. METHODS: We searched eight major electronic databases from their inception to November 1, 2021, for randomized clinical trials (RCTs) comparing CKI plus chemotherapy with chemotherapy alone. Primary outcomes included objective response rate (ORR) and disease control rate (DCR), health-related quality of life (HRQoL), progression-free survival (PFS), and overall survival (OS). Secondary outcomes included adverse drug reactions (ADRs) and tumor marker level. We used Cochrane's RevMan 5.3 for data analysis. The GRADEpro was used to appraise the certainty of evidence. Trial sequential analysis (TSA) was applied to estimate the required sample size in a meta-analysis and test the robustness of the current results. RESULTS: Thirty RCTs with 2556 participants were totally included. CKI plus chemotherapy showed significant effects in increasing ORR (RR 1.30, 95%CI [1.18, 1.43], I 2 = 27%, n = 1694), increasing DCR (RR 1.21, 95%CI [1.15, 1.28], I 2 = 16%, n = 1627), increasing HRQol as measured by Karnofsky Performance Scale (KPS) score improvement rate (RR 1.42, 95% CI [1.26, 1.61], I 2 = 37%, n = 1172), increasing the PFS (MD 2.24 months, 95%CI [1.26, 3.22], n = 94) and the OS (MD 2.24 months, 95%CI [1.45, 3.43], n = 94), compared to chemotherapy alone. The results showed that CKI plus chemotherapy had a lower risk of ADRs than that of chemotherapy alone group. The certainty of evidence of the included trials was generally low to very low. TSA for ORR and KPS score improvement rate demonstrated that the current results reached a sufficient power regarding both numbers of trials and participants. CONCLUSIONS: Low certainty of evidence suggested that the combination of CKI and conventional chemotherapy appeared to improve ORR, DCR, and KPS score in breast cancer patients. Conclusions about PFS and OS could not be drawn due to lack of evidence. Additionally, CKI appeared to relieve the risk of ADRs in patients with breast cancer receiving chemotherapies. However, due to weak evidence, the findings should be further confirmed in large and rigorous trials.

Risk factors for lactation mastitis in China: A systematic review and meta-analysis.

BACKGROUND: Lactation mastitis (LM) affects approximately 3% to 33% of postpartum women and the risk factors of LM have been extensively studied. However, some results in the literature reports are still not conclusive due to the complexity of LM etiology and variation in the populations. To provide nationally representative evidence of the well-accepted risk factors for LM in China, this study was aimed to systematically summary the risk factors for LM among Chinese women and to determine the effect size of individual risk factor. MATERIAL AND METHODS: Six major Chinses and English electronic literature databases (PubMed, Web of Science, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wan fang Database and China Science Technology Journal Database) were searched from their inception to December 5st, 2020. Two authors extracted data and assessed the quality of included trials, independently. The strength of the association was summarized using the odds ratio (OR) with 95% confidence intervals (CI). The population attributable risk (PAR) percent was calculated for significant risk factors. RESULTS: Fourteen studies involving 8032 participants were included. A total of 18 potential risk factors were eventually evaluated. Significant risk factors for LM included improper milking method (OR 6.79, 95%CI 3.45-13.34; PAR 59.14%), repeated milk stasis (OR 6.23, 95%CI 4.17-9.30; PAR 49.75%), the first six months postpartum (OR 5.11, 95%CI 2.66-9.82; PAR 65.93%), postpartum rest time less than 3 months (OR 4.71, 95%CI 3.92-5.65; PAR 56.95%), abnormal nipple or crater nipple (OR 3.94, 95%CI 2.34-6.63; PAR 42.05%), breast trauma (OR 3.07, 95%CI 2.17-4.33; PAR 15.98%), improper breastfeeding posture (OR 2.47, 95%CI 2.09-2.92; PAR 26.52%), postpartum prone sleeping position (OR 2.46, 95%CI 1.58-3.84; PAR 17.42%), little or no nipple cleaning (OR 2.05, 95%CI 1.58-2.65; PAR 24.73%), primipara (OR 1.73, 95%CI 1.25-2.41; PAR 32.62%), low education level (OR 1.63, 95%CI 1.09-2.43; PAR 23.29%), cesarean section (OR 1.51, 95%CI 1.26-1.81; PAR 18.61%), breast massage experience of non-medical staff (OR 1.51, 95%CI 1.25-1.82; PAR 15.31%) and postpartum mood disorders (OR 1.47, 95%CI 1.06-2.02; PAR 21.27%). CONCLUSIONS: This review specified several important risk factors for LM in China. In particular, the incidence of LM can be reduced by controlling some of the modifiable risk factors such as improper breastfeeding posture, improper milking method, repeated milk stasis, nipple cleaning, breast massage experience of non-medical staff and postpartum sleeping posture.

[Systematic review and Meta-analysis of efficacy and safety of Compound Glycyrrhizin Injection in improving chronic hepatitis B liver damage].

To evaluate the efficacy and safety of Compound Glycyrrhizin Injection(CGI) in improving liver damage in chronic hepatitis B(CHB). PubMed, Web of Science, SinoMed, CNKI, Wanfang and VIP databases were retrieved from their inception to February 10, 2020. The randomized controlled trial(RCT) of CGI in the treatment of CHB was included. Data were independently extracted by two authors, and the methodological quality was evaluated using the Cochrane bias risk assessment tool by other two authors. Statistical analysis was performed using RevMan 5.3 software. A total of 18 two-armed RCTs were included, involving 1 915 participants. The methodological quality of all studies included was generally low. In the comparison between CGI and diammonium glycyrrhizinate, the results showed that CGI was superior to the control group in improving the overall clinical effectiveness, but there was no statistical difference between the two groups in increasing ALT normalization rate, reducing ALT and AST level. In the comparison between CGI and diammonium glycyrrhizinate+other general hepatoprotective drugs, the results showed that CGI was superior to the control group in reducing AST level, while there was no statistical difference between the two groups in reducing ALT level and increasing overall clinical effectiveness. In the comparison between CGI+other commonly used drugs(including energy mixture, glutathione, vitamins, potassium magnesium aspartate) and diammonium glycyrrhizinate+other commonly used drugs, the results showed that CGI combined with other commonly used drugs was better than the control group in reducing ALT and AST level and improving the clinical total effective rate, and there was no statistical difference between the two groups in increasing the rate of ALT normalization. In the comparison between CGI+other commonly used drugs and other commonly used drugs, the results showed that CGI combined with other commonly used drugs was superior to the control group in reducing ALT and AST level and improving the overall clinical effectiveness. In the comparison between CGI+vitamins and diammonium glycyrrhizinate+potassium magnesium aspartate+vitamins, the results showed no statistical difference between the two groups in reducing AST level. A small number of studies included reported that CGI caused mild adverse reactions when used alone or in combination with other drugs. Based on the results, CGI has a certain effect in improving CHB liver damage, but the evidence is not enough to prove that CGI would cause serious adverse events. In the future, more well-designed and strictly-enforced RCT with an adequate sample size are needed to further evaluate the effect CGI in alleviating CHB liver damage.

Chinese herbal medicine (Rupi Sanjie capsule) for the treatment of breast pain: A systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Breast pain is one of the most common breast disorders, affecting 41%-69% women in the clinical populations. Chinese herbal medicine (Rupi Sanjie, RPSJ) capsule has been recommended to be commonly used for breast pain in China. This review aimed to systematically collect latest evidence and critically evaluate the eff ;ectiveness and safety of RPSJ capsule for breast pain. METHODS: We searched 6 databases from their inception to June 1, 2020 for randomized clinical trials (RCTs) comparing RPSJ capsule with conventional drug therapies, placebo or no treatment. Primary outcomes were breast pain relief, reduction of breast mass and clinical cure rate. RESULTS: Seventeen RCTs were included in total, involving 2899 participants with breast pain. RPSJ capsule showed a significant effects in shortening duration of the breast pain (MD-6.51 days, 95%CI [-8.57, -4.45], n = 82, 1 trial), shortening the duration of breast mass (MD-5.17 days, 95%CI [-7.56, -2.78], n = 82, 1 trial), improving clinical cure rate (RR 1.55, 95% CI [1.21, 2.00], I² = 64%, n = 1398, 10 trials) and total effective rate (RR 1.08, 95% CI [1.03, 1.14], I² = 71%, n = 2170, 14 trials) compared to Tamoxifen (TAM). The meta-analysis showed that the incidence of total adverse events was higher in TAM group than the RPSJ capsule group (RR 0.30, 95%CI [0.21, 0.42], I² = 49%, n = 2122, 13 trials). CONCLUSIONS: RPSJ capsule appears to be a potentially effective in treating breast pain and seems generally safe for clinical application. However, this potential benefit is inconclusive due to generally weak evidence, and the findings should be further confirmed in large and rigorous trials.

Pediatric tuina for the treatment of anorexia in children under 14 years: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Pediatric tuina is used to prevent and treat disease by employing various manipulative techniques on specific parts of the body, appropriate to the child's specific physiological and pathological characteristics. OBJECTIVE: To evaluate the effects and safety of pediatric tuina as a non-pharmaceutical therapy for anorexia in children under 14 years. METHODS: Randomized controlled trials (RCTs) comparing pediatric tuina with medicine for anorexia were included in this review. Six electronic databases were searched from inception to June 2019. Two authors independently extracted data and assessed the risk of bias. Significant effective rate (defined as appetite improved and food intake returning to 3/4 or more of normal intake) was used as primary outcome. Secondary outcomes included food intake, compliance and adverse events. Trial sequential analysis (TSA) was used to calculate the required information size in a meta-analysis and to detect the robustness of the results. Certainty of the evidence was assessed using the online GRADEpro tool. RESULTS: Of the included 28 RCTs involving 2650 children, the majority had a high or unclear risk of bias in terms of allocation concealment, blinding, and selective reporting. All trials compared tuina with western medicine or Chinese herbs. For significant effective rate, meta-analysis showed that tuina was superior to western medicine (risk ratio (RR) 1.68, 95 % confidence interval (CI) [1.35, 2.08]) and Chinese herbs (RR 1.36, 95 % CI [1.19, 1.55]). For food intake, 9 trials evaluated it in the form of score (1 points, 2 points, 4 points and 6 points) calculated according to the reduction degree of food intake. Six points represented the most serious. Meta-analysis showed tuina was superior to western medicine (mean difference (MD) -0.88, 95 % CI [-1.27, -0.50]) and Chinese herbs (MD -0.69, 95 % CI [-1.00, -0.38]) on lightening the reduction degree of food intake. Two trials reported compliance and six trials reported no adverse events occurred in pediatric tuina group. TSA for significant effective rate demonstrated that the pooled data had insufficient power regarding both numbers of trials and participants. CONCLUSIONS: Low certainty of evidence suggested pediatric tuina was beneficial and safe for the treatment of anorexia in children under 14 years. Furthermore well-designed RCTs with adequate sample sizes are needed.

Evidence Base of Clinical Studies on Qi Gong: A Bibliometric Analysis.

OBJECTIVE: This bibliometric study aimed to systematically and comprehensively summarize the volume, breadth and evidence for clinical research on Qigong. And this bibliometric analysis also can provide the evidence of this field. DESIGN: Bibliometric analysis. METHODS: All types of primary and secondary studies on humans were included: systematic reviews, randomized clinical trials, non-randomized controlled clinical studies, case series and case reports. Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Chinese Scientific Journal Database, Chinese Academic Conference Papers Database and Chinese Dissertation Database, PubMed and the Cochrane Library were searched from the date of inception to December 10, 2018. Bibliometric information, such as publication information, disease/condition, Qigong intervention and research results were extracted and analyzed. RESULTS: A total of 886 clinical studies were identified: including 47 systematic reviews, 705 randomized clinical trials, 116 non-randomized controlled clinical studies, 12 case series and 6 case reports. The studies were conducted in 14 countries. The top 15 diseases/conditions studied were: diabetes, chronic obstructive pulmonary disease, hypertension, stroke, cervical spondylosis, lumbar disc herniation, insomnia, knee osteoarthritis, low back pain, and osteoporosis, Coronary heart disease, breast cancer, periarthritis of shoulder, depression, metabolic syndrome. Of the various Qigong exercises reported in these 886 clinical studies, Ba Duan Jin was the most frequently researched in 492 (55.5%) studies, followed by Health Qigong 107 (12.1%), Dao Yin Shu 85 (9.6%), Wu Qin Xi 67 (7.6%) and Yi Jin Jing 66 (7.4%). The most frequently used comparisons in randomized trials were maintaining normal way of life unchanged 149 (18.1%), the remaining controls included conventional treatment, mainly western medicine, Chinese herbal medicine, acupuncture, health education, psychological therapy, Yoga, Tai Chi and other non-drug therapy. The most frequently reported outcomes were physical function, quality of life, symptoms, pain and mental health indicators. Beneficial results from practicing Qigong were reported in 97% of studies. CONCLUSIONS: Qigong research publications have been increasing gradually. Reports on study types, participants, Qigong Intervention, and outcomes are diverse and inconsistent. There is an urgent need to develop a set of reporting standards for various interventions of Qigong. Further trials of high methodological quality with sufficient sample size and real world studies are needed to verify the effects of Qigong in health and disease management.

Chinese Herbal Medicine Used With or Without Conventional Western Therapy for COVID-19: An Evidence Review of Clinical Studies.

Objective: To present the evidence of the therapeutic effects and safety of Chinese herbal medicine (CHM) used with or without conventional western therapy for COVID-19. Methods: Clinical studies on the therapeutic effects and safety of CHM for COVID-19 were included. We summarized the general characteristics of included studies, evaluated methodological quality of randomized controlled trials (RCTs) using the Cochrane risk of bias tool, analyzed the use of CHM, used Revman 5.4 software to present the risk ratio (RR) or mean difference (MD) and their 95% confidence interval (CI) to estimate the therapeutic effects and safety of CHM. Results: A total of 58 clinical studies were identified including RCTs (17.24%, 10), non-randomized controlled trials (1.72%, 1), retrospective studies with a control group (18.97%, 11), case-series (20.69%, 12) and case-reports (41.38%, 24). No RCTs of high methodological quality were identified. The most frequently tested oral Chinese patent medicine, Chinese herbal medicine injection or prescribed herbal decoction were: Lianhua Qingwen granule/capsule, Xuebijing injection and Maxing Shigan Tang. In terms of aggravation rate, pooled analyses showed that there were statistical differences between the intervention group and the comparator group (RR 0.42, 95% CI 0.21 to 0.82, six RCTs; RR 0.38, 95% CI 0.23 to 0.64, five retrospective studies with a control group), that is, CHM plus conventional western therapy appeared better than conventional western therapy alone in reducing aggravation rate. In addition, compared with conventional western therapy, CHM plus conventional western therapy had potential advantages in increasing the recovery rate and shortening the duration of fever, cough and fatigue, improving the negative conversion rate of nucleic acid test, and increasing the improvement rate of chest CT manifestations and shortening the time from receiving the treatment to the beginning of chest CT manifestations improvement. For adverse events, pooled data showed that there were no statistical differences between the CHM and the control groups. Conclusion: Current low certainty evidence suggests that there maybe a tendency that CHM plus conventional western therapy is superior to conventional western therapy alone. The use of CHM did not increase the risk of adverse events.

The Potential Effects and Use of Chinese Herbal Medicine Pine Pollen (Pinus pollen): A Bibliometric Analysis of Pharmacological and Clinical Studies.

The objectives of this study are to conduct a comprehensive literature search and bibliometric analysis to identify the breadth and volume of pharmacological and clinical studies on pine pollen (Pinus pollen) and to identify the potential effects and the use of pine pollen. Three Chinese electronic databases and two English electronic databases were searched for pharmacological and clinical studies on pine pollen. Data were extracted and analyzed and included publication year, authors, study type, pharmacological research topics or clinical diseases/conditions, usage and type of preparation, authors' conclusions, and adverse effects. Of 239 publications identified, 180 were pharmacological studies, 37 were clinical trials, and 22 were reviews. Numbers of publications increased particularly from 2004 onward. The top 10 most frequent topics in pharmacological studies were immune regulation, antisenility, antioxidation, liver protection, inhibiting prostate hyperplasia, inhibiting tumor cell proliferation, lowering blood glucose, lowering blood lipids, antifatigue, and improving intestinal function. The top 10 most frequent clinical diseases treated or where pine pollen was used as an adjuvant were bedsores, diaper dermatitis, hyperlipidemia, oral mucositis, eczema, hyperplasia of prostate, hypertension, prostatitis, type 2 diabetes mellitus, and radiodermatitis. Eight trials reported no adverse events associated with pine pollen, one reported mild gastrointestinal reactions, but symptoms disappeared without special management. There have been an increasing number of publications on pine pollen during the past 20 years. Pharmacological studies have shown many potential benefits, and clinical studies have indicated some positive effects when it is either used as a single herb or as an adjuvant to treat disease. Its use as a topical agent, especially for skin diseases, was notable.

Acupuncture for Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis.

PURPOSE: To assess the effectiveness and safety of acupuncture for erectile dysfunction (ED). MATERIALS AND METHODS: We searched six major English and Chinese databases included randomized controlled trials (RCTs) testing acupuncture alone or in combination for ED. Dichotomous data were presented as risk ratio (RR) and continuous data were presented as mean difference (MD) both with 95% confidence interval (CI). The Revman (v.5.3) was used for data analyses. Quality of evidence across studies was assessed by the online GRADEpro tool. RESULTS: We identified 22 RCTs, fourteen of them involving psychogenic ED. Most of the included RCTs had high or unclear risk of bias. There was no difference between electro-acupuncture and sham acupuncture with electrical stimulation on the rate of satisfaction and self-assessment (RR, 1.50; 95% CI, 0.71-3.16; 1 trial). Acupuncture combined with tadalafil appeared to have better effect on increasing cure rate (RR, 1.31; 95% CI, 1.00-1.71; 2 trials), and International Index of Erectile Function-5 scores (MD, 5.38; 95% CI, 4.46-6.29; 2 trials). When acupuncture plus herbal medicine compared with herbal medicine alone, the combination therapy showed significant better improvement in erectile function (RR, 1.68; 95% CI, 1.31-2.15; 7 trials). Only two trials reported facial red and dizziness cases, and needle sticking and pruritus cases in acupuncture group. CONCLUSIONS: Low quality evidence shows beneficial effect of acupuncture as adjunctive treatment for people mainly with psychogenic ED. Safety of acupuncture was insufficiently reported. The findings should be confirmed in large, rigorously designed and well-reported trials.

Attitude and willingness of attendance for participating in or completing acupuncture trials: a cross-sectional study.

OBJECTIVE: To explore the influence of patients' participation in and completing the acupuncture clinical trials through a cross-sectional survey. In addition, we explored potential factors involved in improving patient's compliance to treatment, thus enhancing the quality of acupuncture clinical studies. METHODS: A survey was conducted at outpatient department of acupuncture and metabolic diseases in two hospitals in Beijing. The semi-structured questionnaire was designed based on literature review and Delphi methods. It contains 15 questions related to patients' experience and attitude. SPSS 22.0 was used for analyses. OR and 95% CI were used for dichotomous outcomes. Logistic regression analysis (LRA) and multi-LRA were used to explore the factors influencing patients' participation or completion and the relationship between demographic characteristics and potential factors. RESULTS: A survey was conducted from April to September 2016. Five hundred patients were consecutively sampled to fill semi-structured questionnaires regardless of their types of disease. The participants (75.2% were female) were in the age range of 15-85 years and all of them completed the survey. The effect and safety of acupuncture therapy were considered to be the deciding factors by 92% and 96% of the respondents, respectively. Only 40 of the surveyed participants (8.0%) had previously participated in the clinical trials. The LRA showed they paid more attention to treatment regimen (frequency and session of treatment) when deciding whether or not to participate in the trials (OR 1.54, 95% CI 1.02-2.34). Multivariate LRA showed that elder people considered cost (OR 1.36, 95% CI 1.09-1.70) to be an important factor, while the participants having medical insurance (OR 1.45, 95% CI -0.20-0.93) thought informed consent was important. Meanwhile, participants with higher education preferred regular follow-up (OR 1.16, 95% CI 0.02-0.28). CONCLUSION: After providing adequate information regarding the potential benefits and harms of the acupuncture treatment, completion of the treatment within the specific time regimen was found to be the most important factor affecting patient's compliance. Other factors, such as cost and regular follow-up, should also be given special consideration.

Pediatric Tui Na for acute diarrhea in children under 5 years old: A systematic review and meta-analysis of randomized clinical trials.

OBJECTIVE: To evaluate the benefits and harms of pediatric Tui Na as a non-pharmaceutical Chinese medicine therapy for acute diarrhea in children under 5 years of age. DESIGN: Systematic review and meta-analysis of randomized clinical trials. METHODS: We searched seven major English and Chinese databases from their inception to January 2018 for randomized clinical trials (RCTs) comparing pediatric Tui Na therapy with conventional medicine (montmorillonite/diosmectite or probiotics used alone or in combination). Two authors extracted data and assessed the Cochrane risk of bias, independently. The primary outcomes are clinical cure rate and diarrhea duration from admission to the cessation of diarrhea. 'Clinical cure' is defined as the frequency, timing and character of stool back to normal status, as well as disappearance of diarrhea symptoms. We present dichotomous data as risk ratio (RR), and continuous data as mean difference (MD) with their 95% confidence interval (CI). We used the Cochrane's Revman software (v.5.3) for data analysis. Trial sequential analysis (TSA) was applied to calculate the required sample size in a meta-analysis and detect the robustness of the results. The GRADEpro was used to generate a summary of finding table. RESULTS: Totally 26 RCTs were included, involving 2410 children with acute diarrhea. Most of the included trials had high or unclear risk of bias in terms of random sequence generation, blinding, and incomplete outcome reporting. The pooled results demonstrated that pediatric Tui Na was superior to montmorillonite after three-session treatment (RR 1.45, 95% CI 1.29-1.62, n = 772, 10 trials), and also superior to montmorillonite combined with probiotics after three-session treatment (RR 2.04, 95% CI 1.49-2.78, n = 533, 7 trials) and after six-session treatment (RR 1.52, 95% CI 1.34-1.73, n = 631, 5 trials) in improving clinical cure rate. Pediatric Tui Na significantly decreased the duration of acute diarrhea (hrs) (MD -0.40 h, 95% CI -15.31 to -5.48 h, n = 410, 6 trials) and daily stool frequency (MD -1.71times, 95% CI -2.37 to -1.04, n = 217, 3 trials, after three-session treatment). No adverse event related to pediatric Tui Na was reported in the included trials. The quality of evidence of included trials was generally moderate to low. TSA for cure rate demonstrated that the pooled data reached a sufficient power regarding both numbers of trials and participants. CONCLUSIONS: This review shows pediatric Tui Na appears to be effective and safe in improving clinical cure rate and shortening diarrhea duration in childhood aged less than five years of age with acute diarrhea. However, rigorously designed well-reported RCTs are warranted to confirm the findings.

Cupping therapy versus acupuncture for pain-related conditions: a systematic review of randomized controlled trials and trial sequential analysis.

BACKGROUND: Both cupping therapy and acupuncture have been used in China for a long time, and their target indications are pain-related conditions. There is no systematic review comparing the effectiveness of these two therapies. OBJECTIVES: To compare the beneficial effectiveness and safety between cupping therapy and acupuncture for pain-related conditions to provide evidence for clinical practice. METHODS: Protocol of this review was registered in PROSPERO (CRD42016050986). We conducted literature search from six electronic databases until 31st March 2017. We included randomized trials comparing cupping therapy with acupuncture on pain-related conditions. Methodological quality of the included studies was evaluated by risk of bias tool. Mean difference, risk ratio, risk difference and their 95% confidence interval were used to report the estimate effect of the pooled results through meta-analysis or the results from each individual study. Trial sequential analysis (TSA) was applied to adjust random errors and calculate the sample size. RESULTS: Twenty-three randomized trials with 2845 participants were included covering 12 pain-related conditions. All included studies were of poor methodological quality. Three meta-analyses were conducted, which showed similar clinical beneficial effects of cupping therapy and acupuncture for the rate of symptom improvement in cervical spondylosis (RR 1.13, 95% CI 1.01 to 1.26; n = 646), lateral femoral cutaneous neuritis (RR 1.10, 95% CI 1.00 to 1.22; n = 102) and scapulohumeral periarthritis (RR 1.31, 95% CI 1.15 to 1.51; n = 208). Results from other outcomes (such as visual analogue and numerical rating scale) in each study also showed no statistical significant difference between these two therapies for all included pain-related conditions. The results of TSA for cervical spondylosis demonstrated that the current available data have not reached a powerful conclusion. No serious adverse events related to cupping therapy or acupuncture was found in included studies. CONCLUSION: Cupping therapy and acupuncture are potentially safe, and they have similar effectiveness in relieving pain. However, further rigorous studies investigating relevant pain-related conditions are warranted to establish comparative effectiveness analysis between these two therapies. Cost-effectiveness studies should be considered in the future studies to establish evidence for decision-making in clinical practice.