To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi (HHRY) pills for endometriosis-associated dysmenorrhea.

This study constitutes a multicenter, randomized, double-blind, placebo-controlled trial encompassing a three-menstrual cycle intervention followed by a three-menstrual cycle follow-up period. A total of 164 eligible females with endometriosis-associated dysmenorrhea were randomly divided into HHRY pills and placebo groups in a 1:1 ratio. The primary outcome included dysmenorrhea symptoms assessed using Visual Analog Scale (VAS) scores and quality of life, whereas the secondary outcome measures included the maximum VAS for non-menstrual pelvic pain, duration of pain episodes (in days), frequency and quantity of the consumption of ibuprofen sustained-release capsules (or other non-steroidal anti-inflammatory drugs), and days off work/study for staff/student due to dysmenorrhea, ovarian cyst, and/or pelvic nodule size. The safety was monitored throughout the treatment period. All the analyses were based on the intention-to-treat principle. For continuous outcomes, simple or multiple linear regressions were used to estimate the differences between the HHRY pills and placebo groups, with categorical data expressed as the number and percentage of occurrences. Differences were compared using the chi-square test or Fisher's exact test. The predefined analysis was adjusted for concomitant treatment, a variable considered to be associated with outcomes but unaffected by treatment allocation. Estimates of treatment effects were reported with 95% confidence intervals. Two-tailed P values ≤ .05 were considered statistically significant.

Positive results from this trial, upon completion would provide robust evidence for the efficacy and safety of HHRY pills in treating dysmenorrhea in patients with endometriosis.

To evaluate the efficacy and safety of Baimai ointment in patients with lumbar disc herniation (LDH).

This study presents a prospective randomized, double-blind, placebo-controlled, multicenter clinical trial protocol. A total of 194 cases will be employed, with a 1:1 allocation ratio for each group. Patients will receive either Baimai ointment or placebo over a 14-day treatment period, which will be followed by a 1-week follow-up period. Visual analogue scale scores will be used for the level of pain, the Japanese Orthopedic Association score will be measured primarily to determine the functional status, the Likert scale will be graded for the level of numbness, and rescue therapy use and compliance with health education will be recorded. Laboratory tests and adverse event records will also be applied for safety assessments.

In summary, this trial will assess the clinical efficacy and safety of Baimai ointment for LDH for the first time. The use of a placebo has the advantage of precluding anticipatory biases resulting from inadequate blinding. Outcome assessors, data managers, statisticians, and all related study staff will be blinded to avoid any bias caused by subjective factors in the study subjects and investigators. Valuable information for clinical LDH treatment and future research on Baimai ointment will be generated from the findings.

To evaluate the effectiveness and safety of Chinese herbal medicines (CHMs) for incomplete immune reconstruction in patients with HIV/AIDS.

Eight electronic databases were searched for randomized controlled trials (RCTs) on the use of CHM for patients with HIV/AIDS with incomplete immune reconstruction. Outcomes included CD4⁺ cell count, quality of life, and adverse events/effects. The Cochrane Risk of Bias was employed to evaluate the methodological quality of the included RCTs.

We identified 13 eligible RCTs, with an overall high risk of bias, on 10 different CHMs. There was a significant increase in CD4⁺ cell count after the use of Jianpi Yiqi medicinal paste for 3 months; tripterygium glycosides tablets (TGTs) for 3 months (mean difference [MD] 52.63 cells/μL, 95% confidence interval [CI, 46.98, 58.28]), 6, 9, and 12 months; Wenshen Jianpi granules for 6 months; Shenling Fuzheng capsules for 6 months (MD 49.53 cells/μL, 95% CI [8.45, 90.61]) and 12 months; Aikeqing granules for 9 months (MD 61.51 cells/μL, 95% CI [16.25, 106.77]) and 12 months; Guipi decoction for 12 months; Mianyi No.2 granules (JT) for 12 and 18 months; and Chinese medicine granules for 18 months. The increase in the mean difference of CD4⁺ cell count from 6 to 18 months was larger in Chinese medicine granules and Mianyi No.2 granules (JT). Guipi decoction and Jianpi Qushi decoction improved the Karnofsky score. Four RCTs reported the outcome of adverse events/effects, while four cases of minor adverse effects were reported in the TGTs group.

Jianpi Yiqi medicinal paste, Wenshen Jianpi granules, Shenling Fuzheng capsules, Aikeqing granules, Guipi decoction, and TGTs may be effective in increasing CD4⁺ within 12 months, and Mianyi No.2 granules (JT) and Chinese medicine granules may show long-term effects. High-quality large RCTs on the effectiveness and safety of CHMs are still warranted.

Qualitative research on therapeutic components is necessary to evaluate the efficacy of complex interventions in healthcare. As few qualitative syntheses have been conducted, this study aimed to derive a new conceptual framework for understanding the components of complex interventions and provide evidence for the implementation and evaluation of complex healthcare interventions.

A systematic search of seven databases was conducted to identify qualitative studies that explored components of complex healthcare interventions. Meta-ethnography was used to analyze the data and thematic analysis was used to build the conceptual framework.

Of the 35 included studies, most complex interventions were non-pharmacological, with cancer accounting for 22%, mental health for 14%, and stroke for 8%. Half of the studies were conducted in the United Kingdom. Three main categories emerged: what should healthcare workers do? what qualifications should they have? and what should patients do? Five main themes were identified: psychological, biological, cognitive and behavioral, environmental, and social support.

This analysis provides a reference for designing components of complex interventions in further studies.

This study assessed whether Chinese herbal medicine (CHM) combined with probiotics/synbiotics for irritable bowel syndrome - diarrhea (IBS-D) was more effective and safer than probiotics/synbiotics alone.

Ten databases were searched for randomized control trials (RCTs) of IBS-D as diagnosed by Manning or Rome criteria. Trials comparing probiotics and probiotics with CHM were included. The Cochrane risk of bias (ROB) was evaluated for each trial. RevMan 5.3 was used to conduct a meta-analysis.

Twenty-six RCTs were included (25 Chinese, 1 English), involving 2045 participants. Meta-analysis was conducted on two outcomes: overall symptom improvement and relapse. CHM combined with live Bifidobacterium and Lactobacillus preparations reduced relapse rate (RR 0.28, 95%CI 0.15–0.52, 3 trials, n = 205) compared with probiotics alone. The subgroup analysis showed the benefit of CHM prescriptions based on soothing liver and invigorating spleen (1.28, 1.14–1.44, 3,244), invigorating spleen and resolving dampness (1.20, 1.03–1.41, 2,128), or warming and invigorating spleen and kidney formulae (1.27, 1.09–1.46, 2,210) combined with triple Bifidobacterium preparations than the same probiotics alone which improved overall symptoms for IBS-D. There was unclear bias in almost domains of ROB. Most studies had a high risk of bias due to lack of blinding of investigator and participants, and selective reporting.

This study showed that CHM combined with probiotics may reduce relapse rate by 72%, and improve overall symptoms of IBS-D (as diagnosed by Rome Ⅱ and Ⅲ) compared to probiotics alone. From the limited subgroup analysis, only soothing liver and invigorating spleen formulae, represented by Tongxie Yaofang, added to triple Bifidobacterium preparations may be superior to the single preparations in terms of overall symptoms. However, due to the poor methodological quality and small sample size of the trials, these findings must be interpreted with caution.

Herbal remedies have been widely utilized in treating chronic hepatitis C (CHC) worldwide. Selecting appropriate outcomes to reflect both beneficial and harmful effects is a crucial step in designing randomized controlled trials (RCTs). This study evaluated the outcomes reported in RCTs on herbal remedies for CHC with comparison to the core outcomes recommended by the Cochrane Hepato-Biliary Group (CHBG), to check the consistency of the outcomes and to provide recommendation for future researches.

A systematic literature search was conducted in Western and Chinese databases to identify RCTs on herbal remedies for adults with CHC. For each trial, all the outcomes reported in the results section were collected. Comparison between trial outcomes and CHBG core outcomes were evaluated and summarized with descriptive statistics.

A total of 116 RCTs involving 9154 participants were included; 27 outcomes were identified. Commonly reported outcomes included alanine aminotransferase (64 trials, 55.2%), adverse events (58 trials, 50.0%), and end-of-treatment virological response (50 trials, 43.1%). All trials indicated that the herbal remedies under investigation had a positive effect and was markedly more effective than the control. Nearly half of the trials reported that the combination of herbal medicine and antiviral drugs could ameliorate adverse events. Very few trials reported primary core outcomes relating survival and quality of life. The most frequently reported core outcomes are non-serious adverse events (54 trials, 46.6%), viral response (27 trials, 23.3%), and biochemical response (24 trials, 20.7%).

The variation and inconsistency in trial outcomes impedes research synthesis efforts, and indicate the need for comparable outcomes through the development of core outcome sets in CHC. The low concordance of outcome reporting could be improved by following CHBG core outcomes recommendation.

Due to a lack of available effective treatments for atopic eczema (AE), non-pharmaceutical therapy such as Tuina has been frequently sought after as an alternative treatment. We evaluated the benefits and harms of Tuina for children with AE under 14 years of age.

We searched for randomized controlled trials (RCTs) on Tuina in seven Chinese and English databases from their inception to June 2018. We included children under 14 years of age with AE received Tuina alone or combined with conventional medicine. Two authors independently extracted data and used the Cochrane "Risk of bias" tool to assess the methodological quality. Effects were presented as relative risk with 95% confidence interval using RevMan 5.3. Data not suitable for statistical pooling were synthesized qualitatively.

Nine RCTs involving 1246 children with AE were included. The trials were at unclear or high risk of bias. Tuina manipulation in each trial was different. Compared to usual care, three trials showed greater effects of Tuina alone or combined with usual care for global symptoms and signs improvement, such as itching, and skin lesions. Four trials showed that Tuina had ≥50% improvement in symptoms and signs. Due to clinical heterogeneity, meta-analysis was not possible. At follow-up of between 4 weeks and 6 months, five trials of Tuina alone or Tuina combined with usual care showed lower rates of relapse compared to usual care alone. Four trials reported no occurrence of severe adverse events.

Limited evidence demonstrates that Tuina may improve symptoms and signs of AE and reduce relapse rate in children < 14 yrs with AE. Tuina is generally acceptable in these trials. Further well-designed RCTs are warranted to confirm these benefits and to explore safety further.