Traditional Chinese Medicine in Cancer Care: An Overview of 5834 Randomized Controlled Trials Published in Chinese.

BACKGROUND: Traditional Chinese medicine (TCM) is widely integrated into cancer care in China. An overview in 2011 identified 2384 randomized and non-randomized controlled trials (RCTs, non-RCTs) on TCM for cancer published in the Chinese literature. This article summarizes updated evidence of RCTs on TCM for cancer care. METHODS: We searched 4 main Chinese databases: China National Knowledge Infrastructure, Chinese Scientific Journal Database, SinoMed, and Wanfang. RCTs on TCM used in cancer care were analyzed in this bibliometric study. RESULTS: Of 5834 RCTs (477 157 cancer patients), only 62 RCTs were indexed in MEDLINE. The top 3 cancers treated were lung, stomach, and breast cancer. About 4752 RCTs (81.45%) tested TCM combined with conventional treatment, and 1082 RCTs (18.55%) used TCM alone for treating symptoms and side-effects. Herbal medicine was the most frequently used TCM modality (5087 RCTs; 87.20%). The most frequently reported outcome was symptom improvement (3712 RCTs; 63.63%) followed by quality of life (2725 RCTs; 46.71%), and biomarkers (2384 RCTs; 40.86%). The majority of RCTs (4051; 69.44%) concluded there were beneficial effects using either TCM alone or TCM plus conventional treatment compared with conventional treatment. CONCLUSION: Substantial randomized trials demonstrated different types/stages of cancer were treated by various TCM modalities, alone or in combination with conventional medicine. Further evaluation on the effects and safety of TCM modalities focusing on outcomes such as quality of life is required.

Factors influencing the quality of clinical trials on traditional Chinese medicine-Qualitative interviews with trial auditors, clinicians and academic researchers.

BACKGROUND: As clinical trials evaluating the efficacy of traditional Chinese medicine (TCM) therapies have increased, several empirical studies have shown that the quality of TCM trials is generally low in terms of risk of bias. This qualitative study aimed to investigate the factors influencing the quality of TCM clinical trials to provide strategic advice on trial quality improvement. METHODS: One focus group with clinical trial auditors (n = 4) and six in-depth semi-structured interviews with clinical research organization managers (n = 2), lecturers and researchers in TCM academic institutions (n = 2), a chief physician in a TCM oncology department and a PhD candidate specialized in non-pharmaceutical TCM interventions were conducted. The interviews were audio-recorded, transcribed verbatim and thematically analyzed. RESULTS: Factors that influenced the quality of TCM clinical trials emerged with the following 6 themes: trial design; trialists/participants; trial conducting; TCM specified problems; trial monitoring, and finally societal influences. The lack of expertise and time inputs of the trialists were repeatedly mentioned. Methodological difficulties experienced when conducting TCM trials including calculating sample size, analyzing the efficacy of TCM decoctions with multiple ingredients, blinding in trials investigating non-pharmaceutical TCM interventions were highlighted. Interviewees agreed that third-party monitoring can help improving trial quality and improve participant welfare, may accelerate recruiting processes and increase compliance; however more comprehensive regulations and funding requirements would be needed. CONCLUSIONS: This study identified real-life issues influencing the quality of TCM clinical trials from design to reporting. In addition to mandatory training for TCM trial designers and coordinators, more effective institutional oversight is required. Future studies should explore specific measures to address the methodological problems in TCM trials and explore how the quality of TCM trials can affect further evidence synthesis and clinical practice.

The effects of Chinese herbal medicines for treating diabetic foot ulcers: A systematic review of 49 randomized controlled trials.

OBJECTIVE: To assess the effects and associated risks of Chinese herbal medicine (CHM) for diabetic foot ulcer (DFU). METHODS: We systematically searched seven electronic databases for randomized controlled trials (RCTs) about Chinese herbal medicines for treating diabetic foot ulcers. The methodological quality of RCTs was assessed by the Cochrane risk of bias tool. Data was synthesized using review manager (RevMan) 5.3. Meta-analysis was conducted if the data were available. A summary of finding table was generated by The GRADEpro Guideline Development Tool (GDT) online. RESULTS: Forty-nine RCTs, all conducted in China, involving 3646 participants were included. Most of the included trials had unclear or high risk of bias. Twenty-six trials could be pooled in five Meta-analyses, the remaining trials could not be pooled due to the obvious clinical heterogeneity. Only low evidence showed CHM therapy may have 42%-60.4% participants healed completely after treatment, approximately twice (RR 1.42-1.76) as much as the healed rates in conventional therapy (or plus hot water foot bath) group. Majority of the included trials reported benefit of CHM group on shortening healing time (4-23 days) and reducing ulcer wound size (at least 2 cm2). No serious adverse events were reported related to the medication in all trials. CONCLUSION: Weak evidence showed benefit of CHM as add-on treatment of conventional therapy on increasing number of ulcer heals in patients with DFU. That's about twice the healing rate of the conventional treatment (or plus hot water foot bath) group. With insufficient information, we could not draw confirmative conclusion on safety of CHM administration. These findings need to be tested in further large, rigorous trials.