Efficacy and Safety of the TCM Qi-Supplementing Therapy in Patients with Myasthenia Gravis: A Systematic Review and Meta-Analysis

Background. The Traditional Chinese Medicine (TCM) Qi-supplementing therapy has been used widely for treating myasthenia gravis (MG) in China. The purpose of this meta-analysis was to evaluate the efficacy and safety of Qi-supplementing therapy as an adjunctive therapy in MG patients. Methods. Seven electronic databases were searched through June 2016. Randomized controlled trials (RCTs) evaluating the add-on effect of Qi-supplementing therapy in MG patients were included. The outcome measures were the total effective rate, relapse rate, and adverse events. Results. Twenty-three RCTs involving 1,691 MG patients were included. The included studies were of low-to-moderate quality. Meta-analysis showed that Qi-supplementing therapy combined with Western medicine (WM) significantly improved the total response rate and reduced the relapse risk during 6–24 months of follow-up. Subgroup analysis showed that Qi-supplementing therapy only affected the total response rate within the first 6 months of treatment. Moreover, the rate of adverse events was lower with the addition of Qi-supplementing therapy to WM than with WM only. Conclusions. Short-term Qi-supplementing therapy combined with WM appears to be superior to WM for improving the total response rate and reducing the relapse rate. However, more high-quality RCTs are warranted owing to methodological flaws of previous trials.

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Efficacy and safety of Si-Jun-Zi-Tang-based therapies for functional (non-ulcer) dyspepsia: a meta-analysis of randomized controlled trials

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-020-03176-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Yaping Wang ◽

Bin Liu ◽

Xiuqiong Fu ◽

Tiejun Tong ◽

Zhiling Yu

Keyword(s):

Relapse Rate ◽

Large Scale ◽

Primary Outcome ◽

Response Rate ◽

Meta Analysis ◽

Risk Of Bias ◽

Efficacy And Safety ◽

History Of ◽

Non Ulcer Dyspepsia

Abstract Background The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis. Methods Systematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias. Results A total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported. Conclusion SJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management. Trial registration Systematic review registration: [PROSPERO registration: CRD42019139136].

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Efficacy and Safety of Eltrombopag with or without Immunosuppressant in Patients with Relapsed/Refractory Acquired Aplastic Anemia: A Real-World Experience

Blood ◽

10.1182/blood-2021-145549 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 1124-1124

Author(s):

Jiang Ji ◽

Ziqi Wan ◽

Jing Ruan ◽

Yali Du ◽

Miao Chen ◽

...

Keyword(s):

Adverse Events ◽

Aplastic Anemia ◽

Median Time ◽

Relapse Rate ◽

Real World ◽

Reticulocyte Count ◽

Efficacy And Safety ◽

Overall Response ◽

Significant Difference

Abstract Background: Eltrombopag (EPAG) with or without immunosuppressant (IST) has been applied in acquired aplastic anemia (AA), yet data of EPAG+IST in relapsed/refractory AA was limited, and no study has compared efficacy and safety between EPAG+IST and EPAG monotherapy in relapsed/refractory AA patients. Aims: To evaluate and compare the efficacy and safety between EPAG+IST and EPAG monotherapy in relapsed/refractory AA patients in a real-world setting. Methods: Data from patients diagnosed as acquired AA in our center were retrospectively collected. All the enrolled patients were refractory/relapsed to the standard IST for at least 6 months before EPAG. All patients had been treated with EPAG, which was started at 25 mg/day and increased every 2 weeks to a maximum of 150 mg/day until a best response was achieved. Meanwhile, some patients were treated with cyclosporin A (CsA) or tacrolimus (FK506) at the same time. EPAG had to be prescribed for at least 6 months before evaluation. Complete response (CR), overall response (OR) and relapse rate, as well as adverse events and factors which could affect efficacy were analyzed. Results: Totally 99 patients (83 non-severe AA (NSAA) and 16 SAA) were included in the study. The median age at EPAG initiation was 46 (13-88) years old, the median time of EPAG treatment was 11 (6-41) months and the median time of follow-up was 18 (6-41) months. 72 patients were treated with EPAG+IST, including 41 (56.9%) treated with EPAG+FK506 and 31 (43.1%) treated with EPAG+CsA. 27 patients were treated with EPAG alone. No significant difference was found between EPAG+IST group and EPAG group in patient baseline characteristics like age, male proportion, NSAA proportion, presence of PNH clone, proportion of previous ATG+CsA / CsA treatment, previous IST duration and dosage. With compatible follow-up time, EPAG exposure duration and dosage, there was no significant difference in OR/CR rate at 3 rd/6 th/12 th month between patients who was treated with EPAG+FK506 and EPAG+CsA. Under similar compatible baseline conditions, the OR rate was 33.3% vs 22.2% (P=0.284) at 3 rd month, 61.1% vs 37.0% (P=0.032) at 6 th month, and 67.2% vs 42.1% (P=0.051) at 12 th month for patients treated with EPAG+IST and EPAG alone, respectively, but no significant difference was found in time to response (3 (1-12) vs 3 (1-7) months, P=0.679) or CR rate at 3 rd/6 th/12 th month (6.9%/12.5%/20.7% vs 3.7%/7.4%/5.3%, P>0.05) between the two groups. Relapse occurred at 6 th to 12 th month of EPAG treatment, and the relapse rate at 12 th month was 9.8% and 27.3% (P=0.154) for patients treated with EPAG+IST and EPAG alone, respectively. For patients treated with EPAG+IST, responders had a significantly higher baseline reticulocyte count (60.25 (11.5-230.5)×10 9/L vs 16.7 (6.6-56.6)×10 9/L, P=0.040) compared with non-responders. No predictive factors for the overall response were found for patients treated with EPAG alone. Adverse events which led to dosage regulation were gastrointestinal disorders (2.8% vs 3.7%, P=1.000), elevated creatinine (2.8% vs 0, P=0.599), elevated ALT (1.4% vs 0, P=1.000) and arthralgia (0 vs 3.7%, P=0.280) for patients with EPAG+IST and EPAG, respectively. No deaths were found in either group, while the clone evolution rate was 2.8% and 3.7% (P=1.000) in EPAG+IST and EPAG monotherapy group, respectively. Conclusion: EPAG+IST had higher OR rate than EPAG monotherapy with similar side effects for patients with relapsed/refractory acquired AA. Those with higher baseline reticulocyte count were more likely to respond to EPAG+IST. Key words: relapsed/refractory, aplastic anemia, eltrombopag, immunosuppressant, efficacy Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: In the presented study, eltrombopag was prescribed in relapsed/refractory aplastic anemia patients.

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Towards the development of a reciprocal liaison service

Psychiatric Bulletin ◽

10.1192/pb.24.10.379 ◽

2000 ◽

Vol 24 (10) ◽

pp. 379-381 ◽

Cited By ~ 2

Author(s):

Mark Davies

Keyword(s):

Response Rate ◽

Psychiatric Patients ◽

Surgical Patients ◽

Clinical Implications ◽

Total Response ◽

District Health ◽

Total Response Rate ◽

The Mean ◽

Equity Of Access

Aims and MethodThe aim of this survey was to determine attitudes among consultants in different specialities towards the development of a reciprocal liaison service providing access for psychiatric patients to medical and surgical liaison services equal to the access of medical and surgical patients to psychiatric liaison services. All medical, surgical and psychiatric consultants in a district health service were surveyed, with a total response rate of 48%.ResultsThe mean number of medical and surgical patients requiring a psychiatric liaison service was 6%. The mean number of psychiatric patients requiring medical and surgical liaison services was 11%. Ratings overall for various components of the two types of liaison service were generally similar, with acute assessments and follow-up being given a high priority for both types.Clinical ImplicationsAs liaison services are developed, the notion of equity of access for all patients is paramount. Commissioning of such services should thereby specify the reciprocal nature of development. This survey shows that generally there is a positive attitude to the development of such a service.

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The long-term efficacy and safety of combining ablation and left atrial appendage closure: A systematic review and meta-analysis

10.22541/au.162059918.83449955/v1 ◽

2021 ◽

Author(s):

Feng Li ◽

Jin-Yu Sun ◽

Li-Da Wu ◽

Jian-feng Hao ◽

Ru-Xing Wang

Keyword(s):

Pericardial Effusion ◽

Adverse Events ◽

Meta Analysis ◽

Efficacy And Safety ◽

Bleeding Events ◽

Combined Procedure ◽

Term Efficacy ◽

Device Embolization

Backgroud The long-term outcomes of this combined procedure remain elusive. This meta-analysis aimed to assess the long-term efficacy and safety of combined procedure. Methods PubMed, Embase, Cochrane Library, and Web of Science were systematically searched from the establishment of databases to 1 January 2021. Studies on the long-term (defined as a mean follow-up of approximately 12 months or longer) efficacy and safety outcomes of combined ablation and LAAC were included for meta-analysis. Results A total of 16 studies comprising 1,428 patients were included in the meta-analysis. The pooled long term freedom rate from atrial arrhythmia was 0.66 (95% confidence interval [CI], 0.59-0.71), long-term successful rate sealing of LAAC was 1.00 (95% CI, 1.00-1.00), and ischemic stroke/transient ischemic attack/systemic embolism during follow-up was 0.01 (95% CI, 0.00-0.02). Meanwhile, the rates of peri-procedural adverse events included phrenic nerve palsy, intracoronary air embolus, device embolization, peri-procedural death of 0.00 (95% CI, 0.00-0.00), procedure-related bleeding events of 0.03 (95% CI, 0.02-0.04), and pericardial effusion requiring or not requiring intervention of 0.00 (95% CI, 0.00-0.01). Moreover, the rates of long-term adverse events rate included device dislocation, intracranial bleeding, and pericardial effusion requiring or not requiring intervention, and all-cause mortality of 0.00 (95% CI, 0.00-0.00), device embolization of 0.01 (95% CI, 0.00-0.01), and other bleeding events of 0.01 (95% CI, 0.00-0.03). Conclusion This meta-analysis suggests that the strategy of combined atrial ablation and LAAC is effective and safe during long-term follow-up

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Efficacy and safety of rituximab in adult frequent-relapsing or steroid-dependent minimal change disease or focal segmental glomerulosclerosis: a systematic review and meta-analysis

Clinical Kidney Journal ◽

10.1093/ckj/sfaa191 ◽

2020 ◽

Author(s):

Cheng Xue ◽

Bo Yang ◽

Jing Xu ◽

Chenchen Zhou ◽

Liming Zhang ◽

...

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Focal Segmental Glomerulosclerosis ◽

Minimal Change Disease ◽

Meta Analysis ◽

Minimal Change ◽

Efficacy And Safety ◽

Segmental Glomerulosclerosis ◽

Steroid Dependent

Abstract Background The efficacy and safety of rituximab (RTX) in adult frequent-relapsing (FR) or steroid-dependent (SD) nephrotic syndrome (NS), including minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS), are still inconclusive. Methods We performed a systematic review and meta-analysis registered in PROSPERO (CRD42019148102) by pooling data of cohort studies or case series on adult patients with difficult-to-treat NS. Steroid-resistant NS was excluded. The primary outcomes were the complete remission (CR) rate and the relapse rate. Partial remission (PR) rate, no response (NR) rate and adverse events were the secondary outcomes. A random-effects model was performed for all the outcomes. Results We included 21 studies involving 382 adult MCD/FSGS subjects with a median follow-up duration from 12 to 43 months. RTX treatment induced a pooled 84.2% CR rate [95% confidence interval (CI): 67.7–96.3%], while MCD patients had a high 91.6% CR rate and FSGS patients a moderate 43% CR rate. However, 27.4% (95% CI 20.7–34.5%) of the patients relapsed during the follow-up. The pooled PR and NR rates were 5.8% (95% CI 1.2–12.5%) and 5.2% (95% CI 0.0–15.0%), respectively. RTX was associated with trivial adverse events and good tolerance. Conclusions In summary, by pooling results of current pilot studies, RTX may be an effective and relatively safe alternative for most adult FR or SD MCD/FSGS to displace calcineurin inhibitors or prednisone in the hierarchy of treatment. More clinical trials comparing RTX with other immunosuppressants and concerning the long-term adverse events are needed.

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Efficacy and Safety of Hydroxychloroquine for Hospitalized COVID-19 Patients: A Systematic Review and Meta-Analysis

Journal of Clinical Medicine ◽

10.3390/jcm10112503 ◽

2021 ◽

Vol 10 (11) ◽

pp. 2503

Author(s):

Adrian V. Hernandez ◽

Mi T. Phan ◽

Jonathon Rocco ◽

Vinay Pasupuleti ◽

Joshuan J. Barboza ◽

...

Keyword(s):

Adverse Events ◽

Meta Analysis ◽

Efficacy And Safety ◽

Serious Adverse Events ◽

Non Invasive ◽

Non Invasive Ventilation ◽

Inverse Variance ◽

Secondary Outcomes ◽

Meta Analyses

We systematically reviewed the efficacy and safety of hydroxychloroquine as treatment for hospitalized COVID-19. Randomized controlled trials (RCTs) evaluating hydroxychloroquine as treatment for hospitalized COVID-19 patients were searched until 2nd of December 2020. Primary outcomes were all-cause mortality, need of mechanical ventilation, need of non-invasive ventilation, ICU admission and oxygen support at 14 and 30 days. Secondary outcomes were clinical recovery and worsening, discharge, radiological progression of pneumonia, virologic clearance, serious adverse events (SAE) and adverse events. Inverse variance random effects meta-analyses were performed. Thirteen RCTs (n=18,540) were included. Hydroxychloroquine total doses ranged between 2000 and 12,400 mg; treatment durations were from 5 to 16 days and follow up times between 5 and 30 days. Compared to controls, hydroxychloroquine non-significantly increased mortality at 14 days (RR 1.07, 95%CI 0.92–1.25) or 30 days (RR 1.08, 95%CI 1.00–1.16). Hydroxychloroquine did not affect other primary or secondary outcomes, except SAEs that were significantly higher than the control (RR 1.24, 95%CI 1.05–1.46). Eleven RCTs had high or some concerns of bias. Subgroup analyses were consistent with main analyses. Hydroxychloroquine was not efficacious for treating hospitalized COVID-19 patients and caused more severe adverse events. Hydroxychloroquine should not be recommended as treatment for hospitalized COVID-19 patients.

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Efficacy and Safety of CGRP Monoclonal Antibodies for the Prevention of Migraine Compared with Placebo: A Systematic Review and Meta-Analysis

10.21203/rs.3.rs-39329/v1 ◽

2020 ◽

Author(s):

Xiaojing Yi ◽

Yun Chen ◽

Kun Chen ◽

Mo Liu ◽

Jiale Yi ◽

...

Keyword(s):

Systematic Review ◽

Monoclonal Antibodies ◽

Adverse Events ◽

Injection Site ◽

Response Rate ◽

Meta Analysis ◽

Upper Respiratory Tract ◽

Efficacy And Safety ◽

Upper Respiratory ◽

Secondary Outcomes

Abstract Background: Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are a novel class of drugs for migraine that includes erenumab, fremanezumab, galcanezumab and eptinezumab. In clinical trials, CGRP mAbs have been reported to show good efficacy in the prevention of episodic migraines or chronic migraines. Our aim was to evaluate the efficacy and safety of CGRP monoclonal antibodies in this study.Methods: We systematically searched for randomized controlled trials in the PubMed, Embase, ClinicalTrials.gov, and Cochrane Library databases. The primary outcome was overall mean change from baseline to end of treatment in the number of monthly migraine headache days (MMHDs). The secondary outcomes included 50% response rate, in the number of monthly headache days (MHDs), in the number of monthly headache hours (MHHs), and in the number of monthly acute migraine-specific medication days (MSMDs). The safety outcomes were evaluated in terms of reported adverse events. Results: Eighteen studies including 11,099 patients were included in the meta-analysis. The meta-analysis showed that CGRP mAbs exhibited a significant benefit in reducing the number of MMHDs compared to placebo (Episodic migraine: Std. MD -0.42, 95% CI -0.47 to -0.36; Chronic migraine: Std. MD -0.28, 95% CI -0.35 to -0.21). Similarly, CGRP mAbs were superior to placebo in the secondary outcomes of 50% response rate, MHDs, MHHs, and MSMDs. With respect to safety, serious adverse events and withdrawal due to adverse events were not significantly associated with CGRP mAbs. Fremanezumab was associated with a significantly higher incidence of any adverse event compared with placebo (RR 1.10, 95% CI 1.03 to 1.17). Galcanezumab was associated with significantly higher treatment-emergent adverse events compared with placebo (RR 1.11, 95% CI 1.04 to 1.17). Constipation and injection site pain were significantly higher with erenumab than placebo. Injection site erythema and injection site induration were significantly higher with fremanezumab than placebo. Upper respiratory tract infection, injection site erythema, injection site pruritus and injection site reaction were significantly higher with galcanezumab than placebo. Conclusions: This study confirms that CGRP mAbs are effective as preventive treatments for episodic migraines and chronic migraines. Adverse reactions at the injection site were associated with erenumab, fremanezumab and galcanezumab therapy. Constipation was more common with erenumab. The risk of upper respiratory tract infection was higher with galcanezumab.Systematic review registration: Our PROSPERO protocol registration number: CRD42019125928. Registered 26 November 2019.

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Initial and Long-Term Outcomes of Splenectomy in Adult Immune Thrombocytopenic Purpura (ITP) Patients: A Systematic Review and Meta-Analysis.

Blood ◽

10.1182/blood.v110.11.1321.1321 ◽

2007 ◽

Vol 110 (11) ◽

pp. 1321-1321

Author(s):

Joseph Mikhael ◽

Craig M. Kessler ◽

Mark Danese ◽

Robert Deuson

Keyword(s):

Failure Rate ◽

Relapse Rate ◽

Laparoscopic Splenectomy ◽

Response Rate ◽

Meta Analysis ◽

Platelet Response ◽

Open Splenectomy ◽

Chronic Itp

Abstract Splenectomy serves as a common therapy in treating adults with chronic ITP. Laparoscopic splenectomy was introduced in 1991 with the goal of reducing complication rates. This study was designed to estimate both the initial surgical non-response rate and the long-term relapse rate of splenectomy in the post-laparoscopic era. A systematic literature review was conducted by searching PubMed for articles published between January 1, 1991 and October 3, 2006. Selection criteria included: chronic ITP, study enrollment in 1990 or later, ≥12 months of follow-up, ≥15 patients with ITP, ≥75% of patients at least 14 years of age, not HIV positive, and not undergoing a second splenectomy. Response rates for surgery were collected according to an author-defined platelet response criterion (platelet counts <50x109/L or <30x109/L in 75% of studies). Relapse rates post-splenectomy (using the same platelet response criteria) were also collected. A meta-analysis was conducted to estimate a pooled surgical non-response rate as well as a pooled relapse rate in responders by weighting the study-specific estimates by the inverse of their variances, using Stata 9™. The pooled relapse rate was converted to a probability using the exponential formula, e(-rate x time). We identified 161 articles for detailed review. Of these, 24 met our inclusion criteria, all of which were observational studies. These studies represent 1,138 laparoscopic splenectomies (66 or 5.8% were converted to open splenectomy during surgery), and 317 open or undefined splenectomies. The average surgical non-response rate across 21 studies reporting data was 12.2% (95% CI: 10.3–14.3%). The average long-term relapse rate per person year across all studies was 53 per 1,000 patient years (95% CI: 45.0–62.0%). This corresponds to a 5% per year failure rate, or 32% failure rate after 5 years, for all patients initiating surgery. Initial non-response rate to planned splenectomy is 12% in adults with ITP. For patients undergoing laparoscopic splenectomy, 6% required conversion to open splenectomy. The 5 year relapse rate post-splenectomy is 32%. Splenectomy, although the current standard of care, is not always initially successful and does not provide a durable response in all patients. The benefits and risks of splenectomy must be weighed in light of newer options of therapy currently available. Relapse Rate per 1,000 Patient-years of Follow-up for Each Study Relapse Rate per 1,000 Patient-years of Follow-up for Each Study

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Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

Cadernos de Saúde Pública ◽

10.1590/0102-311x00157013 ◽

2013 ◽

Vol 29 (suppl 1) ◽

pp. s17-s31 ◽

Cited By ~ 3

Author(s):

Cassyano Januário Correr ◽

Inajara Rotta ◽

Thaís de Souza Teles ◽

Rangel Ray Godoy ◽

Bruno Salgado Riveros ◽

...

Keyword(s):

Adverse Events ◽

Meta Analysis ◽

Biological Agents ◽

Severe Psoriasis ◽

Biological Agent ◽

Controlled Trials ◽

Efficacy And Safety ◽

Short Term ◽

Serious Adverse Events

We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible.

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Efficacy and Safety of Safflower Yellow in Early Diabetic Nephropathy: A Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/8065376 ◽

2019 ◽

Vol 2019 ◽

pp. 1-10 ◽

Cited By ~ 1

Author(s):

Xiuze Jin ◽

Liuyan Shi ◽

Feng Chang ◽

Yun Lu

Keyword(s):

Conventional Therapy ◽

Urinary Albumin Excretion ◽

Meta Analysis ◽

Fasting Blood Glucose ◽

Effective Rate ◽

Urinary Albumin ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Excretion Rates

Background. Diabetic nephropathy (DN) is a major cause of end-stage renal disease. In order to palliate renal function impairment and reduce kidney related mortality, it is crucial to treating DN patients at the early stage. This study aims to assess the efficacy and safety of conventional therapy combined with safflower yellow versus conventional therapy alone in early DN patients. Methods. A meta-analysis of randomized controlled trials that compared safflower yellow plus conventional therapy with conventional therapy alone in early DN patients was conducted. Papers were searched using the electronic databases and reference lists. Two reviewers working independently extracted relevant data and carried out risk-of-bias assessments. Statistical analysis was undertaken in Review Manager 5.3. Results. Fourteen trials (1,072 patients) were included in the meta-analysis. Conventional therapy combined with safflower yellow was associated with a higher effective rate (RD, 0.24; 95% CI, 0.17 to 0.30) and a greater decline in urinary albumin excretion rates (SMD, -1.34; 95% CI, -1.77 to -0.92), fasting blood glucose (MD, -0.57; 95% CI, -0.98 to -0.16), serum creatinine (MD, -12.36; 95% CI, -14.66 to -10.06), and blood urea nitrogen (SMD, -0.93; 95% CI, -1.13 to -0.73) in the subgroup with a follow-up time > 15 days. The incidence of adverse events did not differ significantly between these two regimens (RD, -0.01; 95% CI, -0.03 to 0.01). Findings were similar in the subgroup with a follow-up time < 15 days. Conclusions. Conventional therapy combined with safflower yellow had a more beneficial effect than conventional therapy alone in early DN patients. There were significant differences in effective rate, urinary albumin excretion rates, fasting blood glucose, serum creatinine, and blood urea nitrogen between the two regimens and no significant difference in adverse events. More randomized controlled research using standardized protocols would be needed in the future to compare these two regimens.

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