Yùquán Wān
Yùquán Wān
Yùquán Wān
Review Article
Efficacy and Safety of the Chinese Patent Medicine Yuquan Pill on
Type 2 Diabetes Mellitus Patients: A Systematic Review
and Meta-Analysis
Sihan Peng ,1,2 Ziyan Xie,1,2 Xiyu Zhang,1,2 Chunguang Xie,1 Jian Kang,1 Haipo Yuan,1
Gang Xu,1,2 Xiangeng Zhang,3 and Ya Liu 1
1
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
2
Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
3
Sichuan Nursing Vocational College, Chengdu, Sichuan, China
Received 7 October 2021; Revised 6 November 2021; Accepted 8 November 2021; Published 2 December 2021
Copyright © 2021 Sihan Peng et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background. Yuquan Pill (YQP), a Chinese patent medicine for the treatment of diabetes, is widely used in the treatment of
diabetes and its complications in China. However, the efficacy of YQP on type 2 diabetes mellitus (T2DM) has not been completely
assessed. The aim of this study is to evaluate the efficacy and safety of YQP in the treatment of T2DM. Materials and Methods. We
systematically searched 9 databases for specific keywords from inception to Oct 2021. We included randomized controlled trials
(RCTs) involving YQP in the treatment of T2DM without language limitation. The study conformed to the Cochrane Handbook
and Review Manager software was used for data analysis. The weighted mean differences (WMDs) and 95% confidence intervals
(CIs) were used to measure treatment effects. Results. The final analysis included 10 publications. Analysis showed that the
combination of YQP and conventional treatment was more effective than conventional treatment alone with regard to the levels of
fasting blood glucose (WMD � −0.83; 95% CI [−1.01,−0.66]; p < 0.00001), two-hour postprandial glucose (WMD � −1.40; 95% CI
[−1.49,−1.31]; p < 0.00001), glycosylated hemoglobin (WMD � −0.87; 95% CI [−1.26, −0.49]; p < 0.00001), total cholesterol
(WMD � −0.50; 95% CI [−0.61, −0.39]; p < 0.00001), c-reactive protein (WMD � −0.58; 95%CI [−0.88, −0.28]; p � 0.0002), and
overall effective rate (RR � 1.21; 95% CI [1.12, 1.31]; p < 0.00001). Conclusion. Evidence suggested that YQP might improve glucose
and lipid metabolism and inflammation in patients with T2DM. Serious adverse events were not reported. The quality of the
evidence analyzed was low and therefore our results should be interpreted with caution. More high-quality RCTs are now needed
to verify these findings.
effectively prevent the progression of diabetes and may cause We systematically searched 9 databases for specific
side effects such as gastrointestinal reactions (nausea, keywords from inception to Oct 2021, including PubMed,
vomiting, and diarrhea), dizziness [13], and hypoglycemia Web of Science, the Cochrane Library, the China National
[14]. Thus, the treatment of T2DM has become a significant Knowledge Infrastructure (CNKI), China Biology Medicine
hotspot for medical research, particularly with regard to Disc (Sino Med), the Wan Fang Database, and the VIP in-
developing new treatments for T2DM. formation resource integration service platform (CQVIP).
Traditional Chinese medicine (TCM) has a long history in YQP (approval number: Z51021085) is a commonly used
the treatment of diabetes and has been associated with re- Chinese patent medicine for the treatment of diabetes in
markable curative effects. TCM plays an important role in the China. In order to avoid missing unpublished clinical trials for
management of diabetes in China [15] and is believed to relieve patent reasons, we additionally searched the patent database.
diabetes by comprehensively regulating the qi and blood A detailed retrieval of domestic and foreign patent infor-
balance in human body. As a representative Chinese patent mation was carried out in Patent Search and Analysis of
medicine, YQP has been approved by the China Food and National Intellectual Property Administration (http://pss-
Drug Administration (CFDA) (approval number: Z51021085) system.cnipa.gov.cn/sipopublicsearch/portal/uiIndex.shtml).
for the treatment of diabetes and its complications. YQP Google scholar was also carefully searched to find missing
comprises the following herbs: Pueraria montana var. publications. We included all RCTs that were associated with
Thomsonii (Benth.) (gě g�en), Trichosanthes kirilowii Maxim. YQP for T2DM without language limitation. The search terms
(ti�an hu�a fěn), Ophiopogon japonicus (Thunb.) Ker Gawl. (mài were as follows: “Yuquan Pill,” “Yuquan wan,” “Yuquan,”
d�ong), Rehmannia glutinosa (Gaertn.) DC. (dı̀ huáng), Schi- “Yu-Quan Pill,” “yuquan pill,” “Diabetes Mellitus,” “Diabetes
sandra chinensis (Turcz.) Baill. (wǔ wèi zǐ), and Glycyrrhiza Insipidus,” “Diet, Diabetic,” “Prediabetic State,” “Glycation
glabra L. (g�an cǎo). According to the basic theory of TCM, End Products, Advanced,” “Gastroparesis,” and “Glucose
T2DM is triggered by yin deficiency. YQP has the efficacy of Intolerance.” Meanwhile, we also carefully studied the ref-
nourishing yin, moistening dryness, and promoting fluid, erences of the relevant literature for more available studies.
which can treat T2DM in essence. The composition and details
of YQP are generalized in Figure 1 and Table 1.
Since its approval, YQP has become one of the most 2.2. Inclusion and Exclusion Criteria. Only randomized
commonly used Chinese patent medicines to treat diabetes and controlled trials (RCTs) that assessed the effects of YQP for
its complications. The Guidelines for the Prevention and T2DM were selected. Reviews, retrospective study, and animal
Treatment of Diabetes by Traditional Chinese Medicine (2011 experiments were excluded. For participants, we only included
Edition) issued by the Chinese Medical Association recom- adult patients with a definite diagnosis of T2DM, without
mends YQP as the prescription for the treatment of diabetes limitations relating to gender, regions, and ethnicity. According
[16]. Studies have shown that YQP can improve insulin sen- to the American Diabetes Association’s diabetes guidelines
sitivity, regulate glucose and lipid metabolism, and improve [28], the diagnostic criteria for T2DM are as follows: fasting
macrovascular disease and microvascular disease in diabetic blood glucose (FBG) ≥126 mg/dL (7.0 mmol/L) or 2-hour
patients [17–19]. YQP has also been shown to protect endo- postprandial blood glucose (2hPG) ≥200 mg/dL (11.1 mmol/L)
thelial cells, alleviate inflammatory responses, and reduce the during Oral glucose tolerance test (OGTT) or glycosylated
serum levels of vascular endothelial growth factor (VEGF) hemoglobin (HbA1c) ≥6.5% (48 mmol/mol) or in a patient
[20–22]. An increasing number of clinical studies have re- with classic symptoms of hyperglycemia or hyperglycemic
ported that YQP may effectively improve the clinical symptoms crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L). In
and indicators of T2DM [23–26]. However, to the best of our terms of types of interventions, the treatment groups were
knowledge, there has been no evaluation that has systematically treated with YQP, including pills, decoction, and granules,
analyzed the efficacy and safety of YQP and whether this drug regardless of frequency and duration. The control group re-
represents an ideal form of alternative therapy. In the present ceived conventional diabetes medicine or placebo treatment. It
study, we used evidence-based methods to evaluate the efficacy was worth mentioning that the studies that adopted multiple
and safety of YQP for the treatment of T2DM. Our aim was to interventions or that YQP was not the primary intervention
provide more robust scientific evidence for clinicians, re- had been excluded. As this research aims to systematically
searchers, and policy makers. evaluate the effects of YQP in the treatment of T2DM, the
primary outcomes of the present study were FBG, 2hPG, and
HbA1c. The secondary outcomes were total cholesterol (TC),
2. Methods c-reactive protein (CRP), and overall effective rate, while the
2.1. Database and Search Strategies. The protocol for this safety was measured by adverse effects.
systematic review was registered in the International Pro-
spective Register of Systematic Reviews (PROSPERO) with a 2.3. Data Collection and Analysis
registration number CRD42021261805.
This review was designed and performed in accordance 2.3.1. Study Selection. Study selection was independently
with the guidelines of Preferred Reporting Items for Sys- done by two investigators (JK and HY), based on the titles
tematic Review and Meta-Analysis Protocols (PRISMA-P) and abstracts to select for appropriate publications. EndNote
2015 [27]. All reviewers received relevant training to grasp V.X9 software was used for literature management. Any
the background, purpose, and process of the review. disagreements were submitted to a senior investigator (GX).
Evidence-Based Complementary and Alternative Medicine 3
Pueraria montana var. thomsonii (Benth.). Trichosanthes kirilowii Maxim. Ophiopogon japonicus (Thunb.) Ker Gawl.
Yuquan Pill
Rehmannia glutinosa (Gaertn.) DC. Schisandra chinensis (Turcz.) Baill. Glycyrrhiza glabra L.
2.3.2. Data Extraction and Management. The following [29]. The grades were rated as “low,” “high,” or “unclear”
information was independently extracted by two reviewers risk of bias, based on the following items: random se-
(JK and GX): general information, including the first author, quence generation, allocation concealment, incomplete
journal, publication time, and country; participant charac- data, blinding, selective reporting, and other sources of
teristics, such as sample size, gender, mean age, and duration bias. Any differences were discussed and resolved with a
of disease; interventions of treatment and control groups; third researcher (HY).
outcomes including FBG, 2hPG, HbA1c, TC, CRP, and
overall effective rate. The information was cross-checked by
two investigators, and any disagreements were resolved by a 2.3.4. Data Analysis. We used Review Manager (version 5.3)
third reviewer (SP). software to analyze all data to evaluate the effect of YQP on
T2DM patients from the aspects of blood glucose, blood lipid,
and so on. Continuous variables, including FBG, 2hPG,
2.3.3. Assessment of Risk of Bias. Two independent in- HbA1c, TC, and CRP, were evaluated by weighted mean
vestigators (JK and GX) assessed the risk of bias in the differences (WMDs) and 95% confidence intervals (CIs). Di-
light of the Cochrane Collaboration’s Risk of Bias tool chotomous data, such as overall effective rate and risk ratio
4 Evidence-Based Complementary and Alternative Medicine
(RR) with 95% CI, was used to measure the treatment effect. 3.3. The Risk of Bias in the Analyzed Studies. We investigated
When important data was incomplete in the reported litera- the risk of bias for all the articles included in our analysis. All
ture, we contacted the authors by various means to get more the study items were randomly divided into a YQP group
relevant information. and a control group. The randomization of treatments was
not consistent when compared across the 10 articles; only
one study [42] was classified as low risk of bias because it was
2.3.5. Subgroup Analysis. The heterogeneity was assessed
randomized using a random number table; another study
by the I2 value. If the I2 value exceeds 50%, it means that
[48] did not include randomization and was therefore as-
there is significant statistical heterogeneity [30]. Subgroup
sociated with a high risk of bias; the other 8 studies did not
analysis was constructed to explore the potential causes of
mention the specific randomization method used; the risk of
heterogeneity. The subgroup analysis focused on the
bias for these papers was therefore determined as being
following factors: different ages (≥50 y or < 50 y), different
‘unclear.’ None of the RCTs reported allocation conceal-
control groups (metformin or other treatments), dura-
ment. In terms of performance bias, none of the 10 articles
tions of T2DM (≥10 y or < 10 y) or different regions, and
included in this analysis reported the blinding of the par-
so on.
ticipants or researchers. Therefore, we classified all 10 studies
as having a high risk of bias in this domain. With regard to
2.3.6. Sensitivity Analysis. When the outcomes were un- other biases, one study [40] did not report the treatment
stable, sensitivity analysis was carried out by removing duration; therefore the risk was classified as being high. The
studies with high risk of bias and recalculating the pooled complete and detailed analysis for the risk of bias is pre-
data to evaluate the robustness of merged results. sented in Figures 3 and 4.
analyses according to different ages, control treatments, and regions showed no significant difference between groups (p
durations of disease showed no significant difference in in- for interaction � 0.84, 0.05, and 0.81, resp.) (Table 3, Sup-
tervention effect between groups (p for interaction � 0.11, plementary Materials 11–13).
0.74, and 0.26, resp.), and the significant heterogeneity was
still observed (Table 3, Supplementary Materials 6–8).
3.4.6. Overall Effective Rate. The overall effective rate was
divided into significant effective, effective, and ineffective
3.4.4. Total Cholesterol. Three studies involving 247 T2DM according to the degree of improvement of clinical symp-
evaluated the effect of adding YQP to conventional treatment toms and related indicators (mainly refers to blood glucose
on TC levels [45, 48, 49]. The combination therapy might level, including FBG, 2hPG, and HbA1c). Six researches that
significantly reduce the TC levels in T2DM patients compared involved 600 patients mentioned overall effective rate as
with control group (WMD � −0.50; 95% CI [−0.61, −0.39]; outcome [41, 43–47]. Since the absence of substantial het-
p < 0.00001, fixed effects model; see Figure 8) and with low erogeneity (χ 2 � 2.70, p � 0.75, and I2 � 0%; see Figure 10),
heterogeneity (χ 2 � 1.65, p � 0.44, and I2 � 0%; see Figure 8). In we used the fixed effects model for statistical analysis. The
subgroup analysis, there was no significant difference between results of the meta-analysis showed that YQP might result in
subgroups of different ages (p � 0.20) and different courses of a significant increase in overall effective rate compared with
treatment (p � 0.97) (Table 3, Supplementary Materials 9–10). conventional treatment (RR � 1.21; 95% CI [1.12, 1.31];
p < 0.00001; see Figure 10). Subgroup analyses by different
ages, control treatments, courses of treatment, and regions
3.4.5. C-Reactive Protein. Four studies explored CRP be- showed no significant difference in effect size (p for inter-
tween treatment group and control group [41, 43–45]. All action � 0.90, 0.79, 0.27, and 0.50, resp.) (Table 3, Supple-
the studies involving 406 T2DM patients showed that YQP mentary Materials 14–17).
plus conventional treatment might significantly reduce CRP
(WMD � −0.58; 95% CI [−0.88,−0.28]; p � 0.0002, random
effects model; see Figure 9). Significant heterogeneity was 3.4.7. Adverse Effects. Adverse effects were reported in 7 of
observed (χ 2 � 17.54, p � 0.0005, and I2 � 83%; see Figure 9). 10 studies. Three of them reported that no adverse effect
Subgroup analyses according to different ages, safety, and was found [42, 43, 48]. Four studies [41, 44, 45, 49]
6
0 25 50 75 100
(%)
4. Discussion
Blinding of participants and personnel (performance bias)
Table 3: Continued.
p value for
Number of comparisons Results p value for overall effect I2
subgroup difference
Age 0.84
<50 y 1 −0.55 [−0.69, −0.41] <0.00001 NA
≥50 y 3 −0.61 [−1.18, −0.05] 0.03 88%
Safety 0.05
No adverse effects 1 −1.13 [−1.49, −0.77] <0.00001 NA
Adverse effects occurring 3 −0.62 [−0.97, −0.26] 0.0007 89%
Region 0.81
Henan province 2 −0.81 [−1.38, −0.25] 0.005 88%
Other provinces 2 −0.69 [−1.52, 0.14] 0.10 94%
Overall effective rate RR (95%CI)
All comparisons 6 1.21 [1.12, 1.31] <0.00001 0%
Age 0.90
<50 y 2 1.22 [1.08, 1.38] 0.001 0%
≥50 y 4 1.21 [1.09, 1.34] 0.0002 0%
Different control treatment 0.79
Metformin 3 1.20 [1.08, 1.34] 0.001 0%
Other treatments 3 1.23 [1.10, 1.37] 0.0003 0%
Course of treatment 0.27
<8 w 1 1.10 [0.92, 1.33] 0.30 NA
≥8 w 5 1.24 [1.14, 1.35] <0.00001 0%
Region 0.50
Henan province 2 1.18 [1.06, 1.30] 0.002 0%
Other provinces 4 1.24 [1.11, 1.38] 0.0001 0%
FBG, fasting blood glucose; 2hPG, two-hour postprandial glucose; HbA1c, glycosylated hemoglobin; TC, total cholesterol; CRP, c-reactive protein; Y, year; W,
week.
and different intervention measures may lead to a certain 4.3. Strengths and Limitations. Our study has several ad-
extent of clinical heterogeneity. Methodological hetero- vantages. For example, this is the first systematic review to
geneity may be caused by differences in trial design and investigate the efficacy and safety of YQP for the treatment
poor methodological quality, such as the inappropriate use of T2DM. Furthermore, we used a wide range of search
of blinding methods and hidden differences in allocation. terms to conduct a comprehensive and systematic search of
In the present study, our subgroup analysis was based on a established national and international databases. When
range of factors, including age, course of disease, inter- missing or unclear data were evident, we actively contacted
vention measures, and the treatment duration; these an- the authors to obtain relevant information. Secondly, in
alyses involved post hoc analysis, thus reducing the order to provide a comprehensive description of the use of
reliability of our subgroup analysis. YQP in the treatment of T2DM, this study was conducted
in strict accordance with established methodology for
systematic reviews. The results were carefully interpreted to
4.2. Certainty of the Evidence. We used GRADEpro software ensure accuracy and avoid misleading conclusions. Thirdly,
to assess the certainty of the evidence that was analyzed in this systematic review and meta-analysis described and
this study. Figure 11 showed that the FBG, 2hPG, and the evaluated the present clinical trials on YQP for T2DM,
effective rate had a moderate quality of evidence, while filling the blank in existing knowledge. We found that,
HbA1c and TC in RCTs had a low certainty of evidence, compared with conventional treatment, the combined use
and CRP had a very low certainty of evidence. The observed of YQP and conventional medicine could improve glucose
reduction in the certainty of evidence was mainly attributed and lipid metabolism and inflammation, associated with
to the high risk of bias in the studies analyzed, inconsis- T2DM. The results of this study provide new treatment
tency between the included studies, and the imprecision of options for T2DM. YQP may improve the inflammatory
the findings. Specifically, this is due to the low methodo- condition of diabetes, which is the pathological basis and
logical quality of the included studies, the high heteroge- key factor of multiple complications of diabetes. It has far-
neity of some studies, and the small sample size of some reaching influence, extensive research prospects, and im-
studies. The poor methodological quality of some of the portant research significance, and it is worth further in-
included studies was indicated by unclear randomization vestigation. Although our current research is limited, we
allocation and blinding strategies. As a direct result of these believe that, with the continuous development and pro-
factors, our current findings should be considered cau- motion of traditional Chinese medicine, the importance of
tiously for clinical practice. Additional and more stan- YQP for T2DM will become increasingly prominent. We
dardized RCTs are now needed to fully validate the effects hope that our study may provide new directions, ideas, and
of YQP on T2DM. methods for the study of T2DM.
10 Evidence-Based Complementary and Alternative Medicine
Although we made every effort to be rigorous and this meta-analysis was small and of low quality; these factors
accurate in our research process, some limitations should be led to a low degree of certainty in terms of evidence.
taken into account. First, the number of studies included in Consequently, our results should be interpreted with
Evidence-Based Complementary and Alternative Medicine 11
Figure 11: Certainty of evidence: Yuquan Pill compared to control treatment for T2DM. CI, confidence interval; MD, mean difference; RR,
risk ratio. a Randomization allocation and the blinding are unclear in articles. b There is serious heterogeneity among the studies included in
the analysis of this outcome. c Results are imprecise since the study included relatively few studies and few patients.
caution. Secondly, there were some defects in the included In addition, the safety of YQP remains unclear because
articles with regard to RCT design. Certain methodologies some studies did not report adverse events; thus, adverse
related to random sequence generation, the allocation events could not be systematically collated and analyzed. In
concealment, and blinding were generally poor. Only one subgroup analyses, the cutoff points for age and duration of
study [42] clearly reported the generation of random se- disease are mainly based on related studies, and more
quences. Furthermore, none of the RCTs involved alloca- biological basis is needed. Although we performed sub-
tion concealment or the blinding of participants or group analyses for each outcome, the source of hetero-
researchers. This may have led to the overestimation of geneity was not fully identified. Due to the limited number
efficacy. Thirdly, since patients were only recruited from of studies included in this meta-analysis, we were unable to
Chinese hospitals, our study may not be globally repre- conduct meta-regression analysis to further explore the
sentative and lacks clinical applicability. Whether YQP can source of heterogeneity. Furthermore, we were unable to
be applied to other ethnic groups remains to be elucidated. apply funnel plots to evaluate publication bias.
12 Evidence-Based Complementary and Alternative Medicine
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14 Evidence-Based Complementary and Alternative Medicine