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Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2013, Article ID 703815, 14 pageshttp://dx.doi.org/10.1155/2013/703815

Review ArticleShengmai Injection, a Traditional Chinese PatentMedicine, for Intradialytic Hypotension: A Systematic ReviewandMeta-Analysis

Chao-yang Chen, Ling-yan Lu, Peng Chen, Kang-ting Ji, Jia-feng Lin,Peng-lin Yang, Ji-fei Tang, and YanWang

Department of Cardiology, e Second Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang 325027, China

Correspondence should be addressed to Ji-fei Tang; [email protected] and Yan Wang; [email protected]

Received 11 July 2012; Revised 5 October 2012; Accepted 11 October 2012

Academic Editor: Wolfgang Weidenhammer

Copyright © 2013 Chao-yang Chen et al. is is an open access article distributed under the Creative Commons AttributionLicense, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properlycited.

Intradialytic hypotension (IDH) is a global public health problem. A rising number of IDH sufferers resort to Chinese patentmedicine, Shengmai Injection (SMI) in China. e objectives of present study are to assess the effectiveness and safety of SMI asan adjunct therapy for IDH. A systematic search of 6 medical databases was performed up to December 2011. Randomized trialsinvolving SMI adjuvant therapy versus conventional therapywere identi�ed. RevMan5.0was used for data analysis. Ten randomizedclinical trials with 437 participants were identi�ed. Methodological quality was considered inadequate in all trials. Compared withconventional therapy, SMI adjunct therapy showed signi�cant effects in improving the clinic effective rate (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃), decreasingthe incidence of IDH episode (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃), decreasing the frequency of nursing interventions (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃), and increasing diastolicblood pressure (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃).ere was no statistical signi�cance in the improvement ofmean arterial pressure (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃) and systolicblood pressure (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃) between two groups. Four studies had mentioned adverse events, but no serious adverse effects werereported in any of the included trials. In conclusion, SMI adjunct therapy appears to be potentially effective in treatment of IDHand is generally safe. However, further rigorous designed trials are needed.

1. Introduction

Intradialytic hypotension (IDH) remains a common andintractable complication for end-stage renal disease (ESRD)patients undergoing hemodialysis [1]. It is de�ned as adecrease in systolic blood pressure (SBP) by ≥20mmHg ora decrease in mean arterial pressure (MAP) by ≥10mmHgassociated with clinical symptoms (dizziness, blurred vision,cramps, and fatigue), affecting approximately 20% to 30% ofdialysis sessions [2, 3]. Frequent hypotension episodes duringdialysis not only lead to a discomfortable feeling, limitationof rehabilitation, and consumption of a disproportionateamount of health care resources, but also contribute to highmortality in hemodialysis patients [4, 5].e etiology leadingto IDH is still complex and incompletely understood, butthe decline in blood volume, poor cardiac function, and aninadequate cardiovascular responsewere themain factors [6].

On the basis of the fundamental physiology of blood pressure,the predisposing factors for IDH can be divided into twocategories [7]: (1) factors affecting cardiac output such as thedecline of cardiac function, blood volume changes duringultra�ltration, and electrolyte changes. e combinationof le ventricular hypertrophy, recurrent cardiac ischemicinjury, and abnormalities of vascular structure and functionmay lead to myocardial �brosis with worsening diastolicfunction, chamber remodeling, and an increase in electricalexcitability and arrhythmias. If the ultra�ltration rate exceedsplasma re�lling rates, the plasma volume, preload, andcardiac output will eventually fall. Electrolyte changes canimpair myocardial electrical stability and contractility. (2)Factors affecting total peripheral resistance such as auto-nomic dysfunction (impaired sympathetic response, reducedbarore�ex sensitivity, and Bezold-Jarisch re�ex), imbalanceof vasoactive agents (impaired vasopressin response, elevated

2 Evidence-Based Complementary and Alternative Medicine

adenosine, and increased nitric oxide activity), temperature(thermogenesis and warm dialysate), and immune responseto dialysis. Currently, there is no speci�c consensus on themedical therapy for the prevention and treatment of IDH.Several common therapies were utilized in the past decadeincluding the Trendelenburg position [3], using of cooldialysate, sodium and ultra�ltration pro�ling, high dialysatecalcium, blood volume control, avoidance of food duringdialysis, correction of anemia, and pressor agents midodrine[8]. However, it remains necessary to seek novel effective andsafe inventions for IDH.

Shengmai San is a well-known traditional Chinese herbalprescription, recorded in Yixueqiyuan (Origins of Medicine)by Zhang Yuansu at the beginning of 1186 [10], and has beenapplied for cardiovascular diseases routinely and prophylacti-cally for thousands of years in China [11]. Shengmai San con-sists of 3 Chinese herbal medicines (CHMs): Renshen (RadixGinseng; Ginseng), Maidong (Radix Ophiopogonis; DwarfLilyturf Tuber), and Wuweizi (Fructus Schisandrae Chinen-sis; Chinese Magnoliavine Fruit). All three herbs of SMIare included in the Chinese Pharmacopoeia (version 2010).eory of traditional Chinese medicine believes that Sheng-mai San has the effect of supplementing Qi and nourishingYin, recovering pulse, and stopping abnormal sweating.Shengmai injection (SMI), which is developed on the basisof Shengmai San, is a popular modern Chinese patent herbalpreparation. SMI is widely used in various cardiovasculardiseases, and at least three systematic reviews to date havebeen conducted to evaluate the effectiveness of SMI on heartfailure [12], fatality rate of acute myocardial infarction [13],and hypotension aer acute myocardial infarction [14].

Evidences have accumulated from former experiments tocon�rm the effect of SMI on regulating blood pressure [15].Especially, the widespread use of SMI on hypotension due toa variety of causes is noteworthy [14]. SMI can signi�cantlyelevate blood pressure in hypotensive patients nomatter if it isessential hypotension or with secondary reasons [14, 16, 17].However, SMI has no signi�cant effect on blood pressure inhealthy subjects [18].

Pharmacological studies have revealed the effects ofSMI on multiaspects of the pathophysiology of IDH [7].e related pharmacological mechanisms of SMI were asfollows: (1) SMI can improve cardiac function throughthe protection of myocardial cells, reduction of ischemia-reperfusion injury, reduction of myocardial apoptosis,prevention of myocardial calcium overload and alleviationof myocardial hypertrophy, enhancement of myocardialcontractility, and protection of endothelial function [19]; (2)SMI can inhibit local angiotensin II activity so as to alleviatele ventricular hypertrophy [20]; (3) SMI had protectiveeffects against oxidative damage in mitochondria, cells,and tissues [21, 22]; (4) SMI had protective effects againstexperimental acute cardiogenic shock by improving thehemodynamics parameter [23]; (5) SMI can inhibit highsensitive C-reactive protein (hs-CRP) and in�ammatorycytokines such as tumor necrosis factor-𝛼𝛼 and interleukin-8and reduce the systemic in�ammatory reaction [24, 25];(6) SMI can enhance humoral immunity and inhibit thecellular immunity aer cardiopulmonary bypass [26]; (7)

SMI can increase sympathetic tone, enhance sinus nodefunction, and improve conduction [27]. (8) Impressively,Shengmai San can signi�cantly attenuate heat stroke-induced arterial hypotension and cerebral ischemia throughinhibition of inducible nitric oxide synthase-(iNOS-)dependent nitric oxide (NO) overproduction in the brainand excessive accumulation of in�ammatory cytokineslike interleukin-1 beta, interleukin-6, and tumor necrosisfactor-alpha in the peripheral blood stream [28]. In addition,Ginseng, as the principal drug in the SMI, showed the effectof improving blood pressure stability in IDH patients.Chewing �orean red ginseng could signi�cantly reduce thedegree of blood pressure drop during hemodialysis and thefrequency of symptomatic IDH, and this bene�cial effectsmay be partially due to decreased NO production and moreactivation of vasoconstrictors including endothelin-1, reninactivity (PRA), and angiotensin II (Ang II) [29].

However, the exact active ingredients of SMI for IDHtreatment are still unclear. For the chemical composition ofthe individual Chinese herb of SMI, ginsenoside, ophio-pogonin and ophiopogonone, and lignan have been pro-posed as the active components of Radix Ginseng, RadixOphiopogonis, and Fructus Schisandrae Chinensis, respec-tively [30]. ere are a number of reports about the effec-tive chemical constitutes and different analytical meth-ods for analyzing constituents in SMI. High performanceliquid chromatography (HPLC) have even been widelyemployed for content determination of Shengmai prepara-tions [31]. Recently, by the use of the liquid chromatography-electrospray ionization source in combination with hybridion trap and high-resolution time-off light mass spectrom-etry (LC-IT-TOF/MS), more than 30 ginsenosides and 20lignans were readily detected and structurally characterizedfrom SMI [30]. Interestingly, by using the on-line highperformance liquid chromatography-diode array detection-chemiluminescence (HPLC-DAD-CL) method and liquidchromatography coupled with tandem mass spectrometry(LC/MS/MS) analysis, the scavenging activities of main com-ponents detected in the individual herb were different fromthose in whole Shengmai San, suggesting that drug inter-actions in complex multiherbal formula could change theactivity of the constituents [32].

Over the past decades, a number of trials have indicatedthat SMI could have therapeutic potential in people with IDHin China. However, the evidences for the effects of SMI havenot been systematically assessed.e objective of the presentstudy is thus to assess the clinical effectiveness and safety ofSMI adjunct therapy for IDH patients.

2. Methods

is systematic review is conducted according to the paper[9].

2.1. Eligibility Criteria

2.1.1. Types of Studies. Only the randomized controlled clin-ical trials (RCTs) that evaluate the effects of SMI as adjunct

Evidence-Based Complementary and Alternative Medicine 3

therapy for IDH patients were included, regardless of blind-ing, publication status, and language. Quasi-RCTs werenot considered such as using the admission sequence fortreatment allocation.

2.1.2. Types of Participants. Patients of any age or sex withend-stage renal disease (ESRD) who were receiving long-term regular hemodialysis and had experienced episodes ofIDH were included. e diagnostic criteria were adopted inaccordance with the following. (1) Diagnosis of IDH wasmade on the basis of “De�nition of IDH” in 2005 from theEuropean Dialysis and Transplant Association and K/DOQIguideline, a decrease in SBP ≥20mmHg or a decrease inmean arterial blood pressure (MAP) ≥10mmHg associatedwith dialysis-related hypotension symptoms [2]. (2)Diagnos-tic criteria of IDH with comparable de�nitions was madeon the basis of �lood puri�cation, second edition writtenby Wang in 2003, a reduction in SBP below 90mmHg, ora decrease in SBP ≥20mmHg from prehemodialysis [33].None of them received antihypertensive drugs or any otherintervention known to in�uence the blood pressure beforedialysis.

2.1.3. Types of Interventions. SMI in any dose comparedwith the conventional therapy for IDH was considered. Weonly included studies that compared SMI with conventionaltherapy. Studies comparing SMI with another CHM wereexcluded.

2.2. Outcome Measures. e outcome measures included theclinical effective rate of SMI for IDH, the incidence rateof hypotension, the number of nursing interventions, bloodpressure level, and adverse events. Clinical effectiveness isde�ned as the ability of SMI to improve hemodynamics andclinical symptoms related to IDH. Evaluation standards forclinical therapeutic effects were as follows [34]: (1) markedlyeffective: the SBP increased more than 20mmHg or SBP>90mmHg or MAP increased by ≥10mmHg comparedwith pretreatment, with no hypotension-related symptoms,and dialysis to be completed successfully; (2) effective: SBPincreased by 10∼20mmHg or SBP >90mmHg or MAPincreased by ≥0–10mmHg compared with pretreatment,with no obvious symptoms of low blood pressure, anddialysis to be completed by adjusting the dialysis program;(3) ineffective or deterioration: blood pressure did not rise orcontinued to decline, SBP dropped to less than 90mmHg,and patients showed signi�cant symptoms of low bloodpressure, need vasopressors, volume expansion and otherdrug treatment to maintain blood pressure or were forced tointerrupt dialysis.

2.3. Search Strategy. We conducted electronic searchesin the following databases: Cochrane Central Registerof Controlled Trials (2011, issue1), Pubmed (Decem-ber 1950–2011), EMBASE (1980–2011), Chinese HospitalKnowledge Database (CHKD, December 1979–2011), Wan-fang Med Online Database (WMOD, December 1998–2011).

We also checked the references of published studies toidentify additional trials.

e following search terms were used as medical subjectheadings and key words when searching electronic databases:end-stage renal disease, end-stage renal failure, end-stagekidney failure, Shengmai, Sheng-mai Injection, hemodialysisrelated hypotension, intradialytic hypotension, IDH, and lowblood pressure. ese terms were used as Mesh and free-text terms (translated into Chinese) to search the Chinesedatabases.

2.4. Study Selection and Data Extraction. Two review authors(C.-y. Chen, L.-y. Lu) independently examined the titlesand abstracts of the potential references. Full articles for allpotentially relevant studies were retrieved. e two reviewersthen read the selected papers independently and made a �nalselection decision. Disagreements were resolved throughdiscussion or consultation with a third author (Y. Wang). Ifnecessary. e authors of the trials were contacted and askedto provide missing data.

e review authors extracted data on study character-istics, including patients, methods, interventions, and out-comes, into a standardized data extraction form. Reasons forthe exclusion of studies were recorded. For eligible studies,two review authors (C.-y. Chen, L.-y. Lu) extracted data inde-pendently. Any disagreements were resolved by consensus orby a third reviewer (Y. Wang).

2.5. Risk of Bias in Individual Studies. Assessment of risk ofbias in included studies: two review authors (C.-y. Chen, L.-y.Lu) independently assessed risk of bias for each included arti-cle, using the twelve criteria recommended by the CochraneBack Review Group [35]. e items were scored with “yes(+),” “no (−),” or “unsure (?).” Disagreements were resolvedthrough discussion with or involving a third author (Y.Wang).

2.6. Data Synthesis and Analysis. e statistical packageRevMan 5.0 provided by the Cochrane Collaboration wasused to analyze the data. Dichotomous data were presentedas odds ratio (OR), with 95% con�dence intervals (CI).Continuous outcomes were presented as weighted meandifference, with 95% CI. Meta-analysis was only performedwithin comparisons where individual trials compared similartreatment and control interventions.

3. Results

3.1. Description of Studies. We identi�ed and screened 181potentially relevant articles. Of these, 102 articles were ini-tially excluded due to duplicate publications by reading titlesand abstracts, and 53 articles were excluded because theywere case reports or lack in-comparison group, or not reportsof clinical trials, or effectiveness of SMI not being objective ofthe studies. In the identi�ed 2� potentially eligible reports,aer reading the full text, 14 articles were excluded due tocomparing SMI with another CHM, and 2 more articles were


Scre

enin

gIn

clu

ded

Eli

gib

ilit

yId

enti

fica

tio

nRecords identified through

database searching Additional records identifiedthrough other sources

Records aJer duplicates removed

Records screened

Records excluded

- Case report or lack in comparisongroup

- Not reports of clinical trials

objective of study

Full-text articles assessedfor eligibility

Studies included inquantitative synthesis

(meta-analysis)

Full-text articles excluded

- Not real RCT (2)

- Comparing SMI with another CHM(14)

- E�cacy of SMI not being

(� = 181) (� = 0)

(� = 102)

(� = 79)

(� = 53)

(� = 26)

(� = 16)

(� = 10)

F 1: �RISMA 2009 �ow diagram, from [9]. For more information, visit http://www.prisma-statement.org/statement.htm.

excluded because they were not real RCTs with hemodialysisorder used for treatment allocation [36, 37]. erefore, atotal of 10 studies were �nally included papers [38–47]. Flowdiagram was summarized in Figure 1.

3.2. Characteristics of Included Studies. A total of 437 partic-ipants were involved in the 10 studies included (Table 1). Allstudies were conducted inChina and published between 1999and 2010 on Chinese journals. Each study was performedin a single center, parallel-designed, and claimed to haveapplied randomization. 8 studies included 180 male and 124female, while the other 2 studies did not mention the gendercondition [44, 46]. e age of the participants ranged from15 years to 78 years. Etiology for ESRD was introducedin 184 patients in 5 studies [38, 41–43, 47], including 107chronic glomerulonephritis, 15 diabetic nephropathy, 35hypertensive nephropathy, 10 obstructive nephropathy, 2polycystic renal disease, 1 chronic pyelonephritis, 5 gouty

nephropathy, and 9 other types of nephropathy. 3 studiesreported the modality of dialysis, on bicarbonate dialysis for4-5 hrs and 2-3 times a wee� with a low-�ux polysulfonehollow-�ber dialyzer [40, 41, 45]. 6 studies reported theduration of the dialysis fromonemonth to 5 years [38, 39, 41–43, 45]. All of the 10 included trials were two-group paralleldesign studies.

In the interventions, conventional therapy referred totreatment according to the European Dialysis and TransplantAssociation and K/DOQI guidelines, including the use ofcool dialysate, sodium and ultra�ltration pro�ling, highdialysate calcium, blood volume control, avoidance of foodduring dialysis, correction of anemia, and the use of pressoragents such asmidodrine [2, 8].edoses of SMI used rangedfrom 40mL to 60mL. SMI was administered intravenouslyin all included studies. A variety of outcome measures werereported. Evaluation of the outcomes was performed at theend of the treatment.


T1:Ch

aracteris

ticso

fincludedstu

dies.

Inclu

destu

dies

Stud

yDesigns

Participants

Durationof

dialysis

Causeo

frenalfailu

reDialysis

equipm

ent

Mod

ality

of dialysis

Interventio

ns

Outcomes

Dateo

fstu

dyFirst

author

𝑛𝑛T/C

Age

(mean

orrang

T/C)

yrs

Gender

M/F

CGNCPNONPRDGNDINHTN

O

Dialyser

Dialysis

mem

brane

Dialysate

Experim

ent

grou

pCon

trol

grou

p

1999

Zhao

RCT

4960/40∗

21–6

528/21

0–5y

rs40

23

4Not

mentio

ned

Not

mentio

ned

SMI4

0mL+

5%glucose

solutio

n200

mLivgtt.

90–100

drop

s/min

0.9%

Sodium

Chlorid

esolutio

n240m

Livgtt.

90–100

drop

s/min

Clinical

effect

Scr

Bun

IDEM

ECG

Clinical

symptom

Adverse

effect

2010

Liu

RCT

7035/35

(53.96

±13.23)

42/28

6mon

ths

–5yrs

Not

mentio

ned

Not

mentio

ned

Not

mentio

ned

SMI6

0mL+

0.9%

sodium

chlorid

esolutio

n250m

Livgtt.

+ conventio

nal

therapy

Con

ventional

therapy

(change

dialysate

temperature,

redu

ceor

stopultra�l-

tration,

slow

downbloo

d�o

w,increase

sodium

con-

centratio

nin

dialysate,

50%glucose

solutio

n250m

Livgtt

rapidly)

Clinical

effect

SBP

DBP

HR

2007

Zhou

RCT

1470/70∗

15–7

8(42)

8/6

Not

mentio

ned

Not

mentio

ned

Gam

broA

K90S

Polysulfo

nBicarbon

ate

4h∗

2-3/Week

SMI6

0mL+

0.9%

sodium

chlorid

esolutio

n250m

Livgtt.

50%glucose

solutio

n60

mL+0.9%

sodium

chlorid

esolutio

n250m

Livgtt.

Hypotensio

nincidence


T1:Con

tinued.

Inclu

destu

dies

Stud

yDesigns

Participants

Durationof

dialysis

Causeo

frenalfailu

reDialysis

equipm

ent

Mod

ality

ofdialysis

Interventio

ns

Outcomes

Dateo

fstu

dyFirst

author

𝑛𝑛T/C

Age

(mean

orrang

T/C)

yrs

Gender

M/F

CGNCPNONPRDGNDINHTN

O

Dialyser

Dialysis

mem

brane

Dialysate

Experim

ent

grou

pCon

trol

grou

p

2009

Zheng

RCT

3518/17

144/136∗

(61.25)

22/13

>1yrs

181

68

2Fresenius4008S

Polysulfo

nBicarbon

ate

4h∗3/Week

Shengm

aiinjection

50mL+50%

glucose

100m

Livgtt.

continuo

usly

durin

gdialysis

50%glucose

100m

Livgtt.

continuo

usly

durin

gdialysis

Hypotensio

nincidence

BP HR

Clinical

effect

Adverse

effect

2006

Jiang

RCT

18200/152∗

43–7

8(61.2±

12.3)

10/8

33.5±

7.6m

o10

22

13

Not

mentio

ned

Not

mentio

ned

30min

before

dialysis:

midod

rine

hydrochlo-

rideT

ablet

5mgpo

.;1h

aer

dialysis:

5mgpo

.;+

SMI6

0mL

ivgtt+

conventio

nal

measures

Oncea

day,

15days

fora

course

oftre

atment,

lasting

for2

-3courses.

30min

before

dialysis:

midod

rine

hydrochlo-

rideT

ablet

5mgpo

.;1h

aer

dialysis:

5mgpo

.+conventio

nal

therapy

(infusio

nof

hyperton

icliq

uid,or

redu

cethe

amou

ntof

ultra�ltra-

tion,

oreven

stopdialysis.)

Oncea

day,

15days

fora

course

oftre

atment,

lasting

for2

-3courses.)

Clinical

effect

SBP

DBP

MAP

HR

Adverse

effect

2009

LvRC

T32

16/16

(66.3)

18/14

>3mo

910

121

Gam

broA

K200

Cellulose

acetate

Bicarbon

ate

Not

mentio

ned

SMI6

0mL+

0.9%

sodium

chlorid

esolutio

n40

mLivgtt.

0.9%

Sodium

Chlorid

esolutio

n100m

Livgtt.

MAP

en

umber

ofnu

rsing

interventio

ns.


T1:Con

tinued.

Inclu

destu

dies

Stud

yDesigns

Participants

Durationof

dialysis

Causeo

frenalfailu

reDialysis

equipm

ent

Mod

ality

of dialysis

Interventio

ns

Outcomes

Dateo

fstu

dyFirst

author

𝑛𝑛T/C

Age

(mean

orrang

T/C)

yrs

Gender

M/F

CGNCPNONPRDGNDINHTN

O

Dialyser

Dialysis

mem

brane

Dialysate

Experim

ent

grou

pCon

trol

grou

p

2008

Wang

RCT

7338/35

T:60–7

2C:

60–7

1Not

mentio

ned

Not

mentio

ned

Not

mentio

ned

Fresenius

4008B

Cellulose

acetate

Bicarbon

ate

Not

mentio

ned

SMI:no

detailed

inform

ation

was

provided.

Con

ventional

therapy:no

detailed

inform

ation

was

provided.

Clinical

effect

en

umber

ofnu

rsing

interventio

ns.

2009

YuRC

T36

100/80

∗53.5

20/16

3mo–

3.5y

rsNot

mentio

ned

Fresenius

4008H/S

Polysulfo

nBicarbon

ate

4h∗

2-3/Week

SMI6

0mL+

0.9%

sodium

chlorid

esolutio

n250m

Livgtt.

+ conventio

nal

therapy

50%glucose

solutio

n250m

Livgtt

+ conventio

nal

therapy

(reduceo

rsto

pultra�l-

tration,

slow

downbloo

d�o

w,increase

sodium

con-

centratio

nin

dialysate)

Hypotensio

nincidence

Clinical

effect

2007

Cao

RCT

6030/30

T:(62.1±

14.4)

C:(60.0±

14.0)

Not

mentio

ned

Not

mentio

ned

Not

mentio

ned

Gam

broA

K200

Cellulose

acetate

Bicarbon

ate

Not

mentio

ned

SMI:no

detailed

inform

ation

was

provided.

Con

ventional

therapy:no

detailed

inform

ation

was

provided.

MAP

en

umber

ofnu

rsing

interventio

ns.

2001

LiRC

T50

100/100∗

18–7

5(48.8)

32/18

Not

mentio

ned

302

412

2

Gam

bro

AK-

10,

AK-

90,

AK-

200

Bicarbon

ate

Not

mentio

ned

SMI

10–40m

L+

50%glucose

solutio

n20–40m

Liv..

0.9%

salin

e300∼

500m

L,or

20%

human

albu

min

50mL,or

fresh

plasma

200∼

400m

Livgtt.

MAP

Clinical

effect

Adverse

effect

RCT:

rand

omized

controlledtrial;HD:h

emod

ialysis;T

/C:treatmentgrou

p/controlg

roup

;M/F:m

ale/female;

yrs:years;CG

N:c

hron

icglom

erulon

ephritis;CP

N:c

hron

icpyelo

neph

ritis;

ON:o

bstructiv

eneph

ropathy;PR

D:p

olycystic

renald

isease;GN:gou

tyneph

ropathy;DIN

:diabetic

neph

ropathy;HTN

:hypertensiven

ephrop

athy

;O:other;SMI:shengm

aiinjection;

SBP:

systo

licbloo

dpressure;D

BP:diasto

licbloo

dpressure;H

R:heartrate;MAP:

meanarteria

lpressure.∗hemod

ialysis

sessions.


T 2: e methodological quality of included studies.

A B C D E F G H I J K L Total +/12 Total −/12 Total ?/12Zhao et al. 1999 [38] ? ? − − ? − − ? ? + + + 3 4 5Liu and Su 2010 [39] ? ? − − ? − − ? + + + + 4 4 4Zhou 2007 [40] ? ? − − ? − − ? ? + + + 3 5 5Zheng et al. 2009 [41] ? ? − − ? − − ? + + + + 4 4 4Jiang et al. 2006 [42] ? ? − − ? − − ? + + + + 4 4 4Lv and Liu 2009 [43] ? ? − − ? − − ? + + + + 4 4 4Wang 2008 [44] ? ? − − ? − − ? + + + + 4 4 4Yu 2009 [45] ? ? − − ? − − ? + + + + 4 4 4Cao et al. 2007 [46] ? ? − − ? − − ? + + + + 4 4 4Li 2001 [47] ? ? − − ? + − ? + + + + 5 3 4A: adequate sequence generation; B: concealment of allocation; C: blinding (patient); D: blinding (investigator); E: blinding (assessor); F: incomplete outcomedata addressed (ITT analysis); G: incomplete outcome data addressed (dropouts); H: free of selective reporting; I: similarity at baseline; J: cointerventionsconstant; K: Compliance acceptable; L: timing outcome assessments similar. +: Yes, −: No, ?: unclear.

3.3. Risk of Bias in Included Studies. e risk of bias of eachstudy was assessed using the twelve criteria recommended byCochrane Back Review Group. e number of criteria metvaried from 2/12 to 5/12. All of the studies included claimedrandomization. No study described allocation concealment.No trials mentioned the blinding procedures. One studydescribed intention-to-treat analyses [47]. None of the trialsmentioned drop-out data. ere was selective reporting in allthe studies. All the studies described similarity of baselineexcept two studies [38, 40]. All of the included studiesappeared to have adequate and acceptable compliance andtiming of outcome assessments were similar. In general, allof 10 RCTs have an unclear risk of bias. e methodologicalquality of each study is summarized in Table 2.

3.4. Results of Individual Studies. Zhao et al. [38] conductedan RCT to test the effect of SMI on correcting IDH. 100hemodialysis sessions were divided into two subgroups: thetreatment group received SMI 40mL intravenously, and thecontrol group received normal saline injection. e resultsshowed that the total clinical effective rate was 85% intreatment group and 55% in control group (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃).

In the study of Liu and Su [39], 70 IDH patients were ran-domly divided into experimental group and control group.e experimental group received SMI 60mL intravenouslyplus conventional therapy, while only conventional therapywas given for control group. e total clinical effective ratewas 88.57% in experimental group and 62.86% in controlgroup (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃). e frequency of �uid infusion treatmentin experimental groupwas signi�cantly lower than that in thecontrol group (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃).

Zhou [40] recruited 14 patients (totally 140 hemodialysissessions) and randomly divided into two groups. e therapygroup was given SMI 60mL intravenously and the controlgroup was given 50% glucose 60mL correspondingly. eresult showed that the hypotension rate was 8% in therapygroup and 38% in control group (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃).

In the study of Zheng et al. [41], patients in treatmentgroup were additionally given SMI 50mL intravenously. e

hypotension rate was 18.8% in treatment group and 33.1%in control group (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃). SBP, diastolic blood pressure(DBP), and MAP were all signi�cantly higher in treatmentgroup than in control group (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃). e difference ofMAP between the two groups was also statistically signi�cant(𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃).

Jiang et al. [42] selected 18 patients (352 hemodialysis ses-sions) and randomly divided them into two groups. Patientsin control group were given midodrine hydrochloride tabletbefore and aer dialysis. Patients in therapy group wereadditionally given SMI 60mL intravenously on that basis.eoverall effective rate was 88.5% in therapy group and 69.7%in control group (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃). SBP, DBP, and MAP were allsigni�cantly higher in therapy group compared with controlgroup (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃). e difference of MAP aer dialysis wassigni�cant between the two groups (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃).

In the study of Lv and Liu [43], patients of treatmentgroup received SMI 60mL treatment, while patients of con-trol group only received 0.9% saline.erewere no signi�cantdifferences between two groups in MAP, systolic pressure,diastolic pressure, and heart rate (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃). Clinical effectiverate in experimental group was signi�cantly higher thancontrol group (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃). Number of measures taken torectify the dialysis-related symptoms were treatment group2𝑃3±𝑃𝑃2 times and control group 𝑃𝑃4±𝑃𝑃𝑃 times.edifferencewas statistically signi�cant (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃).

In the study of Wang [44], the total effectiveness ratewas 86.8% in SMI group and 62.9% in conventional therapygroup (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃). Number of measures taken to rectify thedialysis-related symptoms were: SMI group 2𝑃3 ± 𝑃𝑃𝑃 times,conventional therapy group 𝑃𝑃𝑃 ± 𝑃𝑃3 times (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃).

In the study of Yu [45], control group was given 50%glucose + conventional therapy. Treatment group was givenSMI 60mL + conventional therapy. e rate of hypotensionin treatment group was signi�cantly lower than that ofcontrol group (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃). e clinical effective rate in treat-ment group was higher than that of control group (𝑃𝑃 𝑃 𝑃𝑃𝑃𝑃).

Cao et al. [46] recruited 60 cases of IDH patients andrandomly divided them into 2 groups: SMI group and


0.01 0.1 0 100

Favours experimental Favours control

Study or subgroup

Zheng et al. 2009

Zhao et al. 1999

Yu 2009Wang 2008

Liu and Su 2010

Li 2001

Jiang et al. 2008

Total events

16

51

93

33

31

99

177

500

Total Total

18

60

100

38

35

100

200

Events Events

11

22

70

22

22

88

106

17

40

80

35

35

100

4.1%

12.8%

17.6%

9.7%

8.1%

2.8%

44.8%

M-H, fixed, 95% CI

4.36 [0.74 , 25.74]

4.64 [1.80, 11.91]

1.90 [0.69, 5.23]

3.90 [1.22, 12.49]

4.58 [1.32, 15.93]

13.50 [1.72, 105.93]

3.34 [1.92, 5.82]

Experimental Control Odds ratio Odds ratioWeight M-H, fixed, 95% CI

Total (95% CI) 551 3.74 [2.59, 5.39]

152

459 100%

341

1Heterogeneity: = 3.7, df= 6 (� = 0.72); �2 = 0%Test for overall e�ect: � = 7.05 (� < 0.00001)

�2

F 2: Forest plot of comparison: shengmai injection versus control, the clinical effective rate.

conventional group. e mean arterial blood pressure ofSMI group was, predialysis: 96.4 ± 13.1mmHg; postdialysis:97.8 ± 9.1mmHg; conventional group, predialysis: 99.2 ±9.5mmHg; postdialysis: 99.7 ± 8.6mmHg. Number ofmeasures taken to rectify the dialysis-related symptoms wereSMI group: 2.4±1.1 times; conventional group: 5.4±1.8 times.ere was a signi�cant difference between the two groups(𝑃𝑃 𝑃 𝑃.𝑃5).

In the study of Li [47], the therapy group was giventhe following treatment: SMI + 50% glucose, i.v., while thecontrol group was given 0.9% sodium chloride injection or20% human albumin or fresh plasma, ivgtt. Results showedthat level of blood pressure and improvement of clinicalsymptoms were signi�cantly better in therapy group than incontrol group (𝑃𝑃 𝑃 𝑃.𝑃1).

3.5. Synthesis of Results

3.5.1. e Clinical Effective Rate. 7 trials [38–41, 44, 45, 47]calculated the clinical effective rate with the ratio between theproportion of responders in the treatment group and in thecontrol group.e 7 independent trials showed homogeneityin the consistency of the trial results (chi-square = 3.70, 𝑃𝑃 𝑃𝑃.72, 𝐼𝐼2 𝑃 𝑃%). us, ��ed-effects model should be used forstatistical analysis. e combined effects showed that patientwith IDH receiving SMI therapy had signi�cantly improvedthe clinical effective rate when compared with the controlgroup (OR 3.74, 95% CI 2.59 to 5.39; 𝑍𝑍 𝑃 7.𝑃5, 𝑃𝑃 𝑃𝑃.𝑃𝑃𝑃𝑃1), Figure 2. e funnel plot was roughly symmetric.ere would be little publication bias for the 7 independenttrials (Figure 3).

3.5.2. e Incidence of Hypotension. 4 studies observed theincidence of IDH episode [38, 40, 41, 45]. e 4 trialsdid not show homogeneity (chi-square 12.02, 𝑃𝑃 𝑃 𝑃.𝑃𝑃7,𝐼𝐼2 𝑃 75%). us, random effects model should be usedfor statistical analysis. SMI treatment could signi�cantlydecrease the incidence of IDH episode (OR 0.21, 95%CI 0.10to 0.47, 𝑍𝑍 𝑃 3.79, 𝑃𝑃 𝑃 𝑃.𝑃𝑃𝑃2), Figure 4.

0.01 0.1 1 10 100

0

0.5

1

1.5

2

OR

SE(log[OR])

F 3: Funnel plot of comparison: shengmai injection versuscontrol.

3.5.3. e Number of Nursing Interventions. 4 studiesrecorded the number of nursing interventions for IDHepisode [39, 43, 44, 46]. Routine nursing interventions are asfollows: placing the patient in the Trendelenburg position,saline and hyperoncotic albumin boluses, decreasingthe transmembrane ultra�ltration pressure, and earlytermination of dialysis. e 4 trials showed homogeneity inthe results (chi-square = 0.58, 𝑃𝑃 𝑃 𝑃.9𝑃, 𝐼𝐼2 𝑃 𝑃%). us,��ed effects model should be used for statistical analysis.ere was a signi�cant decrease on frequency of nursinginterventions in SMI group (WMD −3.01, 95% CI −3.33 to−2.69, 𝑍𝑍 𝑃 18.34, 𝑃𝑃 𝑃 𝑃.𝑃𝑃𝑃𝑃1), Figure 5.

3.5.4. Blood Pressure Level. BP change was reported in 3different ways across the studies: pre- and post-SBP, pre- andpost-DBP, and pre- and post-MAP. 5 trials provided data forpre- and post-MAP change [41–43, 46, 47]. e 5 trials didnot showhomogeneity in the trial results (chi-square 7368.34,𝑃𝑃 𝑃 𝑃.𝑃𝑃𝑃𝑃1, 𝐼𝐼2 𝑃 1𝑃𝑃%).us, random-effectsmodel should


Study or subgroup

Yu 2009

Zhao et al.1999

Zheng et al. 2009

Zhou 2007

Total (95% CI)

Total events

Events

12

5

27

8

52

Total Total

100

60

144

70

Events

42

9

45

38

80

40

136

70

Weight

26.4%

19.7%

29.5%

24.4%

Experimental Control Odds ratio

M-H, random, 95% CI M-H, random, 95% CI

Odds ratio

0.12 [0.06, 0.26]

0.31 [0.10, 1.02]

0.47 [0.27, 0.81]

0.11 [0.05, 0.26]

0.21 [0.10, 0.47]326 100%

134

374

0.01 0.1 1 10 100


Heterogeneity: �2 = 0.49, �2 = 12.02, df= 3 (� = 0.007); �2 = 75%.

Test for overall e�ect: � = 3.79 (� = 0.0002)

F 4: Forest plot of comparison: sheng-mai injection versus control: Hypotension incidence.

Study or subgroupMean

2.4

1.82

2.3

2.3

SD

1.1

0.51

1.2

1.5

Total

30

35

16

38

Mean

5.4

4.92

5.4

5.1

SD

1.8

1.35

1.5

1.3

Total

30

35

16

35

WeightExperimental Control

0 50 100


18.1%

45.2%

11.7%

25.0%

− 3.00 [− 3.75, − 2.25]

− 3.10 [− 3.58, − 2.62]

− 3.10 [− 4.04, − 2.16]

− 2.80 [− 3.44, − 2.16]

IV, fixed, 95% CI

116 100%119

Cao et al. 2007

Liu et al. 2010

Lv and Liu 2009

Wang 2008

Total (95% CI)

− 100 − 50

IV, fixed, 95% CI

Mean di�erenceMean di�erence

−3.01 [−3.33, −2.69]

Heterogeneity: = 0.58, df = 3 (� = 0.9); �2 = 0%

Test for overall e�ect: � = 18.34 (� < 0.00001)

�2

F 5: Forest plot of comparison: sheng-mai injection versus control: e number of nursing interventions.

be used for statistical analysis. ere was no statisticalsigni�cance in increasing MAP between two groups (WMD7.83, 95% CI −4.66 to 20.33, 𝑍𝑍 𝑍 𝑍𝑍𝑍𝑍, 𝑃𝑃 𝑍 𝑃𝑍𝑍𝑍), Figure6. 3 studies reported pre- and post-SBP, and pre- and post-DBP [39, 41, 42]. e trials did not show homogeneity inthe trial results, thus random-effects model should be usedfor statistical analysis. ere was no statistical signi�cance inincreasing SBP when compared with control group (WMD9.02, 95% CI −1.07 to 19.11, 𝑍𝑍 𝑍 𝑍𝑍𝑍𝑍, 𝑃𝑃 𝑍 𝑃𝑍𝑃𝑃), Figure7, but there was a signi�cant increase in DBP in SMI group(WMD 2.84, 95% CI 1.42 to 4.27, 𝑍𝑍 𝑍 𝑍𝑍𝑍𝑍, 𝑃𝑃 𝑃 𝑃𝑍𝑃𝑃𝑃𝑍),Figure 8.

3.5.5. Adverse Events. Four studies reported nonseriousadverse events [38, 41, 42, 47]. e other 6 studies didnot report adverse events [39, 40, 43–46]. Zhao et al. [38]indicated no statistically signi�cant difference in serumcreatinine, blood urea nitrogen, serum electrolytes, andelectrocardiogrambefore and aer hemodialysis in treatmentgroup and control group (𝑃𝑃 𝑃 𝑃𝑍𝑃𝑍). ere was no casereport of toxic side effects or allergy in treatment group.Zheng et al. [41] found no signi�cant change in heart ratebefore and aer dialysis. ere were no adverse reactionsin the two groups during dialysis. Jiang et al. [42] reportedthat no signi�cant difference in heart rate before and aer

dialysis in the two groups.ere was no signi�cant differencein routine blood test, blood urea nitrogen, creatinine, alanineaminotransferase, albumin, urea clearance index (Kt/V) inthe two groups before and aer treatment (𝑃𝑃 𝑃 𝑃𝑍𝑃𝑍). erewere no adverse reactions in patients of the two groups, andthe treatment was well tolerated. Li [47] demonstrated thatthe side effects in SMI group were lower than that of controlgroup. In the control group, allergic reactions and transfusionreactions occurred in 4 cases, heart failure in 2 cases, dialyzerclotting in 8 cases, and early termination of dialysis was 6cases due to no improvement of clinical symptoms and bloodpressure. In the SMI group, dialyzer clotting occurred in1 case and could continue hemodialysis aer replacing thedialyzer. All patients completed the expected dialysis andno adverse reactions such as allergic reactions, abdominaldistension, tachycardia, and hypotension happened.

4. Discussion

4.1. Summary of Evidence. 10 studies with 437 individualssuffering from IDH were selected out for the present meta-analysis. e main �ndings are that SMI adjuvant therapycould improve the clinical symptoms of IDH, decrease theincidence of hypotension, reduce the number of nursingintervention, increase DBP, and reduce the adverse effects.



88.4

115.3

113.2

88.5

99.7

SD

2

5.7

1.51

2.1

8.6

Total

18

16

100

200

30

Mean

85.7

108

89

85.6

97.8

SD

1.1

5.4

1.14

1

9.1

Total

17

16

100

152

30


IV, random, 95% CI IV, random, 95% CI

20.2%

19.8%

20.2%

20.2%

19.7%

2.70 [1.64, 3.76]

7.30 [3.45, 11.15]

24.20 [23.83, 24.57]

2.90 [2.57, 3.23]

1.90 [− 2.58, 6.38]

Total (95% CI) 315 100%364

0 50 100


− 100 − 50

Zheng et al. 2009

Lv and Liu 2009

Li 2001

Jiang et al. 2006

Cao et al. 2007

7.83 −4.66, 20.33[ ]

Mean di�erence Mean difference

Heterogeneity: �2 = 201.39, = 7368.34, df= 4 (� < 0.00001); �2 = 100%


�2

F 6: Forest plot of comparison. Shengmai injection versus control: mean arterial pressure.


124.8

128.2

124.7

SD

3.7

9.9

3.6

Total

200

35

18

Mean

123.4

102.8

123.5

SD

4.7

10.3

4.6

Total

152

35

17


Jiang et al. 2006

Liu et al. 2010

Zheng et al. 2009


Total (95% CI) 204 100%253 9.02 −1.07, 199.11

0 50 100


− 100 − 50

34.4%

32.0%

33.6%

1.40 [0.49, 2.31]

25.40 [20.67, 30.13]

1.20 [− 1.55, 3.95]

[ ]

Mean di�erenceMean di�erence

Heterogeneity: �2 = 76.83, = 95.79, df= 2 (� < 0.00001); �2 = 98%


�2

F 7: Forest plot of comparison. Shengmai injection versus control: systolic blood pressure.


70.4

86.5

68.7

SD

1.5

10.1

2.2

Total

200

35

18

Mean

66.8

85.6

66.7

SD

3

9.3

2.9

Total

152

35

17



Jiang et al. 2006

Liu et al. 2010

Zheng et al. 2009

58.5%

8.5%

33.1%

3.60 [3.08, 4.12]

0.90 [− 3.65, 5.45]

2.00 [0.29, 3.71]

Total (95% CI) 204 100%253 2.84 [1.42, 4.27]

0 50 100


− 100 − 50

Mean di�erence Mean di�erence

Heterogeneity: �2 = 0.83, = 4.28, df = 2 (� = 0.12); �2 = 53%

Test for overall e�ect: � = 3.91 (� < 0.0001)

�2

F 8: Forest plot of comparison. Shengmai injection versus control: diastolic blood pressure.

However, the evidences presented in this meta-analysis areinsufficient to warrant a clinical recommendation due tothe generally weak methodological quality of the includedstudies.

4.2. Limitations. Weaknesses of this paper rest with inherentlimitations in the primary studies. In September 2004, themembers of the International Committee of Medical JournalEditors (ICMJE) published a statement requiring that all

clinical trials must be registered in order to be consideredfor publication [48]. However, none of the included studiesin this paper had been formally registered in WHO Interna-tional Clinical Trials Registry Platform.us, protocols werenot available to con�rm free of selective reporting.

ere are also a number of methodological limitations inthis meta-analysis. Firstly, the data were all collected from thepublished articles without directly contacting the authors forobtaining additional information about the included studies.erefore, the twelve criteria of the “risk of bias” assessment


tool could only be classi�ed as “unclear.” Secondly, all studiesincluded in this paper used an “A+B versus B” design wherepatients were randomized to receive SMI plus conventionaltherapy versus conventional therapy, without a rigorouscontrol for placebo effect. is kind of design is likely togenerate false positive results [49]. irdly, all 10 studiesclaimed to be RCTs, but they all failed to give adequateand convincing information on how the random allocationwas generated and concealed, which is necessary to avoidselection bias. ey also did not mention blinding method,and thus could produce performance bias and detectionbias. erefore, outcome assessment was prone to signi�cantsystemic errors. Intention-to-treat analysis was mentionedonly in one study [47], and no dropouts were reported.us, the results generated from these studies should beinterpreted with caution. Fourthly, the included studies wereof relatively small sample size and without formal sample sizecalculation. Trials that lacked proper sample size estimationplaced their statistical analysis’s validity in doubt. Baselineinformation on ESRD patients was insufficient, with 6 trialsprovided information on chronic hemodialysis duration [38,39, 41–43, 45] and 5 studies reported the etiology of ESRD[38, 41–43, 47]. Varying dialyser, dialysis, membrane anddialysate were used in different studies. e lack of baselineinformationmay lead to selection bias and not to comparablebaseline.

No study found severe adverse effects of SMI. Due to thesmall sample size, safety still needs to be assessed. Publicationbias may also exist because only Chinese language publica-tions were found and included.

5. Conclusions

5.1. Implications for Practice. is is the �rst meta-analysis ofrandomized, controlled trials to assess the effectiveness andsafety of SMI adjuvant therapy in patients with IDH. How-ever, the evidences available from this systematic review isinsufficient to recommend the routine use of SMI as adjuvanttherapy for IDH, because the strength of the evidences iscompromised by methodological �aws and lack of replicablevalidation. e effectiveness and safety of SMI therapy forIDH remain to be further determined.

5.2. Implications for Research. First, improvement in themethodological quality of randomized controlled trials iscritical for future research and more methodologically rig-orous studies are justi�ed to con�rm or refute the effectsreported here. Second, the included trials were generally ofsmall sample size. All the trials were in lack of sample sizeestimation, so sample size calculation should be conductedbefore enrollment. Relevant clinical events such as death,dependency, and activities of daily living at the longerfollowup period should be included in outcome assessment.ird, well-designed, randomized, double-blind, placebo-controlled trials need to be carried out and reported in detailaccording to CONSORT [50] or CONSORT for TCM [51,52].

Con�ic� of �n�eres�s

e authors do not have any con�ict of interests.

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